NIH Announces the Availability of Recovery Act Funds for Competitive Revision Applications

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Notice Number: NOT-OD-09-058

Update: The following update relating to this announcement has been issued:

• April 10, 2009 - See Notice NOT-OD-09-083 This notice provides additional guidance to applicants.
• April 10, 2009 - See Notice NOT-HD-09-013 The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) will not participate.
• April 3, 2009 - See Notice NOT-OD-09-079 - ARRA Administrative Supplements and Competitive Revisions: Clarifications on Programmatic Limitations and use of Modular Budgets.

Catalog of Federal Domestic Assistance Number(s)
93.701, 93.702

Key Dates
Release Date: March 18, 2009
Application Due Date: April 21, 2009

(See instructions below to determine appropriate application forms and submission process.)

Issued by
National Institutes of Health (NIH), (http://www.nih.gov)

Purpose

The National Institutes of Health (NIH) announces the opportunity for investigators and United States institutions/organizations with active NIH-supported research project grants (including SBIR and STTR) to submit revision applications (formerly termed competitive supplements) to support a significant expansion of the scope or research protocol of approved and funded projects. Support for these revision applications will come from funds provided to NIH through the American Recovery and Reinvestment Act of 2009 ( Recovery Act or ARRA ), Public Law 111-5. In addition, Recovery Act funds allocated to NIH specifically for comparative effectiveness research (CER) may be available to support supplements. Projects receiving these funds will need to meet this definition of CER: a rigorous evaluation of the impact of different options that are available for treating a given medical condition for a particular set of patients. Such a study may compare similar treatments, such as competing drugs, or it may analyze very different approaches, such as surgery and drug therapy. Such research may include the development and use of clinical registries, clinical data networks, and other forms of electronic health data that can be used to generate or obtain outcomes data as they apply to CER.

This announcement is one of three ARRA administrative supplement/competitive revision notices issued by NIH. Approximately $1 billion of ARRA funds will be obligated by September 30, 2010 to support requests submitted in response to these three notices or any reissuance of these notices.

Funding decisions and awards will be issued on or prior to September 30, 2009 for applications submitted in response to this notice, and on or prior to September 30, 2010 for applications submitted in response to any reissuance of this notice.

The deadline for receipt of these revision applications is April 21, 2009. Resubmissions will only be accepted if this notice is reissued.

Background

The Recovery Act was signed into law on February 17, 2009 with the purpose of stimulating the American economy through job preservation and creation, infrastructure investment, energy efficiency and science, and other means. The Recovery Act provides NIH with up to $10.4 billion to be obligated over two years for a variety of biomedical research and research support activities. This funding opportunity for revisions (formerly called competitive supplements) is one part of the overall NIH Recovery Act investment strategy, as described at www.hhs.gov/recovery.

Eligibility

This announcement is for revision applications to active NIH Research Grants, including, but not limited to, R01, R03, R15, R21, R25, R33, R34, R37, R21/R33, R41, R42, R43, R44, SC1, SC2, SC3 grants, and Program Project grants, Center grants, Cooperative Agreements, Training Grants, and Institutional Career Development Awards. Recognize that these are 2-year awards and probably are most appropriate at the post-doctoral level. (Note: Most Ks and Ts are eligible for administrative supplements [see NOT-OD-09-056].) Individual Institutes and Centers (ICs) have more detailed eligibility information on their own Web sites. See http://grants.nih.gov/recovery/ic_supp.html.
Fellowships (Fs) and Conference Grants (R13s) will not be considered for revisions.

Potential applicants should review the instructions for Revision Applications issued by their funding IC (See NIH Institute & Center (IC) Web Sites) before responding to this Notice. Some ICs will consider Revision Applications only in target areas identified on their Web sites.

To be eligible, the parent grant must be active at the time the revision application is submitted, and the research proposed in the revision must be accomplished within the current competitive segment. That is, the period of support requested for the revision cannot exceed the current project period end date of the parent grant, including projects on a no-cost extension. Also, a no-cost extension must be in place before the revision application is submitted.

Applications from foreign institutions are not permitted. Consistent with the goals of the Recovery Act to preserve and create jobs and promote economic recovery in the United States, applicants must be domestic (United States) institutions/organizations (i.e., located in the 50 states, territories and possessions of the United States, Commonwealth of Puerto Rico, Trust Territory of the Pacific Islands, or District of Columbia).

