FDA Recall Regulations

ICR 201502-0910-005

OMB: 0910-0249

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2015-02-25
IC Document Collections
IC ID
Document
Title
Status
5832
Modified
215023
New
215022
New
215021
New
ICR Details
0910-0249 201502-0910-005
Historical Active 201111-0910-008
HHS/FDA ORA
FDA Recall Regulations
Extension without change of a currently approved collection   No
Regular
Approved without change 03/23/2015
Retrieve Notice of Action (NOA) 02/27/2015
  Inventory as of this Action Requested Previously Approved
03/31/2018 36 Months From Approved 03/31/2015
1,748,460 0 35,079
721,886 0 443,820
0 0 0

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).

US Code: 21 USC 701 Name of Law: FFDCA
  
None

Not associated with rulemaking

  79 FR 45197 08/04/2014
80 FR 7609 02/11/2015
No

4
IC Title Form No. Form Name
Firm Initiated Recall
Recall Status Reports
Termination of a Recall
Recall Communications

  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
No
No
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.

$11,883,000
No
No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 [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.
02/27/2015


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