Part I Overview Information

Department of Health and Human Services

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

Components of Participating Organizations
National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov)

Title: Male Reproductive Health Research Career Development Program

Announcement Type
New

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

Request For Applications (RFA) Number: RFA-HD-05-040

Catalog of Federal Domestic Assistance Number(s)
93.865

Key Dates
Release Date: July 20, 2005
Letters of Intent Receipt Date(s): October 21, 2005
Application Receipt Dates(s): November 21, 2005
Peer Review Date(s): February/March 2006
Council Review Date(s): May 2006
Earliest Anticipated Start Date: July 1, 2006
Additional Information To Be Available Date (Url Activation Date): NA
Expiration Date: November 22, 2005

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
   4. Intergovernmental Review
   5. Funding Restrictions

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

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

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

 Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description

1. Research Objectives

The NICHD invites institutional career development award applications for Male Reproductive Health Research (MRHR) Career Development Programs. These programs will support the research career development of urologists, reproductive endocrinologists and other clinicians who have recently completed sub-specialty training and who are commencing basic, translational and/or clinical research relevant to male reproductive health. The goal of this initiative is to increase the clinical research capacity among practitioners in the area of male reproductive biology and promote the translation of basic science advances to clinical practice. The programs will accomplish this through a mentored program, bridging clinical training with research independence. The intent is to stimulate clinical research in male reproductive health and bring a more holistic approach to fertility regulation in clinical practice in which the male is an equal partner.

Background

There is a clinical void in male reproductive health care that is currently filled by a diffuse collection of practitioners, including urologists, internists, general practitioners and endocrinologists; however, there is a dearth of practitioners in this field who are able to translate the rapid advances in male gamete biology and genetics into effective treatments for male infertility and contraception. Although male contraception and infertility have been included in the scope of many programs sponsored by the NICHD Reproductive Sciences Branch, translational and clinical research in the male has been slow to build on this progress. For example, of the 14 Specialized Cooperative Centers in Reproductive Research, only one focuses on the male. Additionally, of the NIH-funded human research studies in fiscal year 2001, only 29 percent of sex-specific studies were male-only and the majority of those dealt with prostate cancer and benign hyperplasia, diseases atypical of reproductive-aged men (http://www4.od.nih.gov/orwh/GoldReport_2000-01.pdf). Thus, the currently available mechanisms have failed to recruit clinicians with a strong research base into the area of male fertility and contraception.

These areas, however, remain critical components of the NICHD Strategic Plan in Reproductive Health. Establishing a base of clinical investigators in male reproductive health will speed the design of effective treatments for male infertility and male fertility regulation, promote the analysis of the long-term effects of new synthetic hormone treatments designed for contraceptive use, and facilitate the discovery of genetic factors of male infertility by providing the necessary patient population and epidemiology. The basic and clinical investigations on the male reproductive system need to converge to take advantage of the current efforts to discover novel molecular targets of male fertility regulation (http://grants.nih.gov/grants/guide/rfa-files/RFA-HD-01-020.html and http://grants.nih.gov/grants/guide/rfa-files/RFA-HD-02-028.html). This will translate into novel therapeutic agents and diagnostics for male fertility and reproductive health.

In order to facilitate this convergence, the Male Reproductive Health Research Career Development awards provide institutions with an opportunity to support the early careers of junior clinical investigators in male reproductive health. Established investigators at a research institution would combine to establish a career development program -- agreeing to serve as mentors to recruited Scholars who are newly trained in a medical specialty relevant to male reproductive health. The mentors make available their expertise, guidance and laboratory facilities to be utilized by the junior investigators for research projects that will enhance their basic science knowledge and skills. The research projects can be either basic or clinical in nature, as long as there is a described career development plan that would delineate how the project would enhance the Scholar's ability to conduct individual, peer-reviewed research at the end of the project period. Further details of the program are described below under "Special Requirements."

