kristoff@GENBANK.BIO.NET (Dave Kristofferson) (03/16/91)
$$XID RFA CA9111 CA-91-11 P1O1 ***************************************** REQUEST FOR APPLICATIONS RFA: CA-91-11 MINORITY ONCOLOGY LEADERSHIP ACADEMIC AWARD P.T. 34, FF; K.W. 0785140, 0745020, 0745027, 0745070, 0755030, 0795003 National Cancer Institute Letter of Intent Date: April 5, 1991 Application Receipt Date: May 17, 1991 I. PURPOSE The Comprehensive Minority Biomedical Program, Division of Extramural Activities, National Cancer Institute (NCI), invites academic health centers or schools and other health professional schools that employ, educate or serve a preponderance of minority faculty, staff, trainees and communities to submit applications for the support of an individual to pursue leadership activities in the development of research and training programs in clinically oriented cancer research (defined as including population research; surgical, medical or radiation oncology; cancer prevention and control; epidemiology and biostatistics; nutrition; clinical pharmacology and clinical trials; behavioral medicine and related areas of cancer research). II. BACKGROUND The proportion of clinically trained biomedical investigators who are members of minority groups is strikingly lower than the percentage of minority U.S. citizens. For example, while 12 percent of the U.S. population is African American, less than 1 percent of persons holding an M.D. or equivalent degree are African American. Furthermore, the number of doctorates, both M.D.s and Ph.Ds, in other underrepresented ethnic minority groups (such as native Americans and Hispanics) is correspondingly small. The percentage of minority clinicians on the faculty of health professional schools in general is lower still, as is their representation as investigators in research projects funded by agencies of the Federal government. At the same time, minority groups often are underrepresented as subjects in research projects involving human populations. Such deficiencies in representation may call into question the applicability of findings to minority groups, or may fail to uncover significant diversity among different populations that may lead to important new scientific insights. One method of addressing this problem is by broadening the experience of faculty at minority health professional schools that serve these populations in the initiation and participation in cancer research. In doing so, the pool of clinical biomedical investigators in all aspects of cancer research will be increased, and trainees will become more cognizant of research opportunities in oncology and related disciplines. These institutions represent a unique concentration of minority faculty, trainees, and patients to address the needs outlined above. III. GOALS AND SCOPE This award is aimed at encouraging and assisting a designated leader in any of the minority health professional schools to increase his/her institution's efforts in clinical cancer research in the areas such as medical oncology, prevention, etiology, diagnosis, treatment, or control; and to aid in establishing a cadre of faculty and staff capable of developing new research protocols and increasing participation in intervention studies and clinical trials in these areas. These awards offer opportunities for supporting start-up or expansion of such activities, and are intended to meet needs that have not been addressed by other types of awards available from the NCI or other Federal agencies. Priority is given to those minority institutions with an interest in and commitment to expansion of clinical cancer research-related activities in local populations. IV. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health grant-in-aid (K07). Applicants will be responsible for the planning, direction, and execution of the proposed project. Except as otherwise stated in this Request for Applications (RFA), awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1990. Awards are non-renewable and non-transferable from one awardee to another. Funding beyond the first year of the grant is contingent on satisfactory progress during the preceding year. Future program interest in this initiative will be announced through the NIH Program Announcement mechanism. Up to $350,000 in total costs per year will be committed specifically to fund applications submitted in response to this RFA. It is anticipated that between 2 and 4 awards will be made from the competition for this K07 solicitation. This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCI, the award of grants pursuant to this RFA is also contingent upon the continuing availability of funds for this purpose. The earliest feasible start date for the initial award is September 30, 1991. Awards may be requested for a period of 3 to 5 years. Allowable costs include: A. A portion of the salary of the faculty leader up to a maximum of $50,000 per year and related fringe benefits. B. Costs for further optional preparation of the faculty leader in additional clinical or basic research methodologies (this aspect of the program is not to exceed the equivalent of one academic year total over the duration of the award). C. Domestic travel expenses for the awardee to attend professional meetings, training courses, and an annual two-day awardee meeting in Bethesda, MD. D. Partial salary support up to $40,000 per year for one additional faculty or staff researcher as a direct participant in research-related activities or services. E. Up to $10,000 per year in supplies