Amendments made to LOI and application deadline dates.

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention (CDC)

Viral Hepatitis: Cooperative Agreement for Networking, Education, and Training

Announcement Type: New – Type 1

Funding Opportunity Number: CDC-RFA-PS08-862

Catalog of Federal Domestic Assistance Number: 93.283

Key Dates: Letter of Intent Deadline: June 6, 2008

Application Deadline: July 11, 2008

Executive Summary: The purpose of the program is to announce the availability of fiscal year (FY) 2008 funds for a cooperative agreement program for viral hepatitis prevention control networking, education, and training activities that target persons at risk for viral hepatitis. The Division of Viral Hepatitis (DVH) mission is to decrease the incidence of new infections with hepatitis A virus (HAV), hepatitis B virus (HBV), and hepatitis C virus (HCV); increase the identification and appropriate management of individuals chronically infected with HBV or HCV in order to decrease associated risks for chronic liver disease, cirrhosis, and liver cancer; and integrate viral hepatitis prevention and control into existing education, training, and/or service delivery activities. Drawing from these national guidelines for the United States, HHS/CDC has identified seven priority goals be funded under this announcement. Where appropriate, specific priority populations for that goal have also been identified. With these goals in mind, HHS/CDC seeks proposals that address one of the following four categories of activities:

Category A – Networking, Partnership, and Information Dissemination

Category B – Health Education Program

Category C – Diffusion of Effective Programs

Category D – Professional Education

This announcement contains the following information:

Table of Contents

Synoptic Overview/Executive Summary....................................................................................

Funding Opportunity Announcement # PS08-862 - Acronyms.................................................

I. Funding Opportunity Description ..........................................................................................

Authority and Background.................................................................................................

Purpose.............................................................................................................................

Priority Goals and Populations...........................................................................................

Category A Activities.........................................................................................................

Category B Activities.........................................................................................................

Category C Activities.........................................................................................................

Category D Activities.........................................................................................................

Awardee Activities for All Priorities....................................................................................

CDC Activities for All Priorities.........................................................................................

II. Award Information.................................................................................................................

III. Eligibility Information..........................................................................................................

III.1. Eligible Applicants.....................................................................................................

III.2. Cost Sharing Matching..............................................................................................

III.3. Other........................................................................................................................

IV. Application and Submission Information.............................................................................

IV.1. Address to Request Application Package..................................................................

IV.2. Content and Form of Submission/Letter of Intent.......................................................

Applications for Category A.....................................................................................

Applications for Category B......................................................................................

Applications for Category C.....................................................................................

Applications for Category D.....................................................................................

IV.3. Submission Dates and Times.....................................................................................

IV.4. Intergovernmental Review of Applications.................................................................

IV.5. Funding Restrictions..................................................................................................

IV.6. Other Submission Requirements................................................................................

V. Application Review Information...........................................................................................

V.1. Criteria.....................................................................................................................

Criteria for Category A.............................................................................................

Criteria for Category B ............................................................................................

Criteria for Category C.............................................................................................

Criteria for Category D.............................................................................................

V.2. Review and Selection Process....................................................................................

V.3. Anticipated Announcement Award Dates...................................................................

VI. Award Administration Information......................................................................................

VI.1. Award Notices ........................................................................................................

VI.2. Administrative and National Policy Requirements.......................................................

VI.3. Reporting Requirements............................................................................................

VII. Agency Contacts.................................................................................................................

VIII. Other Information..............................................................................................................

Funding Opportunity Announcement PS08-862 - Acronyms

ACIP Advisory Committee on Immunization Practices

AOR Authorizing Organization Representative

ATSDR Agency for Toxic Substances and Disease Registry

FOA Funding Opportunity Announcement

CCR Central Contractor Registry

CDC Centers for Disease Control and Prevention

CEU Continuing Education Units

CME Continuing Medical Education

CNE Continuing Nursing Education

DVH Division of Viral Hepatitis

DUNS Data Universal Numbering System

eRA Commons Electronic Research Administration System

FTE Full-Time Equivalent

FY Fiscal Year

GMO Grants Management Officer

HHS U.S. Department of Health And Human Services

HAV Hepatitis A Virus

HBV Hepatitis B Virus

HBsAg Hepatitis B Surface Antigen

HCV Hepatitis C Virus

HIV Human Immunodeficiency Virus

IDU Injection Drug User

LOI Letter of Intent

MOA Memorandum of Agreement

MOU Memorandum of Understanding

MMWR Morbidity and Mortality Weekly Report

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

NGO Non-Governmental Organization

NoA Notice of Award

NIH National Institutes of Health

OMB Office of Management and Budget

PDF Portable Document Format

PD/PI Program Directors/Principal Investigators

PGO Procurement and Grants Office

SF Standard Form

STD Sexually Transmitted Diseases

TIMS Technical Information Management System

I. Funding Opportunity Description

Authority: This program is authorized under Sections 301 and 317N of the Public Health Service Act (42 U.S.C. section 241 and 247b-15), as amended. The Catalog of Federal Domestic Assistance number is 93.283.

Background: Adults in the United States continue to be at risk for hepatitis A virus (HAV), hepatitis B virus (HBV), and hepatitis C virus (HCV) infections and their sequelae. Despite recommendations and effective vaccines to prevent both HAV and HBV infections, in 2006, an estimated 32,000 persons were newly infected with HAV and 46,000 with HBV. Rates of hepatitis A have been declining dramatically since the licensure of hepatitis A vaccine and implementation of National Advisory Committee on Immunization Practices (ACIP) recommendations for its use (see links on p.6). Hepatitis B incidence has also declined in recent years, and vaccination recommendations for infants, children, and adolescents have been implemented with considerable success; infant hepatitis B vaccination coverage is now equivalent to that of other childhood vaccines. However, there remain a substantial number of unvaccinated adults at risk for HBV infection and an estimated 1.25 million persons living with chronic HBV infection.

Despite the successes, hepatitis A and hepatitis B continue to be among the most prevalent vaccine preventable diseases in the United States, with most new infections occurring among adults as a result of ongoing risk behaviors and low rates of vaccination. The human toll is significant: complications of HBV-associated acute and chronic liver disease lead to approximately 5,000 deaths every year in the United States. Each year, hepatitis A and B are estimated to cost Americans billions of dollars in direct and indirect costs. Persons with chronic HBV infection need essential prevention services and medical management to decrease risks for chronic liver disease; however, many are not aware of their infection nor of the serious consequences of chronic HBV and are not counseled or receiving needed care.

Although the incidence of new HCV infections has also declined over the years to an estimated 19,000 cases in 2006, approximately 1.8% of the U.S. population, or 3.2 million persons, are living with chronic HCV infection. Chronic HCV infection is the leading cause of liver cancer and the most common reason for liver transplantation in the United States. Hepatitis C has been referred to as a “silent epidemic” because many of the millions of people who are infected do not experience symptoms for decades after they are first infected. In addition, 25%-30% of the estimated 1 million Americans living with human immunodeficiency virus (HIV), which causes AIDS, are co-infected with HCV; end stage liver disease associated with HCV is now a major cause of death among people living with HIV/AIDS. Despite the standard of care for all HIV-infected persons to be screened for HCV and for all co-infected patients to receive comprehensive care, too many patients do not receive appropriate screening and care. CDC and numerous other organizations recommend HCV testing and treatment, since direct and indirect costs associated with HCV infection each year are estimated to run in the hundreds of millions of dollars.

Purpose: The purpose of the program is to announce the availability of fiscal year (FY) 2008 funds for a cooperative agreement program for viral hepatitis prevention and networking, education, and training activities that target persons at risk for viral hepatitis and help eliminate health disparities. (A health disparity is the difference that separates a group of interest from a reference group for an health indicator, as measured by a rate, proportion, mean, or some other objective measure. Populations include racial and ethnic minorities, women, incarcerated persons, sexual minorities and other persons disproportionately affected by viral hepatitis, HIV/AIDS, and STDs.) DVH mission is to decrease the incidence of new infections with hepatitis A virus (HAV), hepatitis B virus (HBV), and hepatitis C virus (HCV); increase the identification and appropriate management of individuals chronically infected with HBV or HCV in order to decrease associated risks for chronic liver disease, cirrhosis, and liver cancer; and integrate viral hepatitis prevention and control into existing education, training, and/or service delivery activities.

National ACIP and CDC guidelines for the prevention and control of viral hepatitis have identified specific populations at increased risk for HAV, HBV, and HCV infection and have recommended strategies for reducing infections among these populations, including, where applicable, vaccination, screening, and education of patients, as well as training the health professionals involved in their care. See relevant recommendations for hepatitis A (MMWR 2006; 55 [No.RR-7], hepatitis B (MMWR 2005; 54 [No. RR-16] and MMWR 2006; 55 [No.RR-16]), and hepatitis C (MMWR 1998; 47 [No. RR-19] at:

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5507a1.htm http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5416a1.htm?s_cid=rr5416a1_e

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5516a1.htm?s_cid=rr5516a1_e

http://www.cdc.gov/mmwr/preview/mmwrhtml/00055154.htm

Drawing from these U.S. guidelines, CDC has identified several priority goals to be addressed under this announcement. Where appropriate, specific priority populations have also been identified. These priority goals and populations are as follows:

Increase integration of viral hepatitis prevention services into existing public and private clinical services.
Increase health professional knowledge, skills, and ability to conduct appropriate risk assessments to identify, counsel, and medically manage persons at risk for or with viral hepatitis.
Enhance counseling skills of and testing by health professionals serving populations at risk for HAV, HBV, and/or HCV infection, which may include:

Ø Integration with STD/HIV or substance abuse services

Increase vaccination among adults at increased risk for HBV infection:

Ø Men who have sex with men (along with hepatitis A vaccine)

Ø Settings that serve populations at increased risk for HBV infection

Educate and screen persons at increased risk for chronic HBV infection; counsel persons with chronic HBV infection and refer them for medical management:

Ø Asian Pacific Islanders (Asian Americans, Native Hawaiians and other Pacific Islanders)

Ø Recently pregnant hepatitis B surface antigen (HBsAg)-positive women and their household contacts and sex partners

Ø Africans and other foreign born persons from HBV-endemic countries

Increase the capacity of public health professionals to perform risk reduction counseling and service delivery for at risk populations to prevent new HCV infections:

Ø Current injection drug users (IDUs)

Ø Persons with HIV infection

Ø Inmates of correctional facilities (including current, recently released, or participants in re-entry programs).