Research Scope

Applications responsive to this RFA may propose a program encompassing several aspects of male reproductive health. The following list of topics provides examples and should not be considered exhaustive:

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

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the NIH Mentored Research Career Development Program (K12) award mechanism(s). 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 NICHD intends to commit approximately $600,000 in total costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2006 to support one to two 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 of up to $400,000 per year. F & A costs for these awards are limited to eight percent of modified total costs.

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

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:

A clinical department containing appropriate expertise in relevant areas of male reproductive health may submit applications. Examples of these include departments of Urology, Internal Medicine, Endocrinology, and Reproductive Endocrinology. The applicant institution must have the clinical specialties and subspecialties and the clinical and research facilities sufficient to meet the purposes of the Program, that is, to bridge clinical training with a career in basic, translational and/or clinical research in male reproductive health.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed program is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

The Principal Investigator of the Program must be a senior faculty member such as a Dean, Department Chair or Director of a research institute or center. He/She should possess the scientific background, leadership and administrative skills required to coordinate and supervise a multidisciplinary research and career development program of this scope.

2. Cost Sharing or Matching
Not applicable

3. Other-Special Eligibility Criteria

Special Programmatic Requirements

A. Male Reproductive Health Research (MRHR) Scholars: The Scholar position is a junior faculty appointment, not a fellowship. At the time of the award, the scholar candidates must: 1) be a physician holding the M.D. or M.D./Ph.D. degree; 2) have completed post-graduate residency training normally expected for a faculty appointment in their field (including clinical or postdoctoral fellowship training, or residency if they have chosen not to subspecialize); 3) identify an approved mentor with extensive research experience 4) be able to commit at least 50-75 percent of full-time professional effort conducting research and research career development; 5) not have been a Principal Investigator on an R01, R29, or subproject of a Program Project (P01), Center (P50, P60, U54) grant, a mentored career development (K-series) grant, or other equivalent research grant award. Scholars may have had support on an NRSA grant (F32, T32) or NIH Small Grant (R03) or an NIH Exploratory/Developmental Research Grant (R21); and 6) be a U.S. citizen or non-citizen national or must have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (I-151 or I-155) or some other verification of legal admission as a permanent resident. Individuals on temporary or student visas are not eligible.

Completion of subspecialty training is not required of candidates in general practice in their specialty; however, those who chose to subspecialize must have completed their fellowship. To accommodate the needs of those interested in participation in this program who may have had a career hiatus because of family responsibilities, uniformed service, etc., there is no limit on time elapsed since completion of training. However, Scholars cannot have more than six years of research training experience beyond their last doctoral degree.

Support is in the form of a minimum of two consecutive 12-month appointments, renewable in annual increments for up to five years total, and is contingent upon satisfactory progress as reported to the Advisory Committee and to the NICHD in the annual progress report of the Program. In general, at least 75 percent of the MRHR Scholars' full-time effort must be devoted to the research program of the award. Those Scholars in certain surgical subspecialties may have less than 75 percent effort, but no less than 50 percent effort, proposed and only if sufficiently justified and with the approval of the awarding component. MRHR Scholars may not accept or hold any other PHS award that duplicates the provisions of this career award. Programs are encouraged to recruit members of underrepresented minorities, women and candidates with disabilities. During the period of this award, Scholars are encouraged to apply for, and may accept and hold, independent research grant support with the consent of the awarding component. Individuals mentored through an institutional K12 award may hold concurrent support from their career award and a competing NIH research grant when recognized as a Principal Investigator or subproject Director while in the last two years of career award support. This policy can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html.

B. Program Composition: Applicants must describe or propose a multidisciplinary career development program that will maximize the use of relevant research and educational resources to foster education, training, mentoring and professional development of Scholars, including women and minorities, in biomedical research careers. The Program must have a strong research base, comprising the research investigations of established scientists who will provide expertise, resources and mentoring to the MRHR Scholars. The research base must be broad and relevant to current areas of research interest and need in male reproductive health. The environment should be one that will stimulate and increase the interactions between basic scientists and clinical investigators likely to benefit from mentored research career development. Of major importance, the Program must have a scientifically sound and equitable procedure for recruiting and selecting MRHR Scholars and projects to be supported. There must be documented evidence of an institutional commitment to support the Program's human and tangible resources and its goal of developing and retaining productive, independent investigators in areas of male reproductive health.

