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 of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov/)
National Institute of Biomedical Imaging and Bioengineering (NIBIB), (http://www.nibib.nih.gov)

Title: Extramural Associates Research Development Award (EARDA)

Announcement Type:
This PA is a modification of RFA-HD-04-007 and RFA-HD-04-008, which were released on April 28, 2004. This program will solicit applications using a Program Announcement in place of annually issued Requests for Applications.

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

Program Announcement (PA) Number: PAR-05-053

Catalog of Federal Domestic Assistance Number(s)
93.865, 93.286

Key Dates
Release Date: February 14, 2005
Letters of Intent Receipt Date(s): March 21, 2005; February 21, 2006; February 21, 2007
Application Receipt Dates(s): April 21, 2005; March 21, 2006; March 21, 2007
Peer Review Date(s): July/August 2005, 2006, 2007
Council Review Date(s): September 2005, 2006, 2007
Earliest Anticipated Start Date: January 1, 2006; January 1, 2007; January 1, 2008
Additional Information To Be Available Date (URL Activation Date): April 1, 2005
Expiration Date: March 22, 2007

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

The Extramural Associates (EA) Program, National Institute of Child Health and Human Development (NICHD), NIH, announces an initiative directed at scientific faculty and academic science administrators of women's colleges and institutions with significant underrepresented minority (i.e., Black, Asian/Pacific Islander, Hispanic or Native American) student populations. This PAR is intended for all EA-eligible institutions, i.e., women's colleges and minority-serving institutions that award the Ph.D., Master's, Baccalaureate, or professional degrees, and selected community colleges that have established collaborative research activities or bridge programs with institutions that award at least a baccalaureate science degree. The goal of this initiative is to increase the participation of these institutions in biomedical and behavioral research and research training through an integrated 10-week residency (for first-time applicants) and an institutional grant support program. This program utilizes the NIH Extramural Associates Research Development Award (EARDA) mechanism (G11), and is available for first-time applicants and for applicants seeking continued EARDA support (competing continuation applications).

An institution may submit only one application in response to this solicitation. Eligible women's colleges and underrepresented minority institutions that have never had a faculty member participate in the EA Program are strongly encouraged to apply. Full-time science faculty, i.e., faculty who have earned degrees in the life sciences (biomedical and or behavioral sciences) or in the physical sciences (chemistry, computer science, mathematics, engineering or physics) are eligible to become Principal Investigators. Academic science administrators, or mid-level and senior-level faculty, are also eligible provided they have the flexibility to carry out the expectations outlined in this solicitation. The Principal Investigator will serve as the Extramural Associate (EA) for the program. First-time applicants must be available to participate in the 10-week NIH residency training in preparation for receiving the EARDA grant. An institution may receive EARDA support for no longer than eight years.

Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 9/2004). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at: http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

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
      A. Cooperative Agreement Terms and Conditions of Award
        1. Principal Investigator Rights and Responsibilities
        2. NIH Responsibilities
        3. Collaborative Responsibilities
        4. Arbitration Process
    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

Background

The EA Program was established at the NIH in 1978 to promote the entry and participation of women and underrepresented minority institutions in biomedical and behavioral research. Overall, the program accomplishes this mission by providing Extramural Associates (EAs) from women's colleges and underrepresented minority institutions with the opportunity to come to the NIH to gain the necessary understanding of the processes utilized by the NIH, as well as other Federal agencies, to provide funding to support biomedical and behavioral research and research training. The10-week summer residency program is for all EA Program-eligible institutions with an individual wishing to become a change agent for facilitating increased faculty participation in biomedical and behavioral research, and to support training opportunities for undergraduate and graduate students leading to careers in biomedical or behavioral research. A successful applicant institution receives an Extramural Associates Research Development Award (EARDA) and the individual from the awardee institution who participates in the EA Residency Program is known as the Extramural Associate (EA).

