Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Cancer Institute (NCI)

Funding Opportunity Title

Ancillary Domain Validation Patient-Reported Outcomes Measurement Information System (PROMIS®) Studies (R01) 

Activity Code

R01 Research Project Grant  

Announcement Type

New

Related Notices

  • February 8, 2012 - See Notice NOT-CA-12-011. The purpose of this Notice is to inform potential applicants that NCI is participating.

Funding Opportunity Announcement (FOA) Number

RFA-AR-12-007

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.846, 93.393, 93.394, 93.395, 93.399

FOA Purpose

With this Funding Opportunity Announcement (FOA), the NIH solicits applications that propose to conduct ancillary studies intended to facilitate incorporation of PROMIS® (Patient-Reported Outcomes Measurement Information System) domains into ongoing clinical projects in patient populations that represent the NIH portfolio of diseases (http://www.nih.gov).  The ongoing project can be a clinical trial, observational study or patient care population that can provide a sufficient cohort of well-characterized patients and has an existing infrastructure that can facilitate data collection and subsequent analysis.   In particular, NIH invites applications focusing on outcomes research to use PROMIS® domains and encourages collaborative approaches and data-sharing with the PROMIS® Network contributing to the further validation, testing, and evaluation of the existing PROMIS® item banks in these populations.    

Key Dates
Posted Date

February 6, 2012

Open Date (Earliest Submission Date)
Letter of Intent Due Date

March 10, 2012  

Application Due Date(s)

April 10, 2012, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June 2012

Advisory Council Review

August 2012

Earliest Start Date(s)

September 1, 2012

Expiration Date

April 11, 2012

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (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

Introduction

Many diseases of interest to NIH cause patients to have pain or experience fatigue; impact their sleep; alter their ability to physically or mentally function on a daily basis; or in other ways interfere with their social relationships and overall quality-of-life.  The impact, importance and value of patient self-reporting in the evaluation of efficacy and effectiveness or adverse effects associated with therapeutics support the need for a universal, common metric for its study in order to allow clinically meaningful comparisons of treatments of disease, both within and across diseases. 

Patient outcomes are critical to clinical research and patient care.  They are assessed in a variety of ways by treating physicians, imaging techniques, lab results and self-report. Patient Reported Outcomes (PROs) domains are concepts intended to represent how a patient feels or functions and are important endpoints in clinical research and healthcare delivery.

The Patient Reported Outcomes Measurement Information System (PROMIS®) is an NIH Common Fund initiative.  To date, PROMIS® has developed item banks that have been evaluated, mostly cross-sectionally, in the general population. These populations use a mixture of healthy controls as well as self-reported and clinically diagnosed patients.   However, these item banks have not yet been widely incorporated into longitudinal clinical research and care to allow for further testing of their validity and other measurement properties in the diverse patient populations representative of the NIH portfolio.  Similarly, they have not been widely tested in a variety of clinical populations whose experience with the domain of interest may not correspond to the experience of the general population, or these internet-based clinical applications.  Therefore, PROMIS® sets the stage to develop a strategic approach to progressively develop, validate, and implement the PROMIS® domains in diverse chronic diseases representative of the NIH portfolio of diseases as well as in diverse racial/ethnic populations. 

Importantly, PROMIS® holds the potential to facilitate comparative research on the efficacy, or effectiveness, of therapies and to be integrated into electronic health record (EHR) databases at the point of patient care as well as clinical research.  Incorporation of PROMIS® domains in all phases of NIH-supported research and patient care opens the future to the possibility of improved and more personalized therapeutic options, regardless of language, age, gender, ethnicity, minority, socioeconomic or disability status, or mode of administration.

