MDUFMA Small Business Qualification Certification

Forms and Documents

Document Name	Status
Form FDA 3602 MDUFMA Small Business Qualification Certification (Form FDA 3602 and Form FDA 3602A)) Form and Instruction	Modified
0508-OMB Justification Memo.doc Justification for No Material/Nonsubstantive Change	2016-08-31
0508_Supporting Statemnt.doc Supporting Statement A	2016-02-24

IC Document Collections

IC ID	Document Title	Status
6222	MDUFMA Small Business Qualification Certification (Form FDA 3602 and Form FDA 3602A)) Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0508	ICR Reference No: 201608-0910-019
Status: Historical Active	Previous ICR Reference No: 201602-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: MDUFMA Small Business Qualification Certification
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/21/2016
	Date Received in OIRA: 08/31/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2019	06/30/2019	06/30/2019
Responses	5,000	0	5,000
Time Burden (Hours)	5,000	0	5,000
Cost Burden (Dollars)	0	0	0

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Abstract: The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) requires FDA to collect a user fee from each person who submits certain medical device applications for FDA review. A "small business" is eligible for reduced or waived fees; small business fees for FY 2010. If an applicant does not provide information to FDA demonstrating to FDA's satisfaction that the applicant is a small business, the applicant must pay the standard (full) fee for any application it submits.

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Authorizing Statute(s): US Code: 21 USC 379j Name of Law: Authority to Assess and Use Device Fees
  

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:
	80 FR 55854	09/17/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 11576	03/04/2016
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
MDUFMA Small Business Qualification Certification (Form FDA 3602 and Form FDA 3602A))	FDA 3602A, FDA 3602	MDUFA Small Business Qualification and Certification (In the United States) ,   MDUFA Small Business Qualification and Certification (Outside of United States)

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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	5,000	5,000	0	0	0	0
Annual Time Burden (Hours)	5,000	5,000	0	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: The total reporting burden hours have been adjusted due to an updated number of respondents participating in the program. This resulted in a decrease of 100 hours in the overall burden estimate.

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Annual Cost to Federal Government: $575,000

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]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

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: 08/31/2016

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