National Institute on Aging (NIA)
The NIA Behavioral and Social Research LEaders in Alzheimer’s Disease and Its Related Dementias (NIA BSR LEADR) program supports individual scientists of exceptional creativity who propose to use behavioral and social science perspectives and approaches for highly innovative, impactful, and potentially transformative theoretical, empirical, and clinical research addressing the challenges raised by Alzheimer's disease and Alzheimer's disease-related dementias (AD/ADRD) for individuals, their families, and society. Applications are welcome from individuals with diverse backgrounds. NIA encourages applications on a variety of AD/ADRD topics in which behavioral and social research can contribute, such as dementia care, dementia caregiver research, cognitive and dementia epidemiology, behavioral and social pathways of AD/ADRD, early psychological changes preceding AD/ADRD, prevention of AD/ADRD, and disparities in AD/ADRD or dementia-related outcomes.
Responsive applications must reflect a new insight into a potential solution to an important problem related to AD/ADRD that can be addressed with exceptionally innovative or unconventional behavioral and/or social science methods. This initiative is to support investigators who intend to pursue new research directions distinct from those they currently or previously conducted. While the proposed research may have the investigator’s prior work and expertise as its foundation, it cannot be a minor extension or scale-up of a current or past research enterprise.
October 17, 2019
January 3, 2020
February 3, 2020
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
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.
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.
Alzheimer’s disease and Alzheimer's disease-related dementias (AD/ADRD) are estimated to affect millions of people in the United States, and absent effective treatment or prevention, overall prevalence of AD/ADRD is projected to almost double by 2050. Dementia is a devastating disease for individuals, their families, and society, financially, medically, and emotionally. It has been estimated that the United States spends well over $100 billion per year on the direct and indirect costs of care for people with AD/ADRD.
The NIA Behavioral and Social Research LEaders in Alzheimer’s Disease and Its Related Dementias (NIA BSR LEADR) program supports individual scientists of exceptional creativity who propose to use behavioral and social science perspectives and approaches for highly innovative, impactful, and potentially transformative theoretical, empirical, and clinical research addressing the challenges raised by AD/ADRD for individuals, their families, and society, such as the priority areas listed below. NIA encourages applications on a variety of AD/ADRD-related topics in which behavioral and social research can contribute, such as dementia care, dementia caregiver research, cognitive and dementia epidemiology, behavioral and social pathways of AD/ADRD, early psychological changes preceding AD/ADRD, prevention of AD/ADRD, and disparities in AD/ADRD or dementia-related outcomes.
Examples of NIA priority areas include, but are not limited to, the following:
Emphases are on the qualities of the investigator and the innovativeness and potential impact of the proposed research on the field of AD/ADRD. Preliminary data and detailed experimental plans are not requested.
To be responsive to this RFA, the proposed project must represent a new insight into the potential solution to an important problem related to AD/ADRD that can be addressed with exceptionally innovative or unconventional behavioral and social science methods. While the proposed research may have the applicant's prior work and expertise as its foundation, it cannot be a minor extension or scale-up of a current or past research enterprise.
Awardees are required to commit a large portion (at last 35% or 4.2 person-months per year) of their research effort to activities supported by this NIA BSR LEADR award in the first three years of the project period. Awardees will be allowed to reduce effort to 3 person-months (25%) in the fourth and fifth years, respectively, to help them transition to other sources of support, since this award cannot be renewed. Investigators who will not be able to meet this requirement should not submit applications.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
NIA intends to commit $1.6 million in total costs in FY 2020 to fund 2 awards.
The scope of the proposed project should determine the project period. The maximum project period is 5 years.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
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.
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.
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.
Only single PD/PI applications are allowed. Applications with multiple PDs/PIs will not be accepted.
Investigators at all career levels who meet the eligibility criteria and are currently engaged in research are eligible to submit applications.
This initiative is to support investigators who intend to pursue research that is distinct from that they have currently or previously conducted. Applications for projects that are minor extensions or scale-ups of current or past research enterprises should not be submitted.
NIA BSR LEADR awardees are required to commit a large portion (at last 35% or 4.2 person- months per year) of their research effort to activities supported by this award in the first three years of the project period. Awardees will be allowed to reduce effort to 3 person-months (25%) in the fourth and fifth years, respectively.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
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.
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 IC 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:
The letter of intent should be sent to:
Georgeanne E. Patmios
National Institute on Aging (NIA)
with the following additional instructions:
Agency Routing Identifier: Enter “N/A”.
