FY 2012 MDUFMA Small Business Qualification Certification (Form FDA 3602)

ICR 201301-0910-010

OMB: 0910-0508

Federal Form Document

IC Document Collections
ICR Details
0910-0508 201301-0910-010
Historical Active 201001-0910-004
HHS/FDA 18676
FY 2012 MDUFMA Small Business Qualification Certification (Form FDA 3602)
Extension without change of a currently approved collection   No
Regular
Approved with change 03/20/2013
Retrieve Notice of Action (NOA) 01/31/2013
  Inventory as of this Action Requested Previously Approved
03/31/2016 36 Months From Approved 03/31/2013
5,100 0 3,571
5,100 0 3,571
0 0 0

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.

US Code: 21 USC 379j Name of Law: Authority to Assess and Use Device Fees
  
None

Not associated with rulemaking

  77 FR 23267 04/18/2012
78 FR 6822 01/31/2013
No

1
IC Title Form No. Form Name
FY 2012 MDUFMA Small Business Qualification Certification (Form FDA 3602) 3602 Medical Device User Fee

  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 5,100 3,571 0 0 1,529 0
Annual Time Burden (Hours) 5,100 3,571 0 0 1,529 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$566,100
No
No
No
No
No
Uncollected
Daniel Gitteson 3017965156 [email protected]

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
01/31/2013


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