There should be a plan for ongoing evaluation of the Program in terms of recruitment and retention goals, including for women and minorities, completion success, overall outcome, the curriculum, and Program staff. For purposes of evaluating the impact of research career development programs, awardees must agree to provide NICHD with information on career outcomes for those appointed to the program. The Principal Investigator will supply this information at least annually. There should be a plan for periodic research meetings and networking for all Scholars and mentors. The NICHD will convene an annual meeting for Scholars and relevant program personnel at the NIH.

C. Principal Investigator: The Principal Investigator of a Program must be a senior faculty member such as a Dean, Department Chair or Director of a research institute or Program. He/She should possess the scientific expertise, leadership, and administrative capabilities required to coordinate and supervise a multidisciplinary research and development program of this scope. As an option, the application may request a co-investigator to serve as the Program Director, with responsibility for some or all of the day-to-day operations of the Program. The Program Director should be an established investigator and have experience and qualifications complementing those of the Principal Investigator. The Program Director should possess the scientific expertise, leadership, and administrative capabilities required to coordinate and supervise a program for developing junior investigators. The Program Director should have a record of accomplishment for mentoring successful investigators.

D. Career Development Program: The K12 award provides five years of funding for the Program. The Program will support MRHR Scholars for periods of two to five years consisting of consecutive 12-month appointments. The Program may be divided into two distinct phases, if appropriate: (1) the first one to two years of a basic and/or clinical science-training component, followed by, (2) an intensive research experience under the general guidance of a qualified mentor. At least 50-75 percent of the MRHR Scholar's full-time professional effort must be devoted to the K12 program. The remainder of the recipient MRHR Scholar's time may be devoted to developing other clinical or academic pursuits consonant with the objectives of the award. The 50-75 percent minimum effort in this program is intended to be primarily devoted to research; however, Scholars may, as needed, receive formal didactic coursework to support their career development, which may include, for example, biostatistics, epidemiology, health economics, clinical evaluation sciences, and clinical trials.

E. Advisory Committee: The Advisory Committee will be a group of scientists from the sponsoring department, and other departments or institutions as appropriate, with interests relevant to the Program's research programs. It may include mentors. The two major functions of the committee are to evaluate: (1) applications from MRHR Scholar candidates, and (2) the overall conduct of the Program. Specifically, the committee makes recommendations to the Principal Investigator as to MRHR Scholar appointments, evaluates ongoing research activities annually (including the interaction and integrated nature of the Scholars' research experience), makes recommendations regarding their continuation, and makes recommendations to the Principal Investigator regarding priorities for use of the Resource Laboratory, if applicable. The committee may use institutional or outside consultants if needed. Plans to include members or consultants from outside institutions should be described in the application, but such individuals should not be named. The committee is a formal part of the structure of the Program. It should meet regularly and keep written minutes, which may be reviewed as part of a competing or noncompeting application. In addition, an annual evaluation by the Advisory Committee is recommended.

F. Institutional Environment: The applicant institution must show commitment to the Program's goals, and provide assurances that the institution intends the Program and the supported MRHR Scholars to be an integral part of its research endeavor. Research facilities and training opportunities will be a critical part of the environment. Applicant institutions should provide a guarantee of 50-75 percent protected time for the MRHR Scholars for research. Applicant institutions should demonstrate commitment to recruitment and retention of racial and ethnic minorities and individuals with disabilities.

