cdc-rfa-ps13-1307 amend 1 final 10 09 2012 12 18pm.doc

AMENDMENT 1 (as of 10/05/12):

1. On Page 25, removed language in parentheses that said, “(Narrative portion should not exceed 24 pages double-spaced)”, as this was in direct conflict with language on page 24, that states the project narrative’s maximum length is 15 pages, double spaced.

Table of Contents

Part 1. Overview Information Part 2. Full Text of the Announcement Section I. Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

PART 1. OVERVIEW INFORMATION

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Agency Name: Federal Centers for Disease Control and Prevention (CDC) Funding Opportunity Title: Perinatal Hepatitis B Prevention Program, Supplemental Evaluation Projects (PHBPP-SEP) Announcement Type: New – Type 1 Agency Funding Opportunity Number: CDC-RFA- PS13-1307 Catalog of Federal Domestic Assistance Number: CFDA Number 93.270, Adult Viral Hepatitis Prevention and Control

Key Dates: Letter of Intent Deadline Date: October 09, 2012 AFTER DATE OF PUBLICATION on Grants.gov To receive notification of any changes to CDC-RFA-PS13-1307, return to the synopsis page of this announcement at: www.grants.gov and click on the “Send Me Change Notification Emails” link. An email address is needed for this service.

Application Deadline Date: November 02, 2012 on Grants.gov, 11:59 pm U.S. Eastern Standard Time Executive Summary:

CDC announces the availability of Fiscal Year (FY) 2013 funds for cooperative agreements with state or local jurisdictions that have existing Perinatal Hepatitis B Prevention Programs (PHBPP). The purpose of this funding announcement is for Supplemental Evaluation Projects (SEP) to facilitate or enhance the success of current immunization practice to prevent mother-to-child transmission of hepatitis B through assessment of

1) The completeness of screening and reporting hepatitis B infected (hepatitis B surface antigen positive, [HBsAg-positive]) pregnant women for PHBPP case management of their infants, including immunization.

2) The implementation of prenatal evaluation and antiviral treatment for selected HBsAg-positive pregnant women which may impact the hepatitis B virus (HBV) outcomes of infants receiving hepatitis B immunization.

3) Facility-based reporting of universal hepatitis B “birth dose” vaccine coverage according to guidelines of the National Quality Forum, and the reliability of the reports in a sample of facilities.

The goals of this FOA are derived from the HHS Viral Hepatitis Action Plan (available at: http://www.hhs.gov/ash/initiatives/hepatitis), and reflect the Healthy People 2020 immunization and infectious disease objectives to reduce chronic hepatitis B virus infections in infants and young children (perinatal infections), and provide a birth dose of hepatitis B vaccine (0-3 days between birthdate and date of vaccination).

CDC anticipates awarding 2 to 4 cooperative agreements to eligible health departments with PHBPP that demonstrate

1) the capability for timely collection and tracking of more complete and accurate de-duplicated, individual level data than generally possible during routine PHBPP women and infant case-management activities, and for using a common database across SEP sites for immunization and program assessment

2) an expected minimum of 200 (no required maximum) identified infants born annually to HBsAg-positive women showing racial and ethnic diversity

3) established relationships with area birthing facilities to

a. promote and monitor facility-based annual hepatitis B birth dose vaccine coverage reporting, and

b. Assess the reliability of hepatitis B “birth dose” vaccine coverage reports.

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

HHS Viral Hepatitis Action Plan

· Identify persons infected with viral hepatitis early in the course of their disease (Goal 2.1)

1. Implement routine viral hepatitis testing as part of the standard of care in a reformed health-care system (Strategy 2.1.2)

2. Ensure that HBV-infected pregnant women receive timely care and treatment (Strategy 2.2.2.)

3. Improve prevention for infants born to HBV-infected mothers with high viral loads (Strategy 4.1.3.)

· Eliminate mother-to-child transmission of hepatitis B (Goal 4.1)

1. Provide post-exposure prophylaxis (i.e., hepatitis B immune globulin and hepatitis B vaccine) and care coordination to all neonates born to HBV-infected women (Strategy 4.1.1)

2. Ensure that hospitals and birthing centers administer a “birth dose” of hepatitis B vaccine to all neonates prior to discharge (Strategy 4.1.2.

This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be reviewed. For the definition of research, please see the CDC Web site at the following Internet address:

http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf.

PART 2. FULL TEXT

I. FUNDING OPPORTUNITY DESCRIPTION

Statutory Authority: This program is authorized under Sections 317(k) (2) of the Public Health Service Act (42 U.S.C. Section 247b (k) (d)).

