Data Calls for the Laboratory Response Network

Forms and Documents

Document Name	Status
Laboratory Input to Evaluate Assay Performance - CDC Zika MAC-ELISA Form	New
Requesting Laboratory Input to Evaluate Assay Performance Following Implementation of Updated QC Recommendations (Phase 1) and Standardization (Phase 2, 3) of the CDC Zika MAC-ELISA Form and Instruction	New
SSB 0920-0881.docx Supporting Statement B	2017-02-09
Att 6 - IRB Determination.pdf Supplementary Document	2017-01-23
Att 2 - Published 60 day FRN.pdf Supplementary Document	2017-01-23
Att 1a - Sec. 301 42 USC 241[1].pdf Supplementary Document	2017-02-09
Att 1 - PDD 39 (10ES).doc Supplementary Document	2017-02-09
SSA 0920-0881_Special Data Calls.doc Supporting Statement A	2017-02-09

IC Document Collections

IC ID	Document Title	Status
230836	Laboratory Input to Evaluate Assay Performance - CDC Zika MAC-ELISA Form	New
228589	Requesting Laboratory Input to Evaluate Assay Performance Following Implementation of Updated QC Recommendations (Phase 1) and Standardization (Phase 2, 3) of the CDC Zika MAC-ELISA Form and Instruction	New

ICR Details

OMB Control No: 0920-0881	ICR Reference No: 201701-0920-007
Status: Historical Active	Previous ICR Reference No: 201402-0920-004
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0881
Title: Data Calls for the Laboratory Response Network
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 10/10/2017
	Date Received in OIRA: 02/16/2017
Terms of Clearance: Previous terms continue: 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	10/31/2020	36 Months From Approved	04/30/2017
Responses	408	0	450
Time Burden (Hours)	204	0	225
Cost Burden (Dollars)	0	0	0

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Abstract: This is a Generic information collection. The goal of the GenIC surveys is to collect information about laboratory capabilities, equipment or personnel. The information gathered will assist the LRN Program Office in decisions about testing platforms used by LRN members thereby shaping the scope of emerging infectious disease responses. Surveys will be conducted by email with LRN Helpdesk or through online survey tools.

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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:
	81 FR 81146	11/17/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 9744	02/08/2017
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Requesting Laboratory Input to Evaluate Assay Performance Following Implementation of Updated QC Recommendations (Phase 1) and Standardization (Phase 2, 3) of the CDC Zika MAC-ELISA	NA	Zika MAC-ELISA QC Data Form
Laboratory Input to Evaluate Assay Performance - CDC Zika MAC-ELISA	none	Zika MAC ELISA Verification Panel

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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	408	450	0	-42	0	0
Annual Time Burden (Hours)	204	225	0	-21	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: This is a resubmission of a previously approved Revision for 0920-0881. Burden Hours in the previous package were added incorrectly and have now been changed to reflect the Program's intent for collection (three years). Additionally an incorrectly uploaded GenIC has been removed.

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Annual Cost to Federal Government: $74,246

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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.     No

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: 02/16/2017

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