Draft Guidance for Industry: Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request, 41438-41440 [E9-19640]
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41438
Federal Register / Vol. 74, No. 157 / Monday, August 17, 2009 / Notices
mg/mL), was not withdrawn from sale
for reasons of safety or effectiveness.
The petitioner identified no data or
other information suggesting that
DEMADEX (torsemide) injection, 20 mg/
2 mL (10 mg/mL) and 50 mg/5 mL (10
mg/mL), was withdrawn for reasons of
safety or effectiveness. FDA has
independently evaluated relevant
literature and data for possible
postmarketing adverse events and has
found no information that would
indicate that this product was
withdrawn from sale for reasons of
safety or effectiveness. Accordingly, the
agency will continue to list DEMADEX
(torsemide) injection, 20 mg/2 mL (10
mg/mL) and 50 mg/5 mL (10 mg/mL), in
the ‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. ANDAs that refer
to DEMADEX (torsemide) injection, 20
mg/2 mL (10 mg/mL) and 50 mg/5 mL
(10 mg/mL), may be approved by the
agency if all other legal and regulatory
requirements for the approval of ANDAs
are met. If FDA determines that labeling
for this drug product should be revised
to meet current standards, the agency
will advise ANDA applicants to submit
such labeling.
Dated: August 7, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–19641 Filed 8–14–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0268]
Draft Guidance for Industry: Labeling
of Certain Beers Subject to the
Labeling Jurisdiction of the Food and
Drug Administration; Availability;
Agency Information Collection
Activities; Proposed Collection;
Comment Request
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSKH9S0YB1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance
document entitled ‘‘Guidance for
Industry: Labeling of Certain Beers
Subject to the Labeling Jurisdiction of
the Food and Drug Administration.’’
This guidance, when finalized, will
VerDate Nov<24>2008
17:55 Aug 14, 2009
Jkt 217001
provide industry with information on
how to label beers that are subject to
FDA’s labeling laws and regulations.
This draft guidance is being issued in
light of the recent ruling by the Alcohol
and Tobacco Tax and Trade Bureau
(TTB) (formerly The Bureau of Alcohol,
Tobacco, and Firearms (ATF)) clarifying
that certain beers do not meet the
definition of a ‘‘malt beverage’’ under
the Federal Alcohol Administration Act
(FAA Act). Because these beers are not
subject to the labeling provisions of the
FAA Act, they are subject to the labeling
provisions of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) and the
Fair Packaging and Labeling Act (FPLA).
FDA, in this draft guidance, also
reminds manufacturers that the labeling
of wine beverages containing less than
7 percent alcohol by volume, such as
wine coolers, diluted wine beverages,
dealcoholized or partially dealcoholized
wine and ciders, is also subject to FDA
labeling requirements. FDA is also
announcing an opportunity for public
comment on the proposed collection of
certain information by the agency.
DATES: Submit written or electronic
comments on the draft guidance at any
time. Submit written or electronic
comments on the proposed collection of
information by October 16, 2009.
ADDRESSES: Submit written comments
on this draft guidance, including
comments regarding the proposed
collection of information, to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Submit electronic comments
on the draft guidance, including
comments regarding the proposed
collection of information, to https://
www.regulations.gov. Submit written
requests for single copies of the draft
guidance to Office of Nutrition, Labeling
and Dietary Supplements, Center for
Food Safety and Applied Nutrition
(HFS–800), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740. Send
two self-addressed adhesive labels to
assist that office in processing your
request. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance.
FOR FURTHER INFORMATION CONTACT:
With regard to the draft guidance:
Loretta A. Carey, Center for Food
Safety and Applied Nutrition (HFS–
820), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740,
301–436–2371.
With regard to the proposed collection
of information: Jonna Capezzuto,
Office of Information Management
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
(HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–
3794.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
the draft guidance entitled ‘‘Guidance
for Industry: Labeling of Certain Beers
Subject to the Labeling Jurisdiction of
the Food and Drug Administration.’’
This guidance, when finalized, will
provide industry with information on
how to label beers that are subject to
FDA’s labeling laws and regulations.
FDA, in this draft guidance, also
reminds manufacturers that the labeling
of wine beverages containing less than
7 percent alcohol by volume, such as
wine coolers, diluted wine beverages,
dealcoholized or partially dealcoholized
wine and ciders, is also subject to FDA
labeling requirements (Ref. 1).
