Labeling of Certain Beers Subject to the Labeling Jurisdiction of the FDA

Forms and Documents

Document Name	Status
Beer Labeling Supporting Statement 2012 June 20.doc Supporting Statement A	2012-06-20

IC Document Collections

IC ID	Document Title	Status
204160	Beer Labeling Guidance Other-Agency Guidance	New
204159	Beer Labeling under sec. 403(w)(1) of the FFDCA Other-Agency Guidance	New
204158	Beer Labeling under 21 CFR 101.105	New
204157	Beer Labeling under 21 CFR 101.9	New
204156	Beer Labeling under 21 CFR 101.5	New
204155	Beer Labeling under 21 CFR 101.4	New
204154	Beer Labeling under 21 CFR 101.3 and 101.22	New

ICR Details

OMB Control No: 0910-0728	ICR Reference No: 201209-0910-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Labeling of Certain Beers Subject to the Labeling Jurisdiction of the FDA
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/14/2013
	Date Received in OIRA: 09/18/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2016	36 Months From Approved
Responses	156	0	0
Time Burden (Hours)	186	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Alcohol and Tobacco Tax and Trade Bureau (TTB) (formerly the Bureau of Alcohol, Tobacco, and Firearms (ATF)) has 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 Federal Alcohol Administration Act (FAA Act). TTB stated, therefore, 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 promulgated under the 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).

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 41438	08/17/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 43335	07/24/2012
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 7

IC Title	Form No.	Form Name
Beer Labeling under 21 CFR 101.3 and 101.22
Beer Labeling under 21 CFR 101.4
Beer Labeling under 21 CFR 101.5
Beer Labeling under 21 CFR 101.9
Beer Labeling under 21 CFR 101.105
Beer Labeling under sec. 403(w)(1) of the FFDCA
Beer Labeling Guidance

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	156	0	0	156	0	0
Annual Time Burden (Hours)	186	0	0	186	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new collection.

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Annual Cost to Federal Government: $180,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 09/18/2012

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