Transfer of a Premarket Notification Clearance

Forms and Documents

Document	Type	Status	Availability
NEW_Supporting Statement_3-2018.doc	Supporting Statement A	Uploaded 2018-03-02	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
230335	Submission of 510(k) transfer documentation when more than one party lists the same 510(k)	Other-Guidance	New
230334	Voluntary reporting of transfer of 510(k) Clearance on FDA's Unified Registration and Listing System (Outside of Annual Listing Reporting Requirement)	Other-Guidance	New

ICR Details

OMB Control No: 0910-0852	ICR Reference No: 201803-0910-002
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Transfer of a Premarket Notification Clearance
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/15/2018
	Date Received in OIRA: 03/14/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2021	36 Months From Approved
Responses	6,113	0	0
Time Burden (Hours)	9,152	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR collects information from premarket notification (510(k)) clearance holders and parties claiming to be 510(k) holders who wish to voluntarily report a transfer of 510(k) clearance on FDA’s Unified Registration and Listing System (FURLS), outside of the required listing reporting and the annual listing reporting requirement, or who submit 510(k) transfer documentation when more than one party lists the same 510(k). The information notifies FDA of the transfer of a premarket notification clearance from one holder to another and helps to ensure that the public information in FDA’s databases about the current 510(k) holder for a specific device(s) is accurate and up-to-date.

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Authorizing Statute(s): None

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 76331	12/22/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 10862	03/13/2018
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Voluntary reporting of transfer of 510(k) Clearance on FDA's Unified Registration and Listing System (Outside of Annual Listing Reporting Requirement)
Submission of 510(k) transfer documentation when more than one party lists the same 510(k)

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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	6,113	0	0	6,113	0	0
Annual Time Burden (Hours)	9,152	0	0	9,152	0	0
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: No

Burden Reduction Due to:

Short Statement: New collection

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Annual Cost to Federal Government: $306,800

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: 03/14/2018

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