NCHHSTP Kenya Research RFA-PS-17-005 Revision.pdf

Centers for Disease Control

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

Office

Strengthening HIV/AIDS Research in Kenya

RFA-PS-17-005

Application Due Date: 04/04/2017

Strengthening HIV/AIDS Research in Kenya

RFA-PS-17-005

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 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 Strengthening HIV/AIDS Research in Kenya Activity Code U01 – Research Project - Cooperative Agreement

Funding Opportunity Announcement Type New Funding Opportunity Announcement Number

RFA-PS-17-005

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

Health FOA Purpose The purpose of this funding opportunity announcement (FOA) is to support a project to conduct clinical trials and public health research for the prevention and treatment of HIV in Kenya.

Please note: This FOA was amended on pages 35-37 in Section VIII to include a summary of the conference call for potential applicants held on Wednesday, February 15, 2017; to clarify review criteria in Section V.1 that will be used to evaluate Investigators (page 19) and the Environment (page 21); and to clarify what funding preferences may be used during the Secondary Review of applications (Section V.4, page 24).

Key Dates Publication Date: To receive notification of any changes to RFA-PS-17-005, 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: 03/03/2017

Application Due Date: 04/04/2017

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).

http://www.grants.gov

Scientific Merit Review: 05/18/2017

Secondary Review: 06/08/2017

Estimated Start Date: 09/01/2017

Expiration Date: 04/05/2017 Due Dates for E.O. 12372: Due no later than 60 days after the application receipt date.

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 25 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: To conduct clinical trials and public health research for the prevention and treatment of HIV in Kenya with particular emphasis on biomedical interventions, including alternative methods to deliver HIV pre-exposure prophylaxis such as vaginal rings. Additional studies may include research on: HIV transmission, optimization of HIV care and treatment, alternative biomedical modalities for HV prevention, HIV cure, risk factors for and the epidemiology of HIV infections and interventions that prevent or minimize HIV co-morbidities.

Mechanism of Support: Research Project - Cooperative Agreement (U01).

Funds Available and Anticipated Number of Awards: The estimated total funding available, including direct and indirect costs, for the entire 5-year project period is $5,000,000. The anticipated number of awards is one (1). The award issued under this FOA is contingent upon availability of funds and a meritorious application.

Budget and Project Period: The estimated total funding (direct and indirect) for the first year (12-month budget period) is $1,500,000, ranging from an estimated $500,000 to $1,500,000. The estimated total funding (direct and indirect) for the entire project period is $5,000,000. The project period is anticipated to run from 09/01/2017 to 08/31/2022.

Application Research Strategy Length: Page limits for the Research Strategy are clearly specified in Section IV. “Application and Submission Information” of this announcement.

Eligible Institutions/Organizations: Institutions/organizations listed in Section III.1 of this announcement are eligible to apply.

Eligible Project Directors/Principal Investigators (PDs/PIs): Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. NOTE: CDC does not make awards to individuals directly. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply.

Number of PDs/PIs: There will only be one PD/PI for this project.

Number of Applications: Only one application per institution (normally identified by having a unique DUNS number) is allowed.

Application Type: New.

Special Date(s): A potential applicant conference call will be held on Wednesday, February 15, 2017 at 12:00 noon ET. Telephone number: 1-866-620-0420; Passcode: 8943360.

http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf at 12:00 noon ET. Telephone number: 1-866-620-0420; Passcode: 8943360.

Application Materials: See Section IV.1 for application materials. Please note that Form D is to be used when downloading the application package: http://grants.nih.gov/grants/how-to-apply-application -guide/forms-d/general-forms-d.pdf Hearing Impaired: Telecommunications for the hearing impaired are available at: TTY:

1-888-232-6348

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority Public Health Service Act Sections 301(a), 318(k)(2) [42 USC 241(a) and 247b(k)(2)(d)] and 307 [42 USC 242l].

1. Background and Purpose The NCHHSTP Division of HIV/AIDS Prevention (DHAP) is seeking to initiate a cooperative agreement to support research on HIV prevention with particular emphasis on biomedical interventions, including alternative methods for delivering HIV pre-exposure prophylaxis such as vaginal rings. Additional research studies may include research on: HIV transmission, optimization of HIV care and treatment, alternative biomedical modalities for HIV prevention and safety, HIV treatment cure, risk factors for and the epidemiology of HIV infections, and interventions that prevent or minimize HIV co-morbidities from other infections.

