Emerging Infections Program

Forms and Documents

Document Name	Status
HAIC Candidemia Periodic Laboratory Survey Form and Instruction	Modified
Form 0920-0978 HAIC Invasive Staphylococcus aureus Annual Surveillance Officers Survey Form and Instruction	Modified
HAIC Invasive Staphylococcus aureus Annual Laboratory Survey Form and Instruction	Unchanged
Form 0920-0978 HAIC CDI LTCF Survey Form and Instruction	Unchanged
Form 0920-0978 HAIC CDI Annual Surveillance Officers Survey Form and Instruction	Modified
HAIC CDI Annual Laboratory Survey Form and Instruction	Modified
Flu Surv NET Laboratory Survey Form	Modified
Foodnet Clinical Laboratory Practices and Testing Volume Form and Instruction	Modified
HAIC Candidemia Case Report Form Form and Instruction	Modified
HAIC Invasive Methicillin-Sensitive Staphylococcus aureus (MSSA) Form and Instruction	Modified
HAIC Multi-Site Gram-Negative Surveillance Initiative - Extended Spectrum Beta-Lactamase Producing Enterobacteriaceae (MuGSI-ESBL) Form and Instruction	Unchanged
Form 0920-0978 Influenza Hospitalization Surveillance Project Provider Vaccination History Fax Form (Children/Adults) Form and Instruction	Unchanged
Form 0920-0978 Influenza Hospitalization Surveillance Project Vaccination Telephone Script / Consent Form (Spanish) Form and Instruction	Unchanged
Form 0920-0978 ABCs Severe GAS Infection Supplemental Form Form and Instruction	Unchanged
Form 0920-0978 ABCs H. Influenzae Neonatal Sepsis Expanded Surveillance Form Form and Instruction	Unchanged
HAIC Multi-Site Gram-Negative Bacilli Case Report Form (MuGSI-CRE/CRAB) Form and Instruction	Unchanged
HAIC CDI Case Report Form Form and Instruction	Modified
Form 0920-0978 FoodNet Yersinia Form and Instruction	Modified
Form 0920-0978 Influenza Hospitalization Surveillance Project Vaccination Telephone Script / Consent Form (English) Form and Instruction	Unchanged
Form 0920-0978 FoodNet Hemolytic Uremic Syndrome (HUS) Form and Instruction	Modified
Influenza Hospitalization Surveilance Network Case Report Form Form and Instruction	Modified
ABCs Neonatal Infection Expanded Tracking Form Form and Instruction	Unchanged
Form 0920-0978 ABCs Invasive Pneumococcal Disease in Children Form and Instruction	Unchanged
HAIC Invasive Methicillin-resistant Staphylococcus aureus (MRSA) Form and Instruction	Modified
Form 0920-0978 ABCs Case Report Form Form and Instruction	Modified
Att2_EIP2022_NonSub_Crosswalk_AUG2021.docx Supplementary Document	2021-08-25
Att1_EIP2022_NonSub_DescriptionChanges_AUG2021_final.docx Supplementary Document	2021-08-25
EIP 0920-0978_Non-sub change request_final.docx Justification for No Material/Nonsubstantive Change	2021-08-26
Att2_EIP2021_NonSub_Crosswalk_NOV2020.docx Supplementary Document	2020-11-13
Att1_EIP2021_NonSub_DescriptionChanges_NOV2020.docx Supplementary Document	2020-11-13
EIP 0920-0978_Non-sub change request_11232020v2.docx Justification for No Material/Nonsubstantive Change	2020-11-23
Att2_EIP2021_NonSub_Crosswalk_Sept2020.docx Supplementary Document	2020-09-08
EIP 0920-0978_Non-sub change request_Sept2020.docx Justification for No Material/Nonsubstantive Change	2020-09-08
Att1_EIP2021_NonSub_DescriptionChanges_Sept2020.docx Supplementary Document	2020-09-08
0920-0978 Change Memo - EIP HAIC COVID-19 CRF additions_updated07242020_CLEAN.docx Justification for No Material/Nonsubstantive Change	2020-07-29
0920-0978 Change Memo - EIP HAIC COVID-19 CRF additions.docx Justification for No Material/Nonsubstantive Change	2020-06-24
Att24_Cross walk.pdf Supplementary Document	2019-12-10
Att23_Description of Changes.pdf Supplementary Document	2019-12-10
FoodNetSupplemental1_FN Highlights_FDD MMG cross walk_ALL_20190815.xlsx Supplementary Document	2019-10-25
FoodNetSupplemental2_FoodNet Variable List_mapping to MMG DRAFT.XLSX Supplementary Document	2019-10-25
Non-Sub ChgReq_0920-0978(121019)_OMBupdates (002).doc Justification for No Material/Nonsubstantive Change	2019-12-12
Privacy Act Checklist.docx Supplementary Document	2019-02-22
Attachment 33 - Non-research determination.pdf Supplementary Document	2019-02-22
Att 32- Flu PIA.pdf Supplementary Document	2019-02-22
Att 31- ABCs PIA.pdf Supplementary Document	2019-02-22
Att 30 - FoodNet PIA.pdf Supplementary Document	2019-02-22
Att 29- HAIC PIA.pdf Supplementary Document	2019-02-22
60 Day FRN.pdf Supplementary Document	2019-02-22
Att 1- Authorizing_Regulations_T42_section_241.pdf Supplementary Document	2019-02-22
Non-sub change request_2018.doc Justification for No Material/Nonsubstantive Change	2018-09-13
CDI_Non-sub change request_FINAL_20180524.doc Justification for No Material/Nonsubstantive Change	2018-05-31
Part B_EIP OMB 2018 Revision_20180926.docx Supporting Statement B	2019-02-22
Part A_EIP OMB 2018 Revision_20180926 ICRO revised.docx Supporting Statement A	2019-02-22

