Emergency Shortages Data Collection System

Forms and Documents

Document	Type	Status	Availability
0910-0491--supporting_statement_B1.doc	Supporting Statement B	Uploaded 2015-06-16	Available
0910-0491--supporting_statement_A1.doc	Supporting Statement A	Uploaded 2015-06-16	Repair queued

IC Document Collections

IC ID	Collection	Type	Status	Form
6195	Emergency Shortages Data Collection System (formerly Emergency Medical Device Shortage Program Survey)	Other-Telephone Survey Script	Modified

ICR Details

OMB Control No: 0910-0491	ICR Reference No: 201506-0910-018
Status: Historical Inactive	Previous ICR Reference No: 201206-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Emergency Shortages Data Collection System
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Withdrawn and continue	Conclusion Date: 08/13/2015
	Date Received in OIRA: 07/01/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2015	36 Months From Approved	08/31/2015
Responses	375	0	375
Time Burden (Hours)	188	0	188
Cost Burden (Dollars)	0	0	0

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Abstract: FDA maintains a medical device database which allows FDA to identify locations and manufacturers of hard to locate medical devices in the context of a Federally-declared disaster/emergency, an official emergency preparedness exercise, or a potential public health risk posed by non-disaster-related device shortage. Because of the dynamic nature of the medical device industry, particularly with respect to specific product lines, manufacturing capabilities and raw material/subcomponent sourcing, it is necessary to update the data in the Emergency Shortages Data Collection System at regular intervals, but efforts are made to limit the frequency of outreach to a specific manufacturer to no more than every 4 months. The Emergency Shortages Data Collection System will only include those medical devices for which there will likely be high demand during a specific emergency/disaster, or for which there are sufficiently small numbers of manufacturers such that disruption of manufacture, or loss of one or more of these manufacturers would create a shortage.

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Authorizing Statute(s): US Code: 21 USC 393(d)(2) Name of Law: 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:
	80 FR 14138	03/18/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 36824	06/26/2015
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 Shortages Data Collection System (formerly Emergency Medical Device Shortage Program Survey)

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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: $79,273

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: 07/01/2015

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