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

Title: Multidisciplinary K12 Urologic Research (KURe) Career Development Program

Announcement Type
New

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

Request For Applications (RFA) Number: RFA-DK-07-006

Catalog of Federal Domestic Assistance Number(s)
93.849

Key Dates
Release Date: October 1, 2007
Letters of Intent Receipt Date: February 19, 2008
Application Receipt Date: March 18, 2008
Peer Review Date(s): June-July 2008
Council Review Date(s): August 2008 (New Date October 2008 per NOT-DK-08-011)
Earliest Anticipated Start Date: September 30, 2008  
Additional Information To Be Available Date (URL Activation Date): N/A
Expiration Date: March 19,2008

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
  1. Research Objectives

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

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

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

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

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Overview: The purpose of this Institutional Mentored Urological Research Career Development Program is to assist MDs, PhDs, and MD/PhDs interested in urological research related to the mission of the NIDDK (http://www2.niddk.nih.gov/Research/ScientificAreas/Urology/ ) to develop the skills necessary to initiate and sustain an independent research career. The institutional programs are to include activities and opportunities that will provide candidates with a comprehensive understanding of clinical research, translational, and/or basic science approaches needed to successfully pursue their research careers.  These activities may include didactic education, mentored practical research training, and enhancement experiences in areas such as mentorship and grant-writing skills. Programs should also consider the multidisciplinary nature of a successful research career in urological sciences and should select a group of candidates with mixed scientific, clinical, and/or training backgrounds. Scholars should be exposed to the approaches necessary to foster cross-disciplinary collaborations.

A scholar selected by the institution for the K12 program will work with their mentoring team to propose a thorough, individualized career development program that will prepare the scholar for an independent career in urological research.  Areas of primary focus may include clinical, translational, or basic science research. Didactic training may take advantage of institutional K30 programs, CTSA resources, or extant MS and/or PhD programs.  Also, institutions with O’Brien Centers and large projects supported by the NIDDK are encouraged to take advantage of those resources in ways that benefit their proposed KURe Program. The duration of the career development program should be tailored to fit a scholar’s background and experience. It is anticipated that candidates selected as scholars for this program would have five years or less of research experience beyond a doctoral degree. Final selection of scholars must be approved by NIDDK staff.

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

Background: A recent workshop convened by the NIDDK in February, 2007 provided an overview of the trends in urologic research and training supported by the NIDDK.  A focal point of the February workshop was to design efforts to encourage and enhance training of independent scientists capable of pursuing careers in urologic research of interest to the NIDDK.  Some of the clinical areas of continued interest to the NIDDK (http://www2.niddk.nih.gov/Research/ScientificAreas/Urology/) lack the definitions, phenotyping strategies, and the epidemiological and natural history population studies needed to quantify the disease of interest.  In other areas, experimental models are needed - either animal or computer-generated phantom models - to help translate the experimental findings from the basic laboratory to humans.   Translational tools, such as imaging techniques or biomarkers, could lead to innovative research and further the development of diagnostic or therapeutic tools. 

It was agreed by all participants at the workshop that a multidisciplinary approach would best serve the field.  The development of a sustained robust effort in urological research will depend upon a trained cadre of researchers with MDs, PhDs, and MD/PhDs in many areas which would include (but are not limited to) the following: 

This funding opportunity is intended to address the need for multidisciplinary career development and training at the postdoctoral level and provide a transition to independence. It is hoped that the K12 programs established in response to this announcement will become incubator environments for development of independent researchers able to sustain viable careers and mentor those that follow them.

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the K12 award mechanism.

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

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

2. Funds Available 

The participating IC, The National Institute of Diabetes and Digestive and Kidney Diseases, intends to commit approximately $2 million dollars in FY 2008 to fund up to three new grants 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 $850,000 dollars per year.

