Laboratory Accreditation for Analyses of Foods

Forms and Documents

Document Name	Status
0910-0898 LAAF SS A Clean 121724.docx Supporting Statement A	2024-12-19
0898 Laboratory Accreditation for Analyses of Foods FRIA NOV 2021.pdf Supplementary Document	2021-11-29

IC Document Collections

IC ID	Document Title	Status
247107	LAAF; Recordkeeping	Modified
247106	LAAF; Reporting Requirements Other-LAAF Program Portal; Electronic User Guide; Step-by-Step I	Modified

ICR Details

OMB Control No: 0910-0898	ICR Reference No: 202405-0910-006
Status: Received in OIRA	Previous ICR Reference No: 202111-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: OII
Title: Laboratory Accreditation for Analyses of Foods
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: 12/20/2024

	Requested	Previously Approved
Expiration Date	36 Months From Approved	01/31/2025
Responses	11,117	11,344
Time Burden (Hours)	164,749	174,052
Cost Burden (Dollars)	0	0

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Abstract: The information collection supports implementation of FDA's laboratory accreditation program. Accredited laboratories are required to follow model standards in conducting certain human and animal food testing and would be subject to oversight by FDA-recognized accreditation bodies to help ensure consistently reliable testing results. Respondents to the information collection are accreditation bodies seeking recognition from FDA, recognized accreditation bodies, laboratories seeking accreditation from recognized accreditation bodies, and accredited laboratories. Participation in this program is voluntary for laboratories and accreditation bodies; however only recognized accreditation bodies would be able to accredit laboratories to conduct food testing as specified in the regulations.

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Authorizing Statute(s): US Code: 21 USC 350(k) Name of Law: Laboratory Accreditation for Analyses of 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:
	89 FR 66417	08/15/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 103836	12/19/2024
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
LAAF; Recordkeeping
LAAF; Reporting Requirements

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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	11,117	11,344	0	0	-227	0
Annual Time Burden (Hours)	164,749	174,052	0	0	-9,303	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: We calculate the number of food testing laboratories seeking accreditation based on the number of applicants. As a result, the number of respondents to the information collection decreased. Consequently, we have adjusted our burden estimate, which results in a decrease of 227 responses and 9,303 burden hours from the currently approved information collection.

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Annual Cost to Federal Government: $798,700

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: 12/20/2024

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