Implementation of Sections 222, 223 and 224 of the Food and Drug Administration Act of 2007

Forms and Documents

Document Name	Status
Form 3673 Reporting - Annual Initial Registration Requirement for Foreign Establishments To Report Any Changes, Including Agents ,Brokers etc. Form and Instruction	New
Form 3673 Reporting - Annual Initial Registration Requirements Regarding Any Changes by Foreign Establishments Using FURLS. Establishments Must Specify Listed Product Each Importer Receives Form and Instruction	New
Form 3673 Reporting - Requirement for Foreign Establishment or U.S. Agent to Report Changes in U.S. Agents Name Address of Telephone Number Within 10 Business Days of Change Form and Instruction	New
Form 3673 Reporting- Foreign Establishments Response to Questions By FDA Regarding Products Offered for Import into The U.S. Response is Communicated on Behalf of Foreign Establishments United States Agent Form and Instruction	New
Form 3673 Reporting - Initial Registration & Listing Information ( to be sent by letter) For Owners / Operators Granted a Waiver From Electronic Filing ( one time burden) Form and Instruction	New
Form 3673 Reporting- Fiscal Year Update Requirements For Owners / Operarors to Review / Update Device Listing Information On File With FDA For the Period October 1 and Ending December 31. Form and Instruction	New
Form 3673 Reporting- Updates to Registration & Listing Information to Be Made Within 30 days of Change Form and Instruction	New
Form 3673 Reporting- Annual Registration Requirements Each Fiscal Year For All Establishments Form and Instruction	New
Form 3673 Reporting- Initial Registration & Listing Requirements for Medical Device Establishments Not Previously Entered Into An Operation Form and Instruction	New
Form 3673 Reporting - Creation of New Electronic User Accounts by Medical Device Establishments Using FDA`s Unified Registration & Listing Systems ( FURLS) Form and Instruction	New
Form 3673 21 CFR 807.20 (a) - Reporting - Requirement for Registration & Listing Information for Devices in Commercial Distribution Form and Instruction	Modified
SS - E- Regs & Listing #2.doc Supporting Statement A	2010-04-07

IC Document Collections

IC ID	Document Title	Status
193016	Recordkeeping - Requirement for Owners / Operators to Maintain Additional Listing Information	New
193015	Recordkeeping- Requirement For Owners/Operators To maintain Listing Information Of All Officers	New
193014	Reporting - Annual Initial Registration Requirement for Foreign Establishments To Report Any Changes, Including Agents ,Brokers etc. Form and Instruction	New
193013	Reporting - Annual Initial Registration Requirements Regarding Any Changes by Foreign Establishments Using FURLS. Establishments Must Specify Listed Product Each Importer Receives Form and Instruction	New
193012	Reporting - Requirement for Foreign Establishment or U.S. Agent to Report Changes in U.S. Agents Name Address of Telephone Number Within 10 Business Days of Change Form and Instruction	New
193011	Reporting- Foreign Establishments Response to Questions By FDA Regarding Products Offered for Import into The U.S. Response is Communicated on Behalf of Foreign Establishments United States Agent Form and Instruction	New
193010	Reporting - Initial Registration & Listing Information ( to be sent by letter) ) for Owners / Operators Granted a Waiver ... . ( recurring burden)	New
193009	Reporting - Initial Registration & Listing Information ( to be sent by letter) For Owners / Operators Granted a Waiver From Electronic Filing ( one time burden) Form and Instruction	New
193008	Reporting- Additional Listing Information that May be Submitted by Postal Mail or Electronically by E-Mail Upon FDA Request	New
193007	Reporting- Fiscal Year Update Requirements For Owners / Operarors to Review / Update Device Listing Information On File With FDA For the Period October 1 and Ending December 31. Form and Instruction	New
193006	Reporting- Updates to Registration & Listing Information to Be Made Within 30 days of Change Form and Instruction	New
193005	Reporting- Annual Registration Requirements Each Fiscal Year For All Establishments Form and Instruction	New
193004	Reporting- Initial Registration & Listing Requirements for Medical Device Establishments Not Previously Entered Into An Operation Form and Instruction	New
193003	Reporting - Waiver Request Requirements ... . ( Recurring Burden)	New
193002	Reporting- Waiver Request Requirements For An Owner or Operator, If Use By Electronic Means for Submission of Registration & Listing Information Is Not Reasonable ( One time burden)	New
193001	Reporting - Creation of New Electronic User Accounts by Medical Device Establishments Using FDA`s Unified Registration & Listing Systems ( FURLS) Form and Instruction	New
184861	21 CFR 807.20 (a) - Reporting - Requirement for Registration & Listing Information for Devices in Commercial Distribution Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0625	ICR Reference No: 201005-0910-010
Status: Historical Inactive	Previous ICR Reference No: 200812-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Implementation of Sections 222, 223 and 224 of the Food and Drug Administration Act of 2007
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule and continue	Conclusion Date: 10/01/2010
	Date Received in OIRA: 05/24/2010
Terms of Clearance: OMB files this comment in accordance with 5 CFR 1320.11(c). This OMB action is not an approval to conduct or sponsor an information collection under the Paperwork Reduction Act of 1995. This action has no effect on any current approvals. If OMB has assigned this ICR a new OMB Control Number, the OMB Control Number will not appear in the active inventory. For future submissions of this information collection, reference the OMB Control Number provided. In accordance with 5 CFR 1320, the agency should resubmit this ICR at the final rule stage.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2012	36 Months From Approved	06/30/2012
Responses	58,973	0	58,973
Time Burden (Hours)	71,319	0	71,319
Cost Burden (Dollars)	0	0	0

