View Information Collection Request (ICR) Package
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View Information Collection (IC) List
View Supporting Statement and Other Documents
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:
0910-0752
ICR Reference No:
201512-0910-006
Status:
Historical Active
Previous ICR Reference No:
201308-0910-001
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CFSAN
Title:
Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
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:
02/05/2016
Retrieve Notice of Action (NOA)
Date Received in OIRA:
12/18/2015
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
02/28/2019
36 Months From Approved
Responses
15,591,006
0
0
Time Burden (Hours)
2,669,646
0
0
Cost Burden (Dollars)
167,986,680
0
0
Abstract:
The FSVP regulations require importers of most imported foods to take steps to verify that the foods they import into the United States are produced so they are safe and properly labeled with respect to allergens. These regulations are intended to work in tandem with other provisions of FSMA and the FD&C Act to create a more seamless system of food safety to protect U.S. consumers. Respondents to the collection are persons who import food into the United States subject to agency regulations.
Authorizing Statute(s):
PL:
Pub.L. 111 - 353 301
Name of Law: Food Safety Modernization Act
Citations for New Statutory Requirements:
PL: Pub.L. 111 - 353 805 Name of Law: FSMA; Importation of Food
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
0910-AG64
Final or interim final rulemaking
80 FR 74225
11/27/2015
Federal Register Notices & Comments
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
7
IC Title
Form No.
Form Name
Conduct periodic sampling/testing
Conduct/review audits
Determine and document hazards
Determine and document type of verification activities
Investigate adulteration or misbranding
Investigate and determine FSVP adequacy
RECORDS supporting FSVP including hazard determination; written procedures; reevaluation; audits; and corrective actions
RECORDS under 1.502(b); controls for LACF
RECORDS under 1.511(b); assurances for food produced under dietary supplement GMP
RECORDS under 1.512(b)(1); document very small importer/certain foreign supplier status
RECORDS under 1.512(b); assurances from very small importer/certain small foreign supplier
REPORT under 1.501(c); exemption for food for research
REPORT under 1.509(a), 1.511(c), 1.512(b)(2); importer identification information for filing with CBP.
Review hazard analysis
Review records
Written assurances for food produced under DS CGMPs
Written assurances from suppliers
Written list of suppliers
Written procedures for verification
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
15,591,006
0
0
15,591,006
0
0
Annual Time Burden (Hours)
2,669,646
0
0
2,669,646
0
0
Annual Cost Burden (Dollars)
167,986,680
0
0
167,986,680
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 request in support of agency rulemaking.
Annual Cost to Federal Government:
$134,625
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:
12/18/2015
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