Educate and screen persons at increased risk for chronic HCV infection, counsel persons with chronic HCV infection, and refer them for medical management:

Ø Current injection drug users

Ø Persons with a past history of injection drug use who are unaware of their infection status:

Ø HIV/HCV co-infected individuals

Ø Other populations at increased risk for HCV

HHS/CDC seeks proposals that address one of the following four categories of activities that reference the above priority goals and populations. If an organization wishes to apply for more than one category, separate applications are required for each category.

Category A – Networking, Partnership, and Information Dissemination

The purpose of this category is to (1) build and sustain strong, broad based partnerships and maintain strategic alliances with other stakeholders working in viral hepatitis prevention and control and enable these organizations to speak with a collective voice on issues affecting viral hepatitis prevention programs, practices, and policies at national, state, and local levels; (2) develop, maintain, and use a communications network (or enhance an existing network) among the nation’s public health and health professionals working in viral hepatitis prevention to regularly disseminate information, education, training, policy and other materials on viral hepatitis; (3) promote awareness of the burden of viral hepatitis among national and state public and private opinion leaders, employers, health care organizations, and others who influence public health policy, and service delivery; (4) promote awareness of viral hepatitis among the national and regional media and develop viral hepatitis specific media tools for use by network organizations and other stakeholders; (5) catalog and track the public and private assets of the nation’s viral hepatitis prevention and control efforts, including: [a] descriptions of best practices of viral hepatitis prevention and control activities occurring in local jurisdictions, [b] education and training materials developed by network members, [c] effective prevention and control policies at the local level settings, [d] public and private funding opportunities, and [e] resource directories of viral hepatitis services. The activities under this category are considered cross-cutting and cover all the goals and populations mentioned above, i.e., the activities should address HAV, HBV, and HCV; acute and chronic infections; and primary and secondary prevention.

Required Activities for Category A:

1. Applicants will build collaborative partnerships with national organizations, state and local health departments, and other health related organizations to promote awareness of the burden of viral hepatitis among opinion leaders, health care organizations, and others who influence public health policy, allocation of resources, and service delivery.

2. Applicants will develop or strengthen partnerships or coalitions with other agencies, nongovernmental organizations, voluntary associations, community groups, and others interested in promoting and improving viral hepatitis services.

3. Applicants will build and/or expand ongoing communication vehicles (e.g., listservs, newsletters, conference calls, meetings) to facilitate problem solving and information exchange among organizations involved in viral hepatitis prevention and control.

4. Applicants will implement strategies for sharing resources, experiences, skills, expertise, and lessons learned so that member organizations and other stakeholders can improve the delivery, effectiveness, and sustainability of their programs.

5. Applicants will collaborate with HHS/CDC to develop, disseminate, and regularly update a resource directory of national and state level organizations, resource centers, treatment centers, etc., that can help patients and their health care providers find local viral hepatitis-related prevention, screening, and/or treatment services. This resource directory should provide up to date state by state listings of major public, nonprofit, public and private organizations (e.g., the state chapter of a liver related organizations, major medical centers, state social service or public health agencies) that can provide names of local clinics, care providers, support groups, etc.

6. Applicants will work with public, private, and nonprofit organizations to enhance program sustainability by identifying or securing additional funding options, in-kind support, or collaboration opportunities.

7. Applicants will collaborate with HHS/CDC to identify, collect, and disseminate educational information and resource materials for network organizations and other stakeholders, including:

national and state viral hepatitis profiles to be used to educate media, policy makers, and private and public organizations about the burden of viral hepatitis and the need for integrated service delivery
a media toolkit that can be used by member organizations to educate national, state, and local media about the burden of viral hepatitis
other media and communications tools and templates (e.g., press releases, fact sheets, briefing materials) for state and local adaptation
descriptions of best practices of viral hepatitis prevention and control activities occurring in local jurisdictions, as well as effective prevention and control policies at the local level settings
annotated catalogue of education and training materials developed by the network and other organizations
listing of public and private funding opportunities

Under this category, no more than two organizations will be funded. If two organizations are funded, the work plans of each will be negotiated between CDC and the awardees to ensure that work performed is mutually exclusive and does not duplicate efforts.

Category B – Health Education Program

The purpose of this category is to 1) implement a health education program designed to improve viral hepatitis prevention and control and achieve one or more of goals D, E, F, or G and their respective priority populations; 2) conduct formative evaluation on how to best tailor the strategies, materials, services, and/or program for the specific setting or context selected; 3) conduct process and outcome evaluation to assess the success of the program in achieving its objectives; 4) use the information gained to provide feedback and refine the program; 5) devise strategies to ensure program sustainability; and 6) produce documents, materials and/or trainings that help share lessons learned with others attempting to develop or implement similar programs. The activities under this category should address goals D, E, F, or G.

Proposed health education programs and their evaluation should meet the criteria set forth as “non-research” as outlined by Guidelines for Defining Public Health Research and Public Health Non-Research, available at http://www.cdc.gov/od/science/regs/hrpp/researchDefinition.htm. The primary intent of the proposed program should be to improve viral hepatitis prevention and control services, and the intended benefits of the project must be primarily for the clients of the proposed settings. Evaluation data should primarily be designed to assess and/or improve the program or service.

Health education is defined as a planned and multi-faceted set of learning activities designed to facilitate voluntary adaptations conducive to health and involves the process of assisting individuals, acting separately and collectively, to make informed decisions on matters affecting individual, family, and community health. Health education programs can involve one or more levels of influence, including intrapersonal or individual, interpersonal or small groups, institutions or organizations, and/or community level interventions. They may be implemented in a variety of settings, including worksites, clinical settings, or in the broad community.

Successful health education programs typically are theory based; draw upon existing knowledge of best or evidence based practice; are comprehensive and multi faceted in nature; match clear goals and objectives with proven strategies; go beyond information dissemination and change attitudes, behaviors, and skills; recognize the importance of creating supportive systems and environments; and are flexible, responsive, and persevering.

Required Activities for Category B:

1. Plan the components of a health education program that will help achieve the specified goal for the selected population.

2. Conduct needs assessments and environmental scans of the potential implementation sites in order to identify barriers and/or facilitators to the successful implementation of the health education program.

3. Modify the program as appropriate, based upon the findings of the needs assessment and conduct formative research with members of the target audience to ensure acceptability, appropriateness, and feasibility.

4. Develop an implementation plan, including:

a. The core components and specific elements of the health education program

b. Who should do what by when

c. Resources and supports needed and those already available

d. Anticipated barriers and/or resistance and planned counteractions

e. Strategies to reach the identified populations

f. Collaborators and partner organizations that are needed for implementation and their roles and responsibilities.

5. Implement the programs in a manner that ensures maximum public health impact (e.g., large numbers of at-risk individuals reached).

6. Evaluate the program using process indicators (e.g., number of individuals reached), as well as short term and long term indicators (e.g., changes in knowledge and skills, reduction of unhealthy behaviors, increase in vaccination).

7. Document the success of the program diffusion and produce evaluation reports and/or manuscripts that describe the program, the target population, how the evaluation was conducted, and how the results improved the existing services at that program.

8. Develop and disseminate strategies, documents, and/or training materials to enhance the improvement of existing viral hepatitis programs.

Under this category, no more than five organizations will be funded for goals D, E, F and G combined. If two or more organizations are targeting the same population, the work plans of each will be negotiated between CDC and the awardees, if necessary, to ensure that health education programs are not in conflict with each other. Funding decisions will be based on preferences specified in Section V.2: Review and Selection Process.

Category C Activities: Diffusion of Effective Programs

Professionals and organizations working in viral hepatitis prevention and control have not had significant resources devoted to either extensive intervention research or program evaluation. Nonetheless, with limited or decreasing budgets combined with increasing demand for services, the field could benefit from the diffusion of programs and practices with the highest quality evidence or program evaluation. The activities under this category should address goals D, E, F, or G. The purpose of this category is to 1) to identify an organization's existing viral hepatitis related best practice or model health education program that has successfully addressed one or more of goals D, E, F, or G and their respective priority populations; 2) expand the availability of these programs to organizations or geographical areas serving the same or other priority population(s); 3) document the program’s implementation in order to enhance its widespread adoption and institutionalization.

Required Activities for Category C:

1. Describe the components of a best practice or model health education program that has successfully addressed one or more of goals D, E, F, or G and their respective priority populations.

2. Conduct needs assessments and environmental scans of proposed expansion areas in order to identify barriers and/or facilitators affecting the successful expansion of the program.

3. Modify the program as appropriate, based upon the findings of the needs assessment.

4. Develop strategies and training that will retain the program’s integrity and achieve similar positive outcomes for other target populations and ensure the successful adoption of the model program.

5. Implement the program in a manner that ensures maximum public health impact (e.g., large numbers of at-risk individuals reached).

6. Evaluate the diffusion of the model program using process indicators (e.g., number of individuals reached), as well as short term and long term indicators (e.g., changes in knowledge and skills, reduction of unhealthy behaviors, increase in vaccination).

