Agency Emergency Processing Under OMB Review; Medical Device User Fee Amendments of 2007; Foreign Small Business Qualification Certification Form 3602 A

Forms and Documents

Document Name	Status
Form 3602 A Medical Device User Fee Amendments of 2007; Foreign Small Business Qualification Certification FDA form 3602 A Form and Instruction	New
Cover Memo- Justification 3602A.doc Supplementary Document	2007-10-03
SS-Form 3602 A SBQC.doc Supporting Statement A	2007-10-03

IC Document Collections

IC ID	Document Title	Status
182274	Medical Device User Fee Amendments of 2007; Foreign Small Business Qualification Certification FDA form 3602 A Form and Instruction	New

ICR Details

OMB Control No: 0910-0613	ICR Reference No: 200710-0910-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Agency Emergency Processing Under OMB Review; Medical Device User Fee Amendments of 2007; Foreign Small Business Qualification Certification Form 3602 A
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: 10/10/2007
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/15/2007
	Date Received in OIRA: 10/05/2007
Terms of Clearance: FDA will resubmit this collection to OMB in accordance with the usual PRA procedures prior to the expiration of the 6 month approval period.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2008	6 Months From Approved
Responses	300	0	0
Time Burden (Hours)	458	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Medical Device User Fee Amendments of 2007 ( " the 2007 Amendments"), provides a new way for a foreign business to qualify as a small business eligible to pay a significant lower fee when a medical device user fee must be paid. Foreign establishments requesting small business status would complete Form FDA 3602 A.

Emergency Justfication: The Medical Device User Fee and Modernization Act of 2002, (MDUFMA), expired September 30, 2007. Congress recently passed an omnibus bill that included the Medical Device User fee Amendments of 2007 ("the 2007 Amendments")which will reauthorize medical device user fees for fiscal years 2008 through 2012.The user fee provisions for the 2007 Amendments provides for an October 1,2007 effective date. Thus, emergency approval for this collection of information is neccessary to implement these provisions and comply with the statutoty timeframe.

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Authorizing Statute(s): US Code: 21 USC 379j Name of Law: null
  

Citations for New Statutory Requirements: US Code: 21 USC 738 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:
	72 FR 56077	10/02/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 56077	10/02/2007
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
Medical Device User Fee Amendments of 2007; Foreign Small Business Qualification Certification FDA form 3602 A	3602 A	FY 2008 MDUFMA Small Business Qualification Certification

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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	300	0	300	0	0	0
Annual Time Burden (Hours)	458	0	458	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: $20,610

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: 10/05/2007

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