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

ICR 201411-0910-011

OMB: 0910-0569

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2014-12-01
ICR Details
0910-0569 201411-0910-011
Historical Active 201109-0910-004
HHS/FDA CDRH
Requests for Inspection by an Accredited Person under the Inspection by Accredited Persons Program
Revision of a currently approved collection   No
Regular
Approved with change 04/06/2015
Retrieve Notice of Action (NOA) 12/03/2014
  Inventory as of this Action Requested Previously Approved
04/30/2018 36 Months From Approved 04/30/2015
20 0 15
300 0 1,500
0 0 0

This ICR collects information from manufactures of class II or class III medical devices who meet certain eligibility criteria and who intend to use an "accredited person" to conduct an inspection of their establishment. Under the Inspection by Accredited Persons Program, eligible manufacturers may elect to have third parties that have been accredited by FDA conduct some of their inspections instead of FDA. This program allows manufacturers greater control over the timing of their inspections and, in some cases, may reduce the need for multiple inspections of the same establishment.

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

Not associated with rulemaking

  79 FR 30619 05/28/2014
79 FR 71109 12/01/2014
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 20 15 0 5 0 0
Annual Time Burden (Hours) 300 1,500 0 -1,200 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
Yes
Miscellaneous Actions
We adjusted the estimated number of respondents from 100 to 20 based on current information. This adjustment resulted in a 1,200-hour reduction in our burden estimate.

$283,487
No
No
No
No
No
Uncollected
Amber Sanford 301 796-8867 amber.sanford@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.
12/03/2014


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