Foa_Content_of_RFA-PS-24-040.pdf

Centers for Disease Control and Prevention

NATIONAL CENTER FOR HIV, VIRAL HEPATITIS, STDS AND TB PREVENTION

Understanding Infant Feeding Preferences, Practices, and Outcomes for Mothers and other Parents with HIV in the United States

RFA-PS-24-040

02/08/2024

Table of Contents 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

Overview Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations Components of Participating Organizations:

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Notice of Funding Opportunity (NOFO) Title Understanding Infant Feeding Preferences, Practices, and Outcomes for Mothers and other Parents with HIV in the United States Activity Code U01 – Research Project - Cooperative Agreements

Notice of Funding Opportunity Type New Agency Notice of Funding Opportunity Number

RFA-PS-24-040

Assistance Listings Number(s) 93.084 Category of Funding Activity HL - Health NOFO Purpose

The purpose of this Notice of Funding Opportunity (NOFO) is to support a study to understand the infant feeding preferences, practices, and outcomes for people with HIV in the United States. Women and other people with HIV (PWH) in the United States have increasingly expressed interest in breastfeeding their infants, and federal guidelines have recently changed to support shared decision-making for infant feeding and to provide support for PWH opting to breastfeed or chestfeed. While the risk of HIV transmission via breastfeeding in the context of sustained HIV viral suppression has been shown to be very low in some resource-limited settings, it has not been well quantified in resource-rich settings including the United States.

Applicants will design, develop, and anticipate to conduct mixed methods research: 1) to describe the clinical, behavioral, social, and demographic characteristics of PWH who are pregnant or post-partum and their live born infants.; 2) to understand the nuances and details of preferences of formula feeding or breastfeeding, decisions and practices as well as facilitators and challenges for successful breastfeeding; 3) to explore biologic and clinical factors associated with HIV transmission through breastfeeding; 4) to describe the knowledge, decisions and practices of health care professionals regarding shared-decision making and the provision of support for successful infant feeding, maternal and infant clinical follow up; and

5) to assess feasibility of and pilot implementation of observational registry or interventional studies to monitor and improve care of breastfeeding PWH and their infants with collaborating clinics and other partners. This NOFO is aligned with the HIV National Strategic Plan (2022-2025) and the Ending the HIV Epidemic in the U.S. (EHE) initiative’s “Prevent” and “Treat” Pillars.

Key Dates Publication Date:

To receive notification of any changes to RFA-PS-24-040, 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:

01/08/2024 01/08/2024

Application Due Date:

02/08/2024 02/08/2024

On-time submission requires that electronic applications be error-free and made available to CDC for processing from the NIH eRA system on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov no later than 11:59 PM U.S. Eastern Time.

Applicants will use a system or platform to submit their applications through Grants.gov and eRA Commons to CDC. ASSIST, an institutional system to system (S2S) solution, or Grants.gov Workspace are options. ASSIST is a commonly used platform because it provides a validation of all requirements prior to submission and prevents errors.

For more information on accessing or using ASSIST, you can refer to the ASSIST Online Help Site at: https://era.nih.gov/erahelp/assist. Additional support is available from the NIH eRA Service desk via http://grants.nih.gov/support/index.html.

• E-mail: commons@od.nih.gov

• Phone: 301-402-7469 or (toll-free) 1-866-504-9552

• Hours: Monday - Friday, 7 a.m. to 8 p.m. Eastern Time, excluding Federal holidays https://www.grants.gov/ http://grants.nih.gov/support/index.html mailto:commons@od.nih.gov

Note: HHS/CDC grant submission procedures do not provide a grace period beyond the application due date time 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:

03/28/2024 Secondary Review:

04/25/2024 Estimated Start Date:

09/30/2024 Expiration Date:

02/09/2024 Required Application Instructions It is critical that applicants follow the instructions in the How to Apply - Application Guide except where instructed to do otherwise in this NOFO. Conformance to all requirements (both in the Application Guide and the NOFO) 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 20 pages.

Page Limitations: Pages that exceed the page limits described in this NOFO will be removed and not forwarded for peer review, potentially affecting an application's score.

