Fellowships, grants, & awards.

Technologies for Closing DNA Sequence Gaps and Improving Methods for Obtaining the Sequence of Difficult-to-Sequence Regions

The National Human Genome Research Institute (NHGRI) invites applications to develop strategies and technologies for obtaining DNA sequence in the gaps that, due to limitations in available cloning and sequencing technology, will remain in essentially finished genomic sequence. Such gaps may arise from an inability to clone a region in any available vector system or to obtain sequence from all or part of an available done. Such gaps have been encountered in every large genome sequencing effort to date. NHGRI encourages the development of novel approaches to allow completion of the DNA sequence within the gaps left by current sequencing methods and to improve the efficiency of sequencing in genomic regions that have proved difficult to sequence.

The large-scale sequencing centers have provided lists of clones containing regions with gaps or DNA that was difficult to sequence, posted at http://www. nhgri.nih.gov/About_NHGRI/Der/gapPA.html. Investigators applying for this program announcement (PA) may use this information to find clones on which they may develop and demonstrate their strategy/ technology. This PA is limited to proposals to develop and obtain proof of principle for new technologies.

Approximately $2 million is available for funding, and 5-10 awards may be made during the first year of the program, contingent upon the availability of funds and receipt of a sufficient number of high-quality applications. The anticipated award dates are 1 December 2001, 1 April 2002, and 1 July 2002. This PA will be in effect for three years; additional announcements to continue this program may be issued in the future.

Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and submitted by the standard deadlines as indicated in the application kit. This form is available online at http:// grants.nih.gov/grants/funding/phs398/phs398.html. Applicants planning to submit an investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended/revised version of the preceding grant application types requesting $500,000 or more in direct costs for any year must contact the institute program staff before submitting the application, i.e., as plans for the study are being developed. Furthermore, the applicant must obtain agreement from the institute staff that the institute will accept the application for consideration. Finally, the applicant must identify, in a cover letter sent with the application, the staff member and institute who agreed to accept assignment of the application. More information on this PA is available online at http://grants. nih.gov/grants/guide/pa-files/PAS-00-112.html.

Contact: Jane Peterson, NHGRI, 31 Center Drive, Room B2B07, Building 31, MSC 2033, Bethesda, MD 20892 USA, 301-496-7531, fax: [phone], e-mail: [e-mail]. Reference: PA No. PAS-00-112

Cancer Intervention and Surveillance Modeling Network (CISNET)

The Division of Cancer Control and Population Sciences of the National Cancer Institute (NCI) invites applications to support collaborative research using simulation and other modeling techniques to describe the impact of interventions in population-based settings in the United States or in non-U.S, settings that will shed light on U.S. population-based trends. The goals of this research are to determine both the impact of cancer control interventions on observed trends in incidence and/or mortality and whether recommended interventions are having their expected population impact by examining discrepancies between controlled cancer intervention study results and the population experience. Once a general understanding of the various factors influencing current trends is achieved, several secondary goals may be addressed. Applicants may propose secondary goals of modeling the potential impact of new interventions on future national trends or determining the impact of targeted cancer control interventions on population outcome.

This request for applications (RFA) does not aim to support analysis of hypothetical or trial-based cohorts or cost-effectiveness analyses, but rather to support analyses based on realistic scenarios of population impact. Projects will focus on models describing the population impact of the observed dissemination of cancer control interventions and other factors on observed national incidence or mortality trends.

This second round of funding for CISNET will be limited to applications focusing on prostate, colorectal, and lung cancers. Each application will be limited to a single cancer site. The cooperative agreement mechanism calls for the development of site-specific working groups that will 1) facilitate comparative analyses, 2) allow modeling groups access to a broader array of data resources and interdisciplinary expertise, and 3) provide a forum for discussions of validation and other methodologic issues. CISNET will allow for diversity and originality of modeling approaches that can be compared using uniform criteria.