IMPORTANT: Revision applications must be for costs to support new research objectives and aims that are outside of the scope of the approved parent grant. A request for funds to support work within the general scope of the peer-reviewed activities and aims approved within the parent grant should be submitted as an administrative supplement. To apply for an administrative supplement under the Recovery Act, please see NOT-OD-09-056.

For all revision applications, the Project Director/Principal Investigator (PD/PI) must be the same as the PD/PI on the parent award. For Multiple PD/PI parent awards, the Contact PD/PI must be the PD/PI listed on the revision request. Revisions allow a change in the Multiple PD/PI team as well as a conversion from a single PD/PI to multiple PD/PI. However, applicants must include a multiple PD/PI Leadership Plan with the revision application.

All revision applications must be submitted by the PD/PI (or Contact PD/PI for multi-PI grants) listed on the parent grant.

NIH encourages the participation of individuals from racial and ethnic groups underrepresented in biomedical and behavioral research, individuals with disabilities and individuals from disadvantaged backgrounds.

Examples of the types of revisions that would be appropriate include, but are not limited to the following:

• Hiring students, postdocs or other personnel to accomplish new scientific objectives or to generate novel resources.
• Making investments in technology essential to expand the goals of the project or to enhance energy efficiency in the expansion of the project.
• Requesting that a single PD/PI grant be changed to a multiple PD/PI grant or otherwise modifying the multiple PD/PI team in order to add and pursue new scientific goals. (NOTE: a Multiple PD/PI Leadership Plan will be required as part of the application.)
• Other types of revisions may be appropriate but must be consistent with the goals of the Recovery Act

Please note that ICs may have their own specific areas of emphasis. These can be found on individual IC web sites available at http://grants.nih.gov/recovery/ic_supp.html.
Any cost increases need to result from making modifications to the project in order to take advantage of opportunities that would increase the value of the project goals and objectives or to accelerate the rate of discovery of scientific research. Revision applications are not appropriate when the sole purpose is to restore awards to the full Scientific Review Group-recommended level if they were administratively reduced by the funding agency. In addition, NIH will not consider requests which are solely to restore previously applied budget adjustments to a project nor to supplant institutional commitments supporting individuals and other costs previously committed to projects.

Applicants considering applying for funding for alterations, improvement of research laboratories, or purchase of major equipment items are encouraged to see the following FOAs issued recently by the National Center for Research Resources:

• RFA-RR-09-007: Alteration and Renovation of Existing Research and Animal Facilities (G20)
• RFA-RR-09-008: Extramural Research Facilities Improvement Program (C06)
• PAR-09-118: High-End Instrumentation Grant Program (S10)

Note: Applications for the support of high school and college students, post-baccalaureate and post-master’s personnel, and science educators are also encouraged but have been announced in a separate Notice. See NOT-OD-09-060.

Support for revision applications is contingent on availability of funds and eligibility is restricted to currently-funded Principal Investigators/Project Directors awarded a research project grant.

Budget and Funding Information

Funding for revisions to existing grants will be available from Recovery Act funds in FYs 2009 and 2010. Due to the limited, two-year nature of Recovery Act funds, revision applications may only be requested for up to two years; therefore the scope and budget of the requested revision must reflect aims and goals that can be accomplished within that limited timeframe. Requests selected for funding in FY2010 will be limited to one year for the project and budget period.

There is no maximum dollar limit on the budget request for a revision application; however, the requested budget must be reasonable and appropriate for the work being proposed. (Note that equipment purchases cannot exceed $100,000).

Note: For this revision opportunity, prior approval from the IC staff is not needed to submit an application with a budget greater than $500,000 direct costs in any year. (Applicants should ignore the e-submission validation warning regarding the NIH $500,000 per year limit on direct costs.)

In addition, domestic U.S. institutions planning to submit applications that include foreign components should be aware that requested funding for any foreign components should not exceed 10% of the total requested direct costs or $25,000 per year (per subcontract/subaward or in aggregate for multiple subcontracts/subawards), whichever is less.

Application Review Process

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For funding considerations, revision applications will be assigned to the ICs through which the parent grant was funded. To the extent possible, the locus of initial peer review will be that used for the evaluation of the parent application. That is, if an IC reviewed an application under one of its RFAs, the revision application will go back to the IC for the review. Applications that are complete will be evaluated for scientific and technical merit by appropriate scientific review group(s) in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below. Applicants will be notified regarding the review outcome.

