Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2003 (MDUFMA)

ICR 200304-0910-006

OMB: 0910-0510

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0510 200304-0910-006
Historical Active
HHS/FDA
Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2003 (MDUFMA)
New collection (Request for a new OMB Control Number)   No
Emergency 05/30/2003
Approved with change 06/11/2003
Retrieve Notice of Action (NOA) 04/30/2003
This paperwork is approved on an emergency basis under the following conditions: 1) In the future, FDA will not distribute instructions for paperwork submission as part of a guidance document without first consulting the OMB. 2) FDA will detach the application instruction from the main guidance document. 3) FDA will revise the application instructions to contain the PRA mandated disclosure statement including the collection's OMB number, expiration date and expected burden. 4) FDA will add the following language to the application instruction: "FDA will accept electronic submissions from any applicant that wishes to submit in this format." 5) FDA will provide a copy of the final draft before commencing the collection.
  Inventory as of this Action Requested Previously Approved
11/30/2003 11/30/2003
25 0 0
2,550 0 0
0 0 0

Information from this collection will be used by FDA to implement an Inspection by Accredited Persons program that will train and accredit persons that wish to conduct inspections of eligible manufacturers of class II and class III medical devices. This action is required by MDUFMA.

None
None


No

1
IC Title Form No. Form Name
Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2003 (MDUFMA)

  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 25 0 0 25 0 0
Annual Time Burden (Hours) 2,550 0 0 2,550 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  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.
04/30/2003


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