View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0756
ICR Reference No:
202212-0910-007
Status:
Active
Previous ICR Reference No:
201911-0910-014
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CDRH
Title:
Q-Submission and Early Payor Feedback Request Programs for Medical Devices
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
02/02/2023
Retrieve Notice of Action (NOA)
Date Received in OIRA:
12/29/2022
Terms of Clearance:
Approved contingent upon the following information being displayed on the EPFP form: OMB control number, expiration date, and burden disclosure statement.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
02/28/2026
36 Months From Approved
02/28/2023
Responses
3,730
0
3,593
Time Burden (Hours)
406,438
0
492,241
Cost Burden (Dollars)
0
0
0
Abstract:
This information collection helps implement industry and Food and Drug Administration (FDA) agreed-upon goals that provide for the establishment of systems and procedures intended to improve FDA’s medical device review process under the Medical Device User Fee Act (MDUFA). Consistent with MDUFA performance goal documents developed in collaboration with interested stakeholders, we continue to improve and enhance our processes for providing feedback to sponsors of medical device submissions.
Authorizing Statute(s):
None
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
87 FR 48488
08/02/2022
30-day Notice:
Federal Register Citation:
Citation Date:
87 FR 78693
12/22/2022
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
3
IC Title
Form No.
Form Name
Early Payor Feedback Program (EPFP)
(CDRH/CBER) Q-Submissions using eSTAR - includes eSTAR Setup
(CDRH/CBER) Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
ICR Summary of Burden
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
3,730
3,593
0
0
137
0
Annual Time Burden (Hours)
406,438
492,241
0
0
-85,803
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
We have revised the information collection to include a related feedback request program. We have adjusted our estimated burden to reflect a decrease of 85,803 hours and 137 responses annually. We attribute the decrease in hours to improved technology and the increase in responses to corresponding submissions.
Annual Cost to Federal Government:
$26,780,490
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
Yes
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
No
Agency Contact:
Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov
Common Form ICR:
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
12/29/2022
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