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:
202008-0910-020
Status:
Historical Active
Previous ICR Reference No:
201709-0910-006
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Generic
Title:
Customer/Partner Service Surveys
Type of Information Collection:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
10/16/2020
Retrieve Notice of Action (NOA)
Date Received in OIRA:
09/14/2020
Terms of Clearance:
Previous terms continue: In accordance with 5 CFR 1320, this request is approved for 3 years under the following conditions: 1) FDA shall submit memos for individual surveys (e.g., statement of need, intended use of information, description of respondents, information collection procedures, justification for incentives and estimated burden). 2) OMB will respond with clearance or questions within 10 working days 3) OMB and FDA will jointly evaluate the generic clearance upon resubmission in 3 years. Upon resubmission, FDA will provide a summary of each collection approved under the generic clearance (e.g., use of information). The scope of this collection is limited to surveys.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
10/31/2023
36 Months From Approved
10/31/2020
Responses
55,000
0
55,000
Time Burden (Hours)
13,750
0
13,750
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:
10
IC Title
Form No.
Form Name
CDRH Advisory Committee Satisfaction Survey
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)
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)
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
55,000
55,000
0
0
0
0
Annual Time Burden (Hours)
13,750
13,750
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:
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:
Ila Mizrachi 301 796-7726 ila.mizrachi@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:
09/14/2020
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