cdc-rfa-ps13-13030401supp16 final 05 27 15.pdf

Centers for Disease Control and Prevention

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

Viral Hepatitis - Prevention and Surveillance

CDC-RFA-PS13-13030401SUPP16

Application Due Date: 07/20/2015 imu8 Sticky Note

Viral Hepatitis - Prevention and Surveillance

CDC-RFA-PS13-13030401SUPP16

TABLE OF CONTENTS

Part 1. Overview Information Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 1. Overview Information Federal Agency Name:

Federal Centers for Disease Control and Prevention (CDC) Funding Opportunity Title:

Viral Hepatitis - Prevention and Surveillance Announcement Type:

Agency Funding Opportunity Number:

CDC-RFA-PS13-13030401SUPP16

Catalog of Federal Domestic Assistance Number:

93.270 Key Dates:

Due Date for Application: 07/20/2015 Additional Overview Content:

Executive Summary:

The goals of this FOA are derived from the HHS Viral Hepatitis Action Plan (available at: http://www.hhs.gov/ash/initiatives/hepatitis) and reflect the Healthy People 2020 immunization and infectious diseases objectives. This FOA is comprised of two categories, Viral Hepatitis Prevention (Category A) and Viral Hepatitis Surveillance (Category B), which are described in detail below:

Category A –Viral Hepatitis Prevention This Category A is further divided into two parts: Part 1, Viral Hepatitis Prevention Coordination, and Part 2, Technical Assistance Center. Category A, Part 1 is intended to improve the coordination of viral hepatitis prevention at the state/local level by continuing the support provided to the 52 Viral Hepatitis Prevention Coordinators (VHPCs) that were previously funded at state/local health departments. VHPCs will continue to provide the technical expertise necessary for the management and coordination of activities directed toward prevention of viral hepatitis infections; further, these coordinators help integrate viral hepatitis prevention services into health care settings and public health programs that serve adults at risk for viral hepatitis. Category A, Part 2 was developed to ensure that VHPCs receive ongoing technical assistance, training, and other types of support through a single Technical Assistance Center.

Category B – Viral Hepatitis Surveillance CDC will continue to support the funded seven (7) cooperative agreements to eligible jurisdictions that were previously funded to conduct active, enhanced surveillance for viral hepatitis and collection of more extensive and complete information (e.g., risk factors) than is possible through the passive reporting system (the National Notifiable Disease Surveillance System [NNDSS]) that is currently used by states to report cases of nationally notifiable diseases, including viral hepatitis. Activities must include enhanced, active surveillance for chronic hepatitis B (including perinatal hepatitis B) and past or current hepatitis C as defined by the Council for State and Territorial Epidemiologists (CSTE) to support case investigation and the de-duplication, confirmation, and collation of laboratory and clinical reports of hepatitis B virus (HBV) and hepatitis C virus (HCV) infections from laboratories and care settings.

Measurable outcomes of the program will be in alignment with one (or more) of the following performance goal(s) for the NCHHSTP:

Measurable outcomes of the program will be in alignment with one (or more) of the following performance goal(s) for the NCHHSTP, Division of Viral Hepatitis (DVH), which reflect those outlined in the HHS Viral Hepatitis Action Plan:

an increase in the proportion of persons who are aware of their hepatitis B virus infection;

an increase in the proportion of persons who are aware of their hepatitis C virus infection;

a decrease in the number of new cases of HCV infection; and a decrease in the number of new cases of HBV infection.

This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be reviewed. For the definition of research, please see the CDC Web site at the following Internet address: http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-resea rch-nonresearch.pdf .

Part 2. Full Text

Section I. Funding Opportunity Description

Statutory Authority

This program is authorized under Sections 301(a), 317N, and 318 of the Public Health Service Act (42 U.S.C. Sections 241(a), 247b -15, and 247c), as amended.

Background

An estimated 3.5-5.3 million persons are living with hepatitis B or hepatitis C and about 15,000 Americans die each year from diseases associated with viral hepatitis. The Institute of Medicine (IOM) estimates that of these infected persons, 65%-75% are unaware of their HBV or HCV infection status and are not receiving care and treatment. Without diagnosis and treatment, 15%-40% of those persons living with viral hepatitis will eventually develop liver cirrhosis or hepatocellular carcinoma.

Over the past decade, state and local health departments and community partners have made progress in adapting prevention strategies and implementing activities to decrease viral hepatitis transmission in their jurisdictions. Prevention activities include increasing knowledge and awareness among persons at risk, their health-care providers, and the public at large; increasing access to hepatitis A and hepatitis B vaccines; promoting testing services, increasing communication, and improving collaboration among health agencies, community-based organizations (CBOs), and health professionals; and, in a few funded areas, supporting public health surveillance to monitor burden of disease, identify outbreaks, and focus prevention activities effectively. While rates of acute new hepatitis A virus (HAV) and HBV have declined; HAV, HBV, and HCV infections continue to occur. Indeed, in some states, HCV has increased among adolescents and young adults, many of whom reported engaging in injection drug use.

