Part I Overview Information


Department of Health and Human Services

Participating Organizations
Not applicable

Components of Participating Organizations
Not applicable


Title: ARRA OS: Recovery Act 2009: Accelerating Adoption of Comparative Effectiveness Research Results by Providers and Patients (R18)

Note: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.

Announcement Type

New

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

Request for Applications (RFA) Number: RFA-AE-10-001

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.726

Key Dates
Release/Posted Date: January 8, 2010
Opening Date: February 11, 2010 (Earliest date an application may be submitted to Grants.gov)
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Letters of Intent Receipt Date(s): Not Applicable
Application Due Date(s): March 11, 2010
Peer Review Date(s): June/July 2010
Earliest Anticipated Start Date(s): August 31, 2010
Additional Information To Be Available Date (Activation Date): Not Applicable.
Expiration Date: March 12, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of 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 - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

This FOA invites grant applications from organizations that propose to develop and test strategies to improve the adoption of existing CER information and incorporate these findings into practice in both the public and private sector. Doing so effectively would demonstrate a return on the CER investment, and, more importantly, improve the health of the patients served by a given organization. Funds will be used to support organizations that 1) develop and test evidence-informed and innovative CER-based adoption interventions targeting patients and/or providers; 2) develop proposals that test the implementation of CER-based adoption strategies within and across organizations and delivery systems and analyze any behavior change (in patients and/or providers) associated with the intervention. CER-based entails the applicant describing and justifying the existing comparative evidence that is the focus of the adoption intervention. Organizations applying for these funds will need to utilize existing or create new measurement systems to track adoption or adherence rates (thus measuring behavior changes) associated with the adoption of CER and measurement of health outcomes if possible. Applicants should also seek to understand the underlying factors associated with adoption if possible.

Activities for this funding opportunity may include the following:

Evaluation Requirement: Applicants must develop a plan to evaluate the program/intervention aimed at increasing adoption. This plan should include evaluation metrics and a new or existing mechanism to track and measure adoption or adherence rates to CER evidence (i.e. behavior change). This evaluation activity is necessary for an applicant to be considered for funding.

For all activities above, partnerships and collaborations among organizations, networks, providers, and/or patient groups are strongly encouraged.

Reporting requirement: Submit reports to ASPE for dissemination to the Interagency Task Force for Accelerating Adoption of CER quarterly on the progress of the program. This senior interagency task force is focused on increasing adoption of CER to improve the health outcomes of all Americans. These reports should include a summary of the program’s activities, tracking and measurement system, and any results from the evaluation component of the program.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

CER Definition

The comparative effectiveness research that is the focus of accelerating adoption in this FOA must adhere to the Federal Coordinating Council definition of CER. The definition is as follows:

Comparative effectiveness research is the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat and monitor health conditions in “real world” settings. The purpose of this research is to improve health outcomes by developing and disseminating evidence-based information to patients, clinicians, and other decision-makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances.

Priority-Setting Process and Inputs for Use of ARRA OS Funds

There were four main inputs for priorities for ARRA OS comparative effectiveness research funds: public input, an internal Departmental workgroup, the FCC report, and the Institute of Medicine (IOM) report. The FCC identified the following as minimum threshold criteria which must be met to be considered for funding:

1) Included within statutory limits of ARRA and the Council’s definition of comparative effectiveness research

2) Potential to inform decision-making by patients, clinicians or other stakeholders

3) Responsiveness to expressed needs of patients, clinicians or other stakeholders

4) Feasibility of research topic (including time necessary for research)

The Comparative Effectiveness Research-Coordination and Implementation Team (CER-CIT) will require the use of the FCC’s prioritization criteria for scientifically meritorious research and investments for all projects funded with OS ARRA funds. These criteria are:

1) Potential impact (based on prevalence of condition, burden of disease, variability in outcomes, costs, potential for increased patient benefit or decreased harm)

2) Potential to evaluate comparative effectiveness in diverse populations and patient sub-groups and engage communities in research

3) Addresses existing uncertainty within the clinical and public health communities regarding management decisions and variability in practice

4) Addresses a need or is unlikely to be addressed through other organizations

5) Potential for multiplicative effect

Finally, investments funded from this appropriation must address at least one of the following topic areas:

1) One of the 100 IOM recommendations

2) An issue within one the MMA 14 Priority Conditions identified by AHRQ (pursuant to Section 1013 of the Medicare Prescription Drug Improvement and Modernization Act of 2003) which are not currently addressed; and/or

3) Fall into one of the AHRQ identified evidence gaps.

