Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov/)

Components of Participating Organizations
 National Institute on Deafness and Other Communication Disorders (NIDCD), (http://www.nidcd.nih.gov/)

Title:  NIDCD R21/R33 Phased Infrastructure Grant for Patient-Oriented Research

Announcement Type
New

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

Request For Applications (RFA) Number: RFA-DC-07-002

Catalog of Federal Domestic Assistance Number(s)
93.173

Key Dates   
Release Date: October 26, 2005
Letters of Intent Receipt Date(s): January 15, 2006
Application Receipt Dates(s): February 15, 2006
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Peer Review Date(s): June 2006
Council Review Date(s): September 2006
Earliest Anticipated Start Date: December 2006
Additional Information To Be Available Date (Url Activation Date): Not available
Expiration Date: February 16, 2006

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
  1. Research Objectives

Section II. Award Information
  1. Mechanism(s) of Support
  2. Funds Available

Section III. Eligibility Information
  1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
  2. Cost Sharing or Matching
  3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
  1. Address to Request Application Information
  2. Content and Form of Application Submission
  3. Submission Dates and Times
    A. Receipt and Review and Anticipated Start Dates
      1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
  4. Intergovernmental Review
  5. Funding Restrictions
  6. Other Submission Requirements

Section V. Application Review Information
  1. Criteria
  2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
  3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
  1. Award Notices
  2. Administrative and National Policy Requirements
  3. Reporting

Section VII. Agency Contact(s)
  1. Scientific/Research Contact(s)
  2. Peer Review Contact(s)
  3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives  

The goal of NIH-sponsored research is to improve human health. As part of its mission, the NIDCD supports patient-oriented biomedical and behavioral research in the communication sciences of hearing, balance, smell, taste, voice, speech and language. It is through well designed prevention, treatment and intervention studies, using new clinical tools, prostheses and assistive devices, behavioral therapies or interventions, and medications, that the benefits of the biomedical research enterprise will ultimately reach the individual with communication impairment.

The issues and challenges facing the clinical research enterprise have been delineated throughout the biomedical research literature. The NIH is seeking to address these issues on a national basis. One such effort is the NIH Roadmap initiative, including “Re-engineering the Clinical Research Enterprise”, noting that the current system of clinical research must be re-engineered if it is to respond to changing scientific and health care needs.  New and more efficient approaches to discovering, validating, and disseminating clinical research results are needed. 

The NIDCD held a workshop in March of 2005 focusing on research needs and opportunities in clinical research in the NIDCD mission areas of hearing, balance, smell, taste, voice, speech and language.  One frequently articulated need was improved community access to infrastructure expertise and support.  Other identified needs included a. increased research interaction and collaboration among all interested parties (e.g., industry, patient-advocacy organizations, and foundations), b. support for pilot or preliminary clinical research studies, c. the need for planning and development studies to support early stage activities for generating ideas and developing the design of a trial/study, and d. consideration of the merits and efficiencies of single vs. multi site clinical research.  This RFA is one of three NIDCD research initiatives created in response to the workshop discussion.  Two additional initiatives have also been published: NIDCD R24 Developmental Grant for Patient-Oriented Research (RFA-DC-07-001) and the NIDCD Patient-Oriented Research Grant (PA-06-040).

The purpose of this RFA is to encourage problem-driven innovative approaches to decrease infrastructure barriers to NIDCD patient-oriented research.  Applicants should seek to address and provide infrastructure needs across groups of investigators or across a region, with an emphasis on increased efficiency and access.  These activities should significantly enhance existing capabilities and introduce new approaches to NIDCD patient-oriented research. The new support should allow the participating institutions to develop and/or facilitate access to specialized resources and infrastructure support for patient-oriented research. 

An NIDCD R21/R33 Phased Infrastructure Grant for Patient-Oriented Research may bring together existing study groups in one common research area, or may provide advances to be utilized by investigators in varying mission areas.  This may involve the use of common consent forms, protocols, data management processes, and the pooling of resources and subjects across multiple sites moving research from a single-site to a multi-site approach.  Projects proposed should lead to new or better processes, tools, methodologies, or software that will increase infrastructure access and efficiencies in patient-oriented research in the NIDCD mission areas.  It is anticipated that with this RFA, early stage efforts, resources and processes will be initiated to address infrastructure obstacles in clinical research, and that, in concert with the NIH Roadmap initiatives, those wishing to engage in clinical research addressing communicative disorders will find it easier to do so.