In 2010, IOM,[1] in its report titled, Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C, cited viral hepatitis as “a large and underappreciated health issue for the nation.” The IOM articulated ways to improve prevention and care services and called for an intensified, coordinated national prevention and health-care effort. In response, HHS developed the Viral Hepatitis Action Plan[2], which set prevention goals, established program priorities, and assigned responsibilities for actions to meet priorities to HHS operating divisions, including CDC. The recently updated HHS Action Plan for the http://www.hhs.gov/ash/initiatives/hepatitis http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf imu8 Sticky Note imu8 Sticky Note priorities, and assigned responsibilities for actions to meet priorities to HHS operating divisions, including CDC. The recently updated HHS Action Plan for the Prevention, Care and Treatment of Viral Hepatitis identifies the role that partners such as state/local health departments and community groups can play in adapting prevention strategies and implementing activities to decrease viral hepatitis transmission in their jurisdictions.[3] Prevention activities include increasing knowledge and awareness among persons at risk, their health-care providers, and the public at large; increasing access to hepatitis A and hepatitis B vaccines; promoting testing services, increasing communication and policy development, and improving collaboration among health agencies, community-based organizations (CBOs), and health professionals; and supporting and improving public health surveillance to monitor burden of disease, identify outbreaks, and evaluate and focus prevention activities effectively. To implement activities outlined in this plan, CDC will provide funds in this supplemental FOA for FY 2016 to expand the work that has been accomplished by those funded awardees under CDC-RFA-PS13-1303 for the continuation of prevention and surveillance activities.

[1] Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C http://www.cdc.gov/hepatitis/PDFs/IOM-HepatitisAndLiverCan cerReport.pdf [2] http://www.hhs.gov/ash/initiatives/hepatitis/actionplan_viralhepatitis2011.pdf [3] US DHHS. Combating the silent epidemic of viral hepatitis: Action plan for the prevention, care, and treatment of viral hepatitis. Washington, DC: US DHHS;

2014. (Available at hhtp://aids.gov/pdf/viral-hepatitis-action-plan.pdf).

Purpose

The purpose of the program is to support the goals of the HHS Viral Hepatitis Action Plan by focusing on 1) addressing national viral hepatitis prevention and 2) surveillance priorities for increasing testing and access to care and treatment and strengthening surveillance to detect viral hepatitis transmission and disease. This program addresses the “Healthy People 2020” focus area(s) of Immunization and Infectious Diseases:

IID-1.3 Reduce, eliminate, or maintain elimination of new hepatitis B cases among persons 2 to 18 years;

IID-15 Increase hepatitis B vaccine coverage among high-risk populations;

IID-25.1 Reduce hepatitis B infections in adults aged 19 and older;

IID-25.2 Reduce hepatitis B infections among high risk populations – injection drug users;

IID-25.3 Reduce hepatitis B infections among high risk populations – men who have sex with men;

IID-26 Reduce new hepatitis C infections; and, IID-27 Increase the percentage of persons aware they have hepatitis C infection (http://www.healthypeople.gov/2020/topicsobjectives2020/overview.aspx?topicid =23).

IID-28 Reduce tuberculosis (TB)http://www.healthypeople.gov/2020/topicsobjectives2020/objectiveslist.aspx?topicId=23.

This FOA will help build and sustain the capacity of health departments to reach several viral hepatitis prevention goals by targeting selected settings and at-risk populations (See Box 1 and Box 2 below)

Box 1. Goals for Viral Hepatitis Prevention

Increase the proportion of persons living with HCV infection who are made aware of their HCV infection through testing and are linked to prevention and clinical care services.

Increase the proportion of persons living with HBV infection who are made aware of their HBV infection through testing and are linked to prevention and clinical care services.

Decrease the number of new HCV cases, particularly among adolescents and young adults who inject drugs.

Decrease the number of new HBV cases, particularly among adults with high risk behaviors.

Box 2. Examples of Priority Settings for Viral Hepatitis Prevention

Health department clinics and programs, including clinics serving communities with viral hepatitis health disparities, STD clinics, HIV/AIDS counseling and testing sites, and family planning clinics

Correctional settings

Drug-use prevention, treatment, and harm-reduction programs, including syringe services programs

Community health centers

Community-based organizations serving communities experiencing viral hepatitis-associated health disparities

Other clinical, public health, and outreach settings as described

Program Implementation

Recipient Activities http://www.cdc.gov/hepatitis/PDFs/IOM-HepatitisAndLiverCancerReport.pdf http://www.cdc.gov/hepatitis/PDFs/IOM-HepatitisAndLiverCancerReport.pdf http://www.hhs.gov/ash/initiatives/hepatitis/actionplan_viralhepatitis2011.pdf http://www.healthypeople.gov/2020/topicsobjectives2020/overview.aspx?topicid=23 http://www.healthypeople.gov/2020/topicsobjectives2020/overview.aspx?topicid=23

Category A –Viral Hepatitis Prevention The program activities that accompany Category A are further divided into two parts: Part 1, Viral Hepatitis Prevention Coordination, and Part 2, Technical Assistance Center. Eligible applicants may choose to apply for funding under Part 1 or both Parts 1 and 2.

