It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).

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.

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

Purpose

This Funding Opportunity Announcement (FOA) encourages Research Conference Grant (R13) applications to conduct an intensive workshop/conference/meeting that addresses the needs of early stage HIV/AIDS researchers as they translate their preclinical research from nonhuman primates (NHPs) to human clinical trials. The objectives of the annual meeting(s) supported by this FOA are to provide these early stage HIV/AIDS researchers with guidance on conducting preclinical research to inform HIV/AIDS prevention and treatment strategies for clinical trials; and developing skills related to networking, grantsmanship, career tracking, goal/milestone-oriented project(s); and promoting strategies to enhance reproducibility in biomedical research through rigor and transparency. Applicants for this FOA should be experts in the translation of work on NHPs to human clinical trials and should be associated with a HIV/AIDS clinical trial network and research consortium. Previous experience in organizing similar workshops/conferences is highly desirable.

Background

The FY 2019-2020 Trans-NIH Plan for HIV-Related Research (https://www.oar.nih.gov/sites/default/files/NIH-OAR_FY2019-2020_NIH_Plan_FINAL_508.pdf?ct=t(DIRECTORS_UPDATE_trans-nih_pj_3_23_2018_COPY_01)) identifies high priority areas in HIV/AIDS research including, incidence reduction; next-generation HIV/AIDS therapies; research towards a cure; and HIV-associated comorbidities, coinfections and complications. It is generally accepted that preclinical studies using NHPs are necessary for the development of effective HIV/AIDS vaccines and novel therapies, including potential cure treatments, and to study HIV-associated comorbidities, coinfections and complications. The FY 2019-2020 Trans-NIH Plan for HIV-Related Research also identifies creative research partnerships crosscutting areas of basic research, health disparities, behavioral and social science research, training and information dissemination, capacity building, and infrastructure development with an increased emphasis on multidisciplinary teams and approaches as critical for enhancing HIV/AIDS research.

To address the goal of facilitating the career development of early stage investigators (ESIs) who are engaged in HIV/AIDS research using NHPs, OAR and ORIP established the HIV/AIDS Vaccine Scholars Program (see PAR-16-347: https://grants.nih.gov/grants/guide/pa-files/PAR-16-347.html). The scope of this program was expanded to encompass high priority areas of HIV/AIDS research in addition to vaccine development by Notice NOT-OD-17-116 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-116.html). This scholars program provides funding through the K01 mechanism to scholars in early career stages, such as advanced postdoctoral fellows or Assistant Scientists or Assistant Research Professors, who are performing preclinical research using HIV/AIDS NHP models. For this program to have maximum effect, these scholars and investigators at similar stages of career development will benefit from additional training in networking and other aspects of career development. The R13 Program that is the subject of this FOA will fill this role by providing a venue for early stage HIV/AIDS researchers using NHPs to network with experienced leaders in the field, with the goal of building team science and providing information and training related to translating preclinical research findings from NHP models to clinical trials, to improve current NHP models, and to develop novel HIV/AIDS NHP research programs based on clinical findings in human HIV/AIDS patients. For purposes of this FOA, the conference should target participants who have at least four years of postdoctoral experience and who are currently working on a project related to high priority HIV/AIDS research areas using NHP models.

The funds provided under the R13 grant are envisioned to organize a conference with topics that may include, but are not limited to:

• Infection prevention studies across the lifespan using NHP models;
• Next-generation therapies, including approaches to coinfection/comorbidities and potential cure strategies;
• Critical aspects of human vaccine development, including statistical considerations, host genetics and other factors;
• Methods to translate the results of NHP studies including challenge, treatment, and prevention research to clinical trials in humans;
• Strategies to develop novel HIV/AIDS NHP research programs based on clinical findings in human HIV/AIDS patients;
• Methods to develop milestone-driven projects in HIV/AIDS research;
• Strategies to enhance reproducibility in biomedical research through rigor and transparency;
• Key aspects of career development, including starting a laboratory, securing funding, goal-oriented career tracking, and other related issues;
• Networking early stage HIV/AIDS scholars with their peers and senior/established investigators.

The R13 conference will be open to all interested early-stage investigators working to translate HIV/AIDS research from NHP models to human clinical trials and to senior investigators who will provide information on career development as well as state-of-the-art of HIV/AIDS research.

