83 FR 56856 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 220 (November 14, 2018)

Page Range		56856-56857
FR Document		2018-24786

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.

Federal Register, Volume 83 Issue 220 (Wednesday, November 14, 2018)

[Federal Register Volume 83, Number 220 (Wednesday, November 14, 2018)]
[Notices]
[Pages 56856-56857]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-24786]

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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 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.

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

Federal Register / Vol. 83, No. 220 / Wednesday, November 14, 2018 / Notices 56857

information are manufacturers of beers information. Two comments were beer for transparency to the consumer.
that are subject to our labeling laws and received. One comment was unrelated We are appreciative of these comments.
regulations. to the Paperwork Reduction Act and is At this time, we do not plan on
In the Federal Register of June 29, not addressed. The second comment adjusting our current estimate.
2018 (83 FR 30738), FDA published a was in favor of the practical utility and FDA estimates the burden of this
60-day notice requesting public necessity of labeling the ingredients of
comment on the proposed collection of collection of information as follows:

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

§§ 101.3 and 101.22; principal display and display 12 2 24 0.5 (30 minutes) .......... 12
panel.
§ 101.4; designation of ingredients ........................ 12 2 24 1 .................................. 24
§ 101.5; name of manufacturer; packer; distributor 12 2 24 0.25 (15 minutes) ........ 6
§ 101.9; nutrition labeling ....................................... 12 2 24 4 .................................. 96
§ 101.7 (formerly 101.105); quantity of contents ... 12 2 24 0.5 (30 minutes) .......... 12
Section 403(w)(1) of the FD&C Act ....................... 12 2 24 1 .................................. 24
Review of Guidance Document: ‘‘Labeling of Cer- 12 1 12 1 .................................. 12
tain 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 manufacturers will spend 7.25 hours DEPARTMENT OF HEALTH AND
collection since our last request for (0.5 hours + 1 hour + 0.25 hour + 4 HUMAN SERVICES
OMB approval, we have made no hours + 0.5 hour + 1 hour = 7.25 hours)
adjustments to our burden estimate. Our on each label to comply with our Food and Drug Administration
estimate of the number of respondents labeling regulations and the [Docket No. FDA–2018–D–3931]
is based on the number of regulatory requirements of section 403(w)(1) of the
submissions to TTB for beers that do not FD&C Act, for a total of 174 hours (24 Nonmetastatic, Castration-Resistant
meet the definition of a ‘‘malt beverage’’ labels × 7.25 hours = 174 hours). In Prostate Cancer: Considerations for
under the FAA Act. Based on its records addition, 12 respondents will each Metastasis-Free Survival Endpoint in
of submissions received from spend 1 hour reading the guidance Clinical Trials; Draft Guidance for
manufacturers of such products, TTB document, for a total of 12 hours. Thus, Industry; Availability
estimates the annual number of we estimate the total hour burden of the
respondents to be 12 and the annual AGENCY: Food and Drug Administration,
proposed collection of information to be HHS.
number of disclosures to be 24. Thus,
186 hours (174 hours + 12 hours = 186 ACTION: Notice of availability.
we adopt TTB’s estimate of 12 annual
respondents, and an annual number of hours).
SUMMARY: The Food and Drug
disclosures per respondent of 2 in table The guidance also refers to previously Administration (FDA or Agency) is
1. approved collections of information announcing the availability of a draft
Our estimates of the average burden found in our regulations. The guidance for industry entitled
per disclosure for each collection collections of information in §§ 101.3, ‘‘Nonmetastatic, Castration-Resistant
provision are based on our experience 101.4, 101.5, 101.9, 101.22, and 101.105 Prostate Cancer: Considerations for
with food labeling under the Agency’s have been approved under OMB control Metastasis-Free Survival Endpoint in
jurisdiction. The estimated average number 0910–0381. Allergen labeling of Clinical Trials.’’ This draft guidance
burden per disclosure for §§ 101.3, these beers under section 403(w)(1) of provides recommendations to sponsors
101.4, 101.5, 101.9, 101.22, and 101.105 the FD&C Act, which was added by the regarding the use of metastasis-free
in table 1 are equal to, and based upon, Food Allergen Labeling and Consumer survival (MFS) as an endpoint in
the estimated average burden per Protection Act of 2004, has been clinical trials for nonmetastatic,
disclosure approved by OMB in OMB approved under OMB control number castration-resistant prostate cancer
control number 0910–0381. We further 0910–0792. (nmCRPC) development programs for
estimate that the labeling burden of drug or biological products regulated by
Dated: November 7, 2018.
section 403(w)(1) of the FD&C Act, the Center for Drug Evaluation and
which specifies requirements for the Leslie Kux, Research (CDER) and the Center for
declaration of food allergens, will be 1 Associate Commissioner for Policy. Biologics Evaluation and Research
hour based upon the similarity of the [FR Doc. 2018–24786 Filed 11–13–18; 8:45 am] (CBER).
requirements to that of § 101.4. Finally, BILLING CODE 4164–01–P DATES: Submit either electronic or
FDA estimates that a respondent will written comments on the draft guidance
spend 1 hour reading the guidance. by January 14, 2019 to ensure that the
Thus, we estimate that 12 respondents Agency considers your comment on this
will each label 2 products annually, for draft guidance before it begins work on
a total of 24 labels. We estimate that the the final version of the guidance.

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Document Created: 2018-11-14 03:31:26
Document Modified: 2018-11-14 03:31:26

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by December 14, 2018.
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]
FR Citation		83 FR 56856

83 FR 56856 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 220 (November 14, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration