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

Forms and Documents

Document	Type	Status	Availability
0728 SS Part A 2015.pdf	Supporting Statement A	Uploaded 2015-12-07	Available

IC Document Collections

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

ICR Details

OMB Control No: 0910-0728	ICR Reference No: 201512-0910-005
Status: Historical Active	Previous ICR Reference No: 201209-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Labeling of Certain Beers Subject to the Labeling Jurisdiction of the FDA
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/08/2016
	Date Received in OIRA: 12/09/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2019	36 Months From Approved	01/31/2016
Responses	156	0	156
Time Burden (Hours)	186	0	186
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection request supports the labeling of certain beers subject to the jurisdiction of the FDA. Respondents to the collection are manufacturers of these products in the private sector.

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Authorizing Statute(s): US Code: 21 USC 343 Name of Law: Federal Food, Drug, & Cosmetic Act; Misbranded Foods
  

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:
	80 FR 48322	08/12/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 66539	10/29/2015
Did the Agency receive public comments on this ICR? No

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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	156	0	0	0	0
Annual Time Burden (Hours)	186	186	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement:

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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: 12/09/2015

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