PAR-01-085: MIDCAREER INVESTIGATOR AWARD IN PATIENT-ORIENTED RESEARCH FOR RESEARCHERS IN FEMALE PELVIC FLOOR DISORDERS (K24)

Department of Health
and Human Services (HHS)

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This Program Announcement expires 3 years from the date of release, unless reissued. MIDCAREER INVESTIGATOR AWARD IN PATIENT-ORIENTED RESEARCH FOR RESEARCHERS IN FEMALE PELVIC FLOOR DISORDERS (K24) Release Date: April 27, 2001 PA NUMBER: PAR-01-085 National Institute of Child Health and Human Development (http://www.nichd.nih.gov) National Institute of Diabetes and Digestive and Kidney Diseases (http://www.niddk.nih.gov) PURPOSE The purpose of the National Institute of Child Health and Human Development (NICHD) and National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Midcareer Investigator Award in Patient-Oriented Research for Researchers in Female Pelvic Floor Disorders (K24) is to provide support for clinician researchers in female pelvic floor disorders to allow them protected time to devote to patient-oriented research and to act as mentors for beginning clinical investigators. The target candidates are outstanding clinical scientists who are actively engaged in patient-oriented research related to female pelvic floor disorders; who have demonstrated a high level of research productivity; and who can demonstrate the need to sustain an intensive research focus that will enhance the progress of their own research and provide them greater opportunity to serve as mentors to beginning clinical researchers in female pelvic floor disorders. The award is intended to further both the research and mentoring endeavors of outstanding patient- oriented investigators in the field of female pelvic floor disorders, to enable them to expand their potential for significant contributions to their field, and to act as mentors for beginning clinician researchers. For the purposes of this award, patient-oriented research is defined as research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator directly interacts with human subjects. This area of research includes: (1) mechanisms of human disease; (2) therapeutic interventions; (3) clinical trials; and (4) the development of new technologies. Also for the purposes of this award, female pelvic floor disorders refer to a group of clinical conditions affecting women that includes pelvic organ prolapse, urinary incontinence, fecal incontinence, rectal prolapse, and other sensory and emptying abnormalities of the lower urinary tract and gastrointestinal tract. The NICHD and NIDDK are especially interested in increasing the number of scientists trained to conduct high-quality clinical research in female pelvic floor disorders. Accordingly, this award forms an important part of the NIH initiative to attract and retain talented individuals to the challenges of patient-oriented research. With a view towards stabilizing clinical research settings and preventing an interruption in trainee mentoring, the NIH has established the MIDCAREER INVESTIGATOR AWARD IN PATIENT-ORIENTED RESEARCH (see http://grants.nih.gov/grants/guide/pa-files/PA-00-005.html). This award is intended to relieve clinical investigators from patient care duties and administrative responsibilities, thereby increasing the opportunities for clinicians in midcareer to be well grounded in patient-oriented research. This initiative is consistent with the recommendations of the NIH Director's Panel on Clinical Research (http://www.nih.gov/news/crp/97report/index.htm) and the recommendations of the Institute of Medicine Committee on Addressing Career Paths for Clinical Research. 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 Program Announcement (PA) is related to one or more of the priority areas. Potential applicants may obtain "Healthy People 2010" at http://www.health.gov/healthypeople. ELIGIBILITY REQUIREMENTS Applications may be submitted on behalf of candidates by domestic, non- Federal organizations, public or private, such as medical, dental, or nursing schools or other institutions of higher education. Minorities, women, and individuals with disabilities are encouraged to apply. The prospective candidate for the NICHD/NIDDK Midcareer Investigator Award in Patient-Oriented Research for Researchers in Female Pelvic Floor Disorders should propose a period of patient-oriented research related to female pelvic floor disorders consistent with his or her research and clinical experience and the need for further development of his or her research skills. The program should be carefully tailored to meet the individual needs of the candidate and must include a description of a research project that meets the definition of patient-oriented research related to female pelvic floor disorders. This award is intended to enable the candidate to devote a greater percent effort to patient-oriented research related to female pelvic floor disorders. Candidates for this award must be established clinical researchers in female pelvic floor disorders with a strong track record of publications and successful competition for research support. Candidates must have peer- reviewed, independent research support at the time of this award. This support could include National Institutes of Health (NIH) awards (e.g., R01) or awards from other sources such as private foundations, professional organizations, or industry. However, researchers may apply for this award in the absence of research grant support, if the institutional commitment includes stability of salary and research support. Candidates must have a record of supervising junior researchers. Finally, candidates for this award must be able to demonstrate the need for protected time to advance their research careers and mentoring activities. Candidates for this award must have a health-professional doctoral degree or its equivalent. Such degrees include, but are not limited to, the M.D., D.O., D.D.S., D.M.D., O.D., D.C., Pharm.D., N.D. (Doctor of Naturopathy), as well as doctorally