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/)
Office of Research on Women’s Health (ORWH) (http://www4.od.nih.gov/orwh/)

Title: Cooperative Reproductive Science Research Centers at Minority Institutions (U54)

Announcement Type
This is a reissue of RFA-HD-02-012, which was previously released April 15, 2002.

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

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government, during FY 2006 the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications electronically using Grants.gov. For more information and an initial timeline, see http://era.nih.gov/ElectronicReceipt/. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html. Specific funding opportunity announcements will also clearly indicate if Grants.gov submission and the use of the SF424 (R&R) is required. Investigators should consult the NIH Forms and Applications Web site (http://grants.nih.gov/grants/forms.htm) for the most current information when preparing a grant application.

Request For Applications (RFA) Number: RFA-HD-06-017

Catalog of Federal Domestic Assistance Number(s)
93.865

Key Dates
Release Date:  August 31, 2006
Letters of Intent Receipt Date(s): November 21, 2006
Application Submission Date(s): December 20, 2006  
Peer Review Date(s): March 2007
Council Review Date(s): May 2007
Earliest Anticipated Start Date(s): July 2007
Additional Information To Be Available Date (Url Activation Date): July 24, 2006
Expiration Date: December 21, 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 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. Submission, 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

The National Institute of Child Health and Human Development (NICHD) and Office of Research of Women’s Health (ORWH) invite new and established basic science, translational, and clinical investigators to submit grant applications for the Cooperative Reproductive Science Research Centers at Minority Institutions.  Applications for these centers are sought from investigators willing to participate with the NICHD under a Cooperative Agreement (U54) mechanism in a multicenter cooperative research program.  Center investigators will be expected to work with NICHD staff in facilitating research collaborations and interactions within and between centers. 

The purpose of this initiative is to form a cooperative program that will augment and strengthen the research infrastructure and research capabilities of faculty, students, and fellows at minority institutions by supporting the development of new, and/or the enhancement of ongoing, basic science, translational, and clinical research that focuses on topics deemed to be of high priority and significance because of their critical importance to reproductive health.  The overall focus of the initiative is intended to stimulate the development of a competitive research environment in reproductive science at minority institutions. 

Reproductive scientists at minority institutions are invited to establish a collaborative partnership with an established senior-level investigator with a proven track record of research productivity and current extramural NICHD funding in reproductive science., thereby benefiting from a broader range of resources, experienced leadership, and exposure to ongoing research projects.  Such centers would bring together strong teams of experienced and new investigators, around a reproductive science theme, to share essential facilities, services, knowledge, and other resources.  Long-term comprehensive affiliation can be expected to lead to the development of a stable relationship between the minority institution and the NICHD reproductive science program that can build and foster independent and competitive research capabilities at the minority institution. 

It is envisioned that each center will ultimately become a training and mentoring resource for developing and strengthening the research capacity of the nation by expanding opportunities for junior minority investigators in areas of reproductive science, particularly those underrepresented within the scientific workforce. 

This solicitation augments the NICHD Research Agenda for identifying and characterizing the factors and potential avenues of treatment related to priority areas of reproductive science, represents an extension of ongoing efforts, and demonstrates the Institute's emphasis on expanding research support for reproductive science.  Finally, a major hallmark of the initiative is its inclusiveness in addressing research across the reproductive life span among diverse populations of women and men, thereby improving the health of all citizens.

Background

There has been increased focus on addressing health disparities and improving the health status of all Americans.  The increasing ethnic and racial diversity of the U.S. population heightens the need to understand the impact of health disparities over the reproductive life span of the American public.  The ultimate goal of reproductive science research supported by the NICHD is to strengthen the science base and develop new knowledge leading to clinical applications that will foster improved reproductive health.  One way to support this effort is to increase the cadre of new and experienced minority investigators in ongoing and emerging areas of reproductive science.  Research in reproductive science remains relatively unexplored at minority institutions.  Some minority institutions have had difficulties developing and sustaining independent programs in biomedical research, and there is a dearth of minority scientists who are pursuing successful biomedical research careers.  The low level of involvement of minority institutions in reproductive science and the lack of sufficient training opportunities for minority scientists represent two major obstacles to developing an effective research effort aimed at addressing significant health disparities.  This initiative will support the development of an enhanced research infrastructure in reproductive science at these institutions.  Creating collaborations among minority investigators and other ongoing NICHD reproductive science research investigators would integrate and take advantage of their respective expertise and experience.  The Cooperative Reproductive Science Research Centers at Minority Institutions Program will bring together strong teams of experienced and new investigators, around a reproductive science theme, to share essential facilities, services, knowledge, and other resources.

It is not the intent of this RFA to focus only on studying disease processes and disorders that disproportionately affect the reproductive health of minority groups, but instead to encourage and foster the development of an infrastructure at minority institutions needed to support all aspects of the NIH research agenda.  State-of-the-art reproductive science research centers at minority institutions would accomplish the following objectives: (1) create professional opportunities for minority investigators; (2) cultivate an academic and research milieu that would stimulate interest among students and fellows to pursue research careers in reproductive science; and (3) contribute to providing an environment in research excellence that would increase the competitiveness of minority institutions and investigators for traditional research project grants.  It is envisioned that increasing the diversity among investigators and institutions will strengthen the scientific research conducted at these institutions, and participating in research supported by this initiative will enhance the experience, training, and career development of minority students and investigators associated with these institutions. 

NICHD's strategic framework highlights scientific themes for future exploration and development that emphasize the importance of fostering training opportunities for basic science, translational, and clinical investigators, supporting the research infrastructure of institutions, and translating science to meet the needs of special populations and eliminate health disparities.  The framework acknowledges that for innovative and creative scientific projects to succeed, the appropriate infrastructure, resources, and technologies need to exist. 

