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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:
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
Retrieve Notice of Action (NOA)
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
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)
Authorizing Statute(s):
US Code:
21 USC 222
US Code:
21 USC 223
US Code:
21 USC 224
Citations for New Statutory Requirements:
US Code: 21 USC 222
US Code: 21 USC 223
US Code: 21 USC 224
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
0910-AF88
Proposed rulemaking
75 FR 14510
03/26/2010
Federal Register Notices & Comments
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
17
IC Title
Form No.
Form Name
Reporting - Creation of New Electronic User Accounts by Medical Device Establishments Using FDA`s Unified Registration & Listing Systems ( FURLS)
3673
Device Registration & Listing Module
21 CFR 807.20 (a) - Reporting - Requirement for Registration & Listing Information for Devices in Commercial Distribution
3673
Device Registration & Listing Module
Recordkeeping - Requirement for Owners / Operators to Maintain Additional Listing Information
Recordkeeping- Requirement For Owners/Operators To maintain Listing Information Of All Officers
Reporting - Annual Initial Registration Requirement for Foreign Establishments To Report Any Changes, Including Agents ,Brokers etc.
3673
Devic 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 - Initial Registration & Listing Information ( to be sent by letter) ) for Owners / Operators Granted a Waiver ... . ( recurring burden)
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 - 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 - Waiver Request Requirements ... . ( Recurring Burden)
Reporting- Additional Listing Information that May be Submitted by Postal Mail or Electronically by E-Mail Upon FDA Request
Reporting- Annual Registration Requirements Each Fiscal Year For All Establishments
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- 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- Initial Registration & Listing Requirements for Medical Device Establishments Not Previously Entered Into An Operation
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- 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)
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.
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
Agency Contact:
Jonnalynn Capezzuto 3018274659
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:
05/24/2010
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