The PROMIS® website www.nihpromis.org contains extensive documentation of the qualitative and quantitative evaluations and information about the PROMIS® Network and allows access to the Assessment Center.  The PROMIS® Assessment Center is an online resource that provides a range of PRO research management tools that may be tailored for a group (i.e., the PROMIS® short forms) or individuals (i.e., computerized adaptive testing, CAT).   There are adult and pediatric versions of PROMIS® measures that are either currently available or in development (see below and www.nihpromis.org for details). All available measures have undergone rigorous qualitative and quantitative testing to support the precision and validity of the instruments in several chronic disease populations and the general U.S. population. Relative to paper and pencil, “static” short forms, PROMIS® CAT measures are more precise and can reduce the length of questionnaires (i.e., reduced response burden), yet provide precise measures of a patient's functioning.  The PROMIS® Assessment Center allows investigators to create study-specific websites that securely capture patient data accessible only by the investigator.  The PROMIS® measures have been normed to the general U.S. population so scores provided by PROMIS® are relative to a mean of 50 and standard deviation of 10.  Further, all items or questions in PROMIS® have been calibrated to a common metric to allow scores from multiple studies to be combined for meta-analyses even if the investigators use different PROMIS® measures (e.g., short forms and CATs).  For details on the original FOA , see http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-04-011.html.

PROMIS® seeks to develop instruments that can meaningfully allow an understanding of the relationship between PROs across the spectrum of ages and diseases. At present, the following   version 1.0 domains are available for use as either short forms and/or for computerized adaptive testing (CAT):

A ten (10)-item global health instrument is also available as well as a multi-domain PROMIS® short form (29, 43 or 57-item version). It is anticipated that additional adult and pediatric domains will be available.

It is expected that PROMIS® will continue to expand and improve the science of PRO assessment, while at the same time making the instruments widely available and acceptable to interested stakeholders.  The increased efficiency, flexibility, and sensitivity of the PROMIS® tools are intended to allow greater compatibility between studies and greater statistical power with reduced patient reporting burden. 

Research Objectives
The goal of this FOA is to encourage ancillary studies of existing clinical samples to further validate PROMIS® domains. This FOA solicits grant applications that propose to conduct studies ancillary to existing ongoing clinical research studies. This FOA will only fund studies of patients already enrolled in studies; it will not fund any new patient recruitment. Instead, it would provide the opportunity to ask additional questions in existing clinical trial or cohort studies or other clinical or population-based samples.The ancillary studies should propose the use and evaluation of PROMIS® instruments in clinical settings that are related to the mission of NIH.  Such settings can include ongoing clinical studies, or cohort studies  that can provide a sufficient sample of clinically well-characterized patients to be evaluated longitudinally, as well as the infrastructure to collect and evaluate data.  The purpose of this FOA is to expand clinical validation and further evaluation of PROMIS® domains and instruments in patients with diseases within the NIH mission.   These studies should address important components of validation and should seek to evaluate the usability of the PROMIS® domains and instruments in clinical studies and other clinical research settings.  They could test the items and item banks in different chronic disease areas and ethnic groups to demonstrate their validity, or these studies could evaluate responsiveness to change and address minimally important differences (MID) in order to ensure the usefulness of the items and instruments in clinical research and patient care.   Such testing could also include conducting cognitive interviews and patient-centered focus groups to ensure PROMIS® domains accurately capture the patient experience.

Completion of the ancillary studies to be proposed in response to this FOA, will help ensure that  PROMIS® measures  capture the meaning and importance of these outcomes to advance the understanding of the treatment, prevention and ultimate cure of diseases important to NIH.  As such, these studies are expected to be ancillary or supplementary to existing NIH or privately-supported clinical trials or patient cohorts where PROMIS® instruments currently are not in use, or to be incorporated into new, emerging studies.  In either case, existing PROMIS® methodology (http://www.nihpromis.org/science/methodology) must be implemented in these applications. 

The following are examples of areas of research that might be proposed in populations of interest to the NIH under this FOA. These are only examples and are not meant to be all inclusive:

Applicants must document permission from the parent, ongoing project, to use the patient cohort to conduct proposed ancillary studies.  These proposed studies must not interfere with the parent project or unduly burden participants. Therefore, applicants must document that proper informed consent to conduct ancillary studies has been or will be obtained, and must agree to follow the procedures and policies established by both the parent project and PROMIS®. Ancillary studies may involve the entire cohort of participants in a parent study or selected subsets, depending on the scientific questions posed and the sample size required to answer them. The ancillary studies may also draw patients from two or more parent projects if the applicants are able to obtain approval from these parent projects and if the applicant's research plan is feasible. This FOA will not support the recruitment of patients who are not already enrolled in the parent study or studies. This FOA encourages collaboration between clinical investigators and partnerships with private entities. In addition, this FOA encourages junior investigators to take a leading role in clinical research with the support and collaboration of senior investigators. Although prospective applicants are not necessarily expected to be investigators in the parent study, collaborations in which a senior investigator from the parent study mentors a junior investigator on an ancillary study are encouraged.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
The OER Glossary and the SF 424 (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.

