View Information Collection Request (ICR) Package
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COMMENT
Time Remaining
Days
HR
Min
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OMB Control No:
0910-0332
ICR Reference No:
202505-0910-007
Status:
Received in OIRA
Previous ICR Reference No:
202303-0910-005
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CDRH
Title:
Medical Devices; Humanitarian Use Devices
Type of Information Collection:
Reinstatement without change of a previously approved collection
Common Form ICR:
No
Type of Review Request:
Regular
Date Submitted to OIRA:
12/19/2025
Requested
Previously Approved
Expiration Date
36 Months From Approved
Responses
323
0
Time Burden (Hours)
22,584
0
Cost Burden (Dollars)
0
0
Abstract:
This information collection supports implementation of statutory and regulatory requirements governing humanitarian use devices (HUDs) required by the Federal Food, Drug, and Cosmetic Act. Respondents to the information collection are manufacturers and/or sponsors of these devices.
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:
90 FR 38151
08/07/2025
30-day Notice:
Federal Register Citation:
Citation Date:
90 FR 57067
12/09/2025
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
5
IC Title
Form No.
Form Name
Certification of Compliance with 42 U.S.C. ยง 282(j)(5)(B)
Humanitarian Use Devices; Notification of emergency use--814.124(a)
Information to Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements
Medical Devices; Humanitarian Use Devices - Recordkeeping
Medical Devices; Humanitarian Use Devices - Reporting
ICR Summary of Burden
Total Request
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
323
0
0
0
-63
386
Annual Time Burden (Hours)
22,584
0
0
0
-321
22,905
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:
Our estimated burden for the information collection reflects an overall decrease of 321 hours and a corresponding decrease of 63 responses. The total hour burden for this information collection is estimated to be 22,584 hours.
Annual Cost to Federal Government:
$9,781,342
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
Yes
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
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?
No
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:
12/19/2025
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