Laboratory Accreditation for Analyses of Foods

ICR 202104-0910-016

OMB:

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2021-04-30
Supplementary Document
2021-04-30
IC Document Collections
IC ID
Document
Title
Status
247107
New
247106
New
ICR Details
202104-0910-016
Received in OIRA
HHS/FDA CFSAN
Laboratory Accreditation for Analyses of Foods
New collection (Request for a new OMB Control Number)   No
Regular 05/03/2021
  Requested Previously Approved
36 Months From Approved
9,589 0
58,328 0
0 0

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.

US Code: 21 USC 350k Name of Law: Federal Food, Drug, & Cosmetic Act; Laboratory Accreditation for Analyses of Foods
  
PL: Pub.L. 111 - 353 202(a) Name of Law: Food Safety & Modernization Act

0910-AH31 Proposed rulemaking 84 FR 59452 11/04/2019

No

2
IC Title Form No. Form Name
LAAF; Proposed Recordkeeping
LAAF; Proposed Reporting Requirements

  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
No
No
This is a new information collection request in support of agency rulemaking.

$1,308,178
No
    No
    No
No
No
No
No
Domini Bean 301 796-5733 [email protected]

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
05/03/2021


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