IC Document Collections

IC ID	Document Title	Status
235058	HAIC Candidemia Periodic Laboratory Survey Form and Instruction	Modified
235057	HAIC Invasive Staphylococcus aureus Annual Surveillance Officers Survey Form and Instruction	Modified
235056	HAIC Invasive Staphylococcus aureus Annual Laboratory Survey Form and Instruction	Unchanged
235055	HAIC CDI LTCF Survey Form and Instruction	Unchanged
235054	HAIC CDI Annual Surveillance Officers Survey Form and Instruction	Modified
235053	HAIC CDI Annual Laboratory Survey Form and Instruction	Modified
235052	Flu Surv NET Laboratory Survey Form	Modified
235051	Foodnet Clinical Laboratory Practices and Testing Volume Form and Instruction	Modified
231114	HAIC Candidemia Case Report Form Form and Instruction	Modified
231113	HAIC Invasive Methicillin-Sensitive Staphylococcus aureus (MSSA) Form and Instruction	Modified
231112	HAIC Multi-Site Gram-Negative Surveillance Initiative - Extended Spectrum Beta-Lactamase Producing Enterobacteriaceae (MuGSI-ESBL) Form and Instruction	Unchanged
231111	Influenza Hospitalization Surveillance Project Provider Vaccination History Fax Form (Children/Adults) Form and Instruction	Unchanged
231110	Influenza Hospitalization Surveillance Project Vaccination Telephone Script / Consent Form (Spanish) Form and Instruction	Unchanged
230869	ABCs Severe GAS Infection Supplemental Form Form and Instruction	Unchanged
220380	ABCs H. Influenzae Neonatal Sepsis Expanded Surveillance Form Form and Instruction	Unchanged
217336	HAIC Multi-Site Gram-Negative Bacilli Case Report Form (MuGSI-CRE/CRAB) Form and Instruction	Unchanged
217334	HAIC CDI Case Report Form Form and Instruction	Modified
207663	FoodNet Yersinia Form and Instruction	Modified
207662	FoodNet Vibrio Other-Variable list	Modified
207661	FoodNet Shigella Other-Variable list	Modified
207660	FoodNet Shiga toxin producing E. coli Other-Variable list	Modified
207659	FoodNet Salmonella Other-Variable list	Modified
207658	FoodNet Listeria monocytogenes Other-Variable list	Modified
207657	FoodNet Cyclospora Other-Variable list	Modified
207655	FoodNet Campylobacter Other-Variable list	Modified
207653	Influenza Hospitalization Surveillance Project Vaccination Telephone Script / Consent Form (English) Form and Instruction	Unchanged
207652	FoodNet Hemolytic Uremic Syndrome (HUS) Form and Instruction	Modified
207651	Influenza Hospitalization Surveilance Network Case Report Form Form and Instruction	Modified
207649	ABCs Neonatal Infection Expanded Tracking Form Form and Instruction	Unchanged
207648	ABCs Invasive Pneumococcal Disease in Children Form and Instruction	Unchanged
207647	HAIC Invasive Methicillin-resistant Staphylococcus aureus (MRSA) Form and Instruction	Modified
207646	ABCs Case Report Form Form and Instruction	Modified

ICR Details

OMB Control No: 0920-0978	ICR Reference No: 202108-0920-013
Status: Received in OIRA	Previous ICR Reference No: 202011-0920-004
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0978-21HR
Title: Emerging Infections Program
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 08/26/2021

	Requested	Previously Approved
Expiration Date	04/30/2022	04/30/2022
Responses	100,410	100,480
Time Burden (Hours)	39,300	38,891
Cost Burden (Dollars)	0	0

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Abstract: The Emerging Infections Programs (EIP) is to 1) detect and monitor emerging pathogens, the diseases they cause, and the factors influencing their emergence, and respond to problems as they are identified, 2) integrate laboratory science and epidemiology to optimize public health practice, 3) strengthen infrastructure to support surveillance and research and to implement prevention and control programs, and to 4) ensure implementation of prevention strategies and communication of public health information about emerging diseases. Surveillance efforts of the core EIP activities generate reliable estimates of the incidence of certain infections and provide the foundation for a variety of epidemiologic studies. This Change Request is for minor changes to several instruments and minor burden adjustments. This is a request for a non-substantive change. Requested changes represent minor modifications to already-approved instruments to include a limited number of data elements pertaining to COVID-19.

