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, 56856-56857 [2018-24786]
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56856
Federal Register / Vol. 83, No. 220 / Wednesday, November 14, 2018 / Notices
Dated: November 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–24762 Filed 11–13–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0268]
Agency Information Collection
Activities; 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.
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 December
14, 2018.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed 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:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, 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.
SUMMARY:
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
VerDate Sep<11>2014
18:29 Nov 13, 2018
Jkt 247001
(FD&C Act) (see 21 U.S.C. 321(f)),
includes ‘‘articles used for food or
drink’’ and thus includes alcoholic
beverages. As such, alcoholic beverages
are subject to the FD&C Act’s
adulteration and misbranding
provisions and implementing
regulations related to food. For example,
manufacturers of alcoholic beverages are
responsible for adhering to the
registration of food facilities
requirements in 21 CFR part 1 and to
the good manufacturing practice
regulations in 21 CFR part 110. There
are also certain requirements for
nutrition labeling on menus, menu
boards, and other written materials for
alcohol beverages served in restaurants
or similar retail food establishments in
21 CFR part 101. However, as reflected
in a 1987 Memorandum of
Understanding between FDA and the
Alcohol and Tobacco Tax and Trade
Bureau (TTB), TTB is responsible for the
dissemination and enforcement of
regulations with respect to the labeling
of distilled spirits, certain wines, and
malt beverages issued in the Federal
Alcohol Administration Act (FAA Act).
In TTB Ruling 2008–3, dated July 7,
2008, TTB clarified that certain beers,
which are not made from both malted
barley and hops but are instead made
from substitutes for malted barley (such
as sorghum, rice, or wheat) or are made
without hops, do not meet the definition
of a ‘‘malt beverage’’ under the FAA
Act. Accordingly, TTB stated in its
ruling that such products (other than
sake´, which is classified as a wine under
the FAA Act), are not subject to the
labeling, advertising, or other provisions
of TTB regulations issued under the
FAA Act.
In cases where an alcoholic beverage
is not covered by the labeling provisions
of the FAA Act, the product is subject
to ingredient and other labeling
requirements under the FD&C Act and
the implementing regulations that we
administer. In addition, as provided for
under the Fair Packaging and Labeling
Act (FPLA), alcoholic beverages that are
not covered by the labeling provisions
of the FAA Act are subject to the
provisions of the FPLA, which we
administer.
Therefore, the beers described in
TTB’s ruling as not being a ‘‘malt
beverage’’ are subject to the labeling
requirements under the FD&C Act and
FPLA, and our implementing
regulations. In general, we require that
food products under our jurisdiction be
truthfully and informatively labeled in
accordance with the FD&C Act, the
FPLA, and FDA’s regulations.
Furthermore, some TTB labeling
requirements, such as the Government
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
Health Warning Statement under the
Alcoholic Beverage Labeling Act and
certain marking requirements under the
Internal Revenue Code, continue to
apply to these products.
Persons with access to the internet
may obtain the guidance entitled,
‘‘Labeling of Certain Beers Subject to the
Labeling Jurisdiction of the Food and
Drug Administration,’’ located at
https://www.fda.gov/FoodGuidances.
This guidance is intended to assist
manufacturers on how to label bottled
or otherwise packaged beers that are
subject to our labeling laws and
regulations.
Our food labeling regulations under
parts 101, 102, 104, and 105 (21 CFR
parts 101, 102, 104, and 105) were
issued under the authority of sections 4,
5, and 6 of the FPLA (15 U.S.C. 1453,
1454, and 1455) and under sections 201,
301, 402, 403, 409, 411, 701, and 721 of
the FD&C Act (21 U.S.C. 321, 331, 342,
343, 348, 350, 371, and 379e). Most of
these regulations derive from section
403 of the FD&C Act, which provides
that a food product shall be deemed to
be misbranded if, among other things,
its label or labeling fails to bear certain
required information concerning the
food product, is false or misleading in
any particular, or bears certain types of
unauthorized claims. The disclosure
requirements and other collections of
information in the regulations in parts
101, 102, 104, and 105 are necessary to
ensure that food products produced or
sold in the United States are in
compliance with the labeling provisions
of the FD&C Act and the FPLA.
