Emergency Health 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
6148	Emergency Health Surveys	Migrated

ICR Details

OMB Control No: 0910-0457	ICR Reference No: 200010-0910-006
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Emergency Health 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 without change	Conclusion Date: 02/05/2001
	Date Received in OIRA: 10/31/2000
Terms of Clearance: OMB approves FDA's use of Emergency Health Surveys for 1 year to enable FDA to quickly obtain targeted information on potential medical device problems. The information gathered will be based on purposeful samples and therefore can not be used for estimates of incidents. Instead, the information gathered should be used to trigger a more complete analysis of the problem, and a determination of the extent of a public health problem. As a condition of clearance, FDA will (1) submit a copy of the complete survey along with a justification describing the need for the survey, (2) provide a complete description of the statistical methods to be employed, including the respondent universe and sample selection method, the information collection procedures, and the expected response rate, (3) an estimate of the burden. OMB will review the survey and the accompanying justification in 10 working days or less. At the time of the next submission, FDA and OMB shall evaluate the process used under this generic clearance and determine how well it has worked and whether any changes are necessary.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2002	03/31/2002
Responses	2,000	0	0
Time Burden (Hours)	4,000	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This program will provide data when FDA must quickly determine whether or not a post-market problem with a medical device impacts the public health. The data collectrd will provide FDA with information to: alow a more complete analysis of the problem; determine the existence and extent of a public health problem; and then, if necessary, to disseminate the information to the health care community. All of these processes must be accomplished in a timeframe that limits further incidents causing injury to the public. While the form for data collection will be standardized, the targeted respondent........

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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
Emergency Health 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	2,000	0	0	2,000	0	0
Annual Time Burden (Hours)	4,000	0	0	4,000	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: 10/31/2000

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