Examples of infrastructure issues the R21/R33 may address include, but are not limited to:

This announcement applies only to research applications addressing issues in support of patient-oriented research.  For the purposes of this RFA, patient-oriented research is defined as research on the diagnosis, treatment and intervention of individuals with a communication disorder.  Applications in support of activities not related to patient-oriented research will not be accepted.

Questions about the suitability of applications should be addressed to the research/scientific (program) contact listed in the "Agency Contacts" section.  Investigators are strongly encouraged to contact program staff to ensure that their applications are responsive.  The developmental and/or piloting portion of the research occurs during the R21 portion of the application and implementation occurs within the R33 mechanism.  Transition from the R21 to the R33 is dependent on completion of milestones delineated in the application and subsequently negotiated with NIDCD staff (see Section IV.6).  At the end of a successful R21/R33, it is expected that there will be a measurable and documented improvement in infrastructure access and efficiency. The application should include the organizational structure and how investigators will access the support activities. 

For example, in the R21 portion of the application the PI may propose pilot work in which various patient databases (industry, laboratory, clinical research center) are explored for potential sharing possibilities.  Upon determination of the feasibility, the R33 would provide funds to assist in that endeavor.  A second example might be one in which investigators in a common area are brought together to determine the feasibility of a uniform and standard data collection nomenclature for a specific disease.  Upon determination of feasibility, the R33 would then provide funds to assist in that endeavor.  A third example might be for the IRBs for multicenter projects engaging in collaborative research to agree to unify the IRB process for ease of future multicenter research projects. Upon determination of feasibility and interest, the R33 would then provide funds to assist in the endeavor.  A final example may be one in which, acknowledging the rapid technological advances and decreasing costs associated with genotyping, the R21/R33 goal could be focused on efforts to initiate and create a standard nomenclature and database for communication disorder phenotypes.

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

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the R21/R33 award mechanism.  For the R21 phase of the application, direct costs are limited to a maximum of $125,000 per year for no more than three years. For the R33 phase of the application, direct costs are limited to a maximum of $400,000 per year for no more than four years.  The combined R21/R33 application is limited to a maximum of five years.  Applications may be submitted only as a combined R21/R33 application package. Applications for the R21 only or the R33 only will not be accepted.

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

2. Funds Available

NIDCD intends to commit approximately $500,000 in FY 2007 to fund two to three new grants in response to this RFA. An applicant may request a project period of up to five years for an R21/R33 application. The budget for direct costs in the R21 phase cannot exceed $125,000 per year.  The budget for direct costs in the R33 phase may not exceed $400,000 per year.  

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

Facilities and administrative costs requested by consortium or subcontract participants are not included in the direct cost limitations, see NOT-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

Foreign institutions are not eligible to apply. Foreign institutions may participate only as collaborating Institutions.  

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their 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.

2. Cost Sharing or Matching
 
Cost sharing is not required.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria

Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The combined R21/R33 mechanism allows for a timely transition between the exploratory phase and the development phase of a project.  Transition from the R21 to the R33 is dependent on the successful completion of milestones delineated in the application and subsequently negotiated with the NIDCD Program Director.

Prior to funding an application, the NIDCD Program Director will contact the applicant to discuss the proposed milestones and any changes suggested by the review panel as indicated in the Summary Statement. The Program Director and the applicant will negotiate and agree on a final set of milestones. These will be incorporated into the terms and conditions of the award and will be the basis for judging the success of the R21 work.  For funded applications, the Principal Investigator will submit a progress report to the NIDCD upon completion of the R21 milestones. Receipt of this progress report will trigger a programmatic review that will determine whether or not the R33 should be awarded. The release of R33 funds will be based on successful completion of negotiated scientific milestones, program priorities, and on the availability of funds. For funded applications, peer review is not anticipated between the two phases of the project, although NIDCD reserves the right to conduct an interim peer-review.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. 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

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

Foreign Organizations

Several special provisions apply to applications with foreign organizations as collaborating institutions:

Proposed research should provide a unique research opportunity not available in the U.S.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Letters of Intent Receipt Date(s): January 15, 2006
Application Receipt Dates(s): February 15, 2006
Peer Review Date(s): June 2006
Council Review Date(s): September 2006
Earliest Anticipated Start Date(s): December 2006

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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 determine responsiveness and estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Amy M. Donahue, Ph.D.
Division of Scientific Programs
NIDCD
6120 Executive Blvd, EPS Room 400C MSC 7180 
Bethesda, MD 20892-7180
Telephone: (301) 401-3458
FAX: (301) 402-6251
Email: donahuea@nidcd.nih.gov

3.B. Sending an Application to the NIH
 
Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
 
At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Melissa Stick, Ph.D., MPH
Division of Extramural Activities
NIDCD
6120 Executive Boulevard, Room 400C MSC-7180
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Bethesda, MD 20892-7180
Telephone: (301) 496-8683
FAX: (301) 402-6250
Email: stickm@nidcd.nih.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NIDCD. Incomplete and non-responsive applications will not be reviewed.

