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Centers for Disease Control
National Center for HIV-AIDS, Viral Hepatitis, STD, and TB Prevention
Strengthening Surveillance in Jurisdictions with High Incidence of Hepatitis C Virus (HCV) and Hepatitis B Virus (HBV) Infections
CDC-RFA-PS17-1703Application Due Date: 01/31/2017
Strengthening Surveillance in Jurisdictions with High Incidence of Hepatitis C Virus (HCV) and Hepatitis B Virus (HBV) InfectionsCDC-RFA-PS17-1703TABLE OF CONTENTS
Part I. Overview Information Federal Agency NameA.Funding Opportunity TitleB.Announcement TypeC.Agency Funding Opportunity NumberD.Catalog of Federal Domestic Assistance (CFDA) NumberE.Dates F.Executive Summary G.
Part II. Full Text Funding Opportunity Description A.Award Information B.Eligibility Information C.Required Registrations D.Review and Selection Process E.Award Administration Information F.Agency Contacts G.Other Information H.Glossary I.
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Part I. Overview Information Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Send Me ChangeNotifications Emails" link to ensure they receive notifications of any changes to CDC-RFA-PS17-1703. Applicants also mustprovide an e-mail address to www.grants.gov to receive notifications of changes.
A. Federal Agency Name:
Centers for Disease Control and Prevention (CDC)
B. Funding Opportunity Title:
Strengthening Surveillance in Jurisdictions with High Incidence of Hepatitis C Virus (HCV) and Hepatitis B Virus (HBV)Infections
C. Announcement Type: New - Type 1
This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not beconsidered. For this purpose, research is defined at https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf. Guidance on how CDC interprets the definition of research in the context of public health can be found at http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf . This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not beconsidered. For this purpose, research is defined at https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf. Guidance on how CDC interprets the definition of research in the context of public health can be found at http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf.
D. Agency Funding Opportunity Number:
CDC-RFA-PS17-1703
E. Catalog of Federal Domestic Assistance (CFDA) Number:
93.270
F. Dates:
1. Due Date for Letter of Intent (LOI): 12/16/2016 Is a LOI: Recommended but not Required Letters of intent are requested but not required.
2. Due Date for Applications: 01/31/2017, 11:59 p.m. U.S. Eastern Standard Time, atwww.grants.gov.
3. Date for Informational Conference Call: 12/13/2016The information call will be at 3:00 pm on 13 December 2016.
The call in numbers for the informational call are:
(404) 553-8912 (Atlanta), (855) 348-8390 (toll free) Conference ID: 5419600
Questions about the informational call or the FOA may be sent to [email protected].
G. Executive Summary:
1. Summary Paragraph:The purpose of this funding announcement is to support and improve active surveillance of hepatitis C and B in statewidejurisdictions experiencing high rates of incident cases of HCV, HBV, or both to support implementation of testing, treatment, andprevention services and activities based on surveillance data.
a. Eligible Applicants: Open Competition b. FOA Type: Cooperative Agreement c. Approximate Number of Awards: 14 Anticipate 14 awards for core activities and 10 awards for optional surveillance-based activities.
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Anticipate 14 awards for core activities and 10 awards for optional surveillance-based activities.
Applicants must be funded to support core activities in order to recieve funding for optional surveillance-based activities.
d. Total Project Period Funding: $12,800,000 e. Average One Year Award Amount: $242,857 In year one, the average award is anticipated to be approximately $242,857, including $192,857 for core activities and $50,000 forone optional activity.
f. Number of Years of Award: 4 g. Estimated Award Date: 05/01/2017 h. Cost Sharing and / or Matching Requirements: N Cost sharing or matching funds are not required for this program. Although no statutory matching requirement for this FOA exists,leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged.
Part II. Full TextA. Funding Opportunity Description
1. Background
a. Overview CDC announces the availability of Fiscal Year (FY) 2017 funds for a cooperative agreement program to support and improveactive surveillance of acute and chronic hepatitis C and B in jurisdictions experiencing the highest rates and numbers of incidentHCV, HBV, or both and, as an option, support for implementation of HCV and HBV testing in and reporting from non-traditionalsurveillance sites, such as emergency departments, correctional institutions, etc.
After many years of a decline or plateau in the incidence of hepatitis C virus (HCV) infection, national hepatitis surveillanceidentified a doubling of cases of acute HCV infection reported to CDC from 850 cases in 2010 to 2194 cases in 2014. Thereported cases meet the stringent criteria of CDC/Council of State and Territorial Epidemiologists (CSTE) surveillance casedefinitions, and after adjusting for underreporting, the data indicate that about 30,000 new HCV infections occurred in 2014. Somestates have reported incidence rates of HCV infection that are higher than the national rate. Various studies have shown that manycases of HCV infection are reported from non-urban (rural/suburban) areas (notably, Appalachia, the Midwest and New England)among young, white persons who inject drugs (PWIDs) particularly prescription oral opioid drugs and heroin. At the same time,the number of HCV-related deaths continue to rise and since 2007 have surpassed annual deaths from HIV. In 2010 there were10,017 deaths due to HIV and 16,127 deaths listing HCV as a cause, in 2014 the number of deaths were 8,653 and 19,659,respectively.
In some localities, the incidence of hepatitis B virus (HBV) infection is also increasing related to the same risk behaviorsassociated with the increases in HCV infection incidence. An estimated 20,000 new HBV infections occurred in 2014 in theUnited States. National surveillance data show that from 2004-2013, the number of new cases of acute hepatitis B were declining.However, there was a 5.3% increase in reported cases of acute HBV infection from 2012 to 2013. Although from 2013 to 2014 an8.4% decrease in reported cases was observed nationally, some states continue to report increases. Many of the reported cases ofacute HBV infection were among PWIDs.
As was recently observed in Scott County, Indiana, communities with high incidence and prevalence of HCV infection amongPWID are also at risk for transmission of HIV. Despite these trends, only a fraction of those with acute or chronic HCV or HBVinfection have been identified through testing and subsequently reported to public health authorities. This situation hampersunderstanding of the magnitude of the problem, particularly among persons at increased risk such as PWIDs, and impacts theplanning and implementation of interventions to stop transmission, and referral of HCV- or HBV- infected persons for care andtreatment.
In 2008, the New York State Department of Health reported a cluster of cases of HCV infection among young (aged <30 years),white persons identified through surveillance, most of whom reported a history of injection drug use (IDU) (1). In 2010, theMassachusetts Department of Public Health analyzed surveillance data and described an increase in HCV infection cases from2002-2009 among adolescents and young adults aged 15-24 years. Again, IDU was the most commonly reported risk factoridentified among this cluster of cases (2, 3). Subsequent to the report from Massachusetts, Ohio and several other jurisdictionsbegan reporting similar findings. Review and analysis of case reports submitted to CDC nationally from 2006-2012, revealed theincidence of acute hepatitis C increased significantly in non-urban counties, among young, white persons, 75% of whom reported
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incidence of acute hepatitis C increased significantly in non-urban counties, among young, white persons, 75% of whom reportedinjection drug use (4). In the face of these increases among young PWIDs who are mainly non-minority and non-urban, the needfor reliable surveillance data is essential to the development, support, and evaluation of epidemiologic responses (outbreaks) andprevention programs and policies.
b. Statutory Authorities This program is authorized under Sections 301(a), 317N, and 318 of the PublicHealth Service Act (42 U.S.C. Sections 241(a), 247b -15, and 247c), as amended.
c. Healthy People 2020 This FOA 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).
d. Other National Public Health Priorities and Strategies This FOA supports the goals of the 2011 and 2014-2016 HHS Viral Hepatitis Action Plans by focusing on strengtheningsurveillance to detect viral hepatitis disease, recognizing and describing transmission patterns, monitoring viralhepatitis-associated health disparities, monitoring and evaluating the impact of prevention programs and policies, andexpanding viral hepatitis surveillance methodologies to include new technologies and laboratory procedures. The FOA alsosupports the strategic imperatives of the DVH Strategic Plan: http://www.cdc.gov/hepatitis/pdfs/dvh-strategicplan2016-2020.pdfFOA activities address one of the six topic areas outlined in the 2014-2016 HHS Action Plan for the Prevention, Care, &Treatment of Viral Hepatitis: http://aids.gov/pdf/viral-hepatitis-action-plan.pdfFOA activities will help the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) achieveits overarching goals as defined in the NCHHSTP Strategic Plan through 2020 (http://www.cdc.gov/nchhstp),including decrease incidence of infection, morbidity and mortality, and health disparities health disparities http://healthypeople.gov/2020/about/DisparitiesAbout.aspx).Based on existing evidence, the U.S. Surgeon General has determined that Syringe Services Programs (SSPs), are aneffective public health approach to reduce the spread of HIV. When part of a comprehensive HIV prevention strategy, SSPs:
Play a critical role in preventing HIV among PWID;Facilitate entry into drug treatment and medical services; andDo not increase the illegal use of drugs.
e. Relevant Work This FOA builds upon current HCV and HBV surveillance projects and technical efforts including:
CDC-RFA-PS13-1303 - Viral Hepatitis - Prevention and Surveillance)
2. CDC Project Description
a. Approach Bold indicates project period outcome.The logic model is a visual depiction of the programmatic approach and reflects how the activities, strategies and expectedoutcomes are interrelated to achieve the program goals and objectives. Bolded test indicates outcomes the awardee is expected toachieve during the project period.
This FOA includes two components; core activities and strategies and optional surveillance-based activities and strategies. Applications will be evaluated and scored on each of these components, core and each option, separately. Only applicants that areawarded for core activities will be eligible for funding for the optional activities.
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(CDC-RFA-[PS 17-1703] Logic Model: Enhancing Surveillance in Jurisdictions with High Hepatitis C Virus(HCV) and Hepatitis B Virus (HBV) Incidence
Strategies and Activities Short-Term Outcomes
(Year 1-2)
Intermediate Outcomes
(Year 3-4)
Long-TermOutcomes
A. Core Activities
Notify CDC of all cases meeting CSTEdefinitions of acuteand chronic HBV andHCV, and perinatalhepatitis B and, whenreportable, perinatalhepatitis C to CDC via the NationalNotifiable DiseaseSurveillance System(NNDSS)
1.
Supplement casesurveillance data withdata from existingsources to estimate therisk populations fortransmission of viralhepatitis.
2.
Develop and maintain a registry ofHCV and HBVcases.
3.
Develop and share surveillancedata/reports with stateand local preventionandtreatment programsand assist with datainterpretation andapplication, as needed.
4.
Detect and investigate HCV andHBV outbreaks.
5.
Develop or purchaseinformationaltechnology, as neededto improve surveillance.
6.
B. OptionalSurveillance-based
A. Core Activities 1. Cases submitted to CDCwith complete demographic,geographic, and riskinformation: at least 90 %complete for age and gender;70% complete forrace/ethnicity; 60% completecounty and zip code ofresidence; 50% completesource of testing; and at least70% complete risk information.
> 80% of commercial andpublic health laboratories andpublic health clinics reporting HCV and HBV dataon a continuing basis, to healthdepartment.
2. Increase knowledge of the“true” burden of HCV andHBV by supplementing casesurveillance data with datafrom other sources suchas Medicaid and Medicare,hospital discharge data, anddata from the Behavioral RiskFactor Surveillance System. 3. Increase knowledge of HCVand HBV among preventionprograms.
4. Reduce cases of HCV andHBV due to interruptedtransmission in identifiedoutbreaks.
B. Optional Surveillance-based Activities
1. Increased information
A. Core Activities 1. Cases submitted toCDC with completedemographic,geographic, and riskinformation: at least99% complete for ageand gender; 80%complete forrace/ethnicity; 80%complete county andzip code of residence;80% completesource of testing; andat least 80% completerisk information.
> 90% ofcommercial and publichealth laboratories andpublic clinics reporting HCV and HBV dataon a continuing basis,to health department.
2. Increase knowledgeof the “true” burden ofHCV and HBVby supplementing casesurveillance data withdata from othersources suchas Medicaid andMedicare, hospitaldischarge data, anddata fromthe Behavioral RiskFactor SurveillanceSystem. 3. Increaseknowledge of HCV andHBV among preventionprograms.
4. Reduce cases ofHCV and HBV due tointerruptedtransmissionin identified outbreaks.
B. Optional
A. CoreActivities Improvedcompleteness andtimeliness, of reported HCV andHBV cases.
Improve reportingof newlydiagnosed HBV and HCV cases.
Surveillance datasufficient torecognize transmissionpatterns and needfor linkage to care.
B. OptionalSurveillance-based Activities
Improve reportingof newlydiagnosed HBV and HCV caseamong targetedpopulations,including PWIDs,incarcerated
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Activities- Applicants maypropose one or moreoptional activities.
Promote HCV and HBV testing andreporting in settingsserving targetpopulations* such as emergencydepartments anddetention/incarcerationcenters.
1.
Evaluate the effectiveness of HCVand HBV testing andlinkage torecommendedservices and treatmentat syringe serviceprograms (SSPs)*,alcohol and drug treatment venues, andbuprenorphine/naloxone and otheropioid prevention and treatmentprograms.
2.
Among reported cases, follow-up ontargeted HCV- andHBV-infected persons,especially thosewith evidence ofrecent infection toensure they are linkedto care andtreatment.
3.
about and improved testingand reporting from largeemergency departments and/orlargedetention/incarceration centersidentified. 2. Increased informationabout and improved testingand reporting from large SSPs,large alcohol and drugtreatment venues, and/orlarge buprenorphine/ naloxoneand other opioid preventionand treatment programs.
3. Document that at least 15%of contacted HCV- andHBV-infected persons aresuccessfully linked to care andtreatment.
Surveillance-based Activities
1. Increase in thenumber of emergencydepartments and detention/incarcerationcenters testing forHCV and HBV, thenumber of HCV andHBV test performed,and reporting of testresults to theappropriate healthdepartment. 2. Increase in thenumber of SSPs*, alcohol and drugtreatment venues,and/or buprenorphineprescribers, testing forHCV and HBV, andthe number ofHCV and HBV testperformed in each site,and reporting of testresults tothe appropriate healthdepartment..
3. Documentation thatat least 33% ofcontacted HCV- andHBV infected personssuccessfully linked tocare and treatment.
persons, andpersons in alcoholand drug treatmentfacilities.
* Grantees that choose to work with SSPs should carefully review guidelines for use of federal funds tosupport certain components of SSPs. This information is available at the following links:
http://www.cdc.gov/hiv/risk/ssps.html
http://www.cdc.gov/hiv/risk/ssps.html .
http://www.cdc.gov/hiv/pdf/risk/cdc-hiv-syringe-exchange-services.pdf
i. Purpose The purpose of this funding announcement is to support and improve active surveillance of hepatitis C and B in statewidejurisdictions experiencing high rates of incident cases of HCV, HBV, or both to support implementation of testing, treatment andprevention services and activities based on surveillance data.
ii. Outcomes A. Outcomes from Core Activities for years 1-2:
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A. Outcomes from Core Activities for years 1-2:
Improvement in completeness and timeliness of laboratory and case information (demographic, geographic, and risk)reported through NNDSS over time.
1.
Cases submitted to CDC with complete demographic, geographic, and risk information: at least 90 % complete forage and gender; 70% complete for race/ethnicity; 60% complete county and zip code of residence; 50% completesource of testing; and at least 70% complete risk information.At least 80% of commercial and public health laboratories and public health clinics reporting HCV and HBV data ona continuing basis, to health department.
Increase knowledge of the “true” burden of HCV and HBV by supplementing case surveillance data with data from othersources such as Medicaid and Medicare, hospital discharge data, and data from the Behavioral Risk Factor SurveillanceSystem.
2.
Reduce cases of HCV and HBV due to interrupted transmission in identified outbreaks by using surveillance data to identifyoutbreaks of HCV, HBV, emerging trends in case reports in communities, and/or increases in opioid utilization and overdosedeaths indicative of increased HCV and HBV incidence. Follow established CDC guidelines for investigating outbreaksand report to appropriate authorities and CDC/DVH Surveillance.
