rfa-ps-16-001 final revised 09 21 15.pdf

Centers for Disease Control and Prevention

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Extramural Research Program Office

Minority HIV/AIDS Research Initiative (MARI) to Build HIV Prevention, Treatment and Research Capacity in Disproportionately Affected Black and Hispanic Communities and Among Historically Underrepresented

Researchers

RFA-PS-16-001

Application Due Date: 10/14/2015

Minority HIV/AIDS Research Initiative (MARI) to Build HIV Prevention, Treatment and Research Capacity in Disproportionately Affected Black and Hispanic Communities and Among Historically Underrepresented

Researchers

RFA-PS-16-001

TABLE OF CONTENTS

Part 1. Overview Information Key Dates Required Application Instructions Executive Summary

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

Part 1. Overview Information Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Extramural Research Program Office (NCHHSTP ERPO) National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) Funding Opportunity Announcement (FOA) Title Minority HIV/AIDS Research Initiative (MARI) to Build HIV Prevention, Treatment and Research Capacity in Disproportionately Affected Black and Hispanic Communities and Among Historically Underrepresented Researchers Activity Code U01

Funding Opportunity Announcement Type Reissue of PS11-003 Funding Opportunity Announcement Number

RFA-PS-16-001

Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.941 Category of Funding Activity:

Health FOA Purpose The overall objective of this teaching/mentored award program is to prepare qualified individuals for careers that have a significant impact on the HIV/AIDS-related research needs of the nation, especially in highly-affected minority communities. The objective of the Minority HIV/AIDS Research Initiative (MARI) Award program is to provide support for a sustained period of time for intensive research training and career development under the guidance of an experienced mentor in HIV prevention research and lead to promising HIV prevention activities and researchers who could independently conduct studies in highly-affected communities.

NOTE: A summary of the Conference Call held on Thursday, August 27, 2015 with Potential Applicants for this Funding Opportunity Announcement has been added as an amendment to the FOA in Section VIII. "Other Information" on pages 32-36 and a clarification has been added on pages 2 and 10 regarding indirect cost rates.

Key Dates Publication Date: To receive notification of any changes to RFA-PS-16-001, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link. An email address is needed for this service.

Letter of Intent Due Date: 09/14/2015 http://www.grants.gov

Application Due Date: 10/14/2015

On-time submission requires that electronic applications be error-free and made available to CDC for processing from eRA Commons on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov/eRA Commons no later than 5:00 PM U.S. Eastern Time. Note:

HHS/CDC grant submission procedures do not provide a period of time beyond the application due date to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

Scientific Merit Review: 12/10/2015

Secondary Review: 01/14/2016

Estimated Start Date: 05/01/2016

Expiration Date: 10/15/2015 Due Dates for E.O. 12372: Executive Order 12372 does not apply to this program.

Required Application Instructions It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise in this FOA. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Note: The Research Strategy component of the Research Plan is limited to 12 pages.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348

Executive Summary Purpose. The overall objective of this teaching/mentored award program is to prepare qualified individuals for careers that have a significant impact on the HIV/AIDS-related research needs of the nation, especially in highly-affected minority communities. The objective of the Minority HIV/AIDS Research Initiative (MARI) Award program is to provide support for a sustained period of time for intensive research training and career development under the guidance of an experienced mentor in HIV prevention research and lead to promising HIV prevention activities and researchers who could independently conduct studies in highly-affected communities.

Mechanism of Support. Teaching/mentored cooperative agreement award (U01).

Funds Available and Anticipated Number of Awards. The estimated total funding available is up to $2,400,000 for the first year and up to $9,600,000 for the entire project period of four years. The anticipated number of awards is eight.

Budget and Project Period. The estimated total funding (direct and indirect) for the first year (12-month budget period) is $2,400,000 for 8 awards, with a ceiling of $300,000 per award. The estimated total funding (direct and indirect) for the entire project period is $9,600,000. The project period will run from 05/01/2016 to 04/30/2020. An indirect cost rate of 8% is not automatic; however, grantee institutions can elect to take an indirect cost rate of 8% should they choose to do so.

Application Research Strategy Length: Page limits for the Research Strategy are clearly specified in Section IV. Application and Submission Information of this announcement. For this FOA, the page limit for the Research Strategy section is 12 pages.