A current list of priority conditions includes:

Section II. Award Information


1. Mechanism of Support

This FOA will use the R18 award mechanism. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses “Just-in-Time” information concepts (see SF424 (R&R) Application Guide).

Research & Related Budget required for all applications; No modular budgets will be accepted.

2. Funds Available

This initiative is supported by funds provided to ASPE under the American Recovery & Reinvestment Act of 2009 (“Recovery Act” or “ARRA”), Public Law 111-5. ASPE has designated $300,000 to $3,000,000 in FY 2010 to fund 5-10 grants, contingent upon the submission of a sufficient number of scientifically meritorious applications. Total expected funding is approximately $14,000,000.

Budget proposals are limited to $1,000,000 in total costs per year for a total of $3,000,000 in costs over 3 years. Facilities and administrative (F&A) costs requested by applicants are included in the total cost limitation. Applications with project periods that exceed 3 years or budgets that exceed $1,000,000 total costs per year will not be reviewed.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award will also vary. Although ASPE plans to provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

The total award under this FOA for each awardee will not exceed $1,000,000 annually for the entire project period. Funding beyond the first year will be contingent upon a review by ASPE staff of the non-competing continuation report.

Funding for this program is provided under the American Recovery and Reinvestment Act of 2009 (Recovery Act). The purposes of the Recovery Act are to preserve and create jobs and promote economic recovery in the United States, and to provide investments needed to increase economic efficiency by spurring technological advances in science and health. Consistent with these goals, eligible domestic (United States) institutions/organizations who are planning to submit applications that include foreign components should be aware that requested funding for any foreign component should not exceed 10% of the total requested costs or $25,000 (aggregate total for a subcontract or multiple subcontracts), whichever is less.

HHS grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply. Consistent with the purposes of the Recovery Act (in particular, to preserve and create jobs and promote economic recovery in the United States, and to provide investments needed to increase economic efficiency by spurring technological advances in science and health), applicants must be a domestic (United States) institution/organization listed below. The United States institution/organization must be located in the 50 states, territories and possessions of the U.S., Commonwealth of Puerto Rico, Trust Territory of the Pacific Islands, or District of Columbia. Foreign organizations/institutions are not permitted as the applicant organization.

You may submit an application(s) if your institution/organization has any of the following characteristics:

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI 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 ASPE support.

2. Cost Sharing or Matching

Consistent with ARRA, there are no cost sharing or matching requirements.

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct.

Resubmissions. Resubmission applications are not permitted in response to this FOA.

Renewals. Renewal applications are not permitted in response to this FOA.

Section IV. Application and Submission Information


To download a current SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the “Apply for Grant Electronically” button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered “on-time” (see 3.C.1 for more information about on-time submission).

A one-time registration is required for institutions/organizations at both:

PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.

Several additional separate actions are required before an applicant can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Registered

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Both the PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo -- Telephone 301-435-0714; Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY: (301) 451-5936

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by ASPE (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
Research & Related Budget, as appropriate (See Section IV.6., “Special Instructions,” regarding appropriate required budget component.)

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

SPECIAL INSTRUCTIONS

Applications Involving a Single Institution

When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: February 11, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not Applicable
Application Due Date(s): March 11, 2010
Peer Review Date(s): June/July 2010
Earliest Anticipated Start Date(s): August 31, 2010
Additional Information To Be Available Date (Activation Date): Not Applicable.
Expiration Date: March 12, 2010

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

3.B. Submitting an Application Electronically to ASPE

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow Steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

3.C. Application Processing

3.C.1 Submitting On-Time

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application will not be reviewed.

All applications must meet the following criteria to be considered “on-time”:

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step – applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Once an application package has been successfully submitted through Grants.gov, ASPE provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.