3.
Outcomes from Core Activities for years 3-4
Improvement in completeness and timeliness of laboratory and case information (demographic, geographic, and risk)reported through NNDSS over time. a. Cases submitted to CDC with complete demographic, geographic, and riskinformation: at least 99 % complete for age and gender; at least 80% complete for race/ethnicity, county and zip code ofresidence, source of testing and risk information. b. At least 90% of commercial and public health laboratories and publichealth clinics reporting HCV and HBV data on a continuing basis, to health department.
1.
Increase knowledge of the “true” burden of HCV and HBV by supplementing case surveillance data with data from othersources such as Medicaid and Medicare, hospital discharge data, and data from the Behavioral Risk Factor SurveillanceSystem.
2.
Reduce cases of HCV and HBV due to interrupted transmission in identified outbreaks by using surveillance data to identifyoutbreaks of HCV, HBV, emerging trends in case reports in communities, and/or increases in opioid utilization and overdosedeaths indicative of increased HCV and HBV incidence. Follow established CDC guidelines for investigating outbreaksand report to appropriate authorities and CDC/VH Surveillance.
3.
B. Outcomes from Optional Surveillance-based Activities years 1-2:
For optional activities that include promoting HCV and HBV testing in venues likely to serve infected persons--especiallyPWIDs, who have been traditionally very difficult to reach, increase by at least 10% over baseline, the number of emergencydepartments, drug treatment venues, and/or correctional facilities providing HCV and HBV testing and by at least 10%(over baseline) the number of test provided and results reported to the appropriate health department.
1.
For optional activities to evaluate the effectiveness of HCV and HBV testing and linkage to care and treatment, and throughdata sharing collaborations increase by at least 10% (over baseline) the number of SSPs, alcohol and drug treatment venues,and/or buprenorphine/naloxone and other opioid prevention and treatment programs that provide HCV and HBV testing andby at least 10% (over baseline) the number of test performed and results reported to the appropriate health department.
2.
For optional activities that include linking HCV- and HBV-infected persons, especially PWIDs to care and treatment,including linkage to drug abuse document that at least 15% of contacted HCV- and HBV infected persons successfullylinked to care and treatment.
3.
B. Outcomes from Optional Surveillance-based Activities years 3-4:
For optional activities that include promoting HCV and HBV testing in venues likely to serve infected persons--especiallyPWIDs, who have been traditionally very difficult to reach, increase by at least 25% over baseline, the number of emergencydepartments, drug treatment venues, and/or correctional facilities providing HCV and HBV testing and by at least 25%(over baseline) the number of test provided and results reported to the appropriate health department.
1.
For optional activities to evaluate the effectiveness of HCV and HBV testing and linkage to care and treatment, and throughdata sharing collaborations increase by at least 25% (over baseline) the number of SSPs, alcohol and drug treatment venues,and/or buprenorphine/naloxone and other opioid prevention and treatment programs that provide HCV and HBV testing andby at least 25% (over baseline) the number of test performed and results reported to the appropriate health department.
2.
For optional activities that include linking HCV- and HBV-infected persons, especially PWIDs to care and treatment,documentation that at least 33% of contacted HCV- and HBV infected persons successfully linked to care and treatment.
3.
iii. Strategies and Activities A. Core Activities for year 1-2:
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A. Core Activities for year 1-2:
Notify CDC of all cases meeting CSTE criteria for acute and chronic hepatitis B and C, perinatal hepatitis Band whenreportable, perinatal hepatitis C via the National Notifiable Disease Surveillance System (NNDSS).
1.
If NNDSS has not been updated to receive enhanced or expanded data elements collected by funded sites, alsomonthly submit case-reports with all data elements to CDC/DVH through Secure Access Management Services(SAMS). (Instructions for submitting data through SAMS can be provided by CDC to each funded site.)Develop and implement a plan to: ?
Improve the completeness of case reports and timeliness of reporting from current reporting sourcesparticularly from providers of care for persons at risk for acute or recent HCV infection (i.e., less than 30 yearsof age) and acute HBV infection. Seek to complete demographic (gender, date of birth or age, and race/ethnicity), geographic (county, postalcode), transmission risk and, test setting information. Follow-up with health care providers and/or case patientsis essential to improving completeness of demographic and risk information. Transmission risk and test settinginformation may be completed from other sources (e.g., from CMS coding: hospital, clinic, physician,commercial laboratory).
Routinely review data quality and take appropriate actions to ensure data are accurate and complete.States without existing registries should create them so new reported cases of HBV and HCV can be checked againstthe registry and those cases not already included in the registry can be prioritized for follow-up.
Use existing data sources to improve the quality of case surveillance. Develop and implement a plan to use the identifieddata source(s) to supplement case surveillance data, especially for estimating and reporting prevalent case.
2.
Data from registries may be useful for identifying new infections (e.g., seroconversion), detect transmission networks,monitor indicators of access to care for HBV (e.g., HBsAg, HBV PCR testing) and HCV (e.g., anti-HCV, HCV PCR,HCV genotype) and identifying co-morbidities by linking the registries to other public health registries, especiallyHIV/AIDS surveillance data, Medicaid and Medicare data, as well as birth and death registries.In states/localities where reporting all positive and negative results of HCV tests is mandated by law or regulation,registries can be revised to include these test results. Only test results that meet CSTE reporting criteria will beforwarded to CDC.
On at least a yearly basis produce a surveillance report that provides information needed to prioritize activities for HCVand/or HBV surveillance and prevention, and to evaluate and support prevention programs.
3.
Routinely review and analyze surveillance data to detect and investigate outbreaks of HCV and/or HBV. Surveillance datamay be used to determine cause(s) of outbreaks —i.e., changes in reporting, changes in testing, increase in new infections.Bring possible increases in HCV or HBV transmission to attention of public health staff responsible for viral hepatitisprevention and outbreak response; assist in prevention planning, program implementation and outbreak response, asappropriate.
4.
B. Core Activities for year 3-4:
Notify CDC of all cases meeting CSTE criteria for acute and chronic hepatitis B and C, perinatal hepatitis B and whenreportable, perinatal hepatitis C via the National Notifiable Disease Surveillance System (NNDSS).
1.
If NNDSS has not been updated to receive enhanced or expanded data elements collected by funded sites, alsomonthly submit case-reports with all data elements to CDC/DVH through Secure Access Management Services(SAMS). (Instructions for submitting data through SAMS can be provided by CDC to each funded site.) Continue to improve the completeness of case reports and timeliness of reporting from current reporting sources tomeet goals established for this FOA. Routinely conduct data quality reviews and take appropriate actions to ensure data are accurate and complete.
Use existing data sources to improve the quality of case surveillance. Develop and implement a plan to use the identifieddata source(s) to supplement case surveillance data, especially for estimating and reporting prevalent cases.
2.
Data from registries may be useful for identifying new infections (e.g., seroconversion), detect transmission networks,monitor indicators of access to care for HBV (e.g., HBsAg, HBV PCR testing) and HCV (e.g., anti-HCV, HCV PCR,HCV genotype) and identifying co-morbidities by linking the registries to other public health registries, especiallyHIV/AIDS surveillance data, as well as birth and death registries.In states/localities where reporting all positive and negative results of HCV tests is mandated by law or regulation,registries can be revised to include these test results. Only test results that meet CSTE reporting criteria will beforwarded to CDC.
Analyze surveillance data on at least a yearly basis to produce a surveillance report that provides information needed toprioritize activities for HCV and/or HBV surveillance and prevention, and to evaluate and support prevention programs. Assist and coordinate with local viral hepatitis and other prevention staff, as appropriate, in activities that requiresurveillance data, such as delineation of new trends in transmission ( e.g., geographic, demographic, mode), of the “cascadeof care” (diagnosis, referral to care, receipt of treatment and successful outcome) and evaluation of prevention activities.
3.
4. Routine review and analyze surveillance data to detect and investigate increases in reported acute hepatitis C and hepatitis4.10 of 43
B cases to determine cause(s)—i.e., changes in reporting, changes in testing, increase in new infections. Bring possibleincreases in HCV or HBV transmission to attention of public health staff responsible for viral hepatitis prevention andoutbreak response; assist in prevention planning, program implementation and outbreak response, as appropriate.
C. Optional Surveillance-based Activities for year 1-2: Applicants can request support for one or more optional activities. Forapplicants that include activities with SSPs, support must always be in accordance with federal, state and local laws andregulations and must be consistent with activities as described in the CDC’s Program Guidance for Implementing CertainComponents of SSPs, 2016 (http://www.cdc.gov/hiv/pdf/risk/cdc-hiv-syringe-exchange-services.pdf ).
For optional activities that include promoting HCV and HBV testing and reporting in venues likely to serve infectedpersons, such as emergency departments and correctional facilities:
1.
Identify targeted venues. Develop a plan to include testing results and appropriate demographic, risk, and residential information into thesurveillance system. Obtain documented agreements (such as Memoranda of Understanding) with venues for reporting of HCV and HBVtests results and other relevant information to the appropriate health department. Modify IT system to receive electronic reports from these venues. If the inclusion of additional sites require changes to state reporting regulations, the plan should include an outline andtimeline for this process or documentation that explains why this cannot be accomplished.
For optional activities that evaluate and promote testing and reporting from syringe service programs (SSPs), alcohol anddrug treatment venues, and buprenorphine/naloxone and other opioid prevention and treatment programs:
2.
Identify targeted venues. Develop plans to include HCV and HBV testing results, and appropriate demographic, risk, and residentialinformation into the surveillance system. Obtain documented agreements (such as MOUs,) with venues for reporting of HCV and HBV test results and otherrelevant information to the appropriate health departments. If the inclusion of additional sites require changes to state reporting regulations, the plan should include an outline andtimeline for this process or documentation that explains why this cannot be accomplished.
For optional activities that include linking HCV- and HBV-infected PWIDs, develop a strategy to link such persons to careand treatment. This may include manpower to follow-up with newly identified HCV- and HBV-infected persons.
3.
Identify targeted venues. Develop a plan to include information about linkage to care from these venues into the surveillance system, includinginto HCV and HBV registries. Obtain documented agreements with venues for reporting relevant information to the appropriate health department. If the inclusion of additional sites require changes to state reporting regulations, the plan should include an outline andtimeline for this process or documentation that explains why this cannot be accomplished.
D. Optional Activities for years 3-4:
For optional activities that include promoting HCV and HBV testing and reporting in venues likely to serve infectedpersons, such as emergency departments and correctional facilities:
1.
Implement plan to include HCV and HBV testing results from emergency departments and/or correctional facilitiesinto the surveillance system. Receive and analyze surveillance data from these venues. Produce report(s) describing individuals tested in these targeted venues and share reports with the venues. Use data from the venues and experiences with the venues to improve both the data collection/reporting process anddata quality.
For optional activities that evaluate and promote testing and reporting from syringe service programs (SSPs), alcohol anddrug treatment venues, and buprenorphine/naloxone and other opioid prevention and treatment programs:
2.
Implement plan to include HCV and HBV testing results from SSPs, alcohol and drug treatment venues, andbuprenorphine/naloxone and other opioid prevention and treatment programs. Receive and analyze surveillance data from these venues. Produce report(s) describing individuals tested in these targeted venues and share reports with the venues. Use data from the venues and experiences with the venues to improve both the data collection/reporting process anddata quality.
For optional activities that include linking HCV- and HBV-infected PWIDs, develop a strategy to link such persons to careand treatment. This may include identified manpower to follow-up with newly identified HCV- and HBV-infected persons.
3.
1.Collaborations Applicants must explain how each collaboration will facilitate implementing activities and achieving the FOA project period
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Applicants must explain how each collaboration will facilitate implementing activities and achieving the FOA project periodoutcomes.
Applicants must file MOUs or MOAs, as described in the “Eligible Applicants” and “Collaborations” sections of thisannouncement as appropriate, name the file “MOUs/MOAs”, and upload it as a PDF file at www.grants.gov .
Applicants must file letters of support, as appropriate, name the file “Letters of Support”, and upload it as a PDF file at www.grants.gov
For applicants that apply for Optional Surveillance-based Activities that include SSPs:-
Relevant MOU(s), MOA(s), or letters of support are required from all programs that will be testing and reporting HCV and HBVcases to the applicant and from all programs that will link HCV and HBV infected persons to care and treatment, as described inthe logic model. The types of programs include, but are not limited to, SSPs, alcohol and drug treatment venues, emergencydepartments, and correctional facilities. If applying for optional activities that include SSPs support must always be in accordancein accordance with federal, state and local laws and regulations and must be consistent with activities as described in the CDC’sProgram Guidance for Implementing Certain Components of SSPs, 2016 (http://www.cdc.gov/hiv/pdf/risk/cdc-hiv-syringe-exchange-services.pdf).
Awardees are required to collaboratively partner with CDC. Awardees must also establish, build, and/or maintain workingpartnerships with other CDC awardees (e.g., directly funded jurisdictions and local health departments, community-basedorganizations) to ensure communication, collaboration, and coordination for the implementation of Syringe Services Programs thatare consistent with CDC standards and program guidance. Awardees need to demonstrate receipt of Determination of Need (DON)from consultation with CDC; and, they need to name the source from which they will leverage syringes.
a. With other CDC programs and CDC-funded organizations: Applicants are encouraged to identify and collaborate with CDC-funded programs (e.g., HIV, injury, immunization) within theirjurisdiction to meet the goals and objectives of the project. Security and confidentiality agreements may be required to share databetween CDC-funded programs.
Applicants are required to collaborate with CDC Grant CDC RFA-PS17-1702 grantees (Viral Hepatitis Prevention) in thejurisdiction to increase testing and diagnosis prevent infections and to link persons with infection to care, treatment, andpreventive services. Letters of commitment/support are required from the principal investigator or the project manager todocument this collaboration. CDC/Division of Viral Hepatitis will provide awardees with contact information for the point ofcontact CDC RFA-PS17-1702.
Applicants must address the collaboration requirements stated in the Collaboration section of the Project Narrative.
b. With organizations not funded by CDC: Awardees are encouraged to establish, build, and/or maintain collaborative relationships with external programs (e.g., drugtreatment centers, SSPs, community based organizations providing prevention services, health care providers, commerciallaboratories) to support the implementation of the proposed program. Memoranda of Agreements (MOA), Memoranda ofUnderstanding (MOU), letters of commitment, or service agreements are required to formally document proposed and currentcollaborations. These documents should describe the scope of work, intensity, duration, specific activities, and which parties areresponsible for each specific activities.
Applicants other than state health departments are required to provide a MOU with the state health department specifying that thestate health department will provide the applicant access to statewide surveillance data, will collaborate with the applicant on thisproject to ensure complete data are submitted to CDC/NNDSS according to established guidelines and processes.
If applying for optional activities, relevant MOU(s), MOA(s), or letters of support are required from all programs that will betesting and reporting HCV and HBV cases to the applicant and from all programs that will link HCV and HBV infected persons tocare and treatment, as described in the logic model. The types of programs include, but are not limited to, SSPs, alcohol and drugtreatment venues, emergency departments, and correctional facilities.
If applying for optional activities that include SSPs support must always be in accordance in accordance with federal, state andlocal laws and regulations and must be consistent with activities as described in the CDC’s Program Guidance for ImplementingCertain Components of SSPs, 2016 ( http://www.cdc.gov/hiv/pdf/risk/cdc-hiv-syringe-exchange-services.pdf ).