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

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

Executive Summary

• Purpose: The purpose of this NOFO is to support a study to understand the infant feeding preferences, practices, and outcomes for people with HIV in the United States.

Women and other people with HIV (PWH) in the United States have increasingly expressed interest in breastfeeding or chest feeding their infants, and U.S. federal guidelines have changed to support shared decision-making for infant feeding.

Additionally, the risk of HIV transmission via breastfeeding in resource-rich settings has not been well quantified. Applicants will design, develop, and anticipate to conduct mixed methods research: 1) to describe the clinical, behavioral, social, and demographic characteristics of PWH who are pregnant or post-partum and their live born infants, and health care providers; 2) to understand the nuances and details of infant feeding preferences, decisions and practices as well as facilitators and challenges for successful breastfeeding; 3) to explore biologic and clinical factors associated with HIV transmission through breastfeeding; 4) to describe the knowledge, decisions and practices of health care professionals regarding shared-decision making and the provision of support for successful infant feeding, maternal and infant clinical follow up; and 5) to assess feasibility of and pilot implementation of observational registry or interventional https://grants.nih.gov/grants/how-to-apply-application-guide.html studies to monitor and improve care of breastfeeding PWH and their infants with collaborating clinics and other partners. The research project awarded under this NOFO supports achieving the goals of the National HIV/AIDS Strategy 2022-2025, Ending the HIV Epidemic in the U.S. initiative, and Healthy People 2030.

• Mechanism of Support: U01 – Research Project - Cooperative Agreement

• Funds Available and Anticipated Number of Awards: The estimated total funding available, including direct and indirect costs, for the entire five (5)-year project period is $5,000,000. The number of awards is one (1). The award issued under this NOFO is contingent upon availability of funds and a sufficiently meritorious application. The total amount awarded and will depend upon the quality, duration and cost of the applications received.

• Budget and Project Period: The estimated total funding (direct and indirect) for the first year (12-month budget period) will be $1,000,000. The estimated total funding (direct and indirect) for the entire project period will be $5,000,000. The project period is anticipated to run from 09/30/2024 to 09/29/2029.

• 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 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 each application.

• Number of Applications. Only one application per institution (normally identified by having a unique entity identifier [UEI] number) is allowed.

• Application Type. New.

Application Materials. See Section IV.1 for application materials. Please note that SF424 (R&R) Form H is to be used when completing the application package. Please see https://grants.nih.gov/grants/how-to-apply-application-guide.html

Section I. Funding Opportunity Description Statutory Authority Section 301(a) and Section 317(k)(2) of Public Health Service Act, 42 USC 241(a) and 42 USC 247b(k)(2).

1. Background and Purpose Great progress has been made in the United States in preventing perinatal transmission of HIV.

Fewer than 75 perinatally acquired HIV infections have been reported each year from 2010- 2020. Since 1985, people with HIV (PWH) in the United States have been advised not to breastfeed their infants since transmission of HIV can occur through breastfeeding and safe feeding alternatives exist. However, more recent studies in resource-limited settings have shown http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf that the risk of breastfeeding transmission can be very low if the mother is virally suppressed and adherent with her antiretroviral treatment (ART) regimen. The Health and Human Services (HHS) Perinatal Guidelines now recommend that providers proactively inquire about a woman’s preferences for infant feeding, engage in a shared decision-making approach, and support women and their infants with harm-reduction strategies if they opt to breastfeed. According to organizations of women living with HIV and their providers, increasing numbers of PWH in the United States express interest in breastfeeding, however, women may breastfeed without disclosing to a healthcare provider if they perceive lack of support. Thus, the frequency, maternal characteristics, or duration and type of breastfeeding among PWH is not understood in the United States.

