Electronic Submission of Medical Device Registration and Listing

Forms and Documents

Document Name	Status
Form 3673 Annual Update of Listing Information Form	New
Form FDA 3673 Annual Update of Changes to US Agent Information Form	New
Form FDA 3673 Annual Registration of Foreign Establishments Form	New
Form FDA 3673 Initial Registration Form	New
Form FDA 3673 Annual Update of Registration Information Form	Modified
OMB-FDA Q&A April 2012.doc Supplementary Document	2012-04-18
0910-0625 SUPPORTING_STATEMENT_2012 Final.doc Supporting Statement A	2012-05-11

IC Document Collections

IC ID	Document Title	Status
202258	Labeling and Advertisements and other Promotional Material	New
202257	List of Officers, Directors and Partners Available	New
202256	Annual Waiver Request Other-Guidance	New
202255	Initial Waiver Request Other-Guidance	New
202254	Annual Update of Listing Information Form	New
202253	Annual Update of Changes to US Agent Information Form	New
202252	Annual Registration of Foreign Establishments Form	New
202251	Initial Registration Form	New
184861	Annual Update of Registration Information Form	Modified

ICR Details

OMB Control No: 0910-0625	ICR Reference No: 201201-0910-005
Status: Historical Active	Previous ICR Reference No: 200812-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No:
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 with change	Conclusion Date: 06/12/2012
	Date Received in OIRA: 01/18/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2015	36 Months From Approved	06/30/2012
Responses	121,343	0	58,973
Time Burden (Hours)	72,625	0	71,319
Cost Burden (Dollars)	0	0	0

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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.

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Authorizing Statute(s): US Code: 21 USC 510(j)(2) Name of Law: null
   US Code: 21 USC 510(p) Name of Law: null
   US Code: 21 USC 510(b) Name of Law: null
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 68195	11/03/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 2068	01/13/2012
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 9

IC Title	Form No.	Form Name
Annual Update of Registration Information	FDA 3673	3673
Initial Registration	FDA 3673	3673
Annual Registration of Foreign Establishments	FDA 3673	3673
Annual Update of Changes to US Agent Information	FDA 3673	3673
Annual Update of Listing Information	3673	FDA 3673
Initial Waiver Request
Annual Waiver Request
List of Officers, Directors and Partners Available
Labeling and Advertisements and other Promotional Material

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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	121,343	58,973	0	0	62,370	0
Annual Time Burden (Hours)	72,625	71,319	0	0	1,306	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: There has been an adjustment in the burden hours and annual responses for this collection. FDA attributes the increase in burden to the additional information that must be submitted to comply with FDAAA. FDA attributes the decrease in responses to more accurate estimates. Prior to the electronic system, registrants were not deleted from they rolls unless an FDA District Office confirmed that the registrant was no longer in business. Under the system currently in place, potential registrants were notified that they must confirm their registrations or they would be deleted from the system.

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Annual Cost to Federal Government: $1,528,775

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

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Common Form ICR:  No

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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: 01/18/2012

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