prepared nurses. In addition, individuals holding the Ph.D. degree may apply for the award if they normally perform clinical duties. Generally, candidates must have completed their specialty training within 15 years of submitting the application, but exceptions to this last requirement can be made on a case-by-case basis. For example, an interruption in career progression due to family, military, or other personal circumstances might justify eligibility for candidates with more than 15 years of experience since the completion of clinical training. Candidates are advised to discuss their eligibility with the contacts listed under INQUIRIES, below. Candidates must spend at least 25 percent effort (up to 50 percent effort) conducting patient-oriented research related to female pelvic floor disorders and mentoring. The project period may be up to five years (a minimum of three years is required). At the time of award, candidates must be citizens or noncitizen nationals of the United States, or must have been lawfully admitted to the United States for permanent residence (i.e., in possession of a currently valid Alien Registration Receipt Card I- 551, or other legal verification of such status). Noncitizen nationals are generally persons born in outlying possessions of the United States (i.e., American Samoa and Swains Island). Individuals on temporary or student visas are not eligible. A candidate for this award may not concurrently apply for any other PHS award that duplicates the provisions of this award. Recipients of this award are required to hold independent research support, either federal or private, during the period of this award. However, they may not receive additional compensation on another federal award that exceeds the maximum allowable salary compensation ($161,200 per year as of January 1, 2001; refer to the notice on salary limitation published in the NIH Guide at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-013.html). MECHANISM OF SUPPORT This PA will use the NIH Midcareer Investigator Award in Patient-Oriented Research (K24) award mechanism. Planning, direction, and execution of the program will be the responsibility of the candidate on behalf of the applicant institution. However, the institution must demonstrate a commitment to the candidate and the candidate's goals for career development. The project period may be for up to five years (at least three years are required). Awards are renewable for one additional five-year period if the candidate still meets the stated requirements. RESEARCH OBJECTIVES The objectives of the NICHD/NIDDK Midcareer Investigator Award in Patient- Oriented Research for Researchers in Female Pelvic Floor Disorders (K24) are to: o encourage established, midcareer clinician scientists to devote more time to patient-oriented research related to female pelvic floor disorders and enhance their clinical research skills in order to conduct meritorious patient-oriented research and mentor beginning clinical investigators. o increase the pool of clinical researchers who can conduct patient-oriented studies, capitalizing on the discoveries of biomedical research and translating them to clinical settings. Background In September 1998, the NICHD, in collaboration with NIDDK, the Office of Research on Women's Health, the National Institute on Aging, and the Office of Rare Diseases, held a workshop to examine the state of basic, epidemiological, and clinical research addressing pelvic floor disorders in women. A consensus emerged that underscored the lack of a substantive knowledge related to these disorders, and directions for future research support to remedy these deficiencies were discussed. To that end, NICHD has developed a series of Requests for Applications (RFAs) related to basic science, epidemiologic, and clinical management aspects of pelvic floor disorders in women (Basic Science Research in Female Pelvic Floor Disorders, http://grants.nih.gov/grants/guide/rfa-files/RFA-HD-99-003.html; Epidemiologic Research on Female Pelvic Floor Disorders, http://grants.nih.gov/grants/guide/rfa-files/RFA-HD-00-012.html; and Clinical Trials Network in Female Pelvic Floor Disorders, http://grants.nih.gov/grants/guide/rfa-files/RFA-HD-00-013.html). In addition, NIDDK and NICHD are collaborating on the Urinary Incontinence Treatment Network, a multicenter study of surgical treatment in women with urinary incontinence (http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-99-001.html and http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-01-018.html). In addition, researchers expressed concern that, under current conditions at academic centers, investigators had less time to pursue research activities and to provide guidance to junior investigators. The NIH has recognized this as a global problem facing clinical investigators. To help support clinicians and allow them protected time to devote to patient-oriented research and to act as mentors for beginning clinical investigators, the Midcareer Investigator Award in Patient-Oriented Research was developed by NIH. It was first announced in 1998 and updated in October 1999 (http://grants.nih.gov/grants/guide/pa-files/PA-00-005.html). Female pelvic floor disorders is a high priority area for research funding at NICHD and NIDDK. A need was identified to provide protected time for midcareer investigators for research and mentoring activities. In response, the NICHD and NIDDK developed this modification of the Midcareer Investigator Award in Patient-Oriented Research to specifically solicit applications from researchers in female pelvic floor disorders. A need also was identified for support to provide training and career development opportunities for young investigators in female pelvic floor disorders. This type of support is provided by the K23 Mentored Investigator Award in Patient-Oriented Research (see http://grants.nih.gov/grants/guide/pa-files/PA-00-004.html) or the K12 Women's Reproductive Health Research Scholar Program (see