Eligible Institutions/Organizations. Institutions/organizations listed in Section III.1 are eligible to apply.

Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf knowledge, and resources necessary to carry out the proposed research and who meet the eligibility criteria listed in Section III.3 of this FOA are invited to work with their institution/organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for HHS/CDC support. NOTE: CDC does not make awards to individuals directly.

Number of PDs/PIs. There will only be one PD/PI for each application.

Number of Applications. Each eligible institution/organization may submit more than one application, but each application must have a different PD/PI. If necessary, Co-PI(s) may be listed in the application but only one PI may be the primary CDC contact for the award and must be indicated in the application. NOTE: Only one application may be submitted per topic area from the same institution.

Special Date(s). A conference call with all potential applicants will be held on Thursday, August 27, 2015 at 12:00 pm ET. Phone Number: 1-866-662-8986, Passcode: 8378091 Application Materials. See Section IV.1 for application materials. Please note that Form C is to be used when downloading the application package.

http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf

Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY:

(770) 488-2783.

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority Sections 301 and 318 of the Public Health Service Act; 42 U.S.C. 241 and 247c

1. Background and Purpose The Minority HIV/AIDS Research Initiative (MARI) program was established in 2003 to build capacity for HIV epidemiologic and prevention research in mostly Black and Hispanic communities and among Black and Hispanic investigators working in highly-affected communities. The MARI program supports the CDC's overarching goal to promote health and reduce disease and disability by funding research that has the potential to reduce disease burden and to result in high public health impact.

The overarching national goal stated in the CDC’s HIV prevention strategic plan is to reduce the number of new HIV infections in the U.S. by focusing on eliminating racial and ethnic disparities in new HIV infections. The CDC year-end HIV/AIDS surveillance report, which outlines the racial disparities in HIV/AIDS, reveals that Blacks and Hispanics together represent 65 percent of reported cases of HIV infection, but together make up only 30 percent of the U.S. population.

These statistics highlight the urgent need for HIV epidemiologic and prevention research in minority communities that are at risk for HIV infection.

The goals of the MARI program are:

1. To build HIV prevention research capacity in minority communities in which little research has been conducted by partnering with and developing new investigators in these communities to address pertinent research questions.

2. To engage in career development and provide research opportunities for new investigators from mostly Black and Hispanic communities through collaboration with the Division of HIV/AIDS Prevention at CDC.

This will be achieved by encouraging these scientists to develop independent research skills needed to gain experience in HIV epidemiologic and prevention research, to present the results of their research at national conferences and to publish their results in peer-reviewed journals.

3. To develop and conduct HIV epidemiologic prevention research, in the form of limited case-controlled, cross-sectional or qualitative projects that have public health relevance to communities highly-affected by the HIV epidemic.

Therefore, the overall objective of this teaching/mentored award program is to prepare qualified individuals for careers that have a significant impact on the HIV/AIDS-related research needs of the nation, especially in highly-affected minority communities. The objective of the Minority HIV/AIDS Research Initiative Award program is to provide support for a sustained period of time for intensive research training and career development under the guidance of an experienced mentor in HIV prevention research and lead to promising HIV prevention activities and researchers who could independently conduct studies in highly-affected communities.

Health Equity:

The program supports efforts to improve the health of populations disproportionately affected by HIV/AIDS, viral hepatitis, sexually transmitted diseases (STDs) and TB by maximizing the health impact of public health services, reducing disease prevalence, and promoting health equity consistent with the National HIV/AIDS Strategy available at http://www.whitehouse.gov/administration/eop/onap/nhas .

Health disparity is a particular type of health difference that is closely linked with social or economic disadvantage based on racial or ethnic group, religion, socioeconomic status, gender, mental health, cognitive, sensory, or physical disability, sexual orientation, geographic location, or other characteristics historically linked to discrimination or exclusion [HP 2020 - http://www.healthypeople.gov/2010/hp2020 /advisory/PhaseI/glossary.htm]. Health disparities in HIV, viral Hepatitis, STDs, and TB are inextricably linked to a complex blend of social determinants that influence which populations are most severely affected by these diseases.

Social determinants are the economic and social conditions that influence the health of individuals, communities and jurisdictions and include conditions for early childhood development; education, employment, and work; food security, health services, housing, income, and social exclusion.

