[NCEZID] Laboratory Response Network

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 0920-0850 Surge Event Testing Results/Exercises	Form and Instruction	New	Available
Form 0920-0850 Surge Event Testing Results/Exercises	Form and Instruction	New	Repair queued
Form 0920-0850 Proficiency Testing/Characterization Results	Form and Instruction	New	Available
Form 0920-0850 Proficiency Testing/Characterization Results	Form and Instruction	New	Repair queued
Form 0920-0850 BioFire Inventory Records	Form and Instruction	New	Available
Form 0920-0850 BioFire Inventory Records (LRN-B)	Form and Instruction	New	Repair queued
Form 0920-0850 Surge Events	Form and Instruction	Modified	Available
Form 0920-0850 LRN Surge Events	Form and Instruction	Modified	Repair queued
Form 0920-0850 Proficiency Testing	Form and Instruction	Modified	Available
Form 0920-0850 LRN Proficiency Testing	Form and Instruction	Modified	Repair queued
Form 0920-0850 Biennial Requalification	Form and Instruction	Modified	Available
Form 0920-0850 LRN Biennial Requalification	Form and Instruction	Modified	Repair queued
Form 0920-0850 LRN General Surveillance Testing Results	Form and Instruction	Modified	Repair queued
11 - PIA.pdf	Supplementary Document	Uploaded 2022-11-15	Repair queued
10 - IRB determination.pdf	Supplementary Document	Uploaded 2022-11-15	Repair queued
3a - 60 Day FRN.pdf	Supplementary Document	Uploaded 2022-11-15	Repair queued
4b - Authorizing_Regulations_T42_section_241.docx	Supplementary Document	Uploaded 2022-11-15	Repair queued
4a - Presidential Decision Directive 39.docx	Supplementary Document	Uploaded 2022-11-15	Repair queued
2 - Supporting Statement B_final.docx	Supporting Statement B	Uploaded 2022-11-15	Repair queued
1 - Supporting Statement A_final_LRN-C_LRN-B_final.docx	Supporting Statement A	Uploaded 2022-11-17	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
256960	Surge Event Testing Results/Exercises	Form and Instruction	New	Surge Event Testing Results/Exercises
256960	Surge Event Testing Results/Exercises	Form and Instruction	New
256959	Proficiency Testing/Characterization Results	Form and Instruction	New	Proficiency Testing/Characterization Results
256959	Proficiency Testing/Characterization Results	Form and Instruction	New
256958	BioFire Inventory Records (LRN-B)	Form and Instruction	New	BioFire Inventory Records
256958	BioFire Inventory Records (LRN-B)	Form and Instruction	New
192293	LRN Surge Events	Form and Instruction	Modified	Surge Events
192293	LRN Surge Events	Form and Instruction	Modified
192292	LRN Proficiency Testing	Form and Instruction	Modified	Proficiency Testing
192292	LRN Proficiency Testing	Form and Instruction	Modified
192291	LRN Biennial Requalification	Form and Instruction	Modified	Biennial Requalification
192291	LRN Biennial Requalification	Form and Instruction	Modified
192290	LRN General Surveillance Testing Results	Form and Instruction	Modified
192290	LRN General Surveillance Testing Results		Modified

ICR Details

OMB Control No: 0920-0850	ICR Reference No: 202210-0920-015
Status: Historical Active	Previous ICR Reference No: 201902-0920-020
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0850
Title: [NCEZID] Laboratory Response Network
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/14/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 11/23/2022
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2026	36 Months From Approved
Responses	85,253	0	0
Time Burden (Hours)	422,716	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. 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:
	87 FR 17294	03/28/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 68692	11/16/2022
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 7

table that charts list of burden

IC Title	Form No.	Form Name
BioFire Inventory Records (LRN-B)	0920-0850	BioFire Inventory Records
LRN Biennial Requalification	0920-0850	Biennial Requalification
LRN General Surveillance Testing Results	0920-0850
LRN Proficiency Testing	0920-0850	Proficiency Testing
LRN Surge Events	0920-0850	Surge Events
Proficiency Testing/Characterization Results	0920-0850	Proficiency Testing/Characterization Results
Surge Event Testing Results/Exercises	0920-0850	Surge Event Testing Results/Exercises

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ICR Summary of Burden

table that charts list 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	85,253	0	0	-27	0	85,280
Annual Time Burden (Hours)	422,716	0	0	-1,641,944	0	2,064,660
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The decrease in burden is due to the expansion of LRN-B laboratories implementing to HL7 reporting and decreasing the need for manual entry to Results Messenger. The additional information collection comes from inclusion of the LRN-C counterpart activities.

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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? No

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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: 11/23/2022

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