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	Modified
SS-- 0910-0625.doc Supporting Statement A	2008-12-15

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	Modified

ICR Details

OMB Control No: 0910-0625	ICR Reference No: 200812-0910-006
Status: Historical Active	Previous ICR Reference No: 200805-0910-001
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: Approved without change	Conclusion Date: 03/16/2009
	Date Received in OIRA: 12/18/2008
Terms of Clearance: Previous terms of clearance remain in effect.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2012	36 Months From Approved	03/31/2009
Responses	58,973	0	58,973
Time Burden (Hours)	71,319	0	30,796
Cost Burden (Dollars)	0	0	0

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Abstract: The FDA has amended its regulations governing medical device establishment registration and device listing. FDA has modified 21 CFR Part 807 to reflect amendments to the device registration and listing provisions, section 510 of the Federal Food, Drug and Cosmetic Act (FD&C Act)( 21 U.S.C. 360). The FDA Amendments Act of 2007 ( FDAAA) amends section 510 of the FD& C Act to require domestic and foreign device establishments to submit registration and device listing information to FDA by electronic means instead of continuing to use paper forms, and specifies the timeframes when establishments are required to submit such information. FDAAA requires electronic submission of device registration and listing information unless FDA grants a waiver request.

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Authorizing Statute(s): US Code: 21 USC 510(b) Name of Law: null
   US Code: 21 USC 510(j)(2) Name of Law: null
   US Code: 21 USC 510(p) 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 57106	10/01/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 75723	12/12/2008
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 and 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	58,973	0	0	0	0
Annual Time Burden (Hours)	71,319	30,796	40,523	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: Under the new statutory provisions of the Food and Drug Amendments Act of 2007 (FDAA) the Agency upon further evaluation determine there were also recordkeeping requirements associated with the information collection request, that were not submitted as a component of the package for emergency approval. Thus, FDA is correcting this over sight to include this progran change (increase) in the burden estimate of 40,523 burden hours for recordkeeping.

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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: 12/18/2008

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