The primary user of the information
to be disclosed on the label or labeling
of food products is the consumer that
purchases the food product. Consumers
will use the information to assist them
in making choices concerning their
purchase of a food product, including
choices related to substances that the
consumer must avoid to prevent adverse
reactions. This information also enables
the consumer to determine the role of
the food product in a healthful diet.
Additionally, FDA intends to use the
information to determine whether a
manufacturer or other supplier of food
products is meeting its statutory and
regulatory obligations. Failure of a
manufacturer or other supplier of food
products to label its products in
compliance with section 403 of the
FD&C Act and parts 101, 102, 104, and
105 of FDA’s food labeling regulations
may result in a product being
misbranded under the FD&C Act,
subjecting the firm and product to
regulatory action.
Description of Respondents: The
respondents to this collection of
E:\FR\FM\14NON1.SGM
14NON1
Federal Register / Vol. 83, No. 220 / Wednesday, November 14, 2018 / Notices
information are manufacturers of beers
that are subject to our labeling laws and
regulations.
In the Federal Register of June 29,
2018 (83 FR 30738), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. Two comments were
received. One comment was unrelated
to the Paperwork Reduction Act and is
not addressed. The second comment
was in favor of the practical utility and
necessity of labeling the ingredients of
56857
beer for transparency to the consumer.
We are appreciative of these comments.
At this time, we do not plan on
adjusting our current estimate.
FDA estimates 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
21 CFR section; activity
Average
burden per
disclosure
Total annual
disclosures
Total
hours
§§ 101.3 and 101.22; principal display and display
panel.
§ 101.4; designation of ingredients ........................
§ 101.5; name of manufacturer; packer; distributor
§ 101.9; nutrition labeling .......................................
§ 101.7 (formerly 101.105); quantity of contents ...
Section 403(w)(1) of the FD&C Act .......................
Review of Guidance Document: ‘‘Labeling of Certain Beers Subject to the Labeling Jurisdiction
of the Food and Drug Administration’’.
12
2
24
0.5 (30 minutes) ..........
12
12
12
12
12
12
12
2
2
2
2
2
1
24
24
24
24
24
12
1 ..................................
0.25 (15 minutes) ........
4 ..................................
0.5 (30 minutes) ..........
1 ..................................
1 ..................................
24
6
96
12
24
12
Total ................................................................
........................
........................
........................
.....................................
186
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate. Our
estimate of the number of respondents
is based on the number of regulatory
submissions to TTB for beers that do not
meet the definition of a ‘‘malt beverage’’
under the FAA Act. Based on its records
of submissions received from
manufacturers of such products, TTB
estimates the annual number of
respondents to be 12 and the annual
number of disclosures to be 24. Thus,
we adopt TTB’s estimate of 12 annual
respondents, and an annual number of
disclosures per respondent of 2 in table
1.
Our estimates of the average burden
per disclosure for each collection
provision are based on our experience
with food labeling under the Agency’s
jurisdiction. The estimated average
burden per disclosure for §§ 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.
Thus, we estimate that 12 respondents
will each label 2 products annually, for
a total of 24 labels. We estimate that the
VerDate Sep<11>2014
18:29 Nov 13, 2018
Jkt 247001
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
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.
Dated: November 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–24786 Filed 11–13–18; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–3931]
Nonmetastatic, Castration-Resistant
Prostate Cancer: Considerations for
Metastasis-Free Survival Endpoint in
Clinical Trials; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Nonmetastatic, Castration-Resistant
Prostate Cancer: Considerations for
Metastasis-Free Survival Endpoint in
Clinical Trials.’’ This draft guidance
provides recommendations to sponsors
regarding the use of metastasis-free
survival (MFS) as an endpoint in
clinical trials for nonmetastatic,
castration-resistant prostate cancer
(nmCRPC) development programs for
drug or biological products regulated by
the Center for Drug Evaluation and
Research (CDER) and the Center for
Biologics Evaluation and Research
(CBER).
DATES: Submit either electronic or
written comments on the draft guidance
by January 14, 2019 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
SUMMARY:
E:\FR\FM\14NON1.SGM
14NON1
]]>Agencies
[Federal Register Volume 83, Number 220 (Wednesday, November 14, 2018)]
[Notices]
[Pages 56856-56857]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24786]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
December 14, 2018.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. 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: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[email protected].