As reflected in the 1987
Memorandum of Understanding
between FDA and TTB’s predecessor
agency, the ATF (Ref. 2), TTB is
responsible for the issuance and
enforcement of regulations with respect
to the labeling of distilled spirits, wines,
and malt beverages under the FAA Act.
TTB recently 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 (see TTB Ruling 2008–3) (Ref.
3). 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, and other provisions of the
TTB regulations issued under the FAA
Act. Therefore, these beers are subject to
the labeling requirements under FDA’s
laws and regulations. However, as
explained in the TTB ruling, 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.
This draft guidance is intended to
assist manufacturers in labeling beers
that are subject to FDA’s labeling laws
and regulations. In general, FDA
requires that food products under its
labeling jurisdiction be truthfully and
informatively labeled in accordance
with the FD&C Act and the FPLA, and
FDA’s implementing regulations. These
FDA labeling requirements are
explained in the draft guidance
document.
E:\FR\FM\17AUN1.SGM
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41439
Federal Register / Vol. 74, No. 157 / Monday, August 17, 2009 / Notices
FDA is issuing this draft guidance as
a level 2 guidance consistent with
FDA’s good guidance practices
regulation (21 CFR 10.115). This draft
guidance represents the agency’s current
thinking on this topic. It does not create
or confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statues
and regulations.
II. Paperwork Reduction Act of 1995
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
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Title: Labeling of Certain Beers Subject
to the Labeling Jurisdiction of the Food
and Drug Administration (OMB Control
Number 0910–NEW)
This draft guidance is intended to
assist manufacturers in labeling beers
that are subject to FDA’s labeling laws
and regulations. All labeling regulations
discussed in this draft guidance have
been previously approved by OMB in
accordance with the PRA under OMB
Control No. 0910–0381. The regulations
approved under OMB Control No. 0910–
0381 include §§ 101.3, 101.4, 101.5,
101.9, 101.22, and 101.105 (21 CFR
101.3, 101.4, 101.5, 101.9, 101.22, and
101.105). The proposed information
collection seeks to add manufacturers of
certain beers that do not meet the
definition of a ‘‘malt beverage’’ under
the FAA Act as new respondents to
these labeling regulations. The proposed
information collection also seeks OMB
approval of 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).
Section 101.3 of FDA’s food labeling
regulations requires that the label of a
food product in packaged form bear a
statement of identity, (i.e., the name of
the product), including, as appropriate,
the form of the food or the name of the
food imitated. Section 101.4 prescribes
the requirements for the declaration of
ingredients on the label or labeling of
food products in packaged form,
including using the common or usual
name of each ingredient. Section 101.5
requires that the label of a food product
in packaged form specify the name and
place of business of the manufacturer,
packer, or distributor and, if the food
producer is not the manufacturer of the
food product, its connection with the
food product. Section 101.9 requires
that nutrition information be provided
for all food products intended for
human consumption and offered for
sale, unless an exemption in § 101.9(j)
applies to the product. Section 101.22
contains labeling requirements for the
disclosure of spices, flavorings,
colorings, and chemical preservatives
(§ 101.22(j)) in food products. Section
101.105 specifies requirements for the
declaration of the net quantity of
contents on the label of a food in
packaged form.
Under the FD&C Act, as amended by
the FALCPA, the food source name of
any ‘‘major food allergen’’ present must
be declared (section 403(w)(1) of the
FD&C Act, (21 U.S.C. 343(w)(1))).
Section 201(qq) of the FD&C Act, (21
U.S.C. 321(qq)), defines ‘‘major food
allergen’’ as milk, egg, fish, Crustacean
shellfish, tree nuts, wheat, peanuts, and
soybeans, as well as any food ingredient
that contains protein derived from one
of them, with the exception of highly
refined oils.
Description of respondents: The
respondents to this collection of
information are manufacturers of beers
that are subject to FDA’s labeling laws
and regulations.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Citation
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
12
2
24
.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
mstockstill on DSKH9S0YB1PROD with NOTICES
21 CFR 101.3 and 101.22
12
2
24
0.5
12
Section 403(w)(1) of the Federal Food,
Drug, and Cosmetic Act
12
2
24
1
24
Guidance Document, ‘‘Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration’’
12
1
12
1
12
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E:\FR\FM\17AUN1.SGM
17AUN1
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Federal Register / Vol. 74, No. 157 / Monday, August 17, 2009 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
No. of
Respondents
Citation
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
Total
mstockstill on DSKH9S0YB1PROD with NOTICES
1There
186
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s 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 submissions
annually to be 25. Thus, FDA adopts
TTB’s estimate of 12 respondents, and
an annual frequency per response of 2,
in table 1 of this document.
