Enterprise Laboratory Information Management System

Forms and Documents

Document Name	Status
Form CDC 50.34_v3.3.3 Att 3a_50.34 Form_V3.3.3 Form	New
Form CDC 0920- Att 3b_GFAT_v4.7 Form and Instruction	New
Form CDC 50.34 Att 3a_ 50.34 Form_v3.3.3 Form	New
Privacy Impact Assessment (PIA) - approved.pdf Supplementary Document	2020-09-01
Att 5. IRB Email.msg Supplementary Document	2020-09-01
Att 4 ID ELIMS-approved-PIA.pdf Supplementary Document	2020-09-01
Att 2 Published 60dy2020EC (1).pdf Supplementary Document	2020-09-01
Att 1 Section 301 of the Public Health Service Act (42 USC 241).pdf Supplementary Document	2020-09-01
SSB.docx Supporting Statement B	2020-09-01
SSA.FINAL.docx Supporting Statement A	2020-09-01

IC Document Collections

IC ID	Document Title	Status
243434	Att 3a_50.34 Form_V3.3.3 Form	New
243432	Att 3b_GFAT_v4.7 Form and Instruction	New
243431	Att 3a_ 50.34 Form_v3.3.3 Form	New

ICR Details

OMB Control No: 0920-1309	ICR Reference No: 202009-0920-001
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-20EC
Title: Enterprise Laboratory Information Management System
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: 11/20/2020
	Date Received in OIRA: 09/10/2020
Terms of Clearance: Approved consistent with the understanding that the transition to HL7 messaging is ongoing to enhance information technology and reduce burden on public health laboratories. CDC will submit a revision if/when REDCap is no longer necessary due to completion of the transition.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2023	36 Months From Approved
Responses	25,079	0	0
Time Burden (Hours)	2,131	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Enterprise Laboratory Information Management System (ELIMS) is a system that CDC laboratories use to manage specimen testing work flows. Specimen information is entered into ELIMS via PDF file called the CDC Specimen Submission 50.34 Form or an electronic XSLX file called the Global File Accessioning Template.

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Authorizing Statute(s): US Code: 42 USC 263a Name of Law: Clinical Laboratory Improvement Amendments of 1988
   US Code: 42 USC 301 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:
	84 FR 70550	12/23/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 55456	09/08/2020
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Att 3a_ 50.34 Form_v3.3.3	CDC 50.34	CDC SPECIMEN SUBMISSION FORM: SPECIMENS OF HUMAN ORIGIN
Att 3b_GFAT_v4.7	CDC 0920-	GFATv4.7
Att 3a_50.34 Form_V3.3.3	CDC 50.34_v3.3.3	CDC SPECIMEN SUBMISSION FORM: SPECIMENS OF HUMAN ORGAN

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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	25,079	0	0	0	0	25,079
Annual Time Burden (Hours)	2,131	0	0	0	0	2,131
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: $132,062

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.     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? 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: 09/10/2020

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