NIH intends to fund an estimate of 2-5 awards, corresponding to a total of $ 1M for fiscal year 2012. Future year amounts will depend on annual appropriations.

Award Budget

Direct costs are limited to $250,000 per year.

Award Project Period

A project duration for up to four years may be requested.  

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

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

For-Profit Organizations

Governments

Other

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 allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/()Principal Investigator(s)() (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

Eligible Individuals Program Director(s)/Principal Investigator(s)

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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.   

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

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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.

Letter of Intent

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:

Wm. Phil Tonkins Jr., M.S., Dr.PH
Health Scientist Administrator
Division of Skin and Rheumatic Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Bethesda, MD 20892
Telephone: (301) 594-4979
Email: tonkinsw2@mail.nih.gov

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory 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.

Page Limitations

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

PHS 398 Research Plan Component

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 with the following modification:

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.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application 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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.   

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (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 SF 424(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.

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 Central Contractor Registration (CCR). 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 responsiveness by the NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

In order to expedite review, applicants are requested to notify the NIAMS Referral Office by email at linh1@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD(s)/PI(s) name, and title of the application.

Special Instructions

All ancillary study applications MUST include a letter of support or statement documenting that patients, samples, data and/or materials are available from the ongoing parent clinical project and that the proposed ancillary study has the support of the parent project’s organization/leadership.  This letter should be included as an upload in item 14 of the PHS398 Components “Letters of Support.”  Applications not containing such documentation will be considered non-responsive to this FOA. 

Applicants must include a paragraph or time line to demonstrate that there is adequate time left in the parent project  to carry out the ancillary study. This documentation should be included with the letter of support from the parent project and uploaded to item 14 as above. Additional funds to extend the parent grant will not be allowed.  Applications in which the critical time lines for the parent project and ancillary study are incompatible or ambiguous will not be considered to be within the scope of this FOA.

The draft protocols and draft consent forms for the ancillary study should be included as Appendix I. IRB approval is not required at the time of submission for the ancillary study protocol and related documents.  Successful applicants will be required to submit this information at the time of award.  NIH will treat as confidential any scientific, preclinical, clinical, or formulation data and information that the sponsor deems to be proprietary.

Post Submission Materials

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

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

Reviewers will provide an overall impact/priority 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).

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 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(s)/PI(s), 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?   

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/priority 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

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/priority score.

Applications from Foreign Organizations

 Not Applicable. 

Select Agent Research

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

Resource Sharing Plans

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.

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council . The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD(s)/PI(s) 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.

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) 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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

James Witter, M.D., Ph.D,
Medical Officer/Rheumatic Diseases Clinical Program
Division of Skin and Rheumatic Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institutes of Health
6701 Democracy Blvd, Suite 800
Bethesda, MD 20892-4872
Telephone:  (301) 594-1963
Email:  witterj@mail.nih.gov

Wm. Phil Tonkins Jr., M.S., Dr.PH
Health Scientist Administrator
Division of Skin and Rheumatic Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institutes of Health
6701 Democracy Blvd., Suite 800
Bethesda, MD 20892
Telephone: (301) 594-4979
Email: tonkinsw2@mail.nih.gov

Peer Review Contact(s)

Charles Rafferty, Ph.D.
Chief, Scientific Review Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institutes of Health
6701 Democracy Boulevard, Suite 800
Bethesda, MD  20892-4872
Telephone: (301) 594-5019
Email: raffertycn@mail.nih.gov

Financial/Grants Management Contact(s)

Natalie Reyes
Grants Management Specialist
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institutes of Health
6701 Democracy Boulevard, Suite 800
Bethesda, MD  20892-4872
Telephone: (301) 594-5032
Email: reyesn@mail.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 Parts 74 and 92.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.