G. Mentors: Each MRHR Scholar appointed under the K12 award must have a primary sponsor who is recognized as an independent investigator, who is actively involved in basic, translational, and/or clinical research relevant to this initiative, and who has a successful record of providing research training of a type expected in this Program. An assigned mentor will provide guidance for the development of each MRHR Scholar assigned to the program. The mentor must be committed to continue this involvement throughout the MRHR Scholar's total period of development under the award. Mentors not included in this application must be approved by NICHD Program Staff before being assigned a Scholar.

H. Resource Laboratory: The laboratory resources of the Program comprise the research laboratories of the established investigators serving as mentors, as well as a shared resource laboratory to be utilized by the mentors and the MRHR Scholars whose activities they will supervise. With strong justification, a shared Resource Laboratory may be requested as part of the Program, within the total budget. Such a resource would provide skilled technical services to complement and extend the capabilities of the mentors to promote the career development of the MRHR Scholars. The shared Resource Laboratory might include scientific services such as, but not limited to, assays, molecular biology, histopathology or biostatistics. Requests for this Resource Laboratory must be justified in terms of cost-effective enhancement of the research resources that will serve at least three MRHR Scholars' projects. The laboratories of the mentors are not supported directly by the K12 grant. The Resource Laboratory, if any, may be a new entity or an extension or enhancement of an existing facility. The award may support professional direction of the Resource Laboratory, up to 50 percent effort for a new facility and up to 20 percent effort for an existing facility, as well as technical assistance, supplies, equipment, and appropriate costs of operation. Institutional commitment to the shared Resource Laboratory must be demonstrated, and may take the form of providing or renovating space, purchase of required equipment, and/or support of personnel. The Principal Investigator, Program Director, and Resource Laboratory Director are responsible for efficient and equitable utilization of the Resource Laboratory based on recommendations from the Advisory Committee. If the proposed Resource Laboratory is an existing facility, a clear commitment from the existing Laboratory Director must be provided in the application to supporting the work of the MHRH Scholars.

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.

3. Submission Dates and Times
Applications must be received on or before the receipt date described below (Section IV.3.A).

3.A. Receipt, Review and Anticipated Start Dates

Letters of Intent Receipt Date(s): October 21, 2005
Application Receipt Dates(s): November 21, 2005
Peer Review Date: February/March 2006
Council Review Date: May 2006
Earliest Anticipated Start Date: July 1, 2006

3.A.1. Letter of Intent

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

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NICHD 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:

Tracy L. Rankin, Ph.D.
Reproductive Sciences Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 8B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier; non-USPS service)
Telephone: (301) 435-6979
FAX: (301) 496-0962
Email: rankint@mail.nih.gov

3.B. Sending an Application to the NIH

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

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

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

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

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier or non-USPS delivery service)
Telephone: (301) 496-1485
FAX: (301) 402-4104
Email: stretchr@mail.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 NICHD. Incomplete and non-responsive applications will not be reviewed.

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

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

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

6. Other Submission Requirements

The application must use the Research Career Award (RCA) section of the PHS 398. The table of contents for the RCA should be followed, except for those items modified under Sections I and II (below). The abstract should summarize the actual proposal, including the candidate pool, research topics, goal of the program regarding career development, and the environment.

Section I - Basic Administrative Data: Include all the information requested in this RCA section. List as Key Personnel the Principal Investigator, Program Director, if any, Resource Laboratory Director, if any, and mentors. Do not list Advisory Committee members unless they are also mentors. Budget requests must be provided according to the instructions in form PHS 398. A composite page 4 for the entire Program budget request should be followed by one page 4 for the Scholars' costs and one page 4 for Administration and shared Resource Laboratory (if applicable) costs. Provide page 5 for the composite only. The requests for tuition and fees, books, travel, research development expenses, etc., must be justified and specified by category. Provide a Biographical Sketch and Other Support pages for all Key Personnel.

Section II - Specialized Information: Make the following modifications in this RCA section.

(1) Begin with an overview of the proposed Program: Summarize the immediate and long-term objectives of the Program. Describe the background, purpose and objectives of this career development Program. This description should include a discussion of the strategies to be used to ensure that the objectives of this RFA are met. The description should clearly show how the purpose and objectives meet the broader objectives and intent of NICHD to support the development of independent clinical investigators in male reproductive health.

