Ssb_6-9-2021

Integrated Viral Hepatitis Surveillance and Prevention Funding

for Health Departments

CDC-RFA-PS21-2103

Supporting Statement Part B

June 9, 2021

Contact Information

Point of Contact: Laura Cooley, MD, MPHTM

Epidemiology and Surveillance Branch

Division of Viral Hepatitis

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention

Centers for Disease Control and Prevention

1600 Clifton Road NE, Mailstop US12-3

Atlanta, GA 30329

Voice: (404)639-2096

Email: whz3@cdc.gov

B. Statistical Methods

1. Respondent Universe and Sampling Methods

The Division of Viral Hepatitis (DVH), CDC provides funding through cooperative agreements to 49 U.S. states, the District of Columbia, Puerto Rico and 8 large cities for Components 1 and 2 and 14 jurisdictions for Component 3.

Viral hepatitis case surveillance data will be collected per each jurisdiction’s usual mechanism using variables that have been approved by OMB separately (OMB No. 0920-0728). No sampling methods will be used to select respondents. Absolute case count is preferred to sampling for the following reasons: (1) Viral hepatitis is a reportable disease and, therefore, states routinely collect information on each reportable case, and data collected by the viral hepatitis surveillance system assist local areas by identifying populations that need immediate attention and trends that help focus valuable resources; (2) DVH’s goal is to reduce the burden of viral hepatitis in the United States and an absolute case count provides the best information on disease burden; (3) case surveillance data specifically plays an important role in outbreak detection and response.

2. Procedures for the Collection of Information

Collection of case surveillance data will continue according to the previously established process. CDC collects, analyzes, and disseminates surveillance data on viral hepatitis. Each week, health departments submit cases of viral hepatitis to the CDC through the National Notifiable Diseases Surveillance System. The annual surveillance report, published by the Division of Viral Hepatitis, summarizes information about reported cases of hepatitis A, hepatitis B, and hepatitis C and deaths with either of these hepatitides listed as a cause of death in CDC’s National Vital Statistics System. These surveillance data are used by public health partners to help focus prevention efforts, plan services, allocate resources, develop policy, and detect and respond to clusters of viral hepatitis infection.

For a health department to report cases of viral hepatitis to the CDC, they must have systems and processes in place that ensure each case is detected. Due to varying state laws, resources, and infrastructure, not all health departments report all cases of acute or newly identified chronic viral hepatitis to the CDC. In addition, it is not possible to diagnose every acute case, because symptoms may be either so mild that the person does not seek care or too vague to prompt a health care provider to suspect and test for viral hepatitis.

Case reporting generally begins when a local or state health department receives a positive laboratory report, indicating an individual has a viral hepatitis infection. Since initial reporting provides limited information and clinical symptoms are frequently needed to classify cases as acute, reported cases may require extensive follow-up to obtain full information for establishing case status and case classification.

Health departments prioritize cases for follow-up using their own protocols and may submit cases to CDC with incomplete or missing information. Additionally, the volume of laboratory reports for chronic viral hepatitis infections may be so large that not all health departments are able to consistently detect and report all chronic cases to the CDC. Under-reporting results in an underestimation of chronic viral hepatitis cases when using state reports based on data from NNDSS. Data on chronic hepatitis B and hepatitis C are in this report where available; however, these are newly identified chronic cases and do not measure prevalence.

To ensure consistent reporting across states, the Council for State and Territorial Epidemiologists, in collaboration with CDC, developed case definitions for viral hepatitis A, hepatitis B, and hepatitis C. The case definitions facilitate standardized reporting using uniform criteria and differentiate between acute, chronic, and perinatal cases. When new technologies are developed for laboratory testing or better clinical data becomes available, the case definitions are updated. Changes to case definitions should be considered when examining trends over time.

Collection of cluster/ outbreak data will occur as needed via secure email (Attachments 3d–3e). Collection of Acute Viral Hepatitis Case Reporting information will also occur via secure email (Attachment 3f). Collection of Annual Performance Report data will occur annually via GrantSolutions Grants Management Module (Attachments 3a–3c). Health departments conduct ongoing evaluations of system performance. Minimum performance standards and recent assessments for programs are described in Attachments 3a–3c. Collecting information on data quality is critical for monitoring, evaluating and interpreting viral hepatitis surveillance data used to monitor the Division of Viral Hepatitis 2025 Strategic Plan goals and strategies to reduce new viral hepatitis infections, reduce viral hepatitis-related morbidity and mortality, and reduce viral hepatitis-related disparities.

Jurisdictions will provide an annual narrative description of progress towards achieving program objectives including an implementation plan and timeline as part of their Annual Performance Report.

3. Methods to Maximize Response Rates and Deal with Nonresponse

Maximizing response rates and dealing with non-response are not issues applicable to this data collection. This project funds and provides resources and technical support for comprehensive viral hepatitis surveillance 49 U.S. states, the District of Columbia, Puerto Rico, and 8 large cities for Components 1 and 2 and 14 jurisdictions for Component 3.

4. Test of Procedures or Methods to be Undertaken

No tests of procedures or methods are being proposed. Data reported through the NNDSS surveillance system will be continually evaluated for data quality and completeness.

5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

Local and state health departments are responsible for collecting data on persons eligible to be reported, entering data into the electronic reporting system, and transmitting data to CDC. Data analysis will be performed collaboratively between CDC and relevant health departments.

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