A. Scope and Intent of PROMIS

1. What is the PROMIS initiative?
2. What are the goals of the second funding phase of the NIH RM PROMIS initiative?
3. What are the objectives of the second funding phase of the NIH RM PROMIS initiative?
4. What is the difference between small domain sites and large clinical sites?

B. General Questions

1. How many awards will be made?
2. What budget and project period should I request?
3. How much time/effort are recipients expected to devote?
4. Is there a limit to the number of applications that can be submitted by an individual?
5. Is there a limit to the number of applications that can be submitted by an institution?

C. Eligibility

1. Are foreign scientists and institutions eligible?
2. Are individuals employed by government agencies, non-academic, and/or for-profit organizations eligible?

D. Application Documents

1. What are the dates for submission of applications?
2. What are the page limitations?
3. Where can I find help registering for Grants.gov?
4. Where can I find help in submitting my application to Grants.gov?
5. Where can I find help in registering for the eRA Commons?

E. 2009 Evaluation and Selection of Awards

1. When will my application be reviewed, and by whom?
2. Will I have an opportunity to submit an update before my application is reviewed?
3. Will I receive a summary statement or other comments?
4. How will awards be selected for funding?
5. When will the 2009 awardees be notified?
   
   

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A. Scope anntent of Pd IROMIS

1. What is the PROMIS initiative?

This trans-NIH initiative, managed by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), aims to develop new ways to measure patient-reported symptoms such as pain, fatigue, physical functioning, and other aspects of health-related quality of life across a wide variety of chronic diseases and conditions.

2. What are the goals of the second funding phase of the NIH RM PROMIS initiative?

The overall goals of the second funding phase are to validate the PROMIS domains in the context of clinical studies and to develop the PROMIS system to facilitate adoption by clinical researchers, consistent with the overall goals of the program.

3. What are the objectives of the second funding phase of the NIH RM PROMIS initiative?

The objectives of the NIH RM PROMIS initiative during the next four years include:

• Conduct validation studies and evaluate usability of the PROMIS domains and tools for clinical trials and other clinical research settings,
• Continue testing the items and item banks in different chronic disease areas and ethnic groups to demonstrate their content validity,
• Evaluate responsiveness to change to ensure the usefulness of the items and instruments in clinical research,
• Develop a fully-functional CAT system and scannable short forms,
• Develop additional domains,
• Calibrate items translated into Spanish and other languages and conduct concurrent validity testing,
• Develop additional modes of administration,
• Facilitate use by the clinical research community,
• Build partnerships to secure long-term sustainability for the PROMIS domains and tools.
  
  

4. What is the difference between small domain sites and large clinical sites?

The size of a proposed site relates to the intended goal of this site. Small sites might consider focusing exclusively on psychometric development of new domains. Other small sites may want to conduct some initial validation of these new domains, or further study of domains already in the PROMIS network, in appropriate, enriched patient populations. Large sites could propose to develop new domains, or further evaluate existing PROMIS domains in large scale clinical validation studies similar in size and scope to NIH phase III clinical trials that are intended to change patient care.

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B. General Questions

1. How many awards will be made?

NIH expects to make three U54 awards and five to ten U01 awards in FY09.

2. What budget and project period should I request?

For the U54 awards, the total project period for this funding opportunity should request a 9/1/2009 start date and may not exceed four years. Direct costs are limited to $400,000 per year for a four-year period.

For the U01 awards, the total project period for this funding opportunity may not exceed four years. Direct costs are limited to $350,000 per year for a small domain site and $1,000,000 per year for a large clinical site.

3. How much time/effort are recipients expected to devote?

Principal investigators (PIs) are expected to devote time commensurate to project needs, and follow general guidelines as for other NIH projects of similar size, complexity and duration. PIs of a U54 application are expected to commit 3.6 person months or more effort to ensure success of the program. PIs of a U01 application is expected to commit 3.0 person months or more effort to ensure success of the program.

