ci10-101202pphf11 foa final amend i 4.28.11.doc

AMENDMENT I (Dated April 27, 2011):

Summary of Changes:

Due Date is extended to May 31, 2011 New Activities added –

D.1.C. - Improving Hospital-based Antimicrobial Prescribing towards Reducing Antimicrobial-resistant Hospital-Associated Infections

D.3.A. - Viral Hepatitis Surveillance: Developing capacity to receive electronic laboratory reports, input backlog of paper laboratory reports, and determine the proportion of reports that represent individuals with asymptomatic hepatitis disease D.3.B. - Viral Hepatitis Surveillance: Under reporting of acute viral hepatitis A, B, and C.

D.3.C. - Viral Hepatitis Surveillance: Follow-up of young adults reported with Hepatitis C virus (HCV) Specific FOA language modifications and additions implementing the above changes occur in:

Section I – Funding Opportunity Description, Purpose and Program Implementation, Recipient Activities and CDC Activities Section II – Award Information

Section IV – Application and Submission Information, Project Narrative instructions

Section V – Application Review Information, Criteria 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

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

Patient Protection and Affordable Care Act

Epidemiology and Laboratory Capacity for Infectious Diseases (ELC)

Building and Strengthening Epidemiology, Laboratory and Health Information Systems Capacity in State and Local Health Departments

Announcement Type: Continuation – Type 5 Agency Funding Opportunity Number: CDC-RFA-CI10–101202PPHF11 Catalog of Federal Domestic Assistance Number: 93.521 Key Dates:

Application Deadline Date: May 31, 2011, 5:00pm Eastern Standard Time Additional Overview Content:

This Announcement represents the 2nd year continuation solicitation for existing ELC recipients to continue and expand their Affordable Care Act (ACA) activities initiated in 2010 under Funding Opportunity Announcement # CI10-1012.

Measurable outcomes of the program will be in alignment with one (or more) of the following performance goal(s) for the National Center for Emerging and Zoonotic Infectious Diseases: Protect Americans from Infectious Disease; and the Office for Surveillance, Epidemiology and Laboratory Services: Enhance and Maintain Innovative Public Health Surveillance Systems.

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-research-nonresearch.pdf.

PART 2. FULL TEXT

I. FUNDING OPPORTUNITY DESCRIPTION

Statutory Authority Public Health Service Act Sections 301(a) [42 U.S.C. 241(a)] and 317(k) (2) [42 U.S.C. 247b (k) (2)], as amended and the Patient Protection and Affordable Care Act (PL 111-148), Title IV, Sections 4002 and 4304 (Prevention and Public Health Fund).

Background On March 23, 2010, the President signed into law the Patient Protection and Affordable Care Act (the Affordable Care Act). The Affordable Care Act is designed to improve and expand the scope of health care coverage for Americans. Cost savings through disease prevention is an important element of this legislation, and the Affordable Care Act has established a Prevention and Public Health Fund (PPHF) for this purpose. Specifically, the legislation states in Section 4002 that the PPHF is to “provide for expanded and sustained national investment in prevention and public health programs to improve health and help restrain the rate of growth in private and public sector health care costs.” A number of CDC programs have been implemented in response to the ACA, including programs aimed at building public health infrastructure that will help state and local health departments meet 21st century challenges. These infrastructure building programs include ELC ACA (the subject of this FOA) as well as programs to train/develop the public health workforce and the National Public Health Improvement Initiative (NPHII) managed by the Office for State, Tribal, Local and Territorial Support, which aims to systematically increase the performance management capacity of public health departments in order to ensure that public health goals are effectively and efficiently met (see http://www.cdc.gov/ostlts/nphii/index.html).

This announcement implements second year continuation and expansion ACA funding for the Epidemiology and Laboratory Capacity for Infectious Diseases (ELC) program and continues to build upon ELC’s investment in infrastructure in state and local health departments

The ELC program was initiated in 1995 as one of the first key activities under CDC’s plan to address emerging infectious disease threats. Starting out as limited funding for a small number of states, the program has grown to become one of CDC’s key nationwide cooperative agreements for supporting state and local capacity including both 1) cross-cutting, flexible surveillance, epidemiology, and laboratory capacity and health information systems capacity which serve infectious diseases and all other public health threats, as well as 2) infectious disease-area specific activities (e.g., foodborne diseases, influenza, antimicrobial resistance, etc.). The overall purpose of the ELC cooperative agreement program is to assist state public health agencies improve surveillance for, and response to, infectious diseases and other public health threats by (1) strengthening epidemiologic capacity; (2) enhancing laboratory practice; (3) improving information systems; and (4) developing and implementing prevention and control strategies.

Capacity built and sustained by the ELC helps prevent disease through enhanced surveillance of known and emerging infectious diseases and other public health threats, leading to more rapid response to disease outbreaks and better development, implementation and evaluation of public health interventions.

