Data Calls for the Laboratory Response Network

Forms and Documents

Document Name	Status
Requesting Laboratory Input to Identify Gaps in Preparedness for Testing Environmental Samples Form	New
Requesting Laboratory Input to Support Ebola Response Form	New
SS B Supporting Statement 0881 extension.docx Supporting Statement B	2014-03-25
Att 4 - IRB Determination.pdf Supplementary Document	2014-01-22
Att_3-LRN_Data_Calls_Questions_(10ES).docx Supplementary Document	2014-01-22
Att 2 -60 day published.pdf Supplementary Document	2014-01-22
Attachment 1a Sec. 301 42 USC 241[1].pdf Supplementary Document	2014-01-22
Att_1_PDD_39_(10ES).doc Supplementary Document	2014-01-22
SS A Data_Calls_for_ 0881 extension 3-25-14.doc Supporting Statement A	2014-03-26

IC Document Collections

IC ID	Document Title	Status
217446	Requesting Laboratory Input to Identify Gaps in Preparedness for Testing Environmental Samples Form	New
212941	Requesting Laboratory Input to Support Ebola Response Form	New

ICR Details

OMB Control No: 0920-0881	ICR Reference No: 201402-0920-004
Status: Historical Active	Previous ICR Reference No: 201101-0920-004
Agency/Subagency: HHS/CDC	Agency Tracking No: 21338
Title: Data Calls for the Laboratory Response Network
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 with change	Conclusion Date: 04/07/2014
	Date Received in OIRA: 02/10/2014
Terms of Clearance: Approved consistent with the understanding that CDC will submit individual GenIC requests to OMB for review and approval prior to any information collection under this generic clearance. The Program is encouraged to evaluate the actual amount of burden hours imposed under this collection and to revise the estimates as appropriate. Prior to publication of the next 60-day notice to renew the collection, CDC will provide OMB with a briefing on how (and if) the generic has been utilized during the 3-year approval. The ongoing utility of the collection will be reassessed at that time.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2017	36 Months From Approved	04/30/2014
Responses	450	0	800
Time Burden (Hours)	225	0	400
Cost Burden (Dollars)	0	0	0

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Abstract: CDC is requesting OMB approval for an extension of this generic clearance. Although the Laboratory Response Network (LRN) Program Office at CDC has an extensive database of information regarding all network members, Special Data Calls are sometimes needed to address issues concerning the response capabilities of member facilities for priority threat agents or to assess the network's ability to respond to new emerging threats. Special Data Calls may be conducted via broadcast e-mail that asks respondent to send information via email to the LRN help desk or through online survey tools (i.e., Survey Monkey) which require respondents to go to a web link and answer a series of questions.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Public Health Service 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 72087	12/02/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 7459	02/07/2014
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Requesting Laboratory Input to Support Ebola Response	none	Data Call Instrument
Requesting Laboratory Input to Identify Gaps in Preparedness for Testing Environmental Samples	none	BA Environmental Sample Processing Questionnaire

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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	450	800	0	0	-350	0
Annual Time Burden (Hours)	225	400	0	0	-175	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: This extension request is for a generic clearance that is rarely used but necessary to have available. The burden has been reduced from 400 to 75 hours, the number of respondents reduced to 150, and the responses per respondent 4 to 1 per year.

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Annual Cost to Federal Government: $118,750

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: 02/10/2014

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