Please note that the following caveats apply:

3.C.3 Viewing an Application in the eRA Commons

Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday – Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.

Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the IC. Incomplete and/or non-responsive applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commonshttps://commons.era.nih.gov/commons/. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

ASPE will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an “Introduction” describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review .

5. Funding Restrictions

All ASPE awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement (http://www.hhs.gov/grantsnet/adminis/gpd/index.htm)

6. Other Submission Requirements

Project Summary/Abstract

Applicants shall include a one-page abstract (no more than 500 words) of the application (designated the Project Summary/Abstract attachment in the SF 424 (R&R) application). This abstract is often distributed to provide information to the public and Congress and represents a high-level summary of the project. Applicants should prepare a clear, accurate, concise abstract that can be understood without reference to other parts of the application and which gives a description of the proposed project, including: the project’s goal(s), objectives, overall approach (including target population and significant partnerships), anticipated outcomes, products, and duration.

The Project Abstract must be double-spaced with a font size of not less than 11 point.

The applicant shall place the following information at the top of the Project Abstract (this information is not included in the 500 word maximum):

The Project Abstract must include a brief description of the proposed grant and how the activities support and will enhance the acceleration and adoption of comparative effectiveness research results by providers and patients.

PD/PI Credential (e.g., Agency Login)

ASPE requires the PD(s)/PI(s) to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

PHS398 Research Strategy Component Sections

Item Number and Title

Instructions

1. Introduction to Application

Omit (N/A: Resubmissions and Revisions not allowable)

2. Specific Aims

One page maximum. Separate PDF attachment

3. Research Strategy

Limited to 12 pages. Attach the 12- page Research Strategy as a single PDF document. Figures and illustrations may be included but must fit within the 12-page limit. Do not include links to Web sites for further information. Do not include animations.

Excluded from the 12-page Research Strategy limitation are the following items:

Note the 12-page limit also excludes the Project Summary/Abstract; Bibliography and Literature Cited; and Biographical Sketches (separate PDFs).

Special Instructions for Other Project Information (Section 4.4 of SF424 (R&R) Application)

Item 9. Bibliography and Literature Cited: Limited to one page. Each reference must include names of all authors (in the same sequence in which they appear in the publication), the article and journal title, book title, volume number, page numbers, and year of publication. When citing articles that fall under the Public Access Policy, provide the NIH Manuscript Submission reference number or the PubMed Central (PMC) reference number for each article. If the PMCID is not yet available, indicate "PMC Journal - In Process."

Continue with the instructions in the SF424 (R&R) Application Guide.

Special Instructions for Senior/Key Person Profile (Expanded) Component (Section 4.5 of SF424 (R&R) Application)

Biographical Sketches: Each biographical sketch is limited to two pages. The number of publications cited in each biosketch is limited to ten or fewer items. Individuals should cite their most relevant publications and those that highlight the significance of past accomplishments.

Appendix Materials

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

Do not use the Appendix to circumvent the page limitations. An application that does not comply with the required page limitations may be delayed in the review process.

No supplemental/update information will be accepted.

Resource Sharing Plan(s)

ASPE considers the sharing of unique research resources developed through ASPE-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with ASPE funds and the associated research findings published or provided to ASPE, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.)

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing; the format of the final dataset; the documentation to be provided; whether or not any analytic tools also will be provided; whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use); and the mode of data sharing (e.g., under its own auspices by mailing a disk or posting data on its institutional or personal website or through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Review Process

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 the Center for Scientific Review in accordance with standard NIH peer review procedures that are described in http://grants1.nih.gov/grants/peer/. Incomplete and/or non-responsive applications or applications not following instructions given in this FOA will not be reviewed.

As part of the initial merit review, all applications will:

In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on achieving the goals stated in the FOA. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: The degree to which the application addresses the goals outlined in the Executive Summary and Research objectives. The potential impact, feasibility, and potential to address priority populations as outlined in Federal Coordinating Council report will also be considered.

Approach: The methodology and outcome metrics of the proposal

Innovation: Degree to which the proposed methodology is novel in its design and makes use of available resources

Investigators: Qualification, experience and expertise of the PI and sub-investigators in conducting research of this nature and on this topic.