Purpose The purpose of this Affordable Care Act funding for ELC is to enhance public health programs to improve health and help restrain the rate of growth of health care costs through building epidemiology, laboratory, and health information systems capacity in state and local public health departments. In FY2011, the specific aim is to 1) sustain key activities initiated in the FY2010 awards, 2) advance national implementation of electronic laboratory reporting (ELR), 3) to build or support syndromic surveillance capability at the state or local level and to enable health departments to participate in CDC’s BioSense Program, 4) to build prevention and control capacity in healthcare associated infections (HAI) and 5) to conduct surveillance and effectiveness activities for vaccine preventable diseases.

This guidance addresses the following four inter-related areas which are fully consistent with and build upon the existing ELC activities:

a) Epidemiology Capacity – To ensure staff are well-trained and well-equipped to identify, characterize, and provide rapid, effective, and flexible response to infectious disease threats.

b) Laboratory Capacity – To achieve modern and well-equipped public health laboratories, with well-trained staff, employing high quality laboratory processes and systems that foster communication and appropriate integration between laboratory and epidemiology functions.

c) Health Information Systems Capacity – To develop and enhance current health information infrastructure for public health agencies. Working towards modern, standards-based and interoperable systems that support electronic exchange of information within and between epidemiology and laboratory functions in public health agencies (e.g., systems that support public health surveillance and investigation, laboratory information management systems (LIMS)); among local, state, and federal public health agencies; and between public health agencies and clinical care systems (e.g., health care providers, hospital emergency departments, clinical laboratories). A main emphasis of this FOA is to advance national implementation of ELR, including support for states to accept and work with incoming ELR messages in their surveillance systems and to develop and implement capacity to handle messages according to Meaningful Use (MU) standards. The Health Information Technology for Economic and Clinical Health (HITECH) Act MU incentives and standards for healthcare providers create a vital opportunity to enhance the receipt of electronic reports of reportable laboratory results and syndromic surveillance event reports, and to communicate public health laboratory results to clinicians via their electronic health record systems. An important objective of this funding opportunity is to support states to address challenges and opportunities created by the MU program; however, this funding opportunity is not intended to interrupt or undermine current successful ELR transmissions, even if those transmissions do not yet conform to standards for MU.

d) Targeted Prevention and Control Capacity - (1) To coordinate and implement HAI prevention activities within the state, facilitate the state multidisciplinary advisory group on HAIs, and implement and report on progress of the state HAI plan, to develop and implement multi-facility prevention initiatives for HAIs, including electronic reporting of inpatient antimicrobial use towards improving practices for reducing antimicrobial resistant HAIs. (2) To strengthen surveillance and vaccine evaluation around vaccine preventable diseases such as meningococcal and pneumococcal diseases. (3) To strengthen surveillance of viral hepatitis.

This program addresses the “Healthy People 2020” focus area(s) of Health Communication and Health Information Technology, Healthcare-Associated Infections, Immunizations and Infectious Diseases and Public Health Infrastructure

Program Implementation Recipient Activities

Activities A-D are listed below, each with sub-activities and then suggested (but not exclusive) options for addressing the activity. Applicants may address one or more of the Activities.

Requirement for ALL Activities addressed: Recipients are required to track and report progress and impact through development and use of appropriate performance measures. See Appendix A for guidance and required and suggested examples of performance measures for all Activities.

Activity A: Epidemiology Capacity

1. Enhance outbreak investigation response and reporting:

· Designate an epidemiologist with flexible responsibilities (i.e., multi-disease purpose ‘ELC Epidemiologist’).

· Adopt use of standard investigative questionnaires (e.g., OutbreakNet E. coli O157 standard case interviews), data sharing tools and methods.

· Foster collaboration among city, county, state and federal partners; participate in multi-state outbreak investigations; and assist local jurisdictions in the investigation of outbreaks that are large, complex or of national significance.

· Increase epidemiology skills by participating in existing training or creating new training opportunities.

2. Upgrade and develop surveillance:

· Adapt workflows to accommodate increased volumes of ELR or syndromic reporting.

· Improve review of ongoing surveillance including more robust and varied analyses of surveillance data.

· Facilitate coordination and exchange of surveillance data with other jurisdictions.

· Better define burden of emerging infectious diseases.

· Develop and implement sentinel, syndromic and hospital-based (including emergency department) surveillance systems to better enhance early detection, identify outbreaks and to support all-hazards situation awareness. [Note: syndromic surveillance systems should establish data sharing agreements in accordance with jurisdictional policy and legal authority and participate in the CDC BioSense data-sharing program.]

3.

Evaluate epidemiologic public health practice:

· Evaluate the impact of vaccination and other prevention programs or interventions, which could include evaluation of vaccine effectiveness, disease burden, and barriers to implementation of preventive measures, as well as special surveillance activities.

· Periodically conduct evaluations of public health surveillance activities (e.g., reportable infectious disease surveillance, sentinel surveillance, syndromic surveillance) leading to data quality improvement and greater use of data for public health response.

