30738 Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices 

Dated: June 26, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–14058 Filed 6–28–18; 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; 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 Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (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 in 

response to the notice. 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 August 28, 2018. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before August 28, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of August 28, 2018. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2009–D–0268 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Labeling 

of Certain Beers Subject to the Labeling 

Jurisdiction of the Food and Drug 

Administration.’’ Received comments, 

those filed in a timely manner (see 

ADDRESSES), will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, 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, 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 


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Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices 30739 

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. 

Labeling of Certain Beers Subject to the 

Labeling Jurisdiction of the Food and 

Drug Administration 

OMB Control Number 0910–0728— 

Extension 

The definition of ‘‘food’’ under the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) (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 (the FAA 

Act). In TTB Ruling 2008–3, dated July 

7, 2008, TTB clarified that certain beers, 

which are not made from both malted 

barley and hops but are instead made 

from substitutes for malted barley (such 

as sorghum, rice, or wheat) or are made 

without hops, do not meet the definition 

of a ‘‘malt beverage’’ under the FAA 

Act. Accordingly, TTB stated in its 

ruling that such products (other than 

sake ́, which is classified as a wine under 

the FAA Act), are not subject to the 

labeling, advertising, or other provisions 

of 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 

information are manufacturers of beers 

that are subject to our labeling laws and 

regulations. FDA estimates the burden 

of this collection of information as 

follows: 

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

21 CFR section; activity Number of 

respondents 

Number of 

disclosures 

per respondent 

Total annual 

disclosures 

Average burden 

per disclosure Total hours 

§§ 101.3 and 101.22 ................................ 12 2 24 0.5 (30 minutes) ........ 12 

§ 101.4 ...................................................... 12 2 24 1 ................................ 24 

§ 101.5 ...................................................... 12 2 24 0.25 (15 minutes) ...... 6 

§ 101.9 ...................................................... 12 2 24 4 ................................ 96 

§ 101.105 .................................................. 12 2 24 0.5 (30 minutes) ........ 12 

Section 403(w)(1) of the FD&C Act ......... 12 2 24 1 ................................ 24 


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30740 Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices 

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued 

21 CFR section; activity Number of 

respondents 

Number of 

disclosures 

per respondent 

Total annual 

disclosures 

Average burden 

per disclosure Total hours 

Guidance document entitled ‘‘Labeling of 

Certain Beers Subject to the Labeling 

Jurisdiction of the Food and Drug Administration’’.

12 1 12 1 ................................ 12 

Total .................................................. ............................ ............................ ............................ .................................... 186 

1There 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 

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: June 22, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–14056 Filed 6–28–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1129] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; National 

Agriculture and Food Defense Strategy 

Survey 

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 July 30, 

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–NEW and 

title ‘‘National Agriculture and Food 

Defense Strategy Survey.’’ Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, 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. 

National Agriculture and Food Defense 

Strategy Survey 

OMB Control Number—0910–NEW 

We are seeking OMB approval of the 

National Agriculture and Food Defense 

Strategy (NAFDS) under the FDA Food 

Safety Modernization Act (FSMA), 

section 108. This is a voluntary survey 

of State governments intended to gauge 

government activities in food and 

agriculture defense from intentional 

contamination and emerging threats. 

The collected information will be 

included in the mandatory 2019 NAFDS 

followup Report to Congress. The 

authority for FDA to collect the 

information derives from the 

Commissioner of Food and Drugs’ 

authority provided in section 

1003(d)(2)(c) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 

393(d)(2)(c)). 

Protecting the nation’s food and 

agriculture supply against intentional 

contamination and other emerging 

threats is an important responsibility 

shared by Federal, State, local, tribal, 

and territorial governments as well as 

private sector partners. On January 4, 

2011, the President signed FSMA. 


sradovich on DSK3GMQ082PROD with NOTICES