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:
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
Retrieve Notice of Action (NOA)
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
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.
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:
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
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
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.
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
Agency Contact:
Amber Sanford 301 796-8867 amber.sanford@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:
12/03/2014
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