http://www.nichd.nih.gov/new/releases/whrc99.cfm and http://www.nichd.nih.gov/new/releases/obgyncenter.cfm). Individuals who may be eligible for a mentored research career development award are encouraged to contact the program staff listed in the above sources or program staff listed in this Program Announcement for further information. Scope of Program Environment: The applicant institution must have a well-established research program in female pelvic floor disorders and resources for clinical research career development. Collaboration between different disciplines interested in female pelvic floor disorders (e.g., gynecology and obstetrics, urology, gastroenterology, colorectal surgery, physical therapy) is encouraged, but is not an absolute requirement for the application. If applicable, the existence of advanced training or fellowship programs related to female pelvic floor disorders should be described and the candidate's involvement in such programs should be detailed. The institution must be able to demonstrate a commitment to the candidate as a productive, independent investigator. The candidate and institution must be able to describe a career development program that will utilize the relevant research and educational resources. The institution must certify that the candidate will be released from other duties and be able to devote up to 50 percent effort (at least 25 percent effort) to achieve the research and mentoring objectives of this award. The institution must demonstrate the availability of beginning clinical investigators to be mentored. Program: The award provides up to five (at least three) consecutive 12-month awards. Up to 50 percent of the investigator's effort (at least 25 percent) must be devoted to the patient-oriented research program and mentoring. The remainder may be devoted to other clinical, teaching, or research pursuits consonant with the objectives of the award. The research phase of an award period must be devoted to patient-oriented research related to female pelvic floor disorders. Allowable Costs: 1. Salary: The NIH will provide salary for the award recipient for levels of effort between 25 and 50 percent. The actual salary provided by the award is based on the candidate's full-time, 12-month institutional salary and the level of effort requested up to the maximum legislated salary rate in effect at the time of award. For example, in Fiscal Year 2001, the maximum allowable annual salary is $161,200 for a full-time position (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-013.html for further information on current salary limits). Therefore, in FY 2001, the maximum annual base salary that will be provided for an award recipient at 50 percent effort is $80,600. In all cases, the salary requested 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. The award will also provide fringe benefits on the calculated base salary at the established institutional rate. The institution may supplement the NIH contribution to the salary up to a level that is consistent with the institution's salary scale. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the award. In addition, recipients of this award may derive additional compensation for effort associated with other Federal sources or awards provided the total salary derived from all Federal sources does not exceed the maximum legislated salary rate and the total percent effort does not exceed 100 percent. 2. Research Development Support: It is expected that candidates for this K24 award will have active, independent research support at the time of the award (see ELIGIBILITY REQUIREMENTS). The K24 award provides additional funds of up to $25,000 per year for the following expenses: (a) tuition, fees, and books related to career development; (b) research expenses, such as supplies, equipment, and technical personnel for the Principal Investigator and his/her mentored clinical investigators; (c) travel to research meetings or training; and (d) statistical services including personnel and computer time. 3. Ancillary Personnel Support: Salary for secretaries, technical or administrative assistants, and other ancillary personnel is not allowed. 4. Facilities and Administrative Costs: These costs (formerly called indirect costs) will be reimbursed at eight percent of modified total direct costs. Other Income: Fees 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 funds must be assigned to the grantee institution for disposition by any of the following methods: o 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; o The funds may be used for health-related research purposes; o The funds may be paid to miscellaneous recipients 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; o 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. 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 NICHD or 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 from the NICHD or NIDDK. Evaluation: In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program. Accordingly, recipients 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. Special Leave: Leave to another institution, including a foreign laboratory, may be permitted 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 from the NICHD or NIDDK is required. To obtain prior approval, the award recipient must submit a letter to the NICHD or NIDDK describing the reason for the period of leave and including a description of provisions made to ensure that the awardee will be able to continue meeting the special requirements of this award for a suitable research environment and for the continued mentoring of junior investigators. The plan for the period of leave must be countersigned by his or her 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 career development 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 or NIDDK and will be granted only in unusual situations. 