Activity B: Laboratory Capacity

1. Sustain and enhance laboratory diagnostic capacity:

· Increase the number of labs utilizing modern techniques for diagnosis (e.g. RT-PCR). This may include purchase of equipment, supplies, reagents, etc., necessary to expand capabilities and/or to improve laboratory throughput, efficiency, accuracy, etc.

· Designate and train a laboratorian with flexible responsibilities (i.e., multi-disease purpose ‘ELC Laboratorian’).

· Implement a plan for flexible use and acquisition of laboratory supplies that addresses changing and multi-disease purpose needs.

· Enhance skills and maintain pace with cutting-edge laboratory techniques by participating in existing training or creating new training opportunities.

· Participate fully in PulseNet including arranging for rapid transport of pathogens isolated from clinical specimens to the public health laboratory; rapid determination of molecular subtype of pathogens isolated from clinical specimens and implement next generation of molecular methods for standard serotyping of pathogens in PulseNet.

2. Enhance public health laboratory capacity to detect and diagnose vaccine preventable and other respiratory diseases. Improve laboratory coordination and outreach:

· Designate a laboratory ‘connector’ or liaison responsible for collaboration and coordination between state, clinical and hospital labs both within state/local jurisdiction and across jurisdictions.

· Coordinate and strengthen connections between epidemiology and laboratory functions, at the state and local levels.

Activity C: Health Information Systems Capacity

1. Enhance Informatics Workforce:

· Designate an informatician (i.e. information systems specialist) with flexible responsibilities.

· Increase informatics and information technology skills to support surveillance, epidemiologic, and laboratory efforts and data interchange between health care and public health sector by participating in training or creating new training opportunities.

· Identify and dedicate personnel resources - in IT, informatics, surveillance, and laboratory - for advancing implementation of ELR.

2. Advance national implementation of ELR by improving your capacity to accept and work with incoming ELR messages in surveillance systems as well as to develop and implement capacity to handle messages according to MU standards.

A. Large Reference/Clinical/ Labs to Health Department

i. Enhance the receipt of electronic laboratory reports from large reference or clinical laboratories by arranging for ELR from additional labs, transitioning to use of ONC MU standards for ELR, or both.

ii. Enable NEDSS-compliant surveillance systems to consume electronic lab reports from large reference/ clinical/ labs.

B. Hospital Laboratory to Public Health Agencies

i. Build capacity in your technical infrastructure to test (until successful) transmission of ONC-defined standards-based electronic laboratory reports from certified electronic health record technologies, defined by ONC to be a certified EHR system or EHR system module, such as a Laboratory Information Management System (LIMS), from eligible hospitals and other MU eligible providers . As needed, use message validation tools provided by CDC for testing.

ii. Accept production ELR messages for public health reporting from hospitals and other MU providers to state and local public health agencies.

iii. Enable NEDSS-compliant case reporting systems to consume ONC-defined standard messages in order to process and analyze laboratory reports. Possible solutions include, in the short term, using a translation mapping tool to change incoming HL7 2.5.1 messages into HL7 2.3.1 for consumption in an electronic disease surveillance system and, in the longer term, enhance surveillance systems to consume and work with HL7 2.5.1 messages.

C. LabID Events to NHSN Partner with two or more healthcare facilities within your jurisdiction’s health information exchanges, electronic health record system (EHRs) vendors and/or healthcare associated infection software vendors to build an infrastructure that supports both the reporting of LabID Events to NHSN as well as the reporting of ELR to local or state public health, and to do so using existing implementation guides and common approaches.

i. Create an HL7 CDA document for reporting of LabID events and associated denominators as specified by the implementation guide referenced above and validated at the following website (see http://www.alschulerassociates.com/validator/).

ii. Consider creating an HL7 2.5.1 ELR message of reportable conditions to state or local public health department

iii. Receipt and processing of a valid ELR message at a public health department.

iv. Receipt and processing of a valid CDA document for a LabID Event and associated denominator by NHSN.

v. Creation of shareable artifacts that may be used in replicating this effort in other locations with differing infrastructure and products.

vi. Demonstrate successful transmission of electronic (automated) data submission to NHSN; data already captured for patient care electronically captured in the standardized format and transferred to NHSN.

D.

Public Health Laboratory to Epidemiology/Surveillance Component of Health Department Upgrade LIMS system to enable sending electronic laboratory results for reportable conditions from public health laboratory to a NEDSS-compliant case reporting system using ONC-defined standards.

E. Enhance technical infrastructure and surveillance information systems to accept and work with ELR, in particular, to successfully use an anticipated increased volume of laboratory reporting for reportable conditions.

F. Collaborate with CDC and other ELC recipients to advance and monitor implementation of ELR across the country, including transition to ELR that conforms to Meaningful Use standards. Participate, with CDC, in monitoring ELR implementation, through sites visits, phone calls, data validation efforts, etc., including developing a tally of ELR status by reporting laboratory. Note: ELR implementation is a national priority and this monitoring by all ELC recipients is required.

3.

Establish and enhance syndromic surveillance A. Enhance early detection and situation awareness capability by establishing syndromic surveillance.