Because the nature and scope of the proposed training programs will vary from application to application, it is anticipated that the size of each award will also vary. Although the financial plans of the NIDDK 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:

The applicant institution must have an adequate pool of highly-trained faculty investigators in benign urologic disease, basic urologic research, or related areas (such as infectious disease, physiology, internal medicine, developmental biology, microbiology or others – see Section I. Funding Opportunity Description, Research Objectives). These institutions should also have the commitment and capability to provide career development guidance to promising candidates who aspire to become independent investigators. Institutions with existing K12 or other training programs must explain what distinguishes this new effort from the others, how their efforts will synergize with one another, if applicable, and make it clear that the pool of faculty and potential scholars are robust enough to support additional programs.  

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.

PROGRAM DIRECTOR/PRINCIPAL INVESTIGATOR: The K12 Program Director must be an established researcher in the area of NIDDK-supported urological research who can provide administrative, educational, and scientific leadership to the Program.

1.C. Eligible Projects

The purpose of this opportunity is to solicit applications to support institutional career development programs in urological research in areas of significant interest to the NIDDK (http://www2.niddk.nih.gov/Research/ScientificAreas/Urology/).  Pilot projects and research opportunities included in the proposed multidisciplinary K12 Program should focus on urological research in these areas, including benign urological disease or basic science related to urology. 

2. Cost Sharing or Matching

Although cost sharing is not required, institutions are strongly encouraged to consider provision of matching funds to provide additional support of pilot studies that will allow their candidates to generate preliminary data.

Salaries for ancillary personnel support, such as mentors, secretaries, and administrative assistants, are not allowed.   Partial salary for a dedicated administrator is allowable.  Minimal costs can be allocated for advertising and recruitment in order to attract the best candidates nationally. Some laboratory costs may be provided to mentors, typically no more than two per scholar, to offset expenses generated during the mentored research phase of the scholar’s training. The total amount for ancillary salary support and laboratory costs should not exceed $65,000.  

 The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

Institutions may not submit more than one application for this FOA.

MENTORS: It is expected that each KURe scholar will have a mentoring team which includes at least two individuals from different disciplines and training backgrounds. These mentors should hold a faculty position and be established investigators in clinical, translational, or basic scientific research with track records in mentoring and training. The mentors must interact closely with the scholar in order to develop a tailored career development plan.     

SCHOLARS: Institutions receiving a KURe Program award must recruit and select scholars with the potential to develop into independent investigators capable of interacting with multidisciplinary teams with diverse training and scientific backgrounds. Scholars must have a doctoral level degree such as an MD, DO, MD/PhD, or PhD degree, must have completed residency training (if required), and be committed to a career in independent research in benign urologic disease.  Scholars should have no more than five years of postdoctoral research experience and not more than 10 years should have elapsed since receiving the terminal doctoral degree.  Time spent in clinical fellowships is not considered postdoctoral research training. Mid-career and senior faculty are not eligible. Prior to selection of KURe Scholars, Program Directors are strongly encouraged to discuss advisory committee recommendations with NIDDK Program Staff. Scholars must be willing to commit 75% or more effort (50% for urologic surgeons) to the activities of their career development plan. Funds provided by this award may support full or partial completion of an advanced degree in health-related research.  Scholars with fewer than three years of support under this award will remain eligible to compete for individual career development awards such as the K01, K08, and K23. The maximum duration of support for a scholar under this award is five years. It is expected that most scholars will transition to independent support (either R01 or individual K award) at the end of three years, but appointments may be extended to five years with NIDDK staff approval. Scholars may be eligible for the Loan Repayment Program (LRP) for clinical and pediatric investigators. More information about LRP can be found at http://lrp.info.nih.gov.  The total period of K12 plus individual mentored K support may not exceed 6 years.

Scholars appointed under this K12 program must be U.S. citizens or non-citizen nationals, or have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (I-151 or I-551) or some other verification of legal admission as a permanent resident.