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH 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
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

• Eligible Agencies of the Federal Government

• U.S. Territory or Possession

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration , but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

The PD(s)/PI(s) for the R13 application should be experts in the translation of preclinical NHP models of HIV/AIDS research to human clinical trials. The PD(s)/PI(s) should be associated with a HIV/AIDS clinical trial network and research consortium. Previous experience in organizing similar workshops/conferences is highly desirable.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101)

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide must be followed.

A permission to submit letter is not required for this FOA. Applicants should ignore the system generated warning that a cover letter is not provided.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

Funding can be requested for activities related to planning and implementation of the meeting(s) and for attendee travel.

Allowable Costs: Salary (in proportion to the time or effort spent directly on the conference); rental of necessary equipment; travel and per diem or subsistence allowances; supplies needed for conduct of the conference (only if received for use during the budget period); conference services; publication costs; funds to help defray registration costs for some select attendees (for example, women, racial/ethnic minorities, persons with disabilities, other individuals who have been traditionally underrepresented in science, graduate students); speakers' fees.

Non-allowable costs: Meals/food and beverages; purchase of equipment; transportation costs exceeding U.S. carrier coach class fares; visas; passports; entertainment and personal expenses (such as tips; bar charges; personal telephone calls; laundry charges) dues; honoraria or other payments for the purpose of conferring distinction or communicating respect, esteem or admiration; patient care; alterations or renovations; local participants' expenses; facilities and administrative costs/indirect costs.

Specific Aims:

Specific Aims should address the points below, at a minimum. Additional Specific Aims may be proposed, at the discretion of the applicants. The proposed conference should provide information to ESIs regarding:

• Design of experiments that will translate findings in NHPs to human HIV/AIDS clinical trials.
• Nuances of the design of HIV/AIDS clinical trials, including statistical considerations, host genetics and other factors.
• Design of milestone-driven projects.
• Strategies to enhance reproducibility in biomedical research through rigor and transparency.
• Methods to overcome obstacles faced by early stage HIV/AIDS researchers as they translate their NHP research to human clinical trials.
• Strategies to develop novel NHP HIV/AIDS research programs based on clinical findings in human HIV/AIDS patients.
• Key aspects of career development, including starting a laboratory, securing funding, goal-oriented career tracking, and other related issues.
• Methods to network with peers and senior/established investigators.
• Provide opportunities for early stage HIV/AIDS researchers to participate in one-on-one mentoring sessions at the workshop, with possible continuation post-conference.

Research Strategy: Note that this section will be called "Conference Plan" in the system-generated Table of Contents.

Describe the objectives, program, and logistical arrangements for the conference/meeting. Consider alternate locations for subsequent meetings. Include proposed speakers and topics. Include information on proposed networking venues as well as training/workshop topics. Describe how the program will promote networking and the team science approach to HIV/AIDS research.

Describe the composition and roles of the organizing committee as well as key participants, including the basis of their selection and agreement to participate. In addition to NHP model expertise, members should also have expertise in preclinical and/or clinical aspects of HIV/AIDS research.

Describe plans for publicizing the conference/meeting to the target audience of early stage HIV/AIDS researchers interested in performing HIV/AIDS research in NHP models and translating them to human clinical trials. Include plans to enhance diversity of participants.

Describe plans to incorporate early stage HIV/AIDS researchers' projects into the meeting presentations as well as support to cover travel costs to the meeting for these early stage HIV/AIDS researchers.

Describe plans to identify resources for child care and other types of family care for participants who may need access to this in order to attend. Applicants should make a concerted effort to achieve appropriate representation of women, racial/ethnic minorities, persons with disabilities, and other individuals who have been traditionally underrepresented in science. Describe plans to seek appropriate representation during selection of organizing committee members, speakers, and other invited participants, such as session chairs and panel discussants. Describe plans to encourage attendance by women, minorities, and persons with disabilities. Organizers of scientific conferences must document compliance with the Guidelines for Inclusion of Women, Minorities, and Persons with Disabilities in NIH-Supported Conference Grants policy.

Describe an evaluation plan for the annual meeting. This should include a detailed management plan with timelines and milestones and a proposed meeting report.

Provide additional information for each future annual meeting(s), in as much detail as possible:

• Tentative dates, locations, and participants;
• Contingency plans for future conferences dependent upon, for example, the outcome of the previous year’s conference or developments in the field;
• Evaluation plan and meeting report.