Category D – Professional Education:

The purpose of this category is to 1) develop, evaluate, and disseminate viral hepatitis prevention and control training and educational courses, materials, self-study applications, and/or other educational activities that meet the needs of public and private sector health professionals (e.g., physicians, other clinicians, disease intervention specialists, counselors, health educators, administrators, and/or others responsible for providing viral hepatitis prevention services); and 2) increase the capacity of professionals to integrate viral hepatitis into existing primary care and STD/HIV service delivery activities. The activities under this category should address goals A, B, and/or C.

Training may use any appropriate and established methods, formats, and delivery means, including trainings or seminars; distance learning or satellite courses; and self-study professional education in print, internet, or CD-ROM formats. Training and educational courses, materials, and activities should be evidence and science based and congruent with CDC recommendations, guidelines, programs, and initiatives. Selected methods should use specific techniques to engage adult learners, such as case studies, problem solving exercises, interactive techniques, videotaping exercises, or hands on clinical experience with surrogate patients. In addition, the development and delivery of training and educational programs should employ faculty, trainers, and preceptors with appropriate credentials and demonstrated expertise in viral hepatitis and/or related diseases, such STDs and HIV/AIDS. It is strongly recommended that proposed professional education activities provide a mechanism for awarding continuing medical education (CME) credit, continuing nursing education (CNE) credit, and other continuing education units (CEUs) as appropriate. Credits should be offered at minimal or no cost to participants.

Required Activities for Category D:

1. Conduct an initial assessment of education and training needs from available information sources, including previous or current assessments and training activities; input from CDC/DVH and other federal or national organizations; state or local health department viral hepatitis programs, and other key stakeholders (e.g., STD and HIV/AIDS organizations, programs, or services).

2. Prepare an initial training plan based upon the needs assessment and describe the proposed implementation of the plan. The plan should include:

a. format, number, and type of training activities to be developed and implemented

b. number and type of health professionals expected to participate in those activities

c. system for awarding CEUs

d. strategies to promote available training activities

e. timeline for such activities

f. evaluation plan and instruments

3. Training plans should be updated and revised annually to reflect the ongoing or evolving training needs of constituents.

4. Implementation of the training plan must include strategies to widely promote the training activities to ensure a maximum number of participants.

5. Training activities should be monitored with process indicators (e.g., trainee demographics, ratings of course quality, relevance to practice), as well as short term training outcome indicators (e.g., changes in knowledge and skills) whenever appropriate. If feasible, medium term training outcome indicators (e.g., application of knowledge and skills to practice or delivery of services) should be developed for a select number of training activities.

No more than two organizations will be funded in this category. If two organizations are funded, the work plans of each will be negotiated between CDC and the awardees to ensure that work performed is does not duplicate efforts.

This program addresses the “Healthy People 2010” focus area(s) of Immunization and Infectious Diseases available at http://www.healthypeople.gov/About/hpfact.htm .

Measurable outcomes of the program will be in alignment with one (or more) of the following performance goal(s) for the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP): Reduce Viral Hepatitis.

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 public health non-research, please see the CDC Web site at the following Internet address: http://www.cdc.gov/od/science/regs/hrpp/researchDefinition.htm

Activities:

Awardee activities for this program are as follows, and apply to all categories above:

1. Develop an annual work plan that will be negotiated with and approved by CDC/DVH that addresses the required activities. The work plan should contain:

a. Within the first budget period, the applicant will develop a program inventory and a five year strategic plan, with five year goals (broad statements of program purpose describing the expected long term effect(s) of a program, addressing the program’s effects in viral hepatitis prevention and control). In subsequent budget years, the applicant will review and, if appropriate, revise the work plan in collaboration with CDC/DVH.

b. Objectives written in SMART format (specific, measurable, achievable, realistic, and time phased); rationale for each proposed objective; primary person/agency responsible for accomplishing the objective; methods to monitor progress towards achieving those objectives.

c. Activities, strategies, and tactics planned to address each proposed objective; primary person/agency responsible for accomplishing the activity.

d. Timeline of proposed objectives and activities.

2. Share training, education, and other materials with CDC in their development to ensure consistency with national recommendations and CDC/DVH policies.

3. Develop a carefully designed and well planned evaluation plan to monitor progress on activities and to assess the timeliness, completeness, and success of the project. The plan should be based on a clear rationale relating the activities within the cooperative agreement. Wherever realistic and possible, the measurement of progress toward goals should focus on health outcome indicators, rather than on intermediate processes or outputs. See Updated Guidelines for Evaluating Public Health Surveillance Systems at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5013a1.htm and Framework for Program Evaluation in Public Health at http://www.cdc.gov/mmwr/PDF/RR/RR4811.pdf

4. Develop and describe strategies to ensure program sustainability beyond the project funding period.

5. Participate with the CDC project officer in required conference calls, site visits, annual meetings, as well as other forums as requested, to discuss progress of program activities.

6. Ensure that materials developed under this cooperative agreement are developed for the public domain and that they are provided to CDC to share broadly among those working in viral hepatitis prevention and control.

7. Document and disseminate program results through presentations, reports, and manuscripts.

8. Collaborate and share information in available forums on effective viral hepatitis prevention and control activities with CDC and other Federal, national, state, and local agencies working in viral hepatitis prevention and control.

Awardee activities may be modified during the project period, if necessary, to respond to changes in viral hepatitis incidence and prevalence; advances in viral hepatitis prevention, screening, and treatment; changes in the training needs of health care professionals and prevention specialists; and/or changes in DVH or NCHHSTP performance goals or initiatives.

In a cooperative agreement, CDC staff are substantially involved in the program activities, above and beyond routine grant monitoring. CDC activities for this program are as follows:

1. Collaborate and provide consultation and technical assistance in the planning and implementation of program activities.

2. Provide guidance, support, and monitor grantee success in their programmatic and fiscal activities through review of work plans, technical assistance, consultation, site visits, conference calls, and budget review and approval.

3. Disseminate current information, including best practices, in all areas of viral hepatitis prevention and control.

4. Disseminate information about new viral hepatitis-related policies, recommendations, and testing technologies that are released during the project period.

5. Assist with the development and review of proposed training and education materials.

6. Monitor the organization’s progress toward achieving stated objectives and provide guidance and recommendations for program modifications.

7. Provide consultation and technical assistance in the development of monitoring and evaluation activities, as well as the interpretation of program evaluation data.

8. Facilitate communication among organizations, such as holding regular conference calls, annual meetings, and seminars among recipients and other CDC partners to foster information sharing, collaboration, and peer to peer technical assistance.

9. Provide opportunities for funded partners to share successes and lessons learned through meetings, workshops, conferences, newsletter development, the Internet, and other avenues of communication.

10. Collaborate with the grantee on the presentation and publication of the project’s findings and evaluation results.

II. Award Information: for all categories A, B, C, D

Type of Award: Cooperative Agreement. HHS/CDC’s involvement in this program is listed in the Activities Section above.

Award Mechanism: U54 - Specialized Center- Cooperative Agreements in Occupational Safety and Health Research

Fiscal Year Funds: 2008

Approximate Current Fiscal Year Funding: $ 1,000,000

Approximate Total Project Period Funding: $ 5,000,000 (This amount is an estimate, and is subject to availability of funds.) This amount includes direct and/or indirect costs.

Approximate Number of Awards: nine

Approximate Average Award: $ 100,000 (This amount is for the first 12 month budget period, and includes both direct and/or indirect costs)

Floor of Individual Award Range: $ 80,000 (direct and indirect costs)

Ceiling of Individual Award Range: $ 150,000 total cost, including indirect costs. (This ceiling is for the first 12 month budget period.)

Anticipated Award Date: August 31, 2008

Budget Period Length: 12 months

Project Period Length: Five year budget period

Throughout the project period, HHS/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 is applicable to all categories of A, B, C, and D

III.1. Eligible Applicants

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

· Nonprofit with 501C3 IRS status (other than institution of higher education)

· Nonprofit without 501C3 IRS status (other than institution of higher education)

· For-profit organizations (other than small business)

· Small, minority, and women-owned businesses

· Universities

· Colleges

· Research institutions

· Hospitals

· Community based organizations

· Faith based organizations

· Federally recognized or state recognized American Indian/Alaska Native tribal governments

· American Indian/Alaska native tribally designated organizations

· Alaska Native health corporations

· Urban Indian health organizations

· Tribal epidemiology centers

· State and local governments or their Bona Fide Agents (this includes the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau)

Political subdivisions of States (in consultation with States)

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 letter from the state or local government as documentation of the status is required. Attach with “Other Attachment Forms” when submitting via www.grants.gov .

III.2. Cost Sharing or Matching

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

III.3. Other

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 submission requirements.

Special Requirements:

If the application is incomplete or non-responsive to the special requirements listed in this section, it will not be entered into the review process. The applicant will be notified the application did not meet submission requirements.

Late applications will be considered non-responsive. See section “IV.3. Submission Dates and Times” for more information on deadlines.
The applicant should identify which goal(s) and population(s) are being targeted, and under which category they are submitting an application. This information should be specified in the ‘Executive Summary’ section, as well as in ‘Background, Need, and Impact’ section. If the application does not specify this information or address one of the priority goals and populations listed in this announcement, it will fail to meet the criteria for eligibility and the application will not be reviewed further.
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 is applicable to all categories of A, B, C, and D

IV.1. Address to Request Application Package

To apply for this funding opportunity use the application forms package posted in Grants.gov.

Electronic Submission:

CDC requires the applicant to submit the application electronically by utilizing the forms and instructions posted for this announcement on www.Grants.gov, the official Federal agency wide Egrant Web site.

Registering the applicant’s organization through www.Grants.gov is the first step in submitting applications online. Registration information is located in the “Get Registered” screen of www.Grants.gov. While application submission through www.Grants.gov is optional, HHS\CDC strongly encourage applicants to use this online tool.