Environment: Size of the organization, and ability to implement a project of broad scope. Resources available to the organization are also considered.

Additional Review Criteria

In addition to the above criteria, the following items will be considered in the determination of scientific merit and the impact/priority score:

Inclusion: Adequacy of plans to address the needs of both genders, racial and ethnic minorities (and subgroups).

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed.

Privacy and Security Protections for Patients: The resources and processes to be used to address privacy and security issues in the development and implementation of the intervention will be assessed.

Evaluation Plan: The description and methods to measure the effects of the intervention (e.g. increase in the adoption of CER evidence, provider or patient behavior change)

In addition, the review criteria listed in the “Priority-Setting Process and Inputs for Use of ARRA OS Funds” section will also be used.

This ASPE grant provides support for projects designed to develop, test, and evaluate health service activities, and to foster the application of existing knowledge, in order to improve the quality, safety, efficiency, and effectiveness of health care for all Americans.

Appeals will not be permitted.

Additional Review Considerations

Budget: Specific allocation of funds and the feasibility of the use of funds in the timeline proposed.

Collaboration: Degree to which collaboration within and across the delivery system is utilized. Degree to which the proposal includes collaboration between organizations and groups (e.g. researchers, providers, healthcare organizations, etc.).

Justification of Evidence to be implemented: Adequacy of justification for choice of comparative evidence to be implemented and likelihood such implementation will be beneficial (e.g. the level/type of evidence supporting the CER findings that are the focus of the increasing adoption proposal). Please note the evidence must meet the FCC definition of CER.

Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plan, or the rationale for not sharing the following types of resources, are reasonable: Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm)

Selection Process

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

Generally, applicants should anticipate at least 6 months between the application submission date and the earliest possible start date.

Section VI. Award Administration Information


1. Award Notices

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.

If the application is under consideration 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.

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.

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

In addition to the standard Agency terms of award, all funding provided under the Recovery Act will be subject to the HHS Standard Terms and Conditions for American Recovery and Reinvestment Act of 2009 (ARRA).

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.”

2. Administrative and National Policy Requirements

All ASPE grant and cooperative agreement awards are subject to ASPE’s grants regulations at 42 CFR Part 67, Subpart A, and are subject to the requirements of the HHS Grants Policy Statement that are applicable based on the recipient type and the purpose of this award (see (http://www.hhs.gov/grantsnet/adminis/gpd/index.htm).

As necessary, Terms and Conditions will be incorporated into the award statement.

Activities conducted under this award that involve the collection of information e.g., conducting surveys or requesting responses to uniform questions from nine or more persons, establishments or other entities, are currently required by HHS to be cleared by OMB under the Paperwork Reduction Act (PRA) (44 USC 3501-3521). Submissions for clearance under PRA are through ASPE and HHS. Therefore, affected grantees should include the time in their proposed timelines to develop materials and receive necessary clearances. It typically takes at least six months from date of initial submission to ASPE to receive clearances ,and sometimes much longer if submissions are incomplete or the justification for the proposed data collection plans are questioned during the clearance process. Information collection that requires PRA clearance may not begin until grantees receive written notification via e-mail from ASPE that clearance has been obtained. Detailed information on the PRA can be found at http://www.hhs.gov/ocio/policy/collection/.

3. Reporting

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

The annual progress reports must include Sections a through f as described in the general PHS form 2590 instructions, as well as sections g through j as described in Section IV of the 2590 instructions. For details regarding progress report submission, refer to http://www.ahrq.gov/fund/noncomp.htm.

The Progress Report is to include descriptive and evaluative comments on both completed activities and plans for the remainder of that year, including any changes foreseen in the future. At a minimum, the reports will include descriptive comments on: progress to date measured against project aims; methodological changes implemented; key preliminary findings; significant problems and resolutions; inclusion of priority populations; and project related publications, presentations, and dissemination activities. ASPE will provide the timetable for these progress reports.

Financial Status Reports (FSRs; SF 269) are required annually by ASPE for ALL grant programs as described in the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm). This report must be submitted for each budget period no later than 90 days after the close of the budget period. A hard copy of the report should be submitted to the assigned grants management specialist.