As part of the scientific peer review, all applications will:

• 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/priority score;
• Receive a written critique; and
• Receive a second level of review by the appropriate national advisory council or board.

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 standard review criteria, and additional review criteria (as applicable for the project proposed).

When reviewing a Revision application, the committee will consider the scientific merit of the new work proposed and the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
Because different review criteria apply to different types of applications, the revision applications will be evaluated using the criteria appropriate for that type of application. For example, the standard review criteria for research grant applications and cooperative agreements are Significance, Investigator(s), Innovation, Approach, and Environment (NOT-0D-09-025)

Additional Review Criteria. As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items: Protections for Human Subjects; Inclusion of Women, Minorities, and Children; Vertebrate Animals; and Biohazards.

Additional Review Considerations. As applicable for the project proposed, reviewers will address 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: Budget and Period Support; Select Agent Research; and Resource Sharing Plans.

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 NIH eRA Commons.

Selection Process

Applications submitted in response to this funding opportunity will compete for available Recovery Act funds with all other recommended applications. 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.

Award Notices

While geographic variation will be considered in awarding Recovery Act funding, a proposal’s scientific merit will always be the prevailing criterion. If the application is considered for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General. To meet the various transparency, accountability, and reporting requirements of the Recovery Act, all applications under this notice that are selected for Recovery Act funding and that used a modular budget format at the time of submission will be required to submit a detailed budget as part of the Just-In-Time information.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

Terms of Award

The terms of the NoA will reference the requirements of the Recovery Act.

In addition to the standard NIH terms of award, all awards will be subject to the HHS Standard Terms and Conditions for Recovery Act awards. The full text of these terms approved for NIH awards can be found in the following document: Standard Terms and Conditions for AARA Awards.

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. See Section IV.5., Funding Restrictions.

The resource sharing plan will become part of the terms and conditions of the award.

A Program Official from one or more of the participating NIH Institutes and Centers will be assigned to each funded application and will assume responsibility for normal stewardship of the awards.

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.

In addition, recipients of Recovery Act funds are reminded that such funds must be separately tracked and monitored independently of any non-Recovery Act funding.

Reporting

If the revision application includes support for a future year, awardees will be required to submit a separate Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement. This will be in addition to any annual progress report required for the parent grant. The funded Recovery Act revision application will also require separate closeout reports.

In addition, grantees must comply with the requirements set forth in the Recovery Act, including, but not limited to, the reporting requirements described in Section 1512 of the Act, as well as applicable OMB guidance regarding the use of Recovery Act funds. As noted above, grantees must also comply with the HHS Standard Terms and Conditions for Recovery Act awards. The full text of these terms approved for NIH awards can be found in the following document: Standard Terms and Conditions for ARRA Awards.

Recovery Act-related reporting requirements will be incorporated as a special term of award.

How to Apply

The due date for revision applications is April 21, 2009.

Applicants interested in applying for Revision support under a program (activity code) that has already transitioned to electronic submission must submit the application through Grants.gov, using the Funding Opportunity Announcement (FOA) that was used for the parent grant. Or, if this FOA is no longer active, use the Parent FOA that matches the program (activity code) of the award.

• The activity code (e.g., R01, R03, R15, R21, R25, R33, R34, R21/R33, R41, R42, R43, R44, SC1, SC2, SC3) of the prior submission (referenced by the Federal Identifier on the SF 424 RR Cover page) must match the activity code of the FOA used for the revision. Revision applications for conference grants (R13s) are not permitted.
• For revisions to Program Project grants (P01), Center grants (e.g., P20, P30, P50), Cooperative Agreements (e.g., U01), Training Grants (e.g., T32) and Institutional Career Development Awards submitted in paper, an FOA is not required. This Notice should be mentioned in the cover letter.
• For all other eligible activity codes that have transitioned to electronic submission, use the following chart to identify the appropriate Parent FOA under which to submit through Grants.gov if the original FOA has expired:

For ALL applications:

Follow the instructions as noted below. Note: Font size restrictions apply as designated within the applicable SF424 (R&R) Application or the PHS398 application instructions, and page limitations noted in the original FOA under which the current grant was funded (or if using a Parent FOA because the original FOA expired) should be followed.