There is limited evidence regarding the infant feeding preferences, practices, and outcomes of breastfeeding among women with HIV in the United States, because advising against breastfeeding has been recommended since the beginning of the epidemic. Most evidence on the benefits of antiretroviral therapy (ART) during breastfeeding to reduce HIV transmission comes from studies in low-resource settings, with findings of a marked reduction in transmission rates to as low as or lower than 1% up to 12 months of breastfeeding when women were taking effective ART during pregnancy and breastfeeding. Rare cases of transmission through breastfeeding have been observed among mothers who had suppressed HIV viral load while breastfeeding, but the evidence is scant in resource-rich settings. Data from larger cohorts of mothers with HIV are needed to more accurately evaluate transmission risk during breastfeeding in the United States.

Little is known about experiences and preferences of diverse populations of PWH in the United States who desire to breastfeed infants. While it is likely that infant formula is most often used, shortages and quality concerns with infant formula that were experienced in 2022 in the United States, as well as access and financial hardships precipitated by the COVID-19 pandemic highlight some of the challenges PWH might encounter with infant feeding.

Some PWH desire to breastfeed to promote infant bonding or for the well-established health benefits; cultural norms of many PWH also emphasize breastfeeding. Some women who have emigrated from areas in which breastfeeding with ART is recommended, may desire to breastfeed again. Other PWH report being fearful of disclosing one’s HIV status to family or peers by not breastfeeding, believing that foregoing breastfeeding signals HIV infection.

Pasteurized banked human donor milk is very expensive and may not be as easily available.

In addition, little is known about PWH who opt to breastfeed. Several PWH who breastfed with the support of their health care providers report improvements in mental health, overall well-being, bonding with their infants, and personal empowerment. These and other impacts have not been well studied in resource-rich settings. With changing prevailing norms and preferences, as well as clinical practice guidelines in the U.S., advances in HIV treatment, and an active advocacy movement for reproductive justice for people with HIV on effective ART, more people will likely opt to breastfeed over time. In one recently published small survey of childbearing women with HIV in the United Kingdom, 38% indicated a desire to breastfeed their infants. As more PWH choose to breastfeed, it will be important to understand best practices for engaging parents in shared decision-making and harm reduction approaches while ensuring PWH remain in quality HIV care.

The outcomes of this study can contribute to evidence for the care of PWH and their infants, with specific focus on breastfeeding practices. For this study, it is expected that people with HIV and infants will be under care of their medical providers. This study may document health care professionals’ knowledge and attitudes toward current clinical practice guidelines for infant feeding, actual infant feeding practices and clinical services provided, and may help determine the best strategies on how to support PWH and maximize benefits while reducing potential harms of breastfeeding in the context of HIV infection.

Healthy People 2030 and other National Strategic Priorities Health Equity:

CDC supports efforts to improve the health of populations disproportionately affected by infectious diseases by maximizing the health impact of public health services, reducing disease incidence, and advancing health equity.

A health disparity occurs when a health outcome is seen to a greater or lesser extent between populations. Health disparities in infectious diseases are inextricably linked to a complex blend of social determinants that influence which populations are most disproportionately affected by these infections and diseases.

Social determinants are conditions in the places where people live, learn, work, and play that affect a wide range of health and quality-of life-risks and outcomes (https://www.cdc.gov/socialdeterminants/index.htm). These 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 challenges. 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 health disparities are eliminated.

Applicants should use data, including social determinants data, to identify communities within their jurisdictions that are disproportionately affected by infectious diseases and related diseases and conditions, and plan activities to help eliminate health disparities. In collaboration with partners and appropriate sectors of the community, applicants should consider social determinants of health in the development, implementation, and evaluation of specific efforts and use culturally appropriate interventions and strategies that are tailored for the communities for which they are intended.

Healthy People 2030 and other National Strategic Priorities

By increasing access to, and use of, HIV prevention services among women, this NOFO should support the following Healthy People 2030 goals:

• HIV-01: Reduce the number of new HIV infections.

• HIV-03: Reduce the number of new HIV diagnoses.

• HIV-06: Reduce the rate of mother-to-child HIV transmission.

https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp

By increasing access to, and use of, HIV prevention services among women, this NOFO should support the following national goals:

• Ending the HIV Epidemic in the U.S. (https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview) o Reduce the number of new HIV infections by 75% by 2025 and 90% by 2030.