Over the last 10 years, DHAP alone has invested in excess of $20 million for public health research and infrastructure in Kisumu with Kenya’s Ministry of Health through the Kenya Medical Research Institute (KEMRI). In the Kisumu/Nyanza region, which is the Western Kenya site for KEMRI, the HIV prevalence is about 15% higher than for the rest of Kenya. This provides a need and opportunity for the development of new HIV prevention tools and research beneficial to the peoples of both Kenya and the United States. The Kisumu HIV Research Laboratory serves as a reference laboratory for the region and supports international clinical trials networks, as well as a partnership with the US Army Walter Reed Lab (Kericho). These two laboratories serve as back-up and quality control validation centers for each other, as well as for other African laboratories.

Since 2013, the HIV Research Branch in Kisumu has refined its capacity to conduct Phase II-IV clinical trials and is participating with the following NIH Networks: HIV Prevention Trials Network (HPTN), AIDS Clinical Trials Group (ACTG) and Microbicide Clinical Trials Network (MTN).

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 https://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.

http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf https://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

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 This FOA addresses the Healthy People 2020 focus area(s) of: Immunization and Infectious Diseases; Global Health; and Sexually Transmitted Diseases. The FOA also addresses the US National HIV/AIDS Strategy Goals to Reduce New Infections and to Increase Access to Care and Improve Health Outcomes for People Living with HIV. Additionally, the FOA aligns with CDC strategies and goals, including:

The NCHHSTP performance goal(s) to: a) decrease the incidence of HIV infection, and b) decrease HIV morbidity and mortality;

The CDC Global Health Strategy: Health Impact Goal to improve the health and well-being of people around the world; and Health Capacity Goal to build country public health capacity.

Public Health Impact This FOA specifically focuses on biomedical interventions and alternative interventions to prevent HIV and reduce HIV morbidity and mortality and therefore has the potential to contribute to national, CDC and global goals of HIV prevention and elimination and optimal HIV outcomes. It will address the critically important need to identify and evaluate alternative and improved methods to prevent HIV transmission and infection;

these are crucial components of US, CDC and World Health Organization goals and targets to prevent and ultimately eliminate HIV infections. The FOA supports research on novel biomedical interventions, including alternative methods to deliver and increase the acceptance of, and adherence to, pre-exposure prophylaxis to prevent HIV infection, as well as on HIV vaccines and cures for HIV. Research aimed at drugs and devices that could be scaled up for public health impact will be prioritized.

Relevant Work Gust, DA, Gvetadze, R, Furtado, M, et al. Factors associated with psychological distress among women screened for a contraceptive ring study in Kisumu, Kenya. 2016. Submitted to Culture, Health and Sexuality.

1.

Fogel JM, Hudelson SE, Ou SS, et al. Brief report: HIV drug resistance in adults failing early antiretroviral treatment: results from the HIV prevention trials network 052 trial. J Acquir Immune Defic Syndr. 2016;72:304-9.

2.

McLellan-Lemal E, Gust D, Gvetadze R, Furtado M, Otieno FO, Desai M, Zeh C, Samandari T, Nyagol B, and Makanga EM. (2016). Characteristics of women screened for a contraceptive intravaginal ring study in Kisumu, Kenya, 2014. Res J Women’s Health. 2016;3:1.

3.

Mdodo R, Gust D, Otieno FO, et al. Investigation of HIV Incidence Rates in a High-Risk, High-Prevalence Kenyan Population: Potential Lessons for Intervention Trials and Programmatic

4.

Strategies. J Int Assoc Provid AIDS Care. 2016;15:42-50.

Odhiambo C, Zeh C, Angira F, et al. Anaemia in HIV-infected pregnant women receiving triple antiretroviral combination therapy for prevention of mother-to-child transmission: a secondary analysis of the Kisumu breastfeeding study (KiBS). Trop Med Int Health. 2016;21:373-84.

5.

Zeh C, Inzaule SC, Ondoa P, et al. Molecular Epidemiology and Transmission Dynamics of Recent and Long-Term HIV-1 Infections in Rural Western Kenya. PLoS One. 2016;11:e0147436. doi:

10.1371/journal.pone.0147436.

6.

Akelo V, McLellan-Lemal E, Toledo L, et al. Determinants and experiences of repeat pregnancy among HIV-positive Kenyan women--a mixed-methods analysis. PLoS One. 2015;10:e0131163. doi:

10.1371/journal.pone.0131163. Erratum in: PLoS One. 2015;10:e0134536.

