Annual Reporting for Custom Device Exemption

Forms and Documents

Document Name	Status
Custom Device Exemption ss 4-29-14.doc Supporting Statement A	2014-04-29

IC Document Collections

IC ID	Document Title	Status
211453	Annual Report for Custom Devices Other-Guidance document	New

ICR Details

OMB Control No: 0910-0767	ICR Reference No: 201404-0910-015
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Annual Reporting for Custom Device Exemption
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: 07/03/2014
	Date Received in OIRA: 05/14/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2017	36 Months From Approved
Responses	33	0	0
Time Burden (Hours)	1,320	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR collects information from manufacturers of custom devices through submission of an annual report to FDA that identifies the number of new custom devices unit manufactured and distributed per year. Based on the information provided in the annual report, FDA will determine whether a device continues to meet the qualifications for a custom device exemption. Also, the annual reports will allow FDA to assess several important issues related to the description and use of the custom device in patients and physicians. As a result, manufacturers developing a custom device for a product not generally available in the United States and meet the requirements defined in section 520(b) of FD&C Act, will be required to develop and submit an annual report for the maximum five units per year of a particular device type.

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Authorizing Statute(s): PL: Pub.L. 112 - 144 617 Name of Law: FDASIA
  

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 2446	01/14/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 26434	05/08/2014
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Annual Report for Custom Devices

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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	33	0	0	33	0	0
Annual Time Burden (Hours)	1,320	0	0	1,320	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: This is a new information collection.

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Annual Cost to Federal Government: $0

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: 05/14/2014

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