Applicants are required to submit a separate application for Category A, Part 1 and Part 2. Activities to be undertaken for Category A, Part 1 are intended to improve the coordination of viral hepatitis prevention at the state and local level by continuing the support provided to the 52 Viral Hepatitis Prevention Coordinators (VHPCs) that were funded in state and local health departments. VHPCs provide technical expertise necessary for the management and coordination of activities to prevent viral hepatitis infection and disease. Further these coordinators help integrate viral hepatitis prevention services into health care settings and public health programs (e.g., STD, HIV, immunization, correctional health, substance abuse treatment, syringe exchange) that serve adults at risk for viral hepatitis. Category A, Part 2 was developed to ensure that VHPCs receive ongoing technical assistance, training, and other types of support through a single Technical Assistance Center.

Category B – Viral Hepatitis Surveillance CDC anticipates to continue the support of the seven (7) cooperative agreements that were previously funded to conduct active, enhanced surveillance for viral hepatitis and collection of more extensive and complete information (e.g., risk factors) than is possible through the passive reporting system (the National Notifiable Disease Surveillance System, NNDSS) that is currently used by states to report cases of nationally notifiable diseases, including viral hepatitis. Activities must include enhanced, active surveillance for chronic hepatitis B (including perinatal hepatitis B) and past or current hepatitis C as defined by the Council for State and Territorial Epidemiologists (CSTE) to support case investigation and the de-duplication, confirmation, and collation of laboratory and clinical reports of hepatitis B virus (HBV) and hepatitis C virus (HCV) infections from laboratories and care settings.

Recipient Activities Category A - Viral Hepatitis Prevention

Category A, Part I – Viral Hepatitis Prevention Coordination Activities:

Conduct viral hepatitis prevention activities to address one or more of the four goals as appropriate and feasible (Box1) in a maximum of two settings[1] (Box 2), providing access to at least one at-risk target population[2] per setting. These activities should address health disparities in populations that may be underserved due to language, income, or other barriers to accessing health services. Examples of viral hepatitis prevention activities include viral hepatitis vaccination, testing, referral and linkage to care for persons found to be infected, and provision of training and education to staff.

1.

To facilitate these prevention activities, hire and retain a full-time Viral Hepatitis Prevention Coordinator (VHPC), or ensure that VHPC responsibilities are otherwise assumed. The VHPC should have advanced training and/or professional experience in one or more of the following areas: health education;

prevention of transmission and disease; technical expertise related to screening/testing and program evaluation; coordination/facilitation skills; community planning and assessment; program development; data collection and analysis; and, social media/communication skills. VHPC responsibilities include coordinating, planning, implementing, and evaluating viral hepatitis prevention activities conducted in appropriate public health and clinical settings identified by the applicant in the response to this program announcement. To monitor performance, the VHPC will gather and assess data related to prevention activities and report this information as requested by CDC. The VHPC will direct activities to meet prevention goals (Box 1).

2.

Oversee a project-specific or project-wide viral hepatitis task force (or equivalent) comprised of key stakeholders, including members of non-governmental organizations and representatives from the collaborating settings to address planning and coordination of viral hepatitis prevention activities as well as identifying opportunities for improved collaboration among stakeholders.

Engage other state/local health department programs (e.g., STD, HIV, and TB) to integrate HCV, HBV, and HAV prevention services.

3.

Support and promote viral hepatitis awareness and education in targeted populations and participating settings, including outbreaks.4.

Evaluate implementation and impact of prevention activities, including those outlined above. Report outcome monitoring data using the template and guidelines provided by CDC prior to each reporting period. Examples of reportable data include:

data on testing and referrals to prevention and clinical care services before, during, and at the completion of the project period at each setting;

number of tests conducted for hepatitis B and/or C;

outcome of screening tests (e.g., the number of newly identified cases of hepatitis B or C and sero-positivity results);

number of viral hepatitis co-infections in settings with routine HIV testing;

number of persons referred or linked to care and the number receiving treatment, as applicable; and, mechanisms used by each setting to link hepatitis B and/or C positive persons to health-care services.

5.

Monitor activities intended to facilitate and/or enhance education and training.6.

Evaluate the effectiveness of integrating viral hepatitis activities with those conducted by STD, HIV, and TB programs.7.

Participate in CDC sponsored training opportunities, conference calls, conferences, and workshops that foster viral hepatitis prevention.8.

Category A, Part 2 – Viral Hepatitis Technical Assistance Center Activities:

Collaborate with DVH to ensure that VHPCs receive guidance and technical assistance for strengthening programmatic capacity and support activities under this FOA.

1.

Facilitate monthly working conference calls with VHPCs to share updates, disseminate new resources, and promote collaboration across programs.2.

Provide on-site technical assistance (e.g., for strategic planning development and training) to assist coordinators.3.

Provide tailored group training sessions on topics of shared interest and need.4.