Please visit www.Grants.gov at least 30 days prior to filing the applicant’s application to familiarize the applicant with the registration and submission processes. Under “Get Registered,” the one-time registration process will take three to five days to complete; however, as part of the Grants.gov registration process, registering the applicant’s organization with the Central Contractor Registry (CCR) annually, could take an additional one to two days to complete. HHS\CDC suggest submitting electronic applications prior to the closing date so if difficulties are encountered, applicants can submit a hard copy of the application prior to the deadline.

If access to the Internet is not available, or if there is difficulty accessing the forms online, contact the CDC Procurement and Grants Office Technical Information Management Section (PGO-TIMS) staff at 770-488-2700 and the application forms can be mailed.

IV.2. Content and Form of Submission

Letter of Intent (LOI):

Although a letter of intent (LOI) is not required, a one page courtesy LOI is requested from applicants planning on submitting an application. This information will assist CDC in anticipating the number of applications for each Category and for planning for the review process. Applicants should submit one LOI per anticipated application. The LOI is to be sent electronically by email (either in the body of the email text, or as a PDF file format attachment) to hepatitis@cdc.gov and is due 30 days after date of publication. The information submitted within the LOI will not be scored as part of the application review process.
The LOI, if submitted as a PDF file format, should be no longer than two pages single spaced, using 12 point unreduced, Times New Roman, standard 8.5 by 11 inches paper with one inch margins; and contain the following information:

§ Number and title of this program announcement

§ The organization’s name and address, including the postal address, phone number, fax number, and email address of the primary contact person

§ The name of the organization’s executive director and the name of the primary contact person.

§ The category under which the organization is applying (e.g., Category A, Category B, Category C, or Category D)

§ The name of the program applicants propose to perform under this program announcement.

§ The goal(s) and populations targeted by the proposed program.

Application:

A Project Abstract must be submitted with the application forms. All electronic project abstracts must be uploaded in a PDF file format when submitting via Grants.gov. The abstract must be submitted in the following format, if submitting a paper application:

Maximum of 2-3 paragraphs.

Font size: 12 point unreduced, Times New Roman
Single spaced
Paper size: 8.5 by 11 inches
Page margin size: One inch

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. All electronic narratives must be uploaded in a PDF file format when submitting via Grants.gov. The narrative must be submitted in the following format, if submitting a paper application:

Maximum number of pages: 50. If the applicant’s 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
Paper size: 8.5 by 11 inches
Page margin size: One inch
Printed only on one side of page.
Number all narrative pages; not to exceed the maximum number of pages.
Paper application should be held together only by rubber bands or metal clips; not bound in any other way.

The narrative should address activities to be conducted over the entire project period and must include the following items in the order listed:

Application Content for Category A: Networking, Partnership, and Information Dissemination

Executive Summary (no more than 1 page) for each category (A, B, C, D) for which the applicant is applying.

Concisely and comprehensively describe overall proposed activities and goals of the project, state the category for which funding is requested, and clearly identify which goal(s) and population(s) are being targeted.

Applicant Content for Category A:

1. Background, Need, and Impact (no more than 7 pages)

a. Describe the need for and benefits of national viral hepatitis networks and partnerships.

b. Demonstrate knowledge of existing networks, identify gaps in viral hepatitis prevention and control, and document a clear need for the proposed program activities.

c. Describe how the proposed national activities enhance or complement existing or planned public health activities of the applicant’s organization.

d. Demonstrate how partnerships, networking, and resources have the potential for significant impact and benefit for improving the public’s health.

2. Technical Approach and Work Plan (no more than 12 pages)

a. Describe response to the required activities, and present feasible goals and key strategies to meet the proposed objectives.

b. Present a work plan that includes project goals and objectives that are specific, measurable, achievable, realistic, and time phased (SMART).

c. Present a realistic timeline for the five year period in which activities are sequential, build upon the previous year, and culminate in enhanced networks and improved tools and resources for organizations working in viral hepatitis prevention and control.

d. Identify the key organizations to be included in the network and outline their roles and relationship to the applicant.

e. Include a diverse group of organizations (e.g., representing different types of viral hepatitis, constituents, interests, etc.), present strategies for achieving the stated objectives, and describe how partners will be involved.

f. Describe existing or proposed communication channels or vehicles suitable for disseminating information to key stakeholders.

g. Propose methods and activities consistent with published CDC guidelines on prevention and control of viral hepatitis as listed above and demonstrate willingness and flexibility to respond to new CDC guidelines likely to be issued during the project period (i.e., chronic HBV screening guidelines and new guidelines on HCV prevention and control).

h. Provide a realistic plan for working with CDC and demonstrate willingness to collaborate in all aspects of the agreement with CDC program staff and other relevant organizations as appropriate.

i. Provide a realistic plan for collaboration with organizations and providers of HIV and STD prevention services on maximizing opportunities for service delivery integration.

3. Evaluation (no more than 7 pages)

a. Present a viable evaluation plan for assessing the success of the program in achieving its proposed objectives that includes a timeline and realistic processes for measuring networking activities, reach, and potential impact.

b. Include strategies to pre-test tools, directories, and other resources and in order to ensure their utility.

c. Clearly describe how assessments and evaluation results will be reported and used to enhance progress and performance.

d. Include quality assurance strategies to ensure that directories and other resources are accurate and up to date.

4. Organizational Capacity (no more than 15 pages)

a. Document that the applicant’s organizational mission, goals, and activities focus on viral hepatitis and are consistent with the national viral hepatitis prevention and control priorities and recommendations.

b. Provide evidence of relevant viral hepatitis related national level experience, leadership, capacity, and infrastructure (resources, facilities, and technical and administrative systems) to successfully conduct proposed activities.

c. Describe existing collaborations and partnerships with national organizations, Federal agencies, State, local and/or community based organizations, and describe how they will be expanded to accomplish the proposed activities.

d. Describe the specific agencies, organizations, and individuals with which the applicant is currently collaborating and identify other organizations to be invited to join in the network.

e. Describe how collaborators were and will be involved in designing and implementing activities and include specifics about their roles and requested collaborative activities.

f. Include original letters of support or commitment, memoranda of agreement, or other similar documentation from appropriate non-applicant organizations, individuals, institutions, public health departments, etc., needed to carry out proposed activities and have such letters clearly indicate the organizations’ roles and responsibilities. Letters of commitment will not be counted as part of the application page limit.

5. Management and Staffing Plan (no more than 7 pages)

a. Propose a staffing plan to carry out the objectives of the program; an organizational structure with clear lines of responsibility and authority delineated; and include job descriptions for proposed and current staff.

b. Present the qualifications of staff and demonstrate that they have the credentials, knowledge, training, and experience to perform assigned responsibilities, as evidenced by curriculum vitae and other relevant documents.

c. Describe involvement and/ or coordination with other national organizations in planning, implementing, and evaluating activities throughout the project period and describe their roles and responsibilities.

d. Describe fiscal management and oversight summary for the proposed program with the responsible parties identified.

e. Describe how proposed actions are integrated with HIV, STD, TB, & Immunization activities.

Application Content for Category B: Health Education Programs

1. Background, Need, and Impact (no more than 7 pages)

a. Demonstrate a clear understanding of the needs, gaps, and issues affecting the selected population(s) as t relates to viral hepatitis (and related diseases) and document a clear need for the proposed program activities.

b. Include data and other supporting evidence to justify the proposed approach and target audience(s) and present sources of such data.

c. Demonstrate the potential for significant impact and success in achieving the selected goal for the selected priority population(s).

d. Describe how the proposed activities enhance or complement existing or planned public health activities of the applicant’s organization.

2. Technical Approach and Work Plan (no more than 12 pages)

a. Describe the required activities and present realistic and feasible goals and key strategies to meet the proposed objectives.

b. Describe the feasibility of developing and implementing a program incorporating elements of successful programs or proven practices.

c. Present a work plan that includes project goals and objectives which are specific, measurable, achievable, realistic, and time phased (SMART) and has the potential to successfully address the priority goals and populations.

d. Present a realistic timeline for the five year period in which activities are sequential, build upon the previous year, and culminate in achieving project goals.

e. Describe an appropriate plan for conducting needs assessment and demonstrate how the information will be used to improve the health education program.

f. Present a realistic implementation plan with potential to influence the target population.

g. Describe dissemination strategies, documentation, and/or training materials to enhance or improve other viral hepatitis prevention and control programs.

h. Propose activities consistent with published CDC guidelines on prevention and control of viral hepatitis as listed above and demonstrate willingness and flexibility to respond to new CDC guidelines likely to be issued during the project period (i.e., chronic HBV screening guidelines and new guidelines on HCV prevention and control).

i. Provide a realistic plan for working with HHS/CDC and demonstrate willingness to collaborate in all aspects of the agreement with CDC program staff and other relevant organizations as appropriate.

3. Evaluation (no more than 12 pages)

a. Present a viable evaluation plan for assessing needs and conducting formative and process evaluation in order to document progress towards achieving proposed objectives.

b. Propose ways to evaluate the program using process indicators (e.g., number of individuals reached), as well as short term and long term indicators (e.g., changes in knowledge and skills, reduction of unhealthy behaviors, increase in vaccination, acceptance of referrals).

c. Clearly describe how assessments and evaluation results will be reported and used to enhance progress and performance.

d. Describe how the success of the program will be written up in evaluation reports and/or manuscripts, what will be contained in those reports, and how the results might be used to improve the existing program.

4. Organizational Capacity (no more than 10 pages)

a. Document that the applicant’s organizational mission, goals, and activities are consistent with national viral hepatitis prevention and control priorities and recommendations.

b. Provide evidence of relevant organizational experience with successful health education programs addressing viral hepatitis (and other related diseases).

c. Demonstrate organizational leadership, capacity, and infrastructure (resources, facilities, and technical and administrative systems) to successfully conduct proposed activities.

d. Describe existing or planned collaborations and partnerships with relevant national, state or, and/or community based organizations, and provide a rationale as to how and why these partnerships could help accomplish and sustain the proposed activities. Include original letters of support from appropriate non-applicant organizations needed to carry out proposed activities and clearly indicate the organizations’ roles and commitment.