Background In 2008, an estimated 25,000 infants were born to hepatitis B infected pregnant women (determined by a positive test for hepatitis B surface antigen [HBsAg]). Infants exposed to hepatitis B virus (HBV) at birth have a 40% - 90% risk of hepatitis B infection, and if infected, a 90% risk of developing chronic HBV infection in the absence of post-exposure prophylaxis. An expected 25% infants with chronic HBV infection die prematurely from liver cirrhosis or liver cancer. In early randomized controlled trials, post-exposure prophylaxis (PEP) prevented 85% - 95% of perinatal HBV infections. PEP consists of hepatitis B vaccine and hepatitis B immune globulin (HBIG) administered within 12 hours of birth, completion of the hepatitis vaccine series, post-vaccination testing, and revaccination and retesting if necessary to determine the need for additional medical management. Identifying hepatitis B infected (HBsAg-positive) pregnant women, administering PEP at delivery and during the first year of life constitutes a major medical and public health commitment that seeks optimal prevention outcomes. Screening during pregnancy to identify women with HBV infection is a cornerstone of prevention of perinatal hepatitis B transmission. Assessing the reasons for vaccine and PEP failures is part of evaluating how to increase successful outcomes for exposed infants, and contributes to achieving the national goal for eliminating the burden of morbidity and mortality resulting from chronic hepatitis B infection in the United States.

PHBPP were created in 1990 and have been funded through 2012 with immunization grants to 64 jurisdictions in US states, cities, territories, and freely associated island nations. Key program requirements of the PHBPP are to identify all HBsAg-positive pregnant women and ensure their infants receive and complete timely PEP to optimize prevention of perinatal HBV infection. These key program requirements will continue to be supported from 2013-2017 through the immunization funding opportunity announcement, # CDC-RFA-IP13-1301, “Immunization and Vaccines for Children Program.”

Universal screening of pregnant women for HBsAg is recommended by the Advisory Committee on Immunization Practices (ACIP), American Academy of Pediatrics (AAP), American Academy of Family Physicians (AAFP) and the US Preventive Services Task Force (USPSTF). Reporting persons with HBsAg-positive tests to public health is required in all states and is endorsed by the Council of State and Territorial Epidemiologists. Despite these recommendations, statues, and major efforts by PHBPP, modeling of the expected number of births to HBsAg-positive pregnant women in the United States suggests considerable variability among PHBPPs in the number of infants identified compared to the expected number of these infants. The average number of identified infants born to HBsAg-positive pregnant women in the United States was less than 50% of the expected number born in 2008. Some of the un-identified women and their infants might be managed in the private sector or have no access to traditional health care and may not be identified by the PHBPP. Because these infants are not identified, their outcomes are unknown.

As a “safety net” for preventing perinatal hepatitis B transmission among HBV exposed infants who do not receive PEP starting within 12 hours of birth, the ACIP recommends that all infants in the United States receive the first dose of hepatitis B vaccine before discharge from the birthing facility. This “birth dose” generally is administered by the 3rd day of life or earlier. Although the timing of the birth dose might not be ideal for preventing all perinatal and infant HBV infections, early initiation of hepatitis B immunization followed by completion of the vaccine series is expected to prevent a proportion of HBV infections among infants who are not identified through maternal screening or who do not receive PEP for other reasons. Data from the National Immunization Survey in 2010 estimated birth dose coverage by the third day of life at 64% in the United States. To encourage improvement in hepatitis B birth dose coverage, in May 2012 the National Quality Forum (NQF) endorsed facility-based annual hepatitis B vaccine “birth dose” coverage reporting as a quality measure. Facility-based coverage reports will focus PHBPP efforts on prevention of perinatal hepatitis B infection by increasing the administration of the hepatitis B birth dose as a safety net. Reliability testing of coverage reports will assess their reproducibility and will meet maintenance requirements to retain NQF endorsement of the coverage measure in 2015-2016.

Information characterizing HBsAg-positive pregnant women, their infants, and the outcomes of PEP are not available at an individual level in annual reports required of PHBPP immunization grantees. These reports have a limited number of end points and outcomes are determined in aggregate. To assess programmatic outcomes of case-managed HBsAg-positive women and their infants at an individual level, and to strengthen the evaluation of the PHBPP, CDC awarded additional funds from 2007/2008 through 2012 to 5 US jurisdictions under the Enhanced Perinatal Hepatitis B Case Management Programs (EPHBP). The EPHBP found a high proportion of case-managed HBV-infected women were foreign born of Asian-Pacific Island origin, and a high proportion of US–born case-managed HBV-infected women were non-Hispanic Blacks. Although the 5 EPHBPP jurisdictions reported overall improved outcomes compared to the nationally reported outcomes for PHBPP, the results confirmed the existence of large gaps in information needed to assess PHBPP and to ensure PEP to achieve optimal infant hepatitis B prevention outcomes.