7.

Behling J, Chan AK, Zeh C, Nekesa C, Heinzerling L. Evaluating HIV Prevention Programs: Herpes Simplex Virus Type 2 Antibodies as Biomarker for Sexual Risk Behavior in Young Adults in Resource-Poor Countries. PLoS One. 2015;10:e0128370. doi:10.1371/journal.pone.0128370.

8.

Gumbe A, Gray KM, McLellan-Lemal E, et al. Correlates of prevalent HIV infection among adults and adolescents in the Kisumu Incidence Cohort Study, Kisumu, Kenya. Int J STD AIDS.

2015;26:929-40.

9.

Iuliano AD, Weidle PJ, Brooks JT, et al. Neutropenia in HIV-infected Kenyan women receiving triple antiretroviral prophylaxis to prevent mother-to-child HIV transmission is not associated with serious clinical sequelae . J Int Assoc Provid AIDS Care. 2015;14:261-8.

10.

Ondenge K, McLellan-Lemal E, Awuonda E, Angira F, Mills LA, Thomas T. Disseminating results:

community response and input on Kisumu breastfeeding study. Transl Behav Med. 2015;5:207-15.

11.

Otieno FO, Ndivo R, Oswago S, et al. Correlates of prevalent sexually transmitted infections among participants screened for an HIV incidence cohort study in Kisumu, Kenya. Int J STD AIDS.

2015;26:225-37.

12.

Titchmarsh L, Zeh C, Verpoort T, Allain JP, Lee H. Leukodepletion as a point-of-care method for monitoring HIV-1 viral load in whole blood. J Clin Microbiol. 2015;53:1080-6.

13.

Alemnji GA, Zeh C, Yao K, Fonjungo PN. Strengthening national health laboratories in sub-Saharan Africa: a decade of remarkable progress. Trop Med Int Health. 2014;19:450-8.

14.

Chang J, Omuomo K, Anyango E, et al. Field evaluation of Abbott Real Time HIV-1 Qualitative test for early infant diagnosis using dried blood spot samples in comparison to Roche COBAS Ampliprep/COBAS TaqMan HIV-1 Qual test in Kenya. J Virol Methods. 2014;204:25-30.

15.

Grinsztejn B, Hosseinipour MC, Ribaudo HJ, et al. Effects of early versus delayed initiation of antiretroviral treatment on clinical outcomes of HIV-1 infection: results from the phase 3 HPTN 052 randomised controlled trial. Lancet Infect Dis. 2014;14:281-90. Epub 2014 Mar 4. Erratum in: Lancet Infect Dis. 2014;14:269.

16.

Inzaule S, Otieno J, Kalyango J, et al. Incidence and predictors of first line antiretroviral regimen modification in western Kenya. PLoS One. 2014;9:e93106. doi:10.1371/journal.pone.0093106.

17.

Minniear TD, Girde S, Angira F, et al. Outcomes in a cohort of women who discontinued maternal triple-antiretroviral regimens initially used to prevent mother-to-child transmission during pregnancy and breastfeeding--Kenya,2003-2009. PLoS One. 2014;9:e93556.

18.

Okall DO, Ondenge O, Nyambura M, et al. Men who have sex with men (MSM) in Kisumu, Kenya:

Comfort in accessing health services and willingness to participate in HIV prevention studies. J Homosex. 2014;61:1712-26.

19.

Nyambura, M, Otieno, F, Ndivo, R, Williamson J, Pals, D, Mills LA and Gust, DA. Participant retention in a HIV prevention cohort study in Kisumu, Kenya. Clinical Research in HIV/AIDS and Prevention. 2014;1:13-21.

20.

Ondeng’e, K, Gust, D, Nyikuri, M, Ogendo,A, Ndivo, R. Chen,RT, Laserson, KF and Mills, LA.

Evaluation of recruitment approaches for the HPTN 052 clinical trial of HIV serodiscordant couples in rural western Kenya. Clinical Research in HIV/AIDS and Prevention. 2014;1:1-12.

21.

Otieno FO, Ndivo R, Oswago S, et al. Evaluation of syndromic management of sexually transmitted infections within the Kisumu Incidence Cohort Study. Int J STD AIDS. 2014;25:851-9.

22.

Akelo V, Girde S, Borkowf CB, et al. Attitudes toward family planning among HIV-positive pregnant women enrolled in a prevention of mother-to-child transmission study in Kisumu, Kenya. PLoS One.

