Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) National Center for Complementary and Integrative Health (NCCIH formerly NCCAM) National Institute on Aging (NIA)
Funding Opportunity Title	Research Grants Using the Resources from the Osteoarthritis Initiative (OAI) (R01)
Activity Code	R01 Research Project Grant
Announcement Type	New
Related Notices	October 26, 2017 - This PA has been reissued as PA-18-409. June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same. August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications. May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.
Funding Opportunity Announcement (FOA) Number	PA-13-236
Companion Funding Opportunity	PA-13-237, R21 Exploratory/Developmental Grant
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.846, 93.213, 93.866
Funding Opportunity Purpose	This Funding Opportunity Announcement (FOA) encourages applications for research awards that are focused on the use the Osteoarthritis Initiative (OAI) database, clinical data and images. This FOA seeks to expand the use of these resources by investigators in the broader research community. Examples of possible topics are: identification and validation of risk factors for knee and hip OA, including both modifiable and non-modifiable risk factors; utilization of biospecimens in conjunction with research efforts to determine biochemical markers of early and/or progressive disease; analyses of existing OAI data to assess the effectiveness of biobehavioral, pharmacological, and other interventions that subjects use in response to OA pain; determination of predictive role of MRI changes for subsequent radiographic and clinical outcome changes related to development of knee OA; development of novel and efficient tools for analysis of MR images and x rays that can be applied to large numbers of images with high degrees of reproducibility for diagnosis and monitoring of OA-related changes; and research focused on the trajectory of disease including effects on other joint structures such as muscles, ligaments, and bone, with regard to points where interventions could be made, especially for subsets, to reduce OA severity. The publication of this FOA to the research community indicates to investigators and peer reviewers the importance that the NIAMS and other partners have placed on the use of the OAI resources.

Posted Date	May 31, 2013
Open Date (Earliest Submission Date)	September 5, 2013
Letter of Intent Due Date(s)	Not Applicable
Application Due Date(s)	Standard dates apply, by 5:00 PM local time of applicant organization. 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)	Standard AIDS dates apply, by 5:00 PM local time of applicant organization.
Scientific Merit Review	Standard dates apply
Advisory Council Review	Standard dates apply
Earliest Start Date	Standard dates apply
Expiration Date	January 8, 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.

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

Osteoarthritis (OA), or degenerative joint disease, is the most common form of arthritis. It is a slowly progressing disease characterized clinically by pain, deformity, enlargement of the joints, and limitation of motion. The disease usually occurs late in life and most commonly affects the hand and large weight bearing joints. The prevalence of OA is difficult to determine because many individuals with radiographic evidence of OA have no symptoms, and the degree of radiological change varies. Approximately 27 million adults have physician-diagnosed OA. In individuals age 60 and older, OA is estimated to be present (by history) in 17 percent of men and 29.6 percent of women. OA is a significant contributor to disability and loss of independence among the elderly. These data reinforce the growing need for therapies that prevent or delay degenerative joint diseases. While recent advances have yielded highly effective disease-modifying therapies for rheumatoid arthritis, no such therapies exist for osteoarthritis and current treatment regimens are predominantly designed to relieve pain. Because of the chronic nature of the disease and variable clinical outcomes, clinical trials for new therapies are difficult, take a long time to conduct, and are exceedingly expensive.

One barrier to finding drugs, devices, or nutrients that can halt the painful joint degeneration that characterizes osteoarthritis is the lack of objective, measurable standards of disease diagnosis and progression by which new interventions can be evaluated. To overcome this problem, and to facilitate and accelerate the development of potential therapies, the NIH partnered with private industry sponsors to develop a resource that any researcher can use to identify and evaluate markers of osteoarthritis. The OAI, which began in July 2002, has produced a wealth of data for the research community. Recently, baseline and six years of follow-up data and images have been released for public use and diagnostic readings of knee x-rays have been posted to allow characterization of incident and progression cases. Matched biospecimens, including serum, DNA, peripheral blood RNA, and urine are also available for these visits. While there are many registered users of the OAI website, the number research grant applications using this resource submitted to and funded by NIH are limited. The purpose of this program is to accelerate discoveries related to the onset and progression of knee osteoarthritis with particular emphasis on the development of objective, measureable standards of osteoarthritis diagnosis and progression by which new interventions can be evaluated.

