Electronic Submission of Medical Device Registration and Listing

Forms and Documents

Document Name	Status
Form FDA 3673 Identification of initial importers by foreign establishments Form	Modified
Form FDA 3673 Annual Update of Listing Information Form	Modified
Form FDA 3673 Annual Update of Changes to US Agent Information Form	Modified
Form FDA 3673 Initial Registration & Listing Form	Modified
Form FDA 3673 Annual Registration Form	Modified
0625_Supporting Statement_2019.doc Supporting Statement A	2019-05-17

IC Document Collections

IC ID	Document Title	Status
203608	Intitial Submittal of Manufacturer Information by Initial Importers (One time)	Modified
203607	Identification of other parties that facilitate import by foreign establishments	Modified
203606	Identification of initial importers by foreign establishments Form	Modified
203605	US Agent Responses to FDA Requests for Information	Modified
203604	Annual Registration & Listing when Electronic Filing Waiver granted (recurring)	Modified
203603	Initial Registration & Listing when Electronic Filing Waiver Granted (one time)	Modified
203602	Labeling & Advertisement Submitted at FDA Request	Modified
203601	Creation of electronic system account	Modified
203600	Annual Submittal of Manufacturer Information by Initial Importers (recurring)	Modified
203599	Other Updates of Registration	Modified
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
202251	Initial Registration & Listing Form	Modified
184861	Annual Registration Form	Modified

ICR Details

OMB Control No: 0910-0625	ICR Reference No: 201904-0910-010
Status: Active	Previous ICR Reference No: 201603-0910-006
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: 06/17/2019
	Date Received in OIRA: 05/21/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2022	36 Months From Approved	06/30/2019
Responses	186,230	0	180,585
Time Burden (Hours)	93,798	0	99,470
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:
	83 FR 62583	12/04/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 20138	05/08/2019
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
Identification of initial importers by foreign establishments	FDA 3673	FDA 3673
Identification of other parties that facilitate import by foreign establishments
Intitial Submittal of Manufacturer Information by Initial Importers (One time)
Annual Registration	FDA 3673	FDA 3673
Initial Registration & Listing	FDA 3673	FDA 3673
Annual Update of Changes to US Agent Information	FDA 3673	FDA 3673
Annual Update of Listing Information	FDA 3673	FDA 3673
Initial Request for Waiver from Electronic Registration & Listing (recurring)
Annual Request for Waiver from Electronic Registration & Listing (one time)
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
List of Officers, Directors and Partners
Labeling & Advertisements Available for Review
Other Updates of Registration
Annual Submittal of Manufacturer Information by Initial Importers (recurring)
Creation of electronic system account

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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	186,230	180,585	0	0	5,645	0
Annual Time Burden (Hours)	93,798	99,470	0	0	-5,672	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 following adjustments resulted in a 5,672-hour decrease to the overall total hour burden estimate for this ICR. -We adjusted the number of respondents based on updated registration and listing data. -In the reporting burden table, we corrected the table footnotes to accurately indicate whether the IC is a one-time or reoccurring burden. -We also adjusted some of the IC descriptions in the table for increased clarity. -We updated our estimate of Hours per Response for “807.22(a) Initial Registration & Listing” (+0.5 hours), “807.22(b)(1) Annual Registration” (-0.25 hours), and “807.22(b)(3) Annual Update of Listing Information” (-0.25 hours). Based on our review of the program, we believe these changes to the burden estimate will more accurately reflect the current preparation time for these ICs.

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Annual Cost to Federal Government: $540,610

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? 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: 05/21/2019

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