Health equity is a desirable goal that entails special efforts to improve the health of those who have experienced social or economic disadvantage. It requires:

Continuous efforts focused on elimination of health disparities, including disparities in health and in the living and working conditions that influence health, and Continuous efforts to maintain a desired state of equity after particular health disparities are eliminated.

Programs should use data, including social determinants data, to identify communities within their jurisdiction that are disproportionately affected by HIV, viral hepatitis, STDs and TB and related diseases and conditions, and plan activities to help eliminate health disparities. In collaboration with partners and appropriate sectors of the community, programs should consider social determinants of health in the development, implementation, and evaluation of program specific efforts and use culturally appropriate interventions that are tailored for the communities for which they are intended.

Healthy People 2020 and other National Strategic Priorities Research proposed as part of this teaching/mentored award will support the following Healthy People 2020 objectives related to HIV:

HIV-2, Reduce the number of new infections among adolescents and adults;

HIV-3, Reduce the rate of HIV transmission among adolescents and adults;

HIV-9, Reduce the proportion of persons with a diagnosis of Stage 3 HIV (AIDS) within 3 months of diagnosis of HIV infection;

http://www.whitehouse.gov/administration/eop/onap/nhas http://www.healthypeople.gov/2010/hp2020/advisory/PhaseI/glossary.htm http://www.healthypeople.gov/2010/hp2020/advisory/PhaseI/glossary.htm

HIV-13, Increase the proportion of persons living with HIV who know their serostatus;

HIV-14, Increase the proportion of adolescents and adults who have ever been tested for HIV;

HIV-19, Increase the proportion of persons who are linked to HIV medical care (had a routine HIV medical visit) within 3 months of HIV diagnosis;

HIV-21, Increase the proportion of persons with an HIV diagnosis in medical care who were prescribed antiretroviral therapy for the treatment of HIV infection at any time in the 12-month measurement period;

HIV-22, Increase the proportion of persons with an HIV diagnosis in medical care with a viral load <200 copies/mL at the last test during the 12-month measurement period.

The Healthy People 2020 site is available at: https://www.healthypeople.gov/2020/topics-objectives/topic/hiv

The research conducted as part of the Minority HIV/AIDS Research Initiative (MARI) aligns with all 3 goals of the National HIV/AIDS Strategy (NHAS):

Reducing HIV incidence (MARI projects consist of several studies that provide HIV prevention information to populations at risk of HIV exposure, which increases their abilities to protect themselves from acquiring new HIV infection) Increasing access to care and optimizing health outcomes (MARI projects have consisted of evaluations of providing home-based HIV services to at-risk populations, HIV-infected homeless populations, rural populations and other projects within highly-affected communities of color which serve to ensure increased access to HIV prevention and care) Reducing HIV-related health disparities (MARI is focused on supporting HIV prevention and research activities in disproportionately-affected communities of color by investigators who are fully engaged in those communities).

Additional details about the national HIV/AIDs Strategy are available here: https://www.whitehouse.gov /administration/eop/onap/nhas.

Also, this HIV prevention FOA supports a CDC Winnable Battles goal to reduce new HIV infections in the United States. More information about CDC’s Winnable Battles are available at: http://www.cdc.gov/winna blebattles/HIV/.

Public Health Impact The US National HIV/AIDS Strategy (NHAS) has as one of its major goals the reduction of HIV-related health disparities and notes that to achieve this goal we must diversify the HIV workforce and increase culturally-relevant HIV prevention interventions. This objective is also consistent with the first-ever Department of Heath and Human Services' Action Plan to Reduce Health Disparities. Increasing the number of racial/ethnic minority scientists serving disproportionately-affected communities: (1) diversifies the workforce, (2) may increase the credibility of research findings and confidence in research-driven initiatives among minority communities that have a history of medical research-related distrust, and (3) creates opportunities to increase the portfolio of HIV prevention interventions for disproportionately-affected communities; all are vital to achieving NHAS and Department of Health and Human Services goals.