Objectives

The Cooperative Reproductive Science Research Centers at Minority Institutions Program represents an expansion of research opportunities at minority institutions by creating strong reproductive science programs, stimulating partnerships with research-intensive institutions, enhancing the careers of underrepresented minority scientists, exposing graduate and undergraduate students to meritorious research, and stimulating long-term interest in reproductive science research careers among qualified underrepresented minority students.

The NICHD has demonstrated a long-term commitment to support reproductive science institutional programs that have the framework to stimulate multidisciplinary and interdisciplinary interactions among basic science, translational, and clinical investigators interested in establishing quality research projects in reproductive science.  This RFA is specifically designed to encourage the reproductive science research community to form partnerships and support research-based centers at minority institutions, and to form a cooperative network with NICHD that fosters communication, innovation, and excellence.  Thus, the major goals of this initiative are to support specialized reproductive science programs of distinction and to facilitate the development of a competitive research environment at minority institutions.

Research Career Development and Training Opportunities

Participation in research supported by this initiative can have significant impact on the career development of underrepresented minorities in the scientific workforce. Successful applicants may recruit and appoint graduate students, postdoctoral scientists, and junior investigators with prior clinical and/or postdoctoral training. They may use grant funds and existing research training and/or career development programs to mentor and encourage qualified and interested underrepresented minorities to participate in research funded under this RFA. As an example, research career development and training may include term and/or summer training opportunities for graduate and undergraduate students at the minority institution. Postdoctoral scientists, junior, and senior investigators at the minority institutions may obtain assistance in learning new research methodologies at the partnering institutions. The objective of this endeavor is to increase the diversity of the scientific workforce engaged in biomedical research.  

Research Scope

The Cooperative Reproductive Science Research Centers at Minority Institutions Program is composed of research-based center grants designed to support interactive groups of research projects and supporting core units.  The research activities included in these center grants must comprise, by definition, a multidisciplinary approach to the specific research topic areas announced in this RFA.  These centers may have more than one theme, focus or emphasis, but all of the projects involved must be responsive to one or more of the designated reproductive science research areas supported by NICHD.

There are a number of relevant research themes that would lend themselves to a cooperative center approach and are considered important for the potential development of new leads in reproductive science.  Examples of the scope of research deemed responsive to this RFA include, but are not limited to, the following topics:

(1) Reproductive Biology, Physiology, and Genetics 

Biology of male or female gonads and reproductive tract, including genetic, cellular, molecular, physiologic, hormonal, developmental, and immunologic aspects of production and function of sperm and oocytes, and their union to form an embryo, including the function and regulation of the oviduct and epididymis.

Gametogenesis, gamete maturation, role of gonadal somatic cells, ovulation, gamete transport, acquisition of fertilization potential, and function of corpus luteum.

Fertilization: in vitro and in vivo, abnormal and normal.

Blastocyst-uterus interaction in normal and abnormal implantation, pre- and peri-implantation embryo development, including regulation of implantation.

Genetics of susceptibility to reproductive diseases and disorders, genes and genetic mechanisms, genetics of sex determination, role of inheritance and expression of parental genes in reproduction, mechanism important in imprinting and methylation, targeted genetic animal models of reproductive function and dysfunction.

(2) Reproductive Endocrinology

Mechanisms of action of male or female steroid, protein, and peptide hormones and other compounds important for reproduction, including target cells of the hypothalamic–pituitary-genital tract. 

Studies on gonadotropin regulation, and the biosynthesis, secretion, and metabolism of hormones and other compounds involved in reproductive processes.

Modulation, signal transduction, and intermediary action of reproductive hormones by secondary messengers, receptor modulators [e.g., selective estrogen receptor modulators (SERMs), selective androgen receptor modulators (SARMs)], selective progesterone receptor modulators (SPRMs) and co-activators/co-repressors.

Establishment of cell lines and radioimmunoassays as models of reproductive endocrine activity. 

Reproductive neuroendocrinology, including positive and negative feedback systems that influence reproductive processes, identifying and defining signaling pathways mediating hormone action.

Interactions among the nervous, immune, and endocrine systems in regulating reproductive processes and controlling fertility.

(3) Reproductive Medicine

 Etiology, pathophysiology, prevention, diagnosis, and treatment aspects of male or female infertility and reproductive diseases and disorders.

Clinical studies and clinical trials.

Approaches, efficacy and safety of assisted reproductive technologies and drugs, devices, and surgical treatments for infertility.

Andrology, including endocrine disorders, sperm production, maturation, transport, and function. 

Endocrine dysfunction, including central, hypothalamic, pituitary, and target organ abnormalities of reproductive hormone production and action.

Benign gynecological conditions such as endometriosis, leiomyomata uteri, disorders (and normal function) of the pelvic floor and external genitalia.

Follicular maturation, ovulation and corpus luteum formation, egg quality, and uterine markers of implantation.

Mechanisms underlying hypothalamic, pituitary, and reproductive tract dysfunction in such conditions as gonadotropin deficiency, amenorrhea, polycystic ovary syndrome, and premature ovarian failure.

Female sexual function and dysfunction.

Nutrition, body weight, and exercise as determinants affecting reproductive function and fertility.

(4) Risk Factors for Reproductive Disorders

 Determination of the influence and role of risk factors such as race, ethnicity, culture, and co-morbid medical conditions or previous surgery associated with the occurrence of male or female reproductive disorders (including pathophysiology, etiology, diagnosis, treatment outcomes, and complications).

Prospective new or competing continuation applicants are encouraged to consider relevant topics other than those listed here and to discuss their ideas or issues concerning program relevance with the program staff.

Research proposals involving human in vitro fertilization and/or embryo transfer must be in compliance with NIH policies for such research and should not, therefore, include efforts or activities that create human embryos solely for research purposes. 

