Medical Device User Fee Amendments of 2007; Foreign Small Business Certification Form FDA 3602 A

Forms and Documents

Document	Type	Status	Availability
Form 3602 A Medical Device User Fee Amendments of 2007; Foreign Small Business Qualification Certification FDA form 3602 A	Form and Instruction	Modified	Repair queued
FY 2008 Guidance 0910-0613.pdf	Supplementary Document	Uploaded 2008-04-14	Repair queued
FY 2008 Guidance 0910-0613.pdf	Supplementary Document	Uploaded 2008-04-11	Repair queued
FY 2008 Guidance 0910-0613.pdf	Supplementary Document	Uploaded 2008-04-11	Repair queued
SS- 0910-0613.DOC	Supporting Statement A	Uploaded 2008-04-11	Available

IC Document Collections

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

ICR Details

OMB Control No: 0910-0613	ICR Reference No: 200804-0910-002
Status: Historical Active	Previous ICR Reference No: 200710-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Medical Device User Fee Amendments of 2007; Foreign Small Business Certification Form FDA 3602 A
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/27/2008
	Date Received in OIRA: 04/23/2008
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2011	36 Months From Approved	05/31/2008
Responses	300	0	300
Time Burden (Hours)	461	0	458
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.

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

Citations for New Statutory Requirements: None

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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 2503	01/15/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 19508	04/10/2008
Did the Agency receive public comments on this ICR? Yes

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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	300	0	0	0	0
Annual Time Burden (Hours)	461	458	0	0	3	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:

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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: 04/23/2008

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