Requests for Inspection by an Accredited Person under the Inspection by Accredited Persons Program

ICR 201109-0910-004

OMB: 0910-0569

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2011-09-26
ICR Details
0910-0569 201109-0910-004
Historical Active 200808-0910-004
HHS/FDA
Requests for Inspection by an Accredited Person under the Inspection by Accredited Persons Program
Extension without change of a currently approved collection   No
Regular
Approved without change 02/06/2012
Retrieve Notice of Action (NOA) 09/28/2011
  Inventory as of this Action Requested Previously Approved
02/28/2015 36 Months From Approved 02/29/2012
15 0 15
1,500 0 1,500
0 0 0

Under Section 201 of the Medical Device User Fee and Modernization Act of 2002, a medical device manufacturer may use an accredited person (AP) to perform an inspection of their facility that would otherwise be performed by FDA. The manufacturer must first submit a request to FDA to obtain approval to use an AP.

US Code: 21 USC 374(g) Name of Law: null
  
None

Not associated with rulemaking

  76 FR 29764 05/23/2011
76 FR 59400 09/26/2011
No

1
IC Title Form No. Form Name
Requests for Inspection by an Accredited Person under the Inspection by Accredited Persons Program

  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 15 15 0 0 0 0
Annual Time Burden (Hours) 1,500 1,500 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$125,000
No
No
No
No
No
Uncollected
Daniel Gitteson 3017965156 daniel.gitteson@fda.hhs.gov

  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.
09/28/2011


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