Guidance and Management Structures

The Cooperative Reproductive Science Research Centers program is designed to foster partnership between the applicant minority institution and the collaborating reproductive science research institutional program.  The Center Director is from the minority institution and is the Principal Investigator.  The Co-director is an established NICHD-funded Principal Investigator in reproductive science. Each center will represent a consortium consisting of the grantee institution and the required collaborative partnership with an established NICHD-funded Principal Investigator in reproductive science that should have the flexibility to identify new opportunities through formalized planning, evaluation, and priority-setting activities.  The applicant institution will be expected to support research activities and should have evidence of an existing research infrastructure.  Joint research projects may be in basic science, translational or clinical research specifically addressing targeted areas in reproductive science. 

The Principal Investigator/Center Director affiliated with the applicant institution and the Co-director who is an established senior-level investigator with a proven track record of research productivity and current extramural NICHD funding in reproductive science are collaborating scientists who will be responsible for the overall scientific and administrative leadership of each center.  The management of the Centers Program includes two committees (the Steering Committee and Scientific Advisory Board) as described below in "Terms and Conditions of Award."

Each Center Director will participate as a member of a Steering Committee that will assist in the coordination of all centers.  A Chairperson will be chosen by a majority of the Committee members.  The NICHD Project Coordinator will participate as a voting member and a member of the NICHD grants management staff will serve as a nonvoting advisor to the Committee.  The Steering Committee will employ a consensus decision process to guide the centers in evaluating the progress of member center programs, their proposed new research initiatives within the general scope of the approved programs, and the need for collaboration either within or outside the center.  The Steering Committee will meet at least once a year.

In addition to the Steering Committee, an independent Scientific Advisory Board will assist in identifying and prioritizing research topics appropriate for study.  The Scientific Advisory Board, chosen by the NICHD with the advice of the Steering Committee, will consist of consultants with appropriate research expertise.  A Chairperson will be chosen by a majority of the Board members.  The Board will (1) review the broad goals and accomplishments of the centers, including any mentoring, career development, and training activities; (2) assess interim progress of all scientific projects and their relevance to the broad objectives of this initiative; and (3) assist in identifying, prioritizing, and reviewing proposed research projects that emerge during the course of the grant.  The NICHD program staff will serve as ex officio member(s) of the Board.  The Scientific Advisory Board will meet regularly during the course of the award and will submit a written report to the NICHD that summarizes its evaluation and recommendations.

Further details of the guidance and management structures and processes may be found under “Cooperative Agreement Terms and Conditions of Award,” below.

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

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the NIH Specialized Cooperative Research Center (U54) award mechanism.  As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. At this time, the NICHD has not determined whether this RFA will be reissued.

The NIH U54 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award". Plans beyond the current funding opportunity are indefinite.

This funding opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format described in the PHS 398 application instructions. Otherwise follow the instructions for non-modular research grant applications.
 
2. Funds Available

The NICHD and ORWH intend to commit up to $1.3 million dollars in total costs in FY 2007 to fund one new and/or competing continuation grant in response to this RFA. An applicant may request a project period of up to five years and a budget for direct costs up to $1 million dollars 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 any award(s) will also vary. Although the financial plans of the NICHD 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 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:

Your organization must be a domestic institution located in the United States, its possessions or its territories.  Foreign institutions are not eligible to apply.

Your organization may be a new applicant, or it may have an existing award under the previous RFA and submit an application for competing continuation.

In addition:

Ideally, the collaborating institutions should be in close proximity to one another.  However, if this is not possible, applicants should describe procedures and/or processes that will be used to overcome any potential problems associated with a geographical separation. 

Institutions may submit more than one application, provided they are scientifically distinct and based in different departments.  Under the umbrella of the Cooperative Reproductive Science Research Centers at Minority Institutions, the NICHD will allow funding support of only one meritorious application per institution.

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 support.

In addition, the Principal Investigator from the minority institution, who serves as the Center Director, must be an experienced researcher and be able to provide both administrative and scientific leadership.  The Co-director, from the collaborating institution, must be an established senior-level investigator with a proven track record of research productivity and current extramural NICHD funding in reproductive science. Participating collaborating investigators must be designated NICHD grantees (supported by major research grant mechanisms such as the U-series, R01, P01, P50 or K12 institutional program).

2. Cost Sharing or Matching

Not applicable

3. Other-Special Eligibility Criteria

Applications will only be accepted from minority-serving institutions as defined under eligible institutions.

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 applications instructions at http://grants2.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS398. 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.

SUPPLEMENTAL INSTRUCTIONS

General Format 

Applications are to be submitted on Form PHS 398. All instructions accompanying form PHS 398 (rev 5/2001) are to be followed, except for those items modified by the specific instructions below.  The RFA may also contain specific specialized formatting requirements.

For example, in lieu of the preprinted Table of Contents outline on Form Page 3 of PHS 398, a Table of Contents should be prepared listing all of the major sections described below and paginated to enable reviewers to find specific information readily.  Pagination must be consecutive throughout the application.  Applicants should ensure that all materials directly applicable to the review criteria (see below) are included in the body of the application, not in an appendix. 

The Abstract should consist of a description of the composite research program, indicate the emphasis of the component research projects, and identify the purpose of the proposed core units.  The Table of Contents should contain the types of information suggested below:  Section I - General Information, Section II - Research Plan, and Section III – Appendix, if applicable.  The following guidelines will provide directions and descriptions for preparing each section.  Major areas to be listed should be paginated in the Table of Contents.

The applicant must include a Statement of Eligibility of the applicant institution as a minority institution eligible for this program from the President or Dean.

Section I - General Information

A. Face Page

Complete all items on the application's face page.  This is Form Page 1 of the application; number succeeding pages consecutively.

On line 2, enter the RFA number (HD-06-017) and title ("Cooperative Reproductive Science Research Centers at Minority Institutions"), and mark

the YES box.

B. Description and Personnel

On Form Page 2, describe briefly the overall research program, indicate the emphasis of the component research projects, and identify the purpose of the proposed core units.