for research activities. F. Indirect costs not to exceed a maximum of 8 percent of direct costs, exclusive of tuition fees, if any. G. Categorical amounts cited above notwithstanding, the total award may not exceed $100,000 in direct costs per year. V. ELIGIBILITY AND REQUIRED ELEMENTS A. Minority School A minority health professional school is defined as a medical, dental, pharmacy, public health, or equivalent school in which students of minority ethnic groups including African Americans, Hispanics, American Indians, and Asians or Pacific Islanders comprise a significant proportion of the enrollments and that has a commitment to the special encouragement of minority faculty, students, and investigators. B. Candidate To be eligible, candidates must: o Have an appropriate clinical academic appointment at the institution at the time the award is activated. The candidate must be a citizen, a non-citizen national of the U.S., or have been lawfully admitted to the U.S. for permanent residence. o Have appropriate documented research experience and background in a clinical oncology specialty and/or cancer research. o Specify a program for enhancement of personal research skills as needed, and for the conduct of research in one or more areas cited in this announcement. Proposed research should be described in sufficient detail for reviewers to evaluate the likelihood of success of this element of the plan. All sources of support proposed for this activity should be indicated. o Present a program for developing or improving clinical cancer research and training capabilities at the grantee institution. o Commit a minimum of 60 percent total time and effort to the research and development aspects of the program. o Agree to report annually on the status of the program and to meet annually to exchange information with NCI staff and other awardees. o Specify a plan for evaluating the effect of this award on the candidate and institution. C. Institution The institution must: o Name and sponsor a senior or mid-level faculty member with research competence and a major career interest in oncology and/or clinical cancer research and related training programs. o Present plans to develop or improve cancer-related research and research training educational programs. o Identify and document the availability of resources (populations, patients, manpower, materials, equipment, laboratory facilities) necessary to implement the proposed program. o Provide the candidate with time to acquire any new skills necessary for individual professional development and for the development of the program. o Provide access to facilities for clinical and related research protocols. o Provide evidence of commitment from the highest levels of administration and from the sponsoring Departmental chairpersons to implement the proposed program and to coordinate it with other ongoing activities. o State the mechanisms planned for continued institutional support of the program in the future. VI. REVIEW PROCEDURES AND CRITERIA REVIEW PROCEDURE Upon receipt, applications will be reviewed initially by the Division of Research Grants (DRG) for completeness. Incomplete applications will be returned to the applicant without further consideration. Evaluation for responsiveness to the program requirements and criteria stated in the RFA is an NCI program staff function. Applications that are judged non-responsive will be returned to the applicant . Questions concerning the relevance of proposed research to the RFA should be directed to program staff as described in the INQUIRIES section. Applications will receive technical review by an initial review group appointed by the NCI, with secondary review by the National Cancer Advisory Board. REVIEW CRITERIA A. Background and potential of the named candidate as a leader in research and training activities in oncology and cancer, and demonstration of effectiveness as a leader within the institution. B. Merit of the candidate's personal plan for development and his/her plans for fostering increased research and training within the institution. C. Scope and nature of the collaboration and commitment among participating departments and/or schools. D. Merit of the institutional plan to strengthen research and training activities beyond the current status of activities and capacities. E. Appropriateness and potential efficacy of the proposed use of funds to achieve the goals of the award. F. Potential of the institution for recruitment and utilization of clinical populations and research training of clinical researchers. G. Commitment of the institution to strengthen clinical cancer research and to support the candidate's efforts in this regard. VII. METHOD OF APPLYING The research grant application form PHS 398 (revised 10/88) must be used in applying to this RFA. These forms are available at most institutional business offices, from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, 5333 Westbard Avenue, Bethesda, Maryland 20892, and from the NCI program director named below. The RFA label available in the application form PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in the most timely manner. In addition, the RFA number and title must be typed on line 2 of the face page of the application form. Submit a signed, typewritten original of the application, including the Checklist, and four (4) signed, exact photocopies, in one package to DRG at the address below. The photocopies must be clear and single sided. Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At time of submission, send two (2) additional copies of the application to: Referral Officer Division of Extramural Activitis National Cancer Institute Westwood Building, Room 848 5333 Westbard Avenue Bethesda, MD 20892 Applications must be received by May 17, 1991. If an application is received after that date, it will be returned. If the application submitted in response to this RFA is substantially similar to a research grant application already submitted to the NIH for review, but which has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA which is essentially identical to one that has already been reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. VIII. LETTER OF INTENT Prospective applicants are asked to submit by April 5, 1991, a letter of intent that includes a descriptive title of the proposed research, the name and address of the Principal Investigator, the names of other key personnel, the participating institutions, and the number and title of the RFA in response to which the application is being submitted. The letter of intent is of great benefit to the NCI in planning and implementing the review process although the letter is not required, is not binding, and does not enter into the review of subsequent applications. The letter of intent must be sent to the NCI Program Director: Dr. Lemuel Evans Division of Extramural Activities Comprehensive Minority Biomedical Program National Cancer Institute Building 31, Room 10A04 Bethesda, MD 20892 Telephone: (301) 496-7344 Fax: (301) 402-0062 IX. INQUIRIES Written or telephone inquiries concerning the objectives and scope of this RFA or inquiries about whether or not specific proposed research would be responsive are encouraged and should be directed to Dr. Lemuel Evans at the above address. The Program Director welcomes the opportunity to clarify any issues or questions from potential applicants. For information regarding budgetary/administrative issues related to this RFA, please contact: Mr. Leo Buscher, Jr. Chief, Grants Administration Branch National Cancer Institute National Institutes of Health Executive Plaza South, Room 216 Bethesda, MD 20892 Telephone: (301) 496-7753 This program is described in the catalog of Federal Domestic Assistance No. 93-398, Cancer Research Manpower. Awards are under the authority of Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grant policies and Federal Regulations 42 CFR Part 52 and 45 VCFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$XID RFA DK9108 DK-91-08 P1O1 ***************************************** REQUEST FOR RESEARCH GRANTS APPLICATIONS RFA: DK-91-08 P.T. 34; K.W. 0785095, 0755030, 0765033 STUDIES ON THE ETIOLOGY AND PATHOGENESIS OF POLYCYSTIC KIDNEY DISEASE National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: April 17, 1991 Application Receipt Date: May 15, 1991 The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) through the Division of Kidney, Urologic and Hematologic Diseases (DKUHD), invites research grant applications directed at defining and further characterizing the etiology and pathogenesis of Polycystic Kidney Disease (PKD). BACKGROUND Polycystic Kidney Disease is the most common genetic disease, affecting 500,000 Americans, with 7,000 new patients recognized each year. Since 1982, the number of newly- diagnosed patients has risen steadily, with a compound annual rate of 5.7 percent. Each child of an affected parent has a fifty percent chance of inheriting the gene. Two major types of PKD are recognized, autosomal dominant PKD and autosomal recessive PKD. Polycystic Kidney Disease ranks first among the inherited and congenital conditions leading to end-stage renal disease (ESRD); it ranks fourth as a primary cause of ESRD and as a basic diagnosis among newly identified ESRD patients. Males and females are affected equally, and its worldwide distribution appears to demonstrate that it affects all races. Although PKD was long considered to be primarily an adult disease, it also has been found to be a common cause of cystic disease in children, and thus must be considered in the differential diagnosis of the pediatric patient. The most common form of PKD in humans, autosomal dominant PKD (ADPKD), has nearly complete penetrance, but variable expression. About 25 percent of patients are unable to give a family history consistent with ADPKD, suggesting the possibility of a high rate of spontaneous mutations in the "PKD locus". An alternative possibility is that environmental or other factors may have a strong effect on the expression of ADPKD. A less frequent form of PKD in humans, autosomal recessive PKD (ARPKD), is inherited as an autosomal recessive trait. ARPKD is rarely recognized in parents of affected children, occurring once in 6,000 to 14,000 live births. Patients with less severe forms of the disease who survive the newborn period often develop renal insufficiency at some point during the course of the disease. A newly recognized type of PKD, acquired PKD (ACPKD), develops in kidneys injured by a variety of chronic renal disorders, and leads to progressive renal insufficiency. It also develops in long-term hemodialysis patients. This form of PKD has been associated with a high incidence of malignant transformation. A major advance in understanding PKD etiology was made in 1985. Using gene linkage techniques, a gene for ADPKD was localized to the short arm of chromosome 16. Although the gene itself was not found, DNA markers near the gene were identified. In 1988, an affected family was