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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:
201208-0910-003
Status:
Historical Active
Previous ICR Reference No:
201201-0910-005
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Title:
Electronic Submission of Medical Device Registration and Listing
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
03/25/2013
Retrieve Notice of Action (NOA)
Date Received in OIRA:
08/06/2012
Terms of Clearance:
Following this approval, FDA will discontinue OMB control number 0910-0387, which covers paper-based registration & listing.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
03/31/2016
36 Months From Approved
06/30/2015
Responses
180,585
0
121,343
Time Burden (Hours)
99,470
0
72,625
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(j)(2)
US Code:
21 USC 510(p)
US Code:
21 USC 510(b)
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
0910-AF88
Final or interim final rulemaking
77 FR 45927
08/02/2012
Federal Register Notices & Comments
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
18
IC Title
Form No.
Form Name
Annual Registration
FDA 3673
3673
Annual Registration & Listing when Electronic Filing Waiver granted (recurring)
Annual Registration of Foreign Establishments
FDA 3673
3673
Annual Request for Waiver from Electronic Registration & Listing (one time)
Annual Update of Changes to US Agent Information
3673
FDA 3673
Annual Update of Listing Information
3673
FDA 3673
Creation of electronic system account
Identification of initial importers by foreign establishments
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)
Labeling & Advertisement Submitted at FDA Request
Labeling & Advertisements Available for Review
List of Officers, Directors and Partners
Other Updates of Registration
Submittal of Manufacturer Information by Initial Importers (One time)
Submittal of Manufacturer Information by Initial Importers (recurring)
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
180,585
121,343
0
59,242
0
0
Annual Time Burden (Hours)
99,470
72,625
0
26,845
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:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
There is a program change due to an associated final rule. FDA attributes the increase in burden hours to the more accurate estimates from FURLS and the increase in burden from requiring (1) initial importers to identify manufacturers by product, (2) foreign manufacturers identifying their importers, and (3) contract manufacturers and sterilizers that do not put their devices into commercial distribution to register and list.
Annual Cost to Federal Government:
$208,000
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:
08/06/2012
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