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2. Target Populations All cases of acute and chronic HBV and HCV, and perinatal hepatitis B should be submitted to CDC. Populations targeted foractive surveillance of HBV and HCV infections include:
Persons who inject drugs (PWIDs) or with other risks for HCV transmission, currently, recently, or in their lifetime.Persons in settings that provide care services for persons at increased risk for acute or recent HCV and HBV transmission(drug treatment, emergency departments, syringe exchange programs, specific clinicians (e.g. obstetricians in highlyendemic areas), STD treatment settings and other health care providers and correctional institutions.Target populations for surveillance of HBV infections also include: Asian and Pacific Islanders; and non-Hispanic Blacks.
a. Inclusion Funded programs must include people with disabilities in all aspects of the program (e.g., advisory boards, planning committees,project staff, consultants, etc.). Where appropriate, applicants are encouraged to also include: tribal organizations; ruralpopulations; non-English speaking populations; lesbian, gay, bisexual, and transgender (LGBT) populations; and people withlimited health literacy. For additional information about disability inclusion, go to: http://www.cdc.gov/ncbddd/disabilityandhealth/disability-inclusion.html.
Funded programs are encouraged to collect information about HCV and HBV persons with persons with disabilities using the 6questions that are included in the American Community Survey. These questions and rational for using them are found at http://www2.census.gov/programs-surveys/acs/about/qbyqfact/2016/Disability.pdf .
All persons diagnosed with acute and chronic HCV and HBV infection, including those with disabilities, can benefit from thisFOA. For HCV, the populations with greatest risk for transmissions and new infections include populations with low healthliteracy in rural areas with limited access to testing, prevention and treatment.
Racial ethnic health disparities to be addressed in this announcement include acute hepatitis C among American Indians; acutehepatitis B among African-Americans; chronic hepatitis C among American Indian and African-Americans; and chronic hepatitis Bamong Asian/Pacific IslanderAmericans.
iv. Funding Strategy (for multi-component FOAs only) CDC may fund out of rank order based on the following criteria, using the best data available at the time:
Highest HCV and HBV incidence and numbers of acute infections; Geographic diversity among awardees; Highest HCV or HBV incidence and numbers of acute infections; and Other supporting evidence indicative of increases in HCV or HBV transmission (i.e. mortality data showing increasingdeaths due to drug overdose, data from the Substance Abuse and Mental Health Services Administration showing highand/or increasing injection drug use within the jurisdiction, etc.).
The most recent state-specific incidence data for HCV may be found at http://www.cdc.gov/hepatitis/statistics/2014surveillance/pdfs/2014hepsurveillancerpt.pdf
and for HBV incidence at
http://www.cdc.gov/hepatitis/statistics/2014surveillance/pdfs/2014hepsurveillancerpt.pdf .
b. Evaluation and Performance Measurement
i. CDC Evaluation and Performance Measurement Strategy
Proposed Process Measures:
For Core Activities: These performance measures and evaluation findings will be used by grantees to determine the burden ofviral hepatitis diseases; develop, implement, and evaluate prevention efforts, and plan allocation of resources. The informationwill be used by CDC to document burden of disease; understand trends in incidence and prevalence of disease; develop,implement, and evaluate prevention programs and policies, formulate recommendations for testing, and for working with Statepartners to control and prevent viral hepatitis infections.
Process and outcome measures are presented for each numbered core activity.13 of 43
Process and outcome measures are presented for each numbered core activity.
1. Process measure: The grantee notified CDC of 100% of acute and chronic HCV and HBV cases, and perinatal HBV cases, andwhere reportable perinatal HCV cases via the NNDSS.
Years 1 - 2 Outcome measures: Case demographic, geographic, and risk information completeness, as notified to CDC,should be at least 90% complete for age and gender and 70% complete for race/ethnicity information, 60% complete countyand zip code of residence, 50% complete source of testing, and at least 70% complete risk information.
At least 80% of commercial and public health laboratories and public health clinics report HCV and HBV cases on acontinuing basis, to the local and/or state health department.
Years 3-4 Outcome measures: Case demographic, geographic, and risk information completeness, as notified to CDC, shouldbe at least 99 % complete for age and gender and 80% complete for race/ethnicity information, county and zip code ofresidence, and source of testing, and at least 80% complete risk information.
At least 90% of commercial and public health laboratories and public health clinics report HCV and HBV cases on acontinuing basis, to the local and/or state health department.
2. Process measure: The grantee used data from existing data sources to supplement case reports of HCV and HBV particularlyfor populations at risk for acute or recent HCV infection (i.e., less than 30 years of age. The number of additional cases and adescription of demographic, source of testing, risk, and residential characteristics were reported. This information will be used toevaluate progress towards achieving the goal of determining the burden of acute and chronic HCV and HBV, and perinatal HBVand where reportable perinatal HCV infections.
Years 1-2 Outcome measures: The grantee used data from at least 2 existing data sources, supplementing case surveillancedata to estimate the burden of acute and chronic HCV and HBV infections, perinatal HBV infection, and where reportable,perinatal HCV infections.
Years 3-4 Outcome measures: The grantee used data from 2 existing data sources (for a total of 4 supplemental data sources,2 in years 1-2 and 2 additional sources in years 3-4), supplementing case surveillance data to estimate the burden of acute andchronic HCV and HBV infections, perinatal HBV infections, and where reportable, perinatal HCV infections.
3. Process measure: All identified outbreaks were investigated and for each outbreak the number of cases linked to theinvestigation were identified and provided appropriate notification and testing and treatment recommendations. Summary reportsdescribing cases that were related to the outbreak and actions taken were developed and disseminated to appropriate healthdepartment(s) and CDC/DVH.
Years 1-2 Outcome measures: For the purpose of reporting, health care associated outbreaks; including those in personalcare, assisted living, and nursing facilities, if no new cases are detected within 6 months of the last case, the outbreak will beconsidered over. For community outbreaks, especially among PWIDs, the outbreak is considered over when the rate of newinfections return to the baseline rate.
Years 3-4 Outcome measures: For the purpose of reporting, health care associated outbreaks; including those in personal care,assisted living, and nursing facilities, if no new cases are detected within 6 months of the last case, the outbreak will beconsidered over. For community outbreaks, especially among PWIDs, the outbreak is considered over when the rate of newinfections return to the baseline rate.
For B. Optional Surveillance-based Activities: These performance measures and findings will be used by awardees to determinethe burden of HCV and HBV transmission among the most vulnerable and hard to reach populations; expand partnerships andcollaborations to combat HBV and HCV transmission, develop, implement, and evaluate prevention efforts that target hard toreach populations, and plan more comprehensive approaches to directing prevention services. The information will be used byCDC to document burden of disease among vulnerable and hard to reach populations; understand trends in incidence andprevalence of disease; develop, implement, and evaluate prevention programs and policies, formulate recommendations for testing,and for working with State partners to control and prevent viral hepatitis infections.
Process and Outcome Measures for Optional Surveillance-based Activities :
1. Process measure: HCV and HBV testing and reporting was promoted in settings, such as emergency departments andcorrectional facilities, that serve target populations. A report listing and describing both the identified venues that test and reportcases of HCV and/or HBV infected persons and the number of individuals tested was developed and disseminated to appropriateprevention programs, surveillance systems, and program and policy stakeholders. Progress of this activity will be evaluated basedon the number of eligible venues that collaborate with the health department and the number and percent of HCV and HBV testperformed and case reports submitted to the health department.
Years 1-2 Outcome measures: An increase of at least 10% in the number of emergency departments and/or14 of 43
Years 1-2 Outcome measures: An increase of at least 10% in the number of emergency departments and/ordetention/incarceration centers testing for HCV and HBV and reporting cases to the appropriate health department. Anincrease of at least 10% in the number of HCV and HBV tests performed and results reported to the appropriate healthdepartment.
Years 3-4 Outcome measures: An increase of at least 25% in the number of emergency departments and/ordetention/incarceration centers testing for HCV and HBV and reporting cases to the appropriate health department. Anincrease of at least 25% in the number of HCV and HBV tests performed and results reported to the appropriate healthdepartment.
2. Process measure: HCV and HBV testing and linkage to care and treatment services was promoted in SSPs, alcohol and drugtreatment venues, and/or buprenorphine/naloxone and other opioid prevention and treatment programs. A report listing anddescribing both the identified venues that test individuals for HCV and HBV and list the number of infected individuals who werelinked to recommended care and treatment services was developed and disseminated to appropriate prevention programs,surveillance systems, and program and policy stakeholders. Progress of this activity will be evaluated based on the number ofeligible venues that collaborate with the health department and the number and percent of HCV and HBV test performed and casereports submitted to the health department.
Years 1-2 Outcome measures: An increase of at least 10% in the number of identified SSPs, alcohol and drug treatmentfacilities and/or buprenorphine/naloxone and other opioid prevention and treatment programs that provide HCV and HBVtesting. An increase of at least 10% in the number of HCV and HBV tests performed and results reported to the appropriatehealth department from the identified SSPs, alcohol and drug treatment facilities and/or buprenorphine/naloxone and otheropioid prevention and treatment programs.
Years 3-4 Outcome measures: An increase of at least 25% in the number of SSPs, alcohol and drug treatment facilitiesand/or buprenorphine/naloxone and other opioid prevention and treatment programs that provide HCV and HBV testing. Anincrease of at least 25% in the number of HCV and HBV tests performed and results reported to the appropriate healthdepartment from the identified SSPs, alcohol and drug treatment facilities and/or buprenorphine/naloxone and other opioidprevention and treatment programs .
3. Process measure: Conduct follow-up with targeted HCV and HBV infected persons to ensure linkage to care and treatment. The number and proportion of HCV and HBV infected persons linked to care and treatment was reported to appropriate preventionprograms, surveillance systems, and program and policy stakeholders. Progress of this activity will be based on the number ofeligible venues that collaborate with the health department on this activity and the number and proportion of cases that are linked tocare and treatment.
Years 1-2 Outcome measures: Linked at least 15% of reported HCV and HBV infected persons to care and treatment.
Years 3-4 Outcome measure: Link at least 33% of reported HCV and HBV infected persons to care and treatment.
ii. Applicant Evaluation and Performance Measurement Plan Applicants must provide an evaluation and performance measurement plan that demonstrates how the awardee will fulfill therequirements described in the CDC Evaluation and Performance Measurement and Project Description sections of this FOA. At aminimum, the plan must describe:
How applicant will collect the performance measures, respond to the evaluation questions, and use evaluation findings forcontinuous program quality improvement. How key program partners will participate in the evaluation and performance measurement planning processes.Available data sources, feasibility of collecting appropriate evaluation and performance data, and other relevant datainformation (e.g., performance measures proposed by the applicant).
Where the applicant chooses to, or is expected to, take on specific evaluation studies, they should be directed to:
Describe the type of evaluations (i.e., process, outcome, or both). Describe key evaluation questions to be addressed by these evaluations. Describe other information (e.g., measures, data sources).
Awardees will be required to submit a more detailed Evaluation and Performance Measurement plan within the first 6 months ofaward, as described in the Reporting Section of this FOA.Applicants must submit an evaluation and performance measurement plan with their application.
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Applicants must submit an evaluation and performance measurement plan with their application.
This FOA includes two components; core activities and strategies and optional surveillance-based activities and strategies. Applications will be evaluated and scored on each of these components, core and optional, separately. Only applicants that areawarded for core activities will be eligible for funding for the optional activities.
Data collected must be used for ongoing monitoring of the award to evaluate its effectiveness, and for continuous programimprovement. This plan should incorporate local area performance measurement plans, if applicable. This detailed evaluationplan must build on elements stated in the initial work plan. Awarded applicants will work with CDC on developing a more detailedevaluation and performance measurement plan within the first 6 months of the project.
The basic Evaluation Plan(s) for each component must describe:
how key program partners will be engaged in the evaluation and performance measurement planning processes, the type of evaluation(s) to be conducted, i.e. process and/or outcome,key evaluation questions to be answered,potential data sources, internal and external, for collecting appropriate evaluation and performance data,specific performance measures which are identified for impact and effectiveness and timeline for completion,performance measures which reflect activities proposed in the work plan,how evaluation findings will be used for continuous program and quality improvement, andhow evaluation findings will be disseminated to stakeholders.
For applicants conducting Optional Surveillance-based Activities that involve SSPs: CDC requires awardees to report the numberof syringes distributed as a metric to evaluate performance of SSP activities. Although federal funds cannot be used at present forthe purchase of needles or syringes, the purpose of SSPs is ultimately to provide sterile supplies of injection equipment, includingneedles and syringes, to reduce the risk of infectious complications associated with non-sterile injection. The number of syringesdistributed by an SSP is a reliable, discrete measure of program activity and effectiveness that poses only a modest data collectionburden on awardees.
c. Organizational Capacity of Awardees to Implement the Approach For each component (core and optional), applicants must provide evidence of their capacity to successfully execute all proposedstrategies and activities to meet program objectives. Applicants will describe, workforce capacity and competence, expertise andexperience related to all program focus areas, information and data systems, and electronic information and communicationsystems to implement the award.
For each component, applicants must:
Have the authority and ability to systematically collect viral hepatitis surveillance data from all reporting entities across astate jurisdiction and from other state health departments, as appropriate.Have the capacity to access the NNDSS and SAMS reporting systems.Have the capacity to use electronic medical/health records to enhance viral hepatitis surveillance as described in thestrategies section of this announcement.Have experience with conducting follow-up interviews and collection of laboratory specimens with health care providersand patients and perform medical record abstractions. Staff with experience in conducting contact tracing.Have a staffing plan and structure to include the necessary staff (a principal investigator, project coordinator, datamanager/analyst, and sufficient interviewers/abstractors) to conduct the activities outlined in the logic model. It isanticipated that salaries and duties of staff will be shared across other programs within the health department. Have a data manager/analyst with demonstrated experience using SAS (or comparable software) for sampling andconducting analysis to support all strategies and goals.Include CVs and position descriptions for key staff. Applicants should state whether key staff members have experiencewith or knowledge of viral hepatitis case surveillance.Provide an organizational chart showing position of the viral hepatitis surveillance program within the health departmentand linkages between the viral hepatitis program and other CDC-funded programs within the health department.
d. Work Plan Applicants must provide a detailed work plan for the first year of this award and a separate high-level work plan for the entire 4
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Applicants must provide a detailed work plan for the first year of this award and a separate high-level work plan for the entire 4years. Separate work plans are required for the core activities and each optional activity.
For each component, the Year-One Plan should include the following:
Activities and timelines to support achievement of FOA outcomes. These activities should be in alignment with the FOA’slogic model and should have appropriate performance measures for accomplishing tasks. Each element of the plan mustcontain the following components: the overall goal of the activity, the target populations, SMART* objectives (objectivesthat are specific, measurable, achievable, relevant and time-based), data collection methods, and data sources.The work plan must also include a timeline and list names of persons and positions responsible for completing each activity.Administration and assessment processes to ensure successful implementation and quality assurance.A budget that is consistent with the work plan and include resources needed to support these activities.
For each component, the Four-Year Project Work Plan should include (1) intended outcomes for the entire four-year projectperiod; and (2) a logic model with the conditions, inputs, activities, outputs, and outcomes to be achieved by the end of thefour-year project period (include graphic and narrative).
For applicants who will work with SSPs - Awardees must include a description of SSP programmatic components they intend tosupport, along with an estimated budget for each component, as part of their work plan.
A separate work plan and budget is required for the core and each surveillance-based optional components.
e. CDC Monitoring and Accountability Approach Monitoring activities include routine and ongoing communication between CDC and awardees, site visits, and awardee reporting(including work plans, performance, and financial reporting). Consistent with applicable grants regulations and policies, CDCexpects the following to be included in post-award monitoring for grants and cooperative agreements:
Tracking awardee progress in achieving the desired outcomes.Ensuring the adequacy of awardee systems that underlie and generate data reports.Creating an environment that fosters integrity in program performance and results.
Monitoring may also include the following activities:
Ensuring that work plans are feasible based on the budget and consistent with the intent of the award.Ensuring that awardees are performing at a sufficient level to achieve outcomes within stated timeframes.Working with awardees on adjusting the work plan based on achievement of outcomes, evaluation results and changingbudgets.Monitoring performance measures (both programmatic and financial) to assure satisfactory performance levels.