This FOA is in response to rapidly occurring changes in the healthcare system as related to access to health care, electronic management of laboratory and medical records, and changes in the evaluation and medical management of HBsAg-positive pregnant women, all of which could affect the efficacy of immunization-based PEP on infant outcomes. This FOA also reflects interest in assessing gaps in the number of expected versus identified infants born to HBsAg-positive pregnant women. It seeks to encourage and assess use of the May 2012 endorsed National Quality Forum measure for hepatitis B birth dose coverage. In addition, recent scientific publications suggest infant outcomes might improve when HBsAg-positive pregnant women are identified early and receive additional evaluation for high hepatitis B viral load (e.g., measurement of HBV DNA or the surrogate marker, hepatitis B “e” antigen) and consideration for antiviral treatment during pregnancy. Anecdotal accounts suggest an increasing proportion of HBsAg-positive pregnant women are already receiving anti-viral treatment to prevent “breakthrough” cases of HBV infection in their infants, although no national recommendation for this approach exists. Assessment is needed of the current dynamic influences and barriers to achieving optimal prevention of perinatal HBV infection in the United States, including:

· Closing the gap between the expected and identified number of births to HBsAg-positive pregnant women and assessing potential differences in the infant outcomes.

· Comparing outcomes (vaccine efficacy based on timely implementation of immunization and completion of post-vaccination testing) of infants born to HBsAg-positive pregnant women by access to care as measured by time of initiating prenatal care, insurance coverage, and provider types and use of anti-viral treatment.

· Evaluating the level of reporting and the reliability of facility-based annual NQF- specified hepatitis B vaccine birth dose coverage (NQF measure #0475, “Hepatitis B Vaccine Coverage among All Live Newborn Infants Prior to Hospital or Birthing Facility Discharge”. Specifications can be found at: http://www.qualityforum.org/Measures_List.aspx and at: http://www.cdc.gov/hepatitis/HBV/PerinatalXmtn.htm.)

CDC seeks 2 to 4 PHBPP for Supplemental Evaluation Projects (PHBPP-SEP) during 2013-2015. SEP sites will collaborate with CDC to create a data management and tracking system that is consistent across project sites to assess PHBPP outcomes. CDC, along with SEP, will make the final determination of methods for assessment projects to 1) close the gap between expected and identified HBsAg-positive pregnant women and characterize the HBsAg-positive pregnant women by core demographic, provider and payer information, 2) determine existing evaluation and anti-viral treatment of HBsAg-positive pregnant women and its contribution to infant outcomes, and 3) evaluate facility-based reporting of hepatitis B birth dose coverage and the reliability of the reports.

Purpose

The purpose of the program is to support the goals and strategies of the HHS Viral Hepatitis Action Plan by focusing on 1) eliminating mother-to-child transmission of hepatitis B virus infection, 2) ensuring that HBV-infected pregnant women receive timely evaluation and care, which may improve prevention of hepatitis B virus infection for infants born to HBV-infected women with high viral load, and 3) ensuring that hospitals and birthing centers administer a “birth dose” of hepatitis B vaccine to all neonates prior to discharge from the birthing facility.

This program also addresses the following “Healthy People 2020” focus area(s):

· IID-24: Reduce chronic hepatitis B virus infections in infants and young children (perinatal infections)

· IID-7.9: A birth dose of hepatitis B vaccine (0-3 days between birthdate and date of vaccination) reported by annual birth cohort.

Target IID-24 is addressed by evaluating the outcomes of infants in the context of implementing current ACIP recommendations. It further seeks to determine the potential for improving outcomes by screening women for high hepatitis B viral load with consideration of antiviral treatment during pregnancy to decrease infant breakthrough infections.

Target IID-7.6 is addressed in Goal 3, which assesses the reliability of a new facility-based National Quality Forum birth dose coverage measure to provide feedback for improving birth dose coverage. The special feature of this measure is that provides information to the individuals responsible for ensuring birth dose administration.

Health Equity The FOA supports efforts that will improve the health of populations disproportionately affected by hepatitis B virus by maximizing the health impact of public health services, reducing disease prevalence, and promoting health equity consistent with the National Prevention Strategy. Health disparities in hepatitis B virus are inextricably linked to a complex blend of social determinants that influence populations most severely affected by this disease, including immigrants, refugees and disadvantaged racial minorities. Health equity is a desirable goal that entails special efforts to improve the health of those who have experienced social or economic disadvantage. In collaboration with partners and appropriate sectors of the community, applicants should consider social determinants of health in the development and implementation of program efforts, and use culturally appropriate interventions. (Details of the health equity strategy and approach are outlined in the NCHHSTP Social Determinants of Health White Paper http://www.cdc.gov/socialdeterminants/docs/SDH-White-Paper-2010.pdf.)