List scientific and technical personnel participating in the Cooperative Research Center.  Use continuation pages as necessary, numbering consecutively.

C. Table of Contents

 Prepare the Table of Contents as noted above.  The major areas to be listed are enumerated in these instructions.

 D. Budget Estimates

 Prepare a series of composite Budget Tables for the Cooperative Research Center Grant as requested below.  A separate detailed budget is required for each research project and for each core unit.

1. Composite Budget

a. Use Form Page 4, "DETAILED BUDGET FOR INITIAL BUDGET PERIOD," of the PHS 398 to present the total direct cost budget for all requested support for the first year. For each category, such as "PERSONNEL," "EQUIPMENT," etc., list the amount requested for each research project and for each core unit.

If consortium arrangements have been made involving other institutions or organizations, include total costs (direct and F&A) associated with such third party participation in the "CONSORTIUM/CONTRACTUAL COSTS" category.  Costs for purchased services should be itemized under "OTHER EXPENSES."

b. Use Form Page 5, "BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD," of the PHS 398 to prepare a budget, by category, that provides direct cost totals for each year of requested support.

2. Individual Project and Core Budgets

a. First year (use Form Page 4 of PHS 398 for each)

b. Total project period (use Form Page 5 of PHS 398 for each)  

Consortium Budgets (if applicable) should be presented as described in Item 1. (Composite Budget), including a budget for the entire proposed project period. Total Direct and F & A costs of sub-awardees are to be shown under "CONSORTIUM/CONTRACTUAL COSTS" on individual research project or core budgets and a detailed consortium budget is to be inserted following the appropriate research project or core budgets.

Budget Justifications:  Describe the specific functions of key scientific and technical personnel, consultants, collaborators, and support staff.  For all years, explain and justify any unusual items such as major equipment or alterations and renovations. For future years of support requested, justify any significant increases in any category over the first 12-month budget period.  Identify such significant increases with asterisks against the appropriate amounts.  If a recurring annual increase in "PERSONNEL" or "OTHER EXPENSES" is anticipated, give the percentage.  

E. Biographical Sketch

Biographical sketches are required for all key scientific and technical personnel participating in the research projects and core units as listed on

Form Page 2.

Beginning with the Principal Investigator/Center Director, and following in alphabetical order, submit biographical sketches as described in the PHS 398," using sample format on the Biographical Sketch Format Page.   Do not exceed four pages for each person.

F. Resources

Complete the "RESOURCES" section on Form Page 8 (Resources Format Page) of the PHS 398 for the overall Center. Briefly describe the features of the institutional environment that are or would be relevant to the effective implementation of the proposed program.  As appropriate, describe available resources, such as clinical and laboratory facilities, participating and affiliated units, patient populations, geographical distribution of space and personnel, and consultative resources.  Use continuation pages as needed.

Section II - Research Plan

A proposed five-year research plan that is responsive to the objectives set forth in this RFA and presents the organization and component functions of the center must be included.  The research plan must contain the description of at least three collaborative research projects that will be mutually beneficial to participating investigators through coordinated, cooperative interactions.  The plan should demonstrate the applicant's knowledge, ingenuity, and commitment to developing productive, competitive reproductive science research.

Include a detailed Table of Contents with pagination (numeric only) at the beginning of Section II.  Identify each research project or core unit by title, and assign each research project a number (I, II, III) and each core unit a capital letter (A, B, C) that reflects the order in which the research projects and core units are presented in the application research plan.  For each research project and core unit, provide the names of the Principal Investigator/Co-Principal Investigator or Core Director/Co-director, and biographical sketches for personnel not identified previously.

A. Introductory Overview

Although there is no page limitation for this section, applicants are encouraged to present a concise and succinct overview.  Discuss the objectives of the center and general plans for the proposed grant period.

1. History, Purpose and Objectives of the Center

Discuss the philosophy and objectives of the Center and general plans for the proposed grant period. Discuss the composite research program, highlighting its central theme. List by title and investigator the component research projects and core units, showing the interrelationship between the research projects and the core units and their relationship to the central theme.

2. Center Description/Management

 A description of and justification for the proposed research development core, which consists of the individual research projects, and the administrative core unit should be included.  This should include the capabilities to meet or exceed the minimal requirements for a center, as stated in this RFA.  List by title and investigator the component research projects and core units, showing the interrelationship between the research projects, the core units, and their relationship to the central theme.  Applicants must also provide a detailed description of the process involved in selecting projects included in the center grant application as well as the process that will be used in evaluating their outcomes, and in selecting a new set of projects based on their merit and potential for meeting the objectives of the partnership.

Discuss the general rationale for the partnership and mutual benefits that the minority institution and collaborating institution expect to derive from the affiliation.  Include a discussion of potential opportunities that the partnership may consider as the relationship and affiliation evolves.

The goals of the center must be described and background and significance of the topics being addressed discussed.  In addition, each research project and core unit must be fully explained in light of how they contribute to achieving these goals.  The organizational and administrative structure, the responsibilities of the Center Director, the Co-director, and the individual investigators, and the proposed mechanism for monitoring scientific progress must be addressed.  Describe the organizational framework and provide an organizational chart.

A description of the qualifications and experience of the Center Director and Co-director in terms of their ability to provide scientific and administrative leadership, and how they plan to promote the collaboration and cooperation needed to achieve the center objectives. 

The center must be prepared to participate in a cooperative manner.  Document institutional and departmental commitment to support this cooperative study and staff dedicated to this program. 

Clearly outline the chain of responsibility for decision-making and administration, beginning at the level of the institution's President or other senior official and including all key staff (e.g., Sponsored Program Administrator, Department Chair, and Dean).  Describe the plans for day-to-day administration of the center, including program coordination, planning, and evaluation.  Describe the proposed relationship of the center to existing research activities and, in detail, how the center will augment and strengthen the existing research infrastructure.