Other activities deemed necessary to monitor the award, if applicable.These activities may include monitoring and reporting activities that assist grants management staff (e.g., grants managementofficers and specialists, and project officers) in the identification, notification, and management of high-risk grantees.Monitoring activities include routine and ongoing communication between CDC and awardees by email, telephone, andweb-based applications; site visits; and awardee reporting (including work plans, performance, submission of data, and financialreporting). Consistent with applicable grants’ regulations and policies, CDC expects the following to be included in post-awardmonitoring of each component for grants and cooperative agreements:
Tracking awardees progress in achieving the desired outcomes. Grantees will provide CDC with data on their process andoutcome measures every 6 months, and CDC will summarize process and outcome measures from grantees data and providea feedback report to grantees within 3 months of receiving the data. Outcome measures will not be required until 18 monthspost award.Ensuring the adequacy of awardees systems that underlie and generate data reports.Creating an environment that fosters integrity in program performance and results.
f. CDC Program Support to Awardees (THIS SECTION APPLIES ONLY TO COOPERATIVE AGREEMENTS) In a cooperative agreement, CDC staff are substantially involved in the program activities, above and beyond routine grant
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In a cooperative agreement, CDC staff are substantially involved in the program activities, above and beyond routine grantmonitoring. CDC Subject Matter Experts (SMEs) will provide scientific, programmatic, and evaluation expertise for eachcomponent of the FOA.
CDC will:
Provide technical assistance by SMEs in developing and implementing annual work plans for both core and optionalactivities. Provide technical support, during the first 6 months of the project, in developing a more detailed evaluation andperformance measurement plan, including communication of certain key variables to be collected and mechanism ofde-identified data transfer to CDC. Provide guidance and technical support for identifying target populations and sampling eligible persons for surveillance ofchronic HBV and HCV infections. Participate in joint monthly conference calls, one awardee meeting per project period, and at least 1 site visit to eachawardee during the project period. Disseminate findings jointly with participating project areas. Monitor and provide feedback on awardee progress in developing and implementing the project, through consultations viaroutine conference calls, site visits, email, and review of progress reports. Provide guidance and technical support for project management. Provide technical support for electronic data collection and data transfer to CDC. Provide technical support and consultation for management, analysis, and interpretation of data. Assist with identifying appropriate secondary data sources for conducting viral hepatitis surveillance.Provide at least one annual report that include a summary of the process and outcome performance for all grantees.
B. Award Information
1. Funding Instrument Type: Cooperative Agreement CDC's substantial involvement in this program appears in the CDC Program Support
to Awardees Section.2. Award Mechanism: U51 U51- Infectious Disease Assessments of Prevention, Control & Elimination
3. Fiscal Year: 2017 Estimated Total Funding: $3,200,000
4. Approximate Total Fiscal YearFunding:
$3,200,000
For the first fiscal year, total funding of $3,200.000 includes 2,700,000 for Core activities and $500,000 for optionalsurveillance-based activities.
This amount is subject to the availability of funds.5. Approximate Project Period Funding: $12,800,000 Project period funding is dependent on future allocations. This amount will change if additional resources becomes available.
6. Total Project Period Length: 4
7. Expected Number of Awards: 14 Anticipate 14 awards for core activities and 10 awards for optional surveillance-based activities.
Applicants must be funded to support core activities in order to recieve funding for optional surveillance-based activities.
8. Approximate Average Award: $242,857 Per Budget Period In year one, the average award is anticipated to be approximately $242,857, including $192,857 for core activities and $50,000 forone optional activity.
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This amount is subject to the availability of funds.9. Award Ceiling: $350,000 Per Budget Period For year 1 only, the ceiling is $350,000, including $200,000 for core activities and $150,000 for 3 optional activities at $50,000each.
This ceiling applies only to year 1. The amount awarded in years 2-4 is dependent on future allocations.
10. Award Floor: $100,000 Per Budget Period The floor for year 1 is $100,000 per site for core activities only.
11. Estimated Award Date: 05/01/2017
Throughout the project period, CDC will continue the award based on the availability of funds, the evidence of satisfactoryprogress by the awardee (as documented in required reports), and the determination that continued funding is in the best interest ofthe federal government. The total number of years for which federal support has been approved (project period) will be shown inthe “Notice of Award.” This information does not constitute a commitment by the federal government to fund the entire period.The total project period comprises the initial competitive segment and any subsequent non-competitive continuation award(s).12. Budget Period Length: 12 month(s)
13. Direct Assistance Direct Assistance (DA) is not available through this FOA.
C. Eligibility Information
1. Eligible Applicants
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 Others (see text field entitled "Additional Information on Eligibility" for clarification) Unrestricted (i.e., open to any type of entity above), subject to any clarification in text fieldentitled "Additional Information on Eligibility"
Additional Eligibility Category: Government Organizations:
State (includes the District of Columbia) Local governments or their bona fide agents Territorial governments or their bona fide agents in the Commonwealth of Puerto Rico, theVirgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa,Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and theRepublic of Palau. State controlled institutions of higher education American Indian or Alaska Native tribal governments (federally recognized orstate-recognized)
Non-government Organizations:
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Non-government Organizations:
American Indian or Alaska native tribally designated organizations Other:
Private colleges and universities Community-based organizations Faith-based organizations
2. Additional Information on Eligibility
Foreign Institutions
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement , are not allowed.
The authority to require notification of cases of disease, including viral hepatitis, resides in the respective state legislatures. Statehealth departments and/or state health commissioners are the only sources responsible for administering and enforcing laws, rules,or regulations pertaining to collecting and reporting of viral hepatitis surveillance data. As such, State health departments are theonly entity required to receive reports of acute hepatitis B, acute hepatitis C, chronic hepatitis B, perinatal hepatitis B, and chronichepatitis C from local health departments/jurisdictions and to notify (submit case reports to) the Centers for Disease Control andPrevention of the reported cases. Applicants other than state health departments must provide documentation of access tosurveillance data collected by the state health department through a Memorandum of Understanding (MOUs), Memorandum ofAgreement (MOAs), letters of commitment, or other data sharing agreement.
Additional Information on Eligibility:
State governments or their Bona Fide Agents (this includes the District of Columbia, the Commonwealth of Puerto Rico, the U.S.Virgin Islands)
A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibilityin lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from thestate or local government as documentation of the status is required. Attach with “Other Attachment Forms” when submitting via www.grants.gov .
The award ceiling for year one of this FOA is $350,000 for the core and $150,000 for all optional activity at $50,000 per optionalactivity . CDC will consider any application requesting an award higher than this amount as non- responsive and it will receive nofurther review.
State governments or their Bona Fide Agents (this includes the District of Columbia, the Commonwealth of Puerto Rico, the U.S.Virgin Islands)
A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibilityin lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from thestate or local government as documentation of the status is required. Attach with “Other Attachment Forms” when submitting via www.grants.gov .
The award ceiling for the first year of this FOA is $350,000, including $200,000 for the core and $150,000 for optional activitiesat $50.000 per optional activities. CDC will consider any application requesting an award higher than this amount in the first yearas non- responsive and it will receive no further review.
The award ceiling for each component under Section B. Award Information is $350,000. CDC will not consider any applicationrequesting an award higher than the specified amount. If a pre-application is required, then specify here and include it in thespecial eligibility requirements section. (https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/gpd2-04.pdf)
3. Justification for Less than Maximum Competition 20 of 43
N/A
4. Cost Sharing or Matching
Cost Sharing / MatchingRequirement:
No
Cost sharing or matching funds are not required for this program. Although no statutory matching requirement for this FOAexists, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged.
5. Maintenance of Effort
Maintenance of effort is not required for this program
D. Required Registrations
Additional materials that may be helpful to applicants: http://www.cdc.gov/od/pgo/funding/docs/Financial ReferenceGuide.pdf.
1. Required Registrations An organization must be registered at the three following locations before it can submit an application for fundingat www.grants.gov. a. Data Universal Numbering System: All applicant organizations must obtain a Data Universal Numbering System (DUNS)number. A DUNS number is a unique nine-digit identification number provided by Dun & Bradstreet (D&B). It will be used as theUniversal Identifier when applying for federal awards or cooperative agreements.The applicant organization may request a DUNS number by telephone at 1-866-705-5711 (toll free) or internet at http:// fedgov.dnb.com/webform/ displayHomePage.do. The DUNS number will be provided at no charge.If funds are awarded to an applicant organization that includes sub-awardees, those sub-awardees must provide their DUNS numbersbefore accepting any funds.b. System for Award Management (SAM): The SAM is the primary registrant database for the federal government and therepository into which an entity must submit information required to conduct business as an awardee. All applicant organizations mustregister with SAM, and will be assigned a SAM number. All information relevant to the SAM number must be current at all timesduring which the applicant has an application under consideration for funding by CDC. If an award is made, the SAM informationmust be maintained until a final financial report is submitted or the final payment is received, whichever is later. The SAMregistration process can require 10 or more business days, and registration must be renewed annually. Additional information aboutregistration procedures may be found at www.SAM.gov.c. Grants.gov: The first step in submitting an application online is registering your organization at www.grants.gov, theofficial HHS E-grant Web site. Registration information is located at the “Get Registered” option at www.grants.gov.All applicant organizations must register at www.grants.gov. The one-time registration process usually takes not more than five daysto complete. Applicants should start the registration process as early as possible.Step System Requirements Duration Follow Up
1 Data Universal NumberSystem (DUNS)
1. Click on http:// fedgov.dnb.com/ webform 2. Select Begin DUNS search/request process3. Select your country or territory and followinstructions to obtain your DUNS 9-digit #4. Request appropriate staff member(s) toobtain DUNS number, verify & updateinformation under DUNS number
1-2 Business Days To confirm that you havebeen issues a new DUNSnumber check online at(http:// fedgov.dnb.com/webform) or call 1-866-705-5711
2 System for AwardManagement (SAM)formerly CentralContractor Registration(CCR)
1. Retrieve organizations DUNS number 2. Go to www.sam.gov and designate anE-Biz POC (note CCR username will not workin SAM and you will need to have an activeSAM account before you can register ongrants.gov)
3-5 Business Daysbut up to 2 weeksand must be renewedonce a year
For SAM CustomerService Contacthttps://fsd.gov/ fsd -gov/home.do Calls: 866-606-8220
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3 Grants.gov 1. Set up an individual account inGrants.gov using organization new DUNSnumber to become an authorized organizationrepresentative (AOR) 2. Once the Account is set up theE_BIZ POC will be notified via email 3. Log into grants.gov using the password theE-BIZ POC received and create new password 4. This authorizes the AOR to submit theapplications on behalf of the organization
Same day but cantake 8 weeks to befully registered andapproved in thesystem (note,applicants MUSTobtain a DUNSnumber and SAMaccount beforeapplying togrants.gov
Register early! Log intoGrants.gov andcheck AOR status until itshows you have beenapproved
2. Request Application Package Applicants may access the application package at www.grants.gov.
3. Application Package Applicants must download the SF-424, Application for Federal Assistance, package associated with this funding opportunityat www.grants.gov. If Internet access is not available, or if the online forms cannot be accessed, applicants may call the CDC OGSstaff at 770-488-2700 or e-mail OGS [email protected] for assistance. Persons with hearing loss may access CDCtelecommunications at TTY 1-888-232-6348.
4. Submission Dates and Times If the application is not submitted by the deadline published in the FOA, it will not be processed. Office of Grants Services(OGS) personnel will notify the applicant that their application did not meet the deadline. The applicant must receive pre-approval tosubmit a paper application (see Other Submission Requirements section for additional details). If the applicant is authorized tosubmit a paper application, it must be received by the deadline provided by OGS.
a. Letter of Intent Deadline (must be emailed or postmarked by) Due Date for Letter of Intent: 12/16/2016 Letters of intent are requested but not required.
b. Application Deadline Due Date for Applications: 01/31/2017 , 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov. If Grants.gov is inoperable andcannot receive applications, and circumstances preclude advance notification of an extension, then applications must be submitted bythe first business day on which grants.gov operations resume. Date for Informational Conference Call: 12/13/2016 The information call will be at 3:00 pm on 13 December 2016.
The call in numbers for the informational call are:
(404) 553-8912 (Atlanta), (855) 348-8390 (toll free) Conference ID: 5419600
Questions about the informational call or the FOA may be sent to [email protected].
5. CDC Assurances and Certifications All applicants are required to sign and submit “Assurances and Certifications” documents indicated at http://wwwn.cdc.gov/grantassurances/ (S(mj444mxct51lnrv1hljjjmaa)) /Homepage.aspx.Applicants may follow either of the following processes:
Complete the applicable assurances and certifications with each application submission, name the file “Assurances andCertifications” and upload it as a PDF file with at www.grants.govComplete the applicable assurances and certifications and submit them directly to CDC on an annual basisat http://wwwn.cdc.gov/ grantassurances/ (S(mj444mxct51lnrv1hljjjmaa))/ Homepage.aspx
Assurances and certifications submitted directly to CDC will be kept on file for one year and will apply to all applications submittedto CDC by the applicant within one year of the submission date.
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6. Content and Form of Application Submission Applicants are required to include all of the following documents with their application package at www.grants.gov.
7. Letter of Intent
Is a LOI: Recommended but not Required The purpose of an LOI is to allow CDC program staff to estimate the number of and plan for the review of submitted applications.
Ruth B. Jiles, MS, MPH, PhD
Epidemiology and Surveillance Branch
Division of Viral Hepatitis
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
Center for Disease Control and Prevention
1600 Clifton Rd, NE Mail Stop G-37
Atlanta, GA 30333
Telephone: 404-718-8557
FAX: 404-718-8585
Mailing Address:
1600 Clifton Road, NE Mail Stop G-37
Atlanta, GA 30329
Overnight Mailing Address:
12 Corporate Square Blvd. Room 3425
Atlanta, GA 30341
8. Table of Contents (There is no page limit. The table of contents is not included in the project narrative page limit.): The applicant must provide, as aseparate attachment, the “Table of Contents” for the entire submission package.Provide a detailed table of contents for the entire submission package that includes all of the documents in the application andheadings in the "Project Narrative" section. Name the file "Table of Contents" and upload it as a PDF file under "Other AttachmentForms" at www.grants.gov.
9. Project Abstract Summary A project abstract is included on the mandatory documents list and must be submitted at www.grants.gov. The project abstractmust be a self-contained, brief summary of the proposed project including the purpose and outcomes. This summary must notinclude any proprietary or confidential information. Applicants must enter the summary in the "Project Abstract Summary" textbox at www.grants.gov.
10. Project Narrative If applying for a single component: maximum of 20 pages, single spaced, 12 point font, 1-inch margins, and number all pages. If applying for more than one component: maximum of 15 pages for the “base” (subsections of the Project Description that thecomponents share with each other, which may include target population, inclusion, collaboration, etc.); and up to 4 additionalpages allowed per component for Project Narrative subsections that may be specific to each component. Text should be single spaced, 12 point font, 1-inch margins, and number all pages.Page limits include work plan; content beyond specified limits will not be reviewed. Because applications for each surveillance-based optional activity will be evaluated separately, the Project Narrative for each
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Because applications for each surveillance-based optional activity will be evaluated separately, the Project Narrative for eachoptional component is limited to 20 pages.
a. Background Applicants must provide a description of relevant background information that includes the context of the problem (See CDCBackground).
b. Approach
i. Purpose Applicants must describe in 2-3 sentences specifically how their application will address the problem as described in the CDCBackground section.
ii. Outcomes Applicants must clearly identify the outcomes they expect to achieve by the end of the project period. Outcomes are the resultsthat the program intends to achieve. All outcomes must indicate the intended direction of change (e.g., increase, decrease,maintain). (See the logic model in the Approach section of the CDC Project Description.)
iii. Strategies and Activities Applicants must provide a clear and concise description of the strategies and activities they will use to achieve the project periodoutcomes. Applicants must select existing evidence-based strategies that meet their needs, or describe in the Applicant Evaluationand Performance Measurement Plan how these strategies will be evaluated over the course of the project period. (See CDC ProjectDescription: Strategies and Activities section.)
