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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:
0910-0625
ICR Reference No:
202206-0910-003
Status:
Active
Previous ICR Reference No:
202104-0910-012
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CDRH
Title:
Electronic Submission of Medical Device Registration and Listing
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:
08/04/2022
Retrieve Notice of Action (NOA)
Date Received in OIRA:
06/29/2022
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
08/31/2025
36 Months From Approved
08/31/2022
Responses
220,775
0
192,343
Time Burden (Hours)
113,832
0
102,950
Cost Burden (Dollars)
0
0
0
Abstract:
This information collection request covers the reporting and recordkeeping provisions associated with FDA's implementation of sections 222, 223, and 224 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which require that device establishment registrations and listings under section 21 U.S.C. 360(p) (including the submission of updated information) be submitted to the Secretary by electronic means, unless the Secretary grants a request for waiver of the requirement because the use of electronic means is not reasonable for the person requesting the waiver.
Authorizing Statute(s):
US Code:
21 USC 510(b)
US Code:
21 USC 510(j)(2)
US Code:
21 USC 510(p)
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:
87 FR 7187
02/08/2022
30-day Notice:
Federal Register Citation:
Citation Date:
87 FR 37859
06/24/2022
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
4
IC Title
Form No.
Form Name
Annual Registration & Listing when Electronic Filing Waiver granted (recurring)
Annual Request for Waiver from Electronic Registration & Listing (one time)
Annual Submittal of Manufacturer Information by Initial Importers (recurring)
Annual Update of Changes to US Agent Information
FDA 3673
FDA 3673
Annual Update of Listing Information
FDA 3673
FDA 3673
Identification of initial importers by foreign establishments
FDA 3673
FDA 3673
Identification of other parties that facilitate import by foreign establishments
Initial Registration & Listing
FDA 3673
FDA 3673
Initial Registration & Listing when Electronic Filing Waiver Granted (one time)
Initial Request for Waiver from Electronic Registration & Listing (recurring)
Intitial Submittal of Manufacturer Information by Initial Importers (One time)
Labeling & Advertisement Submitted at FDA Request
Labeling & Advertisements Available for Review
List of Officers, Directors and Partners
Other Updates of Registration
Registration & listing of devices: RECORDKEEPING
Registration & listing of devices: REPORTING
FDA 3673
FDA 3673
Transfer of 510(k) Notification: Agency GFI Recommendations
US Agent Responses to FDA Requests for Information
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
220,775
192,343
0
0
28,432
0
Annual Time Burden (Hours)
113,832
102,950
0
0
10,882
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:
Annual Cost to Federal Government:
$595,122
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:
06/29/2022
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