FDA Recall Regulations

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
0249 Recalls - part 7 2024 SSA EXT.docx	Supporting Statement A	Uploaded 2024-04-30	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
5832	Firm Initiated Recall and Recall Communications		Modified
215023	Recall Communications-third party disclosure (including Agency Guidance recommendations)		Modified
215022	Termination of a Recall		Modified
215021	Recall Status Reports		Modified

ICR Details

OMB Control No: 0910-0249	ICR Reference No: 202403-0910-012
Status: Active	Previous ICR Reference No: 202102-0910-006
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: 06/04/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 04/30/2024
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2027	36 Months From Approved	06/30/2024
Responses	2,592,826	0	1,277,656
Time Burden (Hours)	507,094	0	513,528
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection supports FDA regulations governing recalls. The information collection provisions 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). Respondents to the collection are those who introduce FDA-regulated products into interstate commerce or who are otherwise subject to the applicable regulations.

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Authorizing Statute(s): US Code: 21 USC 301 et seq. 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:
	88 FR 70995	10/13/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 34256	04/30/2024
Did the Agency receive public comments on this ICR? Yes

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

table that charts list of burden

IC Title	Form No.	Form Name
Firm Initiated Recall and Recall Communications
Recall Communications-third party disclosure (including Agency Guidance recommendations)
Recall Status Reports
Termination of a Recall

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ICR Summary of Burden

table that charts list 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	2,592,826	1,277,656	0	0	1,315,170	0
Annual Time Burden (Hours)	507,094	513,528	0	0	-6,434	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: The information collection reflects adjustment. We have increased our estimate of the number of annual responses (+1,315,170) based on an increase in recall communications consistent with 21 CFR 7.49. At the same time, we have decreased our estimate of the overall burden hours (- 6,434) based on annual reporting. We believe the adjustments reflect expected fluctuations in burden attendant to the information collection activities associated with product recalls.

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Annual Cost to Federal Government: $30,139,776

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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? No

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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: 04/30/2024

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