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

Forms and Documents

Document Name	Status
0697_Part B._9-23-14.doc Supporting Statement B	2014-09-23
0697_Supporting Statement_PART A_9-23-14.doc Supporting Statement A	2014-09-23

IC Document Collections

IC ID	Document Title	Status
215848	Request for Comment Cards for CDER Small Business and Industry Assistance Soliciting Feedback on Conferences Other-Survey	New
215841	Request for Surveys CDER Small Business and Industry Assistance (SBIA) Soliciting Feedback on Conferences Other-Survey	New

ICR Details

OMB Control No: 0910-0697	ICR Reference No: 201409-0910-017
Status: Historical Active	Previous ICR Reference No: 201105-0910-006
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: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 11/05/2014
	Date Received in OIRA: 09/24/2014
Terms of Clearance: Previous terms continue: OMB approves this collection for a period of three years. To request approval of information collections under this generic approval, the agency must do the following: 1) Unless an agency is using multiple modes of collection (e.g., paper forms and electronic submissions), provide a Generic Clearance Submission Template for each Instrument; 2) If the agency is using multiple modes of collection (e.g., paper forms and electronic submissions), the same Generic Clearance Submission Template may be used for both instruments; 3) each Generic Clearance Submission Template must be uploaded as a Supplementary document using a naming convention that allows the public to identify the associated instrument; 4) submit no more than five Generic Submission Templates with each request.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2017	36 Months From Approved	11/30/2014
Responses	9,100	0	9,100
Time Burden (Hours)	4,967	0	4,967
Cost Burden (Dollars)	0	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:
	79 FR 23980	04/29/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 56587	09/22/2014
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
Request for Surveys CDER Small Business and Industry Assistance (SBIA) Soliciting Feedback on Conferences
Request for Comment Cards for CDER Small Business and Industry Assistance Soliciting Feedback on Conferences

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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	9,100	9,100	0	0	0	0
Annual Time Burden (Hours)	4,967	4,967	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: $350,000

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: 09/24/2014

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