FDA Recall Regulations

Forms and Documents

Document Name	Status
SUPPORT STATEMENT FINAL 0249 2-25-15.doc Supporting Statement A	2015-02-25

IC Document Collections

IC ID	Document Title	Status
5832	Firm Initiated Recall	Modified
215023	Recall Communications	New
215022	Termination of a Recall	New
215021	Recall Status Reports	New

ICR Details

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
	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

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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).

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Authorizing Statute(s): US Code: 21 USC 701 Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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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

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Number of Information Collection (IC) in this ICR: 4

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

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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.

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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

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Common Form ICR:  No

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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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