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. Termination or Change of Institution: When a grantee institution plans to terminate an award, the NICHD or NIDDK must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. If the individual is moving to another eligible institution, career award support may be continued provided: o Provisions for continued mentoring of junior investigators have been made; o A new career award application (K24) is submitted by the new institution; o All conditions of the award are met at the new institution; o The period of support requested is no more than the time remaining within the existing award period; and o The new application is submitted far enough in advance of the requested effective date to allow the necessary time for review. Review of these materials is usually carried out by NICHD or NIDDK staff. However, depending on the circumstances, the NICHD or NIDDK may also require review by a scientific review group and/or the National Advisory Child Health and Human Development Council, and/or the National Diabetes and Digestive and Kidney Diseases Advisory Council. 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 and career award recipient in writing of this determination, the reasons therefor, the effective date, and the right to appeal the decision. A final progress report, invention statement, and Financial Status Report are required upon either termination of an award or relinquishment of an award in a change of institution situation. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS 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 biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are 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 research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The revisions relate to NIH-defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. 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, published in the NIH Guide for Grants and Contracts, March 6, 1998, and available on the Internet at: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. URLS IN NIH GRANT APPLICATIONS AND 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) using the instructions in Section IV, as appropriate (see Application Instructions, below). These forms are available at most institutional offices of sponsored research, on the Internet at http://grants.nih.gov/grants/funding/phs398/phs398.html, and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892- 7910, telephone 301-710-0267, E-mail: Grantsinfo@nih.gov. Applications will be accepted on standard receipt dates as listed in the PHS 398. Application Instructions Potential candidates are strongly encouraged to contact the NICHD or NIDDK staff person listed under INQUIRIES. Such contact should occur early in the planning phase of application preparation and will help ensure that applications are responsive to the goals and policies of the NICHD and NIDDK. Applicants who will be using a General Clinical Research Center (GCRC) are requested to include a letter from either the GCRC program director or the Principal Investigator with the application. The application must contain the following: Candidate o A description of the candidate's commitment to a career in patient- oriented research. o Evidence of the candidate's ability to conduct high quality patient- oriented research. o A demonstrated record of mentoring or training of clinical investigators or a demonstration of the capability to provide mentoring to beginning clinical investigators. o A description of immediate and long-term career objectives, explaining how the award and the requested protected time will contribute to their attainment. o A description of how the award will contribute to a patient-oriented research program and how it will relieve the candidate from other patient care or administrative duties. Research Plan o A commitment of up to 50 percent effort (at least 25 percent effort) to the patient-oriented research program. o A description of the ongoing patient-oriented research. The research plan should briefly describe the specific aims, the background and significance of the studies, and the research design and methods. Additional research may be proposed as a basis for this award. o Documentation that appropriate and adequate resources, both in terms of support and facilities, are available to the candidate to conduct the research program. This must include a listing of all current and pending research support. Mentoring Plan o A description of plans for providing mentoring opportunities to beginning clinical investigators. This should include a description of the previous training and specialization of clinical investigators who will be mentored, the availability of such individuals at the applicant institution, plans for recruiting and selecting supervisees, and the type of educational and research experiences that will be provided. Environment and Institutional Commitment o The sponsoring institution must document a strong, well-established patient-oriented research and training program related to the candidate's area of interest including a high-quality research environment with staff capable of productive collaboration with the candidate. The sponsoring institution also must provide a statement of commitment to enhancing the candidate's ability as a productive, independent investigator. o The sponsoring institution must provide documentation that the candidate will be relieved of other duties, patient care, administrative, etc., to allow him/her to devote time to the patient-oriented research program. Budget Instructions The total direct costs must be requested in accordance with the K24 program guidelines, following the budget instructions in the application. Biographical Sketch A biographical sketch is required for all key personnel, following the instructions in section IV of Form 398 (rev. 4/98). Submission Instructions The title and number of this Program Announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. 