Individuals who are or were Principal Investigators on NIH Small Grants (i.e. R03s) or Exploratory/Developmental Grants (i.e., R21s) are eligible providing they do not have more than 5 years of postdoctoral research experience and not more than 10 years has elapsed since the granting of the terminal doctoral degree as described above.  However, Principal Investigators who have current or prior support on NIH research projects grants (R01), sub-projects of program projects (P01) or Center grants (P50) or the equivalent are not eligible for appointment under this program.  Individuals who have been previously supported by NIH or non-NIH career development awards are not eligible.  Scholars may not concurrently hold any other PHS award that duplicates the provisions of this award.

Scholars in this program are encouraged to apply for independent research grant support during the period of support under this award.         

Section IV. Application and Submission Information


1. Address to Request Application Information

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

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

2. Content and Form of Application Submission

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

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

Prospective applicants are encouraged to contact the Program Official well in advance to discuss their plans to submit an application.

CONTENT REQUIREMENTS

Applicant institutions are required to include the following elements in their application:

Program Description: The application must include a description of the activities, such as didactic courses, specialized workshops, or tutorials, which will be incorporated into the career development and mentored research experience phases of the program.  The courses should be relevant to diverse areas of urologic research, and they should address the diversity of the trainees’ background and research interests. It is expected that the didactic and research experiences provided by the program will facilitate the ability of the participants to acquire the necessary knowledge and research skills in scientific areas relevant to their career goals.  The institutional program should be designed to accommodate candidates with varying levels of research experience. This individualized design may require career development programs that range between two and five years, depending upon the scholar.

Mentored Research Experiences: These experiences will be particularly important for KURe scholars with little or no previous research training. Plans should be in place to assure a multidisciplinary experience and to ensure that KURe scholars will have the opportunity to acquire the skills necessary for initiation of a successful pilot project.  

Pilot Projects: There should be a plan for scholars to submit pilot projects within the structure of the KURe Program to allow them to develop preliminary data during the course of the research phase of their program. These pilot projects should be distinct from the mentored research training expected earlier in the career development program. The scholar should propose and develop their own project in an area that is expected to become their own as the scholar transitions to independence. The purpose of the pilot project is to generate preliminary data to support an application leading to independent support, whereas the mentored research training component is to expose a scholar to new areas/methodologies of laboratory or clinical research. Since the purpose of the KURe Program is to provide multidisciplinary career development and training, it is anticipated that scholars will be encouraged to pursue research topics in any of the areas of expertise available to them via the participating mentors/training faculty. Plans should be presented in the application for the evaluation, selection, and support of these pilot projects through the Program. Plans should also address efforts to maintain the multidisciplinary nature of the pilot projects; i.e. type and areas of research should vary among the scholars.  It is anticipated that the institution will provide additional resources as necessary.

Instruction in the Responsible Conduct of Research:  Every individual supported by a research career development award must receive instruction in the responsible conduct of research (http://grants2.nih.gov/training/responsibleconduct.htm.  Applications must include a description of a program to provide formal or informal instruction in the responsible conduct of research, including the rationale, subject matter, appropriateness, format, frequency, and duration of instruction, and the amount and nature of faculty participation. Applications without such plans will be considered incomplete and will be returned to the applicant without review.

Evaluation and Tracking: The application must include a plan for program evaluation in terms of recruitment and retention goals, the curriculum and program staff, mentoring, pilot projects, appointee completion success, and overall outcome. There should be a system for tracking graduates throughout their career to determine the success rate of applying for and obtaining Federal and non-Federal research grant support.  Information for these evaluations should be obtained from faculty mentors, staff and candidates.  Applicants are encouraged to: set benchmarks for the goals of their institutional programs in advance; provide a brief summary of the research opportunities available and course work to be offered to scholars; and provide a summary of the research degrees earned and relationship with career research goals.  For the purposes of evaluating the impact of this K12 program, awardees must agree to provide NIDDK with information on the career outcomes for those appointed to the program.  Appointment of scholars should be preceded with a Statement of Appointment Form (Form 2271) and a brief description of the scholars’ background and career goals to facilitate tracking by NIDDK Program Staff. This information must also be provided annually in the progress report and include information for each candidate regarding academic appointments, awards related to scholarly activity, publications, and research grants and contracts received.