1. Collaborations Applicants must describe how they will collaborate with programs and organizations either internal or external to CDC.Applicants must address the collaboration requirements stated in the Collaboration section of the Project Description.
2. Target Populations Applicants must describe the specific target population(s) in their jurisdiction and explain how such a target will achieve the goalsof the award and/or alleviate health disparities. Refer back to the Target Population section in the CDC Project Description.
c. Applicant Evaluation and Performance Measurement Plan Applicants must provide an evaluation and performance measurement plan that demonstrates how the awardee will fulfill therequirements described in the CDC Evaluation and Performance Measurement and Project Description sections of this FOA. At aminimum, the plan must describe:
How applicant will collect the performance measures, respond to the evaluation questions, and use evaluation findings forcontinuous program quality improvement. The Paperwork Reduction Act of 1995 (PRA): Applicants are advised that anyactivities involving information collections (e.g., surveys, questionnaires, applications, audits, data requests, reporting,recordkeeping and disclosure requirements) from 10 or more individuals or non-Federal entities, including State and localgovernmental agencies, and funded or sponsored by the Federal Government are subject to review and approval by theOffice of Management and Budget. See Section E (pages 4 and 5) at http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf . For further information aboutCDC’s requirements under PRA see http://www.hhs.gov/ ocio/policy/collection/.How key program partners will participate in the evaluation and performance measurement planning processes.Available data sources, feasibility of collecting appropriate evaluation and performance data, and other relevant datainformation (e.g., performance measures proposed by the applicant).
Where the applicant chooses to, or is expected to, take on specific evaluation studies, they should be directed to:
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Describe the type of evaluations (i.e., process, outcome, or both). Describe key evaluation questions to be addressed by these evaluations. Describe other information (e.g., measures, data sources).
Awardees will be required to submit a more detailed Evaluation and Performance Measurement plan within the first 6 months ofaward, as described in the Reporting Section of this FOA.
Awardees will be required to submit a more detailed evaluation and performance measurement plan within the first 6 months ofthe project, as outlined in the reporting section of the FOA.
d. Organizational Capacity of Applicants to Implement the Approach Applicant must address the organizational capacity requirements as described in the CDC Project Description.
11. Work Plan (Included in the Project Narrative’s page limit)
Multiple components: maximum of 15 pages for the base and up to 4 additional pages per component)
Single component: maximum of 20 pages)
Applicants must prepare a work plan consistent with the CDC Project Description Work Plan section. The work plan integratesand delineates more specifically how the awardee plans to carry out achieving the project period outcomes, strategies andactivities, evaluation and performance measurement.The work plan for each optional surveillance-based activity is included in the Project Narrative's page limit.
12. Budget Narrative Applicants must submit an itemized budget narrative, which may be scored as part of the Organizational Capacity of Awardees toImplement the Approach. When developing the budget narrative, applicants must consider whether the proposed budget isreasonable and consistent with the purpose, outcomes, and program strategy outlined in the project narrative. The budget mustinclude:
Salaries and wagesFringe benefitsConsultant costsEquipmentSuppliesTravelOther categoriesContractual costsTotal Direct costsTotal Indirect costs
Indirect costs will not be reimbursed under grants to foreign organizations, international organizations, and foreign components ofgrants to domestic organizations (does not affect indirect cost reimbursement to the domestic entity for domestic activities).For guidance on completing a detailed budget, see Budget Preparation Guidelines at:http:// www.cdc.gov /grants /interested inapplying /application resources.html .If applicable and consistent with the cited statutory authority for this announcement, applicant entities may use funds for activitiesas they relate to the intent of this FOA to meet national standards or seek health department accreditation through the PublicHealth Accreditation Board (see: http://www.phaboard.org). Applicant entities to whom this provision applies include state, local,territorial governments (including the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, theCommonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic ofthe Marshall Islands, and the Republic of Palau), or their bona fide agents, political subdivisions of states (in consultation withstates), federally recognized or state-recognized American Indian or Alaska Native tribal governments, and American Indian orAlaska Native tribally designated organizations. Activities include those that enable a public health organization to deliver publichealth services such as activities that ensure a capable and qualified workforce, up-to-date information systems, and the capabilityto assess and respond to public health needs. Use of these funds must focus on achieving a minimum of one national standard thatsupports the intent of the FOA. Proposed activities must be included in the budget narrative and must indicate which standards willbe addressed.Applicants must name this file “Budget Narrative” and upload it as a PDF file at www.grants.gov. If requesting indirect costs inthe budget, a copy of the indirect cost-rate agreement is required. If the indirect costs are requested, include a copy of the current
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negotiated federal indirect cost rate agreement or a cost allocation plan approval letter for those Grantees under such a plan.Applicants must name this file “Indirect Cost Rate” and upload it at www.grants.gov.Resources awarded as part of this FOA may be used to support efforts to build or expand SSPs, but only when certain conditionsare met. In consultation with CDC, awardees must first demonstrate that the jurisdiction (or area) they are serving is at risk for, orexperiencing, a significant increase in hepatitis infections or a HIV outbreak due to injection drug use. More information can befound https://www.aids.gov/pdf/hhs-ssp-guidance.pdf .
• Programs are prohibited from using CDC funds to purchase sterile needles or syringes for the purposes of hypodermic injectionof any drug used illicitly or for the preparation of drugs for injection (e.g., cookers). Applicants should describe the fundingsource that will be used to support the procurement of sterile syringes.
• Applicants can submit the Determination of Need (DON) request, per established SSP processes at the same time theirapplication for funding is submitted. However, funds cannot be allocated to support SSPs until concurrence with the DON hasbeen received.
If applicable and consistent with the cited statutory authority for this announcement, applicant entities may use funds for activitiesas they relate to the intent of this FOA to meet national standards or seek health department accreditation through the PublicHealth Accreditation Board (see: http://www.phaboard.org ). Applicant entities to whom this provision applies include state, local,territorial governments (including the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, theCommonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic ofthe Marshall Islands, and the Republic of Palau), or their bona fide agents, political subdivisions of states (in consultation withstates), federally recognized or state-recognized American Indian or Alaska Native tribal governments, and American Indian orAlaska Native tribal designated organizations. Activities include those that enable a public health organization to deliver publichealth services such as activities that ensure a capable and qualified workforce, up-to-date information systems, and the capabilityto assess and respond to public health needs. Use of these funds must focus on achieving a minimum of one national standard thatsupports the intent of the FOA. Proposed activities must be included in the budget narrative and must indicate which standards willbe addressed.
Applicants must name this file “Budget Narrative” and upload it as a PDF file at www.grants.gov . If requesting indirect costs inthe budget, a copy of the indirect cost-rate agreement is required. If the indirect costs are requested, include a copy of the currentnegotiated federal indirect cost rate agreement or a cost allocation plan approval letter for those Grantees under such a plan.Applicants must name this file “Indirect Cost Rate” and upload it atwww.grants.gov .
13. Tobacco and Nutrition Policies Awardees are encouraged to implement tobacco and nutrition policies.Unless otherwise explicitly permitted under the terms of a specific CDC award, no funds associated with this FOA may be used toimplement the optional policies, and no applicants will be evaluated or scored on whether they choose to implement these optionalpolicies.CDC supports implementing evidence-based programs and policies to reduce tobacco use and secondhand smoke exposure, and topromote healthy nutrition. CDC encourages all awardees to implement the following optional recommended evidence-basedtobacco and nutrition policies within their own organizations. The tobacco policies build upon the current federal commitment toreduce exposure to secondhand smoke, specifically Pro-Children Act of 2001, 20 U.S.C. Sections 7181-7184, that prohibitssmoking in certain facilities that receive federal funds in which education, library, day care, health care, or early childhooddevelopment services are provided to children. Tobacco Policies:
Tobacco-free indoors: Use of any tobacco products (including smokeless tobacco) or electronic cigarettes is not allowed inany indoor facilities under the control of the awardee.
1.
Tobacco-free indoors and in adjacent outdoor areas: Use of any tobacco products or electronic cigarettes is not allowed inany indoor facilities, within 50 feet of doorways and air intake ducts, and in courtyards under the control of the awardee.
2.
Tobacco-free campus: Use of any tobacco products or electronic cigarettes is not allowed in any indoor facilities oranywhere on grounds or in outdoor space under the control of the awardee.
3.
Nutrition Policies:
Healthy food-service guidelines must, at a minimum, align with HHS and General Services Administration Health andSustainability Guidelines for Federal Concessions and Vending Operations. These guidelines apply to cafeterias, snack bars,and vending machines in any facility under the control of the awardee and in accordance with contractual obligations forthese services (see: http:// www.gsa.gov/ graphics/ pbs/ Guidelines_ for_ Federal_ Concessions_ and_ Vending _ Operations.pdf).
1.
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Resources that provide guidance for healthy eating and tobacco-free workplaces are:2.
http://www.cdc.gov/ nccdphp/dnpao/hwi/ toolkits/ tobacco/index.htmhttp://www. thecommunityguide.org/ tobacco/index.htmlhttp:// www.cdc.gov /obesity /strategies /food-serv-guide.html
14. Health Insurance Marketplaces A healthier country is one in which Americans are able to access the care they need to prevent the onset of disease and managedisease when it is present. The Affordable Care Act, the health care law of 2010, creates new Health Insurance Marketplaces, alsoknown as Exchanges, to offer millions of Americans affordable health insurance coverage. In addition, the law helps makeprevention affordable and accessible for Americans by requiring health plans to cover certain recommended preventive serviceswithout cost sharing. Outreach efforts will help families and communities understand these new options and provide eligibleindividuals the assistance they need to secure and retain coverage as smoothly as possible. For more information on theMarketplaces and the health care law, visit: www.HealthCare.gov.
15. Intergovernmental Review
Executive Order 12372 does not apply to this program.
16. Pilot Program for Enhancement of Employee Whistleblower Protections Pilot Program for Enhancement of Employee Whistleblower Protections: All applicants will be subject to a term and condition thatapplies the terms of 48 Code of Federal Regulations (CFR) section 3.908 to the award and requires that grantees inform theiremployees in writing (in the predominant native language of the workforce) of employee whistleblower rights and protectionsunder 41 U.S.C. 4712. 16a. Funds TrackingProper fiscal oversight is critical to maintaining public trust in the stewardship of federal funds. Effective October 1, 2013, a newHHS policy on subaccounts requires the CDC to set up payment subaccounts within the Payment Management System (PMS) forall new grant awards. Funds awarded in support of approved activities and drawdown instructions will be identified on the Noticeof Award in a newly established PMS subaccount (P subaccount). Grantees will be required to draw down funds fromaward-specific accounts in the PMS. Ultimately, the subaccounts will provide grantees and CDC a more detailed and preciseunderstanding of financial transactions. The successful applicant will be required to track funds by P-accounts/sub accounts foreach project/cooperative agreement awarded. Applicants are encouraged to demonstrate a record of fiscal responsibility and theability to provide sufficient and effective oversight. Financial management systems must meet the requirements as described 2CFR 200 which include, but are not limited to, the following:
Records that identify adequately the source and application of funds for federally-funded activities.Effective control over, and accountability for, all funds, property, and other assets.Comparison of expenditures with budget amounts for each Federal award.Written procedures to implement payment requirements.Written procedures for determining cost allowability.Written procedures for financial reporting and monitoring.
16b. Copyright Interests ProvisionsThis provision is intended to ensure that the public has access to the results and accomplishments of public health activities fundedby CDC. Pursuant to applicable grant regulations and CDC’s Public Access Policy, Recipient agrees to submit into the NationalInstitutes of Health (NIH) Manuscript Submission (NIHMS) system an electronic version of the final, peer-reviewed manuscript ofany such work developed under this award upon acceptance for publication, to be made publicly available no later than 12 monthsafter the official date of publication. Also at the time of submission, Recipient and/or the Recipient’s submitting author mustspecify the date the final manuscript will be publicly accessible through PubMed Central (PMC). Recipient and/or Recipient’ssubmitting author must also post the manuscript through PMC within twelve (12) months of the publisher's official date of finalpublication; however the author is strongly encouraged to make the subject manuscript available as soon as possible. The recipientmust obtain prior approval from the CDC for any exception to this provision.The author's final, peer-reviewed manuscript is defined as the final version accepted for journal publication, and includes allmodifications from the publishing peer review process, and all graphics and supplemental material associated with the article.Recipient and its submitting authors working under this award are responsible for ensuring that any publishing or copyrightagreements concerning submitted articles reserve adequate right to fully comply with this provision and the license reserved byCDC. The manuscript will be hosted in both PMC and the CDC Stacks institutional repository system. In progress reports forthis award, recipient must identify publications subject to the CDC Public Access Policy by using the applicable NIHMS
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identification number for up to three (3) months after the publication date and the PubMed Central identification number (PMCID)thereafter. 16c. Reporting of Foreign Taxes (International/Foreign projects only)A. Valued Added Tax (VAT) and Customs Duties – Customs and import duties, consular fees, customs surtax, valued addedtaxes, and other related charges are hereby authorized as an allowable cost for costs incurred for non-host governmental entitiesoperating where no applicable tax exemption exists. This waiver does not apply to countries where a bilateral agreement (orsimilar legal document) is already in place providing applicable tax exemptions and it is not applicable to Ministries of Health. Successful applicants will receive information on VAT requirements via their Notice of Award.B. The U.S. Department of State requires that agencies collect and report information on the amount of taxes assessed,reimbursed and not reimbursed by a foreign government against commodities financed with funds appropriated by the U.S.Department of State, Foreign Operations and Related Programs Appropriations Act (SFOAA) (“United States foreign assistancefunds”). Outlined below are the specifics of this requirement:1) Annual Report: The grantee must submit a report on or before November 16 for each foreign country on the amount offoreign taxes charged, as of September 30 of the same year, by a foreign government on commodity purchase transactions valuedat 500 USD or more financed with United States foreign assistance funds under this grant during the prior United States fiscal year(October 1 – September 30), and the amount reimbursed and unreimbursed by the foreign government. [Reports are required evenif the grantee did not pay any taxes during the reporting period.]2) Quarterly Report: The grantee must quarterly submit a report on the amount of foreign taxes charged by a foreigngovernment on commodity purchase transactions valued at 500 USD or more financed with United States foreign assistance fundsunder this grant. This report shall be submitted no later than two weeks following the end of each quarter: April 15, July 15,October 15 and January 15.3) Terms: For purposes of this clause: “Commodity” means any material, article, supplies, goods, or equipment; “Foreigngovernment” includes any foreign government entity; “Foreign taxes” means value-added taxes and custom duties assessed by aforeign government on a commodity. It does not include foreign sales taxes.4) Where: Submit the reports to the Director and Deputy Director of the CDC office in the country(ies) in which you arecarrying out the activities associated with this cooperative agreement. In countries where there is no CDC office, send reports to [email protected]) Contents of Reports: The reports must contain: a. grantee name; b. contact name with phone, fax, and e-mail;c. agreement number(s) if reporting by agreement(s); d. reporting period; e. amount of foreign taxes assessed byeach foreign government; f. amount of any foreign taxes reimbursed by each foreign government; g. amount of foreigntaxes unreimbursed by each foreign government.6) Subagreements. The grantee must include this reporting requirement in all applicable subgrants and other subagreements.
17. Funding Restrictions Restrictions that must be considered while planning the programs and writing the budget are:
Awardees may not use funds for research.Awardees may not use funds for clinical care except as allowed by law.Awardees may use funds only for reasonable program purposes, including personnel, travel, supplies, and services.Generally, awardees may not use funds to purchase furniture or equipment. Any such proposed spending must be clearlyidentified in the budget.Reimbursement of pre-award costs generally is not allowed, unless the CDC provides written approval to the awardee.Other than for normal and recognized executive-legislative relationships, no funds may be used for:
publicity or propaganda purposes, for the preparation, distribution, or use of any material designed to support ordefeat the enactment of legislation before any legislative bodythe salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activitydesigned to influence the enactment of legislation, appropriations, regulation, administrative action, or Executiveorder proposed or pending before any legislative body
See Additional Requirement (AR) 12 for detailed guidance on this prohibition and additional guidance on lobbying for CDCawardees.The direct and primary recipient in a cooperative agreement program must perform a substantial role in carrying out projectoutcomes and not merely serve as a conduit for an award to another party or provider who is ineligible.
