Customer/Partner Service Surveys

Forms and Documents

Document Name	Status
0360 Summaries 2014.doc Supplementary Document	2014-07-31
0360 ss part B 7-16-2014.doc Supporting Statement B	2014-07-24
0360 ss 7-16-2014.doc Supporting Statement A	2014-07-24

IC Document Collections

IC ID	Document Title	Status
227900	Interagency Food Safety Analytics Collaboration Webinar - Fall 2017 Other-Survey	New
227295	Office of Minority Health's Customer Satisfaction Survey Other-Survey	New
227175	Interagency Food Safety Analytics Collaboration Webinar Survey Other-Survey	New
223102	Customer Satisfaction Survey for FDA CFSAN Technical Assistance Network Web Form for Submitting Food Safety Modernization Act Queries Other-FSMA Inquiry Form - Survey	New
219150	Interviews with Applicants and Other External Stakeholders Regarding Clarity, Understandability, and Usefulness of FDA's Benefit-Risk Framework Other-Survey	New
218969	Customer Satisfaction Survey for Evaluation of the 20.88 Single Signature Long-Term Information Sharing Agreement Other-Survey	New
217160	Pediatric Device Consortia Grant Innovator Feedback Survey Other-PDC survey for innovators	New
213276	User Fee Website Survey Other-Screen shot of webste based survey	New
213270	Division of Drug Information Twitter/Listserv Survey Other-Survey	New

ICR Details

OMB Control No: 0910-0360	ICR Reference No: 201407-0910-016
Status: Historical Active	Previous ICR Reference No: 201107-0910-011
Agency/Subagency: HHS/FDA	Agency Tracking No: Generic
Title: Customer/Partner Service Surveys
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/25/2014
	Date Received in OIRA: 08/01/2014
Terms of Clearance: Previous terms continue: In accordane 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).

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2017	36 Months From Approved	09/30/2014
Responses	50,000	0	30,000
Time Burden (Hours)	12,500	0	7,500
Cost Burden (Dollars)	0	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:
	79 FR 21765	04/17/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 43493	07/25/2014
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 9

IC Title	Form No.	Form Name
Office of Minority Health's Customer Satisfaction Survey
Interviews with Applicants and Other External Stakeholders Regarding Clarity, Understandability, and Usefulness of FDA's Benefit-Risk Framework
Interagency Food Safety Analytics Collaboration Webinar Survey
Pediatric Device Consortia Grant Innovator Feedback Survey
Customer Satisfaction Survey for Evaluation of the 20.88 Single Signature Long-Term Information Sharing Agreement
Customer Satisfaction Survey for FDA CFSAN Technical Assistance Network Web Form for Submitting Food Safety Modernization Act Queries
Interagency Food Safety Analytics Collaboration Webinar - Fall 2017
User Fee Website Survey
Division of Drug Information Twitter/Listserv Survey

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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	50,000	30,000	0	20,000	0	0
Annual Time Burden (Hours)	12,500	7,500	0	5,000	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 increase (adjustment) in burden hours is due to an increasing number of customer satisfaction surveys FDA has conducted over the past 18 months.

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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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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? Uncollected

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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: 08/01/2014

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