(2) The Scholar Candidate: Describe in general terms the pool of potential candidates including information about the types of prior clinical and research training. Do not name prospective Scholars. Describe the criteria to be used for candidate evaluation for selection as MRHR Scholars. Describe plans to recruit candidates including those from racial or ethnic groups that are currently underrepresented in biomedical, behavioral, or clinical sciences and explain how these plans will be implemented.

(3) Statement by Sponsor: Summarize the immediate and long-term career objectives of the Program, explaining how the Program will contribute to their attainment. Describe the career development plans for prospective candidates. Considering the Program goals and the likely goals of prospective candidates, describe a plan to provide the necessary research background and experiences, considering the expected range of prior research training in the applicant pool. For example, candidates with little previous research experience may require a phased developmental period in which the first phase of support under this award may include the first year or two of didactic training in basic and/or clinical research sciences. For these candidates, a second phase would be an intensive, supervised research experience to complete a longer developmental program. More experienced candidates may benefit from entering immediately into a mentored research experience of at least two years supported by this award. Provide brief summaries of career development plans that the Program will employ. The application should contain a description of how the career development plan will be tailored to the needs of the prospective candidates, taking into account their past experiences and competencies, and should distinguish the plan from fellowship training.

(4) Advisory Committee: Describe the composition of the Advisory Committee, identifying by name and role the internal members, and the desired expertise (but not the name or affiliation) of external members, if any. Describe how the Advisory Committee will function in providing oversight of the development, implementation, and evaluation of recruitment strategies and the recruitment and retention of candidates. Describe how the Advisory Committee will monitor and evaluate candidates and the evaluation of the overall effectiveness of the career development program.

(5) Environment and Institutional Commitment to Candidate: Describe the research infrastructure, facilities, etc. that are available and accessible to this Program. This includes the existence of funded laboratories and research activities that will meet and sustain the needs of the Program. Provide information establishing the commitment of the applicant institution, the Principal Investigator, the Program Director, if any, and the faculty mentors to providing developmental experiences that lead to independence in biomedical, behavioral, and/or clinical research relevant to male reproductive health. Letters from faculty mentors are not required unless they are collaborators from other institutions. Include the specifics of institutional support. There is no dollar requirement, but significant commitment will be considered a strength of the application. Provide a statement that Scholars participating in this Program will be guaranteed 50-75 percent protected time to devote to research and research career development.

(6) Research Plan: For each faculty member proposed as a potential mentor, provide a paragraph describing the proposed research relevant to the goals expressed in this RFA that may be the foundation of a MRHR Scholar's research experience in the Program. The research experiences may include basic, translational, and clinical research approaches to biomedical or behavioral problems in male reproductive health. Lengthy, detailed protocols or plans for specific experiments should not be included. No limits are specified for the number of proposed mentors; however, fewer than six may not provide sufficient choice of projects, while more than 15 may dilute the focus on male reproductive health. For each proposed mentor, describe the pertinent research experience and record of accomplishment in training junior investigators. In a table, name up to five current or former students or fellows the faculty member has trained, with dates (month/year), where trained, title of project, academic level, and present position and institution. Include a list of current funded research for each proposed mentor participating in the Program.

The proposed Program Director, if any, should have a record of accomplishment for mentoring successful investigators. Describe the scientific expertise, leadership, and administrative capabilities required to coordinate and supervise a program for developing junior investigators. Describe the career development record of the Program Director, as determined by the success of his/her former students or fellows. In a table, name up to five current or former students or fellows the Program Director has trained, with dates (month/year), where trained, title of project, academic level, and present position and institution. Include a list of current funded research.

Applicants who will be using a General Clinical Research Program (GCRC) are requested to include a letter with the application from either the GCRC Program Director or the Principal Investigator.