FDA’s estimate of the hours per
response for each regulation is based on
FDA’s experience with food labeling
under the agency’s jurisdiction. The
estimated hours per response for
§§ 101.3, 101.4, 101.5, 101.9, 101.22,
and 101.105 in table 1 of this document
are equal to, and based upon, the
estimated hours per response approved
by OMB in OMB Control No. 0910–
0381. FDA further estimates 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, once finalized.
Thus, FDA estimates that 12
respondents will each label two
products annually, for a total of 24
labels. FDA estimates 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 FDA’s
labeling regulations and the
requirements of section 403(w)(1), 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, FDA estimates
the total hour burden of the proposed
collection of information to be 186
hours (174 hours + 12 hours = 186
hours).
Before the proposed information
collection provisions contained in this
draft guidance become effective, FDA
will publish a notice in the Federal
Register announcing OMB’s decision to
approve, modify, or disapprove the
information collection provisions. An
agency may not conduct or sponsor, and
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17:55 Aug 14, 2009
Jkt 217001
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number.
This draft guidance also refers to
previously approved collections of
information found in FDA 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 No. 0910–0381.
III. Comments
Interested persons may submit written
or electronic comments regarding this
draft guidance document, including
comments regarding the proposed
collection of information. Written
comments should be submitted to the
Division of Dockets Management (see
ADDRESSES). Electronic comments
should be submitted to https://
www.regulations.gov. Submit a single
copy of electronic comments or two
paper copies of any mailed comments,
except that individuals may submit one
paper copy. Comments are to be
identified with the docket number
found in brackets in the heading of this
document. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at https://
www.fda.gov/FoodGuidances.
V. References
We have placed the following
references on display in the Division of
Dockets Management (see ADDRESSES).
The references may be seen between 9
a.m. and 4 p.m., Monday through
Friday. FDA has verified the Web site
addresses, but it is not responsible for
any subsequent changes to the Web site
addresses after this document publishes
in the Federal Register.
1. FDA Compliance Policy Guide (CPG)
7101.04 (Dealcoholized Wine and Malt
Beverages- Labeling), available at https://
www.fda.gov/ICECI/ComplianceManuals/
CompliancePolicyGuidanceManual/
ucm074430.htm and CPG 7101.05 (Labeling
—Diluted Wines and Cider with Less Than
7% Alcohol), available at https://
www.fda.gov/ICECI/ComplianceManuals/
CompliancePolicyGuidanceManual/
ucm074431.htm.
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
2. Memorandum of Understanding 225–
88–2000 between FDA and Bureau of
Alcohol, Tobacco and Firearms, available at
https://www.fda.gov/AboutFDA/Partnerships
Collaborations/MemorandaofUnderstanding
MOUs/DomesticMOUs/ucm116370.htm.
3. TTB Ruling 2008–3 dated July 7, 2008,
available at https://www.fda.gov/AboutFDA/
PartnershipsCollaborations/Memorandaof
UnderstandingMOUs/DomesticMOUs/
ucm116370.htm.
Dated: August 11, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–19640 Filed 8–14–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY: National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
Federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301/
496–7057; fax: 301/402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
Development of a New Carbohydrate
Antibody to GalNac1–3Gal
Description of Technology: The
present invention provides a
monoclonal antibody that binds
E:\FR\FM\17AUN1.SGM
17AUN1
Agencies
[Federal Register Volume 74, Number 157 (Monday, August 17, 2009)]
[Notices]
[Pages 41438-41440]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-19640]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0268]
Draft Guidance for Industry: Labeling of Certain Beers Subject to
the Labeling Jurisdiction of the Food and Drug Administration;
Availability; Agency Information Collection Activities; Proposed
Collection; Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance document entitled ``Guidance for
Industry: Labeling of Certain Beers Subject to the Labeling
Jurisdiction of the Food and Drug Administration.'' This guidance, when
finalized, will provide industry with information on how to label beers
that are subject to FDA's labeling laws and regulations. This draft
guidance is being issued in light of the recent ruling by the Alcohol
and Tobacco Tax and Trade Bureau (TTB) (formerly The Bureau of Alcohol,
Tobacco, and Firearms (ATF)) clarifying that certain beers do not meet
the definition of a ``malt beverage'' under the Federal Alcohol
Administration Act (FAA Act). Because these beers are not subject to
the labeling provisions of the FAA Act, they are subject to the
labeling provisions of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) and the Fair Packaging and Labeling Act (FPLA). FDA, in this draft
guidance, also reminds manufacturers that the labeling of wine
beverages containing less than 7 percent alcohol by volume, such as
wine coolers, diluted wine beverages, dealcoholized or partially
dealcoholized wine and ciders, is also subject to FDA labeling
requirements. FDA is also announcing an opportunity for public comment
on the proposed collection of certain information by the agency.