Develop and maintain a resource center of training materials, resources, evaluation tools, and other products.5.

Develop and maintain a list serve to foster real time communication and serve as a mechanism for sharing materials, announcements, and group problem-solving.

6.

Facilitate peer-to-peer mentoring and coaching relationships between professionals.7.

Assist in coordinating and convening conferences and national meetings.8.

Evaluate the impact of technical assistance provided throughout the project period.9.

Category B - Viral Hepatitis Surveillance Surveillance Activities Fully implement Public Health Information Network (PHIN) compliant Health Level 7 (HL7) messages for reporting viral hepatitis surveillance data using current CDC/CSTE case definitions found at http://www.cdc.gov/osels/ph_surveillance/nndss/phs/infdis2011.htm and case report forms http://www.cdc.gov /hepatitis/PDFs/vhsp02.pdf or http://www.cdc.gov/hepatitis/PDFs/vhsp_form.pdf by reporting sources.

1.

Build and maintain a de-duplicated database of viral hepatitis data by event code (acute hepatitis A, acute hepatitis B, acute hepatitis C, chronic hepatitis B, past or present hepatitis C, and perinatal hepatitis B).

2.

Conduct follow-up on all acute cases of viral hepatitis to collect a standard set of information. Follow-up is required on both “chronic” hepatitis C among young persons under 21 years old, that may indicate injection drug use, and “acute” HBV and HCV cases in those over 50 years old, that may indicate transmission in health care and extended care facilities. Follow-up activities include contact with patients, physicians, and/or caregivers to obtain information on exposures and behaviors that increase risk of acquiring hepatitis, history of vaccination and other prevention and care services, and contacts of cases recommended to receive preventive services.

3.

http://www.cdc.gov/osels/ph_surveillance/nndss/phs/infdis2011.htm http://www.cdc.gov/hepatitis/PDFs/vhsp02.pdf http://www.cdc.gov/hepatitis/PDFs/vhsp02.pdf http://www.cdc.gov/hepatitis/PDFs/vhsp_form.pdf recommended to receive preventive services.

Promptly inform CDC of suspected clusters or outbreaks of viral hepatitis via telephone and/or email.4.

Implement surveillance for viral hepatitis using, as minimal standards, the current CDC technical guidance entitled “Guidelines for Viral Hepatitis Surveillance and Case Management” for reporting, investigating, and establishing and maintaining quality assurance. See technical guidance document at http://www.cdc .gov/hepatitis/Statistics/SurveillanceGuidelines.htm.

5.

Submit viral hepatitis surveillance data to CDC weekly in accordance with Morbidity and Mortality Weekly Report (MMWR) notification standards.6.

Review viral hepatitis surveillance data reports supplied by CDC quarterly and annually. Confirm or correct data through the NNDSS or other systems developed or tailored to support this system, as appropriate.

7.

Analyze and interpret local viral hepatitis surveillance data, and summarize, and disseminate key findings including via CDC’s viral hepatitis surveillance report.

8.

Develop and sustain relationships with state/local viral hepatitis prevention coordinators and programs to ensure surveillance activities address current and emerging prevention programmatic goals and objectives.

9.

Provide technical assistance and consultation to staff at state and local health departments to facilitate understanding and use of viral hepatitis surveillance data to target prevention activities.

Document and share with CDC/DVH lessons learned and best practices for automating collection of electronic data from laboratory and clinical care record systems, particularly for cases of chronic hepatitis B and C.

10.

Collaborate with CDC to develop and implement methodologies, including protocols, guidelines, standards, and instruments for conducting surveillance of acute and chronic viral hepatitis. These collaborations encompasses follow-up of a representative sample of chronic hepatitis B and past or present hepatitis C reports to obtain standard data (e.g., laboratory testing, stage of disease, ongoing transmissions risks, and access to prevention, care, and treatment services).

Documentation of methodologies should be submitted to CDC prior to implementation.

11.

Participate in CDC sponsored training opportunities, conference calls, conferences, and workshops that foster data collection, analyses, interpretation, and use of surveillance data and underlying methodologies.

12.

Provide a report that details the security and confidentiality of the viral hepatitis surveillance data that is consistent with the most recent CDC NCHHSTP guidelines. These should include: who has access to the hard-copy and electronic patient-level data; a description of the physical location where patient-level data are stored; a description of the security measures for data stored on local area networks (LANs) or other electronic storage systems; and policies and procedures for accessing the data.

13.

Identify and implement activities and processes to enhance and improve viral hepatitis surveillance, including but not limited to, surveillance case registry (e.g., HIV, cancer) matching, follow-up on cases of public health importance, collection of laboratory specimens for additional testing, projects to categorize cases for which no risk can be identified, monitor performance measures of hepatitis testing, care, and treatment, and provide data to case registries supported by state and local prevention programs.

Report on requested outcome monitoring data. Templates and guidance on outcome monitoring will be provided to funded jurisdictions. Examples of data to be collected and submitted to CDC include, but are not limited to, products of recipient activities 2, 4, 6, 7, 11, 12, and 14.