Program Collaboration and Service Integration within Health Departments To maximize opportunities for hepatitis B virus prevention through vaccination, and referral for care, and treatment of persons found to have chronic HBV infection, this FOA encourages PHBPP collaborations and service integration as a program imperative of the National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP). Such collaborations can 1) increase efficiency, reduce redundancy, and eliminate missed opportunities; and 2) better adapt to improve outcomes through the use of shared data and services. Specifically, applicants should create and build on internal health department collaborations to 1) improve identification of HBsAg-positive pregnant women; screen their household and sexual contacts for hepatitis B and complete vaccination of susceptible persons, 2) refer persons with chronic HBV infection for care and treatment, and 3) report infants, household and sexual contacts with chronic HBV infection to the National Notifiable Diseases Surveillance System (NNDSS).

Populations disproportionately affected by chronic HBV infection may also be affected by other infections, including other types of viral hepatitis, TB, HIV, and STDs. CDC encourages integration of contact screening, testing, and prevention services for the following reasons:

· Hepatitis B disease is transmitted perinatally, through household contact, blood exposure, sexually, and is preventable by safe and highly effective vaccines;

· Pregnant women with HBV infection may have barriers to care, screening, and evaluation, and present late in pregnancy or at delivery without prenatal care;

· Foreign-born populations are at risk for both hepatitis B and other infectious diseases, e.g., TB for which coordinated care may optimize outcomes;

· Some pregnant women with HBV infection may share risks and modes of transmission with adults who acquire hepatitis C virus (HCV), HIV, and sexually transmitted diseases (STDs).

Program Implementation

CDC anticipates awarding 2-4 eligible jurisdictions with PHBPP. Eligible jurisdictions must demonstrate the capacity to conduct routine PHBPP activities in addition to conducting Supplemental Evaluation Projects to meet funding opportunity goal during the anticipated 3-year term of the FOA. Population diversity by race-ethnicity and the total number of annually identified infants born to HBsAg-positive women will be considerations in the selection of recipients.

Goals for Perinatal Hepatitis B Prevention, Supplemental Evaluation Projects

1) Assess and increase the completeness of screening for and reporting of HBsAg-positive pregnant women to PHBPP; determine infant outcomes according to ACIP-recommended immunization and case-management by core-demographic and health care characteristics (e.g., maternal and infant provider specialties, birthing facility policies, and payer types, including VFC status).

2) Determine the proportion of HBsAg-positive pregnant women who received prenatal evaluation of hepatitis B viral load as determined by type and timing of tests (e.g., hepatitis B “e” antigen [HBeAg] and/or HBV DNA); receipt of antiviral treatment during pregnancy; demographic factors (e.g., prenatal care, specialties of providers, insurance types, countries of birth); and infant outcomes (based on completion of immunization, case-management and post-vaccination testing)

3) Assess facility-based annual reporting of the NQF hepatitis B “birth dose” vaccine coverage, and assess the reliability of the reports in a sample of facilities.

Description of Projects and Timeline

1) For Goal 1, applicants will set an objective for an achievable (ideally ≥30%, minimum 10%) increase in identified HBsAg-positive pregnant women compared to the number of women identified by the PHBPP during the previous year. Applicants will propose methods to meet this objective. Examples of approaches might include capture-recapture analysis, provider and/or birthing facility chart review, collaboration with epidemiology and surveillance health department units, and/or collaboration with large private obstetric practices. In each current year, the characteristics of identified women will be compared to those of women identified by the PHBPP during the previous year, as data permit. For each current year, characteristics of the women to be collected will include but will not be limited to provider type, insurance status, race/ethnicity, country of birth, prenatal care, parity, and infant outcomes. Although variables and databases will be uniform across Supplemental Evaluation Project (SEP) sites, the methods proposed may vary by applicant and will be finalized in collaboration with CDC. Efforts to increase identification of HBsAg-pregnant women will continue throughout the project period but will be accomplished by the end of the funding cycle.

2) For Goal 2, applicants will describe the total number and percentage of identified HBsAg-positive women evaluated for liver disease, including the results of tests for hepatitis B viral load and/or receipt of antiviral treatment during pregnancy to improve prevention of mother-to-child hepatitis B transmission. Variables and databases will be uniform across SEP sites and data collection will cover the entire project period.

3) For Goal 3, applicants will provide CDC annually with the number and type of birthing facilities within their jurisdiction that measure hepatitis B birth dose coverage according to the NQF measure specifications. In collaboration with SEP sites, applicants will determine in a sample of these facilities the reliability of the coverage reports (defined by reproducibility of the coverage result) by type of data sources and methods used to determine coverage. Reliability studies will be designed and carried out in years 2 and 3 of the project period.

