Requests for Feedback on Medical Device Submissions

ICR 201911-0910-014

OMB: 0910-0756

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2019-11-14
IC Document Collections
ICR Details
0910-0756 201911-0910-014
Active 201610-0910-002
HHS/FDA CDRH
Requests for Feedback on Medical Device Submissions
Extension without change of a currently approved collection   No
Regular
Approved without change 12/17/2019
Retrieve Notice of Action (NOA) 11/15/2019
  Inventory as of this Action Requested Previously Approved
12/31/2022 36 Months From Approved 01/31/2020
3,593 0 2,544
492,241 0 348,528
0 0 0

The guidance on Requests for Feedback on Medical Device Submissions (Pre-Submissions Program) establishes a structured process for submission and management of Pre-Submissions and supports the procedures that CDRH and CBER intend to follow when manufacturers, their representatives, or application sponsors submit a request for feedback on a medical device submission, including when the preferred method of feedback is a meeting with review staff. The guidance also provides recommendations regarding how to prepare for meetings with FDA staff. These voluntary information collection requirements support a structured process with clear recommendations for sponsors who submit a pre-submission feedback request and for FDA staff and managers involved in their review, as well as expected timeframes for scheduling meetings.

None
None

Not associated with rulemaking

  84 FR 40069 08/13/2019
84 FR 62540 11/15/2019
No

2
IC Title Form No. Form Name
CBER Presubmissions
CDRH Presubmissions

  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 3,593 2,544 0 0 1,049 0
Annual Time Burden (Hours) 492,241 348,528 0 0 143,713 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
Our estimated burden for the information collection reflects an overall increase of 143,713 hours. We attribute this adjustment to an increase in the number of submissions we received based on FY18 data.

$24,327,450
No
    Yes
    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.
11/15/2019


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