DATES: Submit written or electronic comments on the draft guidance at
any time. Submit written or electronic comments on the proposed
collection of information by October 16, 2009.
ADDRESSES: Submit written comments on this draft guidance, including
comments regarding the proposed collection of information, to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments on the draft guidance, including comments regarding the
proposed collection of information, to https://www.regulations.gov.
Submit written requests for single copies of the draft guidance to
Office of Nutrition, Labeling and Dietary Supplements, Center for Food
Safety and Applied Nutrition (HFS-800), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740. Send two self-
addressed adhesive labels to assist that office in processing your
request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance.
FOR FURTHER INFORMATION CONTACT:
With regard to the draft guidance: Loretta A. Carey, Center for
Food Safety and Applied Nutrition (HFS-820), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-
436-2371.
With regard to the proposed collection of information: Jonna
Capezzuto, Office of Information Management (HFA-710), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-796-3794.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of the draft guidance entitled
``Guidance for Industry: Labeling of Certain Beers Subject to the
Labeling Jurisdiction of the Food and Drug Administration.'' This
guidance, when finalized, will provide industry with information on how
to label beers that are subject to FDA's labeling laws and regulations.
FDA, in this draft guidance, also reminds manufacturers that the
labeling of wine beverages containing less than 7 percent alcohol by
volume, such as wine coolers, diluted wine beverages, dealcoholized or
partially dealcoholized wine and ciders, is also subject to FDA
labeling requirements (Ref. 1).
As reflected in the 1987 Memorandum of Understanding between FDA
and TTB's predecessor agency, the ATF (Ref. 2), TTB is responsible for
the issuance and enforcement of regulations with respect to the
labeling of distilled spirits, wines, and malt beverages under the FAA
Act.
TTB recently 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
(see TTB Ruling 2008-3) (Ref. 3). 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, and other provisions
of the TTB regulations issued under the FAA Act. Therefore, these beers
are subject to the labeling requirements under FDA's laws and
regulations. However, as explained in the TTB ruling, 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.
This draft guidance is intended to assist manufacturers in labeling
beers that are subject to FDA's labeling laws and regulations. In
general, FDA requires that food products under its labeling
jurisdiction be truthfully and informatively labeled in accordance with
the FD&C Act and the FPLA, and FDA's implementing regulations. These
FDA labeling requirements are explained in the draft guidance document.
[[Page 41439]]
FDA is issuing this draft guidance as a level 2 guidance consistent
with FDA's good guidance practices regulation (21 CFR 10.115). This
draft guidance represents the agency's current thinking on this topic.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statues and regulations.
II. Paperwork Reduction Act of 1995
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 before submitting
the collection to OMB for approval. To comply with this requirement,
FDA is publishing notice of the proposed collection of information set
forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Title: Labeling of Certain Beers Subject to the Labeling Jurisdiction
of the Food and Drug Administration (OMB Control Number 0910-NEW)
This draft guidance is intended to assist manufacturers in labeling
beers that are subject to FDA's labeling laws and regulations. All
labeling regulations discussed in this draft guidance have been
previously approved by OMB in accordance with the PRA under OMB Control
No. 0910-0381. The regulations approved under OMB Control No. 0910-0381
include Sec. Sec. 101.3, 101.4, 101.5, 101.9, 101.22, and 101.105 (21
CFR 101.3, 101.4, 101.5, 101.9, 101.22, and 101.105). The proposed
information collection seeks to add manufacturers of certain beers that
do not meet the definition of a ``malt beverage'' under the FAA Act as
new respondents to these labeling regulations. The proposed information
collection also seeks OMB approval of 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).