discovered in which the PKD gene was found in a location other than chromosome 16. That this was not a unique finding was confirmed by the subsequent finding of similarly affected families. The first gene, located on chromosome 16, has been called ADPKD1. The other gene(s) not yet localized, has been called ADPKD2 or non-ADPKD1, to convey the possibility that there may be even more than two ADPKD genes or loci. While ADPKD1 appears to account for 90 percent of all ADPKD in the Caucasian population, the distribution between the genotypes for other racial groups remains to be determined. The significance of the apparent correlation of the chromosomal localization with the time of onset of the disease needs to be examined. Thus, ADPKD, which appeared clinically to be one disease, actually may result from different genetic defects. Because the gene products are likely to be different, it is reasonable to expect that the clinical manifestations also will be different. Because the pathogenesis of PKD remains undefined, it is not possible to develop rational approaches to prevention and treatment. The nature of the biochemical defect, which leads to cyst formation and consequent cyst growth, and the relationship between the extent of cyst formation and the development of progressive renal insufficiency are not understood. There are proponents of the idea that the renal cyst may be one of a limited repertoire of responses of the kidney to tubular epithelial injury, and that injurious agents act in a limited number of pathways. However, there is increasing evidence that the primary abnormality is one of disordered cell growth whereby cyst formation and growth are controlled by the combined action of growth-promoting factors. Some evidence suggests that epidermal growth factor may initiate cyst formation, and that cyclic AMP accelerates cyst formation and expansion. PKD presents in a variety of clinical forms, often with a slow progressive course to renal insufficiency. Thus, different avenues of research should be pursued in order to gain a better understanding of the genetic factors leading to PKD, the pathogenetic mechanisms leading to cyst formation and growth, the diversity in clinical expression, and the identification of effective treatment to prevent or control this major problem. OBJECTIVES AND SCOPE The purpose of this Request for Applications is to stimulate high quality research efforts to further the understanding of the etiology and pathogenesis of PKD. Examples of areas for investigation include: Isolation, sequencing and cloning of the ADPKD1 gene(s); gene regulation studies; identification of linkage markers to define chromosomal location for the non-ADPKD1 gene(s) and for the ARPKD gene; examination of the heterogeneity of ARPKD; and characterization of gene mutations. Identification of key cellular and molecular pathogenetic factors leading to cyst formation and growth, including processes and factors resulting in epithelial proliferation, fluid accumulation, and regulation of extracellular matrix formation. Development of in vitro models of renal cyst formation using cell lines or isolates, such as those obtained by the transfection with various types of genetic material or immortalization of cells from affected persons. Applications proposing clinical trials are not requested at this time. MECHANISM OF SUPPORT The support mechanism for this program will be the traditional, individual, investigator-initiated Research Grant (RO1) Application, and it is governed by the policies applicable to such awards. Approximately $1.2 million in total direct and indirect costs are anticipated to be available to fund applications submitted in response to this RFA. However, the funding of such applications is contingent on the actual availability of funds, and the receipt of applications of sufficient scientific merit. It is anticipated that five to seven awards will be made, for an average of 4 years per award. The specific amounts to be awarded will depend on the merit and scope of the applications received. Furthermore, because diverse approaches may represent valid responses to this announcement, it is anticipated that there will be a range of costs among individual awards. Awards may be made to foreign institutions for research of unusual merit and promise, in accordance with PHS policy governing such awards. It is anticipated that support for successful applications will begin on September 30, 1991. Upon initiation of the program, the NIDDK will sponsor periodic meetings to encourage exchange of information among participating investigators, and with other investigators with related interests. Therefore, the application budgets must request travel funds for a two-day meeting each year, most likely to be held in Bethesda, Maryland. The application budget section also must include a statement indicating willingness of the applicant to participate in such meetings. The current policies and requirements that govern the review, funding, and performance of research grant programs of the NIH will prevail. SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Section 2, A-D of the Research Plan AND summarized in Section 2, E, Human Subjects. Applicants/offerors are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATIONS AND REVIEW PROCEDURES Upon receipt, applications will be reviewed by the Division of Research Grants (DRG) for completeness. Incomplete applications will be returned to the applicant without further consideration. Applications also will be