60 Day FRN

Att2- 60-Day FRN_2022.docx

[NCEZID] Emerging Infections Program

60 Day FRN

OMB: 0920-0978

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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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