2013;8:e66593. doi: 10.1371/journal.pone.0066593.

23.

Inzaule S, Yang C, Kasembeli A, et al. Field evaluation of a broadly sensitive HIV-1 in-house genotyping assay for use with both plasma and dried blood spot specimens in a resource-limited country. J Clin Microbiol. 2013;51:529-39.

24.

Ouma KN, Basavaraju SV, Okonji JA, et al. Evaluation of quantification of HIV-1 RNA viral load in plasma and dried blood spots by use of the semiautomated Cobas Amplicor assay and the fully automated Cobas Ampliprep/TaqMan assay, version 2.0, in Kisumu, Kenya. J Clin Microbiol.

2013;51:1208-18.

25.

Cohen MS, Chen YQ, McCauley M, et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011;365:493-505.

26.

Zeh C, Weidle PJ, Nafisa L, et al. HIV-1 drug resistance emergence among breastfeeding infants born to HIV-infected mothers during a single-arm trial of triple-antiretroviral prophylaxis for prevention of mother-to-child transmission: a secondary analysis. PLoS Med. 2011;8:e1000430. doi:

10.1371/journal.pmed.1000430.

27.

Thomas TK, Masaba R, Borkowf CB, et al. Triple-antiretroviral prophylaxis to prevent mother-to-child HIV transmission through breastfeeding--the Kisumu Breastfeeding Study, Kenya: a clinical trial. PLoS Med. 2011;8:e1001015. doi: 10.1371/journal.pmed.1001015.

28.

2. Approach Primary Objectives:

Assess the safety, efficacy, acceptability, adherence to, impact and other characteristics of biomedical interventions to prevent HIV, such as intravaginal rings and multipurpose technologies, to include HIV pre-exposure prophylaxis (PrEP).

Evaluate the feasibility, performance and other characteristics of biomedical interventions, assays and biomarkers to diagnose and monitor HIV infection and its response to treatment.

Evaluate the acceptance, adherence, feasibility and impact of providing HIV PrEP to individuals at high risk for HIV (for example, adolescent and young women [ADYW], sex workers and men who have sex with men [MSM]) and biomarkers to monitor PrEP.

Establish a system and protocol for data collection, tabulation, management, cleaning, storage/archiving that comply with Clinical Data Interchange Standards Consortium (CDISC) regulations and standards as well as the Study Data Standards for Regulatory Submissions.

Establish and/or maintain partnerships with regional/sub-regional ministries of health, provincial and municipal health departments, non-governmental organizations, academic institutions, manufacturers of HIV biomedical interventions and diagnostic/monitoring assays, academic partners and others to facilitate implementation of the priority HIV research.

In addition to the primary objectives, the following additional objectives may also be addressed:

Conduct additional laboratory testing required by Institutional Review Boards and Scientific and Ethics Review Units for research implemented during the period of this award.

Estimate the cost-effectiveness of biomedical interventions to prevent and mitigate HIV infections that are conducted through this award.

Estimate the cost-effectiveness of point-of-care and alternative HIV diagnostics (for diagnosis and monitoring) compared with standards of care.

Evaluate alternative methods to deliver biomedical interventions to prevent HIV.

Assess immune responses to alternative biomedical interventions and therapies for HIV prevention and care, respectively.

Assess the use, feasibility and impact or effect on HIV diagnosis and care, of other alternative tools and interventions.

and interventions.

Evaluate risk factors for HIV infection and transmission and the potential impact of interventions intended to reduce the risk of HIV infection.

Evaluate alternative HIV treatment regimens or treatment (antiretroviral) delivery systems.

Monitor adverse effects and events of HIV biomedical interventions.

Evaluate community and intra-household psychosocial and behavioral issues that influence acceptance and efficacy of alternative biomedical and non-biomedical interventions to prevent HIV.

Assess patterns of acceptance and utilization of biomedical interventions to prevent HIV.

Objectives/Outcomes Whenever possible, applications should include objectives written in the SMART format (e.g., Specific, Measurable, Achievable, Realistic and Time-bound).

The expected outcomes include the following:

Prepare and conduct at least one clinical trial that implements and evaluates use of a biomedical intervention identified as a priority by CDC Division of HIV/AIDS Prevention (DHAP), such as a vaginal ring, including but not restricted to the support of laboratory and epidemiologic aspects of the trial, its monitoring and quality assurance and the procurement of commodities and services required to conduct the trial(s).

