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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:
0910-0767
ICR Reference No:
202008-0910-011
Status:
Historical Active
Previous ICR Reference No:
201706-0910-009
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CDRH
Title:
Annual Reporting for Custom Device Exemption
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:
10/02/2020
Retrieve Notice of Action (NOA)
Date Received in OIRA:
08/31/2020
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
10/31/2023
36 Months From Approved
10/31/2020
Responses
34
0
33
Time Burden (Hours)
1,360
0
1,320
Cost Burden (Dollars)
0
0
0
Abstract:
This ICR collects information from manufacturers of custom devices through submission of an annual report to FDA that identifies the number of new custom devices unit manufactured and distributed per year. Based on the information provided in the annual report, FDA will determine whether a device continues to meet the qualifications for a custom device exemption. Also, the annual reports will allow FDA to assess several important issues related to the description and use of the custom device in patients and physicians. As a result, manufacturers developing a custom device for a product not generally available in the United States and meet the requirements defined in section 520(b) of FD&C Act, will be required to develop and submit an annual report for the maximum five units per year of a particular device type.
Authorizing Statute(s):
PL:
Pub.L. 112 - 144 617
Name of Law: FDASIA
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:
85 FR 10175
02/21/2020
30-day Notice:
Federal Register Citation:
Citation Date:
85 FR 41593
07/10/2020
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
Annual Report for Custom Devices
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
34
33
0
0
1
0
Annual Time Burden (Hours)
1,360
1,320
0
0
40
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 information collection reflects adjustment. We have increased the number of respondents from 33 to 34 to reflect more recent data.
Annual Cost to Federal Government:
$0
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.
No
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:
Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@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:
08/31/2020
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