Include information on the use of the steering and advisory committees, and the method of determining core access and space assignment.

The applicant must identify and outline plans for support staff (e.g., grants management, administrative, and technical) to ensure the timely ordering of research supplies, equipment, and other resources essential to the scientific productivity of the research award.

Describe the availability of existing resources (e.g., clinical and laboratory facilities, patient populations, geographic distributions of space and personnel) and collaborative resources that can support a research program.

Briefly describe how the proposed activities will enhance the scientific capabilities of faculty, students, and fellows in reproductive science and strengthen the reproductive science curriculum.

The applicant should describe a research career development and training plan to recruit and appoint graduate students, postdoctoral scientists, and/or junior investigators with prior clinical and/or postdoctoral training. Discuss an approach to incorporate career development and training into the center and its research activities.

3. Institutional Commitment/Supporting Infrastructure

A letter of commitment from a senior official (e.g., President or Dean) at the applicant institution should outline the commitment for resources and facilities to sustain and support the center throughout the period of funding and beyond the performance of this award; document institutional and department commitment and the availability of technical resources and facilities for the long-term support of the center; delineate features of the institutional environment that are relevant to the overall success of the reproductive science program; provide evidence that senior leadership has addressed issues such as tenure, promotion, research release time, and other personnel matters pertaining to the scientific success of the center. 

A letter of commitment from a senior official (e.g., President or Dean) at the collaborating reproductive science institutional program should outline the commitment for resources and facilities to sustain and support the center throughout the period of funding; document institutional and department commitment and the availability of technical resources and facilities; and delineate features of the institutional environment that are relevant to the scientific success of the center.

4. Assurances and Collaborative Agreements. 

Any arrangements for collaborative and cooperative endeavors or subcontracting should be highlighted.  Letters of Intent to Collaborate and Letters of Agreement from consultants should be referenced here and included at the end of the appropriate research project or core unit.  (This is usually covered under each research project and core.)

B. Progress Report

For Type 2 competing continuation applications, a detailed progress report should be included, as described in the PHS 398 instructions.

List relevant publications during the past five-year grant period.

C. Research Project Plan Description

It is required that at least three research projects be maintained at all times for the duration of the five-year award. These research projects must thematically address one or more research areas listed under Research Scope.

At least two of the research projects must be in the format of a traditional application.  One or more research project(s) may be a short-term pilot project.  The maximum direct costs for each traditional research project is $250,000 per year and for each pilot project is $100,000 per year.

Selection of qualified investigators from the applicant minority institution or collaborating institution to propose and lead meritorious research projects suited to their reproductive science expertise must be identified.  A co-investigator from the other institution must be involved in the projects.  Each of the proposed projects should effectively use the scientific and technical strengths of collaborating investigators, and investigators must clearly define the nature and extent of the research collaboration, such that they fully explain the necessary administrative, fiscal, and scientific focus in the application.  These projects must involve established investigators at affiliated partnering institutions as collaborators.

Each of the research projects and the core units proposed for inclusion in the center should be described using the PHS 398 application format.  However, additional face pages are NOT necessary for each research project.  Each research project description should include an abstract depicting the purpose and objectives of the research.  Another paragraph should include a description explaining how the project relates to the overall priorities and objectives as described in the application.

Identify each project by a Roman numeral (I, II, III…) and a title.

For each component research project, a full description is to be provided following the format presented in Form PHS 398.  A 25-page limitation will apply for each of the traditional research projects and a 10-page limitation will apply for the short-term pilot project(s).  Unless stated otherwise in this RFA, the page limitations for each section provided in the PHS 398 instructions are to be used.  Begin the presentation of each component research project on a separate page. 

For each project, include the following information:

1. Introductory Information

a.  Indicate:

Project Title

Project Principal Investigator, title, location

Other investigators, consultants, and collaborators, titles (e.g., Associate Professor, Postdoctoral Fellow, student).

a.  Abstract of Research Plan (use Form Page 2 of PHS 398)

2. Research Project Information:

Discuss the purpose and nature of the project and its relevance to the application's overall theme.  Address the following:

a.  Specific Aims

b.  Significance

c.  Preliminary Studies and/or progress to date (for competing continuation applications), if applicable.  Describe the research project's use of core unit services, including need for the services, and the advantages and cost effectiveness of core unit usage for the project.

d.  Research Design and Methods.  For research involving human subjects, this section must address the inclusion of women, minorities and their subgroups, and children as research subjects, following relevant policy announcements.

e.  Human Subjects Research

f.  Vertebrate Animals

g.  Literature Cited

h.  Consortium/Contractual/Collaborative arrangements, including pertinent letters of assurance and intent.

i.  Consultants

D.  Core Unit Descriptions

Identify each proposed core unit by a letter (A, B, C…) and a title (Administrative, Biostatistical, Molecular/Cellular…).For each Core unit, a full description is to be provided following the format presented below.  Unless stated otherwise in this RFA, the page limitations for each section provided in the PHS 398 instructions are to be used. 

1. Overall introduction (do not exceed 3 pages, excluding any summary tables)

Briefly summarize the overall objectives of core unit; present the organizational framework or chart; highlight the decision-making process for use of core unit services described, and present plans for quality control, as appropriate. Begin the presentation of each core unit on a separate page. For each proposed core, address cost effectiveness and plans for quality control, as appropriate. For each core, include the following information:

 2. Required Administrative Core Unit

Explain the core facility in light of how it will contribute to achieving the goals of the center, and the ability to provide administrative oversight and coordination.  Provide a description of key personnel, space, physical resources and projected use.  Describe specific functions of the administrative core, such as the daily oversight, travel and logistic services needed to support the center.  This should include organizing meetings, workshops, and seminars, documenting the results of activities, providing critical secretarial services, biostatistical and computer services, etc.  Describe the planning and evaluation component and procedures for internal review of research proposals.  Explain the functioning of the Internal Advisory Board that will be housed in this core.

a. Objective(s)

b. Staffing:  Description of key professional and support staff functions

c. Accomplishments: List accomplishments and services provided during previous funding period (for competing continuation applicants)

d. Resources:  Description of space and physical resources

e. Services Provided:  Describe projected services to other core units and research projects, and the center as a whole.