Description of OAI Resources: Participants in the OAI were recruited at five clinical facilities located in four U.S. cities. Individuals who were eligible based on the telephone evaluation were invited to a Screening Clinic Visit for assessment of additional eligibility and exclusion criteria, MRI contraindications, and to obtain the baseline tibio-femoral knee radiograph. Radiographs were read locally to determine the presence of knee OA and exclusions for bilateral end-stage disease (these and follow up x-rays have been subsequently read centrally). The cohort consists of 4794 subjects (96% of goal) with 58% women and 21% minority participants. The study sample represents three subgroups: 1) Progression cohort (29%) - those with clinically significant knee OA who are at risk for disease progression; 2) Incidence cohort (69%) - those who do not have, but are at high risk for developing, clinically significant knee OA; and "Non-exposed" cohort (2%) - those without risk factors or radiographic evidence of OA. The first group represents individuals likely to be included in clinical trials of treatments for knee OA, while the second group represents persons for whom prevention of disease may be possible. Participants in the Progression cohort have symptomatic knee OA at the baseline exam, defined as the presence in at least one knee of frequent knee symptoms in the past 12 months (pain, aching or stiffness in or around the knee on most days for at least one month) and radiographic tibio-femoral knee OA (definite tibio-femoral osteophytes, or OARSI atlas osteophyte grades 1-3) based on a reading of the baseline posterior-anterior (PA) knee radiograph by a radiologist or rheumatologist at the clinical center at this visit. A small (122) group of non-exposed control subjects without risk factors or disease was also enrolled. Enrollment visits occurred within 3 to 6 weeks of screening. At this visit, baseline questionnaires, knee MRIs, physical exams, additional joint radiographs, and blood and urine specimens were obtained. Follow up visits occurred either in clinic or by phone interview on a yearly basis for 8 years.

Dedicated 3.0 Tesla Siemens Trio MR scanners were installed at four clinical centers for exclusive use by the OAI Clinical Centers. The OAI opted to use 3.0 T MR systems because of the advantage over lower field scanners in signal-to-noise ratio, which can potentially be traded off for spatial resolution and/or imaging speed, and to extend the useful life of the MRI data. These images are archived at and available for use as a public resource at http://oai.epi-ucsf.org/datarelease/.

Another primary goal of the OAI has been the development of archived blood, urine, and DNA specimens. These are available to investigators, through a formal application and review process (http://oai.epi-ucsf.org/datarelease/) for testing and validation of biochemical markers of OA. Morning blood and second morning void urine specimens, after an overnight fast, have been collected. For logistical reasons, a small subset of participants had late morning or early afternoon blood draws after a minimum 2 hour fast. Follow-up visit blood draws are scheduled to within +/-1 hour of the time of the baseline blood draw. The majority of blood is processed and stored as serum. A smaller amount of blood is processed and saved as plasma to accommodate assays that may require plasma. Buffy coat from the plasma samples is saved for DNA extraction. PAXgeneTM tubes are used to collect blood for RNA extraction. All specimens have been stored at 70 C.

The core clinical measurements (examinations and questionnaires) include assessment of joints and OA outcomes, general health and functioning, and risk factors for knee OA. Joint assessments and OA outcomes focus on the knee, with a secondary emphasis on the hip, hand and other common sites of joint symptoms. Knee assessments cover the four core outcome domains of pain, physical function, patient global assessment and joint imaging, as recommended for OA clinical trials. Knee pain, stiffness and knee-related physical function are assessed using the WOMAC Osteoarthritis Index TM (version LK 3.1) and ask about the right and left knee separately during the past 7 days. When utilized in a joint-specific fashion it has been shown to discriminate between outcomes in opposite joint in the same patients. The non-WOMAC components of the Knee Outcomes in Osteoarthritis Survey (KOOS) are administered to assess knee symptoms and function during more demanding activities (e.g. sport and recreation) that are relevant to somewhat younger subjects with knee injuries or post-injury arthritis, which are both common in OAI participants. Global knee pain severity during the past 7 and 30 days is assessed using an 11-point numerical rating scale, which is easy to administer and score, including over the telephone, and can be used with a greater variety of subjects than can a visual analog scale. A patient global assessment of the overall impact of knee problems on the participant’s sense of well-being also uses an 11-point numerical rating scale. In addition to the eligibility risk factors assessed during screening (see above), other baseline risk factor assessments include detailed questions about prior knee surgeries and about the frequency of activities requiring knee bending. Dietary and supplement intake of nutrients of potential importance for OA or that may affect biochemical marker levels during the study data is collected using the Brief Block Questionnaire 2000, as well as with targeted questions. Weight and height are measured for the calculation of body mass index and abdominal circumference assessed as a measure of central adiposity associated with abnormalities of the metabolic syndrome that may affect the risk of OA.

