Electronic Submission of Medical Device Registration and Listing

Forms and Documents

Document Name	Status
Form 3673 Identification of initial importers by foreign establishments Form	New
Form 3673 Annual Update of Listing Information Form	Modified
Form 3673 Annual Update of Changes to US Agent Information Form	Modified
Form FDA 3673 Annual Registration of Foreign Establishments Form	Removed
Form FDA 3673 Initial Registration & Listing Form	Modified
Form FDA 3673 Annual Registration Form	Modified
eReg__Listing_final_rule_supporting_statement Final.doc Supporting Statement A	2013-03-22

IC Document Collections

IC ID	Document Title	Status
203608	Submittal of Manufacturer Information by Initial Importers (One time)	New
203607	Identification of other parties that facilitate import by foreign establishments	New
203606	Identification of initial importers by foreign establishments Form	New
203605	US Agent Responses to FDA Requests for Information	New
203604	Annual Registration & Listing when Electronic Filing Waiver granted (recurring)	New
203603	Initial Registration & Listing when Electronic Filing Waiver Granted (one time)	New
203602	Labeling & Advertisement Submitted at FDA Request	New
203601	Creation of electronic system account	New
203600	Submittal of Manufacturer Information by Initial Importers (recurring)	New
203599	Other Updates of Registration	New
202258	Labeling & Advertisements Available for Review	Modified
202257	List of Officers, Directors and Partners	Modified
202256	Annual Request for Waiver from Electronic Registration & Listing (one time)	Modified
202255	Initial Request for Waiver from Electronic Registration & Listing (recurring)	Modified
202254	Annual Update of Listing Information Form	Modified
202253	Annual Update of Changes to US Agent Information Form	Modified
202252	Annual Registration of Foreign Establishments Form	Removed
202251	Initial Registration & Listing Form	Modified
184861	Annual Registration Form	Modified

ICR Details

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
	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

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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:
0910-AF88	Final or interim final rulemaking	77 FR 45927	08/02/2012

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 18

IC Title	Form No.	Form Name
Annual Update of Changes to US Agent Information	3673	FDA 3673
Annual Update of Listing Information	3673	FDA 3673
Initial Request for Waiver from Electronic Registration & Listing (recurring)
Annual Request for Waiver from Electronic Registration & Listing (one time)
List of Officers, Directors and Partners
Labeling & Advertisements Available for Review
Other Updates of Registration
Submittal of Manufacturer Information by Initial Importers (recurring)
Creation of electronic system account
Labeling & Advertisement Submitted at FDA Request
Initial Registration & Listing when Electronic Filing Waiver Granted (one time)
Annual Registration & Listing when Electronic Filing Waiver granted (recurring)
US Agent Responses to FDA Requests for Information
Identification of initial importers by foreign establishments	3673	FDA 3673
Identification of other parties that facilitate import by foreign establishments
Submittal of Manufacturer Information by Initial Importers (One time)
Annual Registration of Foreign Establishments	FDA 3673	3673
Annual Registration	FDA 3673	3673
Initial Registration & Listing	FDA 3673	FDA 3673

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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	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.

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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

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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: 08/06/2012

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