Laboratory Response Network

Forms and Documents

Document Name	Status
LRN IRB determination.pdf Supplementary Document	2010-03-04
Attachment 1_Presidential Decision Directive 39.doc Supplementary Document	2010-03-04
cleanLRN Supporting Statement_532010.doc Supporting Statement A	2010-05-04

IC Document Collections

IC ID	Document Title	Status
192294	LRN Special Data Call Instruction	New
192293	LRN Surge Events Instruction	New
192292	LRN Proficiency Testing Instruction	New
192291	LRN Biennial Requalification Instruction	New
192290	LRN General Surveillance Testing Results Instruction	New

ICR Details

OMB Control No: 0920-0850	ICR Reference No: 201003-0920-007
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Laboratory Response Network
Type of Information Collection: Existing collection in use without an OMB Control Number	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 05/04/2010
	Date Received in OIRA: 03/17/2010
Terms of Clearance: Approved consistent with the understanding that CDC will pursue a generic clearance to cover LRN special data calls.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2013	36 Months From Approved
Responses	131,500	0	0
Time Burden (Hours)	3,176,400	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Laboratory Response Network is an integrated national and international network of laboratories that can respond to suspected acts of biological, chemical, or radiological terrorism and other public health emergencies. Member laboratories submit information regarding the testing capabilities of the laboratory; report all biological and chemical testing results; and participate in Proficiency Testing Challenges or Validation.

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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:
	74 FR 12133	03/23/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 9900	03/04/2010
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
LRN General Surveillance Testing Results
LRN Biennial Requalification
LRN Proficiency Testing
LRN Surge Events
LRN Special Data Call

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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	131,500	0	0	0	0	131,500
Annual Time Burden (Hours)	3,176,400	0	0	0	0	3,176,400
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: $5,313,750

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? Yes

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)? 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: 03/17/2010

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