Grantees may not use funds for construction.
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Grantees may not use funds for construction.
Resources awarded as part of this FOA may be used to support efforts to build or expand SSPs, but only when certain conditionsare met. In consultation with CDC, awardees must first demonstrate that the jurisdiction (or area) they are serving is at risk for, orexperiencing, a significant increase in hepatitis infections or an HIV outbreak due to injection drug use. More information can befound https://www.aids.gov/pdf/hhs-ssp-guidance.pdf .
• Programs are prohibited from using CDC funds to purchase sterile needles or syringes for the purposes of hypodermic injectionof any drug used illicitly or for the preparation of drugs for injection (e.g., cookers). Applicants should describe the fundingsource that will be used to support the procurement of sterile syringes.
• Applicants can submit the Determination of Need (DON) request, per established SSP processes at the same time theirapplication for funding is submitted. However, funds cannot be allocated to support SSPs until concurrence with the DON hasbeen received.
18. Other Submission Requirements a. Electronic Submission: Applications must be submitted electronically at www.grants.gov. The application package can bedownloaded at www.grants.gov. Applicants can complete the application package off-line and submit the application by uploadingit at www.grants.gov. All application attachments must be submitted using a PDF file format. Directions for creating PDF files canbe found at www.grants.gov. File formats other than PDF may not be readable by OGS Technical Information ManagementSection (TIMS) staff. Applications must be submitted electronically by using the forms and instructions posted for this funding opportunityat www.grants.gov. If Internet access is not available or if the forms cannot be accessed online, applicants may contact the OGS TIMS staff at 770-488-2700 or by e-mail at [email protected], Monday through Friday, 7:30 a.m.–4:30 p.m., except federal holidays. Electronicapplications will be considered successful if they are available to OGS TIMS staff for processing from www.grants.gov on thedeadline date. b. Tracking Number: Applications submitted through www.grants.gov are time/date stamped electronically and assigned atracking number. The applicant’s Authorized Organization Representative (AOR) will be sent an e-mail notice of receiptwhen www.grants.gov receives the application. The tracking number documents that the application has been submitted andinitiates the required electronic validation process before the application is made available to CDC. c. Validation Process: Application submission is not concluded until the validation process is completed successfully. After theapplication package is submitted, the applicant will receive a “submission receipt” e-mail generated by www.grants.gov. A seconde-mail message to applicants will then be generated by www.grants.gov that will either validate or reject the submitted applicationpackage. This validation process may take as long as two business days. Applicants are strongly encouraged to check the status oftheir application to ensure that submission of their package has been completed and no submission errors have occurred.Applicants also are strongly encouraged to allocate ample time for filing to guarantee that their application can be submitted andvalidated by the deadline published in the FOA. Non-validated applications will not be accepted after the published applicationdeadline date. If you do not receive a “validation” e-mail within two business days of application submission, please contact www.grants.gov.For instructions on how to track your application, refer to the e-mail message generated at the time of application submission orthe Grants.gov Online User Guide.http://www.grants.gov/ help/html/help/ index.htm? callingApp=custom#t= Get_Started%2FGet_Started. htm d. Technical Difficulties: If technical difficulties are encountered at www.grants.gov, applicants should contact Customer Serviceat www.grants.gov. The www.grants.gov Contact Center is available 24 hours a day, 7 days a week, except federal holidays. TheContact Center is available by phone at 1-800-518-4726 or by e-mail at [email protected]. Application submissions sent bye-mail or fax, or on CDs or thumb drives will not be accepted. Please note that www.grants.gov is managed by HHS.e. Paper Submission: If technical difficulties are encountered at www.grants.gov, applicants should callthe www.grants.gov Contact Center at 1-800-518-4726 or e-mail them at [email protected] for assistance. After consulting withthe Contact Center, if the technical difficulties remain unresolved and electronic submission is not possible, applicants may e-mailCDC GMO/GMS, before the deadline, and request permission to submit a paper application. Such requests are handled on acase-by-case basis.An applicant’s request for permission to submit a paper application must:
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Include the www.grants.gov case number assigned to the inquiry1.Describe the difficulties that prevent electronic submission and the efforts taken with the www.grants.gov Contact Center tosubmit electronically; and
2.
Be received via e-mail to the GMS/GMO listed below at least three calendar days before the application deadline. Paperapplications submitted without prior approval will not be considered.If a paper application is authorized, OGS will advise the applicant of specific instructions for submitting the application(e.g., original and two hard copies of the application by U.S. mail or express delivery service).
3.
E. Review and Selection Process
1. Review and Selection Process: Applications will be reviewed in three phases.
a. Phase I Review All applications will be initially reviewed for eligibility and completeness by the Office of Grants Services. Complete applicationswill be reviewed for responsiveness by Grants Management Officials and Program Officials. Non-responsive applications will notadvance to Phase II review. Applicants will be notified that their applications did not meet eligibility and/or published submissionrequirements.
b. Phase II Review A review panel will evaluate complete, eligible applications in accordance with the criteria below.i. Approachii. Evaluation and Performance Measurement iii. Applicant’s Organizational Capacity to Implement the Approach .
Approach Maximum Points: 35
Because core and optional components are reviewed and scored separately, the criteria and scoring for each of the scoredsections of the FOA are described separately below. The application should be organized such that the core and optionalsections are independent of each other. Each section of the application (core and optional) should include approach, evaluationand performance measurement, organizational capacity, and budget.
Approach for (A) Core Activities (35 points): The applicant should demonstrate high burden of HCV and/or HBV incidenceand provide a clear and concise description of strategies and activities included in the package of services to achieve the projectperiod outcomes, namely:
1. Burden (10 points maximum) – Describe the need for surveillance of HCV and HBV in the applicant’s jurisdiction. Thedescription should include, but not be limited to a description of the burden of HCV and HBV, document of the prevalence andincidence of risk exposures/behaviors (i.e. injection drug use), current surveillance activities with limitations, facilitatingconditions, and barriers.
2. Core Surveillance activities (25 points)
a. Describe how these activities will address gaps and barriers confronting the viral hepatitis epidemic in the jurisdictionand experiences with and activities to:
i. ascertain and identify all clinicians, and laboratories conducting testing to identify acute or populations at riskfor recent HCV infection (i.e., less than 30 years of age) and HBV infection as well as other cases of HCV andHBV infection. (6 points)
ii. coordinate laboratory reports and medical/health/clinician records—both electronic and hard-copy—tomaximize detection of acute or recent HCV and acute HBV and other cases of HBV and HCV infection in thehealth jurisdiction.
b. Describe the electronic and human infrastructure and capacity to receive, de-duplicate, store, and analyze reports ofpersons with HCV and/or HBV infection and disseminate information for public health action and to the public. (2points)
c. Describe ability and prior history of applying the most recent CDC/CSTE case definitions for viral hepatitissurveillance for acute and chronic HCV and HBV, perinatal HBV, and where applicable, perinatal HCV; including adescription of the capacity to follow-up with case patients and/or health care providers to obtain clinical(signs/symptoms), risk exposure/behavioral data, and demographic information. (3 points)
d. Describe how commercial laboratory, ambulatory and hospital discharge and PWID outreach data, and other
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secondary data will be acquired, stored, analyzed and used to supplement viral hepatitis surveillance case data. (4points)
e. Describe development of registries of HCV and HBV surveillance data. Include description of how data are storedand how new laboratory reports for existing cases will be entered into the registries, and how these data will fill gapsin surveillance data. (3 points)
f. Describe experiences and methods for linking hepatitis surveillance data with vital records and HIV/AIDS data. Instates/localities where reporting of both positive and negative laboratory test results is mandated by law or regulations,describe how registries will be revised to include all test results. (3 points)
g. Describe collaborations with state/local prevention staff to share surveillance data for program planning,implementation, and evaluation. (2 points)
h. Describe how awardees with collaborate with CDC to develop and implement guidelines for submitting data toCDC. (2 points)
Approach for (B) Optional Surveillance-based Activities (35 points for each option): Each option should include narrative toaddress the criteria below. Applicants for (A) Core Activities may apply for one or more (B) optional activities, as indicatedunder Project Description, ii. Strategies and Activities above): promote HCV and HBV testing and reporting in settingsserving target populations such as emergency departments, detention/incarceration centers, drug, treatment venues, etc.; linkHCV- and HBV-infected persons who inject drugs (PWIDs) to care and treatment; and /or evaluate efficacy of and obtain datafrom syringe service programs (SSPs), buprenorphine/ naloxone and other opioid prevention and treatment programs.
Each of the options will be scored separately. Therefore the applications should include “Approach”, “Evaluation andPerformance Measurement”, and “Organizational Capacity to Implement the Approach”, and a Budget for each option. Eachoption may receive a maximum score of 100 points.
Does the applicant provide a clear and concise description of strategies and activities included in the package of services toachieve the project period outcomes, namely:
1. For optional activities that include promoting HCV and HBV testing in venues likely to serve infected persons, especiallyPWIDs—such as in correctional institutions, emergency departments, drug treatment centers, etc.
a. Describe plans and activities to:
• Recruit collaborative partners from appropriate venues;
• Promote testing and reporting test results to the health department
• Analyze data and dissemination findings
• Provide feedback to collaborative partners
b. Also include MOUs, MOAs, and letters of commitment/support.
2. For optional activities that include linking HCV- and HBV-infected PWIDs to care and treatment, clear plans/strategies toincrease linkage to treatment for their infection(s) and to drug abuse cessation program(s).
a. Describe plans and activities to:
• Recruit collaborative partners from appropriate venues;
• Promote testing and reporting test results to the health department
• Promote linkage to care and treatment
• Analyze data and dissemination findings
• Provide feedback to collaborative partners
b. Also include MOUs, MOAs, and letters of commitment/support.
3. For optional activities to evaluate and get more data from programs for PWIDs such as syringe service programs (SSPs),buprenorphine/naloxone and other opioid prevention and treatment programs.
a. Describe plans and activities to:
• Recruit collaborative partners from appropriate venues;
• Promote testing and reporting test results to the health department
• Analyze the impact of programs and collection of surveillance data
• Analyze data and dissemination findings
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• Provide feedback to collaborative partners
b. Also include MOUs, MOAs, and letters of commitment/support.
Evaluation and Performance Measurement Maximum Points: 35
Evaluation and Performance Measurement for (A) Core Activities [35 points, 5 points maximum for each criteria below]:
Evaluate the extent to which the applicant describes:
1. How key program partners will be engaged in the evaluation and performance measurement processes;
2. The type of evaluation to be conducted, expected monitoring and evaluation (M&E) activities, and key evaluation question tobe answered;
3. Available data sources and feasibility of collecting appropriate evaluation and performance measurement data (especiallymeasures to assess the outcome), and specific details on data utilization and data sharing with participating providers;
4. Data management and analysis capacity for local use and for submission to CDC;
5. How evaluation findings will be used for continuous program and quality improvement;
6. Describe how evaluation and performance measurement will contribute to development of the evidence base, where programstrategies that lack a strong evidence base of effectiveness are being employed; and
7. Willingness to collaborate with the evaluation team identified by CDC and tasked with additional evaluation of awardees’overall programmatic implementation of their project.
Evaluation and Performance Measurement for (B) Optional Surveillance-based Activities [35 points for each option, 5points maximum for each criteria below]:
Each option should include narrative to address the criteria below.
Evaluate the extent to which the applicant describes (5 points maximum for each criteria below):
1. How key program partners will be engaged in the evaluation and performance measurement processes;
2. The type of evaluation to be conducted, expected monitoring and evaluation (M&E) activities, and key evaluation question tobe answered;
3. Available data sources and feasibility of collecting appropriate evaluation and performance measurement data (especiallymeasures to assess the outcome), and specific details on data utilization and data sharing with participating providers;
4. Data management and analysis capacity for local use and for submission to CDC;
5. How evaluation findings will be used for continuous program and quality improvement;
6. Describe how evaluation and performance measurement will contribute to development of the evidence base, where programstrategies that lack a strong evidence base of effectiveness are being employed and
7. Describe willingness to collaborate with the evaluation team identified by CDC and tasked with additional evaluation ofawardees’ overall programmatic implementation of their project.
Applicant's Organizational Capacity to Implement the Approach Maximum Points: 30
Because core and optional components are reviewed and scored separately, the criteria and scoring for each of the scoredsections of the FOA are described separately below.
Organizational Capacity to Implement the Approach for (A) Core Activities (30 points): Each option should includenarrative to address each of these 3 criteria. Evaluate the extent to which the applicant:
1. Describe capacity to conduct activities funded by this announcement (10 points). Describe viral hepatitis surveillanceinfrastructure at the state and local levels, including ability to collect and use electronic laboratory data and electronicmedical/health records, capacity for performing laboratory tests, ability to manage case reports, and interpret and disseminatesurveillance data; and reporting practices of local health departments that ensure completeness of case reporting.
Describe laws and/or regulations that mandate reporting for both acute and chronic HCV and HBV, perinatal HBV, and whereapplicable perinatal HCV. Provide URL link(s) to the appropriate laws/regulations.
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applicable perinatal HCV. Provide URL link(s) to the appropriate laws/regulations.
2. Describe experience and capacity to implement the evaluation plan (10 points). If the evaluation plan has been previouslyimplemented, describe implementation, barriers and facilitators to the success of the plan, and lessons learned.
3. Describe the plan for staffing the core component to provide appropriate management and staff to achieve the projectoutcomes (10 points). Clearly define and describe staff roles and relevant experiences that will potentially contribute to thesuccess of the overall project. An organizational chart that include positions and names of staff in the relevant positions shouldbe included. Curriculum vitas should be provided for each staff person who is involved in the project.
Organizational Capacity to Implement the Approach for (B) Optional Surveillance-based Activities (30 points): Eachoption should include narrative to address the criteria below.
The 3 following criteria must be addressed for each of the optional activities proposed. Evaluate the extent to which theapplicant:
1. Describe capacity to conduct activities funded by this announcement; (10 points) Describes and demonstrate ability toidentify and work with non-traditional venues and how data will be received and integrated into the surveillance system.
2. Describe experience and capacity to implement the evaluation plan (10 points). If the evaluation plan has been previouslyimplemented, describe implementation, barriers and facilitators to the success of the plan, and lessons learned. If the plan hasnot been previously implemented, describe anticipated barriers, plans to overcome barriers, and plans to enhance anticipatedfacilitators to the success of the plan.
3. Describe the plan for staffing the optional component(s) to provide appropriate management and staff to achieve the projectoutcomes (10 points). Clearly define and describe staff roles and relevant experiences that will potentially contribute to thesuccess of the overall project. An organizational chart that include positions and names of staff in the relevant positions shouldbe included. Curriculum vitas should be provided for each staff person who is involved in the project.
For optional activities that involve SSPs, an application will be designated as “nonresponsive” if the application does notinclude the DON letter from CDC or proof that a DON request has been submitted to CDC, if DON has not yet been approved.
Budget Maximum Points: 0
Budget Provide a detailed budget and line-item justification for all operating expenses for each component (core and optional). A separate detailed budget is required for each optional activity. An overall budget that includes core and optional activities isalso required. The budget should be consistent with the activities, objectives and outcomes of the project.
The budget should address funds requested, as well as the applicant’s in-kind or direct support. The budget and budgetjustification will be included as a separate attachment, not to be counted in the narrative page limit.
For applicants that include activities with SSPs, support must always be in accordance in accordance with federal, state andlocal laws and regulations and must be consistent with activities as described in the CDC’s Program Guidance forImplementing Certain Components of SSPs, 2016 (http://www.cdc.gov/hiv/pdf/risk/cdc-hiv-syringe-exchange-services.pdf ). Additional information may be found at http://www.cdc.gov/hiv/risk/ssps.html .