Advisory Committee: Plans must be provided for the appointment of an Advisory Committee to monitor the progress of KURe scholars. Composition, responsibilities, frequency of meetings, and other relevant information should be included. This committee should be multidisciplinary in terms of research and training background of the members. An annual evaluation of the program by the Advisory Committee is required. A plan for Advisory Committee approval and selection of scholars should be included. The scholars selected by the Advisory Committee will be forwarded to NIDDK staff for final approval. The Advisory committee minutes should be kept on file for inspection at site visits and for inclusion in annual progress reports.  Note that if the names of the Advisory Committee members do not need to be named in the application, particularly if they include individuals from outside the institution.

Environment: The primary institution must have well-established research programs and highly-qualified faculty mentors.  The academic setting is to include opportunities for research collaborations that exemplify a dynamic exchange of information and ideas between basic and clinical investigators.

Institutional Commitment: Applicant institutions should show commitment to the Program’s goals and provide assurances that the institution intends the Program to be an integral part of its research efforts.  Research facilities, career development and training opportunities will be an essential aspect of the environment. Institutional commitment in support of the KURe Program must be obtained as letters from institutional officials that: (1) describe how the proposed Program will be an integral component of the institution’s broader vision with respect to multidisciplinary research; (2) outline how institutional barriers for multidisciplinary researchers will be or are being addressed; (3) guarantee at least 75% protected time (50% for urologic surgeons) for KURe scholars; and (4) describe the amount of space, release time and support made available to the K12 program.  

Recruitment Plan: Applicants should include a plan describing selection procedures for recruiting scholars. These plans should include recruiting efforts to enhance diversity. The applicant institution may request support for two to five scholars. Programs may appoint scholars at any point during the fiscal year. The total number of scholars appointed at any given time is limited to a total of five.  Institutions are encouraged to design a program that is appropriate for their pool of potential scholars and participating faculty/mentors. The award provides support to institutions for up to five consecutive 12-month periods. Appointments are provided in 12-month increments.

Programmatic Interactions: Applications should include plans to facilitate annual interactions between their KURe scholars and perhaps mentors among KURe sites. KURe scholars will also be invited to attend NIDDK Career Development meetings which are held on a semiannual basis.

APPLICATION FORMAT

The instructions in the Form PHS 398 do not fully apply to the special needs of this grant application. Applicants should follow the modified instructions below in preparing an application for the Multidisciplinary K12 Urologic Research (KURe) Career Development Program. These instructions have been adapted to accommodate the PHS 398 and this K12 program.

1.      Face Page: Use Form Page 1 of the PHS 398. On Line 1, include the title that best represents the nature of the career development program. On Line 2, provide the number of the Request for Applications, RFA DK-07-006 and the RFA title “K12 Urologic Research (KURe) Career Development Program.”  The Program Director will be the Principle Investigator (PI) of the grant application.

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  

Letter of Intent Receipt Date: February 19, 2008
Application Receipt Date: March 18, 2008
Peer Review Date(s): June-July 2008
Council Review Date:August, 2008 (New Date October 2008 per NOT-DK-08-011)
Earliest Anticipated Start Date: September 30, 2008

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:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes, Digestive and Kidney Diseases
6707 Democracy Boulevard 
Democracy 2, Room 752 MSC 5452
Bethesda, MD 20892 (Courier service use 20817)
Telephone: (301) 594-8897
Email: fc15y@nih.gov
 
3.B. Sending an Application to the NIH

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

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

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

Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes, Digestive and Kidney Diseases
6707 Democracy Boulevard 
Democracy 2, Room 752 MSC 5452
Bethesda, MD 20892 (Courier service use 20817)
Telephone: (301) 594-8897
Email: fc15y@nih.gov

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

3.C. Application Processing

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

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

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 http://grants.nih.gov/grants/policy/policy.htm.