14.

[1] Settings are not to be interpreted as single physical locations but rather a type of site in which activities will be targeted throughout the jurisdiction (e.g., setting one could be health clinics and setting two could be drug-use prevention programs).

[2] For a list of target population refer to CDC guidelines and recommendations on prevention and control of hepatitis B and hepatitis C.

In a cooperative agreement, CDC staff is substantially involved in the program activities, above and beyond routine grant monitoring.

CDC Activities

Category A - Viral Hepatitis Prevention

1. Provide technical assistance, guidance, consultation, and training to support and supplement that provided by the recipient of Category A, Part 2 funding. This includes:

DVH IDU prevention expert support to identify effective strategies for providing viral hepatitis prevention services in harm reduction and substance abuse and treatment settings Provide strong directives for Technical Assistance provider to offer high quality training and educational opportunities DVH Education and Training Team support to coordinate National Educational Campaign effort with award recipients (grantees) DVH support and advocacy to work with Health Resources and Services Administration (HRSA) and the National Association of Community Health Centers (NACHCs) to facilitate and assist with strategies to improve collaboration with individual Community Health Centers.

2. Monitor grantee progress in implementing program activities and work with grantees through consultation via site visits, conference calls, electronic correspondence, and review of progress reports.

3. Provide training to enhance staff and program capacity for viral hepatitis prevention program:

Support and provide training for viral hepatitis prevention planning, management, and surveillance.

Provide training in relevant scientific and technical information regarding laboratory methods used to diagnose and evaluate viral hepatitis infections.

4. Conduct site visits to each grantee during the project period to assess progress toward meeting program objectives and provide technical assistance as determined by the grantee and CDC.

5. Provide consultation, technical assistance, and financial assistance (when feasible) for outbreaks, including site support of investigations when requested by health departments.

6. Provide technical assistance in assessing and prioritizing training and educational needs and for planning, implementing, and evaluating training and educational activities.

7. Collaborate in the dissemination of successful findings and experiences.

8. Facilitate coordination, collaboration, and service integration among other HHS offices, CDC programs, health departments and their programmatic divisions, local planning groups, and other partner to improve data sharing and promote sustainability for viral hepatitis programs.

Category B - Viral Hepatitis Surveillance

1. Provide technical assistance, guidance, consultation, and training as related to the grantee activities for developing and enhancing viral hepatitis surveillance.

2. Identify and support opportunities for training in viral hepatitis surveillance methods, projects to improve viral hepatitis surveillance, surveillance program planning and management, and laboratory methods used to diagnose and evaluate viral hepatitis infections.

3. Conduct site visits to each grantee during the project period to assess progress toward meeting program objectives and provide technical assistance as determined by the grantee and CDC.

4. Collaborate with grantees to develop and implement guidelines and standards for conducting viral hepatitis surveillance for acute and chronic disease.

http://www.cdc.gov/hepatitis/Statistics/SurveillanceGuidelines.htm http://www.cdc.gov/hepatitis/Statistics/SurveillanceGuidelines.htm

4. Collaborate with grantees to develop and implement guidelines and standards for conducting viral hepatitis surveillance for acute and chronic disease.

5. Collaborate with grantees to process, analyze, interpret, and disseminate viral hepatitis surveillance data.

6. Develop routine communications and lead collaborative discussions to identify emerging trends in viral hepatitis that merit further investigation by grantees.

7. Provide assistance in the evaluation of viral hepatitis surveillance procedures and the use of viral hepatitis surveillance data for targeting prevention activities.

8. Provide timely feedback to grantees regarding their data quality through both quarterly reports and an annual report prior to close-out of the NNDSS data year.

9. Disseminate multi-state viral hepatitis surveillance data for public health purposes through routine surveillance reports, print and electronic publications, and presentations at conferences, workshops, and seminars.

10. Collaborate with state viral hepatitis surveillance programs to document and disseminate best practices for conducting surveillance of chronic viral hepatitis B and C.

11. Collaborate with state viral hepatitis surveillance programs to document and implement methodologies for obtaining a representative sample of chronic hepatitis B and C reports and conducting follow-up to obtain clinical information about signs and symptoms, results from diagnostic laboratory tests, and information about risk behaviors and exposures within the relevant time periods.

12. Foster and support collaborations between state viral hepatitis surveillance and viral hepatitis prevention coordinators and programs and related activities (e.g., immunization, HIV, STD, etc.)

13. Develop and maintain partnerships with other federal and non-federal organizations to foster and support the state infrastructure for viral hepatitis surveillance.

Section II. Award Information

Type of Award: Cooperative Agreement CDC substantial involvement in this program appears in the Activities Section above.

Award Mechanism: U51

U51- Infectious Disease Assessment, Prevention & Control

Fiscal Year Funds: 2016 Approximate Total Supplemental Funding: $8,400,000

This amount is subject to availability of funds. Includes direct and indirect costs.

