FDA Rapid Response Surveys

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
6210	FDA Rapid Response Surveys	Migrated

ICR Details

OMB Control No: 0910-0500	ICR Reference No: 200210-0910-007
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: FDA Rapid Response Surveys
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 with change	Conclusion Date: 12/27/2002
	Date Received in OIRA: 10/30/2002
Terms of Clearance: Approved consistent with changes and clarification in FDA memos of 12-6-02 and 12-27-02. Aprpoval is for 18 months which will allow FDA and OMB to assess the value of this generic clearance and determine whether it should be continued. FDA should delete similar package for CDRH from its inventory. Individual surveys submitted under this clearance will be submitted to OMB and OMB will respond to FDA with questions or clearance within 10 working days. Individual submissions should include; the use to which the data will be put, the need for a rapid response survey, the representativeness of respondents and the impact of this on the utility, and the expected response rate. The next submission of the generic package will include a comparison of projected and actual response rates for all surveys conducted under this clearance.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2004	08/31/2004
Responses	30	0	0
Time Burden (Hours)	3,000	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This program will obtain on safety information to support quick- turnaround decision-making about potential safety problems or risk management solutions. This information will be collected from health professionals, hospitals, and other user facilities (e.g., nursing homes, ambulatory surgical facilities and out- patient diagnostic and treatment facilities, etc.), consumers, sponsors and manufacturers of biologics, drugs and medical pro- ducts, distributors, and importers when FDA must quickly deter- mine whether or not a problem with a medical product impacts the public health.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:

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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: 1

IC Title	Form No.	Form Name
FDA Rapid Response Surveys

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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	30	0	0	30	0	0
Annual Time Burden (Hours)	3,000	0	0	3,000	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:

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: $0

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 10/30/2002

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