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 Generic ICR - OIRA Conclusion
OMB Control No:
0910-0360
ICR Reference No:
202206-0910-014
Status:
Historical Active
Previous ICR Reference No:
202204-0910-001
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Generic
Title:
Customer/Partner Satisfaction Service Surveys
Type of Information Collection:
No material or nonsubstantive change to a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
07/05/2022
Retrieve Notice of Action (NOA)
Date Received in OIRA:
06/30/2022
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
10/31/2023
10/31/2023
10/31/2023
Responses
83,100
0
83,100
Time Burden (Hours)
30,900
0
30,900
Cost Burden (Dollars)
0
0
0
Abstract:
This generic ICR will allow FDA to conduct customer satisfaction surveys to gain important feedback from all FDA-regulated industries.
Authorizing Statute(s):
EO: EO 12862 Name/Subject of EO: Setting Customer Service Standards
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:
85 FR 3389
01/21/2020
30-day Notice:
Federal Register Citation:
Citation Date:
85 FR 51449
08/20/2020
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
23
IC Title
Form No.
Form Name
(ORA) Independent Course Delivery (ICD) Survey
(ORA) Learning Transfer Evaluation
(ORA) Train the Trainer Course Evaluation
CDRH Advisory Committee Satisfaction Survey
CDRH Customer Satisfaction Survey
Customer Satisfaction Surveys for FDA Food Safety Culture Webinar Series
FDA Customer Feedback Survey for Self-Paced Online Teacher Training (CFSAN)
FDA Food Industry Survey for Coronavirus Disease 2019 (COVID-19) Related Materials (OC)
FDA Food Industry Survey for Coronavirus Disease 2019 Related Materials (OC)
Feedback on Patient-Generated Health Data Workshop (CDRH)
Feedback on Virtual Course Title "IMPACT" Bootcamp: Navigating the Journey from Digital Health Technologies to Meaningful Patient Outcomes (CDRH)
Feedback on Virtual Course Titled "IMPACT Bootcamp: Navigating the Journey from Digital Health Technologies to Meaningful Patient Outcomes" (CDRH)
Food Industry Survey for Coronavirus Disease 2019 (COVID-19) Related Materials
Food and Drug Administration/ CFSAN and the U.S. Depr. of Agriculture /FAS Produce Safety Presentation Series for Produce Stakeholders in Latin America Followup Survey (CFSAN)
Interviews with Applicants and Other External Stakeholders Regarding Use of Patient Experience Data in Regulatory Decision Making (CDER)
Level 2 Training Course Evaluation (ORA)
ORA Ombudsman Program External Stakeholder Satisfaction Survey
Post-Course Satisfaction Evaluation (ORA)
Post-Event Survey for a Continuing Education (CE) Webinar on Pregnancy and Lactation Medication Information for the Healthcare Provider
Scholastic Vaping Education Materials Survey (CTP)
Sponsor and Payor Feedback for the Early Payor Feedback Program (CDRH)
State Program Satisfaction Survey for Remote Assessments (ORA)
U.S. President's Emergency Plan for AIDS Relief Database Customer Survey to Industry and External Stakeholders (CDER)
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
83,100
83,100
0
0
0
0
Annual Time Burden (Hours)
30,900
30,900
0
0
0
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:
The Food and Drug Administration is submitting this nonmaterial/non-substantive change request to add 28,100 responses and 3,400 burden hours. No other changes are occurring. This generic clearance is used by various programs in all Centers within FDA, and because we anticipate more use of this generic approval over the next year, we therefore request an increase in responses and hours until the expiration date in 2023.
Annual Cost to Federal Government:
$2,181
Does this IC contain surveys, censuses, or employ statistical methods?
Yes
Part B of Supporting Statement
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:
Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@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:
06/30/2022