View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
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
Retrieve Notice of Action (NOA)
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
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.
Authorizing Statute(s):
US Code:
21 USC 360(e)
US Code:
21 USC 360(d)
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
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
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
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 ยง 814.108. The new total burden hours for this collection are 12,585.
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
Agency Contact:
Daniel Gitteson 3017965156 daniel.gitteson@fda.hhs.gov
Common Form ICR:
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:
(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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