Recipient Activities

Applicants will have responsibility for the following activities:

1. Align the goals, objectives, and activities of this FOA with the Program Requirements specified in the “Immunization Program Operations Manual” for PHBPP which provides guidance for fulfilling the objectives of the National Center for Immunization and Respiratory Diseases 2013 Funding Opportunity Announcement, “Immunization and Vaccines for Children Program”, CDC-RFA-IP13-1301.

2. Demonstrate capability to achieve the goals outlined in this announcement in addition to implementing routine PHBPP activities.

3. Collaborate with CDC and other SEP sites on conference calls initially at weekly intervals to develop a uniform set of variables and definitions for de-duplicated data collection, using an auxiliary database if necessary to ensure the same variables and format across project sites. Data tracking shall include assigning of a unique identifier to each mother and a corresponding link to her infant(s).

4. Finalize database variables developed as referenced in item # 3 above within 60 days after notice of an award, and commence data entry no later than 90 days after notice of an award.

5. Maintain an up-to-date database of de-duplicated, confirmed demographic, laboratory and demographic data make corrections and provide timely updates to complete missing information.

6. Submit up-to-date, de-identified, complete datasets quarterly to CDC.

7. Participate with CDC and other SEP sites in quarterly (or more frequent as needed) teleconferences to resolve issues as they arise.

8. To address Goal 1, PHBPP will set an objective for a10% minimum to an ideally ≥30% increase in identified HBsAg-positive pregnant women above the most recent annual number identified and collect demographic characteristics of the women using uniform data variables determined by the SEPs. One method for achieving this goal might be a collaboration with epidemiology and surveillance health department units, and/or collaboration with large private obstetric practices or Health Maintenance Organizations (HMOs). (See “Description and Timelines”, Goal 1 for examples). Initiate the proposed methods during year one of the award. Provide CDC data for each year of the award by the end of the first quarter of the following year.

9. To address Goal 2, collaborate with CDC and SEP sites to design a uniform set of variables that describe the screening evaluation and applicable type(s) of anti-viral treatment provided to all identified HBsAg-positive women in the jurisdiction, and the concomitant impact on infant outcomes. Data will be collected throughout the period of the award, and de-identified data will be submitted to CDC at the end of each quarter during the project. Describe the method for obtaining information on HBsAg, HBeAg, and HBV DNA testing dates and results (including negative test results), and for the dates and types of anti-viral treatment for HBsAg-positive pregnant women.

10. To address Goal 3, assess facility-based reporting of NQF measure #0475, hepatitis B vaccine birth dose coverage, by both the type of facility and the data sources employed to calculate birth dose coverage in all birthing facilities in the jurisdiction; provide CDC with the findings for the first year of the award, at the end of the first quarter of the following year, and continue this reporting for each subsequent year of the award.

11. To further address Goal 3 during the 2nd and 3rd year of the award, assess reliability of facility-based reports of hepatitis B birth dose coverage using NQF measure #0475 in a sample of facilities that use a variety of data sources. Methods to assess reliability will be determined in collaboration with CDC and other SEP sites.

12. Provide details regarding the security and confidentiality of the viral hepatitis surveillance data that is consistent with the most recent CDC NCHHSTP guidelines. Details should include: who has access to the hard-copy and electronic patient-level data; a description of the physical location where patient-level data are stored; a description of the security measures for data stored on local area networks (LANs) or other electronic storage systems; and policies and procedures for accessing the data. (For additional information, see: CDC’s Data Security and Confidentiality Guidelines for HIV, Viral Hepatitis, Sexually Transmitted Disease, and Tuberculosis Programs: Standards to Facilitate Sharing and Use of Surveillance Data for Public Health Action at: http://www.cdc.gov/nchhstp/programintegration/docs/PCSIDataSecurityGuidelines.pdf)

13. Demonstrate the capacity and health department support for activities outlined in the FOA.

14. Provide a letter of support from at least 5% (minimum two) of birthing facilities, assuring both a commitment to provide annual reports of hepatitis B birth dose coverage using the NQF measure as well as the facilities’ willingness to participate in one-time reliability testing of the results.

15. Provide evidence that any required Institutional Review of assessment activities in this funding opportunity will not delay initiation of data collection.

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

CDC Activities CDC will have “substantial involvement” in the program including the following:

1. CDC will provide technical assistance, guidance, and consultation to support and supplement development of projects to address Goals 1-3.

2. Collaborate with grantee to define variables for a cross-SEP site database and develop a data dictionary.

3. To address Goal 1, CDC will collaborate with grantee to define the sampling framework and the final design of proposed projects to evaluate the completeness of identifying HBsAg-positive pregnant women and their infants by provider type, insurance status, completion of PEP post-vaccination testing, and infant outcomes.

