Customer/Partner Service Surveys - (Extension)

Forms and Documents

Document Name	Status
FDA CUSTOMER SATISFACTION SURVEYS 83C.doc Justification for No Material/Nonsubstantive Change	2011-06-01

IC Document Collections

IC ID	Document Title	Status
197956	User Fees Customer Survey Other-Survey	New
197949	Premarket Industry Perception Survey 2011 Other-Survey Instrument	New

ICR Details

OMB Control No: 0910-0360	ICR Reference No: 201106-0910-001
Status: Historical Active	Previous ICR Reference No: 200804-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Customer/Partner Service Surveys - (Extension)
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/01/2011
	Date Received in OIRA: 06/01/2011
Terms of Clearance: This generic clearance for FDA customer satisfaction surveys 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	07/31/2011	07/31/2011	07/31/2011
Responses	8,600	0	6,000
Time Burden (Hours)	2,600	0	1,800
Cost Burden (Dollars)	0	0	0

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Abstract: This agreeement will allow FDA to conduct customer satisfaction surveys to gain important feedback from regulated entities such as food processors, cosmetic, drug, biologic, and medical device manufacturers as well as consumers and health professionals and partner surveys of the State and local governments.

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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

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Premarket Industry Perception Survey 2011
User Fees Customer 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	8,600	6,000	0	0	2,600	0
Annual Time Burden (Hours)	2,600	1,800	0	0	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:

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Annual Cost to Federal Government: $7,200

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: 06/01/2011

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