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 Diabetes and Digestive and Kidney Diseases (NIDDK), (http://www2.niddk.nih.gov)

Title: Planning Centers for Interdisciplinary Research in Benign Urology (IR-BU) (P20)

Announcement Type
New

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

Request For Applications (RFA) Number: RFA-DK-10-001

Catalog of Federal Domestic Assistance Number
93.847  

Key Dates
Release Date: December 17, 2009
Letters of Intent Receipt Date: February 18, 2010
Application Receipt Date: March 18, 2010
Peer Review Date: June-July 2010
Council Review Date(s): October 2010
Earliest Anticipated Start Date: September 25, 2010 
Additional Information To Be Available Date (Url Activation Date: December 1, 2009): http://www2.niddk.nih.gov/Funding/FundingOpportunities/RFA/IR-BU_RFA-DK-10-001_conference_call.htm. A conference call is scheduled for January 13, 2010 and January 27, 2010.
Expiration Date: March 19, 2010

Due Dates for E.O. 12372
Not Applicable.

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt, Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
    
D.  Application Assignment
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. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

The overall objective of the Planning Centers for Interdisciplinary Research in Benign Urology (IR-BU) (P20) is to foster the establishment of interdisciplinary teams necessary for advancing our understanding of symptomatic benign urological disorders. Urological disorders of specific interest are those that produce lower urinary tract symptoms, including lower urinary tract symptoms associated with benign prostate hyperplasia (LUTS/BPH), urinary incontinence (UI), overactive bladder (OAB), urinary tract infection, vesicoureteral reflux (VUR), and neurogenic bladder. Because lower urinary tract symptoms are primarily characterized symptomatically, the underlying etiologies have not been determined and, thus, our ability to implement prevention and develop effective treatments has greatly been hindered.    

The intent of these exploratory planning grants is to support the development of research teams that can integrate studies of organ-specific development, structure and function, and physiology and pathophysiology with in vivo animal, and human studies to understand the complex interplay of urologic and non-urologic organs involved in the development and persistence of lower urinary tract symptoms. This strategic approach is partially based on the recommendations presented in the NIDDK Research Progress Report and Strategic Plan for Pediatric Urology (http://www2.niddk.nih.gov/AboutNIDDK/ReportsAndStrategicPlanning/NIDDK_Research_Progress_Report_and+Strategic_Plan_for_Pediatric_Urology_2006.htm),the 2007 NIDDK Advancing Urologic Science and Career Development Meeting (http://www3.niddk.nih.gov/fund/other/_pdfs/2007_Urologic_Science_Workshop_MeetingSummary.pdf), the 2009 Urology 2.0: Advancing Urology Research Workshop (http://conferences.thehillgroup.com/urologymeeting/, and the NIDDK Prostate Research Strategic Plan (http://www.nih.gov/news/health/jul2008/niddk-25.tm).

The impact and burden to patients caused by lower urinary tract symptoms are enormous. Patients suffer considerable morbidity throughout their lives, leading to a decreased quality of life for the patient and their families. Epidemiological data suggest the prevalence of lower urinary tract symptoms, LUTS/BPH, UI, and OAB is high, but measured prevalence varies substantially due to a lack of uniform definitions and the methods of collection. For example, the prevalence of UI appears to vary from 2.5% to 60%, depending on the population. Despite this variation, UI is the leading cause for admission to nursing homes. Management of UI is dependent upon surgery (which is only partially effective) or a single class of approved drugs. This class of drugs is only 13-25% more effective than placebo and 2/3 of patients discontinue use because of side effects. LUTS/BPH and OAB are treated with a wide variety of costly drug, surgical, and behavioral treatments that are only aimed at alleviating the symptoms, even though diverse causes are likely to underlie both syndromes. Neurogenic bladder is treated by surgical or other invasive procedures that ultimately do not address the underlying etiology. 