3. Optional Research Laboratory Core Unit(s)

a. Objective

b. Staffing: Brief description of scientific, technical, as well as support staff functions

c. Resources: Description of space and physical resources

d. Administration: Description of overall management of the research core unit

e. Justification: Description of services provided and their bearing on productivity and quality, as well as documentation of cost-effectiveness and quality control

f. Accomplishments: List accomplishments and services provided during previous funding period (for competing continuation applicants)

g. Utilization: Indicate past and/or current usage (e.g., assays performed, animals supplied, etc.) and list projects proposed for core usage, identified by full title.

h. If core service involves human subjects (e.g., recruitment; screening), discuss the inclusion of women, minorities and their subgroups, and children as research subjects, following relevant policy announcements (see RFA for references)

E. Accomplishments of Center Not Previously Cited (Competing Continuation Applicants only)

1. Results of completed research projects not previously included (competing continuation applicants).

2. Use of administrative funds by Center Director for activities such as consultant services, scientific seminars, renovations, or travel (competing continuation applicants).

3. Training activities in the center:

a. Previous trainees, preceptors, present positions

b. Current trainees, preceptors, research topics

4. Investigators attracted to the field by this cooperative specialized research center grant and its facilities:

a. New investigators

b. Visiting investigators

5. Impact on institution and community

6. Role of the Center in facilitating research, assisting young investigators, attracting other research funds, and enhancing collaboration and interdisciplinary research.

7. Other

F.  Checklist - As required in Checklist Form PHS 398

Section III – Appendix, if applicable.

Include materials as appropriate (see PHS 398).

3. Submission Dates and Times

Applications must be submitted on or before the receipt date described below (Section IV.3.A).

3.A. Submission, Review and Anticipated Start Dates

Letters of Intent Receipt Date(s): November 21, 2006
Application Submission Date(s): December 20, 2006
Peer Review Date(s): March 2007
Council Review Date(s): Council May 2007
Earliest Anticipated Start Date(s): July 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:

Estella Parrott, M.D., M.P.H.
Reproductive Sciences Branch
Center for Population Research
National Institute of Child Health and Human Development
6100 Executive Boulevard, Rm., 8B01, MSC 7510

Bethesda, MD 20892
Telephone: (301) 496-6515
Email: parrotte@mail.nih.gov  

3.A.2. Preapplication Workshop

An information/technical assistance preapplication workshop addressing the scientific and administrative issues associated with this initiative will be held in Bethesda, Maryland.  The purpose of the workshop is to (1) familiarize the potential applicants with established NIH guidelines and criteria for review, (2) discuss the areas of NICHD programmatic emphasis, and (3) respond to potential applicants' technical questions about application format, procedures, etc.  Logistic information, including time and location, will be posted at http://www.nichd.nih.gov/RFA/HD-06-017/SupplementaryInformation.htm and may be obtained from program staff listed under WHERE TO SEND INQUIRIES, above.  For those who cannot attend the workshop, a written summary will be posted at that web site.  

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms. 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:

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; non-USPS service)
Email: stretchr@mail.nih.gov
Fax: 301 402-4104

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 applications receipt date described above (Section IV.3.A.) If an application is received after that date, it will not be reviewed. Upon receipt applications will be evaluated for completeness by CSR and responsiveness by NICHD. Incomplete and non-responsive applications will not be reviewed.

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

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

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 (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/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

Under the umbrella of the Cooperative Reproductive Science Research Centers at Minority Institutions, the NICHD will allow funding support of only one meritorious application per institution.

6. Other Submission Requirements

Description of a Center

The minimal requirements for a Center described in this RFA are as follows

 1.  Center Description.  The applicant institution must offer Ph.D., M.D., and/or equivalent health professional degrees, 50 percent or more of the students enrolled must be from racial/ethnic minority groups, and a significant proportion of the minority students must be underrepresented in the biomedical sciences (e.g., African Americans, Hispanics, Native Americans, Alaskan Natives, Native Hawaiians, and Pacific Islanders).  Each center consists of the applicant minority institution and the collaborating reproductive science research institutional program.  The Center Director is from the minority institution and is the Principal Investigator.  The Co-director is an established NICHD-funded Principal Investigator in reproductive science.  Joint research projects may be in basic science, translational or clinical research specifically addressing targeted areas in reproductive science.

Each center will represent a consortium consisting of the grantee institution and the required collaborative partnership with an established NICHD-funded Principal Investigator in reproductive science that should have the flexibility to identify new opportunities through formalized planning, evaluation, and priority-setting activities.  The applicant institution will be expected to support research activities and should have evidence of an existing research infrastructure.

The application should include letters of commitment from leadership within the minority institution and the identified collaborating institution that are fully supportive of this activity and that commit the additional resources necessary to ensure that these partnerships will have the maximum chance of success.  Institutions comprising each consortium should be selected to facilitate attainment of the scientific objectives of the center.  Each application must justify the specific pattern of collaboration in light of the scientific aims of the center and the resources that the participating institutions have to contribute, and should outline the mutual benefits to be gained as a result of the affiliation.  Research partnerships are also encouraged between departments, divisions, and schools within a single institution to facilitate attainment of the scientific goals of the center.

2.  Center Administration.  The Principal Investigator/Center Director affiliated with the applicant institution and a Co-director affiliated with the NICHD reproductive science collaborating institution will be responsible for the scientific and administrative leadership of the center. 

Each center partnership should develop a planning and evaluation component to assure the progress of the collaboration, and procedures should be in place for reviewing internal research proposals, enhancing infrastructure, and recruiting new investigators on the basis of their merit and potential to contribute effectively in achieving stated goals and objectives.