Approximate Number of Awards: 60

CATEGORY A – Viral Hepatitis Prevention Part 1 - Viral Hepatitis Prevention Coordination 52 awards Part 2 - Technical Center 1 award

CATEGORY B – Viral Hepatitis Surveillance 7 awards

Approximate Average Award: $90,000 This amount is for a 12-month budget period, and includes both direct and indirect costs.

Floor of Individual Award Range: $20,000 Ceiling of Individual Award Range: $500,000

This ceiling is for a 12-month budget period.

CATEGORY A – Viral Hepatitis Prevention Approximate Average Award:

Part 1 - Viral Hepatitis Prevention Coordination $94,000 Part 2 - Technical Center $150,000

Floor of Individual Award:

Part 1 - Viral Hepatitis Prevention Coordination $20,000 Part 2 - Technical Center $100,000

Ceiling of Individual Award Range:

Part 1 - Viral Hepatitis Prevention Coordination $150,000 Part 2 - Technical Center $200,000

CATEGORY B – Viral Hepatitis Surveillance Approximate Average Award: $475,000 Floor of Individual Award Range: $200,000 Ceiling of Individual Award Range: $600,000

Anticipated Award Date: 11/02/2015 Budget Period Length: 12 month(s) Project Period Length: 1 year(s) Competing Continuation Project Period Length: 1 year(s)

Section III. Eligibility Information

Eligible Applicants The following recipients may submit an application:

Eligibility Category: State governments County governments City or township governments Special district governments Independent school districts Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education For profit organizations other than small businesses Small businesses

Reasons to Justify Limited Competition, where eligibility is not limited by statute or regulation and the circumstances are not urgent.

Limited competition for this Expansion Supplement is justified based on the following.

In 2010, Institute of Medicine (IOM), in its report titled, Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C, cited viral hepatitis as “a large and underappreciated health issue for the nation.” The IOM articulated ways to improve prevention and care services calling for an intensified, coordinated national prevention and health-care effort. In response, HHS developed the Viral Hepatitis Action Plan, which set prevention goals, established program priorities, and assigned responsibilities for actions to meet priorities to HHS operating divisions, including CDC. To implement activities outlined in the Viral Hepatitis Action plan, CDC funded state and local health departments for the last three years to implement or sustain prevention and surveillance activities. Below is a detailed description of the characteristics of the applicant organizations that makes them uniquely qualified to perform the programmatic activities; prior activities performed in cooperation with CDC; the relationship of the new project to any prior or ongoing CDC-funded activities; and impact the disapproval if the Expansion Supplement is denied.

Category A, Part 1 – Viral Hepatitis Prevention Coordinator CDC’s DVH Viral Hepatitis Prevention and Surveillance project has existed since 2012. The Division of Viral Hepatitis currently funds 52 state and local health departments to improve the delivery of primary and secondary viral hepatitis prevention in health-care settings and public health programs that serve at-risk adults and adolescents under, FOA PS13-1303. Competition is limited to these 52 state and local health departments because they are the only organizations within the broader field of viral hepatitis prevention and control that have coordinated jurisdictional wide viral hepatitis strategic planning, developed education and training for health care providers; implemented policies and protocols locally; integrated viral hepatitis prevention services into health care settings and public health programs (e.g., STD, HIV, correctional health, substance abuse treatment, syringe exchange, diabetes care and prevention, and vaccination of susceptible household and sexual contacts) that serve adults at risk for viral hepatitis; and implemented viral hepatitis testing and linkage to care for key population impacted by viral hepatitis. Due to the nature of the activities required under the proposed one-year Expansion Supplement, accomplishments of all of the above items is a pre-requisite for any entity to be successful in fulfilling these programmatic objectives. Therefore, these 52 awardees are the only entities that have achieved all of the above requirements and have the capacity to complete the program activities during the supplemental expansion. This Expansion Supplement serves as a bridge to support current awardees until a new and more comprehensive FOA is announced and awarded in FY 2017.

Awardees will maintain on going viral hepatitis prevention efforts to identify ways to integrate viral hepatitis prevention, vaccination, testing and linkage to care into existing public health, clinical care and community settings.

Awardees will use local data to sustain viral hepatitis prevention activities currently underway for their jurisdiction and to maintain local partnerships and resources that support viral hepatitis activities.

List the characteristics of the eligible applicants that make them uniquely qualified to perform the programmatic activities For the past three years, the 52 state/local awardees (through the Viral Hepatitis Prevention Coordinator position) funded under PS13-1303 FOA have engaged in specific activities to build state and local capacity to improve and integrate the delivery of primary and secondary viral hepatitis prevention within specific settings in their jurisdictions. Through continuous training, education and technical assistance, these coordinators have gained strong expertise, knowledge and skills in the areas of health education; prevention of transmission and disease; technical expertise related to screening/testing and program evaluation; coordination/facilitation skills; community planning and assessment; program development; data collection and analysis; and, social media/communication skills that were needed to successfully accomplished the activities of the FOA PS13-1303. Specially, 86% of coordinators have facilitated, coordinated or supported viral hepatitis services and reported outcome data to CDC. So far, coordinators have conducted nearly 700 education and training sessions, reaching more than 15,000 health care providers. Over 187,000 hepatitis C tests have been facilitated with more than 27,700 persons identified with hepatitis B infection. In 18 jurisdictions, VHPCs facilitated, coordinated, or monitored hepatitis B testing activities conducting 55,000 hepatitis B tests of which 2,000 hepatitis B positive patients were identified and referred to care. In 16 jurisdictions, VHPCs coordinated vaccine programs reporting over 300,000 doses of vaccine have been administered in the health departments & partner sites.