Evaluate the feasibility, performance and other characteristics of at least one other biomedical intervention, assay and biomarker for the diagnosis and monitoring of HIV infection and its response to treatment that are developed within this cooperative agreement.

Evaluate the acceptance, adherence, feasibility and impact of providing HIV PrEP to individuals at high risk for HIV (for example, adolescent and young women [ADYW], sex workers and men who have sex with men [MSM]) and biomarkers to monitor PrEP that are developed within this cooperative agreement.

Establish a system and protocol for Clinical Data Interchange Standards Consortium (CDISC)-compliant data collection, tabulation, management, cleaning, storage/archiving that follows the Study Data Standards for Regulatory Submissions.

Establish and/or maintain partnerships and relationships needed to support the execution of the priority HIV research activities by this cooperative agreement.

Target Population All temporary or permanent residents of Western Kenya, particularly the Kisumu/Nyanza area, including groups at high risk for HIV such as: adolescent and young women (ADYW); commercial sex workers (CSW); and men who have sex with men (MSM).

Collaboration/Partnerships The awardee is expected to maintain the current collaboration and partnership between CDC and the Kenya Medical Research Institute (KEMRI) and the Kenya Ministry of Health and to support experienced and qualified staffing of KEMRI HIV research as approved by the clinical research site advisors and leadership.

The awardee is also expected to maintain fiduciary oversite over the use of award funds and to facilitate access and cooperation in meeting research study objectives. The awardee will be responsible for oversight of human subjects protections and any OMB-PRA requirements, in collaboration with CDC scientists.

The application should include documentation indicating a close collaboration with KEMRI as exhibited by a Memorandum of Understanding (MOU).

Evaluation/Performance Measurement The grantee will be evaluated on the ability to support the conduct of HIV research as described in the

The grantee will be evaluated on the ability to support the conduct of HIV research as described in the Primary Objectives and listed potential additional objectives of this FOA. The grantee will also be evaluated on the ability to perform fiduciary oversight of the award and monthly updates on the distribution and balance of award funds. The grantee will be evaluated for adequate oversight of human subjects protections and any OMB-PRA requirements, in collaboration with CDC scientists.

As part of the application, the applicant should include measurable goals and aims and interim reporting timelines for quarterly reporting of expenditures, based on a five-year research project period. The grantee will collaborate with CDC to: (1) establish Specific, Measurable, Achievable, Realistic and Time-bound (SMART) project objectives for each activity described in the application's project plan; and (2) develop and implement project performance measures that are based on specific programmatic objectives. Also, the grantee must submit an annual progress report to CDC that shows grantee’s activities and outcomes with timelines. For more information on required Reporting, please see Section VI of this FOA.

Translation Plan Applications must include a plan to estimate and report the potential translatability and public health impact of the research. A plan for the dissemination of findings should be developed in collaboration with CDC and

KEMRI.

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.

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: $5,000,000

Anticipated Number of Awards:

The ceiling and floor amounts listed below are for individual awards for the first 12-month budget period.

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

Award Ceiling: $1,500,000 Per Budget Period Award Floor: $500,000 Per Budget Period Total Project Period Length:

5 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/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf) will apply to the applications submitted and awards made in response to this FOA.

http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

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

Additional Eligibility Category:

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 Foreign Organizations: a Foreign Organization is a public or private organization, whether non-profit or for-profit, located in a country other than the United States (U.S.) and its territories that is subject to the laws of the country in which it is located, irrespective of the citizenship of project staff or place of performance.

Bona Fide Agents: a Bona Fide Agent is an agency/organization identified by the state as eligible to

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 https://dap.dau.mil/acquipedia/Pages/ArticleDetails.aspx?aid=5e3079b8-44f2-43df-a0e7-9f379e8c48ed

2. Foreign Organizations Foreign Organizations are eligible to apply.

Foreign (non-US) organizations must follow policies described in the HHS Grants Policy Statement (http ://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf), and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide. International registrants can confirm DUNS by sending an e-mail to ccrhelp@dnb.com, including Company Name, D-U-N-S Number, and Physical Address, and Country. Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: https ://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf .

Foreign components of U.S. Organizations are eligible to apply.

For this announcement, applicants may include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

3. Special Eligibility Requirements

N/A

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 https://dap.dau.mil/acquipedia/Pages/ArticleDetails.aspx?aid=5e3079b8-44f2-43df-a0e7-9f379e8c48ed http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf mailto:ccrhelp@dnb.com 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://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

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.