Local and state syndromic surveillance practice should maintain consistency with community-consensus statements regarding the business process and technological requirements of the current state of public health syndromic surveillance practice. [ISDS Meaningful Use Workgroup, Final Recommendation: Core Processes and EHR Requirements for Syndromic Surveillance, www.syndromic.org/projects/meaningful-use B. Establish syndromic surveillance data sharing agreements with CDC in accordance with jurisdictional policy and legal authority and participate in the CDC BioSense data-sharing program.

C. Link local syndromic surveillance systems within jurisdiction and support local efforts to sustain syndromic surveillance practice, in cooperation with the BioSense Program.

D. Update jurisdiction’s information on the number of emergency departments participating in its syndromic surveillance network(s), estimated population under surveillance, and other information on the BioSense Program Redesign collaboration site (https://sites,google.com/site/biosenseredesign).

Activity D: Targeted Prevention and Control Capacity

1. Healthcare-Associated Infections A. State Healthcare-associated Infection (HAI) Prevention Infrastructure

The purpose of this activity is to coordinate and implement HAI prevention activities within the state, facilitate the state multidisciplinary advisory group on HAIs, and implement and report on progress of the state HAI plan. Funding under this activity will ensure that state health departments can continue to make and monitor progress towards the HHS HAI Prevention targets. The HAI prevention activity supported by this project must be specified in the State HAI plan. Implement and monitor State HAI Prevention Efforts and progress towards targets specified in the state HAI action plan;

· Coordinate activities of the HAI multidisciplinary advisory group to support the prevention effort.

· Assess needs within the state and work to address priority needs.

· Work with other patient safety collaborations within the state for HAI and other healthcare acquired conditions.

· Set a goal for the number of facilities to be enrolled in the prevention effort(s) and strive to meet that goal.

· Assess the impact of the prevention efforts through outcome measures which must include 1) number of facilities enrolled in the prevention activity and 2) at least one additional measure of each facility’s prevention success.

B. Prevention of Healthcare-associated Infections Across the Spectrum of Healthcare This activity builds upon successes from CDC’s work with states on HAI prevention through the development and implementation of multi-facility prevention initiatives. Current efforts have demonstrated that many HAIs can be prevented through the implementation of best-practice recommendations for infection prevention. To meet national targets for HAI prevention, adherence to these recommendations must be expanded to all healthcare settings. Prevention activities funded under this cooperative agreement address critical needs for moving towards the elimination of HAIs in all healthcare settings and building upon specific advances made through investments in states. States can propose HAI prevention initiatives that meet the requirements in this activity. Prevention activities could include, but are not limited to:

· Assess impact of the proposed prevention initiative(s), including number of infections prevented (Required Activity if applying for Activity D.1.B).

· Establish partnerships for the prevention of catheter associated urinary tract infections (CAUTI), central line associated blood stream infections (CLABSI), and surgical site infections (SSI).

· Prevent MDRO and Clostridium difficile infections across the spectrum of healthcare facilities.

· Collaborate with other state HAI and healthcare acquired condition prevention activities, as appropriate.

C. Improving hospital-based antimicrobial prescribing towards reducing antimicrobial-resistant healthcare-associated infections.

This activity builds on a decade of development of risk adjusted antimicrobial use metrics for inter-facility comparison of hospital-based antimicrobial use to inform hospital-based antimicrobial stewardship activities. The ability to measure antimicrobial usage provides the foundation for implementing and evaluating interventions targeting the reduction of unnecessary and/or inappropriate use of antimicrobials. To facilitate this activity, the CDC’s NHSN has launched the Antimicrobial Use Surveillance Option in Spring 2011 to allow facilities to electronically report antimicrobial usage data and compare facility-specific usage rates to a national risk-adjusted benchmark. This comparative metric can be used as a tool to identify areas of excessive use and guide stewardship activities. Facilities are required to submit these data electronically using specifications consistent with the NHSN electronic reporting standards. Complying with these standards will require vendors of “Electronic Medication Administration Records” (eMAR) or Bar Code medication administration (BCMA) systems used in acute-care facilities to modify the applicable software to allow such reporting by hospitals directly to NHSN. Currently, several vendors of eMAR are participating in a pilot to demonstrate ability to report data, but insufficient data is being reported currently to provide any facility with useful risk adjusted comparisons. For a list of eMAR/BCMA vendors currently working with CDC on the reporting of antibiotic use data through NHSN visit: www.sidp.org. Applicants should address critical needs for establishing baseline antimicrobial use data to produce risk adjusted comparative measures of hospital-based antimicrobial use, and the evaluation of useful facility-specific metrics to improve usage patterns. Activities must include each of the following:

· Identify and recruit participation of 15-30 acute care facilities already utilizing eMAR/BCMA systems in their hospitals to begin reporting surveillance data of antimicrobial use through NHSN and provide the department of health ‘right of access’ to these data through the group user function of NHSN. Choice of facilities should be made to maintain a low ratio of eMAR/BCMA vendors to participating facilities (i.e., around 1 vendor per 10 facilities).