4. Is there a limit to the number of applications that can be submitted by an individual?

No. Applicants may submit more than one application, provided each application is scientifically distinct. An individual may serve as PI on only one U54 award. The PI of a U54 award may also serve as a co-PI on a U01 award. The same project may not be included by any investigator in more than one application.

5. Is there a limit to the number of applications that can be submitted by an institution?

No. Institutions are not limited in the number of applications that may be submitted in response to any of the four interrelated RFAs of this funding opportunity announcement (FOA): RFA-RM-08-022 (U54), RFA-RM-08-023 (U01), RFA-RM-08-024 (U54), or RFA-RM-08-025 (U54). If an institution applies for more than one U54, the applicant needs to give careful consideration to the different scope of each of the U54s and the value of diversity of scientific leadership and project teams to each application in optimally achieving the overall goals of the program. An institution should also ensure that commitment levels in each submission are adequate and consistent for the proposed project.

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C. Eligibility

1. Are foreign scientists and institutions eligible?

Foreign institutions are not eligible to apply as the primary applicant but they may enter into collaborations with a domestic institution that is the primary applicant.

2. Are individuals employed by non-academic, and/or for-profit organizations eligible?

Yes. Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PI is invited to work with his/her institution 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 programs.

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D. Application Documents

1. What are the dates for submission of applications?

The deadline for Letters of Intent (LOI) is 5:00 p.m. local time, February 3, 2009. Applications must be successfully received by Center for Scientific Review and the National Institute of Arthritis Musculoskeletal Skin Diseases no later than 5:00 p.m. local time (of the applicant institution/organization), March 3, 2009. Application materials will not be accepted after that time and applications that are not complete will not be evaluated. Submit the original and five identical, legible, single-sided photocopies of each application. The original must be signed by an authorized organizational official.

2. What are the page limitations?

All applications and proposals for NIH funding must be self-contained within specified page limitations.

The page limit for the U54 application research plan (including overview, and specific aims, background, and significance, preliminary studies, and research design and methods) is 40 pages. The page limit for the U01 application research plan is 25 pages.

3. Where can I find help registering for Grants.gov?

For help with the Grants.gov registration process, contact Grants.gov Contact Center at 1-800-518-4726 (Toll Free), Monday–Friday, 7:00 a.m. to 9:00 p.m. (Eastern Standard Time), or at support@grants.gov.

4. Where can I find help in submitting my application to Grants.gov?

For help with the technical aspects of submitting an application to Grants.gov, check the resources available at Grants.gov. If you need assistance, contact Grants.gov Contact Center at 1-800-518-4726 (Toll Free), Monday through Friday, 7:00 a.m.–9:00 p.m. (Eastern Standard Time), or at support@grants.gov.

5. Where can I find help in registering for the eRA Commons?

Step-by-step directions for registering with eRA Commons are available at http://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. For questions regarding the Commons registration process, contact the NIH eRA Commons help desk at phone: 301-402-7469 or 866-504-9552 (Toll Free); 301- 451-5939 (TTY) business hours Monday–Friday, 7:00 a.m.–8:00 p.m. (Eastern Standard Time).

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E. 2009 Evaluation and Selection of Awards

1. When will my application be reviewed, and by whom?

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by CSR and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/).

2. Will I have an opportunity to submit an update before my application is reviewed?

Questions about review should be directed to the scientific review officer (SRO) assigned to the application.

3. Will I receive a summary statement or other comments?

Yes. All applicants will receive a summary statement.

4. How will awards be selected for funding?

The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by peer review
• Availability of funds
• Relevance of the proposed project to program priorities
• The potential for productive collaborations among PROMIS investigators
• Relevance to NIH Roadmap PROMIS priorities
• Adequacy of resource sharing and IP management statements.
  
  

5. When will the 2009 awardees be notified?

Awardees will be notified of review outcomes in August 2009. The earliest anticipated award start date will be September 1, 2009.

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