(7) Responsible Conduct of Research: Applications must describe a program to provide formal and informal instruction on scientific integrity and ethical principles in research. Applications without plans for instruction in the responsible conduct of research will be considered incomplete and may be returned to the applicant without review.

Budget and Related Issues

(1) Allowable costs

The Program structure may have these elements:

a) Administration costs: Salary and fringe benefits for the Program Director, if any, up to 10 percent effort, as well as a part-time administrative assistant whose duties are specifically devoted to this program, may be requested. No compensation may be requested for the Principal Investigator. Travel to an annual NICHD Directors' meeting for the Principal Investigator and the Program Director, as well as travel to an annual NICHD meeting for current Scholars, must be requested. Travel must also be requested for one additional training or scientific meeting per year for current Scholars.

b) Resource Laboratory costs: Budgets may include salaries and fringe benefits for a Resource Laboratory Director (up to 50 percent for a new facility, up to 20 percent for an existing facility), other technical staff, supplies, animals, and equipment purchase and maintenance. The budget for the Resource Laboratory must be included in the Administration cost. The sum of the budgets for Administration and a Resource Laboratory may not exceed $100,000 total costs (Direct plus F & A costs) per year.

c) Scholars' costs: As part of the Scholars' costs, an application must request a minimum of three MRHR Scholar positions. The NICHD will provide support for each MRHR Scholar position of up to $100,000 total costs (Direct plus F & A) per year.

Salary Support: Scholars may be provided salary support of no more than $75,000 plus fringe benefits annually. The institution may supplement the NICHD salary contribution up to a level that is consistent with the institution's salary scale; however, 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 supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the Program. The total salary requested for each MRHR Scholar must be based on a full-time, 12-month staff appointment. It must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. See also, the NIH policy on determining full-time professional effort for career awards (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-056.html).

Individuals mentored through an institutional K12 award may hold concurrent support from their career award and a competing NIH research grant when recognized as a Principal Investigator or subproject Director while in the last two years of career award support. This policy can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html.

Research Development Support: Within each MRHR Scholar's total award, up to $25,000 annually is allocated for research and development support, which can include expenses such as (a) travel to training or scientific meetings; (b) tuition, fees; (c) supplies and equipment; and (d) technical support and statistical or computer services. These career and development costs must be specifically documented for each individual candidate and must be specifically related to the candidate's research activities. They cannot be pooled and used for other programs unrelated or indirectly related to the research activities of individual Scholars.

d) Facilities and Administrative costs: F & A (formerly, indirect) costs will be reimbursed at eight percent of modified total direct costs.

(2) Non-allowable Costs

Grant funds may not be requested for the following: Compensation for the Principal Investigator or mentors; direct support of the mentors' laboratories; compensation of administrative personnel normally paid from institutional overhead charges; administrative activities such as public relations, or health or educational services; travel of the Principal Investigator, Program Director or mentors to scientific meetings; costs of clinical care; and alterations and renovations.

Other Income

Scholars may retain royalties and fees for activities such as scholarly writing, service on advisory groups, honoraria from other institutions for lectures or seminars, fees resulting from clinical practice, professional consultation or other comparable activities, provided that these activities remain incidental, are not required by the research and research-related activities of this award, and provided that the retention of such pay is consistent with the policies and practices of the grantee institution.

All other income and fees, not included in the preceding paragraph as retainable, may not be retained by the scholar.  Such fees must be assigned to the grantee institution for disposition by any of the following methods:

Usually, funds budgeted in an NIH supported research grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted.  The awarding component 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 NIH awarding component.