Type of Application: Must be “New”.
Proposed Project: Enter start date: 09/01/2020; enter end date: 08/31/2025
Total Federal Funds Requested: Enter $2,500,000.
Total Non-Federal Funds: Enter $0.
Total Federal & Non-Federal Funds: Enter $2,500,000. (See note below.)
Estimated Program Income: Enter $0.
Note: The Budget Request is entered only in the fields for "Total Federal Funds Requested" and "Total Federal & Non-Federal Funds" as described above. Funds may be requested for personnel (including collaborators), supplies, equipment, sub-contracts, and other allowable costs. Only the five-year total - $2.5 million - should be entered in the fields for "Total Federal Funds Requested" and "Total Federal & Non-Federal Funds". Applicable Facilities and Administrative (F&A) costs will be determined at the time of award and should not be included in the budget request. A detailed budget is not requested and will not be accepted.
Bibliography & References Cited: Do not use. Reference citations cannot be attached here, but may be included in the Essay.
Current and Pending Support: Attach a list of current and pending support from all sources, including current year direct costs and percent effort devoted to each project.
Profile - Senior Key Person 1: Do not use. Submit information only for PD(s)/PI(s). Information on collaborators or other key personnel is not required but may be included in the Essay.
Specific Aims: Do not use.
Research Strategy: Upload the Essay here. Describe your innovative vision for addressing a major problem or challenge related to AD/ADRD for individuals, families, or society; the importance of this problem or challenge; and your qualifications to address it using innovative or unconventional behavioral and social science methods. No detailed scientific plan should be provided, since the research plan is expected to evolve during the tenure of the grant. The Essay should include the following sections in the order given with the headings as shown below:
Project title: The project title must be descriptive of the proposed project.
Project description: What is the scientific problem or challenge that will be addressed, and why is this important? What are the exceptionally innovative or unconventional behavioral and social science methods/approaches that, if successful, would lead to groundbreaking or paradigm-shifting results? Prominently indicate that neither a detailed experimental plan nor extensive preliminary data are being provided per the FOA. However, the reviewers must still have a clear sense of what is being proposed to be done and why. The writing should be at a level that conveys the significance and impact of the application to broadly knowledgeable scientists with expertise in different domains.
Evidence of PD's/PI's innovativeness: What concrete evidence can you provide for your claim of innovativeness and creativity, without duplicating information provided in your biosketch? For example, qualities common to many highly innovative people include the ability to integrate diverse sources of information; an inclination to question paradigms; a willingness to work with intellectual uncertainties; persistence in the face of failure; an ability to work collaboratively with researchers from diverse disciplines; and the energy and concentration necessary to plan and execute effective strategies for accomplishing goals.
How the planned research differs from the PD's/PI's past or current work: How does the proposed project represent a new and distinct direction for your research? While a new research direction may have the applicant's prior work and expertise as its foundation, it cannot be a minor extension or scale-up of a current or past research enterprise. Applications for projects that are extensions of ongoing research should not be submitted.
Compatibility with the goal of the NIA Behavioral and Social Research LEaders in Alzheimer’s Disease and Its Related Dementias Award: Why is the planned research uniquely suited to the stated goal of this FOA rather than a traditional grant mechanism? How will the planned research move the field forward in a truly transformative way?
Statement of research effort commitment: A statement must be included that, if chosen to receive an award, the applicant will commit a minimum of 35% or 4.2 person-months of his/her research effort per year to the project in the first three years, and a minimum of 25% or 3 person-months per year in the fourth and fifth years. Applications without such a statement will be considered incomplete.
Note: Information on collaborations may be included in the Essay. Literature references are not required but, if included, must fit within the page limit. Figures and illustrations may be included but must also fit within the page limit. Provide letters of support from significant collaborators for the proposed research.
The following modifications also apply:
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.
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.
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
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.
This initiative is not subject to intergovernmental review.
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.
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.
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 and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant, and/or nonresponsive will not be reviewed.
In order to expedite review, applicants are requested to notify the NIA Referral Office by email at email@example.com when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
Letters of Reference. Letters of reference are an important part of the application. Applicants must arrange to have three (and only three) letters of reference submitted on their behalf. Applications that are missing letters of reference will be considered incomplete and will not be reviewed. Late letters will not be accepted. Applicants are responsible for monitoring the submission of their letters to ensure that three letters have been submitted prior to the submission deadline. Applicants are encouraged to check the status of their letters in their Commons accounts.