· Facilitate implementation of surveillance by participating facilities through piloting data submission, validating initial data submission, analyzing and reporting back data to facilities.

· Support efforts of and provide appropriate resources to the eMAR/BCMA software systems in place at the participating facilities to (1) modify their applications to electronically capture antimicrobial usage data and configure the software system to enable the generation of standard formatted files of aggregate antimicrobial usage to be imported into NHSN (http://www.cdc.gov/nhsn/CDA_eSurveillance.html), and (2) pilot, validate, and implement such reporting at the participating facilities

· Evaluate submitted data during a reporting phase of 6-9 months and work with hospital staff to correct irregularities in submitted data

· Evaluate the utility of versions of reports to hospital-staff during a piloting evaluation phase of at least 3 months to improve utility of surveillance reports to improve antimicrobial use

2. Vaccine Effectiveness (VE)

A. Evaluation of Meningococcal Conjugate Vaccine

· Identify and serogroup all cases of meningococcal disease (defined by isolation from a normally sterile site or detection of meningococcal DNA on polymerase chain reaction) in the entire state or proposed catchment area in which enrollment will occur.

· Transfer all isolates and specimens to CDC for confirmation of serogroup.

· Implement a protocol for enrolling cases and controls in a case-control investigation of vaccine effectiveness. This includes participating in conference calls and training sessions, collecting data including consenting participants, and transmitting data to CDC.

· Complete case investigations to determine demographic information, clinical presentation and outcome, vaccination status, type of vaccine, and date of vaccine for all cases of meningococcal disease, and vaccination status, type of vaccine, and date of vaccination for controls enrolled in the investigation.

B. Assessing effectiveness of 13-valent pneumococcal conjugate vaccine

· Collaborate with CDC, Emerging Infections Program (EIP) sites, and other ELC sites via conference calls to develop protocols that will include enrollment criteria, procedures for identifying appropriate controls and procedures for requesting participation from cases and controls.

· Assist with developing and pilot testing instruments (e.g., questionnaires, chart abstract forms) and enrollment procedures to be used in the project.

· Work with CDC to develop appropriate data systems that allow for secure collection and electronic transmission of data related to enrolled cases and controls.

· Identify all cases of Invasive Pneumococcal Disease (IPD - defined by isolation of pneumococcus from normally sterile body sites) in residents of the 2009 catchment areas (if conducting population-based surveillance) or occurring at sentinel sites (if using sentinel site surveillance). Identification of all cases is necessary to establish the baseline incidence of disease and to minimize any bias (especially toward more severe presentations) in case enrollment. Awardees are encouraged to consider expanding their 2009 surveillance areas for the purpose of increasing the potential number of cases enrolled, provided that such an expansion can maintain complete case ascertainment.

· Attempt to obtain pneumococcal isolates from all cases for storage and subsequent shipment to existing CDC’s Streptococcal Laboratory.

· Enroll cases (identified from ELC surveillance) and age-matched controls (identified by searching of birth certificates or another method mutually agreed upon with CDC), beginning after PCV-13 licensure and vaccine use among U.S. infants commences.

· Collect vaccine histories and information on potential risk factors for disease through interviews with parents of enrolled children and contact with their healthcare providers.

· Transmit to CDC data collected on cases and controls using data systems and timelines (see above).

· Collaborate with CDC to monitor enrollment, analyze data, interpret results, and prepare reports for presentation and publication.

C. Strengthening pertussis reporting for vaccine evaluation

· Utilize state-based pertussis reporting systems to conduct routine surveillance for pertussis with systematic case investigation and follow-up.

· Collect complete information on clinical course of infection, vaccination history (including information on vaccination dates, lot numbers and manufacturers), and other epidemiologic information of interest.

· Perform laboratory confirmation of Bordetella pertussis specimens, when available, at state public health laboratory.

· Utilize state immunization registries to obtain and/or verify vaccine history; link immunization registry data with pertussis surveillance data.

· Build and strengthen infrastructure to conduct evaluations of the U.S. pertussis vaccination program.

3. Viral Hepatitis Surveillance A. Developing capacity to receive electronic laboratory reports, input backlog of paper laboratory reports, and determine the proportion of reports that represent individuals with asymptomatic hepatitis disease.

An estimated 800,000 and 3.2 million people in the US are living with chronic hepatitis B and C, respectively. The extremely large burden of these 2 diseases poses substantial challenges for hepatitis surveillance which, as indicated in the 2010 Institute of Medicine (IOM) report on Hepatitis and Liver Cancer, is largely a fragmented, poorly developed, and vastly under-resourced surveillance system in the U.S. Because of the vast number of positive laboratory reports of hepatitis B and C submitted to local and state health departments, states have difficulty inputting the results into electronic databases. As a result, many states have an enormous back log of laboratory reports that have never been reported through the National Notifiable Disease Surveillance System. To document the burden of disease, characterize transmission patterns, and develop appropriate interventions, it is important to have access to all available reports. Utilizing electronic lab reporting (ELR) would greatly improve the efficiency in handling these large numbers of laboratory tests being reported to state/local health departments and CDC. The intent of this activity is to assist states in improving viral hepatitis surveillance by developing capability to receive case reports into their State’s NEDSS compatible reportable conditions system and input existing backlog of lab reports. Concurrently, surveillance reports indicate a decline in the number and rate of acute viral hepatitis A, B, and C cases over time. Historically, it has been demonstrated that not all cases of viral hepatitis are reported to the state health department. To estimate the magnitude of and impact of hepatitis disease it is important to document and characterize the proportion of acute cases that are not reported through the surveillance system.

