Customer/Partner Satisfaction Service Surveys

Forms and Documents

Document Name	Status
0360 Gen IC Summaries.docx Supplementary Document	2023-09-06
0360 OMB Memo Template FINAL 8-14-2023.docx Supplementary Document	2023-09-06
0360 83-C July 2022.docx Justification for No Material/Nonsubstantive Change	2022-06-30
0360 Request for nonsubstantive change to increase responses and burden hours 04-05-22.docx Justification for No Material/Nonsubstantive Change	2022-04-05
0360 Non Sub Change for burden increase 2021.docx Justification for No Material/Nonsubstantive Change	2021-11-03
0360 Non Sub Change for burden increase 2021.docx Justification for No Material/Nonsubstantive Change	2021-10-27
0360 SSB FINAL 8-14-2023.docx Supporting Statement B	2023-09-06
0360 SSA FINAL 8-14-2023.docx Supporting Statement A	2023-09-06

IC Document Collections

IC ID	Document Title	Status
266424	(ORA) OTED Self-Paced Course Evaluation Other-Invitation	New

ICR Details

OMB Control No: 0910-0360	ICR Reference No: 202309-0910-007
Status: Received in OIRA	Previous ICR Reference No: 202206-0910-014
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: 09/07/2023

	Requested	Previously Approved
Expiration Date	36 Months From Approved	10/31/2023
Responses	85,000	83,100
Time Burden (Hours)	35,700	30,900
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:
	88 FR 24992	04/25/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 59928	08/30/2023
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 0

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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	85,000	83,100	0	0	1,900	0
Annual Time Burden (Hours)	35,700	30,900	0	0	4,800	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: Since the last OMB approval of this ICR, FDA submitted three requests to increase the total burden hours. Therefore, taking into consideration the overall burden increase, as a result of the non-substantive changes, in ROCIS the burden hour increase is 4,800.

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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: 09/07/2023

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