Until such time as HHS has migrated to the SF 425 FFR, award recipients will use the SF 269 FSR.

In addition to the standard ASPE terms of award, all funding provided under the Recovery Act will be subject to the HHS Standard Terms and Conditions for American Recovery and Reinvestment Act of 2009 (ARRA). The full text of these terms approved for ASPE 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.

A final Progress Report and Financial Status Report are required when an award ends. For further details regarding grant closeout requirements, refer to http://www.ahrq.gov/fund/closeout.htm.

Section 1512 of the Recovery Act requires prime recipients of the ARRA funds to submit quarterly reports, due no later than 10 calendar days after each calendar quarter in which the recipient receives the award (January 10, April 10, July 10, and October 10). Accordingly, in addition to the standard ASPE terms of award, all funding provided under the Recovery Act must comply with the statutory reporting requirements and will be subject to the HHS Standard Terms and Conditions for American Recovery and Reinvestment Act of 2009 (ARRA) as described above and found on the HHS Website at http://www.hhs.gov/recovery/grantscontracts/recoverytermsconditions.html

Section VII. Agency Contacts


This funding announcement is subject to restrictions on oral conversations during the period of time commencing with the submission of a formal application by an individual or entity and ending with the award of the competitive funds. Federal officials may not participate in oral communications initiated by any person or entity concerning a pending application for a Recovery Act competitive grant or other competitive form of Federal financial assistance, whether or not the initiating party is a federally registered lobbyist. This restriction applies unless:

(i) the communication is purely logistical;

(ii) the communication is made at a widely attended gathering;

(iii) the communication is to or from a Federal agency official and another Federal Government employee;

(iv) the communication is to or from a Federal agency official and an elected chief executive of a state, local or tribal government, or to or from a Federal agency

official and the Presiding Officer or Majority Leader in each chamber of a state legislature; or

(v) the communication is initiated by the Federal agency official.

[1] Formal application includes the preliminary application and letter of intent phases of the program.

For additional information see http://www.whitehouse.gov/omb/assets/memoranda_fy2009/m09-24.pdf

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research (program), peer review, and financial or grants management issues:

1. Scientific/Research Contact(s):

Patrick Conway, MD, MSc.
Office of the Assistant Secretary for Planning and Evaluation
Office of the Secretary
Department of Health and Human Services
Room 415F
200 Independence Avenue, SW
Washington, DC 20201
Phone: 202-690-7858
Fax: 202-690-7383
Email: Patrick.conway@hhs.gov

2. Peer Review Contact(s):

Estina Thompson, Ph.D., MPH
Center for Scientific Review
Room 3178, MSC 7848
6701 Rockledge Drive
Bethesda, MD 20892-7848
Phone: 301-496-5749
Fax: 301-435-0014
Email: thompsone@csr.nih.gov

3. Financial/Grants Management Contact(s):

Cheryl Wall
Grants Management Specialist (Contractor)
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases, NIH
6700B Rockledge Drive
Room 2221R, MSC 7614
Bethesda, MD 20892-7614
(Express Mail: Bethesda, MD 20817)
Phone: 301-451-3167
Fax: 301-493-0597
Email: wallcy@niaid.nih.gov

Section VIII. Other Information


Required Federal Citations

The American Recovery and Reinvestment Act of 2009 (Pub. L. No. 111-5): http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h1enr.pdf.

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: http://grants.nih.gov/grants/policy/NIH_HHS_ARRA_Award_Terms.pdf.

Human Subjects Protection:
Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Sharing Research Data:
Investigators submitting an ASPE application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions, on issues related to institutional policies and local institutional review board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are: (1) first produced in a project that is supported in whole or in part with Federal funds; and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Inclusion of Women And Minorities in Clinical Research:
This FOA adheres to the NIH policy on women and minorities in clinical research. It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
This FOA adheres to the NIH policy on children as participants in clinical research. The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the HHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. 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. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The HHS Grants Policy Statement can be found at http://www.hhs.gov/grantsnet/adminis/gpd/index.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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