· Ensure the State’s NEDSS compatible reportable conditions disease surveillance system can receive electronic laboratory reports and that it will allow manual entry of existing hard copy laboratory reports.

· Develop and implement algorithms to identify laboratory reports that require follow-up with clinicians and or patients to determine case status (meet Council of State and Territorial Epidemiologists (CSTE)/CDC case definition).

· Conduct follow-up with clinicians and/or patients on newly identified cases as well as backlogged cases to collect information necessary to determine case status (symptomology) and risk behavior/exposure status.

· Use the system to receive electronic laboratory reports and enter the backlog of hepatitis B virus and hepatitis C virus laboratory reports. Analyze data in the system to identify and document reports that meet the laboratory criteria for a case, but do not meet the clinical criteria, (asymptomatic cases).

· Assure that activities are developed and implemented consistent with the principles and intents for ELR as described in Activity C.2., above.

B. Under-reporting of acute viral hepatitis A, B, and C.

Surveillance reports indicate a decline in the number and rate of acute viral hepatitis A (HAV), B (HBV), and C (HCV) cases over time. Historically, it has been demonstrated that not all cases of viral hepatitis are reported to the state health department. To estimate the magnitude of and impact of hepatitis disease it is important to document and characterize the proportion of acute cases that are not reported through the surveillance system. The objective of this activity is to estimate the number and percentage of unreported acute cases of HAV, HBV, and HCV infections.

· Select a representative sample of laboratories and providers that submit laboratory reports of viral hepatitis to the state.

· Review and compare:

a. Reports submitted from selected laboratories to the state health department,

b. Laboratory reports conducted by the selected laboratories but not submitted to state health departments, and

c. Laboratory requests and diagnoses from provider records.

· Calculate the proportion of cases that are not reported through the surveillance system by determining:

a. Number and proportion of laboratory reports that meet the laboratory portion of the case definitions for acute HAV, HBV, and HCV infections, but are not reported to the state health department, and

b. Number and proportion of cases in the provider system that meet the CSTE/CDC case definition, but was not reported to the state health department.

C. Follow-up of Young Adults reported with Hepatitis C virus (HCV) Recent increases in reported hepatitis C cases among 18-25 year olds has highlighted the importance of enhanced surveillance with young adolescents. Information from this surveillance will better characterize risk factors and guide prevention efforts.

a. Analyze surveillance data on reported cases of HCV among 18-25 year olds in a recent 6-month period;

b. Follow-up with providers and cases to obtain information to complete case report forms (e.g. risk and clinical information) and determine case status (acute vs. chronic);

c. Update surveillance database with additional risk and case status information that more accurately characterizes HCV cases in this population;

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

CDC Activities

1. Provide subject matter expertise, consultation, and technical assistance to grantees in enhancing epidemiologic, laboratory, and information systems capacity for prevention and control of infectious diseases, including:

a. Provide technical assistance and subject matter expertise in the areas of electronic laboratory data exchange requirements, standards, and infrastructure, including:

i. Semi-monthly Nationwide Meaningful Use Calls with public health partners.

ii. CDC Meaningful Use Website that will include links to public health agency websites with MU contact information for use by vendors, eligible professionals, and eligible hospitals.

iii. Guidance for use of Public Health Information Network (PHIN) Messaging Guides: Electronic Laboratory Reporting, Immunizations, and Syndromic Surveillance.

iv. Tools for MU pre-test message validation.

v. Mapping tools for HL7 2.3.1 and HL7 2.5.1 translations for jurisdictions using Rhapsody integration engine technology.

vi. Strategy for secure message transport of electronic messages to public health, which will include guidance and tools as necessary.

vii. LOINC and SNOMED mapping to Reportable Conditions for ELR.

viii. Provide technical assistance and subject matter expertise on at least monthly teleconferences with eMAR/BCMA vendors and funded sites involved in piloting reporting of antimicrobial use metrics to NHSN and related technical documents; coordination of activities across funded sites to synergize efforts across the involved eMAR/BCMA vendors (anticipate 4 vendors involved across all funded sites)

b. Provide technical assistance and subject matter expertise in the areas of syndromic surveillance practice and use of surveillance data for early detection and enhanced situation awareness during a public health response.

2. Assist in developing metrics, monitoring, and evaluating public health and program impacts, including progress in achieving the purpose of this program.