The consequences of many congenital urinary malformations also lead to lower urinary tract symptoms. Thus, advancements in our knowledge of the developmental processes underlying lower urinary tract structure and function, as well as further understanding of the physiological changes associated with urinary tract symptoms will also enhance our ability to develop improved treatment for the consequences of urinary tract malformation. Vesicoureteral reflux (VUR) is such a developmental defect and affects up to 10% of newborns (approximately 450,000 babies) every year). VUR results from the abnormal attachment of the ureter to the bladder that causes retrograde flow of urine into the ureter and kidney. Depending upon the severity, VUR will resolve spontaneously or can lead to renal failure. A severe complication of VUR is urinary tract infection that can lead to renal damage or scarring. Current treatment of VUR is moderately successful and ranges from antibiotic prophylaxis and regular radiographic evaluation to surgical procedures. Establishing effective prevention and management of lower urinary tract symptoms and congenital urinary malformation will require an understanding of the underlying causes and the normal and abnormal development of the organ systems involved.

The strategy of the IR-BU program is to create interdisciplinary teams capable of undertaking studies to identify the root causes and systems involved in lower urinary tract symptoms. To accomplish this will require an understanding of the normal development, maturation, and physiology of organ systems likely to be involved. These studies and studies of the pathophysiology of animal models that mimic aspects of lower urinary tract symptoms and the closer examination of relevant patient populations will provide a basis for developing testable conceptual and mechanistic models. To date discipline-focused, research teams have not undertaken such approaches.

Development of conceptual and mechanistic models and in vivo animal experimental systems that recapitulate specific lower urinary tract symptoms is crucial for understanding and testing the complex interplay of urologic and non-urologic organs. Knowledge gained from these studies will serve as the foundation to develop effective treatments and strategies for prevention.  In addition, characterization of in vivo animal models that mimic aspects of specific lower urinary tract symptoms will help direct the improved detailed phenotyping of patients and thereby support the development of more informative patient subgroups. Stratification of patient populations should provide a means to select optimal prevention and therapeutic strategies to improve the clinical outcomes for patients with lower urinary tract symptoms.

Overall structure and goals

Each IR-BU Center will consist of a collaborative interdisciplinary team coalesced around a single scientific topic and scientific project. Each center will be expected to have an Administrative Core that includes an Educational Enrichment Program. Because the goal of the IR-BU program is to foster new interdisciplinary teams, applications will not require preliminary data to establish the collaborative interactions of the team members, but rather the proposed Scientific Project should be used to generate the preliminary data necessary to establish the bona fides of the IR-BU participants as a well-integrated interdisciplinary research team. The IR-BU Centers are expected within a two-year period to develop well-designed interdisciplinary projects suitable for submission for a George M. O’Brien Urology Research Center (P50), a multi-PI R01, or a Program Project (P01) award.

Center Director

The Center Director must be an established investigator and will be responsible for scientific and administrative leadership. This includes, but is not limited to, the following duties:

Interdisciplinary teams

The goal of the IR-BU program is to build teams that draw upon diverse disciplines to investigate lower urinary tract function and the underlying causes of lower urinary tract symptoms. Investigators within and outside of urology are encouraged to interact in the broad field of lower urinary tract biology to build the basic knowledge essential for establishing conceptual/mechanistic models, tools, and resources necessary for developing translational studies in lower urinary tract symptomatic disorders. Inclusion of a urological clinician or physician scientist in the research team is required to maintain awareness of the clinical relevance of the project to lower urinary tract symptoms. In addition, teams are required to include new and/or established investigators with appropriately diverse expertise. Investigators who are part of an existing O’Brien Urology Center may not submit an application. Specific examples of interdisciplinary team members might include:

Scientific Research Project

The Scientific Research Project will be a single project and will be overseen by a Principal Investigator plus co/investigators or by multiple Principal Investigators (see Section IV. 2 Applications with Multiple PDs/PIs). The Scientific Research Project will contribute to our understanding of the etiology of lower urinary traction symptoms through studies of the normal development, physiology, and pathophysiology of the lower urinary tract and associated organs and tissues. Because a goal of the IR-BU Center is to build new interdisciplinary teams, preliminary data are not required to establish the collaborative interactions of the team members. The Scientific Project may include human studies, and/or use mouse and other animal experimental systems. Animal studies are appropriate for the study of normal development, maturation, and physiology of the lower urinary tract system and associated organs, and animal models are acceptable even though they might only recapitulate aspects of urologic symptoms. To accelerate the ability to plan for future translational studies, phenotypes identified in animal studies should be examined, where possible, in previous or ongoing clinical studies/trials or in preliminary human phenotyping studies within the Scientific Project. Knowledge from human phenotyping projects will be critical in stratifying patient populations with specific lower urinary tract symptoms into more informative subgroups. Stratification should allow the selection of optimal prevention and therapeutic strategies to improve the clinical outcomes for patients with lower urinary tract symptoms.

