Medical Devices; Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA)

ICR 201301-0910-011

OMB: 0910-0510

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2013-01-31
ICR Details
0910-0510 201301-0910-011
Historical Active 201001-0910-005
HHS/FDA 18659
Medical Devices; Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA)
Extension without change of a currently approved collection   No
Regular
Approved without change 04/10/2013
Retrieve Notice of Action (NOA) 01/31/2013
  Inventory as of this Action Requested Previously Approved
04/30/2016 36 Months From Approved 04/30/2013
1 0 3
80 0 240
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.

US Code: 21 USC 374 Name of Law: Food and Drug Cosmetic Act.
  
None

Not associated with rulemaking

  77 FR 27234 05/09/2012
78 FR 6821 01/31/2013
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 1 3 0 0 -2 0
Annual Time Burden (Hours) 80 240 0 0 -160 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$47,160
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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