Program Objectives

The specific objectives of the EARDA grant program are to: (1) enhance faculty opportunities to conduct biomedical and behavioral research and engage in research training; (2) increase the EA's knowledge of the NIH and related agencies' research and research training funding opportunities; (3) develop skills in the fundamentals of preparing research grant applications, research contract proposals, training grant and fellowship applications; (4) aid EA-eligible institutions, including a selected group of community colleges, in developing collaborative and consortium arrangements with other academic institutions for the purpose of promoting biomedical and behavioral research; (5) assist EAs in increasing student participation in research; and (6) assist EAs in effectively guiding students toward careers in science and research. A major focus addresses strategies and processes for attracting women and underrepresented minority students into research experiences that will lead to biomedical and behavioral research careers. It is anticipated that the individuals participating in the program will become the institutional focal point in promoting biomedical and behavioral research and research training activities among students and faculty at their institutions. It is also expected that the trained EA will establish an Office of Research Development (ORD) that will work cooperatively with an existing Sponsored Research Office or, in the absence of a Sponsored Research Office, work independently.

Scope

The overall goal of the EA Program is to increase the participation of these institutions in biomedical and behavioral research and research training. The objective of the Extramural Associates Research Development Award (EARDA) is to further enhance the research capacity of EARDA-eligible institutions by providing support for the continuation of research activities and training in the biomedical and behavioral sciences.

Activities supported under this solicitation include, but are not limited to:

A major focus of the program is the development of strategies and processes for attracting women and underrepresented minorities pursuing the Baccalaureate, Masters, Ph.D., and professional degrees into research experiences that will lead to biomedical and behavioral research careers.

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 NIH Extramural Associates Research Development Award (G11) grant mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The anticipated award date is after completion of the NIH residency training for first-time applicants and January 1, 2006, 2007 or 2008 for applicants applying for continued support.

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

A first-time applicant may request a project period of up to five years and a budget for direct costs of up to $60,000 plus facilities and administrative (F & A) costs for the first 12-month period for training and for the establishment of an Office of Research Development. In Years 02 through 05, a budget for direct costs of up to $60,000 (plus F & A costs) may be requested for the administration of an Office of Research Development. In addition, up to $40,000 in direct costs (plus F & A costs) may be requested for faculty pilot research projects. Applicants applying for continuing support may request a project period of up to five years and a budget for direct costs of up to $60,000 per year (plus F & A costs) for the administration of an Office of Research Development and up to $40,000 in direct costs (plus F & A costs) for faculty pilot research projects. An institution may receive EARDA support for a total of no more than eight years; the number of years of continuation support requested will be governed by the length of the grant already awarded. Pilot research funds may not exceed $40,000 and the awarding of these funds is contingent upon the administrative review of proposed pilot projects by NICHD Staff. Included in each pilot award are provisions for one trip to a scientific meeting or symposium for the PI and for student participation. However, in both of these instances the amounts budgeted should be minimal.

Facilities and Administrative (F&A) costs for these awards are limited to eight percent of total direct costs.

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 the IC(s) 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 participants are not included in the direct cost limitation; see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html.

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:

An institution may submit only one application in response to this solicitation. Eligible women's colleges and underrepresented minority institutions that have never had a faculty member participate in the EA Program are strongly encouraged to apply. Institutions that have received a Research Centers in Minority Institutions (RCMI) award, if successful in applying for this award, may have their budget requests reduced if there is significant overlap in funding infrastructure components.

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.

The Principal Investigator will serve as the Extramural Associate (EA) for the program. Full-time science faculty, i.e., faculty who have earned degrees in the life sciences (biomedical and or behavioral sciences) or in the physical sciences (chemistry, computer science, mathematics, engineering or physics) are eligible to become Principal Investigators. Academic science administrators, or mid-level and senior-level faculty, are preferable provided they have the flexibility to carry out the expectations outlined in this solicitation. First-time applicants must also be available to participate in the 10-week NIH residency training in preparation for receiving the EARDA grant.

2. Cost Sharing or Matching

Cost sharing is not required for this program.

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
Not applicable

Section IV. Application 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. 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 PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (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.