evaluated for responsiveness to the RFA. Those judged non-responsive will be returned to the applicant but may be submitted as investigator-initiated regular research grants at the regular receipt dates. Questions concerning the responsiveness of proposed research to the RFA should be directed to Program staff (see the final page of this below). If the application submitted in response to this RFA is substantially similar to a research grant application already submitted to the NIH for review, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. In cases where the number of applications is large compared to the number of anticipated awards, the NIH may conduct a preliminary scientific peer review to eliminate those applications which clearly are not competitive. The NIH will withdraw administratively from competition those submissions judged to be noncompetitive, and will notify the applicant and the institutional business official. Those applications judged to be both competitive and responsive will be reviewed for scientific and technical merit by an Initial Review Group convened by the Division of Extramural Activities, NIDDK, solely to review these applications. Review criteria include: extent of relevance and/or contribution of the proposed research to the overall goals and objectives of the RFA; significance and originality of research goals and approaches; feasibility of the research and adequacy of the experimental design; experience and research competence of the investigator(s); adequacy of available facilities; inclusion of women and minorities (when applicable) or a clear rationale provided for their exclusion; appropriate consent forms for patient participation (when applicable); provision for the humane care of animals (when applicable); and appropriateness of the requested budget relative to the work proposed. Funding decisions will be based on scientific merit, program relevance, and availability of funds, and on recommendations by the Initial Review Group and the National Diabetes and Digestive and Kidney Diseases Advisory Council. METHOD OF APPLYING LETTER OF INTENT: Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the grant application, the name of the Principal Investigator, and any participating institutions. Such letters are requested in order to determine the number and scope of applications likely to be received. Their receipt will not be acknowledged. A letter of intent is not binding and will not enter into the review of any application submitted subsequently, nor is it required for application. This letter of intent, which should be received by April 17, 1991, must be sent to: Robert D. Hammond, Ph.D. Chief, Review Branch, DEA National Institute of Diabetes and Digestive and Kidney Diseases National Institutes of Health Westwood Building, Room 406 Bethesda, MD 20892 Applications must be submitted on form PHS 398 (revised 10/88) available in the Business or Research Grants Offices of most academic or research institutions, and from the Office of Grants Inquiries, Division of Research Grants, Room 449, Westwood Building, 5333 Westbard Avenue, National Institutes of Health, Bethesda, Maryland, 20892. Applications will be accepted until close of business on May 15, 1991. No extensions will be granted on the application deadline. The phrase "RFA DK-91-08: Studies on the Etiology and Pathogenesis Polycystic Kidney Disease" must be typed on line 2 of the face page of form PHS 398. Applicants should request a start date of September 30, 1991. THE RFA LABEL (AVAILABLE IN THE 10/88 REVISION OF APPLICATION FORM 398) MUST BE AFFIXED TO THE BOTTOM OF THE FACE PAGE OF THE ORIGINAL COPY OF THE APPLICATION. FAILURE TO USE THIS LABEL COULD RESULT IN DELAYED PROCESSING OF THE APPLICATION. The completed original application and four (4) signed, exact photocopies should be sent or delivered to: Grants Application Receipt Office Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Two additional copies of the application should be sent to: Robert D. Hammond, Ph.D. Chief, Review Branch, DEA National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 406 Bethesda, MD 20892 IT IS IMPORTANT TO SEND THESE TWO COPIES AT THE SAME TIME THAT THE ORIGINAL AND FOUR COPIES ARE SENT TO THE DIVISION OF RESEARCH GRANTS. IF THESE ARE NOT SENT IT CANNOT BE GUARANTEED THAT THE APPLICATION WILL BE REVIEWED IN COMPETITION FOR THIS RFA PROGRAM. TIME TABLE Letter of Intent April 17, 1991 Application Receipt Date May 15, 1991 Review by Council September 12-13, 1991 Anticipated Award Date September 30, 1991 Inquiries regarding this announcement may be directed to: Gladys H. Hirschman, M.D. Director, Chronic Renal Diseases Program National Institute of Diabetes and Digestive and Kidney Diseases National Institutes of Health Federal Building, Room 102 Bethesda, MD 20892 Telephone: (301) 496-8218 For fiscal and administrative matters, contact: Ms. Donna Huggins Grants Management Specialist Grants Management Branch National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 653 Bethesda, MD 20892 Telephone: (301) 496-7467 These programs are described in the catalog of Federal Domestic Assistance No. 93.849 - Kidney, Urologic and Hematologic Diseases Research - and awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 78- 4110, as amended; 42 USC 241) and administered under PHS Grant policies and federal regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subjected to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$XID RFA CA9113 CA-91-13 P1O1 ***************************************** REQUEST FOR APPLICATIONS RFA: CA-91-13 P.T. 34, FF; K.W. 0715035, 0710030 MINORITY SCHOOL FACULTY DEVELOPMENT AWARD National Cancer Institute Letter of Intent Receipt Date: April 5, 1991 Application Receipt Date: May 17, 1991 I. PURPOSE The Comprehensive Minority Biomedical Program, Division of Extramural Activities, National Cancer Institute (NCI), invites academic health centers or schools and other health professional schools that employ, educate or serve a preponderance of minority faculty, staff, trainees, and communities, to submit applications for support of activities directed at the development of faculty investigators at minority schools in areas relevant to cancer. The intent of the award is to provide the awardee with increased access to research opportunities through collaborative arrangements with outstanding cancer research scientists, usually at institutions within a 100 mile radius of the applicant organization. II. BACKGROUND Despite a variety of efforts directed toward increasing minority faculty representation, the percentage of minority faculty in U.S. medical and other health professional schools has remained at consistently low levels. The continuation of this deficiency is projected by observing the discrepancies between the proportion of underrepresented minorities in the medical school population and the general population. While 12 percent of the U.S. population is African American, less than 1 percent of persons holding a Ph.D. in science is African American and percentages for other minority groups are correspondingly small. The proportion of minority biomedical investigators, receiving funding support from agencies of the Federal government is strikingly low. This program is designed to offer support for cancer-related research to minority school faculty members at the M.D., Ph.D., or equivalent level who have the interest and capability to do state-of-the-art research in this area. III. GOALS AND SCOPE The objective of this Request for Applications (RFA) is to broaden the experience of faculty members at minority schools, to increase the pool of biomedical and behavioral investigators in cancer research, and have graduate and undergraduate students, most of whom will be minority individuals, become more cognizant of research opportunities in cancer research. IV. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health grant-in-aid (K14). Applicants will be responsible for the planning, direction, and execution of the proposed project. Except as otherwise stated in this RFA, awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1990. Applicants may request three to five years of support. Awards are non-renewable and nontransferable from one awardee to another. Funding beyond the first year of the grant is contingent on satisfactory progress during the preceding year. Future program interest in this initiative will be announced through the NIH program announcement mechanism. A set-aside of approximately $300,000 in total costs per year has been designated for this group of applications. The earliest feasible starting date for the initial award will be September 30, 1991. It is anticipated that three to four awards will be made. This funding level is dependent upon the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCI, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. V. ELIGIBILITY A Minority School A minority school is defined as a medical or non-medical college, university or equivalent school in which students of minority ethnic groups including African Americans, Hispanics, American Indians, and Asian or Pacific Islanders comprise a significant proportion of the school enrollment and that has a commitment to the special encouragement of minority faculty, students and investigators. B Faculty Development Award Candidate Candidates for this award are minority school faculty members who (1) are citizens of the United States, noncitizen nationals or permanent residents at the time of application, (2) have a M.D., PhD., or equivalent in a biomedical or behavioral science, (3) wish to receive specialized training in cancer research and (4) have the background and potential to become an independent biomedical investigator. A minimum of 50 percent effort annually must be committed to the award. Applicants may not apply for, or accept, other Public Health Service research grant support or its equivalent at the time of Minority School Faculty Development Award application, nor may they apply currently for any other type of academic award. However, they may apply for, and accept research grant support subsequent to award of the Minority School Faculty Development Award. C Mentor at Research Center Each candidate must also identify and complete arrangements with a mentor, preferably at a nearby majority or minority institution (within reasonable commuting distance) who is recognized as an accomplished, independently funded investigator in the research area proposed and who will provide guidance for the awardee's development and research plan. Plans for an intensive training period should be developed with the mentor. The commitment of the mentor and his institution to both the summer and academic year training must be evidenced by letters of support to be included in the application. A commitment from the mentor's department chairman must be included in the application. D Allowable Costs o Salary: The salary of the candidate may be requested up to a maximum of $50,000, plus fringe