5. Management and Staffing Plan (no more than 7 pages)

a. Propose a staffing plan to carry out the objectives of the program, an organizational structure with clear lines of responsibility and authority delineated, and include job descriptions and curricula vitae for proposed and current staff.

b. Present the qualifications of staff and demonstrate that they have expertise in health education, viral hepatitis and/or related diseases (e.g., STDs and HIV/AIDS) as evidenced by current and past experience, curriculum vitae, and other relevant documents.

c. Describe involvement and/or coordination with other national, state, or community based organizations, as appropriate, in planning, implementing, and evaluating activities throughout the project period and describe their roles and responsibilities.

d. Provide a fiscal management and oversight summary for the proposed program with the responsible parties identified.

Application Content for Category C: Diffusion of Effective Programs

1. Background, Need, and Impact (no more than 7 pages)

a. Demonstrate a clear understanding of the needs, gaps, and issues affecting the selected population(s) as they relate to viral hepatitis (and related diseases) and document a clear need for the proposed program activities.

b. Include data and other supporting evidence to justify the proposed approach and target audience(s) and present sources of such data.

c. Demonstrate the potential for significant impact and success in expanding programs and services for the selected priority population(s).

d. Describe how the proposed activities sufficiently expand existing activities of the applicant’s organization.

2. Technical Approach and Work Plan (no more than 12 pages)

a. Describe the required activities and present realistic and feasible goals and key strategies to meet the proposed objectives.

b. Justify the selection of the program for diffusion and expansion.

c. Present a work plan that includes project goals and objectives that are specific, measurable, achievable, realistic, and time phased (SMART) and that has the potential to sufficiently expand services and programs to the priority populations.

d. Present a realistic timeline for the five year period in which activities are sequential, build upon the previous year, and culminate in widespread diffusion of the effective program.

e. Describe an appropriate plan for conducting needs assessment and demonstrate how the information will be used to improve and expand the health education program.

f. Describe strategies that will retain the program’s integrity and achieve similar positive outcomes for other target populations and ensure the successful adoption of the model health education program.

g. Propose activities consistent with published CDC guidelines on prevention and control of viral hepatitis as listed above and demonstrate willingness and flexibility to respond to new CDC guidelines likely to be issued during the project period (i.e., chronic HBV screening guidelines and new guidelines on HCV prevention and control).

h. Provide a realistic plan for working with HHS/CDC and demonstrate willingness to collaborate in all aspects of the agreement with CDC program staff and other relevant organizations as appropriate.

3. Evaluation (no more than 12 pages)

a. Present a viable evaluation plan for assessing needs in order to identify barriers and/or facilitators affecting the successful expansion of the program.

b. Include a realistic timeline and an adequate process for measuring progress.

c. Propose ways to evaluate the program using process indicators (e.g., number of individuals reached), as well as short term and long term indicators (e.g., changes in knowledge and skills, reduction of unhealthy behaviors, increase in vaccination, acceptance of referrals).

d. Clearly describe how assessments and evaluation results will be reported and used to enhance progress and performance.

e. Describe plans to document the success of the program diffusion, produce evaluation reports and/or manuscripts that describe the process and communicate program accomplishments to HHS/CDC and others working in the field.

4. Organizational Capacity (no more than 10 pages)

a. Document that the applicant’s organizational mission, goals, and activities are consistent with the national viral hepatitis prevention and control priorities and recommendations.

b. Provide evidence of relevant organizational experience with successful health education programs addressing viral hepatitis (and other related diseases) that can be justified for diffusion.

c. Demonstrate organizational leadership, capacity, and infrastructure (resources, facilities, and technical and administrative systems) to successfully conduct proposed activities.

d. Describe plans to establish or form appropriate collaborations and partnerships with relevant national, state, and/or community based organizations; and provide rationale on how and why these partnerships could help accomplish and sustain the proposed activities. Include original letters of support from appropriate non-applicant organizations needed to diffuse the program and clearly indicate the organizations’ roles and commitment.

5. Management and Staffing Plan (no more than 7 pages)

b. Present the qualifications of staff and demonstrate that they have the appropriate credentials and demonstrated expertise in health education, viral hepatitis, and/or related diseases (e.g., STDs and HIV/AIDS) as evidenced by current and past experience, curriculum vitae, and other relevant documents.

d. Provide a fiscal management and oversight summary for the proposed program with the responsible parties identified.

In order to apply for diffusion of a “best practice or model program,” the applicant must include the following materials in the appendices:

· A detailed description of the program and its goals, objectives, and target audience

· Summary of process measures of the evaluation, including the number of individuals reached during specified time periods

· Copies of program materials and implementation strategies

· A description of the evaluation methods and results of the evaluation

· Copies of manuscripts, abstracts, presentations and/or awards describing the program and/or its evaluation

Application Content for Category D: Professional Education

1. Background, Need, and Impact (no more than 7 pages)

a. Describe the need for training on viral hepatitis and how the current situation affects viral hepatitis prevention and control.

b. Identify gaps in knowledge of and training for constituents.

c. Document a clear need for the proposed program activities and include supporting evidence to justify the proposed approach and the professional audience(s) targeted.

d. Demonstrate the potential for significant impact from increasing health professionals’ knowledge, skills, and abilities.

e. Describe how training activities enhance or complement existing training and educational activities of the applicant’s organization.

2. Technical Approach and Work Plan (no more than 12 pages)

a. Describe the response to the required activities and present realistic and feasible goals and key strategies to increase the capacity of professionals to integrate viral hepatitis prevention and control into existing primary care and STD/HIV & Immunization service delivery activities.

b. Present a work plan that includes project goals and objectives that are specific, measurable, achievable, realistic, and time phased (SMART), as well as strategies to assess initial training needs.

c. Present a realistic timeline for the five year period in which activities are sequential, build upon the previous year, and culminate in achieving project goals.

d. Propose a comprehensive training plan that uses appropriate and justified methods, formats, and dissemination strategies.

e. Describe strategies to regularly reassess the target audience training needs and meet those needs.

f. Include a quality control process to ensure that training content is appropriate for adult learners, is evidence and science based, and is congruent with CDC recommendations, guidelines, programs, and initiative.

g. Include a plan for promoting training activities to constituents and specify a system for acquiring and awarding CME, CNE, and/or CEUs as appropriate for trainees.

h. Provide a realistic plan for working with HHS/CDC and demonstrate willingness to collaborate in all aspects of the agreement with CDC program staff and other relevant organizations as appropriate, and demonstrate willingness and flexibility to respond to new CDC guidelines likely to be issued during the project period (i.e., chronic HBV screening guidelines and new guidelines on HCV prevention and control).

3. Evaluation (no more than 7 pages)

a. Present a viable evaluation plan for assessing the quality and reach of the training sessions.

b. Include a system to monitor the success of the program in achieving its proposed training objectives and an adequate process for measuring progress.

c. Present a viable evaluation plan with process indicators (e.g., trainee demographics, ratings of course quality, relevance to practice), as well as short term training outcome indicators (e.g., changes in knowledge and skills) whenever appropriate. If feasible, describe plans to develop medium term training outcome indicators (e.g., application of knowledge and skills to practice or delivery of services) for a select number of training activities.

d. Clearly describe how assessments and evaluation results will be reported and used to enhance training and promotional activities, as well as to communicate program accomplishments to HHS/CDC.

4. Organizational Capacity (no more than 12 pages)

a. Document that the applicant’s organizational mission, goals, and activities are consistent with the national viral hepatitis prevention and control priorities and recommendations.

b. Provide evidence of relevant organizational training experience, expertise, and infrastructure (resources, facilities, and technical and administrative systems) to successfully conduct proposed activities.

c. Demonstrate experience in training professionals in viral hepatitis and other related topics, as evidenced by the types and numbers of courses/trainings developed and taught; curricula developed, piloted, and diffused; number of experts qualified to develop and/or teach trainings and courses; and number of years the organization has been conducting or developing trainings.

d. Demonstrate organizational leadership, capacity, and readiness to perform proposed training activities.

5. Management and Staffing Plan (no more than 10 pages)

a. Propose a staffing plan to carry out the objectives of the program, an organizational structure with clear lines of responsibility and authority delineated, job descriptions, and curricula vitae for both proposed and current staff.

b. Present the qualifications of faculty, trainers, and preceptors and demonstrate that they have the appropriate credentials and demonstrated expertise in viral hepatitis and/or related diseases (e.g., STDs and HIV/AIDS) as evidenced by training experience, job descriptions, curriculum vitae, and other relevant documents.

c. Include a plan for keeping training faculty, trainers, and others current on content area(s) and educational methodologies (e.g., through periodic attendance at relevant seminars, classes, or conferences; periodic peer critique of content and methodology).

d. Present a fiscal management and oversight summary for the proposed program, with the responsible parties identified.

Budget and Justification (required; not scored; no page limit) for each category (A, B, C, D) for which you are applying

Provide a detailed budget and justification consistent with the proposed program objectives and activities. The budget justification will not be counted in the stated page limit. In accordance with Form CDC 0.1246E www.cdc.gov/od/pgo/forms/01246.pdf , applicants are required to provide a line item budget and narrative justification for all requested costs that are consistent with the purpose, objectives, and proposed program activities. Within this budget, please provide the documentation requested for each cost category:

Provide a line item budget and justification for all personnel (i.e., name, position title, annual salary, percentage of time and effort, and amount requested).

