FDA Recall Regulations

Forms and Documents

Document Name	Status
0249 ss final 4-6-2018.pdf Supporting Statement A	2018-04-06

IC Document Collections

IC ID	Document Title	Status
5832	Firm Initiated Recall and Recall Communications	Modified
230580	General Industry Guidance	New
215023	Recall Communications-third party disclosure	Modified
215022	Termination of a Recall	Modified
215021	Recall Status Reports	Modified

ICR Details

OMB Control No: 0910-0249	ICR Reference No: 201802-0910-013
Status: Active	Previous ICR Reference No: 201502-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: ORA
Title: FDA Recall Regulations
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 04/06/2018
	Date Received in OIRA: 03/08/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2021	36 Months From Approved	04/30/2018
Responses	1,523,502	0	1,748,460
Time Burden (Hours)	584,477	0	721,886
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 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:
	82 FR 54359	11/17/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 8284	02/26/2018
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
General Industry Guidance
Firm Initiated Recall and Recall Communications
Recall Status Reports
Termination of a Recall
Recall Communications-third party disclosure

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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	1,523,502	1,748,460	0	-225,915	-1,896	2,853
Annual Time Burden (Hours)	584,477	721,886	0	-147,024	-33,180	42,795
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The adjustment in burden is due to the decreased number of respondents from 3,801 to 2,853 (-948). FDA discovered that 21 CFR 7.59 (general industry guidance) contained information collection that was not previously approved and, therefore, added it to this ICR request for extension of OMB approval. Despite this addition the estimated total burden has decreased 137,409 hours.

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Annual Cost to Federal Government: $27,313,886

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? 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: 03/08/2018

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