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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:
0910-0520
ICR Reference No:
201005-0910-017
Status:
Historical Active
Previous ICR Reference No:
200701-0910-002
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Title:
Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
Type of Information Collection:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
12/01/2010
Retrieve Notice of Action (NOA)
Date Received in OIRA:
05/28/2010
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
12/31/2013
36 Months From Approved
11/30/2010
Responses
10,038,502
0
8,045,878
Time Burden (Hours)
1,859,474
0
1,749,913
Cost Burden (Dollars)
0
0
0
Abstract:
Section 801(m) of the Federal Food Drug and Cosmetic Act(the act) (21 U.S.C.381(m) requires that FDA receive prior notice for food, including food for animals, that is imported or offered for import into the United States. Sections 1.278 to 1.282 of FDAs regulations ( 21 CFR 1.278 to 1.282) set forth the requirements for submitting prior notice; sections 1.283 (d) and 1.285 (j)set forth the procedure for requesting FDA review after an article of food has been refused admission under section 801 ( m )(1) of the act or placed under hold under section 801 (l) of the act; and section 1.285 (i) ( 21 CFR 1.285 ( i) sets forth the procedure for post- hold submissions. Advance notice of imported food allows FDA, with support of the Bureau of Customs and Border Protection ( CBP), to target import inspections more effectively and help protect the nations` food supply against terrorist acts and other public health emergencies.
Authorizing Statute(s):
US Code:
21 USC 381 (m)
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
75 FR 12549
03/16/2010
30-day Notice:
Federal Register Citation:
Citation Date:
75 FR 30036
05/28/2010
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
21 CFR 1.280, 1.281- Reporting: New Prior Notice Submisions Submitted Through The ABI/ACS System. Regulation Sets Forth Information That the Prior Notice Is Required to Contain
21 CFR 1.280,1.281 - Reporting: New Prior Notice Submission Submitted Through The PN System Interface. Regulation Sets Forth Information That The Prior Notice Is Required to Contain
3540
Prior Notice Submission
21 CFR 1.282 Reporting; Prior Notice Cancellation Through the ABI/ACS System. Regulation Sets Forth Cancellation Requirements & Information That Prior Notice Is Required to Contain.
3540
Prior Notice Submission
21 CFR 1.282, 1.283(a)(5)- Reporting: Prior Notice Cancellation Through The PN Systen Interface. Regulation Sets Forth Cancellation Requirements & Information That the Prior Notice ... .
3540
Prior Notice Submission
21 CFR 1.283 (d);1.285(i);1.285(j) - Reporting: Prior Notice Requests for Review & Post - Hold Submissions Under 801 (m)(1) of The Federal Food, Drug & Cosmetic Act.
21 CFR 1.285 ( i) - Reporting: Prior Notice Requests For Review & Post - Hold Submissions Under 801 ( l ) of The Federal Food Drug & Cosmetic Act.
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
10,038,502
8,045,878
0
0
1,992,624
0
Annual Time Burden (Hours)
1,859,474
1,749,913
0
0
109,561
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:
Annual Cost to Federal Government:
$12,500,000
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:
Jonnalynn Capezzuto 3018274659
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:
05/28/2010
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