benefits, per annum for the time and effort committed to the activities of the award, consistent with similar pay scales at the applicant institution. o Research Support: A maximum of $10,000 annually for years 01 and 02 and $20,000 annually for succeeding years to provide for categories listed below: Equipment: Specialized research equipment essential to the proposed program; in accordance with PHS policy, title to such equipment will vest with the grantee institution. Supplies: Consumable supplies essential to the proposed program. Travel: Domestic travel for the awardee that is essential to the proposed program. Tuition and Fees: If essential to the awardee's individual research development program; and Other: Personnel, publication costs, computer costs, and other costs necessary for the research program. o Indirect costs will be provided for at a rate of eight percent of the total direct costs of each award, exclusive of tuition, fees, and expenditures for equipment. VI. REVIEW PROCEDURES AND CRITERIA Review Procedures Upon receipt, applications will be reviewed by the Division of Research Grants (DRG) DRG for completeness. Incomplete applications will be returned to the applicant without further consideration. Applications will be evaluated by NCI program staff to determine whether they are responsive to this announcement and meet the stated goals and objectives of this program. Applications that are judged non-responsive will be returned to the applicant. Questions concerning the relevance of proposed research to the announcement should be directed to program staff, as described in the INQUIRIES section. In cases where the number of applications is large compared to the number of awards to be made, the NCI will conduct a preliminary scientific peer review to eliminate those that are clearly not competitive. The NCI will remove from competition those applications judged to be noncompetitive for award and notify the applicant and institutional business official. Those applications judged to be both competitive and responsive will be reviewed for scientific technical merit by an appropriate review group convened by the Division of Extramural Activities, NCI. The second level of review by the National Cancer Advisory Board considers the special needs of the Institute and the priorities of the National Cancer Program. Review Criteria o The overall merit of the candidate's plan for research and the development of research skills. o The background and potential of the proposed candidate for development into an independent biomedical investigator. o The candidate's commitment to a research career. o The ability of both the minority institution and the training center to provide facilities, resources, and opportunities necessary for the candidate's research development. o The commitment of the institution to the faculty candidate's research and development must clearly be presented in the application, including statement(s) from the sponsor and the department chairman. o The qualifications, ability, and plans of the mentor who will provide the candidate with the guidance necessary for career development in research. Recognition of the mentor as reflected by receipt of support from national peer reviewed funding sources. VII. METHOD OF APPLYING A - Research grant application form PHS 398 (revised 10/88), must be used in applying for these grants. These forms are available at most institutional business offices; from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Room 449, Westwood Building, 5333 Westbard Avenue, Bethesda, Maryland 20892; and from the NCI Program Director named below. The RFA label available in the revised 10/88 revision of application form PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of your application such that it may not reach the review committee in time for review. In addition, the RFA number and title must be typed on line 2 of the face page of the application form. Submit a signed, typewritten original of the application, including the Checklist, and four (4) signed, exact photocopies, in one package to the address below. The photocopies must be clear and single sided. Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At time of submission, send two (2) additional copies of the application to: Referral Officer Division of Extramural Activities National Cancer Institute Westwood Building, Room 838 5333 Westbard Avenue Bethesda, MD 20892 Applications must be received by May 17, 1991. If an application is received after that date, it will be returned. If the proposed research section of the application submitted in response to this RFA is substantially similar to a research grant application already submitted to the NIH for review, but which has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA which is essentially identical to one that has already been reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. B - Instructions for Completing Applications Items on the application form that require explanation are listed below. Those not listed are considered to be self-explanatory. If additional space is needed to complete any of the items, use continuation pages and identify each item with its number. o Face Page (Page 12 of application form): Numbers below refer to items of Face Page. 1 - Title of Application must be the "NCI Minority School Faculty Development Award: K-14." 2 - Total Period must be at least three and no more than five years. 