Although the budget is not scored, applicants should consider the following in development of their budget.
The extent to which the budget is itemized for conducting the project and the justification is reasonable and consistentwith stated objectives and planned program activities.If the applicant requests indirect costs in the budget, a copy of the indirect cost rate agreement is required.If the indirect cost rate is a provisional rate, the agreement must reflect a rate obtained within the previous 12 months.The indirect cost rate agreement should be uploaded as a PDF file with “Other Attachment Forms” when submitting viaGrants.gov.
Not more than thirty days after the Phase II review is completed, applicants will be notified electronically if their application doesnot meet eligibility or published submission requirements.
c. Phase III Review Review of risk posed by applicants.Prior to making a Federal award, CDC is required by 31 U.S.C. 3321 and 41 U.S.C. 2313 to review information available throughany OMB-designated repositories of government-wide eligibility qualification or financial integrity information as appropriate. Seealso suspension and debarment requirements at 2 CFR parts 180 and 376.In accordance 41 U.S.C. 2313, CDC is required to review the non-public segment of the OMB-designated integrity and
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performance system accessible through SAM (currently the Federal Awardee Performance and Integrity Information System(FAPIIS)) prior to making a Federal award where the Federal share is expected to exceed the simplified acquisition threshold,defined in 41 U.S.C. 134, over the period of performance. At a minimum, the information in the system for a prior Federal awardrecipient must demonstrate a satisfactory record of executing programs or activities under Federal grants, cooperative agreements,or procurement awards; and integrity and business ethics. CDC may make a Federal award to a recipient who does not fully meetthese standards, if it is determined that the information is not relevant to the current Federal award under consideration or there arespecific conditions that can appropriately mitigate the effects of the non-Federal entity's risk in accordance with 45 CFR §75.207.CDC’s framework for evaluating the risks posed by an applicant may incorporate results of the evaluation of the applicant'seligibility or the quality of its application. If it is determined that a Federal award will be made, special conditions that correspondto the degree of risk assessed may be applied to the Federal award. The evaluation criteria is described in this funding opportunityannouncement.In evaluating risks posed by applicants, CDC will use a risk-based approach and may consider any items such as the following:(1) Financial stability;(2) Quality of management systems and ability to meet the management standards prescribed in this part;(3) History of performance. The applicant's record in managing Federal awards, if it is a prior recipient of Federal awards,including timeliness of compliance with applicable reporting requirements, conformance to the terms and conditions of previousFederal awards, and if applicable, the extent to which any previously awarded amounts will be expended prior to future awards;(4) Reports and findings from audits performed under subpart F 45 CFR 75 or the reports and findings of any other availableaudits; and(5) The applicant's ability to effectively implement statutory, regulatory, or other requirements imposed on non-Federal entities.CDC must comply with the guidelines on government-wide suspension and debarment in 2 CFR part 180, and require non-Federalentities to comply with these provisions. These provisions restrict Federal awards, subawards and contracts with certain parties thatare debarred, suspended or otherwise excluded from or ineligible for participation in Federal programs or activities.Applications will be reviewed, scored, and ranked by the review panel. CDC reserves the right to fund applications out of rankorder based on:
1. Higher than national average of HCV and HBV incidence and number of cases, as reported in Tables 3.1 and 4.1 at https://www.cdc.gov/hepatitis/statistics/2014surveillance/index.htm.
2. Geographical diversity to assure distribution across the United States.
3. Higher than average HCV or HBV incidence and number of cases, as reported in Tables 3.1 and 4.1 at https://www.cdc.gov/hepatitis/statistics/2014surveillance/index.htm.
4. Other supporting evidence indicative of increases in HCV or HBV transmission (i.e. mortality data showing increasing deathsdue to drug overdose, data from the Substance Abuse and Mental Health Services Administration showing high and/or increasinginjection drug use within the jurisdiction, etc.).
2. Announcement and Anticipated Award Dates
Awardees will receive an electronic copy of the Notice of Award (NOA) from CDC OFR.
The anticipated date of award is 1 May 2017.
F. Award Administration Information
1. Award Notices Awardees will receive an electronic copy of the Notice of Award (NOA) from CDC OGS. The NOA shall be the only binding,authorizing document between the awardee and CDC. The NOA will be signed by an authorized GMO and emailed to theAwardee Business Officer listed in application and the Program Director.Any applicant awarded funds in response to this FOA will be subject to the DUNS, SAM Registration, and Federal FundingAccountability And Transparency Act Of 2006 (FFATA) requirements.Unsuccessful applicants will receive notification of these results by e-mail with delivery receipt or by U.S. mail.Awardees will receive an electronic copy of the Notice of Award (NOA) from CDC OFR.
The NOA shall be the only binding, authorizing document between the awardee and CDC. The NOA will be signed by anauthorized GMO and emailed to the Awardee Business Officer listed in application and the Program Director.
Any applicant awarded funds in response to this FOA will be subject to the DUNS, SAM Registration, and Federal FundingAccountability And Transparency Act Of 2006 (FFATA) requirements.
Unsuccessful applicants will receive notification of these results by e-mail with delivery receipt or by U.S. mail.
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2. Administrative and National Policy Requirements Awardees must comply with the administrative and public policy requirements outlined in 45 CFR Part 75 and the HHS GrantsPolicy Statement, as appropriate. Brief descriptions of relevant provisions are available at http://www.cdc.gov/grants/additionalrequirements/index.html#ui-id-17. The HHS Grants Policy Statement is availableat http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf. The following Administrative Requirements (AR) apply to this project:
AR-1: Human Subjects Requirements
AR-2: Inclusion of Women and Racial and Ethnic Minorities in Research
AR-3: Animal Subjects Requirements
AR-4: HIV/AIDS Confidentiality Provisions
AR-5: HIV Program Review Panel Requirements
AR-6: Patient Care
AR-7: Executive Order 12372 Review
AR-8: Public Health System Reporting Requirements
AR-9: Paperwork Reduction Act Requirements
AR-10: Smoke-Free Workplace Requirements
AR-11: Healthy People 2020
AR-12: Lobbying Restrictions (June 2012)
AR-13: Prohibition on Use of CDC Funds for Certain Gun Control Activities
AR-14: Accounting System Requirements
AR-15: Proof of Non-profit Status
AR-16: Security Clearance Requirement
AR-17: Peer and Technical Reviews of Final Reports of Health Studies – ATSDR
AR-18: Cost Recovery – ATSDR
AR-19: Third Party Agreements – ATSDR
AR-20: Conference Support
AR-21: Small, Minority, And Women-owned Business
AR-22: Research Integrity
AR 23: Compliance with 45 CFR Part 87 (faith-based organizations)
AR-24: Health Insurance Portability and Accountability Act Requirements
AR-25: Release and Sharing of Data
AR-26: National Historic Preservation Act of 1966
AR-27: Conference Disclaimer and Use of Logos
AR-28: Inclusion of Persons Under the Age of 21 in Research
AR-29: Compliance with EO13513, “Federal Leadership on Reducing Text Messaging while Driving”, October 1, 2009
AR-30: Compliance with Section 508 of the Rehabilitation Act of 1973
AR 31 - Research Definition
AR 32 - Enacted General Provisions
AR-34: Language Access for Persons with Limited English Proficiency
Awardees must comply with the administrative and public policy requirements outlined in 45 CFR Part 75 and the HHS GrantsPolicy Statement, as appropriate.
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Policy Statement, as appropriate.
For more information on the CFR visit http://www. access.gpo.gov/ nara/cfr/cfr-table- search.html.
3. Reporting Reporting provides continuous program monitoring and identifies successes and challenges that awardees encounter throughout theproject period. Also, reporting is a requirement for awardees who want to apply for yearly continuation of funding. Reporting helpsCDC and awardees because it:
Helps target support to awardees;Provides CDC with periodic data to monitor awardee progress toward meeting the FOA outcomes and overall performance;Allows CDC to track performance measures and evaluation findings for continuous quality and program improvementthroughout the project period and to determine applicability of evidence-based approaches to different populations, settings,and contexts; andEnables CDC to assess the overall effectiveness and influence of the FOA.
The table below summarizes required and optional reports. All required reports must be sent electronically to GMS listed in the“Agency Contacts” section of the FOA copying the CDC Project Officer.
Report When? Required?
Awardee Evaluation and PerformanceMeasurement Plan
6 months into award Yes
Annual Performance Report (APR) No later than120 days before end ofbudget period. Serves as yearlycontinuation application.
Yes
Data on Performance Measures CDC program determines. Onlyif program wants more frequentperformance measure reporting thanannually in APR.
No
Federal Financial Reporting Forms 90 days after end of calendar quarter inwhich budget period ends
Yes
Final Performance and Financial Report 90 days after end of project period. Yes
Report When? Required?
Awardee Evaluation and PerformanceMeasurement Plan
6 months into award Yes
Annual Performance Report (APR) No later than120 days before end ofbudget period. Serves as yearlycontinuation application.
Yes
Data on Performance Measures Case surveillance data from coreactivities should be submitted to NNDSSweekly, based on the Morbidity andMortality Weekly Report (MMWR)schedule and, if applicable to SAMSmonthly.
Case data from optionalsurveillance-based activities will beintegrated into the NNDSS dataset andsubmitted to CDC along with data fromCore activities.
Yes
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Core activities.
Federal Financial Reporting Forms 90 days after end of calendar quarter inwhich budget period ends
Yes
Final Performance and Financial Report 90 days after end of project period. Yes
a. Awardee Evaluation and Performance Measurement Plan (required) With support from CDC, awardees must elaborate on their initial applicant evaluation and performance measurement plan. Thisplan must be no more than 20 pages; awardees must submit the plan 6 months into the award. HHS/CDC will review and approvethe recipient’s monitoring and evaluation plan to ensure that it is appropriate for the activities to be undertaken as part of theagreement, for compliance with the monitoring and evaluation guidance established by HHS/CDC, or other guidance otherwiseapplicable to this Agreement.Applicants must submit an evaluation and performance measurement plan with their application.
This FOA includes two components; core activities and strategies and optional surveillance-based activities and strategies. Applications will be evaluated and scored on each of these components, core and optional, separately. Only applicants that areawarded for core activities will be eligible for funding for the optional activities.
Data collected must be used for ongoing monitoring of the award to evaluate its effectiveness, and for continuous programimprovement. This plan should incorporate local area performance measurement plans, if applicable. This detailed evaluationplan must build on elements stated in the initial work plan. Awarded applicants will work with CDC on developing a moredetailed evaluation and performance measurement plan within the first 6 months of the project.
The basic Evaluation Plan(s) for each component must describe:
how key program partners will be engaged in the evaluation and performance measurement planning processes, the type of evaluation(s) to be conducted, i.e. process and/or outcome,key evaluation questions to be answered,potential data sources, internal and external, for collecting appropriate evaluation and performance data,specific performance measures which are identified for impact and effectiveness and timeline for completion,performance measures which reflect activities proposed in the work plan,how evaluation findings will be used for continuous program and quality improvement, andhow evaluation findings will be disseminated to stakeholders.
For applicants conducting Optional Surveillance-based Activities that involve SSPs: CDC requires awardees to report the numberof syringes distributed as a metric to evaluate performance of SSP activities. Although federal funds cannot be used at present forthe purchase of needles or syringes, the purpose of SSPs is ultimately to provide sterile supplies of injection equipment, includingneedles and syringes, to reduce the risk of infectious complications associated with non-sterile injection. The number of syringesdistributed by an SSP is a reliable, discrete measure of program activity and effectiveness that poses only a modest data collectionburden on awardees
Awardee Evaluation and Performance Measurement Plan (required): This plan should provide additional detail on the following:Performance Measurement• Performance measures and targets• The frequency that performance data are to be collected.• How performance data will be reported.• How quality of performance data will be assured.• How performance measurement will yield findings to demonstrate progress towards achieving FOA goals (e.g., reaching targetpopulations or achieving expected outcomes).• Dissemination channels and audiences.• Other information requested as determined by the CDC program. Evaluation• The types of evaluations to be conducted (e.g. process or outcome evaluations).• The frequency that evaluations will be conducted.
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• The frequency that evaluations will be conducted.• How evaluation reports will be published on a publically available website.• How evaluation findings will be used to ensure continuous quality and program improvement.• How evaluation will yield findings to demonstrate the value of the FOA (e.g., effect on improving public health outcomes,effectiveness of FOA, cost-effectiveness or cost-benefit).• Dissemination channels and audiences.HHS/CDC or its designee will also undertake monitoring and evaluation of the defined activities within the agreement. Therecipient must ensure reasonable access by HHS/CDC or its designee to all necessary sites, documentation, individuals andinformation to monitor, evaluate and verify the appropriate implementation the activities and use of HHS/CDC funding under thisAgreement.
b. Annual Performance Report (APR) (required) The awardee must submit the APR via www.grants.gov 120 days before the end of the budget period. This report must not exceed45 pages excluding administrative reporting. Attachments are not allowed, but weblinks are allowed.This report must include the following:
Performance Measures: Awardees must report on performance measures for each budget period and update measures, ifneeded.Evaluation Results: Awardees must report evaluation results for the work completed to date (including findings fromprocess or outcome evaluations).Work Plan: Awardees must update work plan each budget period to reflect any changes in project period outcomes,activities, timeline, etc.Successes
Awardees must report progress on completing activities and progress towards achieving the project period outcomesdescribed in the logic model and work plan.Awardees must describe any additional successes (e.g. identified through evaluation results or lessons learned)achieved in the past year.Awardees must describe success stories.
ChallengesAwardees must describe any challenges that hindered or might hinder their ability to complete the work plan activitiesand achieve the project period outcomes.Awardees must describe any additional challenges (e.g., identified through evaluation results or lessons learned)encountered in the past year.
CDC Program Support to AwardeesAwardees must describe how CDC could help them overcome challenges to complete activities in the work plan andachieving project period outcomes.
Administrative Reporting (No page limit)SF-424A Budget Information-Non-Construction Programs.Budget Narrative – Must use the format outlined in "Content and Form of Application Submission, Budget Narrative"section.Indirect Cost Rate Agreement.
The awardee must submit the Annual Performance Report via www.grants.gov 120 days before the end of the budget period.
c. Performance Measure Reporting (optional) CDC programs may require more frequent reporting of performance measures than annually in the APR. If this is the case, CDCprograms must specify reporting frequency, data fields, and format for awardees at the beginning of the award period.Complete case surveillance data, consistent with variables included on the Viral Hepatitis Case Report Form OMB No. 0920-0728,should be submitted to NNDSS weekly, based on MMWR week. The form may be found at: https://www.cdc.gov/hepatitis/pdfs/hepatitiscaserprtform.pdf .
Implementation of the newly developed Message Mapping Guide may require reporting of additional variables. The CDCprogram will ensure OMB approval for any new data collection prior to implementation.
Complete case data should be submitted to SAMS at least monthly.
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d. Federal Financial Reporting (FFR) (required) The annual FFR form (SF-425) is required and must be submitted 90 days after the end of the calendar quarter in which the budgetperiod ends. The report must include only those funds authorized and disbursed during the timeframe covered by the report. Thefinal FFR must indicate the exact balance of unobligated funds, and may not reflect any unliquidated obligations. There must be nodiscrepancies between the final FFR expenditure data and the Payment Management System’s (PMS) cash transaction data. Failureto submit the required information by the due date may adversely affect the future funding of the project. If the information cannotbe provided by the due date, awardees are required to submit a letter of explanation to OGS and include the date by which theGrants Officer will receive information.The annual FFR form (SF-425) is required and must be submitted 90 days after the end of the calendar quarter in which the budgetperiod ends. The report must include only those funds authorized and disbursed during the timeframe covered by the report. Thefinal FFR must indicate the exact balance of unobligated funds, and may not reflect any unliquidated obligations. There must be nodiscrepancies between the final FFR expenditure data and the Payment Management System’s (PMS) cash transaction data. Failureto submit the required information by the due date may adversely affect the future funding of the project. If the information cannotbe provided by the due date, awardees are required to submit a letter of explanation to OGS and include the date by which theGrants Officer will receive information.
e. Final Performance and Financial Report (required) This report is due 90 days after the end of the project period. CDC programs must indicate that this report should not exceed 40pages. This report covers the entire project period and can include information previously reported in APRs. At a minimum, thisreport must include the following:
Performance Measures – Awardees must report final performance data for all process and outcome performance measures.Evaluation Results – Awardees must report final evaluation results for the project period for any evaluations conducted.Impact/Results/Success Stories – Awardees must use their performance measure results and their evaluation findings todescribe the effects or results of the work completed over the project period, and can include some success stories.Additional forms as described in the Notice of Award (e.g., Equipment Inventory Report, Final Invention Statement).