ALLOWABLE COSTS

Salary:  KURe scholars may be provided salary support of up to $140,000 each year. The level of salary support must be consistent with the applicant institution’s salary structure for persons of equivalent qualifications, experience, and rank.  The candidate is required to devote a minimum of 75% full-time effort (50% for urologic surgeons).  The institution may supplement the NIDDK contribution; however, the supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived.  In no case may PHS funds be used for salary supplementation.  Institutional salary supplementation may not require extra duties or responsibilities that would interfere with the purpose of this award. The total salary requested must be based on a full-time, 12-month staff appointment.

Research and Development Support:  Up to $55,000 per scholar can be requested for the following types of expenses: (a) research supplies, equipment and technical personnel; (b) tuition and fees related to didactic courses or career development; and (c) travel to research meetings or training. Of the funds requested, $35,000 should specifically be used for support of the candidate’s research-related activities to generate preliminary data (pilot projects or other research costs). Although not required, institutions are strongly encouraged to match or exceed this $35,000 for pilot projects.

Ancillary Salary Support: Salaries for ancillary personnel support, such as mentors, secretaries, and administrative assistants, are not allowed.  Partial salary for a dedicated administrator is allowable.  Minimal costs can be allocated for advertising and recruitment in order to attract the best candidates nationally. Some laboratory costs may be provided to mentors, typically no more than two per scholar, to offset expenses generated during the mentored research phase of the scholar’s training. The total amount for ancillary salary support and laboratory costs should not exceed $65,000.  

Facilities and Administrative Costs:  These costs, which were formerly called indirect costs, will be reimbursed at 8 percent of modified total direct costs.  The KURe Program award, using a K12 mechanism and administered by the NIDDK, is not subject to the Streamlined Non-competing Application Process (SNAP).  In general, this means that all reporting of budgetary information and program progress are provided in greater detail in an annual progress report. 

Carryover of Unobligated Balances: The K12 award is subject to Expanded Authorities, with the exception of the authority to carry forward funds from one fiscal year to the next.  Such carryover must be approved by the NIDDK Grants Management Branch.  An FSR should be submitted annually as part of the progress report.

Other Income: Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, or honoraria from other institutions for lectures or seminars, provided these activities remain incidental and provided that the retention of such pay is consistent with the policies and practices of the grantee institution.

Fees other than those named above including those resulting from clinical practice, professional consultation, or other comparable activities required by the research and research-related activities of this award may not be retained by the career award recipient. Such fees must be assigned to the grantee institution for disposition by any of the following methods: (a) the funds may be expended by the grantee institution in accordance with the NIH policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation.  Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution; (b) the funds may be used for health-related research; or (c) the funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks should be made payable to the Department of Health and Human Services, NIH and forwarded to the Director, Division of Financial Management, NIH, Bethesda, Maryland, 20892.  Checks must identify the relevant award account and reason for payment.

Usually, funds budgeted in an NIH supported research or research training grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted.  The NIDDK will give consideration to approval for the use of released funds only under unusual circumstances.  Any proposed retention of funds released as a result of a career award must receive prior written approval of the NIDDK.

Pre-Award Costs: 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.

Leave: In general, scholars may receive salary during the normal periods of vacation and holidays observed by individuals in comparable positions at the grantee institution.  For the purpose of these awards, however, the period between the spring and fall semesters is considered to be an active time of research and is not considered to be a vacation or holiday.  Scholars may receive salary for annual and sick leave, according to the institution’s policy. Scholars also may receive salaries for up to 30 calendar days of parental leave per year for the adoption or birth of a child when those in comparable positions at the grantee institution have access to paid leave for this purpose and the use of parental leave is approved by the Program Director. 

A period of terminal leave is not permitted and payment may not be made from grant funds for leave not taken.  Individuals requiring periods of time away from their research career development experience longer than 30 days must seek approval from the NIDDK for an unpaid leave of absence.