Relevant Work This FOA builds upon previous awards to MARI with historically underrepresented researchers working in highly-affected minority communities. An update about MARI and relevant publications by MARI investigators can be found in the following report: http://ajph.aphapublications.org/doi/abs/10.2105/AJPH .2013.301345

2. Approach https://www.healthypeople.gov/2020/topics-objectives/topic/hiv https://www.whitehouse.gov/administration/eop/onap/nhas https://www.whitehouse.gov/administration/eop/onap/nhas http://www.cdc.gov/winnablebattles/HIV/ http://www.cdc.gov/winnablebattles/HIV/ http://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2013.301345 http://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2013.301345

Applicants must submit investigator-initiated proposals that address one of the following six research topic areas for high-impact HIV prevention in disproportionately-affected communities. In the application, applicants must state which topic the application will address.

Topic 1: Optimizing HIV continuum of care outcomes for disproportionately-affected men who have sex with men (MSM), especially Blacks/African Americans and Hispanics/Latinos.

Black/African American MSM in the U.S. have been disproportionately affected by HIV since the beginning of the epidemic in the 1980s, although studies show that Black/African-American men do not engage in more risk-associated behaviors than White men, and are just as consistent about condom use and HIV testing. Yet disparities in HIV incidence and prevalence between Black/African-American and White MSM in the U.S. remain largely unexplained. Racial/ethnic disparities have been noted at all stages of the HIV care continuum – only 33 percent of HIV-positive Black MSM were retained in care, compared with 51 percent of White MSM; and only 16 percent of Black MSM were virally suppressed, compared with 34 percent of White MSM.

Applications addressing this topic may wish to consider the following research gap questions:

1) What are some strategies (including considerations of social and structural determinants of health) to improve linkage and retention in care for persons living with HIV who face multiple barriers to effective care and treatment? Also consider clinical approaches that include multiple disciplines.

2) How can interventions strengthen use of antiretroviral treatments and reaching viral suppression among disproportionately affected racial/ethnic minority MSM?

3) What are some additional HIV testing strategies for identifying persons with acute HIV infections in clinical and non-clinical settings?

4) How can programs that provide free and/or low-cost HIV medications be scaled up and effectively delivered to persons who desire to be on treatment?

Topic 2: Effective implementation science strategies for HIV prevention, early diagnosis of acute infection, and treatment: expanding upon what works in highly-affected Black/African-American and Hispanic/Latino MSM communities.

Implementation science focuses on how to improve the uptake, translation and implementation of research into common practices. These efforts build the evidence base for HIV programs and maximize the impact of HIV education and prevention. Disproportionately-affected minority communities may benefit from increased implementation science efforts to more strategically evaluate promising HIV prevention and treatment interventions.

Applications addressing this topic may wish to consider the following research gap questions:

1) How do we improve access to HIV services among persons not currently reached by HIV services?

2) How do we effectively engage highly-affected communities in HIV education and prevention strategies that engage families, providers and community facilities (centers, churches)?

3) What strategies can be considered to deliver and use the 4th generation HIV tests for more timely diagnoses of acute HIV infection and early initiation of treatment?

Topic 3: Developing networks of young, Black/African-American men who have sex with men (YBMSM) for HIV education, prevention and care using social determinants of health (SDH) and empowerment-driven approaches that are most relevant for successful HIV prevention, care and treatment.

Among gay and bisexual men, Black/African-American gay and bisexual men—especially those who are younger—are the group most affected by HIV. Young African-American men who have sex with men (MSM) aged 13 to 24 years are especially affected by HIV. In 2010, they accounted for approximately 4,800 new HIV infections—more than twice as many estimated new infections as either young White or young Hispanic/Latino gay and bisexual men. Addressing this alarming epidemic among YBMSM requires a multifaceted approach that considers social and structural determinants of health, stigma, homophobia and discrimination.

Applications addressing this topic may wish to consider the following research questions:

1) What do YBMSM suggest as engaging and effective HIV prevention and treatment strategies for them and/or their networks?

2) What are sustainable, cost-effective, and culturally-tailored strategies for incorporating SDH solutions into HIV prevention and treatment approaches for YBMSM?

Topic 4: Increasing access to and uptake of treatment as prevention (TasP) and pre-exposure prophylaxis (PrEP) for communities of color: innovative strategies.

Data show that successfully engaging persons living with HIV in effective treatment can decrease HIV transmission to uninfected partners by up to 96% (treatment as prevention). Data also show that pre-exposure prophylaxis (PrEP) can be an effective strategy for decreasing the chance of acquiring HIV by up to 92% (if exposed) among uninfected, at-risk persons. These evidence-based solutions have not been fully implemented in disproportionately-affected Black/African-American and Hispanic/Latino communities.