Letters must be submitted no later than 5:00 p.m. (local time of the referee) on the Application Due Date of the competition, February 3, 2020.
To submit a letter of reference, the referee (the individual submitting the letter) will need the following information:
Funding Opportunity Number (FOA) for this announcement: RFA-AG-20-033;
The PD/PI's (Applicant's) eRA Commons User ID (Note: Referees do not need to be registered in eRA Commons and do not need their own Commons User Name – only the PD/PI's (Applicant's) Commons User ID is required);
The applicant's first and last name (note – the name must match exactly the applicant's name in the Commons);
The URL to the letter submission page: (https://public.era.nih.gov/commons/public/reference/submitReferenceLetter.do?mode=new ).
The letter of reference submission deadline: The deadline for receipt of letters is 5:00 p.m. (local time of the referee) on the Application Due Date of the competition, February 3, 2020.
Letters of reference are confidential. Applicants will not have access to the letters. Email confirmations will be sent to both the applicant and the referee. The confirmation sent to the applicant will include the referee’s name and the date and time the letter was submitted. The confirmation sent to the referee will include the referee and applicant’s names, a confirmation number, and the date and time the letter was submitted.
Note: Since email can be unreliable, it is the applicant’s responsibility to check the status of his/her letters of reference periodically in eRA Commons.
Applicants are strongly encouraged to send the following to their referees:
Instructions for Referees:
Letters must be submitted to eRA Commons at (https://public.era.nih.gov/commons/public/reference/submitReferenceLetter.do?mode=new) by 5:00 p.m. (local time of the referee), on the Application Due Date of the competition, February 3, 2020. . Late letters will not be accepted, and applications with fewer than three letters will not be reviewed. Letters must be submitted using the link above – paper copies or emails will not be accepted.
IMPORTANT: The applicant’s name should be placed at the top of the letter. Although signatures are not required, the letter must include a signature block with the referee’s full name, title, institution, and contact information.
In two pages or less, describe the applicant’s qualities that support the applicant’s claim to scientific innovativeness and creativity which would allow him/her to use methods and approaches from the behavioral and social sciences to address a problem or challenge related to AD/ADRD. When possible, give specific examples that illustrate these qualities. Address the likelihood that the applicant will conduct groundbreaking research in the proposed research area.
Note: The letter submission page can be accessed without signing into eRA Commons, and referees do not need to be registered in eRA Commons. Referees must enter the following information when submitting letters:
REFEREE INFORMATION (the individual providing the letter of reference):
APPLICANT INFORMATION (applicants must send this information to their referees):
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.
For this particular announcement, note the following:
Applications are meant to support individual scientists of exceptional creativity who propose to use exceptionally innovative or unconventional behavioral and social science methods to address a major problem or challenge related to AD/ADRD for individuals, families, or society. Applications do not require preliminary data, scientific aims, or a detailed research plan. Accordingly, reviewers will emphasize the following:
1) The significance and innovation of the proposed project.
2) The investigator's evidence of past innovation and demonstrated ability to devote at least 35% or more research effort in the first three years and at least 25% or more research effort in fourth and fifth years.
3) Evidence that the proposed research uses exceptionally innovative or unconventional behavioral and social science methods, that it is sufficiently innovative and has a substantial potential impact, and that the proposed research represents a significant departure from the PD/PI's ongoing or past research directions.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Does the application use exceptionally innovative or unconventional behavioral and social science methods/approaches to conduct cutting-edge and possibly transformative research to address an important problem or challenge related to AD/ADRD that affects individuals, families, and/or society?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Is there clear evidence (appropriate for the applicant's career stage) that the applicant has the ability to address challenging research questions related to AD/ADRD using innovative, creative, or unconventional behavioral and social sciences methods? Is it likely that the research will result in major contributions to the field? Are there indicators that demonstrate the investigator’s ability to pursue groundbreaking research that is at once high risk and high payoff?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Is the project of higher risk than a traditional research project? Does the project represent a distinctly new scientific direction, rather than a mere refinement or scale up of existing studies by the applicant or other researchers?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project ? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Does the scientific environment provide the level of support needed to execute an exceptionally creative program of study?
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
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).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan and (2) Genomic Data Sharing Plan (GDS).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute on Aging 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.
Programmatic balance across AD/ADRD topic areas.
Information regarding the disposition of applications is available 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.
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.
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.
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)
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Georgeanne E. Patmios
National Institute on Aging (NIA)
Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
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