Agency Emergency Processing Under Office of Management and Budget Review; Implementation of Sections 222,223,and 224 of the Food and Drug Administration Act of 2007

Forms and Documents

Document Name	Status
Form 3673 Implementation of Sections 222, 223, and 224 of the Food and Drug Administratin Amendments Act of 2007 Form and Instruction	New
Guidance E-Regs. & listing.doc Supplementary Document	2008-05-09
SS-E Regs & Listing.DOC Supporting Statement A	2008-05-09

IC Document Collections

IC ID	Document Title	Status
184861	Implementation of Sections 222, 223, and 224 of the Food and Drug Administratin Amendments Act of 2007 Form and Instruction	New

ICR Details

OMB Control No: 0910-0625	ICR Reference No: 200805-0910-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Agency Emergency Processing Under Office of Management and Budget Review; Implementation of Sections 222,223,and 224 of the Food and Drug Administration Act of 2007
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 06/20/2008
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/11/2008
	Date Received in OIRA: 05/12/2008
Terms of Clearance: This ICR is approved for 6 months as submitted. OMB notes that information was collected prior to OMB approval, so FDA should report this as a PRA violation in the next ICB.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2009	6 Months From Approved
Responses	58,973	0	0
Time Burden (Hours)	30,796	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Effective September 27, 2007,Congress passed the Food and Drug Administration Amendments Act of 2007 (FDAAA). The FDAAA require that device establishment registrations and listing under section 21 U.S.C. 360(p), (including submission of updated information) be submitted by electronic means. Establishments may request and the Secetary may grant a request for waiver of the requirement if the use of "electronic means" is not reasonable for the establishment requesting the waiver. FDA expects 20,000 to 30,000 establishments will need to register between now and December 31, 2008.

Emergency Justfication: Effective September 27, 2007, sections 222, 223, and 224 of the Food and Drug Administration Amendments Act of 2007 (FDAA) require that device establishment registrations and listing under 21 U.S.C. 360(p) (including submission of updated information) be submitted to the Scretary by electronic means unless the Scretary grants a request for waiver of the requirement because the use of "electronic means" is not reasonable for the person requesting the waiver. FDA expects 20,000 to 30,000 establishments will need to register between now and December 31, 2008. In addition, these establishments must have available the opportunity to request waivers. Thus, emergency approval for this request is necessary to implement these provisions of the statue.

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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: 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:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 25750	05/07/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 25750	05/07/2008
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Implementation of Sections 222, 223, and 224 of the Food and Drug Administratin Amendments Act of 2007	3673	Device Registration & Listing Module

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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	58,973	0	58,973	0	0	0
Annual Time Burden (Hours)	30,796	0	30,796	0	0	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: This is a new collection

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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]? Uncollected

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)? Uncollected

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: 05/12/2008

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