Customer/Partner Satisfaction Service Surveys

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
0910-0360_Supporting Statement A_2026 10_29_2026.docx	Supporting Statement A	Uploaded 2026-10-30	Available
0360 Gen IC Summaries.docx	Supplementary Document	Uploaded 2026-10-28	Available
0910-0360_Supporting Statement B_2026.docx	Supporting Statement B	Uploaded 2026-10-28	Available
0360 OMB Memo Template FINAL 8-14-2023.docx	Supplementary Document	Uploaded 2023-09-06	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
283354	Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) Event Feedback Survey	Other-Instrument	New
283352	CDRH Advisory Committee Satisfaction Survey	Other-Survey	New
283351	CDER NextGen Portal Survey to System Users (CDER/Office of Business Informatics (OBI))	Other-Questionnaire	New
283349	(OII) OTED Self-Paced Course Evaluation	Other-Invitation	New
283347	(OC) FDA.gov Site-Wide Customer Satisfaction Survey	Other-FDA Website Survey	New
283345	CDRH Customer Satisfaction Survey	Other-CDRH Customer Experience and Satisfaction Question Set	New

ICR Details

OMB Control No: 0910-0360	ICR Reference No: 202610-0910-011
Status: Received in OIRA	Previous ICR Reference No: 202309-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: Generic
Title: Customer/Partner Satisfaction Service Surveys
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 10/30/2026

table that charts list comparision

	Requested	Previously Approved
Expiration Date	36 Months From Approved	10/31/2026
Responses	35,000	85,000
Time Burden (Hours)	19,054	35,700
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:
	91 FR 16951	04/03/2026
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 58130	09/14/2026
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

table that charts list of burden

IC Title	Form No.	Form Name
CDRH Advisory Committee Satisfaction Survey
(OC) FDA.gov Site-Wide Customer Satisfaction Survey
(OII) OTED Self-Paced Course Evaluation
CDER NextGen Portal Survey to System Users (CDER/Office of Business Informatics (OBI))
CDRH Customer Satisfaction Survey
Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) Event Feedback Survey

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ICR Summary of Burden

table that charts list 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	35,000	85,000	0	0	-50,000	0
Annual Time Burden (Hours)	19,054	35,700	0	0	-16,646	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: This is a request to extend approval of an existing overarching generic clearance and a subset of GenICs that have been approved over the past three years. Burden estimates have been adjusted to reflect estimated new collections over the next three years as well as burden for currently approved ongoing data collections. Adjustments reflect a revised estimate of anticipated collection activity under the generic clearance. Specifically, we have reduced the estimated annual number of respondents and responses for new collections under the umbrella. We also retained burden for existing and continuing approved individual clearances. Cumulatively, the information reflects a decrease of 16,646 hours but an additional 13,023 responses. The estimated completion time remains 0.42 hours (approximately 25 minutes) per response. No changes have been made to the collection instruments or scope of activity.

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Annual Cost to Federal Government: $338,464

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: 10/30/2026

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