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

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
204160	Beer Labeling Guidance Other-Agency Guidance	Modified
204159	Beer Labeling Under Section 403(w)(1) of the FFDCA Other-Agency Guidance	Modified
204158	Quantity of Contents	Modified
204157	Nutrition Labeling	Modified
204156	Name of Manufacturer; Packer; Distributor	Modified
204155	Designation of Ingredients	Modified
204154	Principal Display and Display Panel	Modified

ICR Details

OMB Control No: 0910-0728	ICR Reference No: 202112-0910-005
Status: Received in OIRA	Previous ICR Reference No: 201812-0910-004
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	Date Submitted to OIRA: 12/20/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	01/31/2022
Responses	156	156
Time Burden (Hours)	186	186
Cost Burden (Dollars)	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
	Other Documents for OIRA Review

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 27631	05/21/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 64941	11/19/2021
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 Guidance
Beer Labeling Under Section 403(w)(1) of the FFDCA
Designation of Ingredients
Name of Manufacturer; Packer; Distributor
Nutrition Labeling
Principal Display and Display Panel
Quantity of Contents

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ICR Summary of Burden

	Total Request	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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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? No

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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: 12/20/2021

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