Accreditation of Third Party Certification Bodies to Conduct Food Safety Audits and Issue Certifications

ICR 201605-0910-010

OMB: 0910-0750

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2016-05-13
IC Document Collections
IC ID
Document
Title
Status
208299
Removed
208298
Removed
208297
Removed
208296
Removed
208295
Removed
208294
Removed
208293
Removed
208292
Removed
208291
Removed
208290
Removed
208289
Removed
208288
Removed
208287
Removed
208286
Removed
208285
Removed
208284
Removed
208283
Removed
208282
Removed
208281
Removed
208280
Removed
208279
Removed
208278
Removed
208277
Removed
208276
Removed
208275
Removed
208274
Unchanged
208273
Modified
208272
Unchanged
208271
Unchanged
208270
Modified
208269
Modified
ICR Details
0910-0750 201605-0910-010
Historical Active 201605-0910-001
HHS/FDA CFSAN
Accreditation of Third Party Certification Bodies to Conduct Food Safety Audits and Issue Certifications
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 06/08/2016
Retrieve Notice of Action (NOA) 05/16/2016
  Inventory as of this Action Requested Previously Approved
06/30/2019 36 Months From Approved
72,977 0 0
74,822 0 0
11,585,345 0 0

This ICR collects information from recognized accreditation bodies and accredited auditors/certification bodies regarding food and feed products of eligible entities that offer their food or feed for import to the United States. Eligible entities will participate in FDA Third Party program to obtain food safety audits and certifications from third party auditors/certification bodies on an annual basis for the purpose of verifying that the food is produced in compliance with applicable regulations.

US Code: 21 USC 384d Name of Law: FFDCA
  
PL: Pub.L. 111 - 353 307 Name of Law: Food Safety Modernization Act

0910-AG66 Final or interim final rulemaking 80 FR 74570 11/27/2015

  78 FR 45781 07/29/2013
80 FR 74570 11/27/2015
Yes

6
IC Title Form No. Form Name
CB public dissemination of information via website
CB reporting conditions that could contribute to seroius risk to public health to ABs
Unaccredited CBs--accreditation burden
Directly accredited CB submission of regulatory audit report to FDA
AB submission of self-assessments
AB application for renewal of recognition
CB application for direct accreditation (ONE TIME BURDEN)
Report SAHCODHA conditions
CB submission of regulatory audit report to FDA
CB modification of certification design (ONE TIME BURDEN)
ANNUAL recordkeeping certfication bodies (CBs)
ANNUAL reporting ABs and CBs
ONE TIME recordkeeping for accreditation bodies (ABs)
ONE TIME recordkeeping for certification bodies (CBs)
AB application for recognition
AB public dissemination of information via website
CB modification of food safety audit report
Directly accredited CB submission of self assessment to FDA
CB submission of self assessment to its AB
CB completion of additional information on certificates
ONE TIME reporting ABs and CBs
Unaccredited CBs (ADDITIONAL ONE TIME BURDEN)
CB application for renewal of direct accreditation
ANNUAL recordkeeping accreditation bodies (ABs)
Unaccredited CBs--accreditation burden (ONE TIME BURDEN)
Unaccredited CBs--additional reporting burden
CB reporting conditions that could contribute to serious risk to public health to its eligible entities clients
CB reporting conditions to FDA that could contribute to serious risk to public health
CB submission of regulatory audit report to FDA
AB submission of assessment of its CBs
AB maintenance of regulatory audit records

  Total Approved 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 72,977 0 11,008 61,969 0 0
Annual Time Burden (Hours) 74,822 0 60,650 14,172 0 0
Annual Cost Burden (Dollars) 11,585,345 0 0 11,585,345 0 0
Yes
Changing Regulations
No
This is a new information collection associated with rulemaking.

$17,000,000
No
No
No
No
No
Uncollected
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.
05/16/2016


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