4. To address Goal 2, CDC will collaborate with grantee to define the variables for tests, test results, and anti-viral treatment for HBsAg-positive women during pregnancy in order to prevent perinatal hepatitis B, and thereby impact the resultant hepatitis B outcomes of their infants.

5. To address Goal 3, CDC will collaborate with grantee to define a template for annual evaluation of facility-based hepatitis B birth dose coverage. This template will be based on the sources or types of data used for the calculation and data variables for SEP site evaluation of the reliability of facility-based reporting in the 2nd or 3rd year of the funding cycle.

6. CDC will provide timely feedback on the quality and completeness of quarterly data submissions.

7. CDC will monitor progress on implementing program activities; provide technical assistance as requested and as needed when determined by CDC through site visits, conference calls, electronic correspondence, and review of progress reports.

8. CDC will develop a schedule of routine communications and lead collaborative discussions. Initiate additional communications as needed.

9. CDC will foster and support collaborations between state PHBPP, viral hepatitis surveillance and viral hepatitis prevention coordinators and other related programs (e.g., immunization, HIV, STD, etc.)

10. CDC will collaborate with SEP sites to process, analyze, interpret data, and disseminate the results.

II. AWARD INFORMATION

Type of Award: Cooperative Agreement.

Award Mechanism: U51 – Infectious Disease Assessments of Prevention, Control & Elimination Fiscal Year Funds:

Approximate Current Fiscal Year Funding:

$400,000 Approximate Total Project Period Funding:

$1,200,000 This amount is an estimate, and is subject to availability of funds. It includes direct and/or indirect costs.

Approximate Number of Awards:

2-4 Approximate Average Award for Year One:

$ 95,000 This amount is for the first 12-month budget period, and includes both direct and indirect costs.

Floor of Individual Award Range:

$ 70,000 Ceiling of Individual Award Range:

$ 200,000 This ceiling is for the first 12-month budget period. This includes direct and indirect costs.

Anticipated Award Date:

January 1, 2013 Budget Period Length:

Project Period Length:

3 years Throughout the project period, CDC’s commitment to continuation of awards will be conditioned on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the Federal government.

III. ELIGIBILITY INFORMATION

Eligible Applicants Eligible applicants that can apply for this funding opportunity are listed below:

The following entities are eligible to apply:

· The current 64 grantees with established Perinatal Hepatitis B Prevention Programs (PHBPP), which include the 50 state health departments or their bona fide agent and the District of Columbia, the cities of New York, Philadelphia, Houston, Chicago, San Antonio, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, and Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau. Competition is limited to the entities listed above because they have the primary responsibility for carrying out the public health assurance functions required to achieve the desired outcomes and performance goals established by CDC.

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

Limited competition for this RFA is justified based on the following:

This FOA is limited to State or local health department jurisdictions with established Perinatal Hepatitis B Prevention Programs (PHBPP). The PHBPP have the necessary infrastructure in place to perform the activities required, and have the experience needed to successfully complete the required objectives. PHBPP have the primary responsibility for carrying out the public health assurance functions required to achieve the desired outcomes and progress toward elimination of mother-to-children hepatitis B transmission which is a national goal of HHS, CDC, ACIP, and Healthy People 2020. PHBPP have been funded by CDC since 1990 through immunization Program grants to 64 jurisdictions in the United States, cities, territories, and freely associated island nations Key program requirements of the PHBPP programs are to identify all hepatitis B infected pregnant women and case-manage their infants for timely receipt and completion of post-exposure interventions to prevent mother-to-child hepatitis B transmission. Despite active efforts, in 2008 (last data available) PHBPPs identified approximately 50% of the expected number of births to hepatitis B infected pregnant women. Although hepatitis B birth dose provides a safety net for infants who are not identified for coverage in the United States, coverage was only 64% in 2010. Core PHBPP will continue to be supported by CDC from 2013-2017 through an immunization funding opportunity announcement # CDC-RFA-IP13-1301, “Immunization and Vaccines for Children Program”.

Required Registrations

Registering an organization through www.Grants.gov, the official agency-wide E-grant website, is the first step in submitting an application online. Registration information is located on the “Get Registered” screen of www.Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting an application to become familiar with the registration and submission processes. The “one-time” registration process will take three to five days to complete. However, the Grants.gov registration process also requires that applicants register their organization with the Central Contractor Registry (CCR) and DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) which will require up to at least 4 weeks to complete registration in its entirety. The CCR registration can require an additional two weeks to complete. Applicants are required to maintain a current registration in CCR. CCR registration must be renewed annually.

Central Contractor Registration and Universal Identifier Requirements

No foreign entity is eligible.