A long term goal of establishing IR-BU teams is to provide the intellectual infrastructure to develop conceptual/mechanistic models for specific lower urinary tract symptoms, to generate bona fide in vivo animal models that can recapitulate specific urinary tract symptoms, to improve clinical phenotyping protocols, to develop resources and tools that will facilitate the identification of new therapeutic targets and to develop novel prevention and management approaches.

Specific examples of research topics that are responsive to this solicitation are listed below. Although cell culture studies are permissible, they will need to be carefully justified. These are broad examples meant only to provide illustration of potential directions, and not to be restrictive.

Applications primarily focused on kidney injury secondary to urologic disorders are not responsive to the FOA, and will be not be reviewed. 

Administrative Core

An Administrative Core will serve as a foundation for the synergistic activities of the Center, provide travel support for Center personnel, and be responsible for an Educational Enrichment Program.

The Educational Enrichment Program may comprise and include funds for 

To support the team building activities of the P20 centers the IR-BU teams will meet bi-annually in Bethesda, initially to introduce the IR-BU teams and subsequently to discuss progress on the establishment of integrative research teams.

 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 Exploratory Grant (P20) award mechanism.
The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.  

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).   

2. Funds Available

The estimated amount of funds available for support of 3-4 projects awarded as a result of this announcement is $1 million for fiscal year 2010 with a maximum of $200,000 direct costs per year. An applicant may request project periods for up to two years. The anticipated award date is September 25, 2010. Future year amounts will depend on annual appropriations.

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

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

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

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her 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.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a “team science” approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application.  Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

The Center Director must be an established investigator, but need not have a record of accomplishment in urological research; however, the inclusion of a urologic clinician or physician scientist in the IR-BU team is required. It is expected that other IR-BU team members will have the diverse expertise appropriate for the proposed studies in the Scientific Project.  Therefore, new or established investigators from diverse fields not traditionally involved in urological studies are expected to be included. Because not all relevant expertise may be represented at a single institution, applicants are encouraged to establish interdisciplinary teams through collaborations with research groups outside their own institution.

Investigators who are part of an existing O’Brien Urology Center are not eligible to apply.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may submit more than one application, provided they are scientifically distinct.

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

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

Section IV. Application and Submission Information


1. Address to Request Application Information

The current PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the 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 in item (box) 2 only of the face page of the application form and the YES box must be checked.

Applications with Multiple PDs/PIs 

When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a – 3h for all PD/PIs. NIH requires one PD/PI be designated as the “contact PD/PI” for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the “Contact PD/PI, et. al.” The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the Research Plan, entitled “Multiple PD/PI Leadership Plan” must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators. 

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

Additional information is available in the PHS 398 grant application instructions.

3. Submission Dates and Times

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

3.A. Receipt, Review and Anticipated Start Dates

Letters of Intent Receipt Date: February 18, 2010
Application Receipt Date: March 18, 2010
Peer Review Date: June-July 2010
Council Review Date: October 2010
Earliest Anticipated Start Date: September 25, 2010

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 in Section IV.3.A.

The letter of intent should be sent to: 

Dr. Francisco O. Calvo
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 752 MSC 5452
Bethesda, MD  20892-5452 (for express/courier service: Bethesda, MD   20817)
Telephone:  (301) 594-8897
E-mail:  fc15y@nih.gov

3.B. Sending an Application to the NIH

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

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

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Dr. Francisco O. Calvo
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 752 MSC 5452
Bethesda, MD  20892-5452
(for express/courier service: Bethesda, MD   20817)
Telephone:  (301) 594-8897
E-mail:  fc15y@nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed.  Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute. Incomplete and/or non-responsive applications will not be reviewed.

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

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. The Grants Policy Statement can be found at NIH Grants Policy Statement.

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 award if such costs: 1) are necessary to conduct the project, and 2) 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 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.)

Except under extenuating circumstances as discussed below, NIDDK funds may not be used to support any research project (regardless of the size of the budget or the length of the project period) that was not requested in the application, peer reviewed by NIH, and approved for funding by NIDDK at the time of award.  

