Generic Clearance for the Collection of Qualitative Feedback on Food and Drug Administration Service Delivery

Forms and Documents

Document Name	Status
0697 83-C July 2022.docx Justification for No Material/Nonsubstantive Change	2022-06-30
0697 OMB Memo Template.docx Supplementary Document	2020-11-27
0697 Supporting Statement Part B 2020.docx Supporting Statement B	2020-11-27
0697 Supporting Statement Part A 2020.docx Supporting Statement A	2020-11-27

IC Document Collections

IC ID	Document Title	Status
251530	Small Group Discussions with Applicants and Other External Stakeholders Regarding Clarity, Understandability, and Usefulness of FDA's Benefit-Risk Framework (BRF) Other-External Discussion Informed Consent	Unchanged
250285	Email Survey Audience Analysis Study (CTP) Other-Protocol	Unchanged
249637	Patient and Caregiver Diversity in FDA Patient Engagement Activities - Interviews (OC) Other-Interview Guide - Patient Advocacy Org.	Unchanged
248074	Educational Outreach Focus Groups with Health Educators (CTP) Other-Initial Email Screener	Unchanged
246467	Strengthening Interactions Between CBER's Office of Tissues and Advanced Therapies and Cell and Gene Therapy Sponsors (CBER) Other-Invitation	Unchanged
246151	Environmental Scan (CVM) Other-Survey Instrument	Unchanged
246110	This is Our Watch Retailer Feedback Study (CTP) Other-Discussion Guide	Unchanged
245364	Assessments of Patient and Patient Advocate Experience with the FDA For Patients Website and Patient Listening Session Program (OC) Other-Interview Guide	Unchanged
245262	Accreditation Scheme for Conformity Assessment Accreditation Body Training Feedback (CDRH) Other-Survey Instrument	Unchanged
245261	Survey to Determine Euthanasia Practices and Use of Pentobarbital Among Veterinarians Practicing in the United States (CVM) Other-Survey Instrument	Unchanged

ICR Details

OMB Control No: 0910-0697	ICR Reference No: 202206-0910-016
Status: Received in OIRA	Previous ICR Reference No: 202011-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: Generic
Title: Generic Clearance for the Collection of Qualitative Feedback on Food and Drug Administration Service Delivery
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: 06/30/2022

	Requested	Previously Approved
Expiration Date	12/31/2023	12/31/2023
Responses	15,752	15,752
Time Burden (Hours)	8,491	8,491
Cost Burden (Dollars)	0	0

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Abstract: The information collected from our customers and stakeholders will help ensure that users have an effective, efficient, and satisfying experience with FDA's programs. This feedback will provide insights into customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative and actionable communications between FDA and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management.

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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 18989	04/03/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 70181	11/04/2020
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 10

IC Title	Form No.	Form Name
Accreditation Scheme for Conformity Assessment Accreditation Body Training Feedback (CDRH)
Assessments of Patient and Patient Advocate Experience with the FDA For Patients Website and Patient Listening Session Program (OC)
Educational Outreach Focus Groups with Health Educators (CTP)
Email Survey Audience Analysis Study (CTP)
Environmental Scan (CVM)
Patient and Caregiver Diversity in FDA Patient Engagement Activities - Interviews (OC)
Small Group Discussions with Applicants and Other External Stakeholders Regarding Clarity, Understandability, and Usefulness of FDA's Benefit-Risk Framework (BRF)
Strengthening Interactions Between CBER's Office of Tissues and Advanced Therapies and Cell and Gene Therapy Sponsors (CBER)
Survey to Determine Euthanasia Practices and Use of Pentobarbital Among Veterinarians Practicing in the United States (CVM)
This is Our Watch Retailer Feedback Study (CTP)

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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	15,752	15,752	0	0	0	0
Annual Time Burden (Hours)	8,491	8,491	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:

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Annual Cost to Federal Government: $400,000

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: 06/30/2022

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