View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0750
ICR Reference No:
201605-0910-010
Status:
Historical Active
Previous ICR Reference No:
201605-0910-001
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CFSAN
Title:
Accreditation of Third Party Certification Bodies to Conduct Food Safety Audits and Issue Certifications
Type of Information Collection:
New collection (Request for a new OMB Control Number)
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
06/08/2016
Retrieve Notice of Action (NOA)
Date Received in OIRA:
05/16/2016
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
06/30/2019
36 Months From Approved
Responses
72,977
0
0
Time Burden (Hours)
74,822
0
0
Cost Burden (Dollars)
11,585,345
0
0
Abstract:
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.
Authorizing Statute(s):
US Code:
21 USC 384d
Name of Law: FFDCA
Citations for New Statutory Requirements:
PL: Pub.L. 111 - 353 307 Name of Law: Food Safety Modernization Act
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
0910-AG66
Final or interim final rulemaking
80 FR 74570
11/27/2015
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
78 FR 45781
07/29/2013
30-day Notice:
Federal Register Citation:
Citation Date:
80 FR 74570
11/27/2015
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
6
IC Title
Form No.
Form Name
AB application for recognition
AB application for renewal of recognition
AB maintenance of regulatory audit records
AB public dissemination of information via website
AB submission of assessment of its CBs
AB submission of self-assessments
ANNUAL recordkeeping accreditation bodies (ABs)
ANNUAL recordkeeping certfication bodies (CBs)
ANNUAL reporting ABs and CBs
CB application for direct accreditation (ONE TIME BURDEN)
CB application for renewal of direct accreditation
CB completion of additional information on certificates
CB modification of certification design (ONE TIME BURDEN)
CB modification of food safety audit report
CB public dissemination of information via website
CB reporting conditions that could contribute to serious risk to public health to its eligible entities clients
CB reporting conditions that could contribute to seroius risk to public health to ABs
CB reporting conditions to FDA that could contribute to serious risk to public health
CB submission of regulatory audit report to FDA
CB submission of regulatory audit report to FDA
CB submission of self assessment to its AB
Directly accredited CB submission of regulatory audit report to FDA
Directly accredited CB submission of self assessment to FDA
ONE TIME recordkeeping for accreditation bodies (ABs)
ONE TIME recordkeeping for certification bodies (CBs)
ONE TIME reporting ABs and CBs
Report SAHCODHA conditions
Unaccredited CBs (ADDITIONAL ONE TIME BURDEN)
Unaccredited CBs--accreditation burden
Unaccredited CBs--accreditation burden (ONE TIME BURDEN)
Unaccredited CBs--additional reporting burden
ICR Summary of Burden
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
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Changing Regulations
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
This is a new information collection associated with rulemaking.
Annual Cost to Federal Government:
$17,000,000
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]?
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?
Uncollected
Agency Contact:
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov
Common Form ICR:
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:
(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:
05/16/2016
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