Laboratory Response Network

Forms and Documents

Document Name	Status
Form 0920-0850 LRN Surge Events Form and Instruction	Modified
Form 0920-0850 LRN Proficiency Testing Form and Instruction	Modified
Form 0920-0850 LRN Biennial Requalification Form and Instruction	Modified
Form 0920-0850 LRN General Surveillance Testing Results Form and Instruction	Modified
Att 5 - PIA.pdf Supplementary Document	2019-03-07
Att 4 - IRB determination.pdf Supplementary Document	2019-03-07
Att 3e - Screen shots of Biennial Requalification.docx Supplementary Document	2019-03-07
Att 2a - 60-day FRN.pdf Supplementary Document	2019-03-07
Att 1b - Authorizing_Regulations_T42_section_241.doc Supplementary Document	2019-03-07
Att 1a - Presidential Decision Directive 39.doc Supplementary Document	2019-03-07
LRN Supporting Statement B 02122019.doc Supporting Statement B	2019-03-07
LRN Supporting Statement A 02122019 final.doc Supporting Statement A	2019-03-07

IC Document Collections

IC ID	Document Title	Status
192293	LRN Surge Events Form and Instruction	Modified
192292	LRN Proficiency Testing Form and Instruction	Modified
192291	LRN Biennial Requalification Form and Instruction	Modified
192290	LRN General Surveillance Testing Results Form and Instruction	Modified

ICR Details

OMB Control No: 0920-0850	ICR Reference No: 201902-0920-020
Status: Active	Previous ICR Reference No: 201512-0920-007
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0850
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 without change	Conclusion Date: 04/19/2019
	Date Received in OIRA: 03/20/2019
Terms of Clearance: OMB is approving this information collection request for a period of three years during which time CDC will request approval to extend or revise the collection if CDC seeks to continue the information collection activity beyond the period approved under this action. LRN special data calls will continue to be submitted as Generic requests under 0920-0881.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2022	36 Months From Approved	04/30/2019
Responses	85,280	0	98,400
Time Burden (Hours)	2,064,660	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 is a reduction in Burden Hours from the previously approved collection due to a decrease in participating laboratories.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Public Health Service Act
   EO: EO 39 Name/Subject of EO: Presidential Decision Directive 39
  

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:
	83 FR 50096	10/04/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 10090	03/19/2019
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
LRN General Surveillance Testing Results	0920-0850	General Surveillance Testing
LRN Biennial Requalification	0920-0850	Biennial Requalification
LRN Proficiency Testing	0920-0850	Proficiency Testing
LRN Surge Events	0920-0850	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	85,280	98,400	0	-13,120	0	0
Annual Time Burden (Hours)	2,064,660	2,382,300	0	-317,640	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Burden decrease is due to fewer participating laboratories.

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Annual Cost to Federal Government: $4,426,147

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 03/20/2019

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