Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60 Day-19-0978; Docket No. CDC-2018-0098]

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 (EIP). The EIP is a population-based surveillance activity performed via active, laboratory case finding that is used for detecting, identifying, and monitoring emerging pathogens.

DATES:

CDC must receive written comments on or before January 14, 2019.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2018-0098 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 NE, 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 CONTACT:

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 NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email:

omb@cdc.gov.

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 OMB# 0920-0978 Exp. Date: 05/31/2021—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 40,601 hours. There is no cost to respondents other than their time.

Estimated Annualized Burden Hours

Type of

respondent

Form name

Number of

respondents

Number 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 Case Report Form

10

22

10/60

37

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

942

21/60

3297

FoodNet Cyclospora

10

163

10/60

272

FoodNet Listeria monocytogenes

10

15

20/60

50

FoodNet Salmonella

10

789

21/60

2761

FoodNet Shiga toxin producing E. coli

10

205

20/60

683

FoodNet Shigella

10

213

10/60

355

FoodNet Vibrio

10

34

10/60

56

FoodNet Yersinia

10

48

10/60

80

FoodNet Hemolytic Uremic Syndrome Case Report Form

10

10

1

100

FoodNet Clinical Laboratory Practices and Testing Volume—NEW

10

70

20/60

233

Influenza Hospitalization Surveillance Network Case Report Form

10

1000

25/60

4167

Influenza Hospitalization Surveillance Project Vaccination Phone Script Consent Form (English/Spanish)

10

333

5/60

278

Influenza Hospitalization Surveillance Project Vaccination Phone Script (English/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—NEW

10

23

10/60

38

HAIC CDI Case Report Form

10

1650

35/60

9625

HAIC CDI Annual Laboratory Survey—NEW

10

16

10/60

27

HAIC CDI Annual Surveillance Officers Survey—NEW

10

1

15/60

3

HAIC CDI LTCF Survey—NEW

10

45

5/60

38

HAIC Multi-site Gram-Negative Bacilli Case Report Form

(MuGSI-CRE/CRAB)

10

500

25/60

2083

HAIC Multi-site Gram-Negative Surveillance Initiative—Extended-Spectrum Beta-Lactamase-Producing Enterobacteriaceae (MuGSI-ESBL)

10

1200

25/60

5000

HAIC Invasive Methicillin-resistant

Staphylococcus aureus

(MRSA)

10

474

25/60

1975

HAIC Invasive Methicillin-sensitive

Staphylococcus aureus

(MSSA)

10

754

25/60

3142

HAIC Invasive

Staphylococcus aureus

Annual Laboratory Survey—NEW

10

11

8/60

15

HAIC Invasive

Staphylococcus aureus

Annual Surveillance Officers Survey—NEW

10

1

10/60

2

HAIC Candidemia Case Report Form

9

800

20/60

2400

HAIC Candidemia Periodic Laboratory Survey—NEW

9

15

20/60

45

Total

40,601

Jeffrey M. Zirger,

Acting Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention.

[FR Doc. 2018-24969 Filed 11-14-18; 8:45 am]

BILLING CODE 4163-18-P