Requests for Nonbinding Feedback After Certain FDA Inspections of Device Establishments

ICR 202002-0910-008

OMB: 0910-0886

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0886 202002-0910-008
Active
HHS/FDA CDRH
Requests for Nonbinding Feedback After Certain FDA Inspections of Device Establishments
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 04/15/2020
Retrieve Notice of Action (NOA) 03/31/2020
  Inventory as of this Action Requested Previously Approved
04/30/2023 36 Months From Approved
220 0 0
110,000 0 0
0 0 0

FDA issued the draft guidance document “Nonbinding Feedback After Certain FDA Inspections of Device Establishments” to explain how the owner, operator, or agent in charge of a device establishment may submit a request for nonbinding feedback to FDA regarding actions the firm has proposed to take to address certain kinds of inspectional observations that have been documented on an FDA Inspectional Observations Form (Form FDA 483) and issued to the firm upon completion of an inspection of the firm’s establishment. This information collection request identifies the estimated burden of submitting requests for nonbinding feedback to FDA.

None
None

Not associated with rulemaking
Other Documents for OIRA Review

  84 FR 4823 02/19/2019
85 FR 14684 03/13/2020
Yes

1
IC Title Form No. Form Name
Requests for nonbinding feedback after certain FDA inspections of device establishments

  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 220 0 0 220 0 0
Annual Time Burden (Hours) 110,000 0 0 110,000 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new data collection.

$10,271,590
No
    Yes
    No
No
No
No
Uncollected
Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@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.
03/31/2020


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