• National HIV/AIDS Strategy 2022-2025 (https://www.hiv.gov/federal-response/national-hiv-aids-strategy/national-hiv-aids-strategy-2022-2025) o Goal 1: Prevent new HIV infections.

o Goal 2: Improve HIV-related health outcomes of people with HIV.

▪ 2.4: Increase the capacity of the public health, health care delivery systems, and health care workforce to effectively identify, diagnose, and provide holistic care and treatment for people with HIV

Public Health Impact The research supported by this NOFO should address the CDC Winnable Battle - HIV Elimination.

Relevant Work The research supported by this NOFO should build upon previous and current HIV prevention programs, including those supported by:

• CDC-RFA-PS17-1712: Assuring Comprehensive Prevention and Treatment for Families Affected by HIV to Eliminate Perinatal HIV Transmission in the United States

• CDC-RFA-PS23-0013: Assuring Comprehensive Perinatal, Maternal and Infant Health and the Elimination of Perinatal HIV in the United States https://www.grants.gov/web/grants/view-opportunity.html?oppId=344600

2. Approach The NOFO supports investigator-driven research and invites applicants to design, develop, direct, and propose to conduct data collection to meet the project goals outlined in the Purpose section. The NOFO will support a mixed-methods study to understand the infant feeding preferences, practices, and outcomes for people with HIV in the United States. There is a particular interest in understanding barriers and facilitators to choosing formula feeding and/or breastfeeding among PWH, and supportive models of care. Applicants are invited to propose research designs and methodology appropriate to address their research questions around health and outcomes of pregnant and postpartum PWH and their infants. Mixed methods can include but are not limited to epidemiologic study designs (e.g., a prospective cohort study), implementation research study to evaluate an intervention, and formative research. Options for data collection include medical records abstraction, surveys, interviews, and biomedical specimen evaluations, and other approaches to achieve the NOFO purpose. A mixed methods approach is expected to yield details and nuances of decision-making and circumstances related to infant feeding that may not be possible to gather through quantitative or qualitative data collection methods alone. Domains to be explored through in-depth qualitative interviews (IDI) with PWH could include barriers and facilitators to infant feeding choices during pregnancy and birth, breastfeeding intent/perceptions, practical/logistical concerns, benefits vs. risk (infant https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview https://www.hiv.gov/federal-response/national-hiv-aids-strategy/national-hiv-aids-strategy-2022-2025 https://www.hiv.gov/federal-response/national-hiv-aids-strategy/national-hiv-aids-strategy-2022-2025 https://www.grants.gov/web/grants/view-opportunity.html?oppId=344600 https://www.grants.gov/web/grants/view-opportunity.html?oppId=344600 health/bonding; fears), social/cultural barriers, maternal identity, HIV disclosure, social pressure, and stigma. Domains to be explored via IDIs with providers could include knowledge of current guidelines, reflections on their experiences advising PWH about infant feeding choices, and barriers and facilitators encountered supporting PWH who choose to breastfeed. In each case, if qualitative methods are used, a sufficient sample of women should be enrolled to achieve thematic saturation.

An example of quantitative approach would be a longitudinal cohort study of pregnant women/people with HIV and their live-born infants recruited at clinical sites and followed to ascertain infant feeding practices. Topics of interest may include socio-demographics, social determinants of health, HIV and STI history, substance use history, behavioral risk factors, pregnancy history, HIV care and treatment, prenatal care, infant HIV prophylaxis, infant feeding preferences and plans, maternal-infant bonding, child development, HIV viral measures in blood and breast milk, and maternal mental and physical well-being.

Applicants may consider partnering with sites that operate within or are affiliated with clinical facilities that serve pregnant and post-partum PWH and their infants. Additional potential partners could include pharmacies, community-based organizations, social services organizations, health departments, or other agencies that provide HIV care to pregnant and post-partum PWH and infants born to PWH, including laboratory services.

Applications should describe a mixed methods approach that fits the target population as well as the goals and objectives of the research. In addition to ensuring that all proposed research activities adhere to ethical standards and employ rigorous methods, it is recommended that qualitative research design addresses the following: concept validity, verification, and reliability;

and quantitative research designs address statistical power to detect a meaningful effect or change over time.

