Department of Health and Human Services
Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)

Funding Opportunity Title

Conference for Early Stage HIV/AIDS Vaccine Researchers (R13)

Activity Code

R13 Support for Conferences and Scientific Meetings

Announcement Type

New

Related Notices
  • May 3, 2019 - This PA has been reissued as PAR-19-268.
Funding Opportunity Announcement (FOA) Number

PAR-16-351

Companion Funding Opportunity

None

Number of Applications

Only one application per institution is allowed, as defined in. Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.351

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages Research Conference Grant (R13) applications to conduct intensive workshop/conference/meeting(s) that address the needs of early stage HIV/AIDS vaccine researchers as they translate preclinical research from nonhuman primates (NHPs) to human clinical trials. The objectives of the meeting supported by this FOA are to provide these early stage HIV/AIDS vaccine researchers with guidance on conducting preclinical research to inform HIV vaccine strategies for clinical trials and developing skills related to networking, work-life balance, grantsmanship, and goal/milestone-oriented projects. Conference topics should include, but not be limited to: critical aspects of human vaccine development, including statistical considerations, host genetics and others; methods to translate the results of NHP challenge studies to clinical trials in humans; and methods to develop milestone-driven projects.

Key Dates
Posted Date

June 30, 2016

Open Date (Earliest Submission Date)

August 6, 2016

Letter of Intent Due Date(s)

Not applicable

Application Due Date(s)

September 6, 2016, by 5:00 PM local time of applicant organization. All types of applications allowed for this funding opportunity announcement are due on this date.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

September 6, 2016, by 5:00 PM local time of applicant organization. All types of applications allowed for this funding opportunity announcement are due on this date.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Scientific Merit Review

November, 2016

Advisory Council Review

January, 2017

Earliest Start Date

April, 2017

Expiration Date

September 7, 2016

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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


Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement

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 2. Full Text of Announcement
Section I. Funding Opportunity Description

Purpose

This Funding Opportunity Announcement (FOA) encourages Research Conference Grant (R13) applications to conduct intensive workshop/conference/meeting(s) that address the needs of early stage HIV/AIDS vaccine researchers as they translate their preclinical research from nonhuman primates (NHPs) to human clinical trials. The objectives of the meeting supported by this FOA are to provide these early stage HIV/AIDS vaccine researchers with guidance on conducting preclinical research to inform HIV vaccine strategies for clinical trials and developing skills related to networking, work-life balance, grantsmanship, and goal/milestone-oriented project and career tracking. 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 2017 Trans-NIH Plan for HIV-Related Research (http://www.oar.nih.gov/strategic_plan/plan_17.asp) identifies development of active and passive vaccines as a high priority area of prevention research. It is generally accepted that preclinical studies using nonhuman primates are necessary for development of effective HIV/AIDS vaccines. The FY 2017 Trans NIH Plan for HIV-Related Research also identifies training, capacity building, and infrastructure development 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 vaccine research using NHPs, ORIP has established the HIV/AIDS Vaccine Scholars Program (see PAR-16-028). This 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 NHP vaccine 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 vaccine researchers 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. 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 aspects of HIV/AIDS vaccine development 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:

  • Critical aspects of human vaccine development, including statistical considerations, host genetics and others.
  • Methods to translate the results of NHP challenge studies to trials in humans.
  • Methods to develop milestone-driven projects.
  • Key aspects of career development, including starting a laboratory, securing funding, work-life balance, goal-oriented career tracking, and others.
  • Networking early stage vaccine scholars with senior/established investigators.

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

The PD(s)/PI(s) for the R13 application should be experts in the translation of preclinical NHP models of HIV/AIDS vaccine 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.

See Section VIII. Other Information for award authorities and regulations.
Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. ORIP anticipates providing one award.

Award Budget

Application budgets cannot exceed $100,000 direct costs per meeting per year.