3. Submission Dates and Times
Applications must be mailed 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): March 21, 2005; February 21, 2006; February 21, 2007
Application Receipt Dates(s): April 21, 2005; March 21, 2006; March 21, 2007
Peer Review Date(s): July/August 2005, 2006, 2007
Council Review Date(s): September 2005, 2006, 2007
Earliest Anticipated Start Date: January 1, 2006; January 1, 2007; January 1, 2008
Additional Information To Be Available Date (URL Activation Date): April 1, 2005
Expiration Date: March 22, 2007

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 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:

Matthew A. Kinnard, Ph.D.
Director, Extramural Associates Program
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E03, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 435-2736
FAX: (301) 480-0393
Email: kinnardm@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. 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)

Send two signed photocopies in one package to:

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)

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 CSR and responsiveness by the NICHD and NIBIB.

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. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

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 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 (see also Section VI.3. Reporting).

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

Allowable Costs

Funding for the program may be used to support the activities of the EA upon completing the NIH residency and training requirements. These activities include equipping an Office of Sponsored Programs, support of small pilot research studies, student/teacher seminars, and workshops to enhance research interest and to establish consortium research arrangements. Funds may also be used for other purposes including, but not limited to, the following:

For first–time applicants, travel costs during the week-long orientation for the EA, university president, and business officer may be covered under this award. Salary support for the EA during the 10-week residency program will be provided through an Intergovernmental Personnel Act (IPA) mechanism described below, not through or from the EARDA grant itself. Therefore, salary should be requested for only 42 weeks in the first 12-month budget period of the EARDA. The costs for supporting the residency program are entirely separate from the EARDA award. Selected EAs will come to the NIH for the assignment under the IPA. The IPA enables temporary appointments to the Federal government for employees of academic institutions. The IPA provides partial support for the EA while he/she is at NIH. Under the IPA arrangement, up to 67 percent of the cost of the EA's salary while at the NIH is reimbursed. Similarly, per diem (food and lodging) costs are reimbursed at 75 percent by NIH and the institution contributes 25 percent. The cost of relocating the EA from the home institution and any other cost incurred that is related to the residency program are reimbursed at 100 percent.

The Principal Investigator's time and effort may range from 25 to 50 percent, depending on the level of complexity of EARDA activities.

Although institutions with an existing or similar Office of Research Development or with funding through programs such as the RCMI may apply, adjustments in the final funding level for budgetary overlap may be made prior to the award.

Special Requirements for First-Time Applicants

(1) Institutional Commitment:

Institutions may nominate only one Principal Investigator for participation in the program. In nominating the EA candidate, the sponsoring institution is expected to commit adequate resources to formulate and implement an Institutional Plan that will build upon the EA's residency training experience including:

(2) The Extramural Associate (EA)/Principal Investigator:

First-time applicants for the EARDA award must nominate an EA who is a full-time scientific faculty or academic science administrator at the applicant institution. If approved and invited to participate, the EAs will be required to spend 10 weeks during the first summer of the grant at the NIH in residency training. The cost of the residency training (salary and per diem) is supported by a cost-sharing IPA agreement, which is totally separate and apart from the EARDA grant. The program has the flexibility necessary to allow each EA to participate in activities that are consistent with the institution's concerns, capabilities and interests in health-related research. Upon entering the program, EAs are assigned a preceptor and participate in the EA Program curriculum. The EA's preceptor, a senior NIH or Public Health Service (PHS) official, is available for guidance with respect to working assignments and related activities to assure consistency with the Institutional Plan presented in the EARDA application. Associates attend an initial series of orientation sessions as well as in-depth seminars that prepare them to use their time effectively at the NIH. Working assignments are intended to provide in-depth exposure to the administration of NIH and other Federal extramural research programs. EAs have the opportunity to learn about the Federal legislative and budgetary processes, to study administrative procedures, and to observe staff meetings and scientific review meetings. In the course of the program, EAs visit other Federal agencies and a nearby university's office of sponsored research. Opportunities may also be provided to observe NIH site visits to grantee institutions.