Special Leave: A KURe scholar may be allowed to take leave to another institution, including a foreign laboratory, if directly related to the purpose of the award.  Only local, institutional approval is required if such leave does not exceed three months.  For longer periods, prior written approval of NIDDK staff is required. To obtain prior approval the KURe scholar must submit a letter to NIDDK Program Staff describing the plan, countersigned by his or her mentors, the Program Director, department head and the appropriate institutional official. A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the award will continue during such leave.

6. Other Submission Requirements

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.
 
Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

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 expects that grant 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 NIDDK in accordance with the review criteria stated below.

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

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed career development program will have a substantial impact on the pursuit of these goals and those described in the purpose of this RFA. 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, the application may not propose a particularly innovative approach, but the other elements of the proposed program may be very strong.

1. Ability to Meet the Intent of this RFA: Will the proposed program be able to facilitate the career development of scholars in a multidisciplinary environment for independent careers in urologic research?  Will the program provide individualized career development for scholars? Will scholars be exposed to approaches necessary to foster cross-disciplinary collaborations?  Are there plans to ensure distribution of scholars among the mentors and participating divisions and to maintain a multidisciplinary environment throughout the Program? Are there adequate plans for ancillary enrichment activities? If there are NIDDK-supported Centers or other large projects at the applicant institution, are there plans to take advantage of the resources provided for the benefit of the proposed KURe Program? If there are other training-related programs at the applicant institution, is there adequate consideration given to potential interactions with the proposed KURe Program? Is there adequate information provided to understand what distinguishes the proposed KURe Program from these other training-related or career development efforts?

2. Program Director: Does the Program Director have the track record in leadership, research, and administration to direct the K12 Program? Does he/she have a track record in career development, mentorship and training? Does the Program Director have an active urology-related research program in an area relevant to the interests of the NIDDK?

3. Faculty Trainers/Mentors: Are the members of the training faculty and the proposed mentors successful in research? Do they have research interests in benign urologic disease, basic urologic research, and/or mission interests of the NIDDK (http://www2.niddk.nih.gov/Research/ScientificAreas/Urology/)?  Do they have a track record of mentorship and training? Are plans to mentor candidates appropriate? Are there formal mechanisms for providing programmatic guidance to mentors who may also be new to multidisciplinary approaches? Are there plans to provide general mentorship training and feedback to mentors?

4. Candidate Pool/Selection Process: Does the application demonstrate an adequate pool of potential high-quality KURe scholars and a well-defined selection process? Are there adequate plans to meet diversity objectives? Are there enough high-quality scholars to allow multidisciplinary training? If the applicant currently has or has had another K12 program, did that program have sufficient high-quality scholars and are those scholars engaged in research at the present time as judged by their current position, publications, and evidence of independent support? Are there enough high-quality scholars and faculty mentors to support an additional program?

5. Support of Pilot Projects: Will the process and review criteria for evaluating the KURe Scholars’ research projects meet the high scientific standards of an NIH review? Will they be adherent to all applicable Federal rules and regulations? Are the plans for review and selection of pilot projects sufficiently rigorous such that a scholar is likely to successfully transition to independent support? Does the institution provide additional funds to support the pilot projects? Are there adequate means for ensuring that as a group, the scholars’ research projects span the breadth of the interests of the participating faculty and divisions?

6. Programmatic Interactions: Are there formal and informal programmatic activities to enhance interactions among the scholars? Are the plans for interactions with scholars in other KURe Programs or other career development programs? Are there plans for programmatic enrichment activities, and are these plans appropriate for enhancement of the multidisciplinary training of the expected scholar pool at the institution?     

7. Institutional Commitment: Is the institutional leadership committed to this Program and its goals? Does the institution provide assurances that it intends the Program to be an integral part of its research endeavor? Have institutional barriers to multidisciplinary training and career development been adequately addressed? Does the commitment include specific commitments such as tuition rebates, seed monies for pilot projects, and adequate space? Is there a commitment to protected time for all scholars, particularly clinicians?