Provide a line item breakdown and justification for all contracts, including:

a. Name of contractor

b. Period of performance

c. Method of selection (e.g., competitive or sole source)

d. Description of activities

e. Justification

Additional information may be included in the application appendices. The appendices will not be counted toward the narrative page limit but must not exceed 50 pages. This additional information includes budget information, organizational documentation, letters of support, and “Best Practice or Model Program” documentation.

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

Attachment 1: Budget

Attachment 2: Budget Justification
Appendix A: Supporting Organizational Documentation
- Appendix A.1: Organizational Mission and Goals
- Appendix A.2: Organizational and Staffing Charts
- Appendix A.3: Curriculum Vitae or Resumes
Appendix B: Letters of Support
Appendix C: Best Practice or Model Program Documentation
- Appendix C.1: Program Description (including goals, objectives, and target audience)
- Appendix C.2: Summary of Evaluation Process Measures
- Appendix C.3: Program Materials and Implementation Strategies
- Appendix C.4: Evaluation Methods and Results.
- Appendix C.5: Program Publications (including manuscripts, abstracts, presentations, and/or awards)

No more than 15 electronic attachments should be uploaded per application.

The agency or organization is required to have a Dun and Bradstreet Data Universal Numbering System (DUNS) number to apply for a grant or cooperative agreement from the Federal government. The DUNS number is a nine digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, access the Dun and Bradstreet website or call 1-866-705-5711.

Additional requirements that may request submission of additional documentation with the application are listed in section “VI.2. Administrative and National Policy Requirements.”

IV.3. Submission Dates and Times

Letter of Intent (LOI) Deadline Date: Courtesy LOI is requested by June 6, 2008

Application Deadline Date: July 11, 2008

Applications must be submitted electronically at www.Grants.gov. Applications completed online through Grants.gov are considered formally submitted when the applicant organization’s Authorizing Organization Representative (AOR) electronically submits the application to www.Grants.gov. Electronic applications will be considered as having met the deadline if the application has been successfully submitted electronically by the applicant organization’s AOR to Grants.gov on or before the deadline date and time.

When submission of the application is done electronically through Grants.gov (http://www.grants.gov), the application will be electronically time/date stamped and a tracking number will be assigned, which will serve as receipt of submission. The AOR will receive an email notice of receipt when HHS/CDC receives the application.

This announcement is the definitive guide on LOI and application content, submission address, and deadline. It supersedes information provided in the application instructions. If the application submission does not meet the deadline above, it will not be eligible for review. The application face page will be returned by HHS/CDC with a written explanation of the reason for non-acceptance. The applicant will be notified the application did not meet the submission requirements.

IV.4. Intergovernmental Review of Applications

Executive Order 12372 does not apply to this program.

IV.5. Funding Restrictions

Restrictions, which must be taken into account while writing the budget, are as follows:

Recipients may not use funds for research.
Recipients may not use funds to provide direct delivery of patient care or treatment services.
Recipients may not use funds for medical or substance abuse treatment.
Recipients may only expend funds for reasonable program purposes, including personnel, travel, supplies, and services, such as contractual.
Awardees may not generally use HHS/CDC/ATSDR funding for the purchase of furniture or equipment. Any such proposed spending must be identified in the budget.
The direct and primary recipient in a cooperative agreement program must perform a substantial role in carrying out project objectives and not merely serve as a conduit for an award to another party or provider who is ineligible.

Reimbursement of pre-award costs is not allowed.

Recipients may only expend funds for reasonable program purposes, including personnel, travel, supplies, and services, such as contractual.
Federal funds awarded under this program announcement may not be used to supplant state or local funds.

If requesting 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 should be less than 12 months of age. The indirect cost rate agreement should be uploaded as a PDF file with “Other Attachment Forms” when submitting via Grants.gov.

The recommended guidance for completing a detailed justified budget can be found on the CDC Web site, at the following Internet address:

http://www.cdc.gov/od/pgo/funding/budgetguide.htm.

IV.6. Other Submission Requirements

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 the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

Application Submission Address:

Electronic Submission:

HHS/CDC requires applicants to submit applications electronically at www.Grants.gov. The application package can be downloaded from www.Grants.gov. Applicants are able to complete it offline, and then upload and submit the application via the Grants.gov Web site. Email submissions will not be accepted. If the applicant has technical difficulties in Grants.gov, customer service can be reached by Email at support@grants.gov or by phone at 1-800-518-4726 (1-800-518-GRANTS). The Customer Support Center is open from 7:00a.m. to 9:00p.m. Eastern Time, Monday through Friday.

HHS/CDC recommends that submittal of the application to Grants.gov should be prior to the closing date to resolve any unanticipated difficulties prior to the deadline. Applicants may also submit a back-up paper submission of the application. Any such paper submission must be received in accordance with the requirements for timely submission detailed in Section IV.3. of the grant announcement. The paper submission must be clearly marked: “BACK-UP FOR ELECTRONIC SUBMISSION.” The paper submission must conform to all requirements for non-electronic submissions. If both electronic and back-up paper submissions are received by the deadline, the electronic version will be considered the official submission.

The applicant must submit all application attachments using a PDF file format when submitting via Grants.gov. Directions for creating PDF files can be found on the Grants.gov Web site. Use of file formats other than PDF may result in the file being unreadable by staff.

V. Application Review Information

V.1. Criteria

Applicants are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the cooperative agreement. Measures of effectiveness must relate to the performance goals stated in the “Purpose” section of this announcement. Measures must be objective and quantitative and must measure the intended outcome. The measures of effectiveness must be submitted with the application and will be an element of evaluation.

The application will be evaluated against the following criteria:

Executive Summary (not scored) for each category (A, B, C, D) for which the applicant is applying.

Extent to which applicant concisely and comprehensively describes overall proposed activities and goals of the project, and states the category for which funding is requested, and clearly identifies which goal(s) and population(s) are being targeted.

Criteria for Category A: Networking, Partnership, and Information Dissemination

1. Background, Need, and Impact (15 points)

The extent to which the applicant:

a. describes the need for and benefits of national viral hepatitis networks and partnerships;

b. demonstrates knowledge of existing networks, identifies gaps in viral hepatitis prevention and control, and documents a clear need for the proposed program activities;

c. describes how the proposed national activities enhance or complement existing or planned public health activities of the applicant’s organization;

d. demonstrates how partnerships, networking, and resources have the potential for significant impact and benefit for improving the public’s health.

2. Technical Approach and Work Plan (25 points)

The extent to which the applicant:

a. responds to the required activities, and presents feasible goals and key strategies to meet the proposed objectives;

b. presents a work plan that includes project goals and objectives that are specific, measurable, achievable, realistic, and time-phased (SMART);

c. presents a realistic timeline for the five year period in which activities are sequential, build upon the previous year, and culminate in enhanced networks and improved tools and resources for organizations working in viral hepatitis prevention and control;

d. identifies the key organizations to be included in the network and outlines their roles and relationship to the applicant;

e. includes a diverse group of organizations (e.g., representing different type of viral hepatitis, constituents, interests, etc.), presents strategies for achieving the stated objectives, and describes how partners will be involved;

f. describes existing or proposed communication channels or vehicles suitable for disseminating information to key stakeholders;

g. proposes methods and activities consistent with published CDC guidelines on prevention and control of viral hepatitis as listed above and demonstrates willingness and flexibility to respond to new CDC guidelines likely to be issued during the project period (i.e., chronic HBV screening guidelines and new guidelines on HCV prevention and control);

h. provides a realistic plan for working with CDC and demonstrates willingness to collaborate in all aspects of the agreement with CDC program staff and other relevant organizations as appropriate.

i. Provides a realistic plan for collaboration with organizations and providers of HIV and STD services that identifies opportunity for service delivery integration.

3. Evaluation (15 points)

The extent to which the applicant:

presents a viable evaluation plan for assessing the success of the program in achieving its proposed objectives that contains a timeline and realistic processes for measuring networking activities, reach, and potential impact;
includes strategies to pre-test tools, directories, and other resources in order to ensure their utility;
clearly describes how assessments and evaluation results will be reported and used to enhance progress and performance;
includes quality assurance strategies to ensure that directories and other resources are accurate and up to date.

4. Organizational Capacity (30 points)

The extent to which the applicant:

a. documents that its organizational mission, goals, and activities focus on viral hepatitis and are consistent with the national viral hepatitis prevention and control priorities and recommendations;

b. provides evidence of relevant viral hepatitis related national level experience, leadership, capacity, and infrastructure (resources, facilities, and technical and administrative systems) to successfully conduct proposed activities;

c. has already established collaborations and partnerships with national organizations, Federal agencies, State, local and/or community based organizations and will expand these networks to accomplish the proposed activities;

d. describes the specific agencies, organizations, and individuals with whom the applicant is currently collaborating on viral hepatitis related issues and identifies other organizations to be invited to join in the network;

e. describes how collaborators were and will be involved in designing and implementing activities and includes specifics about their roles and requested collaborative activities;

f. Includes original letters of support or commitment and/or memorandum of agreements or understanding (MOA/MOUs) from appropriate non-applicant organizations, individuals, institutions, public health departments, etc., needed to carry out proposed activities that clearly indicate the organization’s roles and responsibilities. Letters of commitment will not be counted as part of the application page limit.

5. Management and Staffing Plan (15 points)

The extent to which the applicant:

a. proposes a staffing plan to carry out the objectives of the program and an organizational structure with clear lines of responsibility and authority delineated and includes job descriptions for proposed and current staff;

b. employs qualified staff who have the credentials, knowledge, training, and experience to perform assigned responsibilities, as evidenced by curriculum vitae and other relevant documents;

c. involves and/or coordinates with other national organizations in planning, implementing, and evaluating activities throughout the project period and describes their roles and responsibilities;

d. has provided a fiscal management and oversight summary for the proposed program with the responsible parties identified.