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Authorizing Statute(s): 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:
	83 FR 57488	11/15/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 5685	02/22/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 32

IC Title	Form No.	Form Name
ABCs Case Report Form	0920-0978	2022 ABC Surveillance Case Report
ABCs H. Influenzae Neonatal Sepsis Expanded Surveillance Form	0920-0978	ABC H. Influenzae Neonatal Sepsis Expanded Surveillance Form
ABCs Invasive Pneumococcal Disease in Children	0920-0978	ABC Invasive Pneumococcal Disease in Children (age>2 months to <5 years
ABCs Neonatal Infection Expanded Tracking Form	none	Neonatal Infection Expanded Tracking Form
ABCs Severe GAS Infection Supplemental Form	0920-0978	ABC Severe GAS Infection Supplemental Form
Flu Surv NET Laboratory Survey	none	FluSurv Lab Survey
FoodNet Campylobacter
FoodNet Cyclospora
FoodNet Hemolytic Uremic Syndrome (HUS)	0920-0978	FoodNet HUS CRF
FoodNet Listeria monocytogenes
FoodNet Salmonella
FoodNet Shiga toxin producing E. coli
FoodNet Shigella
FoodNet Vibrio
FoodNet Yersinia	0920-0978	Foodborne and DIarrheal Diseases Message Mapping Guide (FDD MMG - FoodNet only portion)
Foodnet Clinical Laboratory Practices and Testing Volume	none	FoodNET Lab Practices Volume
HAIC CDI Annual Laboratory Survey	n/a	Annual Survey of Laboratory Testing Practices for C. difficile Infection
HAIC CDI Annual Surveillance Officers Survey	0920-0978	Surveillance Officer's Survey
HAIC CDI Case Report Form	none	CDI Case Report
HAIC CDI LTCF Survey	0920-0978	Emerging Infections Progrom C. difficile Surveillance Nuring Home Telephone Call Survey
HAIC Candidemia Case Report Form	none	Candidemia Case Report
HAIC Candidemia Periodic Laboratory Survey	none	Candidemia Lab Survey
HAIC Invasive Methicillin-Sensitive Staphylococcus aureus (MSSA)	none	MSSA Report 2021
HAIC Invasive Methicillin-resistant Staphylococcus aureus (MRSA)	none	Invasive MRSA Case Report
HAIC Invasive Staphylococcus aureus Annual Laboratory Survey	none	Invasive Staph aureus Lab Survey
HAIC Invasive Staphylococcus aureus Annual Surveillance Officers Survey	0920-0978	2019 HAIC Invasive Staphylococcus aureus Supplemental Surveiallance Officer Survey
HAIC Multi-Site Gram-Negative Bacilli Case Report Form (MuGSI-CRE/CRAB)	n/a	2021 Carbapenem Resistant Enterobacteriaceae (CRE)/ Carbapenem resistant A. baumannii (CRAB) MuGSI HAIC Case Report Form
HAIC Multi-Site Gram-Negative Surveillance Initiative - Extended Spectrum Beta-Lactamase Producing Enterobacteriaceae (MuGSI-ESBL)	n/a	2021 MuGSI Extended-Spectrum Beta-Lactamase (ESBL)-Producing Enterobacteriaceae Case Report Form
Influenza Hospitalization Surveilance Network Case Report Form	none	Influenza Hospitalization Surveillance Network Case Report
Influenza Hospitalization Surveillance Project Provider Vaccination History Fax Form (Children/Adults)	0920-0978	FluSurv Net Provider Vaccination History Fax Form
Influenza Hospitalization Surveillance Project Vaccination Telephone Script / Consent Form (English)	0920-0978, 0920-0978	FluSurv NET Vaccination Phone Script ,   FluSurv NET Consent From English
Influenza Hospitalization Surveillance Project Vaccination Telephone Script / Consent Form (Spanish)	0920-0978, 0920-0978	FluSurv NET Vaccination Phone Script ,   FluSurv NET Consent Form Spanish

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ICR Summary of Burden

	Total Request	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	100,410	100,480	0	-70	0	0
Annual Time Burden (Hours)	39,300	38,891	0	409	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Slight burden changes are due to slight modifications to the respondent numbers or to burden estimate adjustments. Some of the changes are due to correction of errors from the previous change request entry. The other changes described in this Change Request are primarily modifications to enhance the usability and clarity of existing forms.

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Annual Cost to Federal Government: $31,091,990

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.     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? Yes

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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: 08/26/2021

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