Generic Clearance for the Collection of Qualitative Feedback on FDA Service Delivery

Forms and Documents

Document Name	Status
OMB fast track ss PART B 4-26-11.doc Supporting Statement B	2011-04-26
OMB fast track ss PART A 4-26-11.doc Supporting Statement A	2011-04-26

IC Document Collections

IC ID	Document Title	Status
208765	Request for Surveys and Focus Groups in Support of FDA Programs for Small Pharmaceutical Businesses Other-SURVEY QUESTIONS	New
203521	Request for Qualitative Feedback Generic Clearance About FDA . gov Web Site Customers Other-Survey	New
202329	Request for Medical Product Safety Network (MedSun) Qualitative Feedback Generic Clearance about Newsletter Services Other-Survey Appendix A	New

ICR Details

OMB Control No: 0910-0697	ICR Reference No: 201105-0910-006
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Generic Clearance for the Collection of Qualitative Feedback on FDA Service Delivery
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 11/06/2011
	Date Received in OIRA: 05/26/2011
Terms of Clearance: 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	11/30/2014	36 Months From Approved
Responses	9,100	0	0
Time Burden (Hours)	4,967	0	0
Cost Burden (Dollars)	0	0	0

---

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.

---

Authorizing Statute(s): EO: EO 12862 Name/Subject of EO: Setting Customer Service Standards
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 80542	12/22/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 29763	05/23/2011
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Request for Qualitative Feedback Generic Clearance About FDA . gov Web Site Customers
Request for Medical Product Safety Network (MedSun) Qualitative Feedback Generic Clearance about Newsletter Services
Request for Surveys and Focus Groups in Support of FDA Programs for Small Pharmaceutical Businesses

---

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	0	0	9,100	0	0
Annual Time Burden (Hours)	4,967	0	0	4,967	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: This is a new generic information collection request for approval.

---

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

---

Common Form ICR:  No

---

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: 05/26/2011

---