Proposals must include a central focus on modeling the impact of cancer control interventions and other factors on observed national trends in incidence or mortality. Examples of this type of research include 1) modeling the population impact of the introduction of new therapies using estimates of the impact of these therapies in controlled settings and population dissemination patterns; 2) modeling the impact of interventions aimed at changing modifiable risk factors on population trends in incidence and/or mortality; 3) modeling the impact of screening on population incidence and/or mortality patterns using a model of disease natural history, the population dissemination of screening, and the operating characteristics of these screening modalities; and 4) using discrepancies between modeled and observed population trends to study the community effectiveness of interventions. In addition to a central focus on observed trends in incidence or mortality, applications may also include applications of models that predict the impact of new interventions on national trends and determine the impact of targeted cancer control interventions on population outcome.

The purpose of these efforts is to model the impact of the observed dissemination of cancer control interventions in the population, rather than using observed population trends to postulate new risk factors. However, these models can include components that model the impact of population changes in both modifiable and nonmodifiable risk factors. Models that include the impact of multiple interventions simultaneously are desirable. Models can be of the entire U.S. population, a region of the country, or some specific identified population where unique data exist on the implementation of an intervention, or in a subpopulation of specific interest. Models developed for non-U.S, populations should be justified as to their applicability to understanding U.S. cancer trends. Models can focus on one aspect of a disease, but justification must be given as to how one part of the disease process can be modeled separately and how this model can be integrated into the complete disease picture.

The deadline for letters of intent is 9 October 2001, with final applications due 13 November 2001. Further information is available online at http://grants. nih.gov/grants/guide/rfa-files/RFA-CA-02-010.html. The total project period for applications submitted in response to this RFA may not exceed four years. The anticipated award date is July 2002.

The NCI plans to commit approximately $1.25 million in total costs in fiscal year 2002 to fund 4-6 new grants in response to this RFA. It is anticipated that the award for each application for modeling of a single cancer site will be $75,000-250,000 in total costs for the first year.

Contact: Eric Feuer, DCCPS, NCI, 6116 Executive Boulevard, Room 5041, MSC 8317, Bethesda, MD 20892-8317 USA, 301-496-5029, fax: [phone], e-mail: [e-mail]. Reference: RFA No. RFA-CA-02-010

Population Research Infrastructure Program

The National Institute of Child Health and Human Development (NICHD), through the Demographic and Behavioral Sciences Branch (DBSB) of the Center for Population Research, invites applications for infrastructure grants in support of population research relevant to the DBSB mission. The primary purposes of the Population Research Infrastructure Program are to provide resources to support and advance research that will improve the understanding of the antecedents and consequences of population structure and change, facilitate interdisciplinary collaboration among investigators conducting population-related research, and promote innovative approaches to population research questions. An additional goal is to facilitate interaction among scientists in locations throughout the United States to contribute to the integration and coordination of population research. Applicants may request funds to support infrastructure and/or research designed to enhance the quality and quantity of population research conducted at an institution and develop new research capabilities to advance population research through innovative approaches.

This request for applications (RFA) invites applications for two types of awards: developmental awards and full-fledged research infrastructure awards. Developmental awards are intended to support the development and demonstrate the feasibility of programs that have high potential for advancing population research but that have not yet fully developed the necessary resources and mechanisms to qualify for a research infrastructure award.

Applicants responding to this RFA must articulate a clear vision for their research unit and its current and future contributions to population research. Applicants must identify the central scientific objectives and signature population-related themes of the unit, and these must be relevant to the DBSB mission, a description of which is available at http:// www.nichd.nih.gov/about/cpr/dbs/dbs.htm. Examples of population research topics that fall within the DBSB mission include 1) antecedents and consequences of changes in population size, structure, and composition, including the relationship of economic development to population change, population modeling and the projection and/or prediction of human population change, and the interrelationship between population and the physical environment; 2) family and household dynamics, including issues related to intergenerational relationships; 3) fertility and family planning, including issues related to union formation and dissolution, births and birth spacing, family size, gender in relation to fertility, and social acceptability of measures for the biological regulation of human fertility; 4) spatial distribution of human population groups and causes and consequences of migration, including issues related to international and internal migration, residential mobility, and interrelationships between population and the environment; 5) demographic aspects of health, morbidity, disability, and mortality, including issues related to the influence of early life on later life development and outcomes, status of children, and the interrelationship between health and socioeconomic status; and 6) social, demographic, and behavioral studies of sexual behavior, sexually transmitted diseases, and contraception.

