Labeling of major food allergens

OMB Control No: 1513-0121	ICR Reference No: 200607-1513-012
Status: Historical Inactive	Previous ICR Reference No: 200607-1513-010
Agency/Subagency: TREAS/TTB	Agency Tracking No:
Title: Labeling of major food allergens
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule and continue	Conclusion Date: 09/27/2006
Retrieve Notice of Action (NOA)	Date Received in OIRA: 07/28/2006
Terms of Clearance: The request is not approved at this time to allow the agency to collect and consider public comments on the associated proposed rule. In the next submission of this request, the agency should summarize any public comments on the information collection and provide their responses to the comments.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2009	36 Months From Approved	07/31/2009
Responses	520	0	520
Time Burden (Hours)	730	0	730
Cost Burden (Dollars)	64,000	0	64,000

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Abstract: The collection of information requires labeling of major food allergens used in the production of alcohol beverages and corresponds to the recent amendments to the FD&C Act in Title II of Public Law 108-282, 118 Stat.905

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Authorizing Statute(s): PL: Pub.L. 108 - 282 118 Stat. 905 Name of Law: Food Allergen Labeling and Consumer Protection Act of 2004    US Code: 21 USC 301 Name of Law: Federal Food, Drug and Cosmetic Act

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
1513-AB08	Proposed rulemaking	71 FR 42329	07/26/2006

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title Form No. Form Name Labeling of major food allergens

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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: The previous collection of information for labeling of major food allergens was voluntary. We estimate approximately 500 businesses would voluntarily label major food allergens. We are proposing to make major food allergen labeling mandatory. Accordingly more industry members will be required to comply with the information collection, our records indicate that approximately 5,000 businesses will be required to comply with the proposed regulations.

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Annual Cost to Federal Government: $0

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

Is this ICR related to the Pandemic Response? Uncollected

Agency Contact: Jessica Bungard 202 927-8210 [email protected]

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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: 07/28/2006

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