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 BETHESDA, MD 20817-7710 (for express/courier service) For investigators in obstetrics and gynecology (including urogynecology), at the time of submission, two additional copies of the application should be sent to: L. R. Stanford, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E03, MSC 7510 Bethesda, MD 20892-7510 Bethesda, MD 20852 (for express/courier service) For investigators in urology or digestive diseases, at the time of submission, two additional copies of the application should be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes, Digestive and Kidney Diseases 6707 Democracy Boulevard Room 653, MSC 5452 Bethesda, MD 20892-5452 Bethesda, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the Center for Scientific Review and for eligibility for the K24 award by NICHD or NIDDK staff. Incomplete and/or ineligible applications will be returned to the applicant without further consideration. Applications will be evaluated for scientific and technical merit by a peer review group convened by the NICHD or NIDDK Division of Scientific Review in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the National Advisory Child Health and Human Development Council and/or the National Diabetes and Digestive and Kidney Diseases Advisory Council. Review Criteria Candidate: o Quality of the candidate's academic and research record, track record as a successful leader of a productive research program, and commitment to a continuing career in patient-oriented research related to female pelvic floor disorders; o Evidence of ongoing high quality patient-oriented research related to female pelvic floor disorders; o Demonstrated record of mentoring or training of junior investigators, or a demonstration of the capability to provide mentoring to beginning clinical investigators; o Appropriateness of the content and duration of the proposed research program; o A record of monetary support for patient-oriented research related to female pelvic floor disorders. Research Plan: Although K24 applications do not require the level of detail necessary in regular research grant applications, a fundamentally sound research plan must be provided. In general, less detail is expected with regard to research planned for the later years of the award, but the application should outline the general goals for these years. o Appropriateness of the research plan as a vehicle for demonstrating skills and capabilities to junior investigators in patient-oriented research related to female pelvic floor disorders; o Scientific and technical merit of the proposed research; o Relevance of the proposed research to the candidate's career objectives; o Availability of adequate resources to conduct the research program; o Demonstration that the proposed program and protected time will relieve the candidate from non-research patient care and administrative duties and allow him or her to devote additional time to patient-oriented research related to female pelvic floor disorders; and o Adequacy of plans for including women, minorities, and children as appropriate for the scientific goals of the research, or justification for exclusion. Mentoring Plan: o Experience or potential to serve as a mentor; o Adequacy of the plans for mentoring or supervising beginning clinicians in patient-oriented research related to female pelvic floor disorders; o Appropriateness of the proposed level of effort committed to the mentoring component. Environment and Institutional Commitment: o Applicant institution's commitment to the scientific development of the candidate and assurances that the institution intends the candidate to be an integral part of its research program; o Adequacy of research facilities and the availability of appropriate educational opportunities; o Quality and relevance of the environment for scientific and professional development of the candidate and others pursuing patient-oriented research in female pelvic floor disorders; and o Applicant institution's commitment to provide adequate protected time for conduct of the research and mentoring program. AWARD CRITERIA Applications will compete for available funds with all other scored career development award applications. Funding decisions will be based on the recommendations of the scientific review group and the National Advisory Child Health and Human Development Council and/or the National Diabetes and Digestive and Kidney Diseases Advisory Council, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this PA are strongly encouraged especially during the planning phase of the application. Direct inquiries regarding programmatic issues to: Anne M. Weber, M.D., M.S. Center for Population Research National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8B-13C, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6972 Fax: (301) 496-0962 Email: webera@mail.nih.gov Leroy M. Nyberg, M.D., Ph.D. Urology Program Director Division of Kidney, Urologic and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Two Democracy Plaza, Room 617 6707 Democracy Boulevard Bethesda, MD 20892-5458 Telephone: (301) 594-7718 Fax: (301) 480-3510 Email: nybergl@extra.niddk.nih.gov Direct inquiries regarding fiscal and administrative issues to: Diane M. Watson Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17J, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (Express Mail) Telephone: (301) 496-5001 FAX: (301) 402-9015 Email: dw40j@nih.gov Trude Hilliard Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Telephone: (301) 594-8859 FAX: (301) 480-3504 Email: hilliardt@extra.niddk.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.864, Population Research (NICHD), and No. 93.849 (NIDDK). Awards are made under the authority of Title III, Section 301 of the PHS Act as amended. The Code of Federal Regulations, Title 42 Part 52 and Title 45 Part 74, are applicable to this program. This program is not subject to the intergovernmental review requirements of Executive Order 12372 to Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-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.

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