Applications addressing this topic may wish to consider the following research gap questions:

1) What are new approaches to increase dialogue and administration of PrEP for at-risk persons in disproportionately-affected Black/African-American and Hispanic/Latino communities (at the patient level or at the provider level)?

2) What are strategies to increasingly engage highly-affected communities in strengthening understanding of and buy-in for treatment as prevention for persons living with HIV infection?

Topic 5: Developing strategies to more effectively engage and retain Black/African-American and Hispanic/Latina women in HIV care: cross-specialty and interdisciplinary approaches.

Women comprise 25% of persons living with HIV in the United States. Among women, Black/African-Americans and Hispanic/Latinas are disproportionately affected, with HIV diagnoses rates that are 19 and 3.5 times, respectively, higher than the rate for non-Hispanic White women. Data suggest that women are less often engaged in regular HIV care and less often achieve viral suppression.

Applications addressing this topic may wish to consider the following research gap questions:

1) What are promising approaches to effectively engage Black/African-American and Hispanic/Latina women in sustained HIV care?

2) What data are needed to increase engagement of women at each stage of the continuum of care?

Topic 6: Investigator-initiated, innovative projects.

We anticipate that investigators working in affected Black/African-American and Hispanic/Latino communities, including MSM communities, will have their own ideas for HIV prevention research in their communities. Strong, innovative applications that address research topics outside of the CDC-suggested research areas (above), but that are specific to addressing the HIV epidemic in highly-affected Black/African-American, Hispanic/Latino, Native American and MSM communities, will also be considered.

The applicants should demonstrate that they have been actively working in and with

The applicants should demonstrate that they have been actively working in and with disproportionately-affected populations as part of their HIV prevention activities.

Objectives/Outcomes Each application should provide detailed descriptions of the research goals based on the above stated topics of MARI (to engage disproportionately-affected minority populations in culturally-tailored, effective HIV prevention research strategies).

The following logic model summarizes the strategies and outcomes of MARI as a mentored, teaching award for HIV prevention.

Purpose: The overall objective of this teaching/mentored Award program is to prepare qualified early-career scientists for careers that have a significant impact on the HIV/AIDS-related research needs of the nation, especially in highly-affected racial/ethnic and sexual minority (LGBT) communities. The objective of the Minority HIV/AIDS Research Initiative (MARI) Award program is to provide support for a sustained period of time for intensive research training and career development under the guidance of an experienced mentor in HIV prevention research leading to promising HIV prevention activities and programs and research independence in communities disproportionately affected by HIV.

Strategies Outcomes

Strategy 1: Work with early-career investigators to develop research protocols and respond to human subjects inquiries to conduct high-impact HIV prevention research in communities that are disproportionately affected by HIV, especially Black/African American, Hispanic/Latino, and MSM communities.

(Year 1)

Strategy 2: Provide training and technical assistance to funded MARI investigators in support of study implementation, data dissemination, writing scientific abstracts and manuscripts, and presenting at scientific conferences (Years 2-4)

Short-term Intermediate Long-term

1. Increased funded research training and capacity building for historically underrepresented HIV prevention scientists doing community-level research.

2. Increased engagement by affected, minority communities as part of HIV research and developing effective interventions.

3. Improved capacity of historically underrepresented, highly-affected communities to engage in developing solutions for HIV education and prevention.

1. Improved capacity of historically-underrepresented, highly-affected communities to engage in developing solutions for HIV education and prevention.

2. For the target population, improved sexual health self-efficacy, awareness and skills regarding HIV prevention.

3. Improved skills for successfully presenting at national and international scientific conferences and publishing research findings in peer-reviewed journals.

4. Improved ability to navigate academic and research pathways for career progression.

1. Reduced HIV incidence in affected communities.

2. Increased access to care and treatment for persons living with HIV infection.

3. Reduced HIV-related health disparities.

4. Sustainable HIV prevention research capacity in minority communities by partnering with and developing new investigators in these communities to address pertinent research questions.

5. Improved health equity for a diverse HIV scientific workforce.

Strategy 3: To develop cost-effective, culturally-tailored, and sustainable HIV prevention interventions for communities highly affected by the HIV epidemic. (Years 3-4)

6. More successful attempts for larger, federally-funded HIV and health disparities research, such as NIH grants.

7.Inform local and federal policy-makers as it relates to HIV prevention in highly-affected communities.

