Laboratory Accreditation for Analyses of Foods

Forms and Documents

Document Name	Status
LAAF 21 CFR 1 subpart R NEW SSA 2021 0910 AH31.docx Supporting Statement A	2021-04-30
Laboratory Accreditation for Analyses of Foods PRIA Posted NOV 2019.pdf Supplementary Document	2021-04-30

IC Document Collections

IC ID	Document Title	Status
247107	LAAF; Proposed Recordkeeping	New
247106	LAAF; Proposed Reporting Requirements	New

ICR Details

OMB Control No:	ICR Reference No: 202104-0910-016
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Laboratory Accreditation for Analyses of Foods
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 05/03/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	9,589	0
Time Burden (Hours)	58,328	0
Cost Burden (Dollars)	0	0

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Abstract: The information collection supports implementation of FDA's laboratory accreditation program. Once established, accredited laboratories would be 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 would be 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 proposed regulations.

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Authorizing Statute(s): US Code: 21 USC 350k Name of Law: Federal Food, Drug, & Cosmetic Act; Laboratory Accreditation for Analyses of Foods
  

Citations for New Statutory Requirements: PL: Pub.L. 111 - 353 202(a) Name of Law: Food Safety & Modernization Act

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AH31	Proposed rulemaking	84 FR 59452	11/04/2019

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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: 2

IC Title	Form No.	Form Name
LAAF; Proposed Recordkeeping
LAAF; Proposed 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	9,589	0	9,589	0	0	0
Annual Time Burden (Hours)	58,328	0	58,328	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: This is a new information collection request in support of agency rulemaking.

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Annual Cost to Federal Government: $1,308,178

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: 05/03/2021

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