Each Center Director will participate as members of a Steering Committee that will assist in the coordination of all centers.  A Chairperson will be chosen by a majority of the Committee members.  The NICHD Project Coordinator will participate as a voting member, and a member of the NICHD grants management staff will serve as a nonvoting advisor to the Committee.  The Steering Committee will employ a consensus decision process to guide the centers in evaluating the progress of member center programs, their proposed new research initiatives within the general scope of the approved programs, and the need for collaboration either within or outside the center.  The Steering Committee will meet at least once a year.

An independent External Scientific Advisory Board will advise the Steering Committee in identifying and prioritizing research topics appropriate for study.  The Scientific Advisory Board, chosen by the NICHD with the advice of the Steering Committee, will consist of consultants with appropriate research expertise.  A Chairperson will be chosen by a majority of the Board members.  The Board will (1) review the broad goals and accomplishments of the center, including any mentoring, career development, and training activities; (2) assess interim progress of all scientific projects and their relevance to the broad objectives of this initiative; and (3) assist in identifying, prioritizing, and reviewing proposed research projects that emerge during the course of the grant.  The NICHD program staff will serve as ex officio member(s) of the Board.  The Scientific Advisory Board will meet regularly and submit a written report to the NICHD that summarizes its evaluation and recommendations.

3.  Research Project Plan.  The function of the projects is to strengthen, stabilize and consolidate interaction and cooperation between the minority institution and the affiliated NICHD reproductive science program.  Each center will consist of at least three research projects that thematically address one or more research areas responsive to the objectives set forth in the Research Scope.  It is required that at least three research projects be maintained at all times for the duration of the five-year award period.

Applicants are required to propose at least three meritorious reproductive science research projects and must describe the nature and scope of the proposed scientific research collaborations.  Qualified investigators from the applicant minority institution or the collaborating institution should be selected to propose and lead research projects suited to their respective reproductive science expertise.  A co-investigator from the other institution must be involved in each project.

Each of the proposed projects should effectively use the scientific and technical strengths of collaborating investigators, and investigators must clearly define the nature and extent of the research collaboration, addressing administrative, fiscal, and scientific matters in the application.  All projects must include collaborating reproductive science investigators at the partnering institutions.

At least two of the projects must be traditional research projects.  Each project will involve participation by accomplished co-investigators from the collaborating institutions.  Each traditional research project may not exceed $250,000 in direct costs per year.

Each center may include, in addition to the two traditional research projects, one or more short-term research pilot projects.  The total project period may not exceed three years, and each pilot project may not exceed $100,000 direct costs per year.  The purpose of the short-term project(s) is to support pilot or feasibility studies that can lead to a traditional research project(s) funded as part of the center grant.  Each project will involve participation by accomplished co-investigators from the collaborating institutions.  The expectation is that successful pilot projects will become traditional R01-type research projects.

4.  Administrative Core Unit.  This required unit will be located in the applicant institution.  Core resources supporting center development activities, educational activities, administrative services, salaries of key personnel, biostatistical and computer services, a planning and evaluation component, and shared equipment should be included.  The function of the core is to strengthen, stabilize, and consolidate interaction and cooperation between the minority institution and the affiliated NICHD reproductive science program.  This core unit should support an Internal Advisory Board.  The level of support for core resources must be commensurate with the level of research proposed and funded.  The administrative core should include support for meetings (workshops and seminars) or other activities to explore new and expanded collaborative research, research training, and career development activities.  Travel for the Center Director and key investigators at the minority institution to an annual meeting of NICHD Center Directors must be budgeted in the administrative core.  This budget must also include travel for the Center Director and Co-director to the Steering Committee meetings.   

5.  The applicant must include a Statement of Eligibility of the applicant institution as a minority institution eligible for this program from the President or Dean.

6. All applicants must document their ability to meet or exceed the minimum requirements as set forth in this RFA.  This specifically includes understanding of and commitment to the cooperative nature of this program and willingness to meet the Terms and Conditions of Award.

Allowable Costs

Items fundable under an NICHD U54 grant include:

a.  Direct support of individual research projects.

b.  Research Projects), Administrative Core activities used by these research projects, optional Research Laboratory Core (s).

c.  Salaries and support for a limited number of administrative and clerical personnel, such as the Center Director, Co-director, Center Administrator, secretaries, and clerical support staff.  The criteria defined under revised OMB Circular A-21 will be used by NICHD staff to determine if funding of administrative and clerical support staff is allowable.

d.  Administrative support services, including supplies, duplication, telephone, and maintenance contracts for equipment when not covered by institutional Facilities and Administrative (F&A) charges.

e.  As described in the RFA, travel to meetings to confer with other NICHD senior reproductive science investigators, Center Directors, and Administrators or to visit other center facilities pursuant to the administration of the center.

f.  Travel of Center Director, Co-director, and other investigators to scientific meetings.

g.  Travel of technical staff for training that would enhance the quality of the research projects supported by the U54 grant.

h.  Seminars or meetings designed to promote interdisciplinary interaction, education, or center cohesiveness.

i.  Consultants providing specific scientific and/or technical support to center projects or cores.

J.  Costs related to internal program advisory committee meetings.

K.  Costs related to Steering Committee and NICHD Center Directors' meetings.

L.  Salary support for research career development and training opportunities for undergraduate and graduate students, postdoctoral scientists, and junior investigators.

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.

The reasonableness of the data sharing plan or the rationale for not sharing research data may 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/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.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

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

The following will be considered in making funding decisions:

2. Review and Selection Process

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 NICHD in accordance with the review criteria stated below.

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

The scientific and technical merit peer review focuses on three areas:  (1) review of the overall center as an integrated effort; (2) review of the administrative core and any research cores, and (3) review of the component research projects that make up the research plan.

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.

