Customer/Partner Service Surveys

Forms and Documents

Document Name	Status
0360 OMB Memo Template.docx Supplementary Document	2020-08-20
Summary of User Fee Website Survey.docx Supplementary Document	2020-08-20
Summary of Technical Assistance Network FSMA Web Form Feedback.docx Supplementary Document	2020-08-20
Summary of Physician Survey.docx Supplementary Document	2020-08-20
Summary of International OFRR Training Satisfaction.docx Supplementary Document	2020-08-20
Summary of Consumer Update Articles.docx Supplementary Document	2020-08-20
Summary of CDRH Customer Service Survey.docx Supplementary Document	2020-08-20
0360 Supporting Statement Part B 2020.docx Supporting Statement B	2020-08-20
0360 Supporting Statement Part A 2020.docx Supporting Statement A	2020-09-14

IC Document Collections

IC ID	Document Title	Status
244440	FDA Food Industry Survey for Coronavirus Disease 2019 Related Materials (OC) Other-Survey Instrument	New
244195	Interviews with Applicants and Other External Stakeholders Regarding Use of Patient Experience Data in Regulatory Decision Making (CDER) Other-Applicant Script	New
244137	CDRH Advisory Committee Satisfaction Survey Other-Survey Instrument	New

ICR Details

OMB Control No: 0910-0360	ICR Reference No: 202008-0910-020
Status: Active	Previous ICR Reference No: 201709-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: Generic
Title: Customer/Partner Service Surveys
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: 10/16/2020
	Date Received in OIRA: 09/14/2020
Terms of Clearance: Previous terms continue: In accordance 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). The scope of this collection is limited to surveys.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2023	36 Months From Approved	10/31/2020
Responses	55,000	0	55,000
Time Burden (Hours)	13,750	0	13,750
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:
	85 FR 3389	01/21/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 51449	08/20/2020
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
FDA Food Industry Survey for Coronavirus Disease 2019 Related Materials (OC)
CDRH Advisory Committee Satisfaction Survey
Interviews with Applicants and Other External Stakeholders Regarding Use of Patient Experience Data in Regulatory Decision Making (CDER)

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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	55,000	55,000	0	0	0	0
Annual Time Burden (Hours)	13,750	13,750	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: $2,181

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.     Yes

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? No

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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: 09/14/2020

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