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

Forms and Documents

Document Name	Status
0697_Supporting Statement Part A_10-2017.doc Supporting Statement A	2017-10-20
0697_Supporting Statement Part B_10-2017.doc Supporting Statement B	2017-10-20

IC Document Collections

IC ID	Document Title	Status
243760	FDA CTP Emails Survey Audience Analysis Study (CTP) Other-Survey Timeline	New
243442	CTP Exchange Lab Customer Satisfaction Survey Other-Survey Instrument	New
239379	Strategic Plan Survey (ORA) Other-Survey Instrument	New
238020	2019 FDA Center for Tobacco Products' CTP E-Blast Survey Other-Invitation Email Announcement	New
236405	FDA CTP Exchange Lab Syndication Study - Current Users Other-Invitation Email	New
236394	FDA CTP Exchange Lab Survey Invitation Email Announcement and Reminders (POTENTIAL USERS) Other-EXCHANGE LAB INFORMED CONSENT (POTENTIAL USERS)	New
236349	Assessments of Patient and Patient Advocate Experience with the FDA For Patients Website, Patient Listening Sessions, and Patient Affairs Staff Inquiry System Other-Patient Listening Sessions - Interview Guide	New
234569	State Medical Board Directors Follow-up Questions to the November 1, 2018 Training Other-Survey	New
234083	FDA CTP Industry Public Meeting Study Instruction	New
233246	Assessments of Patient and Patient Advocate Experience with the FDA For Patients Website, Patient Listening Sessions, and Patient Affairs Staff Inquiry System Other-Screenshot of Web Based Survey	New
232659	2018 FDA Center for Tobacco Products' CTP E-Blast Survey Other-EBLAST SURVEY INVITATION RECRUITMENT EMAI	New
232487	Food Defense Plan Builder Usability Study Other-FDPB Questionnaire	New
230722	CDRH/DHC Webinar Survey Other-Survey	New
229570	Request for Career Fair Evaluation For Job Seekers Qualitative Feedback Generic Clearance about FDA Service Delivery Other-Pre and Post Career Fair Survey	New

ICR Details

OMB Control No: 0910-0697	ICR Reference No: 201710-0910-006
Status: Historical Active	Previous ICR Reference No: 201507-0910-009
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: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/01/2017
	Date Received in OIRA: 11/01/2017
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	12/31/2020	36 Months From Approved	11/30/2017
Responses	14,925	0	9,100
Time Burden (Hours)	8,491	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:
	82 FR 27508	06/15/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 49834	11/01/2017
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 14

IC Title	Form No.	Form Name
Request for Career Fair Evaluation For Job Seekers Qualitative Feedback Generic Clearance about FDA Service Delivery
CDRH/DHC Webinar Survey
FDA CTP Exchange Lab Survey Invitation Email Announcement and Reminders (POTENTIAL USERS)
2019 FDA Center for Tobacco Products' CTP E-Blast Survey
FDA CTP Emails Survey Audience Analysis Study (CTP)
2018 FDA Center for Tobacco Products' CTP E-Blast Survey
FDA CTP Exchange Lab Syndication Study - Current Users
Assessments of Patient and Patient Advocate Experience with the FDA For Patients Website, Patient Listening Sessions, and Patient Affairs Staff Inquiry System
Strategic Plan Survey (ORA)
State Medical Board Directors Follow-up Questions to the November 1, 2018 Training
Food Defense Plan Builder Usability Study
FDA CTP Industry Public Meeting Study
Assessments of Patient and Patient Advocate Experience with the FDA For Patients Website, Patient Listening Sessions, and Patient Affairs Staff Inquiry System
CTP Exchange Lab Customer Satisfaction 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	14,925	9,100	0	0	5,825	0
Annual Time Burden (Hours)	8,491	4,967	0	0	3,524	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: $400,000

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.     No

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? 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: 11/01/2017

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