Due to the considerable investment and effort in developing these coordinators only those applicants who have participated in FOA PS13-1303 for last three years and have the training to continue activities under this Expansion Supplement. CDC is anticipating a substantial increase in its viral hepatitis funding line in the next 12 months and this extension of the current awardees will allow time to build in the expectations of new funding in a future announcement.

List any prior activities the organizations have performed in cooperation with CDC For the past three years, the 52 awardees funded under PS13-1303 FOA have worked with CDC to identity and support the implementation of the HHS Viral Hepatitis Action Plan at the state and local levels. Specifically, these awardees leverage opportunities to increase awareness about viral hepatitis, prioritize those activities that can make the greatest difference in the lives of individuals at risk in their jurisdiction and promote the adoption of CDC and US Preventive Task Force Recommendations. This Expansion Supplement announcement will allow the continuity of services at the 52 sites that currently support and promote prevention services and activities in those jurisdictions. Second, this Expansion Supplement will allow critical viral hepatitis prevention efforts to continue and will also prevent the breakdown of established partnerships and collaborations with state/local public health partners.

Describe the impact of disapproval Without this Expansion Supplement awardees’ ability to continue key components of viral hepatitis prevention to improve the delivery of primary and secondary viral hepatitis prevention in health-care settings and public health programs that serve at-risk adults and adolescents would be interrupted. Among the services that would be affected are:

Coordination and promotion of viral hepatitis activities Viral hepatitis integration and collaboration efforts

Testing for hepatitis C Testing for hepatitis B Dissemination of guidelines, recommendation, and information Policy development and implementation Education and awareness training for professional and public health staff Data collection and reporting CDC’s ability to monitor and track viral hepatitis activities in the state

Lastly, if the Expansion Supplement is disapproved, it would hinder CDCs ability to implement activities outlined in the Viral Hepatitis Action plan.

Category A, Part 2 - Viral Hepatitis Technical Assistance Center The Institute of Medicine (IOM) Report 2010 concluded that insufficient provider knowledge leads to critical missed opportunities for providers to educate patients about prevention of hepatitis B (HBV) and hepatitis C (HCV), to identify patients who may be at risk for these infections and to test for chronic HBV and HCV infection in patients and their sexual, family, and household contacts in the case of hepatitis B and in drug-use networks in the case of hepatitis C. The IOM further recommended that “The CDC should work with key stakeholders including professional organizations, health-care organizations and educational institutions to develop hepatitis B and hepatitis C educational programs for health-care and social-service providers.” Based on the aforementioned guidelines, the Division of Viral Hepatitis identified and funded one Technical Assistance Center to strengthen programmatic capacity and support activities required under by Part A.

For last three years, the NYS Technical Assistance Center (TA Center) has provided over 150 trainings to Viral Hepatitis Prevention Coordinators as well as conducted the following vital functions: facilitated monthly working conference calls with VHPCs to share updates, disseminate new resources, and promote collaboration across program; provided on-site technical assistance (e.g., for strategic planning development and training) to assist coordinators; provided tailored group training sessions on topics of shared interest and need; maintained a list serve to foster real time; facilitated 52 peer-to-peer mentoring and coaching relationships between professionals; assisted in coordinating and convening 2 conferences and national meetings; and evaluated the impact of technical assistance provided throughout the project period. The substantial progress made by the awardees involved in the ongoing project clearly indicates that they are well-qualified, have expert knowledge and experience and demonstrate the capacity necessary to accomplish the goals of this supplement.

The overall goals of the Expansion supplement will ensure that TA Center can continue to train new and current AVHPCs to facilitate and increase the integration of viral hepatitis prevention activities and services into the targeted organizations’ existing prevention programs and health care services nationwide. In addition, the TA Center will remain a critical element for increasing and reinforcing awareness and knowledge of trained participants of the need for program collaboration and service integration across a variety of service settings; enhancing their knowledge, skills, and abilities to assess client/patient risks for hepatitis; and, in providing needed services that fit within their existing organizational scope of client/patient management practices, outreach, and health education programs.

The TA Center performs an extremely critical service to these awardees as described under Category A, Part A above that if interrupted CDC would hamper our current capability and capacity to train them and build their expertise. Therefore, the TA Center follow on activities under this Program Expansion supplement are an efficient and economical use of funding and time which benefits the government effort to prevent and control viral hepatitis.