Plan for Sharing Research Data
Not applicable

Sharing Research Resources
Not applicable

Section V. Application Review Information

1. Criteria

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

The following will be considered in making funding decisions:

2. Review and Selection Process

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

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

The goal of this career development program is to bridge the transition to research independence for junior faculty who are conducting research in men's reproductive health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed Progam will have a substantial impact on the pursuit of these goals:

Program Overall:

Candidates:

Career Development Plan:

Research Plan:

Mentors:

Resource Laboratory, if applicable:

Environment:

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

2.C. Sharing Research Data
Not applicable

2.D. Sharing Research Resources
Not applicable

3. Anticipated Announcement and Award Dates
Not applicable

Section VI. Award Administration Information

1. Award Notices

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

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the Notice of Award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

Special Administrative Issues

(1) Special Leave: Candidates appointed to this program career award may engage in research experiences at another institution, including a foreign site, 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 or for work at a foreign site, prior written approval of NICHD is required. To obtain prior approval, the Principal Investigator must submit a letter describing the plan, countersigned by the appropriate institutional official, to the NICHD. A copy of a letter or other evidence from the performing institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made.

Support from the career award will continue during such leave. Leave without award support may not exceed 12 months. Such leave requires the prior written approval of the NICHD and will be granted only in an unusual situation. Support from other sources is permissible during the period of leave. Such leave does not reduce the total number of months of program support for which an individual is eligible. Parental leave will be granted consistent with the policies of the NIH and the grantee institution.

(2) Termination: The Director of the NIH may discontinue an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, the Director of the NIH shall notify the grantee institution in writing of this determination, the reasons therefore, the effective date, and the right to appeal the decision.

(3) Change of Institution: The Program cannot be transferred from one institution to another.

(4) Change of Principal Investigator and Program Director: Awards are made to a specific institution for a specific Program under the guidance of a particular Principal Investigator and Program Director, if any. Changes in any of these parameters require prior approval by the NICHD under the following conditions:

a) The current Principal Investigator of the awardee institution has submitted a written request to NICHD staff for change of Principal Investigator or Program Director, countersigned by the appropriate institutional business official, describing the reasons for the change. The Biographical Sketch of the proposed new Principal Investigator or Program Director, including a complete listing of active research grant support, has been provided. The information in the request establishes that the specific aims of the original peer-reviewed program to be conducted under the direction of the new Principal Investigator or Program Director will remain unchanged, and that the new Principal Investigator or Program Director has the appropriate research and administrative expertise to lead the program.

b) The request is submitted far enough in advance of the requested effective date to allow the necessary time for review.

(5) Changes of Program: Awards are made for a specific Program, and any planned changes must be immediately discussed with and receive approval from the NICHD Scientific/Research contact listed in Section VII.

3. Reporting

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

Special Reporting Requirements

(1) Progress Reports: An Annual Progress Report for the grant is required. This report should provide information about career outcomes, changes in the Program, an evaluation of the Program made by the Advisory Committee, and a description of the research and career progress of each candidate. These Annual Reports will be closely monitored by NICHD staff to ensure that the grant is achieving the goals of this initiative.

Progress reports are submitted using the Form PHS 2590 (http://grants.nih.gov/grants/funding/2590/2590.htm). The procedure for obtaining the face page for the application is described at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-066.html.

Since the Form PHS 2590 does not apply easily to the K12 grant, adapt the application for continuation to contain the following information:

(2) Evaluation: In carrying out its stewardship of human resource related programs, the NICHD may request information essential to an assessment of the effectiveness of this program. Accordingly, recipients (PIs, individual Scholars) are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

(3) Final Progress Report: A final progress report, invention statement, and Financial Status Report are required upon either completion of an award or relinquishment of an award.

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:

Tracy L. Rankin, Ph.D.
Reproductive Sciences Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 8B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier or non-USPS delivery service)
Telephone: (301) 435-6979
FAX: (301) 496-0962
Email: rankint@mail.nih.gov

2. Peer Review Contacts:

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

3. Financial or Grants Management Contacts:

Ms. Victoria Connors
Grants Management Team Leader
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier or non-USPS delivery service)
Telephone: (301) 496-5482
FAX: (301) 451-5510
Email: connorsv@mail.nih.gov

Section VIII. Other Information

Required Federal Citations

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

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

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

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data-sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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/archive/archive/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.

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.

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

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

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

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

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

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

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

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

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50 percent 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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