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Abstract: The FDA is proposing to amend its regulations governing medical device establishment registration and device listing. The Food and Drug Administration Amendments Act of 2007 (FDAA) which was enacted on September 27,2007, amended section 510 of the FD&C Act by requiring domestic and foreign device establishments to begin submitting their registration and device listing information to FDA by electronic means rather than on paper form and also specified the timeframes when establishments are required to submit such information. In accordance with FDAAA, the agency launched FDAs Unified Registration and Listing System (FURLS), an internet-based registration and listing system. FDAAA requires electronic submission of device registration and listing information unless FDA grants a waiver. In addition, this proposal would facilitate FDA`s collection of additional registration information from foreign establishments as required by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act)

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Authorizing Statute(s): US Code: 21 USC 222 Name of Law: null
   US Code: 21 USC 223 Name of Law: null
   US Code: 21 USC 224 Name of Law: null
  

Citations for New Statutory Requirements: US Code: 21 USC 222 Name of Law: null
US Code: 21 USC 223 Name of Law: null
US Code: 21 USC 224 Name of Law: null

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AF88	Proposed rulemaking	75 FR 14510	03/26/2010

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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: 17

IC Title	Form No.	Form Name
Reporting- Initial Registration & Listing Requirements for Medical Device Establishments Not Previously Entered Into An Operation	3673	Device registration & Listing Module
Reporting- Annual Registration Requirements Each Fiscal Year For All Establishments	3673	Device Registration & Listing Module
Reporting- Updates to Registration & Listing Information to Be Made Within 30 days of Change	3673	Device registration & Listing Module
Reporting- Fiscal Year Update Requirements For Owners / Operarors to Review / Update Device Listing Information On File With FDA For the Period October 1 and Ending December 31.	3673	Device registration & Listing Module
Reporting- Additional Listing Information that May be Submitted by Postal Mail or Electronically by E-Mail Upon FDA Request
Reporting - Initial Registration & Listing Information ( to be sent by letter) For Owners / Operators Granted a Waiver From Electronic Filing ( one time burden)	3673	Device Registration & Listing Module
Reporting - Initial Registration & Listing Information ( to be sent by letter) ) for Owners / Operators Granted a Waiver ... . ( recurring burden)
Reporting- Foreign Establishments Response to Questions By FDA Regarding Products Offered for Import into The U.S. Response is Communicated on Behalf of Foreign Establishments United States Agent	3673	Device Registration & Listing Module
Reporting - Requirement for Foreign Establishment or U.S. Agent to Report Changes in U.S. Agents Name Address of Telephone Number Within 10 Business Days of Change	3673	Device Registration & Listing Module
Reporting - Annual Initial Registration Requirements Regarding Any Changes by Foreign Establishments Using FURLS. Establishments Must Specify Listed Product Each Importer Receives	3673	Device Registration & Listing Module
Reporting - Annual Initial Registration Requirement for Foreign Establishments To Report Any Changes, Including Agents ,Brokers etc.	3673	Devic Registration & Listing Module
Recordkeeping- Requirement For Owners/Operators To maintain Listing Information Of All Officers
Recordkeeping - Requirement for Owners / Operators to Maintain Additional Listing Information
21 CFR 807.20 (a) - Reporting - Requirement for Registration & Listing Information for Devices in Commercial Distribution	3673	Device Registration & Listing Module
Reporting- Waiver Request Requirements For An Owner or Operator, If Use By Electronic Means for Submission of Registration & Listing Information Is Not Reasonable ( One time burden)
Reporting - Creation of New Electronic User Accounts by Medical Device Establishments Using FDA`s Unified Registration & Listing Systems ( FURLS)	3673	Device Registration & Listing Module
Reporting - Waiver Request Requirements ... . ( Recurring Burden)

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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 current approved reporting and recordkeeping burden for electronic registration and listing under OMB Control No. 0910-0625 is 71,319 hours. The estimated reporting and recordkeeping burden for electronic registration and listing under the proposed rule is 103,536 hours. This increase is due to the incremental increase of respondents no longer exempt from these requirements.

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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]? Uncollected

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: 05/24/2010

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