Customer/Partner Satisfaction Service Surveys

Forms and Documents

Document Name	Status
0360 Non Sub Change for burden increase 2021.docx Justification for No Material/Nonsubstantive Change	2021-10-27
0360 Supporting Statement Part B 2020.docx Supporting Statement B	2020-08-20
0360 Supporting Statement Part A 2020.docx Supporting Statement A	2020-09-14

IC Document Collections

IC ID	Document Title	Status
249808	U.S. President's Emergency Plan for AIDS Relief Database Customer Survey to Industry and External Stakeholders (CDER) Other-Survey Instrument	Unchanged
249376	Sponsor and Payor Feedback for the Early Payor Feedback Program (CDRH) Other-Scripts and Emails	Unchanged
248333	Scholastic Vaping Education Materials Survey (CTP) Other-Screener	Unchanged
248316	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) Other-Survey Questions - Three Translations	Unchanged
247695	State Program Satisfaction Survey for Remote Assessments (ORA) Other-Survey Instrument	Unchanged
246428	Feedback on Patient-Generated Health Data Workshop (CDRH) Other-Email Invitation	Unchanged
246076	Feedback on Virtual Course Title "IMPACT" Bootcamp: Navigating the Journey from Digital Health Technologies to Meaningful Patient Outcomes (CDRH) Other-Survey Instrument	Unchanged
244440	FDA Food Industry Survey for Coronavirus Disease 2019 Related Materials (OC) Other-Survey Instrument	Unchanged
244195	Interviews with Applicants and Other External Stakeholders Regarding Use of Patient Experience Data in Regulatory Decision Making (CDER) Other-Applicant Script	Unchanged
244137	CDRH Advisory Committee Satisfaction Survey Other-Survey Instrument	Unchanged

ICR Details

OMB Control No: 0910-0360	ICR Reference No: 202110-0910-011
Status: Received in OIRA	Previous ICR Reference No: 202008-0910-020
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	Date Submitted to OIRA: 10/28/2021

	Requested	Previously Approved
Expiration Date	10/31/2023	10/31/2023
Responses	55,000	55,000
Time Burden (Hours)	27,500	13,750
Cost Burden (Dollars)	0	0

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Abstract: This generic ICR will allow FDA to conduct customer satisfaction surveys to gain important feedback from all FDA-regulated industries.

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Authorizing Statute(s): EO: EO 12862 Name/Subject of EO: Setting Customer Service Standards
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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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

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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)

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ICR Summary of Burden

	Total Request	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)	27,500	13,750	0	13,750	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

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 13,750 burden hours. No other changes are occurring.

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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

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Common Form ICR:  No

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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: 10/28/2021

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