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 (FD&C Act) (see 21 U.S.C. 321(f)), includes ``articles
used for food or drink'' and thus includes alcoholic beverages. As
such, alcoholic beverages are subject to the FD&C Act's adulteration
and misbranding provisions and implementing regulations related to
food. For example, manufacturers of alcoholic beverages are responsible
for adhering to the registration of food facilities requirements in 21
CFR part 1 and to the good manufacturing practice regulations in 21 CFR
part 110. There are also certain requirements for nutrition labeling on
menus, menu boards, and other written materials for alcohol beverages
served in restaurants or similar retail food establishments in 21 CFR
part 101. However, as reflected in a 1987 Memorandum of Understanding
between FDA and the Alcohol and Tobacco Tax and Trade Bureau (TTB), TTB
is responsible for the dissemination and enforcement of regulations
with respect to the labeling of distilled spirits, certain wines, and
malt beverages issued in the Federal Alcohol Administration Act (FAA
Act). In TTB Ruling 2008-3, dated July 7, 2008, TTB clarified that
certain beers, which are not made from both malted barley and hops but
are instead made from substitutes for malted barley (such as sorghum,
rice, or wheat) or are made without hops, do not meet the definition of
a ``malt beverage'' under the FAA Act. Accordingly, TTB stated in its
ruling that such products (other than sak[eacute], which is classified
as a wine under the FAA Act), are not subject to the labeling,
advertising, or other provisions of TTB regulations issued under the
FAA Act.
In cases where an alcoholic beverage is not covered by the labeling
provisions of the FAA Act, the product is subject to ingredient and
other labeling requirements under the FD&C Act and the implementing
regulations that we administer. In addition, as provided for under the
Fair Packaging and Labeling Act (FPLA), alcoholic beverages that are
not covered by the labeling provisions of the FAA Act are subject to
the provisions of the FPLA, which we administer.
Therefore, the beers described in TTB's ruling as not being a
``malt beverage'' are subject to the labeling requirements under the
FD&C Act and FPLA, and our implementing regulations. In general, we
require that food products under our jurisdiction be truthfully and
informatively labeled in accordance with the FD&C Act, the FPLA, and
FDA's regulations. Furthermore, some TTB labeling requirements, such as
the Government Health Warning Statement under the Alcoholic Beverage
Labeling Act and certain marking requirements under the Internal
Revenue Code, continue to apply to these products.
Persons with access to the internet may obtain the guidance
entitled, ``Labeling of Certain Beers Subject to the Labeling
Jurisdiction of the Food and Drug Administration,'' located at https://www.fda.gov/FoodGuidances. This guidance is intended to assist
manufacturers on how to label bottled or otherwise packaged beers that
are subject to our labeling laws and regulations.
Our food labeling regulations under parts 101, 102, 104, and 105
(21 CFR parts 101, 102, 104, and 105) were issued under the authority
of sections 4, 5, and 6 of the FPLA (15 U.S.C. 1453, 1454, and 1455)
and under sections 201, 301, 402, 403, 409, 411, 701, and 721 of the
FD&C Act (21 U.S.C. 321, 331, 342, 343, 348, 350, 371, and 379e). Most
of these regulations derive from section 403 of the FD&C Act, which
provides that a food product shall be deemed to be misbranded if, among
other things, its label or labeling fails to bear certain required
information concerning the food product, is false or misleading in any
particular, or bears certain types of unauthorized claims. The
disclosure requirements and other collections of information in the
regulations in parts 101, 102, 104, and 105 are necessary to ensure
that food products produced or sold in the United States are in
compliance with the labeling provisions of the FD&C Act and the FPLA.
The primary user of the information to be disclosed on the label or
labeling of food products is the consumer that purchases the food
product. Consumers will use the information to assist them in making
choices concerning their purchase of a food product, including choices
related to substances that the consumer must avoid to prevent adverse
reactions. This information also enables the consumer to determine the
role of the food product in a healthful diet. Additionally, FDA intends
to use the information to determine whether a manufacturer or other
supplier of food products is meeting its statutory and regulatory
obligations. Failure of a manufacturer or other supplier of food
products to label its products in compliance with section 403 of the
FD&C Act and parts 101, 102, 104, and 105 of FDA's food labeling
regulations may result in a product being misbranded under the FD&C
Act, subjecting the firm and product to regulatory action.