(3) EA Training Curriculum for First-time Applicants:

The purpose of the training is to provide the EA with the skills needed to improve the research infrastructure at the participating institution. Toward this end, the curriculum will focus on eight core areas:

(1) The Organization and Function of the NIH;
(2) Extramural Program Policies and Procedures;
(3) Extramural Scientific Review Policies and Procedures;
(4) Compliance and Regulatory Issues;
(5) Project Administration and Financial Management;
(6) Extramural Funding Mechanisms and Opportunities;
(7) Other Federal Funding Programs and Opportunities; and
(8) Grantsmanship Workshops and Seminars.

Individual training tailored to needs of the EAs or their institutions will be provided by their assigned preceptors. Specifically, the EA Curriculum for first time applicants will be carried out in three phases:

Phase I: Introduction to the EARDA Program

In this part of the program, the selected participants (EAs) will be required to attend a week-long orientation at the NIH in late January or the beginning of February as a prerequisite to the NIH residency training. In addition to the EAs, presidents and institutional business officials will also be required to attend a portion of the orientation. Among the NICHD participants will be the administrative staff, the EA Program Director and selected NIH professional staff. The purpose of the orientation will be to discuss EARDA program expectations, program structure and requirements, training syllabus, institutional commitment, IPA agreement and management of the EARDA award, and to hold a demonstration of the computer training modules. There will also be presentations on how to conduct an institutional capability assessment so that EAs can work on this during Phase II of training (see below).

Phase II: EA Pre-Residency Web-Based Training

The EAs will complete this part of their training while at their home institutions from March-May, with the understanding by the top institutional officials that the time devoted to this portion of the training is required and must be completed before the grant is awarded. Thus it is NICHD's expectation that the EAs will not be overloaded with other institutional duties that would detract from the EA's concentration on the details of this phase of training. NICHD will present a series of training modules with timed-assessments. For example, once the first module is completed, the trainee will have to take an exam restricted to a given amount of time before he/she can proceed to the next one. Training modules will include such topics as introduction to NIH, NIH terminology and funding mechanisms, role of NIH officials (SRA and HSA), receipt and referral, peer review process, program funding cycle, grants management basics, use of animals in research, use of human subjects in research, etc.

The EAs will also be expected to conduct an institutional capability assessment with assistance from other institutional officials based on the information received during the orientation. However, the final document will not be required until after the module on “Institutional Capability Assessment” has been presented.

Periodically, NICHD staff will conduct videoconferencing and collaborative, interactive real-time document mark-up to check on the EAs' progress. The final document on the institutional capability assessment will be submitted to NICHD-EA professional staff by a pre-determined deadline for the planning of part of the Phase III training.

Phase III: NIH Residency

NIH Residency will be scheduled for 10 weeks during the summer months (June-August) so that EAs can more easily make arrangements for a brief leave of absence from their institution. During the first two weeks, interactive training will be provided on Electronic Research Administration (eRA), compliance, grants management and NIH grants policy. For this part of the residency, the participation of an institutional business official will also be required. Substantial input for this part of the training will be sought from various sectors of the NICHD/NIH staff.

Attendance to review sessions, council meetings, and other hands-on grant writing seminars will be included. There will be visits to other agencies, meetings with targeted program directors based on the EA's institutional assessment report, and a two-day workshop on how to set up and manage an office of sponsored programs. A visit to an office of sponsored programs in the area will be used to further analyze the functions and duties of this structure at the institutional level.

Upon completion of the third phase, the NIH residency program, the EAs will have: (1) a comprehensive working knowledge of the range of Federal support of biomedical and behavioral research available to them; (2) skills in preparation of research grant applications; (3) a plan to establish or expand the institution's "Office of Research Development;" (4) knowledge of the composition of an Advisory Committee with membership capable of reviewing, recommending for funding, and monitoring faculty pilot research projects; (5) a network of contacts at the NIH and other Federal agencies, so they can serve as a liaison for faculty and students to access NIH opportunities, as well a those of other Federal and private agencies; and (6) the embryonic stage of a meaningful partnership with a research intensive institution.

Absence During Residency Training

The EA and the institution must be fully committed to all three phases of the EA training. Because of the time and effort expended in scheduling and conducting training, only in extreme cases will the EA be excused from any part of the training to engage in institutional responsibilities incurred prior to or during the residency training.

