Undetermined cause of Serratia marcescens infections - Emergency

Forms and Documents

Document Name	Status
Records abstraction form for patients who suffered from Serratia marcescens infection Form and Instruction	New
Emergency SSB Serratia BSI Multiple States.docx Supporting Statement B	2018-04-26
Emergency SSA Serratia BSI Multiple States.docx Supporting Statement A	2018-04-26
Emergency Review Request Memo.pdf Supplementary Document	2018-04-26
Att 4 - Non-research determination.pdf Supplementary Document	2018-04-26
Att 1 - Section 301 of the Public Health Service Act (42 USC 241).pdf Supplementary Document	2018-04-26

IC Document Collections

IC ID	Document Title	Status
231226	Records abstraction form for patients who suffered from Serratia marcescens infection Form and Instruction	New

ICR Details

OMB Control No: 0920-1226	ICR Reference No: 201804-0920-013
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-18ACN
Title: Undetermined cause of Serratia marcescens infections - Emergency
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 04/30/2018
OIRA Conclusion Action: Approved with change	Conclusion Date: 04/26/2018
	Date Received in OIRA: 04/26/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2018	6 Months From Approved
Responses	100	0	0
Time Burden (Hours)	200	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The goal of this New Emergency Clearance is to request approval for an investigation is to identify potential risk factors leading to an outbreak of Serratia maraescens infections among US healthcare patients. Data will be used to identify a cause of the infections and prevent additional events from occurring. On March 27, 2018, the Colorado Department of Public Health and Environment (CDPHE) notified CDC of 4 cases of Serratia marcescens bacteremia among pediatric patients with central lines in an acute care hospital between January 20 and March 23, 2018. This cluster of cases was above the normal baseline of 1–3 cases per year at that facility. The facility examined exposures including common staff and medications and identified commonalities related to the maintenance and care of central lines as well as several medical products including prefilled normal saline syringes and prefilled heparin flushes. On March 28, CDPHE issued a call for cases to other state and local health departments through the Epidemic Information Exchange (Epi-X) system. On March 29, the Tennessee Department of Health (TDH) notified CDC of 3 cases of Serratia marcescens bacteremia in pediatric patients with central lines in a pediatric hospital between March 6 and March 21, 2018; initial examination of medications and common products identified central venous catheter line products as a possible source of infections, including prefilled heparin and normal saline syringes. CDC is currently conducting a multistate investigation to support state health departments. Currently, eight state health departments have reported a total of 26 cases to CDC.

Emergency Justfication: Serratia marcescens is a Gram-negative bacillus that can be found in the environment and thrives in moist environments. In healthcare settings, it can be found on the hands of healthcare workers and as a contaminant of medical products and devices, particularly aqueous products. It is a known cause of healthcare-associated infections, particularly urinary tract infection, wound infections, and bloodstream infections, and it is an important opportunistic pathogen in neonatal and pediatric intensive care units. Serratia marcescens has been implicated previously in multistate outbreaks of bloodstream infections caused by intrinsic contamination of prefilled syringes of heparin and isotonic sodium chloride solution.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: U.S. PHSA
  

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

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Records abstraction form for patients who suffered from Serratia marcescens infection	NA	Undetermined cause of Serratia marcescens infections - Multiple States,2018 Records Abstraction Tool

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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	100	0	0	100	0	0
Annual Time Burden (Hours)	200	0	0	200	0	0
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: No

Burden Reduction Due to:

Short Statement: Submission of 0920-18ACN is a New Emergency ICR designed to collect information on the undetermined cause of Serratia marcescens infections in multiple States.

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Annual Cost to Federal Government: $26,329

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: 04/26/2018

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