1.  Overall Center Evaluation Criteria

Significance: Does this application address an important scientific health problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of this program on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the program? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Is the program original and innovative? For example: Does the program challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the program 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 PD/PI and other researchers? Does the investigative team bring complementary and integrated expertise to the program (if applicable)?

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?

For competing continuation applications

Past Performance:

2.  Research Plan:  Research Project Evaluation Criteria

Each research project (as defined in this solicitation) will be individually evaluated for its scientific and technical merit using the standard NIH review criteria. 

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?

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?

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)?  

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?

3.  Evaluation Criteria Required Administrative Core Unit

4.  Evaluation Criteria for Optional Research Core Unit(s) 

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).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research may be assessed by the reviewers. Is the percent effort listed for the PI appropriate for the work proposed? Is each budget category realistic and justified in terms of the aims and methods?

Period of Support: The appropriateness of the requested period of support in relation to the proposed research.

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/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.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

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

 After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.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.

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/grants/policy/nihgps_2003/NIHGPS_Part4.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/grants/policy/nihgps_2003/NIHGPS_part9.htm).

The following Terms and Conditions will be incorporated into the NoA and will be provided to the Principal Investigator and the appropriate institutional official at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement NIH Specialized Cooperative Research Center U54, an "assistance" mechanism (rather than an "acquisition" mechanism such as a contract), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility reside with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

2.A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator/Center Director affiliated with the awardee institution and the Co-director at the partnering institution will be responsible for the scientific and administrative leadership of each center. 

The Prinicipal Investigator will be responsible for:  defining the scientific objectives and pursue research approaches; planning and conducting experiments; collecting and analyzing data; and publishing results, interpretations, and conclusions of the studies.  The nature and scope of research on common protocols must be adequately documented and must ensure participation, sharing of methods and data among collaborating organizations.

The awardees will agree to: 1) accept the coordinating role of the Steering Committee which includes evaluating objectives and research goals of the Centers Program, and recommending modification, deletion or addition of protocols within the Centers Program; 2) follow any common protocols in which they participate for multicenter projects that are approved by the Steering Committee; and 3) accept the cooperative nature of the group process.

The management of the Centers Program includes two committees (the Steering Committee and Scientific Advisory Board) as described below in "2.A.3. Collaborative Resonsibilities."  

The center partnership must have a planning and evaluation component in place for reviewing internal proposals for pilot and traditional research projects based on their merit and potential to contribute effectively to achieving high priority goals and objectives.  The center partnership will have responsibility for directing the research projects and flexibility to discontinue and start new projects based on the regular evaluation of progress and identification of new opportunities through formalized and priority setting activities.  Beyond this, the center should develop opportunities for information exchange, seminar presentation, and research training opportunities for students and fellows.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

2.A.2. NIH Responsibilities

An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

NICHD Project Coordinator (Project Scientist)

The role of the NICHD Project Coordinator (Project Scientist) will be to assist the awardees, the Steering Committee, and the Scientific Advisory Board in the following ways:

Additionally, NICHD will appoint a Program Official, apart from the Project Coordinator (Project Scientist), who will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

NICHD Program Official will:

2.A.3. Collaborative Responsibilities  

Overall coordination of the program, consistent with the stated intent of the RFA, will be managed by a Steering Committee, Scientific Advisory Board, and the NICHD program staff. 

Each Center Director will participate as a member of a Steering Committee that will assist in the coordination of all centers.  The Steering Committee will be composed of the Center Directors and the NICHD Project Coordinator (Project Scientist).  A Chairperson other than the NICHD Project Coordinator (Project Scientist) will be chosen by a majority vote of the Committee members.  The purpose of these meetings is to share scientific information, assess scientific progress, identify new research opportunities and potential avenues of collaboration, establish priorities, reallocate resources, and conduct the business of the cooperative research program.  The Committee will have the responsibility for monitoring the progress of the research projects.  The NICHD Project Coordinator (Project Scientist) will participate as a voting member of the Committee and any subcommittees.  A member of the NICHD grants management staff will serve as a nonvoting advisor on the committee.  The Steering Committee will meet at least once a year.  Each full member will have one vote.  Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

An independent Scientific Advisory Board will advise the Steering Committee in identifying and prioritizing research topics appropriate for study.  The Scientific Advisory Board, chosen by the NICHD with the advice of the Steering Committee, will consist of consultants with appropriate research expertise.  A Chairperson will be chosen by a majority vote of Board members.  The Board will (1) review the broad goals and accomplishments of the center, and identify areas of new opportunity based on continuing evaluation; (2) assess interim progress of all scientific projects and their relevance to the broad objectives of this initiative; and (3) assist in identifying, prioritizing, and reviewing proposed research projects that emerge during the course of the award period.  The NICHD Project Coordinator (Project Scientist) will serve as an ex officio member of the Board.  The Scientific Advisory Board will meet regularly and will submit a written report to the NICHD that summarizes its evaluation and recommendations for improvement.

2.A.4. Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

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:

Estella Parrott, M.D., M.P.H.  
Reproductive Sciences Branch
Center for Population Research   
National Institute of Child Health and Human Development
6100 Executive Boulevard, Rm., 8B01, MSC 7510  
Bethesda, MD 20892-7510  
Telephone: (301) 496-6515  
Email: parrotte@mail.nih.gov   

2. Peer Review Contacts:

Robert Stretch, Ph.D.
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
Email: stretchr@mail.nih.gov
Fax: 301 402-4104

3. Financial or Grants Management Contacts:

Ms. Cecilia E. Bruce
Grants Management Specialist
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17L, MSC 7510  
Bethesda, MD  20892-7510
Telephone: (301) 496-1304
FAX: (301) 480-4782
Email: brucec@mail.nih.gov  

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

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).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

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 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.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

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 SF424 (R&R); 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.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.

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://PublicAccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/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. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for 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 93.865 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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