3 - Enter the total amount requested for the entire three to five-year project period (from the "Budget Estimates for All Years of Support Requested," page five of the application form). 4 - The application form requires signatures of the candidate and an authorized official of the applicant organization as certification that they agree to abide by PHS policies if an award is made. o Budget (Use pages four and five of application form and continuation pages): Refer to the section of this announcement entitled: "Provisions of the Award" for allowable budgetary items and amounts of support that may be requested. o Budget Justification: All budget items should be clearly labeled and justified. o Initial 12-month period: Present a detailed budget with justification for all requested items. o Future years: Indicate totals for each budget category and justify items other than the awardee's salary for each of the four future years. o Other support: The candidate should include all Federal and non-Federal fellowship, grant and contract awards - past, current, and pending. For each grant listed, give its number, subject of the research and title of the candidate's position, (e.g., co-investigator, research assistant) and level of effort. o Reference letters: Ask three persons to submit letters of reference to the following address by the application receipt date. Please list the names, titles, and complete addresses of these individuals on the last page of the grant application under the title "Reference Letters." These letters are to be forwarded by the referees directly to: Referral Officer Division of Extramural Activities National Cancer Institute Westwood Building, Room 838 5333 Westbard Avenue Bethesda, MD 20892 o Research and career development plans to be completed by the candidate. 1. Describe the research and career development plans for the requested five-year period of the award. a. Background Information i. Aspects of the candidate's education and training background that qualify him/her for participation in the program described. ii. Areas in the candidate's educational and training background that can be developed by the proposed program. b. Research Project The candidate should follow the guidelines in the instructions for PHS 398 (rev. 10/88) applications, pages 19-23. The candidate should describe the proposed five-year research program in sufficient detail to permit adequate evaluation. If, during the course of the outlined study, the awardee should find that he/she would like to alter the direction or emphasis of the research, such a change may be made with the approval of the mentor and of the NCI. 2. Information Provided by Mentor: The mentor should describe in detail: a. His/Her concept of the research and career development plan of the awardee. b. Specific plans for guidance counseling or any other formal or informal training of the candidate. c. How the supervision and training provided the candidate will promote his/her transition toward the status of an independent investigator in areas relevant to cancer by the end of the grant award period. d. His/Her curriculum vitae, bibliography, and research support. 3. Information Provided by Department Chairperson The chairperson of the department sponsoring the candidate should submit, as part of the application, a signed statement detailing the Department's commitment to the candidate during the term of the award. 4. Information Provided by the Mentor's Institution The chairperson of the participating Department at the Mentor's Institution should submit a signed statement detailing the Department commitment to the development of the candidate during the term of the award. SIGNED STATEMENT BY THE CANDIDATE: Candidates should submit as part of the application a signed statement indicating that they will abide by the requirements in this RFA and the PHS policies for grants and awards. VII. LETTER OF INTENT Prospective applicants are asked to submit, by April 5, 1991, a letter of intent that includes descriptive title of the proposed research, the name and address of the Principal Investigator, the names of other key personnel, the participating institutions, and the number and title of the RFA in response to which the application is being submitted. The letter of intent is of great benefit to the NCI in planning for and implementing the review process although the letter is not required, is not binding, and does not enter into the review of subsequent applications. VIII. INQUIRIES Written or telephone inquiries concerning the objectives and scope of the RFA or inquiries about whether or not specific proposed research would be responsive should be directed to: Dr. Lemuel A. Evans Director Comprehensive Minority Biomedical Program National Cancer Institute Building 31, Room 10A04 9000 Rockville Pike Bethesda, MD 20892 Telephone: (301) 496-7344 FAX: (301) 402-0062 The Program Director welcomes the opportunity to clarify any issues or questions from potential applicants, and to aid in identification of institutions and potential mentors appropriate to the interests of the applicant. For information regarding budgetary/administrative issues related to this RFA, please contact: Mr. Leo Buscher, Jr. Chief, Grants Administration Branch National Cancer Institute National Institutes of Health Executive Plaza South, Room 216 Bethesda, MD 20892 Telephone: (301) 496-7753 This program is described in the Catalogue of Federal Domestic Assistance No. 93,398, Cancer Research Manpower. Awards are under the authority of Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review.