Target Population This FOA focuses on populations that are disproportionately-affected by HIV infections (MSM, Blacks/African Americans and Hispanic/Latinos), as stated in the National HIV/AIDS Strategy and is consistent with the National HIV Surveillance Report, which can be found here: http://www.cdc.gov/hiv/libra ry/reports/surveillance/2013/surveillance_Report_vol_25.html

Collaboration/Partnerships The PI may choose to collaborate with partners (optional) who are also subject matter experts for their HIV prevention research proposal. The application should include letters of support that indicate a Memorandum of Understanding (MOU) will be developed with each proposed partner after receiving an award. The letters of support should include: 1) specific roles and responsibilities of each partner, 2) names and titles of individuals who will be committed to this project, 3) a description of how progress will be measured, and 4) whether any funding will go to the proposed partner. This may be separate from the local senior mentor who will be supported at the 5-10% level on the proposal budget.

Evaluation/Performance Measurement As part of the application, the PI should include measurable goals and aims based on a four-year research project period. The grantee will collaborate with CDC to: (1) establish specific, measurable, achievable, realistic and time-phased (SMART) project objectives for each activity described in the applicant’s project plan, and (2) develop and implement project performance measures that are based on specific programmatic objectives. Also, funded PIs must submit an annual progress report showing their activities and outcomes based on their overall research goals and timeline. For more information on required Reporting, please see Section VI of this FOA.

Translation Plan As a teaching/mentored award, MARI PIs are supported in their data analyses, abstract/manuscript writing, and data dissemination efforts. Dissemination plans should include efforts with local communities, as well as presentations at national and international scientific meetings and publication of results in peer-reviewed journals.

Section II. Award Information

Funding Instrument Type: Cooperative Agreement A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

http://www.cdc.gov/hiv/library/reports/surveillance/2013/surveillance_Report_vol_25.html http://www.cdc.gov/hiv/library/reports/surveillance/2013/surveillance_Report_vol_25.html

Application Types Allowed:

New - An application that is submitted for funding for the first time. Includes multiple submission attempts within the same round.

Estimated Total Funding: $9,600,000 Year 1: up to $300,000

Year 2: up to $300,000

Year 3: up to $300,000

Year 4: up to $300,000

Estimated total funding available for the first year is up to $2,400,000.

Anticipated Number of Awards: 8 An indirect cost rate of 8% is not automatic; however, grantee institutions may elect to take an indirect cost rate of 8% should they choose to do so.

Awards issued under this FOA are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

Award Ceiling: $300,000 Per Budget Period Award Floor: $0 Per Budget Period Total Project Period Length: 4 year(s)

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

HHS/CDC grants policies as described in the HHS Grants Policy Statement (http://www.hhs.gov/ asfr/ogapa/aboutog/hhsgps107.pdf) will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category: State governments

County governments City or township governments Special district governments Independent school districts Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education For profit organizations other than small businesses http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf

Small businesses Others (see text field entitled "Additional Information on Eligibility" for clarification)

The following types of Higher Education Institutions are always encouraged to apply for CDC support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education:

Nonprofits (Other than Institutions of Higher Education)

Governments:

Eligible Agencies of the Federal Government U.S. Territory or Possession

Other:

Native American tribal organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations Bona Fide Agents: a Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required. Attach with "Other Attachment Forms" when submitting via www.grants.gov.

Federally Funded Research and Development Centers (FFRDCs): FFRDCs are operated, managed, and/or administered by a university or consortium of universities, other not-for-profit or nonprofit organization, or an industrial firm, as an autonomous organization or as an identifiable separate operating unit of a parent organization. A FFRDC meets some special long-term research or development need which cannot be met as effectively by an agency's existing in-house or contractor resources. FFRDC's enable agencies to use private sector resources to accomplish tasks that are integral to the mission and operation of the sponsoring agency. For more information on FFRDCs, go to http:// ecfr.gpoaccess.gov /cgi/t/text/ text-idx?c=ecfr& sid=512ff78311f427c00454772dcf21523a&rgn=div8 &view=text&node=48:1.0.1.6.34.0.1.18& idno=48

2. Foreign Organizations Foreign Organizations are not eligible to apply.

http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=512ff78311f427c00454772dcf21523a&rgn=div8&view=text&node=48:1.0.1.6.34.0.1.18&idno=48 http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=512ff78311f427c00454772dcf21523a&rgn=div8&view=text&node=48:1.0.1.6.34.0.1.18&idno=48 http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=512ff78311f427c00454772dcf21523a&rgn=div8&view=text&node=48:1.0.1.6.34.0.1.18&idno=48

Foreign components of U.S. Organizations are not eligible to apply.