All applicant organizations must obtain a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number is a nine-digit number assigned by Dun and Bradstreet Information Services. An Authorized Organization Representative (AOR) should be consulted to determine the appropriate number. If the organization does not have a DUNS number, an AOR should complete the US D&B D-U-N-S Number Request Form or contact Dun and Bradstreet by telephone directly at 1-866-705-5711 (toll-free) to obtain one. A DUNS number will be provided immediately by telephone at no charge. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a DUNS number.

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

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

Other

Supplemental Evaluation Project-Perinatal Hepatitis B Prevention Program If a funding amount greater than the ceiling of the award range is requested, the application will be considered non-responsive and will not be entered into the review process. The applicant will be notified that the application did not meet the eligibility requirements.

Special Requirements:

The following additional requirements should be considered by applicants.

· Late applications are considered non-responsive. See Section IV –Submission Dates and Times for more information on deadlines.

· If the application organization is a Bona Fide agent of the health department, the organization must be located in the eligible jurisdiction and provide a letter from the state or local government as documentation of their Bona Fide agent status. This documentation should be placed behind the first page of the application form and submitted in grants.gov Note: Title 2 of the United States Code Section 1611 states that an organization described in Section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting a grant, loan, or an award.

IV. Application and Submission Information

Submission Dates and Times This announcement is the definitive guide on Letters of Intent and application content, submission, and deadline. It supersedes information provided in the application instructions. If the application submission does not meet the deadline published herein, it will not be eligible for review and the applicant will be notified the application did not meet the submission requirements.

Letter of Intent (LOI) Deadline Date:

October 09, 2012, AFTER DATE OF PUBLICATION IN GRANTS.GOV. This is not required but potential applicants are encouraged to submit so that the program can prepare for the review process.

Application Deadline Date:

November 02, 2012, PUBLICATION ON GRANTS.GOV, 11:59 pm U.S. Eastern Standard Time.

Applicants must download the SF424 application package associated with this funding opportunity from Grants.gov. If access to the Internet is not available or if the applicant encounters difficulty in accessing the forms on-line, contact the HHS/CDC Procurement and Grant Office Technical Information Management Section (PGO TIMS) staff at (770) 488-2700 email:pgotim@cdc.gov Monday-Friday 7:00am – 4:30pm U.S. Eastern Standard Time for further instruction. CDC Telecommunications for the hearing impaired or disabled is available at: TTY 1-888-232-6348.

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

Content and Form of Application Submission

Unless specifically indicated, this announcement requires submission of the following information:

· Applicants should submit one, single application package.

· A table of contents must be included with the application. The table of contents will not count toward the page limit of the project narrative for viral hepatitis prevention and surveillance programs. It must include page numbers where each section starts and a list of all application sections and appendices within the application package. A cover letter is required within the application and must contain the following information:

· The applicant’s name, address, and the name of the principal investigator/program director.

· The application cover letter must be written in the following format:

· Maximum number of page – 1

· Font size: 12 point unreduced, Times New Roman

· Single-spaced

· Paper size: 8.5 by 11 inches

· Page margin size: 1 inch

· Print only on one side of the page

Each detailed budget and narrative justification should support the activities for the first year of funding in response to this FOA and a summary narrative for the entire project period.

All applicants are required to sign and submit CDC Assurances and Certifications that can be found on the CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/grants/foamain.shtm

Letter of Intent (LOI):

LOI Submission Address: Submit the LOI by express mail, delivery service, fax, or E-mail to:

Project Officer Name: Trudy V. Murphy, MD

CDC, National Center for HIV, Viral Hepatitis, STD and TB Prevention

Address: 1600 Clifton Road, Mailstop G-37, Atlanta, GA 30333 Telephone Number: 404-639-8845

Fax: 404-718-8588

E-mail address: tkm4@cdc.gov Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CDC Program staff to estimate and plan the review of submitted applications.

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

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

· Maximum number of pages: 15. If your narrative exceeds the page limit, only the first pages which are within the page limit will be reviewed.

· Font size: 12 point unreduced, Times New Roman

· Double-Spaced

· Page margin size: One inch

· Number all narrative pages of the application (excluding the forms provided in the application package) sequentially from page 1 (application face page) to the end of the application, including charts, figures, tables, and appendices

· Printed only on one side of the page.

The narrative content will include:

· Background and Need

· Operational Plan

· Evaluation Plan/Performance Measures

· Staffing and Management

The Budget and Budget Justification will be included as a separate attachment, not to be counted in the narrative page limit.

Additional Information may be included in the application appendices. The appendices will not be counted toward the narrative page limit. This additional information might include:

· Curriculum Vitas

· Resumes,

· Organizational Charts,

· Letters of Support

· Statues providing authority for data collection.