Category B, - Viral Hepatitis Surveillance CDC’s DVH Viral Hepatitis Prevention and Surveillance project has existed since 2012. The Division of Viral Hepatitis currently provides funding for seven (7) cooperative agreements to conduct active and enhanced surveillance for viral hepatitis under FOA PS13-1303. Awardees include Florida, Massachusetts, Michigan, New York State, City of Philadelphia, San Francisco, and Washington State. Under this cooperative agreement, these awardees are supported to conduct enhanced surveillance, monitoring the burden of acute and chronic viral hepatitis disease through core surveillance of hepatitis A, acute hepatitis B and C, and chronic hepatitis B and C. Funding is limited to state and local departments of health because they are the only entity within their jurisdictions responsible for administering and enforcing laws, rules, or regulations pertaining to collecting and reporting of viral hepatitis surveillance data. Competition is further limited to seven (7) sites (Florida, Massachusetts, Michigan, New York, Philadelphia, San Francisco, and Washington) currently funded to conduct enhanced viral hepatitis surveillance under Funding Opportunity Announcement PS13-1303. The current surveillance funding for the seven awardees will end on 31 October 2015. This Expansion Supplement serves as a bridge to support current awardees to complete a number of essential activities until a new and more comprehensive FOA is announced and awarded in FY 2017.

Awardees will continue to identify and receive laboratory report of all laboratory tests that were positive for viral hepatitis (HAV, acute, chronic, and perinatal HBV, and past/present or chronic HCV) through 31 December 2015. Additional time and funding is needed to allow awardees to follow-up the 2015 positive reports to obtain clinical information that is necessary to determine if the individual meets the CDC and Council of State and Territorial Epidemiologists (CSTE) surveillance case definition. Awardees will notify CDC of all case patients who meet both the laboratory and clinical (signs and symptoms) criteria of the surveillance case definition. This will fulfil terms of the initial FOA PS13-1303. Without the additional year of funding, states will not have the resources to conduct the required follow-up activities.

CDC is in the process of updating guidelines for conducting surveillance of viral hepatitis, with emphasis on surveillance of chronic viral hepatitis.

Awardees will collaborate with CDC in this process to ensure that lessons learned are included in the document. Three to six months after collection of laboratory reports (prior to the end of follow-up data collection) awardees and CDC will begin compiling information and writing the guidelines document.

The guidelines will include methodologies, protocols, standards, and instruments for conducting surveillance of acute and chronic viral hepatitis.

CDC would not benefit from one year announcement with competition for these supplemental/additional funds. New awardees would need at least 9-12 months to hire and train appropriate staff, develop and implement appropriate data collection and reporting systems, and document protocols, methodologies, and lessons learned.

List the characteristics of the eligible applicants that make them uniquely qualified to perform the programmatic activities.

The eligible applicants, seven current awardees, are already conducting enhanced surveillance on both acute and chronic viral hepatitis. This means they are already following-up with health care providers and case-patients and are collecting information on an expanded number of characteristics/variables about case patients. Some states do not conduct surveillance on chronic viral hepatitis B or C thus could not provide the information needed to estimate burden of disease, identify outbreaks, characterize at risk populations, or identify individuals for referral to care and treatment. Most states do not have sufficient support (CDC only supports viral hepatitis surveillance in the 7 sites supported by FOA PS13-1303) to follow-up hundreds of positive laboratory reports to determine if the case-patient has the clinical criteria to meet the surveillance case definition. Thus, the currently funded 7 sites are unique and the only entities that have the capacity and ability to complete the required program activities. Furthermore, entities other than those that have been funded under the prior program announcements would not have time to hire staff and put contracts in place for one year.

List any prior activities the organizations have performed in cooperation with CDC Current awardees provide not only surveillance data, but also work on a number of projects that require expanded viral hepatitis surveillance data. For example, there is no current surveillance case definition for hepatitis E (HEV) infection. In respond to a recent external inquiry about DVH’s activities with regard to developing a case definition for HEV, awardees were contacted. Florida, Massachusetts, Michigan, San Francisco, and Washington indicated HEV is a reportable condition. These states collect information on all positive HEV laboratory reports. HEV is not reportable in New York State and City of Philadelphia but some laboratories do send positive HEV laboratory reports to the health department. All awardees indicated they currently include hepatitis E in their surveillance activities and all indicated they will work with CDC to formulate a case definition to be presented to CSTE for consideration.

Describe the impact of disapproval Without this program expansion supplement awardees’ ability to continue key components of enhanced viral hepatitis surveillance will be compromised.

Specifically, without continued funding awardees will not have the ability to build and maintain a de-duplicated database of viral hepatitis data by event code

Specifically, without continued funding awardees will not have the ability to build and maintain a de-duplicated database of viral hepatitis data by event code (acute hepatitis A, acute hepatitis B, acute hepatitis C, chronic hepatitis B, past or present hepatitis C, and perinatal hepatitis B), or the capacity to conducting follow-up investigations of all acute cases of viral hepatitis to collect a standard set of information, nor the ability to collaboration with CDC to develop and implement methodologies, protocols, guidelines, standards, case definitions, and instruments for conducting surveillance of acute and chronic viral hepatitis.

Furth…