Application Requirements for First-Time Applicants

For section I.C.9, Specific Instructions - Research Plan, use Continuation Pages to provide information on the three parts described below. The total length for these three parts combined should not exceed 15 pages.

The Research Plan for EARDA applications consists of three parts. These parts are required and it is imperative that applicants fully address each point described in the outline below because they are reflected in the review criteria.

Part I: The Nominee

This part pertains to the nominee's background and potential as an EA. It should be prepared by the nominee and must include:

Part II: The Institution

This part pertains to the institution's mission and goals related to the EA Program. It should be prepared by institutional officials and must include the following:

Part III: Institutional Plan

The individual identified to serve as the EA will submit a preliminary plan that describes the establishment or enhancement of the institution's Office of Research Development. This plan should describe an approach for enhancing the research capabilities of the institution using the skills to be gained by the nominee. The plan also should include details about steps to be taken to identify, fund, and monitor progress of scientifically meritorious pilot research studies, as well as the development of seminars and workshops, and plans to involve students in research activities. This section should be developed by both faculty and administrators and should include:

Special Instructions for the Appendix

The Appendix to the application should include the following items:

Application Requirements for Competing Continuation Applicants

Individuals applying for continuation support must address in detail the following two areas: (I) Progress and Accomplishments, and (II) Future Plans:

(I) Progress and Accomplishments

(II) Future Plans

Change of Principal Investigator (First-time and Competing Continuation Applicants)

If a request to change the Principal Investigator is received at any time during the initial grant period, support may be suspended by NICHD pending approval of a substitute Principal Investigator by the NICHD EA Program Director. Additionally, the new PI must attend a modified EA training course to be conducted by the EA program staff. The expense for residency training for the new PI will be borne entirely by the grantee institution.

Inclusion of Pilot Research Projects (First-time and Competing Continuation Applicants)

Please do not include in this application any descriptions of pilot studies that will be conducted by faculty at your institution. These pilot studies will not be considered by the peer reviewers of your grant application; therefore, such information will not influence the evaluation. Detailed instructions for submitting proposed pilot studies for evaluation of scientific and technical merit, human subjects protection and animal welfare, and the inclusion of women, minorities and children will be available at: http://www.nichd.nih.gov/PA/HD-04-107/HD-04-107.htm.

Plan for Sharing Research Data
Not applicable

Sharing Research Resources
Not applicable

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

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

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

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

The following will be considered in making funding decisions:

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.

Review Criteria for First-Time Applicants

I. The Nominee

II. The Institution

In the context of the institution's history and stage of development:

III. The Institutional Plan

Review Criteria for Competing Continuation Applications

I. Progress and Accomplishments

II. Future Plans

2.A. Additional Review Criteria
Not applicable

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
Not applicable

2.D. Sharing Research Resources
Not applicable

3. Anticipated Announcement and Award Dates
Not applicable

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

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 Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA 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.

Once all administrative and programmatic issues have been resolved, the Notice of Grant Award will be generated via email notification from the awarding component, NICHD, 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 Notice of Grant Award will be mailed to the business official.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. 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).

2.A. Cooperative Agreement Terms and Conditions of Award
Not applicable

3. Reporting

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:

Matthew A. Kinnard, Ph.D.
Director, Extramural Associates Program
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E03, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 435-2736
FAX: (301) 480-0393
Email: kinnardm@mail.nih.gov

Meredith D. Temple-O'Connor, Ph.D.
Acting Division Director, Division of Interdisciplinary Training
Extramural Science Programs
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Boulevard, Suite 200, MSC 5477
Bethesda, MD 20892-5477
Telephone: (301) 451-4792
FAX: (301) 480-1614
Email: templeocm@mail.nih.gov

2. Peer Review Contacts:

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-1485
FAX: (301) 402-4104
Email: stretchr@mail.nih.gov

3. Financial or Grants Management Contacts:

Myrtle Coleman
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 402-4572
FAX: (301) 451-5510
Email: colemama@mail.nih.gov

Section VIII. Other Information

Required Federal Citations

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.healthypeople.gov/.

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/.


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