Medical Devices; Humanitarian Use Devices; 21 CFR Part 814 - Subpart H

Forms and Documents

Document	Type	Status	Availability
0332 SS 2011.doc	Supporting Statement A	Uploaded 2012-01-03	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
5922	Medical Devices; Humanitarian Use Devices; 21 CFR Part 814 - Subpart H		Modified

ICR Details

OMB Control No: 0910-0332	ICR Reference No: 201201-0910-003
Status: Historical Active	Previous ICR Reference No: 200812-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Medical Devices; Humanitarian Use Devices; 21 CFR Part 814 - Subpart H
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: 02/28/2012
	Date Received in OIRA: 01/04/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2015	36 Months From Approved	02/29/2012
Responses	154	0	45
Time Burden (Hours)	12,585	0	11,144
Cost Burden (Dollars)	0	0	0

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Abstract: The information gathered by this collection activity enables FDA to determine whether an Humanitarian Device Exception (HDE) holder is in compliance with the HDE requirements. It also allows FDA to determine whether to: (1) Grant Humanitarian Use Device (HUD) designation of a medical device, (2) exempt a HUD from the effectiveness requirements under sections 514 and 515 of the act (21 U.S.C.360d and 360e)provided that the device meets requirements set forth in section 520m of the act, and (3)grant marketing approval(s)for HUD. Failure to collect this information would prevent FDA from making that determination.

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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:
	76 FR 55394	09/07/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 82301	12/30/2011
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	154	45	0	0	109	0
Annual Time Burden (Hours)	12,585	11,144	0	0	1,441	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: The burden represented by this collection of information has increased by 1,441 hours and 109 respondents since the last time OMB approved this information collection. This increase in burden is the result of adjustments of the number of respondents for each section based on data from the previous 3 years (fiscal years 2008 through 2010) and the number of anticipated responses to § 814.108. The new total burden hours for this collection are 12,585.

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Annual Cost to Federal Government: $2,668,500

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: 01/04/2012

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