Section 101.3 of FDA's food labeling regulations requires that the
label of a food product in packaged form bear a statement of identity,
(i.e., the name of the product), including, as appropriate, the form of
the food or the name of the food imitated. Section 101.4 prescribes the
requirements for the declaration of ingredients on the label or
labeling of food products in packaged form, including using the common
or usual name of each ingredient. Section 101.5 requires that the label
of a food product in packaged form specify the name and place of
business of the manufacturer, packer, or distributor and, if the food
producer is not the manufacturer of the food product, its connection
with the food product. Section 101.9 requires that nutrition
information be provided for all food products intended for human
consumption and offered for sale, unless an exemption in Sec. 101.9(j)
applies to the product. Section 101.22 contains labeling requirements
for the disclosure of spices, flavorings, colorings, and chemical
preservatives (Sec. 101.22(j)) in food products. Section 101.105
specifies requirements for the declaration of the net quantity of
contents on the label of a food in packaged form.
Under the FD&C Act, as amended by the FALCPA, the food source name
of any ``major food allergen'' present must be declared (section
403(w)(1) of the FD&C Act, (21 U.S.C. 343(w)(1))). Section 201(qq) of
the FD&C Act, (21 U.S.C. 321(qq)), defines ``major food allergen'' as
milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and
soybeans, as well as any food ingredient that contains protein derived
from one of them, with the exception of highly refined oils.
Description of respondents: The respondents to this collection of
information are manufacturers of beers that are subject to FDA's
labeling laws and regulations.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
Citation Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
21 CFR 101.3 and 12 2 24 .5 12
101.22
----------------------------------------------------------------------------------------------------------------
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) 12 2 24 1 24
of the Federal
Food, Drug, and
Cosmetic Act
----------------------------------------------------------------------------------------------------------------
Guidance 12 1 12 1 12
Document,
``Labeling of
Certain Beers
Subject to the
Labeling
Jurisdiction of
the Food and
Drug
Administration''
----------------------------------------------------------------------------------------------------------------
[[Page 41440]]
Total ................. ................. ................. ................. 186
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA's 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 submissions annually to be 25. Thus, FDA adopts TTB's
estimate of 12 respondents, and an annual frequency per response of 2,
in table 1 of this document.
FDA's estimate of the hours per response for each regulation is
based on FDA's experience with food labeling under the agency's
jurisdiction. The estimated hours per response for Sec. Sec. 101.3,
101.4, 101.5, 101.9, 101.22, and 101.105 in table 1 of this document
are equal to, and based upon, the estimated hours per response approved
by OMB in OMB Control No. 0910-0381. FDA further estimates 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, once finalized.
Thus, FDA estimates that 12 respondents will each label two
products annually, for a total of 24 labels. FDA estimates 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
FDA's labeling regulations and the requirements of section 403(w)(1),
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, FDA estimates the total hour
burden of the proposed collection of information to be 186 hours (174
hours + 12 hours = 186 hours).
Before the proposed information collection provisions contained in
this draft guidance become effective, FDA will publish a notice in the
Federal Register announcing OMB's decision to approve, modify, or
disapprove the information collection provisions. 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.
This draft guidance also refers to previously approved collections
of information found in FDA 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 No. 0910-0381.
III. Comments
Interested persons may submit written or electronic comments
regarding this draft guidance document, including comments regarding
the proposed collection of information. Written comments should be
submitted to the Division of Dockets Management (see ADDRESSES).
Electronic comments should be submitted to https://www.regulations.gov.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
IV. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at https://www.fda.gov/FoodGuidances.
V. References
We have placed the following references on display in the Division
of Dockets Management (see ADDRESSES). The references may be seen
between 9 a.m. and 4 p.m., Monday through Friday. FDA has verified the
Web site addresses, but it is not responsible for any subsequent
changes to the Web site addresses after this document publishes in the
Federal Register.
1. FDA Compliance Policy Guide (CPG) 7101.04 (Dealcoholized Wine
and Malt Beverages- Labeling), available at https://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074430.htm
and CPG 7101.05 (Labeling --Diluted Wines and Cider with Less Than
7% Alcohol), available at https://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074431.htm.
2. Memorandum of Understanding 225-88-2000 between FDA and
Bureau of Alcohol, Tobacco and Firearms, available at https://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/DomesticMOUs/ucm116370.htm.
3. TTB Ruling 2008-3 dated July 7, 2008, available at https://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/DomesticMOUs/ucm116370.htm.
Dated: August 11, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-19640 Filed 8-14-09; 8:45 am]
BILLING CODE 4160-01-S