60 Day FRN

BILLING CODE: 4163-18-P

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-19-xxxx; Docket No. CDC-2019-xxxx]

Proposed Data Collection Submitted for Public Comment and Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS)

ACTION: Notice with comment period

SUMMARY: The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Emerging Infections Program, population-based surveillance via active, laboratory case finding that is used for detecting, identifying, and monitoring emerging pathogens.

DATES: CDC must receive written comments on or before [INSERT DATE 60 DAYS AFTER PUBLICATION DATE IN THE FEDERAL REGISTER].

ADDRESSES: You may submit comments, identified by Docket No. CDC-201x-xxxx by any of the following methods:

• Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments.

• Mail: Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road, N.E., MS-D74, Atlanta, Georgia 30329.

Instructions: All submissions received must include the agency name and Docket Number. CDC will post, without change, all relevant comments to Regulations.gov.

Please note: Submit all comments through the Federal eRulemaking portal (regulations.gov) or by U.S. mail to the address listed above.

FOR FURTHER INFORMATION: To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road, N.E., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; E-mail: [email protected].

SUPPLEMENTARY INFORMATION:

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

3. Enhance the quality, utility, and clarity of the information to be collected; and

4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses.

5. Assess information collection costs.

Proposed Project

Emerging Infections Program – Revision - National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The Emerging Infections Programs (EIPs) are population-based centers of excellence established through a network of state health departments collaborating with academic institutions; local health departments; public health and clinical laboratories; infection control professionals; and healthcare providers. EIPs assist in local, state, and national efforts to prevent, control, and monitor the public health impact of infectious diseases.

Activities of the EIPs fall into the following general categories: (1) active surveillance; (2) applied public health epidemiologic and laboratory activities; (3) implementation and evaluation of pilot prevention/intervention projects; and (4) flexible response to public health emergencies. Activities of the EIPs are designed to: (1) address issues that the EIP network is particularly suited to investigate; (2) maintain sufficient flexibility for emergency response and new problems as they arise; (3) develop and evaluate public health interventions to inform public health policy and treatment guidelines; (4) incorporate training as a key function; and (5) prioritize projects that lead directly to the prevention of disease.

A revision is being submitted to make existing collection instruments clearer and to add several new forms specifically surveying laboratory practices. These forms will allow the EIP to better detect, identify, track changes in laboratory testing methodology, gather information about laboratory utilization in the EIP catchment area to ensure that all cases are being captured, and survey EIP staff to evaluate program quality.

The total estimated burden is 61,956 hours. There is no cost to respondents other than their time.

Estimated Annualized Burden Hours

Type of Respondent	Form Name	No. of respondents	No. of responses per respondent	Avg. burden per response (in hours)	Total burden (in hours)
State Health Department	ABCs Case Report Form	10	809	20/60	2697
	ABCs Invasive Pneumococcal Disease in Children and Adults Case Report Form	10	127	10/60	212
	ABCs H.influenzae Neonatal Sepsis Expanded Surveillance Form	10	6	10/60	10
	ABCs Severe GAS Infection Supplemental Form	10	136	20/60	453
	ABCs Neonatal Infection Expanded Tracking Form	10	37	20/60	123
	FoodNet Campylobacter	10	970	21/60	3395
	FoodNet Cyclospora	10	42	10/60	70
	FoodNet Listeria monocytogenes	10	16	20/60	53
	FoodNet Salmonella	10	855	21/60	2993
	FoodNet Shiga toxin producing E. coli	10	290	20/60	967
	FoodNet Shigella	10	234	10/60	390
	FoodNet Vibrio	10	46	10/60	77
	FoodNet Yersinia	10	55	10/60	92
	FoodNet Hemolytic Uremic Syndrome Case Report Form	10	10	1	100
	FoodNet Clinical Laboratory Practices and Testing Volume	10	70	20/60	233
	FluSurv-NET Influenza Hospitalization Surveillance Network Case Report Form	10	764	25/60	3183
	FluSurv-NET Influenza Hospitalization Surveillance Project Vaccination Phone Script Consent Form (English)	10	333	5/60	278
	FluSurv-NET Influenza Hospitalization Surveillance Project Vaccination Phone Script (Spanish)	10	333	5/60	278
	Influenza Hospitalization Surveillance Project Provider Vaccination History Fax Form (Children/Adults)	10	333	5/60	278
	FluSurv-NET Laboratory Survey	10	16	10/60	26
	HAIC - MuGSI Case Report Form for Carbapenem-resistant Enterobacteriaceae (CRE) and Acinetobacter baumannii (CRAB)	10	500	28/60	2333
	HAIC - MuGSI Extended-Spectrum Beta-Lactamase-Producing Enterobacteriaceae (ESBL/iEC)	10	4200	25/60	17,500
	HAIC - Invasive Methicillin-resistant Staphylococcus aureus (MRSA) Infection Case Report Form	10	340	28/60	1587
	HAIC - Invasive Methicillin-sensitive Staphylococcus aureus (MSSA) Infection Case Report Form	10	584	28/60	2725
	HAIC - CDI Case Report and Treatment Form	10	1650	38/60	10450
	HAIC Candidemia Case Report	10	200	30/60	1134
	HAIC- Annual Survey of Laboratory Testing Practices for C. difficile Infections	10	16	19/60	51
	HAIC- CDI Annual Surveillance Officers Survey	10	1	15/60	3
	HAIC- Emerging Infections Program C. difficile Surveillance Nursing Home Telephone Survey (LTCF)	10	45	5/60	38
	HAIC- Invasive Staphylococcus aureus Laboratory Survey	10	11	20/60	37
	HAIC- Invasive Staphylococcus aureus Supplemental Surveillance Officers Survey	10	1	10/60	17
	HAIC- Laboratory Testing Practices for Candidemia Questionnaire	10	20	12/60	40
	HAIC MuGSI CA CP-CRE Health interview (new)	100	10	30/60	50
	HAIC MuGSI Supplemental Surveillance Officer Survey (new)	10	1	15/60	3
	HAIC Death Ascertainment Variables (no form)	10	8	1440/60	10,080
Total					61,956

Jeffrey M. Zirger,

Acting Chief,

Information Collection Review Office,

Office of Scientific Integrity,

Office of the Associate Director for Science,

Office of the Director,

Centers for Disease Control and Prevention.

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