Description of Respondents: The respondents to this collection of
[[Page 56857]]
information are manufacturers of beers that are subject to our labeling
laws and regulations.
In the Federal Register of June 29, 2018 (83 FR 30738), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Two comments were received. One comment was
unrelated to the Paperwork Reduction Act and is not addressed. The
second comment was in favor of the practical utility and necessity of
labeling the ingredients of beer for transparency to the consumer. We
are appreciative of these comments. At this time, we do not plan on
adjusting our current estimate.
FDA estimates 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
21 CFR section; activity respondents per disclosures Average burden per disclosure Total hours
respondent
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. Sec. 101.3 and 101.22; principal 12 2 24 0.5 (30 minutes)........................... 12
display and display panel.
Sec. 101.4; designation of ingredients... 12 2 24 1.......................................... 24
Sec. 101.5; name of manufacturer; packer; 12 2 24 0.25 (15 minutes).......................... 6
distributor.
Sec. 101.9; nutrition labeling........... 12 2 24 4.......................................... 96
Sec. 101.7 (formerly 101.105); quantity 12 2 24 0.5 (30 minutes)........................... 12
of contents.
Section 403(w)(1) of the FD&C Act.......... 12 2 24 1.......................................... 24
Review of Guidance Document: ``Labeling of 12 1 12 1.......................................... 12
Certain Beers Subject to the Labeling
Jurisdiction of the Food and Drug
Administration''.
------------------------------------------------------------------------------------------------------------
Total.................................. .............. .............. .............. ........................................... 186
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate. Our estimate of the number of respondents is based on the
number of regulatory submissions to TTB for beers that do not meet the
definition of a ``malt beverage'' under the FAA Act. Based on its
records of submissions received from manufacturers of such products,
TTB estimates the annual number of respondents to be 12 and the annual
number of disclosures to be 24. Thus, we adopt TTB's estimate of 12
annual respondents, and an annual number of disclosures per respondent
of 2 in table 1.
Our estimates of the average burden per disclosure for each
collection provision are based on our experience with food labeling
under the Agency's jurisdiction. The estimated average burden per
disclosure for Sec. Sec. 101.3, 101.4, 101.5, 101.9, 101.22, and
101.105 in table 1 are equal to, and based upon, the estimated average
burden per disclosure approved by OMB in OMB control number 0910-0381.
We further estimate that the labeling burden of section 403(w)(1) of
the FD&C Act, which specifies requirements for the declaration of food
allergens, will be 1 hour based upon the similarity of the requirements
to that of Sec. 101.4. Finally, FDA estimates that a respondent will
spend 1 hour reading the guidance.
Thus, we estimate that 12 respondents will each label 2 products
annually, for a total of 24 labels. We estimate that the manufacturers
will spend 7.25 hours (0.5 hours + 1 hour + 0.25 hour + 4 hours + 0.5
hour + 1 hour = 7.25 hours) on each label to comply with our labeling
regulations and the requirements of section 403(w)(1) of the FD&C Act,
for a total of 174 hours (24 labels x 7.25 hours = 174 hours). In
addition, 12 respondents will each spend 1 hour reading the guidance
document, for a total of 12 hours. Thus, we estimate the total hour
burden of the proposed collection of information to be 186 hours (174
hours + 12 hours = 186 hours).
The guidance also refers to previously approved collections of
information found in our regulations. The collections of information in
Sec. Sec. 101.3, 101.4, 101.5, 101.9, 101.22, and 101.105 have been
approved under OMB control number 0910-0381. Allergen labeling of these
beers under section 403(w)(1) of the FD&C Act, which was added by the
Food Allergen Labeling and Consumer Protection Act of 2004, has been
approved under OMB control number 0910-0792.
Dated: November 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24786 Filed 11-13-18; 8:45 am]
BILLING CODE 4164-01-P