For this announcement, applicants may not include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

3. Special Eligibility Requirements Foreign institutions and components of foreign institutions are not eligible to apply.

Documentation of the following five requirements must be included in the application. This includes, but is not limited to, documentation in the PI's biosketch indicating involvement in HIV/AIDS research and/or HIV/AIDS-related publications and letters of support in the application’s Appendix.

The PI from the applying institution must be able to meet and demonstrate the following five requirements:

1) Possess a research or health-professional master's or doctorate-level degree from an accredited school/program;

2) Never have been a Principal Investigator on an HHS HIV research award for $250,000 or greater;

3) Be knowledgeable about HIV/AIDS epidemiology and prevention, as well as have basic and documented research experience in, or related to, the field of HIV/AIDS, STD, and racial/ethnic or sexual minorities;

4) Have a documented history of working in Black/African-American, Hispanic/Latino, or Native American communities and ability to access study populations from these communities that are affected by HIV;

5) Demonstrate engagement to partner and apply with a local senior investigator who is able to devote 5-10% full-time effort to the project as a mentor. A letter of support from the mentor is required in the application appendix.

4. Justification for Less than Maximum Competition N/A

5. Responsiveness N/A

6. Required Registrations Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: https://eportal.nspa.nato. int/AC135Public/Docs/US%20Instructions%2 0for%20NSPA%20NCAGE.pdf System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, https://www.sam.gov/portal/SAM/#1.

Grants.gov eRA Commons

All applicant organizations must register with Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and submission processes.

https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://www.sam.gov/portal/SAM/%231 http://www.Grants.gov https://public.era.nih.gov/commons/public/login.do?TYPE=33554433&REALMOID=06-1edb031f-46c7-44b3-b803-60b537de74d2&GUID=&SMAUTHREASON=0&METHOD=GET&SMAGENTNAME=-SM-938PYmoLVb4VrDeXo04LZUDVDvc%2b3899ByInEAjuSUvWNIGfB2zRpWiCivYGCogG&TARGET=-SM-http%3a%2f%2fpublic%2eera%2enih%2egov%2fcommons http://www.Grants.gov

The “one-time” registration process will take three to five days to complete. However, it is best to start the registration process at least two weeks prior to application submission.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization. All registrations must be successfully completed and active before the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

7. Universal Identifier Requirements and System for Award Management (SAM) All applicant organizations must obtain a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements.

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

Additionally, all applicant organizations must register in the System for Award Management (SAM).

Organizations must maintain the registration with current information at all times during which it has an application under consideration for funding by CDC and, if an award is made, until a final financial report is submitted or the final payment is received, whichever is later. SAM is the primary registrant database for the Federal government and is the repository into which an entity must provide information required for the conduct of business as a recipient. Additional information about registration procedures may be found at the SAM internet site at https://www.sam.gov/index.html.

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

8. Eligible Individuals (Project Director/Principal Investigator) in Organizations/Institutions Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for HHS/CDC support.

9. Cost Sharing This FOA does not require cost sharing as defined in the HHS Grants Policy Statement (http:// www.hhs.gov/ asfr/ ogapa/ aboutog/ hhsgps107.pdf).

10. Number of Applications As defined in the HHS Grants Policy Statement, (http: //www.hhs.gov /asfr /ogapa /aboutog /hhsgps107.

pdf), applications received in response to the same funding opportunity announcement generally are scored individually and then ranked with other applications under peer review in their order of relative programmatic, technical, or scientific merit. HHS/CDC will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Each eligible institution/organization may submit more than one application, provided that each application is scientifically distinct and has a different PD/PI. If necessary, Co-PI(s) may be listed in the application but only one PI may be the primary CDC contact for the award and must be indicated in the application.

NOTE: Only one application may be submitted per topic area from the same institution.