· Additional relevant descriptions of Perinatal Hepatitis B Prevention Program structure and outcomes.

Additional information submitted via Grants.gov should be uploaded in a PDF file format, and should be named:

· “Other Attachments Forms” to be titled/named when uploaded under Mandatory Documents into Grants.gov (i.e., Curriculum vitae, Letters of Support, etc.).

Requirements for additional documentation with the application are listed in Section VII. Award Administration Information, subsection entitled “Administrative and National Policy Requirements.”

The narrative should address activities to be conducted over the entire project period and must provide specific information for the activities during the first year, to include the following items in the order listed.

A. Background and Need

1. Describe the current PHBPP infrastructure, including state and local levels, if appropriate. Include the annual number of infants identified from 2008-2010 and expected number of infants born to HBsAg-positive pregnant women for 2008, the methods for identifying the HBsAg-positive pregnant women and their infants, including birth certificates, metabolic screening cards if used. Provide hypotheses for not meeting or for exceeding identification of the expected number of births, as appropriate. Indicate the proportion of infants identified who are case-managed initially and to completion, including obtaining documented post-vaccination testing results.

2. Describe ongoing data collection at an individual level for laboratory, demographic, and/or clinical information that would assist in assessing the effectiveness of the PHBPP and post-exposure vaccination prevention strategies. Describe existing tracking systems for this information.

3. Describe existing collaborations between the PHBPP and other health department units (e.g., viral hepatitis coordinators, epidemiology and surveillance, HIV prevention) for identifying HBsAg-positive women and for referring these women for evaluation and care, for screening and vaccination of their household and sexual contacts, and for reporting hepatitis B infected infants and adults to the National Notifiable Diseases Surveillance System (NNDSS).

4. Describe the number of birthing facilities by type in the jurisdiction, and how overall hepatitis B birth dose coverage for the jurisdiction is determined. Describe relevant collaborations with outside parties, partners, or agencies.

5. Identify gaps and barriers to improved outcomes of infants born to HBsAg-positive pregnant women and routine birth dose vaccination.

B. Operational Plan

The Year One operational plan contains both the narrative supporting the project objectives and the annual plan for the first year of the project. In addition, the plan will include a description of how the applicant will address the recipient activities, the goals and objectives to be achieved during the project period along with methods and timelines for accomplishing them. The project objectives are to be specific, measurable, achievable, relevant, and time-phased, and the methods proposed for accomplishing them should be feasible.

· To address Goal 1, describe the PHBPP objective and methods for increasing identification of HBsAg-positive pregnant women, including women who might not be screened during each pregnancy and/or who are managed in the private sector and not reported to the PHBPP. Describe how finding HBsAg-positive pregnant women using these methods will contribute toward elimination of perinatal hepatitis B transmission.

· To address Goal 2, describe how existing data on key variables will be obtained, including but not limited to:

· For HBsAg-positive women: race/ethnicity, country of birth, parity, estimated date of delivery, date of delivery, birthdate, specialty of each provider, insurance type, HBsAg or other tests for screening, and hepatitis B tests performed to evaluate viral load during pregnancy (HBV DNA, HBeAg), test dates and results, name of anti-viral treatment medications and dates administered during pregnancy, and history of hepatitis B outcomes for infants born in previous pregnancies.

· For infants: birthdate, birth weight, gestational age if < 38 weeks, hour of administration after birth of HBIG and first dose of hepatitis B vaccine, dates and types of hepatitis B vaccine, post-vaccination testing dates and results, any subsequent management, including revaccination, testing and results, infant provider specialties, insurance type.

· To address Goal 3, describe how annual reporting by birthing facilities of the National Quality Forum (NQF) specified hepatitis B birth dose coverage will be assessed, including the data sources used by the birthing facility to determine coverage, and provide evidence of facility support for determining the reliability of the coverage estimate in a sample of facilities.

· Identify anticipated barriers and challenges for reaching the specific funding opportunity goals, and provide solutions for overcoming them.

C. Evaluation Plan/Performance Measures

1. Describe the procedures currently used or planned to monitor the performance of the data collection, completeness of reports, and timeliness of reporting.

2. Discuss plans to assign a unique identifier to each HBsAg-woman and her respective infant(s), and to monitor and achieve “de-duplication” of records such that each pregnant woman and each infant represents a unique individual.

3. Describe procedures for timely correction of data and/or gathering of missing data.

D. Staffing and Management

1. Describe the staffing plan (to include at least one senior staff member who will be responsible for scientific direction of the program) and how this plan will accommodate the requirements of this funding opportunity.

2. Describe how the proposed program will be managed, including the location of the program within the applicant organization.

3. Include in an attachment:

a. A job description for each position, specifying job title and general duties, for staff funded through this…