There are six annual follow-up clinic visits (at 12, 24, 36, 48, 72, and 96 months after baseline) for all participants, which will include MRI and radiographs of the knees (visits 12, 24, 36, 48, 72, 96) and radiographs of the hips and hands (BL, 48, 96 months). More limited data are collected by phone interviews at 60 and 84 months after baseline. Approximately 800 participants in the Progression sub-cohort will also have a knee MRI, biospecimen collection and outcome assessment at the midway point between two annual follow-up visits, either at 18 or at 30 months after baseline. All data and images are available at http://oai.epi-ucsf.org/datarelease/StudyOverview.asp.

This FOA seeks to expand the use of the OAI resources (See http://oai.epi-ucsf.org/datarelease/StudyOverview.asp) by investigators in the broader research community. Examples of possible topics are: identification and validation of risk factors for knee and hip OA, including both modifiable and non-modifiable risk factors; utilization of biospecimens in conjunction with research efforts to determine biochemical markers of early and/or progressive disease; analyses of existing OAI data to assess the effectiveness of biobehavioral, pharmacological, and other interventions that subjects use in response to OA pain; examination of racial/ethnic differences in disease onset, distribution, course, and/or outcomes, determination of predictive role of MRI changes for subsequent radiographic and clinical outcome changes related to development of knee OA; development of novel and efficient tools for analysis of MR images and x rays that can be applied to large numbers of images with high degrees of reproducibility for diagnosis and monitoring of OA-related changes; and research focused on the trajectory of disease including effects on other joint structures such as muscles, ligaments, and bone, with regard to points where interventions could be made, especially for subsets, to reduce OA severity.

NIA encourages combining existing data sets with the OAI data (where appropriate) for comparison of OA-related outcomes across different cohorts. NIA encourages potential applicants to consider the following additional sources of data:

• Multicenter Osteoarthritis Study (MOST): http://most.ucsf.edu/default.asp
• Health, Aging, and Body Composition (Health ABC):http://www.grc.nia.nih.gov/branches/ledb/healthabc/
• Baltimore Longitudinal Study of Aging (BLSA): http://www.blsa.nih.gov/.

NCCAM is interested in applications that would conduct secondary data analysis of the OAI resources to elucidate utilization, safety and impact of complementary/integrative health practices for treatment of symptoms due to osteoarthritis. Interventions commonly used for treatment of OA symptoms include, but are not limited to, massage, acupuncture, meditation, yoga, and dietary supplements, such as glucosamine.

While the Osteoarthritis Initiative resource has been used widely by OAI investigators, musculoskeletal imagers, and others (http://oai.epi-ucsf.org/datarelease/docs/publications/OAIReferenceList.pdf), rich opportunities remain for exploration of OAI data and images, analysis of the epidemiology and natural history of osteoarthritis, and application of emerging technologies to the biospecimens and genetic data. Additionally, the resource can also serve as an excellent training vehicle within the area of musculoskeletal research and bring together non-OAI investigators from a variety of disciplines.

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 Resubmission 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.
Award Budget	Application budgets are not limited, but need to reflect the actual needs of the proposed project.
Award Project Period	The maximum project period is 5 years.

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.

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

Other

• 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
• Non-domestic (non-U.S.) Entities (Foreign Institutions)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

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 (PDs/PIs)

All PDs/PIs must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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.

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Applicants must download 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.

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

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

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

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

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

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

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

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

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

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

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

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

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.

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. 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.

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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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 Applying Electronically.

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 by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

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 the project address an important problem or a critical barrier to progress in the field? 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?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or 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?

Innovation

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?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

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?

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.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six 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 six 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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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.

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 project.

Renewals

Not Applicable

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.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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

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; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

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.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) 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 appropriate national Advisory Council or Board. 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.

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.

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

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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) 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.

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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post-submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: [email protected]

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

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
TTY 301-451-5936
Email: [email protected]

Gayle E. Lester, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-3511
Email: [email protected]

Chhanda Dutta, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-435-3048
Email: [email protected]

Partap S. Khalsa, DC, PhD, DABCO
National Center for Complementary and Alternative Medicine (NCCAM)
Telephone: 301-594-3462
Email: [email protected]

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Steve Austin
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-3504
Email: [email protected]

Richard Proper
National Institute on Aging (NIA)
Telephone: 301-402-7735
E-mail: [email protected]

Shelley Carow
National Center for Complementary and Alternative Medicine (NCCAM)
Telephone: 301-594-3788
Email: [email protected]

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.

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 Parts 74 and 92.