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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:
0910-0249
ICR Reference No:
201502-0910-005
Status:
Historical Active
Previous ICR Reference No:
201111-0910-008
Agency/Subagency:
HHS/FDA
Agency Tracking No:
ORA
Title:
FDA Recall Regulations
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 without change
Conclusion Date:
03/23/2015
Retrieve Notice of Action (NOA)
Date Received in OIRA:
02/27/2015
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
03/31/2018
36 Months From Approved
03/31/2015
Responses
1,748,460
0
35,079
Time Burden (Hours)
721,886
0
443,820
Cost Burden (Dollars)
0
0
0
Abstract:
FDA's recall regulations provide guidance to manufacturers on recall responsibilities. The guidelines apply to all regulated products (i.e., food, including animal feed; drugs, including animal drugs; medical devices, including in vitro diagnostic products; cosmetics; biological products intended for human use; and tobacco).
Authorizing Statute(s):
US Code:
21 USC 701
Name of Law: FFDCA
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:
79 FR 45197
08/04/2014
30-day Notice:
Federal Register Citation:
Citation Date:
80 FR 7609
02/11/2015
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
4
IC Title
Form No.
Form Name
Firm Initiated Recall
Recall Communications
Recall Status Reports
Termination of a Recall
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
1,748,460
35,079
0
0
1,713,381
0
Annual Time Burden (Hours)
721,886
443,820
0
0
278,066
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:
First, FDA re-estimated the burden by conducting a search of the FDA database. There was an increase in 21 CFR 7.46, Firm Initiated Recalls and 21 CFR 7.49, Recall Communications by 700 (number of respondents) and an increase of 36,030 hours. The total estimated annual reporting burden has increased by 349,102 (from 278,063 to 627,165) total hours. This search was performed in order to update the data set used to estimate the number of respondents per year for FDA Recalls. Due to the variability in frequency that voluntary recalls occur from industry, FDA has taken the three year average of the number of recalls which took place during fiscal years 2011 – 2013, and applied that result to estimate the annual number of respondents. Adjustments were necessary for this information collection renewal. The second is the average number of termination requests received per year was adjusted to be equal to the number of recalls per year. The third is Recall Strategy (21 CFR 7.42) is no longer included in the table since there is no reporting recommendation or requirement in this regulation. The reporting recommendation for recall strategy is contained in 21 CFR 7.46. Hence, the average burden for response previously reported under 7.42 has now been added to the average burden for response for 7.46. The fourth, reference, Section C.II.IV - Hours per 3rd Party Disclosure Estimates - FDA estimates the burden for 3rd Party Disclosure per recall event to be an average of 25 hours. This burden estimate factored out to the average number of consignees per recall (445) results in a burden per disclosure estimate of approx. hrs (25 hrs per recall/445 disclosures/recall = 0.056hr) versus previous reporting .0282485 hours per average burden per disclosure.
Annual Cost to Federal Government:
$11,883,000
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:
Ila Mizrachi 301 796-7726 ila.mizrachi@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:
02/27/2015
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