For example, a grantee may seek to replace a research study due to the departure of a PI from the institution. The institution must submit a written request, with sufficient justification, seeking to replace the current research study with a new research study and PI.  Prior approval from NIDDK ensures that any applicable requirements for a change in scope or aims or deviation from award terms and conditions have been met. In such cases, grantees are advised to discuss pending developments with the designated program official and grants management specialist.

6. Other Submission Requirements

Modify the PHS 398, starting with the Table of Contents, to include the following items in the following order and using the page limits below when provided:

Appendix

Supplemental instructions for major areas:

1. Description of the Proposed IR-BU Center (limited to 6 pages)

Describe the IR-BU Center, the overall purpose of the Scientific Research Project and its scientific focus including how the Scientific Research Project will contribute to our understanding of the etiology of lower urinary tract symptoms, the disciplines involved, and the Administrative Core. Provide a brief description of the proposed research project. Describe how the team was assembled, and the complementary institutional/investigator strengths and expertise, as appropriate, that contribute to the likelihood that this team will achieve the proposed scientific goals and objectives. Describe efforts that have been taken to ensure the success of the team building and the steps taken to ensure that the center will remain focused throughout the course of the award. Provide a plan for ensuring the solvency of the proposed team once an award has been made and for resolving conflicts within the IR-BU Center. Specifically address administrative responsibilities between the collaborating institutions, organizational components, faculty, and staff. Provide an official signed letter of understanding establishing the collaboration between the institutions or organizational components and document all significant inter-institutional commitments. Applicants should decide what and how much is appropriate to include about the collaboration in this section versus the administrative core.

2.  Administrative Core (mandatory, limited to 6 pages) 

Applicants should describe the administrative structure of the center and the roles and responsibilities of all key personnel. The Administrative Core Director need not be the Center Director. The administrative core is responsible for 1) the allocation and oversight of all IR-BU Center resources, 2) establishing and maintaining all collaborations and the Educational Enrichment program, and 3) working with the local regulatory bodies to ensure that human subject or vertebrate animal research is in compliance with appropriate regulations and guidelines governing animal use and studies involving human subjects research. 

Describe the Educational Enrichment program, how it will support or augment the development of an interdisciplinary approach to the proposed studies, and its governance through the center’s advisory board. All IR-BU Centers are expected to establish and maintain a website to advertise and highlight the activities of the Educational Enrichment program.

3. The Research Plan

The research plan for the project must follow the format above, which is a modification of the PHS 398 program project format.  The specific aims are limited to 1 page. The research strategy is limited to 12 pages.  Include as applicable in the research plan the other sections listed in the PHS 398 (see below):   

The following sections or items are excluded from the above page limits of the research plan but should be included in the research plan as applicable:

4. Other requirements  

Include detailed budget pages for the project in the composite budget section. Include the title and page number for the project in the table of contents for the IR-BU Center and provide in the proposal a face page. The face page should include the title, name(s) and affiliation of the PI(s). Also, include the role and responsibilities of all of the members of the research team. If research using human subjects is proposed, provide a human subjects section as directed in the PHS 398 guidelines.  If multiple PD/PI will be designated, include a multiple PD/PI Leadership Plan. 

The Center Director must be an established investigator, but need not have a record of accomplishment in urological research; however, the inclusion of a urologic clinician or physician scientist in the IR-BU team is required. It is expected that other IR-BU teams will have diverse expertise appropriate for the proposed studies in the Scientific Project and therefore, new or established investigators from diverse fields not traditionally involved in urological studies are expected to be included. Because not all relevant expertise may be represented at a single institution, applicants are encouraged to establish interdisciplinary teams through collaborations with research groups outside their own institution.

Applicants must budget for travel for at least three investigators to attend bi-annual reverse site visit/progress meetings to be held in Bethesda, Maryland.

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

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

Resource Sharing Plan(s)

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

(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible.  A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition.  For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Section V. Application Review Information


1. Criteria

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

2. Review and Selection Process

Review Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIDDK and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

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

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

Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the Center to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed). 

Core Review Criteria.  Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each.  An application does not need to be strong in all categories to be judged likely to have major scientific impact.  For example, a Center that by its nature is not innovative may be essential to advance a field.

Significance.  Does the Center address an important problem or a critical barrier to progress in the field?  If the aims of the Center are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?  How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? For the ADMINISTRATIVE CORE will the proposed activities of the Educational Enrichment Program make significant contributions to the goals/specific aims of the IR-BU Center to foster integrative research approaches to understand the underlying causes of benign lower urinary tract symptoms, or developmental, functional, physiologic, or pathophysiological changes associated with lower urinary tract symptoms?