It is anticipated that experience in conducting this mixed-methods study may assist the recipient in assessing the feasibility of a voluntary nationwide breastfeeding and HIV registry, and in formulating and piloting interventions to optimize health of pregnant and post-partum PWH and their infants.

Objectives/Outcomes The proposed research study is expected to address the following objectives:

Infant feeding (e.g., formula and breastfeeding):

• Understand preferences for infant feeding among PWH.

• Investigate aspects of clinical, behavioral, and social epidemiology pertaining to infant feeding decision-making among PWH, including both the pregnant person and those supporting her decision such as physicians, nurses, lactation consultants, family, and social workers.

• Determine best practices, costs, and benefits of supporting PWH to safely feed their infants.

• Describe and monitor HIV transmission during breastfeeding and explore potential risk or protective factors, including comprehensive laboratory evaluations of the viral profile of breast milk whether transmission occurs or not.

• Determine the feasibility of establishing a confidential voluntary registry of breastfeeding PWH and their breastfed infants nationwide to determine the risk and magnitude of HIV transmission via breastfeeding in the United States.

• Contribute to knowledge base on effective approaches to support health and optimize care for pregnant and postpartum PWH and their infants.

A complete list of outcomes and associated indicators should be finalized in the first 6 months post award. Study intermediate and long-term outcomes could include, but are not limited to:

• Increased knowledge of PWH preferences for infant feeding.

• Increased understanding of factors pertaining to infant feeding choices such as behavioral, social, and clinical factors.

• Increased knowledge of best practices for supporting PWH who opt to breastfeed their infants.

• Increased knowledge of provider beliefs and attitudes about breastfeeding among persons with HIV, as well as knowledge of new guidance.

• Increased knowledge of the feasibility of establishing a voluntary registry of PWH breastfeeding their infants.

• Increased evidence for best practices for infant HIV testing and prophylaxis during breastfeeding.

• Increased knowledge of the effective implementation models and their costs of supporting PWH to safely breastfeed their infants.

• Increased knowledge of the biologic and other parameters associated with the risk of HIV transmission through breastfeeding.

• Increased understanding of best practices for infant antiretroviral prophylaxis during breastfeeding.

• Increased understanding of the risk and magnitude of HIV transmission through breastfeeding in the United States.

Target Population The priority populations for this study are pregnant and postpartum people with HIV and their live-born infants. The recipient may consider conducting the study at several clinics to maximize the opportunity for recruitment of a sufficient sample of pregnant and post-partum people with HIV who opt to breastfeed their infants and who are diverse by race/ethnicity, sociodemographic status, gender (including transmen and nonbinary persons), and country of birth (relevant to cultural breastfeeding practices).

Collaboration/Partnerships With other CDC programs and CDC-funded Organizations

If applicable, recipients should consider their other CDC-funded programs in an effort to identify opportunities to leverage patient and/or staff participation in this project.

With organizations not funded by CDC

The applicants are expected to propose collaborative partnerships that may include clinics, pharmacies, community-based organizations, social services organizations, health departments, or other agencies that provide HIV care to pregnant and post-partum PWH and infants born to

PWH. Of particular relevance, are clinical centers that provide HIV care and treatment to pregnant people with HIV or infants born to persons with HIV, where study participants may be recruited.

Memoranda of Agreement or Understanding (MOA/MOU), letters of commitment, or service agreements are encouraged to document proposed and current partnerships with participating clinics.

Guidelines for an MOU/MOA with Participating Clinics Applications should demonstrate that there is an MOU/MOA with all participating clinics signifying commitment to engage in the proposed study activities. Each MOU/MOA should be submitted with the application.

The purpose of each MOU/MOA is to set forth the responsibilities of the applicant and the participating clinic relative to the proposed goals of the project. The MOU/MOA must indicate a commitment of participation for the entire project period.

