MDUFMA Small Business Qualification Certification

ICR 201608-0910-019

OMB: 0910-0508

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Justification for No Material/Nonsubstantive Change
2016-08-31
Supporting Statement A
2016-02-24
ICR Details
0910-0508 201608-0910-019
Historical Active 201602-0910-007
HHS/FDA CDRH
MDUFMA Small Business Qualification Certification
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 09/21/2016
Retrieve Notice of Action (NOA) 08/31/2016
  Inventory as of this Action Requested Previously Approved
06/30/2019 06/30/2019 06/30/2019
5,000 0 5,000
5,000 0 5,000
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

  80 FR 55854 09/17/2015
81 FR 11576 03/04/2016
No

  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
No
No
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.

$575,000
No
No
No
No
No
Uncollected
Amber Sanford 301 796-8867 [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.
08/31/2016


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