Investigator(s).  Are the PD/PIs, collaborators, and other researchers well suited to the Center?  If Early Stage Investigators or New Investigators, do they have appropriate experience and training?  If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?  If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? What is the likelihood for meaningful collaboration among Center investigators? Are there sufficient interaction and cross-fertilization among scientists from non-urologic fields of expertise? Does the investigator team include a urologic clinician or physician scientist with relevant urology expertise? Are the scientific and administrative leadership abilities of the proposed Center Director appropriate? Does the Center Director have an appropriate time commitment for the effective management of the Center? Is the composition of the investigators appropriate for building an interdisciplinary research team? Is there evidence that the researchers and faculty of the partnering institutions have worked closely together in the preparation of the application and will continue to do so in meeting the proposed objectives?

Innovation.  Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?  Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense?  Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach.  Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  Are potential problems, alternative strategies, and benchmarks for success presented?   If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

While preliminary data is not required to establish the collaborative interactions of the team members, will the Center foster new multidisciplinary teams, and generate the preliminary data necessary to establish a well-integrated multidisciplinary research team that is capable of generating new and innovative research grant applications?    If the project involves basic research using animal models, is there a clear vision for how the studies will contribute to the development of translational studies?

For the ADMINISTRATIVE CORE are the arrangements and organizational structure adequately developed and appropriate to the aims of the Scientific Project and the Educational Enrichment program? Does the application describe how internal communication and cooperation among Center investigators will be maintained? Are the arrangements for oversight and use of funds for travel and the Educational Enrichment Program adequately described? Are the resources and responsibilities appropriately distributed and justified given the goal and objectives of the proposed IR-UVS center? Does the applicant describe an effective process for resolving conflicts between investigators? 

Environment.  Will the scientific environment in which the work will be done contribute to the probability of success?  Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?  Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? 

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects.  For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects  and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children.  When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals.  The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.

Biohazards.  Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Additional Review Considerations

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

Budget and Period Support.  Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans.  Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:  1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

Selection Process

The following will be considered in making funding decisions:

NIH considers the following in evaluating Center grant applications:

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.

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

An NIDDK Program Director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the NoA. The assigned Program Director may also serve as the Project Scientist.

An NIH Project Scientist will have some programmatic involvement that is beyond the normal stewardship role in awards through establishment of regular phone calls and bi-annual scientific meetings. The dominant role and prime responsibility however, in quality control, interim data analysis, safety monitoring, and final data analysis and interpretation, and preparation of publications resides with the awardees for the project as a whole.

An independent Scientific Evaluation Committee to be appointed by the NIDDK will review scientific focus, approaches, and collaborations for potential synergy and progress. The Scientific Evaluation Committee will meet at least annually and report to the Director, Division of Kidney, Urologic and Hematologic Diseases.

The NIDDK reserves the right to terminate or curtail the project in the event of (a) failure to develop or implement a mutually agreeable educational enrichment program, provide updates prior to the bi-annual meetings, or attend the bi-annual meeting, (b) substantive changes in the agreed-upon studies with which NIDDK cannot concur, (c) lack of progress, or (d) human subject ethical issues that may dictate a premature termination.

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 award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

3. Reporting

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement. Interim updates prior to the bi-annual meetings are required. 

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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:

Deborah K. Hoshizaki, Ph.D.
Division of Kidney, Urologic and Hematologic Disease 
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Democracy Two, Room 645
6707 Democracy Boulevard
Bethesda, MD 20892
Telephone: (301) 594-7712
FAX: (301) 480-3510
Email: deborah.hoshizaki@nih.gov

2. Peer Review Contacts:

Dr. Francisco O. Calvo
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 752 MSC 5452
Bethesda, MD  20892-5452
(for express/courier service: Bethesda, MD  20817)
Telephone:  (301) 594-8897
E-mail:  fc15y@nih.gov

3. Financial or Grants Management Contacts:

Pamela Love
Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases
Two Democracy Plaza, Room Number 743
6707 Democracy Boulevard
Bethesda, MD 20892-5464

Telephone: (301) 435-6198
Email:pl48m@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.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.

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 new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

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

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-09-116.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.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

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 FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 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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