3. Provide national coordination of activities where appropriate.

4. Collaborate with recipients on specific activities to develop a sustainable infrastructure which may include site visits, webinars, and teleconferences.

5. Work with recipients to monitor the status and progress of ELR and electronic laboratory information exchange capacity of the hospital and commercial laboratories that participate in electronic laboratory information exchange with state and local public health agencies.

6. Provide local and state health departments access to regional (i.e., multistate) and national views of BioSense program data to enhance their situation awareness.

7. Provide local and state health departments with mechanism to provide input into the BioSense Program redesign (https://sites.google.com/site/biosenseredesign).

8. Provide subject matter expertise, consultation, and technical assistance to grantees in the areas of hepatitis surveillance; case definitions for hepatitis A, B, and C infections; laboratory testing procedures and interpretation of results; and statistical methodology, including:

a. Development of a sampling frame

b. Sampling design and sample selection

c. Processing sample data (including weighting if appropriate)

d. Analyses, and

e. Interpretation.

9. Provide Epi-AID support upon request in conjunction with Young Adult Hepatitis C Virus activity

II. AWARD INFORMATION

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

Award Mechanism: U50 Fiscal Year Funds: FY 2011 Approximate Total Funding: $ 50,407,500 including approximately $45,062,500 ACA funding and $4,000,000 non-ACA funding. These amounts are estimates and include both direct and indirect costs. Approximate Funding Available by Activity:

Activity A- Epidemiology: $7,500,000

Activity B - Laboratory: $8,800,000

Activity C – Health Information Systems: $21,700,000

Activity D.1.A – HAI Prevention Infrastructure: $3,440,000

Activity D.1.B – HAI Prevention Collaboratives: $4,500,000

Activity D.1.C – HAI Antimicrobial Use Surveillance: $1,860,000

Activity D.2.A – VE MCV: $600,000

Activity D.2.B – VE PCV: $262,500

Activity D.2.C – VE Pertussis: $400,000

Activity D.3.A – Enhanced Viral Hepatitis Surveillance: $1,035,000

Activity D.3.B – Under-reporting of Viral Hepatitis: $210,000

Activity D.3.C – Young Adults with Hepatitis C Virus: $100,000 Approximate Number of Awards: 58 Approximate Average Award: $869,094 (This amount is for a 12-month budget period, and includes both direct and indirect costs.)

Activity A- Epidemiology: $129,310 assuming 58 recipients

Activity B - Laboratory: $151,724 assuming 58 recipients

Activity C – Health Information Systems: $374,138 assuming 58 recipients. (This includes continuation activities and ELR and syndromic surveillance enhancements)

Activity D.1.A – HAI Prevention Infrastructure: $66,154 assuming 52 recipients

Activity D.1.B – HAI Prevention Collaboratives: $450,000 assuming 10 recipients

Activity D.1.C – HAI Antimicrobial Use Surveillance: $465,000 assuming 4 recipients Activity D.2.A – VE MCV: $75,000 assuming 8 recipients

Activity D.2.B – VE PCV: $131,250 assuming 2 recipients

Activity D.2.C – VE Pertussis: $100.000 assuming 4 recipients

Activity D.3.A - Enhanced Viral Hepatitis Surveillance: $172,500 assuming 6 recipients

Activity D.3.B – Under-reporting of Viral Hepatitis: $52,500 assuming 4 recipients

Activity D.3.C – Young Adults with Hepatitis C Virus: $25,000 assuming 4 recipients Floor of Individual Award Range: None Ceiling of Individual Award Range: None

Anticipated Award Date: June 15, 2011 Budget Period Length: 12 Months (August 1, 2011 to July 31, 2012) Project Period Length: This FOA represents the second budget period continuation for the 22-month Project Period that began September 30, 2010.

First Budget Period: September 30, 2010 – July 31, 2011

Second Budget Period: August 1, 2011 – July 31, 2012

III. ELIGIBILITY INFORMATION

Eligible Applicants

This FOA provides second budget period continuation with enhancement of ELC-ACA awards initiated in 2010 under FOA# CI10-1012. Therefore, eligible applicants are limited to the 58 current ELC ACA grantees (or their established bona fide agents) under FOA# CI10-1012, and are listed below:

Alabama, Alaska, Arizona, Arkansas, California, Chicago IL, Colorado, Commonwealth of Puerto Rico, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Houston TX, Idaho, Iowa, Illinois, Indiana, Kansas, Kentucky, Los Angeles County CA, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, New York City NY, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Philadelphia PA, Republic of Palau, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required. Attach with “Other Attachment Forms” when submitting via www.grants.gov.

Eligibility is further limited for the following activities:

Activities D.1.A and D.1.B. - Healthcare-Associated Infections – Eligibility is limited to only those grantees required to develop and submit an HAI plan as required by Congress. Eligible applicants thus are all 50 states, the District of Columbia and Puerto Rico. Eligibility is limited to these grantees because the intention is to continue support for specific activities previously supported in the 2009 American Recovery and Reinvestment Act (ARRA) HAI awards under FOA# CI07-70402ARRA09. The ARRA language specific to that ARRA HAI funding required that funding only go to “States.”