The NIH 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.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review
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. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
 
Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.
 
6. Other Submission Requirements

SPECIFIC INSTRUCTIONS FOR PREPARING A COMBINED R21/R33 PHASED INFRASTRUCTURE GRANT APPLICATION.  Applications not following these instructions will be returned as non-responsive.

The R21/R33 Phased Infrastructure Grant application must be submitted as a single application with one face page. Although it is submitted as a single application, it should be clearly organized into two phases. To accomplish a clear distinction between the two phases, applicants should submit Sections a-d (Specific Aims, Background and Significance, Preliminary Studies, Research Design) for the R21 phase, then the milestones, and then sections a and d (Specific Aims, Research Design) for the R33 phase. The Form 398 Table of Contents should be modified to show the sections for each phase as well as the milestones. There is a page limit of 25 pages for the composite research plan. Section a-d of the R21 research plan must not exceed 15 pages.  The milestones and the a. and d. sections for the R33 application can take, at most, an additional 10 pages. The clarity and completeness of the R21/R33 application with regard to the specific goals and feasibility milestones are critical.

The application must include the specific aims for each phase and the quantitative milestones that would justify transition to the R33 phase. Applications must include a specific section labeled Milestones following the Research Plan of the R21 phase. Milestones should be well described, quantifiable and scientifically justified. A discussion of the milestones relative to the progress of the R21 phase and the implications of successful completion of the milestones for the R33 phase should be included. The Milestones section should be indicated in the Table of Contents. Applications lacking this information, as determined by the NIDCD staff, will be returned to the applicant without review.

Prior to funding an application, the NIDCD Program Director will contact the applicant to discuss the proposed milestones and any changes suggested by the review panel as indicated in the Summary Statement. The Program Director and the applicant will negotiate and agree on a final set of milestones. These will be incorporated into the terms and conditions of the award and will be the basis for judging the success of the R21 work. For funded applications, the Principal Investigator will submit a progress report to the NIDCD upon completion of the R21 milestones. Receipt of this progress report will trigger a programmatic review that will determine whether or not the R33 should be awarded. The release of R33 funds will be based on successful completion of negotiated scientific milestones, program priorities, and on the availability of funds. For funded applications, peer review is not anticipated between the two phases of the project, although NIDCD reserves the right to conduct an interim peer-review.

Items 7 and 8: Costs Requested

For the R21 phase of the application, direct costs are limited to a maximum of $125,000 per year for no more than three years. For the R33 phase of the application, direct costs are limited to $400,000 for no more than four years.  The combined R21/R33 application is limited to five years in duration. Item 7a. should include direct costs (less any consortium F & A for the first year R21 only) and 8a. should include direct costs (less any consortium F & A) for all years R21/R33 combined.

2. On Page 2 in the Description:

As part of the description, concisely identify the problem, the manner in which it will be addressed with new processes, tools or technologies, its innovative nature, its relationship to presently available capabilities, and its expected impact on biomedical research.

3. On the Budget pages:

The application should provide a detailed budget for the Initial Budget Period (form page 4) for the first year of the R21 phase and a second detailed budget (form page 4) for the first year of the R33 phase. Form page 5 should be used to provide a budget for the entire proposed period of support. Form pages should indicate which years are R21 and which are R33. All budgets should include a written justification. The modular budget format should not be used.

4. In the Research Plan:

Item a: Specific Aims.

Specific aims must be presented which the applicant considers to be scientifically appropriate for the relevant phases of the project.  Clear statements of the specific aims should be made within this section.

Item b: Background and Significance

Elaborate on the innovative and/or developmental nature of the proposed research. Clarify how the activities proposed will result in a significant improvement over existing approaches. Explain the potential and the expected impact on infrastructure access and efficiency for NIDCD patient-oriented research.  Clearly identify how the project, if successful, will result in new capabilities, how implementation will occur, and how the proposed outcomes vary or differ from what currently exists.  This item should not be included in the R33 portion of the application.

