Generic FDA Rapid Response Surveys

Forms and Documents

Document Name	Status
0500 summary of CTP survey 4-18-14.doc Supplementary Document	2014-04-18
0500 ss PART B 3-19-14.doc Supporting Statement B	2014-04-18
0500 ss PART A 3-19-14.doc Supporting Statement A	2014-04-18

IC Document Collections

IC ID	Document Title	Status
226469	Online Survey of Commercial Pharmaceutical Product Importers Other-online survey	New
221354	Surveillance Sampling Outreach Survey Other-Survey	New
218411	Rapid Response Survey for Hepatitis E Virus-Exposure Blood Donors Other-Survey	New
217019	Babesia-Exposure Rapid Survey of Blood Donors Other-Consent Form	New
213536	Rapid Interviews and Survey of Patients Being Treated with Ambien or Lunesta or their Health Care Professionals Other-Interview Script	New

ICR Details

OMB Control No: 0910-0500	ICR Reference No: 201404-0910-010
Status: Historical Active	Previous ICR Reference No: 201012-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: Generic
Title: Generic FDA Rapid Response 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: 07/03/2014
	Date Received in OIRA: 04/23/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2017	36 Months From Approved	07/31/2014
Responses	60,000	0	60,000
Time Burden (Hours)	30,000	0	30,000
Cost Burden (Dollars)	0	0	0

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Abstract: This program will obtain data 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 outpatient diagnostic and treatment facilities, etc.), consumers, sponsors and manufacturers of biologics, drugs and medical products, distributors, and importers when FDA must quickly determine whether or not a problem with a medical product impacts the public health.

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Authorizing Statute(s): US Code: 21 USC 355 Name of Law: FD&C Act
   US Code: 21 USC 360 Name of Law: Federal Food, Drug, and Cosmetic Act
  

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:
	78 FR 77686	12/24/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 19618	04/09/2014
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Rapid Response Survey for Hepatitis E Virus-Exposure Blood Donors
Babesia-Exposure Rapid Survey of Blood Donors
Online Survey of Commercial Pharmaceutical Product Importers
Surveillance Sampling Outreach Survey
Rapid Interviews and Survey of Patients Being Treated with Ambien or Lunesta or their Health Care Professionals

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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	60,000	60,000	0	0	0	0
Annual Time Burden (Hours)	30,000	30,000	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: $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]? 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: 04/23/2014

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