Activity D.2.A - Evaluation of Meningococcal Conjugate Vaccine – Eligibility is limited to ELC grantees that received ARRA funds for Meningococcal vaccine (MCV) effectiveness projects under opportunity CI07-70403ARRA09. Eligible applicants thus are: Alabama, Arizona, California, Florida, Houston, Indiana, Iowa, Kansas, Maine, Massachusetts, Mississippi, New York City, North Carolina, Oklahoma, Philadelphia, South Carolina, Tennessee, Washington, and Wisconsin. Eligibility is limited to these grantees because the intention is to continue support for specific activities previously supported in the 2009 ARRA 317 Immunization awards for MCV under FOA# CI07-70403ARRA09.

Activity D.2.B - Assessing effectiveness of 13-valent pneumococcal conjugate vaccine Eligibility is limited to ELC grantees that received ARRA funds for Pneumococcal vaccine (PCV) effectiveness projects under opportunity CI07-70404ARRA09. Eligible applicants thus are: Los Angeles County, CA and Utah. Eligibility is limited to these grantees because the intention is to continue support for specific activities previously supported in the 2009 ARRA 317 Immunization awards for PCV under FOA# CI07-70404ARRA09.

Required Registrations Central Contractor Registration and Universal Identifier Requirements

All applicant organizations must obtain a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number is a nine-digit number assigned by Dun and Bradstreet Information Services.

The recipient is required to have the original DUNS identifier to apply for additional funds.

An AOR should be consulted to determine the appropriate number. If the organization does not have a DUNS number, an AOR should complete the US D&B D-U-N-S Number Request Form or contact Dun and Bradstreet by telephone directly at 1-866-705-5711 (toll-free) to obtain one. A DUNS number will be provided immediately by telephone at no charge. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a DUNS number.

Additionally, all applicant organizations must register in the Central Contractor Registry (CCR) and maintain their CCR registration with current information at all times during which it has an application under consideration for funding by CDC and, if an award is made, until a final financial report is submitted or the final payment is received, whichever is later. CCR is the primary registrant database for the Federal government and is the repository into which an entity must provide information required for the conduct of business as a recipient. Additional information about registration procedures may be found at the CCR internet site at www.ccr.gov .

If an award is granted, the grantee organization must notify potential sub-recipients that no organization may receive a sub-award under the grant unless the organization has provided its DUNS number to the grantee organization.

Cost Sharing or Matching Cost sharing or matching funds are not required for this program.

Maintenance of Effort Maintenance of Effort is not required for this program.

IV. Application and Submission Information

Address to Request Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity from Grants.gov. If access to the Internet is not available or if the applicant encounters difficulty accessing the forms on-line, contact the HHS/CDC Procurement and Grants Office Technical Information Management Section (PGO TIMS) staff at (770) 488-2700 for further instruction. CDC Telecommunications for the hearing impaired or disable is available at: TTY 1-888-232-6348.

If the applicant encounters technical difficulties with Grants.gov, the applicant should contact Grants.gov Customer Service. The Grants.gov Contact Center is available 24 hours a day, 7 days a week, with the exception of all Federal Holidays. The Contact Center provides customer service to the applicant community. The extended hours will provide applicants support around the clock, ensuring the best possible customer service is received any time it is needed. You can reach the Grants.gov Support Center at 1-800-518-4726 or by email at support@grants.gov. Submissions sent by email, fax, CD’s or thumb drives of applications will not be accepted.

Content and Form of Application Submission Unless specifically indicated, this announcement requires submission of the following information:

A Project Abstract must be completed in the Grants.gov application forms. The Project Abstract must contain a summary of the proposed activity suitable for dissemination to the public. It should be a self-contained description of the project and should contain a statement of objectives and methods to be employed. It should be informative to other persons working in the same or related fields and insofar as possible understandable to a technically literate lay reader. This abstract must not include any proprietary/confidential information.

A Project Narrative must be submitted with the application forms. The project narrative must be uploaded in a PDF file format when submitting via Grants.gov. The narrative must be submitted in the following format:

· Maximum number of pages: 40. If your narrative exceeds the page limit, only the first pages which are within the page limit will be reviewed.

· Font size: 12 point unreduced, Times New Roman

· Single spaced

· Page margin size: One inch

· Number all narrative pages; not to exceed the maximum number of pages.

Submit one narrative for each activity addressed (there are 12 Activities that could be addressed:

A - Epidemiology

B - Laboratory

C - Health Information Systems

D – Targeted Prevention and Control

D.1.A - HAI Prevention Infrastructure

D.1.B - HAI Prevention Initiatives D.1.C – HAI Antimicrobial use surveillance

D.2.A - VE MCV

D.2.B - VE PCV

D.2.C - VE Pertussis D.3.A – Viral Hepatitis Surveillance

D.3.B – Viral Hepatitis Backlog

D.3.C. – Young Adults reported with Hepatitis C HCV

Each Activity narrative…