Medical Device Recall Authority

Forms and Documents

Document Name	Status
0432--Device Recall Authority--SS--05-28-2015.doc Supporting Statement A	2015-05-29

IC Document Collections

IC ID	Document Title	Status
6106	Collections Specified in the Order--810.10(d)	Unchanged
202312	Notification of Consignees by Recipients--810.15(e)	Unchanged
202311	Notification to Recipients; Follow-up--810.15(d)	Unchanged
202310	Notification to Recipients--810.15(a)-(c)	Unchanged
202309	Documentation of Notifications to Recipients--810.15(b)	Unchanged
202308	Termination Request--810.17(a)	Unchanged
202307	Periodic Status Reports--810.16(a-b)	Unchanged
202306	Mandatory Recall Strategy--810.14	Unchanged
202305	Written Request for Review--810.12(a-b)	Unchanged
202300	Request for Regulatory Hearing--810.11(a)	Unchanged

ICR Details

OMB Control No: 0910-0432	ICR Reference No: 201505-0910-004
Status: Historical Active	Previous ICR Reference No: 201202-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Medical Device Recall Authority
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: 09/30/2015
	Date Received in OIRA: 06/15/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2018	36 Months From Approved	09/30/2015
Responses	48	0	48
Time Burden (Hours)	1,090	0	1,090
Cost Burden (Dollars)	0	0	0

---

Abstract: This ICR collects information from manufacturers, importers, distributors, and retailers of a medical device. If FDA finds that there is a reasonable probability that a device intended for human use would cause serious adverse health consequences or death, FDA has the authority to issue an order requiring the appropriate person; including manufacturers, importers, distributors, and retailers of a device to: immediately cease distribution of such device; notify health professionals and device user facilities of the order; and instruct those professionals and device user facilities to cease use of the device. The information collections associated with this are: Collections specified in the order, requests for a regulatory hearing, written requests for review, mandatory recall strategy, notifications to recipients (and follow-up), documentation of notifications to recipients, notification of consignees by recipients, periodic status reports, and termination requests.

---

Authorizing Statute(s): US Code: 21 USC 360h Name of Law: null
  

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:
	80 FR 13586	03/16/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 33524	06/12/2015
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 10

IC Title	Form No.	Form Name
Mandatory Recall Strategy--810.14
Collections Specified in the Order--810.10(d)
Request for Regulatory Hearing--810.11(a)
Written Request for Review--810.12(a-b)
Periodic Status Reports--810.16(a-b)
Termination Request--810.17(a)
Documentation of Notifications to Recipients--810.15(b)
Notification to Recipients--810.15(a)-(c)
Notification to Recipients; Follow-up--810.15(d)
Notification of Consignees by Recipients--810.15(e)

---

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	48	48	0	0	0	0
Annual Time Burden (Hours)	1,090	1,090	0	0	0	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:

---

Annual Cost to Federal Government: $349,487

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

---

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: 06/15/2015

---