Criteria for Category B: Health Education Programs

1. Background, Need, and Impact (15 points)

The extent to which the applicant:

e. demonstrates a clear understanding of the needs, gaps, and issues affecting the selected population(s) as they relate to viral hepatitis (and related diseases) and documents a clear need for the proposed program activities;

f. includes data and other supporting evidence to justify the proposed approach and target audience(s) and presents sources of such data;

g. demonstrates the potential for significant impact and success in achieving the selected goal for the selected priority population;

h. describes how the proposed activities enhance or complement existing or planned public health activities of the applicant’s organization.

i. demonstrates an understanding of the need to collaborate with organizations and providers of HIV and STD services.

2. Technical Approach and Work Plan (25 points)

The extent to which the applicant:

a. responds to the required activities and presents realistic and feasible goals and key strategies to meet the proposed objectives;

b. describes the feasibility of developing and implementing a program incorporating elements of successful programs or proven practices;

c. presents a work plan that includes project goals and objectives that are specific, measurable, achievable, realistic, and time phased (SMART) and has the potential to successfully address the priority goals and populations;

d. presents a realistic timeline for the five year period in which activities are sequential, build upon the previous year, and culminate in achieving project goals;

e. describes an appropriate plan for conducting needs assessment and demonstrates how the information will be used to improve the health education program;

f. presents a realistic implementation plan with potential to influence the target population;

g. describes dissemination strategies, documentation, and/or training materials to enhance or improve other viral hepatitis prevention and control programs;

h. proposes activities consistent with published CDC guidelines on prevention and control of viral hepatitis as listed above and demonstrates willingness and flexibility to respond to new CDC guidelines likely to be issued during the project period (i.e., chronic HBV screening guidelines and new guidelines on HCV prevention and control);

i. provides a realistic plan for working with HHS/CDC and demonstrates willingness to collaborate in all aspects of the agreement with CDC program staff and other relevant organizations as appropriate.

3. Evaluation (25 points)

The extent to which the applicant:

presents a viable evaluation plan for assessing needs and conducting formative and process evaluation in order to document progress towards achieving proposed objectives;
proposes ways to evaluate the program using process indicators (e.g., number of individuals reached), as well as short term and long term indicators (e.g., changes in knowledge and skills, reduction of unhealthy behaviors, increase in vaccination, acceptance of referrals);
clearly describes how assessments and evaluation results will be reported and used to enhance progress and performance;
documents the success of the program and produces evaluation reports and/or manuscripts that describe the program, the target population, how the evaluation was conducted, and how the results improved the existing program.

4. Organizational Capacity (20 points)

The extent to which the applicant:

documents that its organizational mission, goals, and activities are consistent with the national viral hepatitis prevention and control priorities and recommendations;
provides evidence of relevant organizational experience with successful health education programs addressing viral hepatitis (and other related diseases);
demonstrates organizational leadership, capacity, and infrastructure (resources, facilities, and technical and administrative systems) to successfully conduct proposed activities;
has established or will form appropriate collaborations and partnerships with relevant national, state, and/or community based organizations; has provided a rationale as to how and why these partnerships could help accomplish and sustain the proposed activities; and has included original letters of support from appropriate non-applicant organizations needed to carry out proposed activities and clearly indicated the organization’s role and commitment.

5. Management and Staffing Plan (15 points)

The extent to which the applicant:

proposes a staffing plan to carry out the objectives of the program, an organizational structure with clear lines of responsibility and authority delineated, and includes job descriptions and curricula vitae for both proposed and current staff;
employs qualified staff with appropriate credentials and demonstrated expertise in health education, viral hepatitis and/or related diseases (e.g., STDs and HIV/AIDS), as evidenced by current and past experience, curriculum vitae, and other relevant documents;
involves and/or coordinates with other national, state, or community based organizations, as appropriate, in planning, implementing, and evaluating activities throughout the project period and has provided a description of their roles and responsibilities;
has provided a fiscal management and oversight summary for the proposed program with the responsible parties identified.

Criteria for Category C: Diffusion of Effective Programs

1. Background, Need, and Impact (15 points)

The extent to which the applicant:

demonstrates a clear understanding of the needs, gaps, and issues affecting the selected population(s) as they relate to viral hepatitis (and related diseases) and documents a clear need for the proposed program activities;
includes data and other supporting evidence to justify the proposed approach and target audience(s) and presents sources of such data;
demonstrates the potential for significant impact and success in expanding programs and services for the selected priority population(s);
describes how the proposed activities sufficiently expand existing activities of the applicant’s organization.
describes how the proposed activities link with organizations and providers of HIV and STD prevention services.

2. Technical Approach and Work Plan (25 points)

The extent to which the applicant:

responds to the required activities and presents realistic and feasible goals and key strategies to meet the proposed objectives;
justifies the selection of the program for diffusion and expansion;
presents a work plan that includes project goals and objectives that are specific, measurable, achievable, realistic, and time phased (SMART) and has the potential to sufficiently expand services and programs to the priority populations.
presents a realistic timeline for the five year period in which activities are sequential, build upon the previous year, and culminate in achieving project goals;
describes an appropriate plan for conducting needs assessment and demonstrates how the information will be used to improve and expand the health education program;
describes strategies that will retain the program’s integrity and achieve similar positive outcomes for other target populations and ensure the successful adoption of the model health education program;
proposes activities consistent with published CDC guidelines on prevention and control of viral hepatitis as listed above and demonstrates willingness and flexibility to respond to new CDC guidelines likely to be issued during the project period (i.e., chronic HBV screening guidelines and new guidelines on HCV prevention and control);
provides a realistic plan for working with CDC and demonstrates willingness to collaborate in all aspects of the agreement with CDC program staff and other relevant organizations as appropriate.

3. Evaluation (25 points)

The extent to which the applicant:

f. presents a viable evaluation plan for assessing needs in order to identify barriers and/or facilitators affecting the successful expansion of the program;

g. includes a realistic timeline and an adequate process for measuring progress;

h. proposes ways to evaluate the program using process indicators (e.g., number of individuals reached), as well as short term and long term indicators (e.g., changes in knowledge and skills, reduction of unhealthy behaviors, increase in vaccination, acceptance of referrals);

i. clearly describes how assessments and evaluation results will be reported and used to enhance progress and performance;

j. documents the success of the program diffusion and produces evaluation reports and/or manuscripts that describe the process;

k. communicates program accomplishments to CDC and others working in the field.

4. Organizational Capacity (20 points)

The extent to which the applicant:

documents that its organizational mission, goals, and activities are consistent with the national viral hepatitis prevention and control priorities and recommendations;
provides evidence of relevant organizational experience with successful health education programs addressing viral hepatitis (and other related diseases) that can be justified for diffusion;
demonstrates organizational leadership, capacity, and infrastructure (resources, facilities, and technical and administrative systems) to successfully conduct proposed activities;
has established or will form appropriate collaborations and partnerships with relevant national, state, and/or community based organizations; has provided a rationale as to how and why these partnerships could help accomplish and sustain the proposed activities; and includes original letters of support from appropriate non-applicant organizations needed to diffuse the program that clearly indicate the organizations’ roles and commitment.

5. Management and Staffing Plan (15 points)

The extent to which the applicant:

proposes a staffing plan to carry out the objectives of the program, an organizational structure with clear lines of responsibility and authority delineated, and includes job descriptions and curricula vitae for proposed and current staff.
employs qualified staff with appropriate credentials and demonstrated expertise in health education, viral hepatitis and/or related diseases (e.g., STDs and HIV/AIDS), as evidenced by current and past experience, curriculum vitae, and other relevant documents;
involves and/or coordinates with other national, state, or community based organizations, as appropriate, in planning, implementing, and evaluating activities throughout the project period and has provided a description of their roles and responsibilities;
has provided a fiscal management and oversight summary for the proposed program with the responsible parties identified.

Criteria for Category D: Professional Education

1. Background, Need, and Impact (15 points)

The extent to which the applicant:

a. describes the need for training on viral hepatitis and how the current situation affects viral hepatitis prevention and control;

b. identifies gaps in knowledge of and training for constituents;

c. documents a clear need for the proposed program activities and includes supporting evidence to justify the proposed approach and the professional audience(s) targeted;

d. demonstrates the potential for significant impact by increasing health professionals’ knowledge, skills, and abilities;

e. describes how training activities enhance or complement existing training and educational activities of the applicant’s organization.

2. Technical Approach and Work Plan (25 points)

The extent to which the applicant:

responds to the required activities and presents realistic and feasible goals and key strategies to increase the capacity of professionals to integrate viral hepatitis prevention and control into existing primary care and STD/HIV service delivery activities;
presents a work plan that includes project goals and objectives that are specific, measurable, achievable, realistic, and time phased (SMART), as well as strategies to assess initial training needs;
presents a realistic timeline for the five year period in which activities are sequential, build upon the previous year, and culminate in achieving project goals;
proposes a comprehensive training plan that uses appropriate and justified methods, formats, and dissemination strategies;
describes strategies to regularly reassess the target audience training needs and meet those needs;
includes a quality control process to ensure that training content is appropriate for adult learners, is evidence and science based, and is congruent with CDC recommendations, guidelines, programs, and initiatives;
includes a plan for promoting training activities to constituents and specifies a system for acquiring and awarding CME, CNE, and/or CEUs as appropriate for trainees;
provides a realistic plan for working with CDC and demonstrates willingness to collaborate in all aspects of the agreement with CDC program staff and other relevant organizations as appropriate, and demonstrates willingness and flexibility to respond to new CDC guidelines likely to be issued during the project period (i.e., chronic HBV screening guidelines and new guidelines on HCV prevention and control).