Section IV. Application and Submission Information http://fedgov.dnb.com/webform https://www.sam.gov/index.html http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf

1. Address to Request Application Package Applicants must download the SF424 (R&R) application package associated with this funding opportunity from www.Grants.gov.

If access to the Internet is not available or if the applicant encounters difficulty accessing the forms on-line, contact the HHS/CDC Procurement and Grants Office Technical Information Management Section (PGO TIMS) staff at (770) 488-2700 or pgotim@cdc.gov for further instructions. Hours: Monday - Friday, 7am – 4:30pm U.S. Eastern Standard Time. CDC Telecommunications for the hearing impaired or disabled is available at: TTY 1-888-232-6348.

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/ 424/SF424_RR_Guide_General_VerC.pdf), except where instructed in this Funding Opportunity Announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

The forms package associated with this FOA includes all applicable components, mandatory and optional.

Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF 424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

In conjunction with the SF424 (R&R) components, CDC grants applicants should also complete and submit additional components titled “PHS398.” Note the PHS398 should include assurances and certifications, additional data required by the agency for a complete application. While these are not identical to the PHS398 application form pages, the PHS398 reference is used to distinguish these additional data requirements from the data collected in the SF424 (R&R) components. A complete application to CDC will include SF424 (R&R) and PHS398 components.

3. Letter of Intent Due Date for Letter of Intent: 09/14/2015

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 CIO staff to estimate the potential review workload and plan the review.

By the date listed above and in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Name of the Applicant Descriptive title of proposed research Name, address, and telephone number of the PD(s)/PI(s) Names of other key personnel Participating institutions Number and title of this funding opportunity

The letter of intent should be sent to:

Gregory Anderson, MPH, MS

Extramural Research Program Office

Office of the Associate Director for Science

National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention http://www.Grants.gov mailto:pgotim@cdc.gov

Centers for Disease Control and Prevention

U.S. Department of Health and Human Services

1600 Clifton Road, MS E-60

Atlanta, GA 30333

Telephone: 404-718-8833

Fax: 404-718-8822

Email: GAnderson@cdc.gov

4. Required and Optional Components A complete application has many components, both required and optional. The forms package associated with this FOA in Grants.gov includes all applicable components for this FOA, required and optional.

5. PHS 398 Research Plan Component The SF424 (R&R) Application Guide includes instructions for applicants to complete a PHS 398 Research Plan that consists of 16 components. Not all 16 components of the Research Plan apply to all Funding Opportunity Announcements (FOAs). Specifically, some of the following 16 components are for Resubmissions or Revisions only. See Part I, Section 5.5 of the SF 424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf) for additional information. Please attach applicable sections of the following Research Plan components as directed in Part 2, Section 1 (Funding Opportunity Announcement Description).

Follow the page limits stated in the SF 424 unless otherwise specified in the FOA. As applicable to and specified in the FOA, the application should include the bolded headers in this section and should address activities to be conducted over the course of the entire project, including but not limited to:

1. Introduction to Application (for Resubmission and Revision ONLY) - provide a clear description about the purpose of the proposed research and how it addresses the specific requirements of the FOA.

2. Specific Aims – state the problem the proposed research addresses and how it will result in public health impact and improvements in population health.

3. Research Strategy – the research strategy should be organized under 3 headings: Significance, Innovation and Approach. Describe the proposed research plan, including staffing and timeline.

4. Inclusion Enrollment Report (Renewal and Revision applications ONLY)

5. Progress Report Publication List (for Continuation ONLY)

Human Subjects Section

6. Protection of Human Subjects

7. Inclusion of Women and Minorities

8. Targeted/Planned Enrollment Table (for New Application ONLY)

9. Inclusion of Children

Other Research Plan Sections

10. Vertebrate Animals

11. Select Agent Research

12. Multiple PD/PI Leadership Plan.

13. Consortium/Contractual Arrangements

14. Letters of Support

15. Resource Sharing Plan(s)

16. Appendix

Component 4 (Inclusion Enrollment Report) applies only to Renewal and Revision applications for clinical research. Clinical research is that which is conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues mailto:GAnderson@cdc.gov that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies). Follow the page limits in the SF 424 unless otherwise specified in the FOA.

All instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf) must be followed along with any additional instructions provided in the FOA.

6. Appendix Do not use the appendix to circumvent page limits. A maximum of 10 PDF documents are allowed in the appendix.