Each MOU/MOA must include:

• An effective date range that aligns with all 5 years of the NOFO

• Overview of the participating clinic’s plan and the estimated budget for implementing study activities

• Agreement that the recipient will engage clinic representatives in relevant study-related meetings and processes, where appropriate, and that the clinic will participate accordingly

• Commitment of the recipient to work with the clinic and other collaborative partners to address project requirements, including the designation of a point of contact among the study team dedicated to the implementation of study activities

• Commitment of the clinic to either participate in, or assist recipient with, data reporting and evaluation activities, including EMR data abstraction

• Signatures for both parties by authorized representatives

Applications should identify expected implementation research collaborators and established partnerships. The application should describe plans to collaborate with clinics that provide HIV treatment to pregnant and post-partum PWH and their infants. Applications should describe operation of, or capability to, enroll pregnant and post-partum PWH in the study.

Evaluation/Performance Measurement The application should include measurable goals and aims based on a five (5)-year research project period. The application should describe specific, measurable, achievable, realistic, and time-phased (SMART) project objectives for each activity described in the application’s project plan and describe the development and implementation of project performance measures based on specific programmatic objectives.

The plan should describe if and how electronic health records at clinical sites will be used to facilitate collection of longitudinal, patient-level data to evaluate project outcomes. When relevant to the design of the proposed study, plans for a cohort study with quantitative and qualitative data collection, specimen collection, and an assessment of the feasibility of and potential establishment of a national registry of HIV and breastfeeding should be described.

CDC staff will not be engaged in the study but will provide technical assistance and support to the recipient as needed. CDC will neither interact with study participants nor their identifiable information. The recipient will be solely responsible for defining the scope, methods, and data collection design.

Translation Plan Findings from this study will help identify key strategies to advance health equity in infant feeding for PWH and will serve as the basis for future studies, demonstration projects, and technical assistance that aim to scale-up and expand the use of identified best practices to support PWH and their infants with infant feeding. CDC and the recipient will collaborate to disseminate key findings at national and international conferences and meetings and in peer-reviewed journals.

Questions to consider in preparing this section include:

• How will successful strategies be identified?

• How will findings be disseminated to public health, clinical, and community organizations?

• How will successful strategies be incorporated into routine clinical practice?

• How will this work inform or contribute to efforts for a potential national registry of HIV and breastfeeding?

3. Funding Strategy Section II. Award Information Funding Instrument Type:

CA (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 Estimated total funding available for the first year (first 12 months), including direct and indirect costs: $1,000,000

Estimated total funding available for the entire project period, including direct and indirect costs: $5,000,000

Estimated Total Annual Budget Period Funding:

Year 1: $1,000,000 Year 2: $1,000,000 Year 3: $1,000,000 Year 4: $1,000,000

Year 5: $1,000,000

Anticipated Number of Awards:

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

Award Ceiling:

$1,000,000 Per Budget Period

Award Floor:

$500,000 Per Budget Period

Total Period of Performance Length:

5 year(s)

Throughout the Period of Performance, 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 (https://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 NOFO.

If you are successful and receive a Notice of Award, in accepting the award, you agree that the award and any activities thereunder are subject to all provisions of 45 CFR Part 75, currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category:

00 (State governments)

01 (County governments)

02 (City or township governments)

04 (Special district governments)

05 (Independent school districts)

06 (Public and State controlled institutions of higher education) https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

07 (Native American tribal governments (Federally recognized))

08 (Public housing authorities/Indian housing authorities)

11 (Native American tribal organizations (other than Federally recognized tribal governments))

12 (Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education)

13 (Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education)

20 (Private institutions of higher education)

22 (For profit organizations other than small businesses)

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

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:

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."

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://gov.ecfr.io/cgi-bin/searchECFR.

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

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. Additional Information on Eligibility 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 Unique Entity Identifier (UEI) number in order to begin each of the following registrations.

PLEASE NOTE: Effective April 4, 2022, applicants must have a Unique Entity Identifier (UEI) at the time of application submission. The UEI replaced the Data Universal Numbering System (DUNS) and is generated as part of SAM.gov registration. Current SAM.gov registrants have already been assigned their UEI and can view it in SAM.gov and Grants.gov. Additional information is available on the GSA website, SAM.gov, and Grants.gov-Finding the UEI.