3. Evaluation (15 points)

The extent to which the applicant:

presents a viable evaluation plan for assessing the quality and reach of the training sessions;
includes a system to monitor the success of the program in achieving its proposed training objectives and an adequate process for measuring progress;
presents a viable evaluation plan with process indicators (e.g., trainee demographics, ratings of course quality, relevance to practice), as well as short term training outcome indicators (e.g., changes in knowledge and skills) whenever appropriate. If feasible, medium term training outcome indicators (e.g., application of knowledge and skills to practice or delivery of services) should be developed for a select number of training activities;
clearly describes how assessments and evaluation results will be reported and used to enhance training and promotional activities, as well as to communicate program accomplishments to CDC.

4. Organizational Capacity (25 points)

The extent to which the applicant:

documents that its organizational mission, goals, and activities are consistent with the national viral hepatitis prevention and control priorities and recommendations;
provides evidence of relevant organizational training experience, expertise, and infrastructure (resources, facilities, and technical and administrative systems) to successfully conduct proposed activities;
demonstrates experience in training professionals in viral hepatitis and other related topics as evidenced by the types and numbers of courses/trainings developed and taught; curricula developed, piloted, and diffused; number of experts qualified to develop and/or teach trainings and courses; and number of years the organization has been conducting or developing trainings;
demonstrates organizational leadership, capacity, and readiness to perform proposed training activities.

5. Management and Staffing Plan (20 points)

The extent to which the applicant:

proposes a staffing plan to carry out the objectives of the program, an organizational structure with clear lines of responsibility and authority delineated, job descriptions, and curricula vitae for both proposed and current staff.
employs faculty, trainers, and preceptors with appropriate credentials and demonstrated expertise in viral hepatitis and/or related diseases (e.g., STDs and HIV/AIDS) as evidenced by training experience, job descriptions, curriculum vitae, and other relevant documents
includes a plan for keeping training faculty, trainers, and others current on content area(s) and educational methodologies (e.g., through periodic attendance at relevant seminars, classes, or conferences; periodic peer critique of content and methodology);
has provided a fiscal management and oversight summary for the proposed program with the responsible parties identified.

Budget and Justification (required; not scored; no page limit) for each category (A, B, C, D) for which the applicant is applying.

The extent to which the applicant provides a detailed budget and justification consistent with the proposed program objectives and activities. The budget justification will not be counted in the stated page limit. In accordance with Form CDC 0.1246E www.cdc.gov/od/pgo/forms/01246.pdf , applicants are required to provide a line item budget and narrative justification for all requested costs that are consistent with the purpose, objectives, and proposed program activities. Within this budget, the following documentation should be provided for each cost category:

A line item budget and justification for all personnel (i.e., name, position title, and annual salary, percentage of time and effort, and amount requested).

Line item breakdown and justification should be provided for all contracts, including:

Name of contractor
Period of performance
Method of selection (e.g., competitive or sole source)
Description of activities
Justification

V.2. Review and Selection Process

Applications will be reviewed for completeness by the Procurement and Grants Office (PGO) staff and for responsiveness jointly by the Division of Viral Hepatitis, NCHHSTP, and PGO. Incomplete applications and applications that are non-responsive to the eligibility criteria will not advance through the review process. Applicants will be notified the application did not meet submission requirements.

An objective review panel will evaluate complete and responsive applications according to the criteria listed in the “V.1 Criteria” section above. An objective review panel composed of CDC professionals (representing a mix of individuals from within and outside NCHHSTP) will evaluate complete and responsive applications according to the criteria listed above.

In addition, the following factors may affect the funding decision. Preference for funding will be given to ensure that:

§ For Categories B and C, funded applicants will primarily represent projects with a focus on secondary prevention (e.g., screening and referral), with the outcome of having a mixture of both primary (e.g. immunization, risk reduction counseling) and secondary prevention.

§ Funded applicants proportionately represent the burden of viral hepatitis infection, i.e., the greatest burden represents those chronically infected with HCV, followed by HBV.

§ Funded applicants are balanced in terms of priority populations targeted and potential to reduce health disparities. (The number of funded applicants serving each population may be adjusted based on the burden of infection in that group as measured by best available surveillance data.)

§ Funded organizations have extensive experience serving the proposed target population.

HHS/CDC will provide justification for any decision to fund out of rank order.

V.3. Anticipated Announcement Award Dates

August 31, 2008

VI. Award Administration Information

VI.1. Award Notices

Successful applicants will receive a Notice of Award (NoA) from the CDC Procurement and Grants Office. The NoA shall be the only binding, authorizing document between the recipient and HHS/CDC. The NoA will be signed by an authorized Grants Management Officer and emailed to the program director and a hard copy mailed to the recipient fiscal officer identified in the application.

Unsuccessful applicants will receive notification of the results of the application review by mail.

VI.2. Administrative and National Policy Requirements

Successful applicants must comply with the administrative requirements outlined in 45 CFR Part 74 and Part 92, as appropriate. The following additional requirements apply to this project:

AR-4 HIV/AIDS Confidentiality Provisions
AR-6 Patient Care
AR-9 Paperwork Reduction Act Requirements
AR-10 Smoke Free Workplace Requirements
AR-11 Healthy People 2010
AR-12 Lobbying Restrictions
AR-14 Accounting System Requirements

Additional information on the requirements can be found on the CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/Addtl_Reqmnts.htm.

CDC Assurances and Certifications can be found on the CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/grants/foamain.shtm

For more information on the Code of Federal Regulations, see the National Archives and Records Administration at the following Internet address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html

VI.3. Reporting Requirements

The applicant must provide CDC with an annual interim progress report via www.grants.gov:

1. The interim progress report is due no less than 90 days before the end of the annual budget period. The progress report will serve as the non-competing continuation application, and must contain the following elements:

a. Standard Form (“SF”) 424S Form.

b. SF-424A Budget Information-Non-Construction Programs.

c. Budget Narrative.

d. Indirect Cost Rate Agreement.

e. Project Narrative.

f. Additional Requested Information.

2. Additionally, the applicant must provide HHS/CDC with the following elements in the Project Narrative:

a. A succinct description of the program accomplishments/narrative and progress made in meeting each program objective during the budget period (no more than 25 pages).

b. The reason for not meeting established program goals and objectives and strategies to be implemented to achieve unmet objectives.

c. Work plan for the next budget period (e.g., fiscal year.)

d. A description of any new objectives being added to the established work plan and an explanation as to why they are being added.

e. Other pertinent information, including, when appropriate, analysis and explanation of unexpected high cost of performance.

3. A final performance report and financial status report, due no more than 90 days after the end of the five year project period.

4. Financial status report and annual progress report, no more than 90 days after the end of each budget period.

These reports must be submitted to the attention of the Grants Management Specialist listed in the “VII. Agency Contacts” section of this announcement.

Annual Continuation of Funding: Categories A, B C, and D

To be granted a continuation award, applicants must have:

§ completed all recipient requirements;

§ submitted appropriate data and programmatic reports on the applicant’s annual target levels of performance for each program performance indicator; and

§ demonstrated sufficient progress in programmatic activities.

VII. Agency Contacts

CDC encourages inquiries concerning this announcement.

For general questions, contact:

Technical Information Management Section

Department of Health and Human Services

CDC Procurement and Grants Office

2920 Brandywine Road, MS E-14

Atlanta, GA 30341

Telephone: 770-488-2700

For program technical assistance, contact:

Cynthia Jorgensen, DrPH, Project Officer

Department of Health and Human Services

Centers for Disease Control and Prevention

Division of Viral Hepatitis, MS G-37

1600 Clifton Rd

Atlanta, GA 30333

Telephone: 404-718-8534

Email: cjorgensen@cdc.gov

For financial, grants management, or budget assistance, contact:

Kang Lee, Grants Management Specialist

Department of Health and Human Services

CDC Procurement and Grants Office

2920 Brandywine Road, MS E-15

Atlanta, GA 30341

Telephone: 404-639-5357

Fax: 404-639-8095

Email: kil8@cdc.gov

CDC Telecommunications for the hearing impaired or disabled is available at: TTY 770-488-2783.

VIII. Other Information

Other CDC funding opportunity announcements can be found on the CDC Web site, Internet address: http://www.cdc.gov/od/pgo/funding/FOAs.htm. Technical references and recommendations can be found at http://www.cdc.gov/hepatitis .

Applicants may access the application process and other awarding documents using the Electronic Research Administration System (eRA Commons). A one time registration is required for interested institutions/organizations at http://era.nih.gov/ElectronicReceipt/preparing.htm

Program Directors/Principal Investigators (PD/PIs) should work with their institutions/organizations to make sure they are registered in the eRA Commons.

1. Organizational/Institutional Registration in the eRA Commons

To find out if an organization is already eRA Commons registered, see the "List of Grantee Organizations Registered in eRA Commons.”
Direct questions regarding the eRA Commons registration to:
eRA Commons Help Desk
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Business hours Monday -Friday 7:00 a.m. – 8:00 p.m. Eastern Time
Email commons@od.nih.gov

2. Project Director/Principal Investigator (PD/PI) Registration in the eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

The individual designated as the PD/PI on the application must also be registered in the eRA Commons. It is not necessary for PDs/PIs to register with Grants.gov.
The PD/PI must hold a PD/PI account in the eRA Commons and must be affiliated with the applicant organization. This account cannot have any other role attached to it other than the PD/PI.
This registration/affiliation must be done by the Authorized Organization Representative/Signing Official (AOR/SO) or their designee who is already registered in the eRA Commons.
Both the PD/PI and AOR/SO need separate accounts in the eRA Commons since both hold different roles for authorization and to view the application process.

Note that if a PD/PI is also an HHS peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should check with their business official to determine whether their organization/institution is already registered in the eRA Commons. HHS/CDC strongly encourages applicants to register to utilize these helpful online tools when applying for funding opportunities.

CDC Home Page: http://www.cdc.gov

CDC Funding Web Page: http://www.cdc.gov/od/pgo/funding/FOAs.htm

CDC Forms Web Page: http://www.cdc.gov/od/pgo/funding/grants/app_and_forms.shtm