• Include a Cover Letter and cite the Notice Number (NOT-OD-09-058) in the first sentence.
• Explicitly cite the Notice Number (NOT-OD-09-058) and Notice Title: NIH Announces the Availability of Recovery Act Funds for Competitive Revision Applications in the Project Summary/Abstract Component of the application.
• Provide a one-page Introduction that describes the nature of the revision and how it will expand the scope of the specific aims, research design, and methods of the current grant. Use Item 2.1, Introduction to application, of the PHS 398 Research Plan component to provide this information.
• The body of the application should contain sufficient information from the original grant application to allow evaluation of the proposed revision in relation to the goals of the original application.
• Applicants must submit a budget using the same budget format as was used for the current award. That is, for electronic submissions, use the SF424 (R&R) PHS398 Modular Budget or Research & Related Budget, as appropriate, and for paper applications, use the PHS 398 detailed budget. Any budgetary changes for the remainder of the project period of the current grant must be discussed in the Budget Justification.
• If the revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the Scientific Review Group, then the applicant must respond to the criticisms in the prior Summary Statement, and substantial revisions must be clearly evident and summarized in the Introduction.
  
• Include the following additional information in the revision application:

a) Scope of the overall project and the anticipated contribution of the requested revision. Summarize the activities that were included in the parent grant that encompass those proposed in the revision request. This section should include a description of the revision’s specific aims, including research design and methods and data analysis. Describe the relationship of the revision request to the parent grant.

b) The research project plan should discuss how the revision will accelerate the tempo of scientific research and/or allow for job creation and retention. In order to ensure that all expenditures in support of a revision advance the objectives of the Recovery Act, all applications must address Recovery Act justifications, including how the revision is expected to stimulate the economy by:

1) enabling hiring of additional staff;
2) enabling increased hours of current part-time staff;
3) procuring additional needed equipment (costing under $100,000); and/or
4) contracting for additional needed skills.

c) Budget for the revision with a justification that details the items requested, including Facilities and Administrative costs and a justification for all personnel and their role in this project. The budget provided for the revision application must match the budget provided in the parent application. For instance, if the parent application was submitted using the Modular budget component, then the revision application must also use the Modular budget component.

d) Biographical Sketch for PD/PI and all new Senior/Key Personnel (those who are additions on the revision project). You will need to include an updated biographical Sketch for the PD/PI and new Senior/Key Personnel, using the forms, which are available as MS Word (http://grants.nih.gov/grants/funding/phs398/biosketch.doc) or PDF (http://grants.nih.gov/grants/funding/phs398/biosketch.pdf). There is no need to repeat information previously provided for other Senior/Key Personnel.

e) Human Subjects/ Vertebrate Animal documentation (if applicable). Include a current Human Subjects/IRB or Vertebrate Animals/IACUC approval letter, if available. Otherwise, this will be required at the time of funding. All appropriate IRB and IACUC approvals must be in place prior to a revision award being made. Any differences in the involvement or use of human subjects or specimens, or use of vertebrate animals, between the administrative revision activity and the parent grant should be noted. When appropriate, details should be provided on the protection of human subjects and inclusion of women, children, and minorities. Additional guidance on Human Subjects Research and Vertebrate Animals is provided under Part II of the PHS 398 instructions (http://grants1.nih.gov/grants/funding/phs398/phs398.html).

For electronic applications (R01, R03, R15, R21, R25, R33, R21/R33, R41, R42, R43, R44, SCs: Use the SF424 (R&R) Application Guide available at: http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Adobe_VerA.doc (MS Word [3.5 MB]) or http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Adobe_VerA.pdf (PDF [4.5 MB]).

For paper Program Project, Center, and Cooperative Agreement applications: Use the PHS 398 forms (rev. 11/2007; available at: (http://grants.nih.gov/grants/funding/phs398/phs398.html).

Note: Paper applications will not be accepted for activity codes that have transitioned to electronic submission.

Inquiries

Inquiries and discussion of plans for responding to this Notice are strongly encouraged.

For scientific or technical questions relating to research that would be supported by this solicitation, contact the Program Administrator assigned to the parent grant.

For administrative questions related to this solicitation, contact the Grants Management Specialist noted on the Notice of Award for the parent grant.

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NIH Funding Opportunities and Notices

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