• (Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: NCAGE Tool / Products / NCS Help Center (nato.int).

• System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, SAM.gov.

• 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.

https://gov.ecfr.io/cgi-bin/searchECFR?ob=r&idno=&q1=FFRDC&r=&SID=1510a9feb7999d185d40b026ad998cc0&mc=true https://www.gsa.gov/about-us/organization/federal-acquisition-service/office-of-systems-management/integrated-award-environment-iae/iae-systems-information-kit/unique-entity-identifier-update https://sam.gov/content/home https://grantsgovprod.wordpress.com/2021/09/14/how-to-find-an-applicants-uei-within-grants-gov/ https://grantsgovprod.wordpress.com/2021/09/14/how-to-find-an-applicants-uei-within-grants-gov/ https://eportal.nspa.nato.int/Codification/Support/en/Products/NCAGE/ https://eportal.nspa.nato.int/Codification/Support/en/Products/NCAGE/ https://sam.gov/content.gov https://grants.gov https://public.era.nih.gov/commons https://www.Grants.gov

All Senior/Key Personnel (including Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing Principal Investigator (PD/PI) 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 eRA Commons registration process at least four (4) weeks prior to the application due date. ASSIST requires that applicant users have an active eRA Commons account in order to prepare an application. It also requires that the applicant organization's Signing Official have an active eRA Commons Signing Official account in order to initiate the submission process.

During the submission process, ASSIST will prompt the Signing Official to enter their Grants.gov Authorized Organizational Representative (AOR) credentials in order to complete the submission, therefore the applicant organization must ensure that their Grants.gov AOR credentials are active.

7. Universal Identifier Requirements and System for Award Management (SAM) All applicant organizations must obtain a Unique Entity Identifier (UEI) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The UEI number is a twelve-digit number assigned by SAM.gov. An AOR should be consulted to determine the appropriate number. If the organization does not have a UEI number, an AOR should register through SAM.gov. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a UEI number.

Additionally, 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.gov 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 SAM.gov and the SAM.gov Knowledge Base.

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

https://sam.gov/content/home https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fsd.gov%2Fgsafsd_sp%3Fid%3Dgsa_kb_view2%26kb_id%3Df66d8e6cdb76d4100d73f81d0f9619c6&data=04%7C01%7Ccshifflett%40dminc.com%7C8eee7a2adab549a3b3c008d925e9a364%7Cdb7ac9ef779d46e59bca00509580ad6b%7C0%7C0%7C637582507851821018%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=UrR%2B%2FM2wWF2fZG05Z8O6JS2C3FXXSl%2F7B3%2FB45XHRrg%3D&reserved=0 https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

10. Number of Applications As defined in the HHS Grants Policy Statement, (https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf), applications received in response to the same Notice of Funding Opportunity 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 NOFO 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 entity identifier [UEI] number) is allowed.

Section IV. Application and Submission Information

1. Address to Request Application Package Applicants will use a system or platform to submit their applications through Grants.gov and eRA Commons to CDC. ASSIST, an institutional system to system (S2S) solution, or Grants.gov Workspace are options. ASSIST is a commonly used platform because, unlike other platforms, it provides a validation of all requirements prior to submission and prevents errors.

To use ASSIST, applicants must visit https://public.era.nih.gov where you can login using your eRA Commons credentials, and enter the Notice of Funding Opportunity Number to initiate the application, and begin the application preparation process.

If you experience problems accessing or using ASSIST, you can refer to the ASSIST Online Help Site at: https://era.nih.gov/erahelp/assist. Additional support is available from the NIH eRA Service desk via: http://grants.nih.gov/support/index.html

• Email: commons@od.nih.gov

• Phone: 301-402-7469 or (toll-free) 1-866-504-9552.

Hours: Monday - Friday, 7 a.m. to 8 p.m. Eastern Time, excluding Federal holidays.

