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

ICR 201803-0910-010

OMB: 0910-0569

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2018-04-12
ICR Details
0910-0569 201803-0910-010
Active 201411-0910-011
HHS/FDA CDRH
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 05/17/2018
Retrieve Notice of Action (NOA) 04/13/2018
  Inventory as of this Action Requested Previously Approved
05/31/2021 36 Months From Approved 05/31/2018
10 0 20
150 0 300
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

  82 FR 55379 11/21/2017
83 FR 15846 04/12/2018
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 10 20 0 0 -10 0
Annual Time Burden (Hours) 150 300 0 0 -150 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The information collection reflects adjustments since last OMB approval. We have updated the estimated number of respondents based on the number of notifications received in recent years. We have reduced the number of respondents from 20 to 10 which results in a decrease in annual responses by 10 and a corresponding decrease in annual burden hours by 150.

$260,286
No
    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.
04/13/2018


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