Award Project Period

The project period must be three years, with a maximum of one meeting per year.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o 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)
  • U.S. Territory or Possession
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

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) (formerly CCR) 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 and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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 NIH support.

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 vaccine 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

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

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).
Section IV. Application and Submission Information
1. Requesting an Application Package

Applicants must obtain the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for 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.

SF424(R&R) Cover

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.

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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 and for attendee travel. Requested support can include, but is not limited to: Salary (in proportion to the time or effort spent directly on the conference); rental of necessary equipment; supplies needed for conduct of the conference (only if received for use during the budget period); conference services; travel expenses for speakers, mentors, and early stage HIV/AIDS vaccine researchers; and printing and publication expenses.

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.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

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 transition findings in NHPs to human HIV/AIDS vaccine trials.
  • Nuances of the design of HIV/AIDS vaccine trials, including statistical considerations, host genetics and others.
  • Design of milestone-driven projects.
  • Methods to overcome obstacles faced by early stage HIV/AIDS vaccine researchers as they translate their NHP research to human clinical trials.
  • Key aspects of career development, including starting a laboratory, securing funding, work-life balance, goal-oriented career tracking, and others.
  • Methods to network with senior/established investigators. Encourage early stage HIV/AIDS vaccine researchers to participate in one-on-one mentoring sessions at the workshop with possible continuation post-conference.

Research Strategy:

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 vaccine 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. Members should have expertise in preclinical and/or clinical aspects of HIV/AIDS vaccine research.

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

Describe plans to incorporate early stage HIV/AIDS vaccine researchers' projects into the meeting presentations as well as support to cover travel costs to the meeting for these early stage HIV/AIDS vaccine 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, and 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 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, in as much detail as possible:

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

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide , with the following modification: The appendix is limited to announcements and reports of previous conferences under the same sponsorship. No other information or material should be submitted as appendices, including programs, speaker presentations, agenda, abstract books, evaluations, or letters of support.

PHS Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

PHS Assignment Request Form

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information
1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

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/meeting 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.

Scored Review Criteria

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 vaccine 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 vaccine research?

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 vaccine research? Will the conference enhance the ability of early stage HIV/AIDS vaccine researchers to transition work based on NHPs to human studies? Will the conference enhance career development of early stage HIV/AIDS vaccine researchers? Does the proposed program provide adequate instruction and advice on: 1) Design of experiments that will successfully transition findings in NHPs to human HIV/AIDS vaccine trials, including nuances such as statistical considerations, host genetics, and others; 2) Design of milestone-driven projects; 3) Methods to overcome the obstacles faced by early stage HIV/AIDS vaccine researchers as they transition NHP-related preclinical research to human trials; 4) Key aspects of career development, including starting a laboratory, securing funding, work-life balance, goal-oriented career tracking, and others; and 5) Methods to network with senior/established investigators? Is the evaluation plan for the meeting suitable? Are plans to publicize the meeting adequate? Do these include plans 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?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

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 Children

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

Not Applicable

Renewals

Not Applicable

Revisions

Not applicable.

Additional Review Considerations

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

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

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 research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, NIH, 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.

As part of the scientific peer review, all applications:

  • 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. 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

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

Section VI. Award Administration Information
1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

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

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

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.

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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, 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.

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726

Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Scientific/Research Contact(s)

Stephanie J. Murphy, VMD, PhD, DACLAM
Division of Comparative Medicine,
Office of Research Infrastructure Programs (ORIP))
Telephone: 301-451-7818
Email: stephanie.murphy@nih.gov

Jean Patterson
Office of AIDS Research (OAR)
Phone: 301-496-4077
Email: pattersj@od.nih.gov

Peer Review Contact(s)

Cathleen Cooper, Ph.D.
Center for Scientific Review
Telephone: 301-443-4512
Email: cooperc@csr.nih.gov

Financial/Grants Management Contact(s)

Nyron Rouse
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0840
Email: nyron.rouse@nih.gov

Section VIII. Other Information

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.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

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