Item c: Preliminary Studies

While preliminary data are not required for submission of the R21 phase, this section should provide current thinking or evidence in the field that substantiates the feasibility of the R21 phase and the expertise of the research team.  If the applicant does have preliminary data, it should be presented in this section. This item should not be included in the R33 portion of the application.

Item d: Research Design and Methods

Follow the instructions in the PHS 398 form. Applicants should also address plans to make the outcomes, processes, products, tools, or technologies forthcoming from this research available to the relevant NIDCD patient-oriented research community.

5. In the Milestones section:

A specific section labeled Milestones must be included immediately following the Research Design and Methods of the R21 phase. Milestones should be well described, quantifiable, and scientifically justified. Applicants should write the milestones assuming that a scientifically literate non-expert will use them to evaluate the progress that has been achieved. Milestones should not be simply a restatement of the specific aims or a timeline. The milestones section should be indicated in the Table of Contents. Applications lacking this information will be returned to the applicant without review.

When the R21 milestones have been achieved, the Principal Investigator must submit a progress report to NIDCD.  Receipt of this progress report will elicit a programmatic review to determine whether or not the R33 should be awarded. The release of R33 funds will be based on successful completion of milestones, program priorities, and on the availability of funds. For funded applications, peer review is not anticipated between the two phases of the project, although NIDCD reserves the right to conduct an interim peer-review.

Plan for Sharing Research Data

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 their own auspices by mailing a disk or posting data on their institutional or personal website, 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.
 
All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria 

The following will be considered in making funding decisions:

2. Review and Selection Process

Applications submitted for this RFA will be reviewed for completeness by the CSR and for responsiveness by the NIDCD.  Incomplete and/or non-responsive applications will not be reviewed. 


Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIDCD in accordance with the review criteria stated below.

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

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. 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 the pursuit of these goals. 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 high 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: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the application address an important infrastructure problem, barrier or issue in patient-oriented research? Will these activities significantly enhance access and efficiency to existing capabilities or bring new capabilities beyond currently available resources for patient-oriented research?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?  Will the approach provide participating institutions better infrastructure support? Will the approach allow for the potential for resource sharing beyond the local institutions? Is the administrative structure of the application appropriate? Are the milestones feasible, well developed and quantifiable with regard to specific goals and accomplishments?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?   

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? Have appropriate partnerships been made and are the participating institutions and collaborators appropriate?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?  

2.A. Additional Review Criteria:
 
In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

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 (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data
 
Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources
 
NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible. Scientific reviewers will be asked to comment upon the reasonableness of the sharing research resources plan. 

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates
Not applicable 

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. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

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 (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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 Also Section IV.5. Funding Restrictions.

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 (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

3. Reporting

When the R21 milestones have been achieved, the Principal Investigator must submit a progress report. Receipt of this progress report will elicit a programmatic review to determine whether or not the R33 should be awarded. The release of R33 funds will be based on successful completion of milestones, program priorities, and on the availability of funds.

 Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts

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, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:
 
Amy Donahue, Ph.D.
Division of Scientific Programs
NIDCD
6120 Executive Blvd, EPS 400C MSC-7180
Bethesda, MD 20892-7180
Telephone: (301) 402-3458
FAX: (301) 402-6251
Email: donahuea@nidcd.nih.gov  

2. Peer Review Contacts:

Melissa Stick, Ph.D., MPH
Division of Extramural Activities
NIDCD
6120 Executive Boulevard, ESP 400C MSC-7180
Bethesda, MD 20892-7180
Telephone: (301) 496-8683
FAX: (301) 402-6250
Email: stickm@nidcd.nih.gov

3. Financial or Grants Management Contacts:

Christopher Myers
Division of Extramural Activities
NIDCD
6120 Executive Blvd., EPS 400B MSC-7180 
Bethesda, MD 20892-7180
Telephone: (301) 435 0713
FAX: 301 402 1759
Email: Myersc@mail.nih.gov

Section VIII. Other Information

Required Federal Citations

Human Subjects Protection:
Federal regulations (45CFR46) 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 NIH 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 IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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:
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 new PHS Form 398; 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:
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).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://www.nih.gov/about/publicaccess/ and view the Policy or other Resources and Tools including the Authors' Manual (http://www.nih.gov/about/publicaccess/publicaccess_Manual.htm).

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) 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 DHHS 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.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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 PA 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 or Health Systems Agency review. 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 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 NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.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.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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