Medical Devices; Humanitarian Use Devices--21 CFR 814

Forms and Documents

Document Name	Status
0332-SS--11-17-14.doc Supporting Statement A	2014-12-01

IC Document Collections

IC ID	Document Title	Status
5922	Medical Devices; Humanitarian Use Devices; 21 CFR Part 814 - Subpart H	Modified

ICR Details

OMB Control No: 0910-0332	ICR Reference No: 201411-0910-010
Status: Historical Active	Previous ICR Reference No: 201212-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Medical Devices; Humanitarian Use Devices--21 CFR 814
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/06/2015
	Date Received in OIRA: 12/03/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2018	36 Months From Approved	02/28/2015
Responses	192	0	154
Time Burden (Hours)	19,710	0	12,585
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR collects information from manufactures who wish to obtain "Humanitarian Use Device" (HUD) designation for a medical device and marketing approval for the HUD notwithstanding the absence of reasonable assurance of effectiveness that would otherwise be required. To the extent consistent with the protection of the public health and safety and with ethical standards, this program encourages the discovery and use of devices intended to benefit patients in the treatment or diagnosis of diseases or conditions that affect or are manifested in fewer than 4,000 individuals in the United States per year. Obtaining marketing approval for a HUD involves two steps: (1) Obtaining designation of the device as a HUD from FDA's Office of Orphan Products Development and (2) submitting a Humanitarian Device Exemption (HDE) application to the Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH), the Center for Biologics Evaluation and Research (CBER), or the Center for Drug Evaluation and Research (CDER), as applicable. A person granted an exemption must submit periodic reports.

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

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 33197	06/10/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 71110	12/01/2014
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
Medical Devices; Humanitarian Use Devices; 21 CFR Part 814 - Subpart H

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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	192	154	0	38	0	0
Annual Time Burden (Hours)	19,710	12,585	0	7,125	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: After a review under the PRA, we have determined that it is more appropriate to categorize the "Notification of emergency use-814.124(a)" information collection as third-party disclosure because respondents (physicians) provide written notification to the IRB, a "third-party," rather than directly to FDA. We have therefore moved the IC to the newly added third-party disclosure burden table above.

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Annual Cost to Federal Government: $6,378,458

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: 12/03/2014

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