A final performance and financial report is due 90 days after the end of the project period and should not exceed 40 pages. Thisreport covers the entire project period and can include information previously reported in APRs. At a minimum, this report mustinclude the following:
Performance Measures – Awardees must report final performance data for all process and outcome performance measures.Evaluation Results – Awardees must report final evaluation results for the project period for any evaluations conducted.Impact/Results/Success Stories – Awardees must use their performance measure results and their evaluation findings todescribe the effects or results of the work completed over the project period, and can include some success stories.Additional forms as described in the Notice of Award (e.g., Equipment Inventory Report, Final Invention Statement).
4. Federal Funding Accountability and Transparency Act of 2006 (FFATA) Federal Funding Accountability and Transparency Act of 2006 (FFATA), P.L. 109–282, as amended by section 6202 of P.L.110–252 requires full disclosure of all entities and organizations receiving Federal funds including awards, contracts, loans, otherassistance, and payments through a single publicly accessible Web site, http://www.USASpending.gov.Compliance with this law is primarily the responsibility of the Federal agency. However, two elements of the law requireinformation to be collected and reported by applicants: 1) information on executive compensation when not already reportedthrough the SAM, and 2) similar information on all sub-awards/subcontracts/consortiums over $25,000.For the full text of the requirements under the FFATA and HHS guidelines, go to:
https://www.gpo.gov/fdsys/pkg/PLAW-109publ282/pdf/PLAW-109publ282.pdf, https://www. fsrs.gov/documents /ffata_legislation_ 110_252.pdf http://www.hhs.gov/grants/grants/grants-policies-regulations/index.html#FFATA.
G. Agency Contacts
CDC encourages inquiries concerning this FOA.
Program Office Contact For programmatic technical assistance, contact:Ruth Jiles, Project OfficerDepartment of Health and Human Services
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Centers for Disease Control and Prevention12 Corporate Blvd.Mail Stop G-37Atlanta, GA 30329Telephone: (404) 718-8557Email: [email protected]
Grants Management Office Information For financial, awards management, or budget assistance, contact:Valerie McCloud, Grants Management SpecialistDepartment of Health and Human ServicesCDC Procurement and Grants Office2960 Brandywine RoadMail Stop K-14Atlanta, GA 30341Telephone: (770) 488-4790Email: [email protected]
For assistance with submission difficulties related to www.grants.gov, contact the Contact Center by phone at 1-800-518-4726. Hours of Operation: 24 hours a day, 7 days a week, except on federal holidays.
For all other submission questions, contact: Technical Information Management Section Department of Health and Human Services CDC Office of Financial ResourcesOffice of Grants Services2920 Brandywine Road, MS E-14 Atlanta, GA 30341 Telephone: 770-488-2700 E-mail: [email protected]
CDC Telecommunications for persons with hearing loss is available at: TTY 1-888-232-6348.
H. Other Information
Following is a list of acceptable attachments applicants can upload as PDF files as part of their application at www.grants.gov.Applicants may not attach documents other than those listed; if other documents are attached, applications will not be reviewed.
Project AbstractProject NarrativeBudget NarrativeCDC Assurances and CertificationsTable of Contents for Entire Submission
For international FOAs:
SF424SF424A Funding Preference Deliverables
Optional attachments, as determined by CDC programs:
Resumes / CVs
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Resumes / CVsPosition descriptionsLetters of SupportOrganization ChartsMemorandum of Agreement (MOA)Memorandum of Understanding (MOU)Bona Fide Agent status documentation, if applicable
Determination of Need, if applicable.
I. Glossary
Activities: The actual events or actions that take place as a part of the program.Administrative and National Policy Requirements, Additional Requirements (ARs): Administrative requirements found in 45CFR Part 75 and other requirements mandated by statute or CDC policy. All ARs are listed in the Template for CDC programs.CDC programs must indicate which ARs are relevant to the FOA; awardees must comply with the ARs listed in the FOA. To viewbrief descriptions of relevant provisions, see http:// www.cdc.gov/ grants/ additional requirements/ index.html. Note that 2 CFR200 supersedes the administrative requirements (A-110 & A-102), cost principles (A-21, A-87 & A-122) and audit requirements(A-50, A-89 & A-133).Award: Financial assistance that provides support or stimulation to accomplish a public purpose. Awards include grants and otheragreements (e.g., cooperative agreements) in the form of money, or property in lieu of money, by the federal government to aneligible applicant.Budget Period or Budget Year: The duration of each individual funding period within the project period.Traditionally, budgetperiods are 12 months or 1 year.Carryover: Unobligated federal funds remaining at the end of any budget period that, with the approval of the GMO or under anautomatic authority, may be carried over to another budget period to cover allowable costs of that budget period either as an offsetor additional authorization. Obligated but liquidated funds are not considered carryover.Catalog of Federal Domestic Assistance (CFDA): A government-wide compendium published by the General ServicesAdministration (available on-line in searchable format as well as in printable format as a .pdf file) that describes domesticassistance programs administered by the Federal Government.CFDA Number: A unique number assigned to each program and FOA throughout its lifecycle that enables data and fundingtracking and transparency.CDC Assurances and Certifications: Standard government-wide grant application forms.Competing Continuation Award: A financial assistance mechanism that adds funds to a grant and adds one or more budgetperiods to the previously established project period (i.e., extends the “life” of the award).Continuous Quality Improvement: A system that seeks to improve the provision of services with an emphasis on future results.Contracts: An award instrument used to acquire (by purchase, lease, or barter) property or services for the direct benefit or use ofthe Federal Government.Cooperative Agreement: A financial assistance award with the same kind of interagency relationship as a grant except that itprovides for substantial involvement by the federal agency funding the award. Substantial involvement means that the recipient canexpect federal programmatic collaboration or participation in carrying out the effort under the award.Cost Sharing or Matching: Refers to program costs not borne by the Federal Government but by the awardees. It may include thevalue of allowable third-party, in-kind contributions, as well as expenditures by the awardee.Direct Assistance: A financial assistance mechanism, which must be specifically authorized by statute, whereby goods or servicesare provided to recipients in lieu of cash. DA generally involves the assignment of federal personnel or the provision of equipmentor supplies, such as vaccines. DA is primarily used to support payroll and travel expenses of CDC employees assigned to state,tribal, local, and territorial (STLT) health agencies that are recipients of grants and cooperative agreements. Most legislativeauthorities that provide financial assistance to STLT health agencies allow for the use of DA. http:// www.cdc.gov /grants/additionalrequirements /index.html.DUNS: The Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number is a nine-digit number assigned byDun and Bradstreet Information Services. When applying for Federal awards or cooperative agreements, all applicant organizationsmust obtain a DUNS number as the Universal Identifier. DUNS number assignment is free. If requested by telephone, a DUNSnumber will be provided immediately at no charge. If requested via the Internet, obtaining a DUNS number may take one to twodays at no charge. If an organization does not know its DUNS number or needs to register for one, visit Dun & Bradstreet at http://fedgov.dnb.com/ webform/displayHomePage.do.Evaluation (program evaluation): The systematic collection of information about the activities, characteristics, and outcomes ofprograms (which may include interventions, policies, and specific projects) to make judgments about that program, improveprogram effectiveness, and/or inform decisions about future program development.Evaluation Plan: A written document describing the overall approach that will be used to guide an evaluation, including why theevaluation is being conducted, how the findings will likely be used, and the design and data collection sources and methods. The
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plan specifies what will be done, how it will be done, who will do it, and when it will be done. The FOA evaluation plan is used todescribe how the awardee and/or CDC will determine whether activities are implemented appropriately and outcomes are achieved.Federal Funding Accountability and Transparency Act of 2006 (FFATA): Requires that information about federal awards,including awards, contracts, loans, and other assistance and payments, be available to the public on a single websiteat www.USAspending.gov.Fiscal Year: The year for which budget dollars are allocated annually. The federal fiscal year starts October 1 and ends September30.Grant: A legal instrument used by the federal government to transfer anything of value to a recipient for public support orstimulation authorized by statute. Financial assistance may be money or property. The definition does not include a federalprocurement subject to the Federal Acquisition Regulation; technical assistance (which provides services instead of money); orassistance in the form of revenue sharing, loans, loan guarantees, interest subsidies, insurance, or direct payments of any kind to aperson or persons. The main difference between a grant and a cooperative agreement is that in a grant there is no anticipatedsubstantial programmatic involvement by the federal government under the award.Grants.gov: A "storefront" web portal for electronic data collection (forms and reports) for federal grant-making agenciesat www.grants.gov.Grants Management Officer (GMO): The individual designated to serve as the HHS official responsible for the businessmanagement aspects of a particular grant(s) or cooperative agreement(s). The GMO serves as the counterpart to the businessofficer of the recipient organization. In this capacity, the GMO is responsible for all business management matters associated withthe review, negotiation, award, and administration of grants and interprets grants administration policies and provisions. The GMOworks closely with the program or project officer who is responsible for the scientific, technical, and programmatic aspects of thegrant.Grants Management Specialist (GMS): A federal staff member who oversees the business and other non-programmatic aspectsof one or more grants and/or cooperative agreements. These activities include, but are not limited to, evaluating grant applicationsfor administrative content and compliance with regulations and guidelines, negotiating grants, providing consultation and technicalassistance to recipients, post-award administration and closing out grants.Health Disparities: Differences in health outcomes and their determinants among segments of the population as defined by social,demographic, environmental, or geographic category.Healthy People 2020: National health objectives aimed at improving the health of all Americans by encouraging collaborationacross sectors, guiding people toward making informed health decisions, and measuring the effects of prevention activities.Inclusion: Both the meaningful involvement of a community’s members in all stages of the program process and the maximuminvolvement of the target population that the intervention will benefit. Inclusion ensures that the views, perspectives, and needs ofaffected communities, care providers, and key partners are considered.Indirect Costs: Costs that are incurred for common or joint objectives and not readily and specifically identifiable with aparticular sponsored project, program, or activity; nevertheless, these costs are necessary to the operations of the organization. Forexample, the costs of operating and maintaining facilities, depreciation, and administrative salaries generally are consideredindirect costs.Intergovernmental Review: Executive Order 12372 governs applications subject to Intergovernmental Review of FederalPrograms. This order sets up a system for state and local governmental review of proposed federal assistance applications. Contactthe state single point of contact (SPOC) to alert the SPOC to prospective applications and to receive instructions on the State’sprocess. Visit the following web address to get the current SPOC list: http://www.whitehouse.gov/omb/ grants_spoc/.Letter of Intent (LOI): A preliminary, non-binding indication of an organization’s intent to submit an application.Lobbying: Direct lobbying includes any attempt to influence legislation, appropriations, regulations, administrative actions,executive orders (legislation or other orders), or other similar deliberations at any level of government through communication thatdirectly expresses a view on proposed or pending legislation or other orders, and which is directed to staff members or otheremployees of a legislative body, government officials, or employees who participate in formulating legislation or other orders.Grass roots lobbying includes efforts directed at inducing or encouraging members of the public to contact their electedrepresentatives at the federal, state, or local levels to urge support of, or opposition to, proposed or pending legislative proposals.Logic Model: A visual representation showing the sequence of related events connecting the activities of a program with theprograms’ desired outcomes and results.Maintenance of Effort: A requirement contained in authorizing legislation, or applicable regulations that a recipient must agree tocontribute and maintain a specified level of financial effort from its own resources or other non-government sources to be eligibleto receive federal grant funds. This requirement is typically given in terms of meeting a previous base-year dollar amount.Memorandum of Understanding (MOU) or Memorandum of Agreement (MOA): Document that describes a bilateral ormultilateral agreement between parties expressing a convergence of will between the parties, indicating an intended common lineof action. It is often used in cases where the parties either do not imply a legal commitment or cannot create a legally enforceableagreement.Nonprofit Organization: Any corporation, trust, association, cooperative, or other organization that is operated primarily forscientific, educational, service, charitable, or similar purposes in the public interest; is not organized for profit; and uses netproceeds to maintain, improve, or expand the operations of the organization. Nonprofit organizations include institutions of highereducations, hospitals, and tribal organizations (that is, Indian entities other than federally recognized Indian tribal governments).
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Notice of Award (NoA): The official document, signed (or the electronic equivalent of signature) by a Grants ManagementOfficer that: (1) notifies the recipient of the award of a grant; (2) contains or references all the terms and conditions of the grantand Federal funding limits and obligations; and (3) provides the documentary basis for recording the obligation of Federal funds inthe HHS accounting system. Objective Review: A process that involves the thorough and consistent examination of applications based on an unbiasedevaluation of scientific or technical merit or other relevant aspects of the proposal. The review is intended to provide advice to thepersons responsible for making award decisions.Outcome: The results of program operations or activites; the effects triggered by the program. For example, increased knowledge,changed attitudes or beliefs, reduced tobacco use, reduced morbidity and mortality.Performance Measurement: The ongoing monitoring and reporting of program accomplishments, particularly progress towardpre-established goals, typically conducted by program or agency management. Performance measurement may address the type orlevel of program activities conducted (process), the direct products and services delivered by a program (outputs), or the results ofthose products and services (outcomes). A “program” may be any activity, project, function, or policy that has an identifiablepurpose or set of objectives.Plain Writing Act of 2010: Plain Writing Act of 2010, Public Law 111-274 requires federal agencies to communicate with thepublic in plain language to make information more accessible and understandable by intended users, especially people with limitedhealth literacy skills or limited English proficiency. The Plain Writing Act is available at www.plainlanguage.gov. Program Strategies: Strategies are groupings of related activities, usually expressed as general headers (e.g., Partnerships,Assessment, Policy) or as brief statements (e.g., Form partnerships, Conduct assessments, Formulate policies). Program Official: Person responsible for developing the FOA; can be either a project officer, program manager, branch chief,division leader, policy official, center leader, or similar staff member.Project Period Outcome: An outcome that will occur by the end of the FOA’s funding period.Public Health Accreditation Board (PHAB): A nonprofit organization that works to promote and protect the health of the publicby advancing the quality and performance of public health departments in the U.S. through national public health departmentaccreditation http://www.phaboard.org.Statute: An act of the legislature; a particular law enacted and established by the will of the legislative department of government,expressed with the requisite formalities. In foreign or civil law any particular municipal law or usage, though resting for itsauthority on judicial decisions, or the practice of nations.Statutory Authority: Authority provided by legal statute that establishes a federal financial assistance program or award.System for Award Management (SAM): The primary vendor database for the U.S. federal government. SAM validates applicantinformation and electronically shares secure and encrypted data with federal agencies' finance offices to facilitate paperlesspayments through Electronic Funds Transfer (EFT). SAM stores organizational information, allowing www.grants.gov to verifyidentity and pre-fill organizational information on grant applications.Technical Assistance: Advice, assistance, or training pertaining to program development, implementation, maintenance, orevaluation that is provided by the funding agency.Work Plan: The summary of project period outcomes, strategies and activities, personnel and/or partners who will complete theactivities, and the timeline for completion. The work plan will outline the details of all necessary activities that will be supportedthrough the approved budget.HCV – Hepatitis C Virus
HBV – Hepatitis B Virus
SSPs – Syringe Services Programs
Components – this FOA includes 2 components Core Surveillance Activities and Optional Surveillance-based activities.
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