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/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf).

10. Number of Applications As defined in the HHS Grants Policy Statement,(http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/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 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 http://fedgov.dnb.com/webform https://www.sam.gov/index.html 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.

Only one application per institution (normally identified by having a unique DUNS number) is allowed.

Section IV. Application and Submission Information

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 Office of Grants Services (OGS) Technical Information Management Section (TIMS) staff at (770) 488-2700 or ogstims@cdc.gov for further instructions. Hours: Monday - Friday, 7am – 4:30pm U.S. Eastern 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/how-to-apply-application-guide.htm and here:

http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.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. These forms can be downloaded from http://grants.nih.gov/grants/forms.htm

3. Letter of Intent Due Date for Letter of Intent: 03/03/2017 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 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 http://www.Grants.gov mailto:pgotim@cdc.gov http://grants.nih.gov/grants/how-to-apply-application-guide.htm http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf http://grants.nih.gov/grants/forms.htm

Number and title of this funding opportunity announcement

The letter of intent should be sent to:

Gregory Anderson, MPH, MS

Extramural Research Program Office

Office of the Associate Director of Science

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

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 the SF 424 (R&R) Application Guide http://grants.nih.gov/grants/how-to-apply-application-guide.htm and here:

http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.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 (R&R) 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 http://grants.nih.gov/grants/how-to-apply-application-guide.htm http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf

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 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 (R&R) Application Guide unless otherwise specified in the FOA. All instructions in the SF424 (R&R) Application Guide http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf must be followed along with any additional instructions provided in the FOA.

Applicants that plan to collect public health data must submit a Data Management Plan (DMP) in the Resource Sharing Plan section of the PHS 398 Research Plan Component of the application. A DMP is required for each collection of public health data proposed. Applicants who contend that the public health data they collect or create are not appropriate for release must justify that contention in the DMP submitted with their application for CDC funds.

The DMP may be outlined in a narrative format or as a checklist but, at a minimum, should include:

• Descriptions of the data to be produced in the proposed project

• How access will be provided to the data (including provisions for protection of privacy, confidentiality, security, intellectual property, or other rights)

• Use of data standards that ensure all released data have appropriate documentation that describes the method of collection, what the data represent, and potential limitations for use

• Plans for archival and long-term preservation of the data, or explaining why long-term preservation and access cannot be justified Examples of DMPs may be found here: University of California https://dmp.cdlib.org/, or USGS, http://www.usgs.gov/datamanagement/plan/dmplans.php

Please note the new requirement for a Data Management Plan (DMP) in the Resource Sharing Plan section of the PHS 398 Research Plan Component of the application (see immediately above).

6. Appendix Do not use the appendix to circumvent page limits. A maximum of 10 PDF documents are allowed in the appendix. Additionally, up to 3 publications may be included that are not publically available. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

7. Page Limitations All page limitations described in this individual FOA must be followed. For this specific FOA, the Research Strategy component of the Research Plan narrative is limited to 25 pages. Supporting materials for the Research Plan narrative included as appendices may not exceed 10 PDF files with a maximum of 50 pages for all appendices.

http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf%20 http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf https://dmp.cdlib.org/ http://www.usgs.gov/datamanagement/plan/dmplans.php

8. Format for Attachments Designed to maximize system-conducted validations, multiple separate attachments are required for a complete application. When the application is received by the agency, all submitted forms and all separate attachments are combined into a single document that is used by peer reviewers and agency staff. Applicants should ensure that all attachments are uploaded to the system.

CDC requires all text attachments to the Adobe application forms be submitted as PDFs and that all text attachments conform to the agency-specific formatting requirements noted in the SF424 (R&R) Application Guide http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf.

9. Submission Dates & Times Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov (http://www.grants.gov), the online portal to find and apply for grants across all Federal agencies. The eRA Commons systems retrieve the application from Grants.gov and check the application against CDC business rules. If no errors are found, the application will be assembled in the eRA Commons for viewing by the applicant before moving on for further CDC processing.

If errors are found, the applicant will be notified in the eRA Commons. They must make required changes to the local copy of their application and submit again through Grants.gov.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Once you can see your application in the Commons, be sure to review it carefully as this is what the reviewer will see. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons (http:// grants.nih. gov/grants /guide/url_redirect .htm? id=11123).

Information on the submission process is provided in the SF424 (R&R) Application Guide.

Note: HHS/CDC grant submission procedures do not provide a period of time beyond the grant application due date to correct…