8. Evaluation/Tracking Plan: Do the proposed plans adequately provide a means to receive meaningful feedback about the program?  Is it clear how the Program will respond to feedback and incorporate suggestions? Is there a tracking system to follow candidates and evaluate outcomes after they leave the Program?

9. Advisory Committee: Are the members of the Advisory Committee representative of the variety of disciplines and training backgrounds involved in the Program?

10. Innovation: Does the proposed Program offer innovative ways to cross-train the candidates? Are there novel approaches to assisting candidates in developing an independent research career?

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. The priority score should not be affected by the evaluation of the budget.

Training in the Responsible Conduct of Research: Every KURe candidate supported by the K12 must receive instruction in the responsible conduct of research.  (For more information on this provision, see http://grants.nih.gov/grants/guide/notice-files/not92-236.html ) Applications must include a description of a program to provide formal or informal instruction in scientific integrity or the responsible conduct of research.  Applications without plans for instruction in the responsible conduct of research will be considered incomplete and will be returned to the applicant without review.

Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, and policies regarding the use of human and animal subjects.  Within the context of training in scientific integrity, it is also beneficial to discuss the relationship and the specific responsibilities of the institution and the predoctoral students appointed to the program.

NIH scientific review groups will assess the applicant’s plans on the basis of the appropriateness of topics, format, amount and nature of the faculty participation, and the frequency and duration of instruction.  The plan will be discussed after the overall determination of merit, so that the review panel’s evaluation of the plan will not be a factor in the determination of the priority score. Plans will be judged Acceptable or Unacceptable. The acceptability of the plan will be described in an administrative note on the summary statement.  Regardless of the priority score, applications with unacceptable plans will not be funded until the applicant provides a revised acceptable plan.  Staff within the NIH awarding component will judge the acceptability of the revised plan.

2.C. Sharing Research Data
 
Data Sharing Plan: 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. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing.

2.D. Sharing Research Resources

NIH policy expects that grant 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 (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/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).

3. Reporting

SPECIAL ADMINISTRATIVE REQUIREMENTS

Change of Institution: The KURe Program cannot be transferred from one institution to another.

Change of Program Director: If the Program Director moves to another institution or resigns from the position, support of the award may be continued with NIDDK prior approval provided:

PROGRESS REPORTS 

An Annual Progress Report for the grant is required. This report should provide information about changes in the Program, an FSR, a summary of the on-going evaluation results, a summary report from the Program Advisory Committee (including information about newly selected candidates if applicable), and a description of the research and career progress of each candidate. These Annual Progress Reports will be closely monitored by NIDDK staff to ensure that the grant is achieving the goals of the KURe program. Progress reports should be submitted using the Form PHS 2590, which can be obtained at the following website address: http://grants.nih.gov/grants/funding/2590/2590.htm . Forms are also available at most institutional offices of sponsored research.

Since the Form PHS 2590 is used for many different grant mechanisms across the NIH, the following information should be included:

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.  An FSR should be submitted with the annual progress report as described above.

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:

Laura K. Moen, Ph.D.
Division of Kidney, Urologic, and Hematologic Diseases
National Institute of Diabetes, Digestive, and Kidney Diseases
6707 Democracy Boulevard
Democracy 2, Room 623 MSC 5458
Bethesda, MD 20892 (Courier service use 20817)
Telephone: (301) 594-4748
FAX: 301-480-3510
Email: lm232f@nih.gov

2. Peer Review Contacts:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes, Digestive and Kidney Diseases
6707 Democracy Boulevard 
Democracy 2, Room 752 MSC 5452
Bethesda, MD 20892 (Courier service use 20817)
Telephone: (301) 594-8897
Email: fc15y@nih.gov

3. Financial or Grants Management Contacts:

William Etti
Grants Management Branch
National Institute of Diabetes, Digestive and Kidney Diseases
6707 Democracy Boulevard
Democracy 2, Room 722, MSC 5456
Bethesda, MD 20892
Telephone: (301) 594-7451
Email: we20o@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 the scientific merit or the priority score.

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

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

Authority and Regulations: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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

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


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