2. Content and Form of Application Submission Applicants must use FORMS-G application packages for due dates on or before January 24, 2023 and must use FORMS-H application packages for due dates on or after January 25, 2023.

Application guides for FORMS-G and FORMS-H application packages are posted to the How to Apply - Application Guide page.

It is critical that applicants follow the instructions in the SF-424 (R&R) Application Guide How to Apply - Application Guide except where instructed in this Notice of Funding Opportunity 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 package associated with this NOFO includes all applicable mandatory and optional forms. Please note that some forms marked optional in the application package are required for submission of applications for this NOFO. Follow the instructions in the SF-424 https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://public.era.nih.gov http://grants.nih.gov/support/index.html https://grants.nih.gov/grants/how-to-apply-application-guide.html https://grants.nih.gov/grants/how-to-apply-application-guide.html

Application Guide to ensure you complete all appropriate “optional” components.

When using ASSIST, all mandatory forms will appear as separate tabs at the top of the Application Information screen; applicants may add optional forms available for the NOFO by selecting the Add Optional Form button in the left navigation panel.

Please include all of the eight (8) mandatory forms listed below in the application package:

Mandatory:

1. SF424(R&R)

2. PHS 398 Cover Page Supplement

3. Research and Related Other Project Information

4. Project/Performance Site Location(s)

5. Research and Related Senior/Key Person Profile (Expanded)

6. Research and Related Budget

7. PHS 398 Research Plan

8. PHS Human Subjects and Clinical Trials Information

Letters of Support from partners or other organizations should be placed in the PHS 398 Research Plan "Other Research Plan Section" of the application under "9. Letters of Support".

Please note: If requesting indirect costs in the budget based on a federally negotiated rate, a copy of the indirect cost rate agreement is required. Include a copy of the current negotiated federal indirect cost rate agreement or cost allocation plan approval letter.

Please note: Follow the instructions in this NOFO for including a Data Management Plan in the Resource Sharing Plan section of the PHS 398 Research Plan Component of your application.

If multiple collaborating institutions will be involved, please include in this section of the application your single IRB (sIRB) Plan:

• Describe how you will comply with the single IRB review requirement under the Revised Common Rule at 45 CFR 46.114 (b) (cooperative research). If available, provide the name of the IRB that you anticipate will serve as the sIRB of record.

• Indicate that all identified engaged institutions or participating sites will agree to rely on the proposed sIRB and that any institutions or sites added after award will rely on the sIRB.

• Briefly describe how communication between institutions and the sIRB will be handled.

• Indicate that all engaged institutions or participating sites will, prior to initiating the study, sign an authorization/reliance agreement that will clarify the roles and responsibilities of the sIRB and participating sites.

• Indicate which institution or entity will maintain records of the authorization/reliance agreements and of the communication plan.

• Note: Do not include the authorization/reliance agreement(s) or the communication plan(s) documents in your application.

• Note: If you anticipate research involving human subjects but cannot describe the study at the time of application, include information regarding how the study will comply with the single Institutional Review Board (sIRB) requirement prior to initiating any multi-site study in the delayed onset study justification.

Please include the one (1) optional form listed below, if applicable, in the application package:

Optional

1. R&R Subaward Budget Attachment(s) Form 5 YR 30 ATT.

The application should include the budget and justification of each subawardee/contractor included in the application.

Please use the form and instructions for SF424 (R&R) Forms-H for applications due on or after January 25, 2023.

3. Letter of Intent Due Date for Letter Of Intent 01/08/2024

01/08/2024 Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CDC 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 organization 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 notice of funding opportunity

The letter of intent should be sent to:

Seraphine Pitt Barnes, PhD, MPH, CHES 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 Telephone: 770-488-6115 Email: SPittBarnes@cdc.gov

4. Required and Optional Components A complete application has many components, both required and optional. The forms package associated with this NOFO in Grants.gov includes all applicable components for this NOFO, required and optional. In ASSIST, all required and optional forms will appear as separate tabs at the top of the Application Information screen.

5. PHS 398 Research Plan Component The SF424 (R&R) Application Guide includes instructions for applicants to complete a PHS 398 Research Plan that…