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

ICR 201201-0910-003

OMB: 0910-0332

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2012-01-03
IC Document Collections
ICR Details
0910-0332 201201-0910-003
Historical Active 200812-0910-004
HHS/FDA
Medical Devices; Humanitarian Use Devices; 21 CFR Part 814 - Subpart H
Extension without change of a currently approved collection   No
Regular
Approved without change 02/28/2012
Retrieve Notice of Action (NOA) 01/04/2012
  Inventory as of this Action Requested Previously Approved
02/28/2015 36 Months From Approved 02/29/2012
154 0 45
12,585 0 11,144
0 0 0

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.

US Code: 21 USC 360(e) Name of Law: null
   US Code: 21 USC 360(d) Name of Law: null
  
None

Not associated with rulemaking

  76 FR 55394 09/07/2011
76 FR 82301 12/30/2011
No

1
IC Title Form No. Form Name
Medical Devices; Humanitarian Use Devices; 21 CFR Part 814 - Subpart H

  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
No
No
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.

$2,668,500
No
No
No
No
No
Uncollected
Daniel Gitteson 3017965156 [email protected]

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
01/04/2012


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