• Generally, Resource Sharing Plans are expected, but they are not required for this FOA.

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

After considering all of the review criteria, briefly summarize the significant strengths and weaknesses of the application and judge the likelihood that the proposed conference will have a substantial impact on the pursuit of the goals of NIH supported research, which is to advance our understanding of biological systems, to improve the control of disease, and to enhance health.

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does this conference address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these endeavors on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

Is(are) the PD(s)/PI(s) well suited for organizing and fulfilling the goals of this conference? Are the qualifications and past performance of the PD(s)/PI(s) appropriate, and are they well suited for their described roles in the conference? Are the key personnel and selected speakers appropriate and well suited for their described roles in the conference?

Are the PD/PI(s) experts in the translation of preclinical NHP models of HIV/AIDS research to human clinical trials? Are the PD/PI(s) associated with a HIV/AIDS clinical trial network and research consortium? Do they have previous experience in organizing similar workshops/conferences? Do the organizing committee members have suitable expertise in preclinical and/or clinical aspects of HIV/AIDS research and NHP models of HIV/AIDS?

Innovation

Does the conference employ novel approaches or methods to fulfill its purpose? Does the conference draw together appropriate experts who may otherwise not have an opportunity to meet?

Approach

Are the format and agenda for the conference appropriate for achieving the specified goals? Is the conference timely for the subject matter? For applications designating multiple PDs/PIs, is the Leadership Plan approach, including the designated roles and responsibilities, governance and organizational structure consistent with and justified by the topics of the conference and the expertise of each of the PDs/PIs?

Will the conference promote team science-based approaches in HIV/AIDS research?Will the conference enhance the ability of early stage HIV/AIDS researchers to translate work based on NHPs to human studies?Will the conference enhance career development of early stage HIV/AIDS researchers?

Does the proposed program provide adequate instruction and advice on: 1) Design of experiments that will successfully translate findings in NHPs to human HIV/AIDS clinical trials; 2) Nuances of the design of HIV/AIDS trials such as statistical considerations, host genetics, and other factors; 3) Design of milestone-driven projects; 4) Methods to overcome the obstacles faced by early stage HIV/AIDS researchers as they transition from NHP-related preclinical research to human clinical trials; 5) Strategies to develop novel NHP HIV/AIDS research programs based on clinical findings in human HIV/AIDS patients; 6) Key aspects of career development, including starting a laboratory, securing funding, work-life balance, goal-oriented career tracking, and other related issues; and 7) Methods to network with senior/established investigators?

Is the evaluation plan for the meeting(s) suitable? Are plans to publicize the meeting adequate? Do these plans include efforts to enhance participant diversity?

Environment

Is the conference site appropriate? Does the applicant organization have the ability to contribute to the probability of success? Do the proposed meetings, exhibits, interactions, etc., take advantage of unique features of the environment or employ useful collaborative arrangements? Is institutional support evident?

Appropriate Representation

How well do the plans for inclusion of women, racial/ethnic minorities, persons with disabilities, and other individuals who traditionally have been underrepresented in science provide for their appropriate representation in the planning, organization, and execution of the proposed conference? For more information, visit Inclusion of Women, Minorities and Persons with Disabilities in NIH-Supported Conference Grants.

Protections for Human Subjects

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Vertebrate Animals

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Biohazards

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Resubmissions

For resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the application.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not applicable.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Provision of Family Care Facilities

Are the plans to inform attendees about family care resources adequate?

Applications from Foreign Organizations

Not applicable.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Not applicable.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed conference.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by th e Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

• Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the NIH Council of Councils.. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

1. Award Notices

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

2. Administrative and National Policy Requirements

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Not applicable.

3. Reporting

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Ronald Adkins, PhD
Division of Comparative Medicine,

Office of Research Infrastructure Programs (ORIP)
Telephone: 301-435-4511
Email: ronald.adkins@nih.gov

Brenda Fredericksen, PhD
Office of AIDS Research (OAR)
Telephone: 240-669-5566
Email: brenda.fredericksen@nih.gov

Mark Caprara, PhD
Center for Scientific Review (CSR)
Telephone: 301-827-3076
Email: capraramg@mail.nih.gov

Stephanie Blackford
National Heart Lung and Blood Institute (NHLBI)
Telephone: 301-827-7536
Email: stephanie.page@nih.gov

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.