Laboratory Response Network

Forms and Documents

Document Name	Status
Att 4 -- LRN IRB determination.pdf Supplementary Document	2016-01-13
Att 3e Screen shots of Biennial Requalification.docx Supplementary Document	2016-01-13
Att 2 Published 60 Day FRN.pdf Supplementary Document	2016-01-13
LRN Supporting Statement B 13JAN2016.doc Supporting Statement B	2016-01-13
LRN Supporting Statement A_22APR2016.doc Supporting Statement A	2016-04-25
Attachment 1b_Presidential Decision Directive 39.doc Supplementary Document	2013-02-21
Attachment 1 a Section 361 PHS Act.docm Supplementary Document	2013-02-21
Attachment 3a LRN Biennial Requalification data elements.doc Supplementary Document	2013-02-28

IC Document Collections

IC ID	Document Title	Status
192293	LRN Surge Events Other-Data Elements	Unchanged
192292	LRN Proficiency Testing Other-Data Elements	Unchanged
192291	LRN Biennial Requalification Other-Screenshots	Unchanged
192290	LRN General Surveillance Testing Results Other-Data Elements	Unchanged

ICR Details

OMB Control No: 0920-0850	ICR Reference No: 201512-0920-007
Status: Historical Active	Previous ICR Reference No: 201303-0920-002
Agency/Subagency: HHS/CDC	Agency Tracking No: 0850
Title: 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: 04/28/2016
	Date Received in OIRA: 01/26/2016
Terms of Clearance: Previous terms continue: 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	04/30/2019	36 Months From Approved	04/30/2016
Responses	98,400	0	98,400
Time Burden (Hours)	2,382,300	0	2,382,300
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. The goal of the study is to identify gaps in preparedness for biological threats and emerging infectious diseases. The data will be used to develop strategies, policies, and operating procedures for responding to biological threat emergencies. The LRN website, Results Messenger data exchange application, and Special Data Calls Questionnaires are methods used to collect data from member laboratories. There are no changes anticipated to the Respondents or Burden Hours from the previously approved collection.

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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:
	80 FR 68542	11/05/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 3138	01/20/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
LRN General Surveillance Testing Results
LRN Biennial Requalification
LRN Proficiency Testing
LRN Surge Events

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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	98,400	98,400	0	0	0	0
Annual Time Burden (Hours)	2,382,300	2,382,300	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: $5,018,750

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: 01/26/2016

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