This RFA will use the NIH Resource-Related Research Project Grant (R24) mechanism for research infrastructure awards and the Exploratory/ Developmental Grant (R21) mechanism for developmental awards. The total project period for an application submitted in response to this RFA should equal five years for R24 applications and up to three years for R21 applications. R21 applications are nonrenewable and may not be submitted by institutions that have held a P30 or P50 grant related to population research in the 10 years prior to the application date. A table summarizing the differences between the R21 and R24 mechanisms as applied to this RFA is available at http://www.nichd.nih.gov/RFA/ HD-01-010/HD-01-010.htm#summary. The NICHD expects to issue an RFA annually to solicit applications for this program. Applications may be submitted only in response to an RFA. The anticipated award date is 1 July 2002. Specific application instructions for R21 applications have been modified to reflect modular grant and "just-in-time" streamlining efforts being examined by the NIH. Complete and detailed instructions and information on modular grant applications can be found at http://grants. nih.gov/grants/funding/modular/modular.htm.

The deadline for letters of intent is 15 October 2001, with final applications due 16 November 2001. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. This form is available on the Internet at http:// grants.nih.gov/grants/funding/phs398/phs398.html. More information on this RFA is available online at http://grants.nih.gov/grants/guide/rfa-files/ RFA-HD-01-010.html.

Contact: Christine Bachrach, DBSB, CPR, NICHD, 6100 Executive Boulevard, Room 8B07, MSC 7510, Bethesda, MD 20892-7510 USA, 301-496-9485, fax: [phone], e-mail: cbachrach@ nih.gov (e-mail communication preferred). Reference: RFA No. RFA-HD-01-010

Flexible System to Advance Innovative Research for Cancer Drug Discovery by Small Businesses

Discovery and development of new drugs and biologicals for cancer treatment, including gene therapy and drug delivery approaches, normally involves lengthy and costly projects. The multiple components of the overall process including discovery, efficacy testing, development of lead agents, toxicology and pharmacology, investigational new drug application filing, and clinical evaluation may require years and several million dollars. The small business community is an active participant in the cancer therapy discovery effort. Thus it is important that their innovative ideas be supported. The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs were developed to support innovative research with a commercial intent by small businesses. This program announcement (PA) provides a flexible system within the SBIR and STTR programs to accommodate the special needs of the complex discovery and development process, at least partially, from basic discovery through proof-of-principle demonstration in clinical trials. It is hoped that this initiative will stimulate drug discovery research efforts in the small business community.

This PA must be read in conjunction with the 2001 omnibus solicitation for the NIH SBIR and STTR grant applications, found online at http:// grants.nih.gov/grants/funding/sbirsttr1/index.pdf. All of the instructions within the omnibus solicitation apply with the following exceptions: 1) special receipt dates, 2) initial review convened by the Division of Extramural Activities, National Cancer Institute, 3) additional review considerations, 4) more flexible time and budget specifications, and 5) no modular format. Instructions for detailed budgets will be followed.

This PA provides a flexible funding mechanism with regard to budgets and time of award to support the research activities necessary for small businesses to bring their efforts for drug discovery and development to clinical validation. Projects submitted in response to this PA should focus on discovery and development of a specific agent or class of agents. Applications devoted to topics relating more generally to drug discovery such as technology and model development without direct relevance to development of a specific agent are not appropriate.

Flexibility within the PA allows for projects to be presented at all stages of the drug discovery and development process. Projects will be evaluated on overall innovation, strength of the drug discovery approach, and probability of clinical success, with less emphasis on the nature of the specific stage proposed in the application. This latter aspect is especially important if applications are focused on later stages of the drug discovery and evaluation process that may be more routine and often considered less innovative as stand-alone projects.

The deadlines for letters of intent are 8 October 2001 and 6 March 2002, with final applications due 10 April 2002 and 12 November 2002. Institute policy requires that all applicants requesting greater than $500,000 direct costs in any one year must obtain approval from program staff prior to submission of the application. If more than $500,000 per year is requested, this fact must be clearly stated and approval requested in the letter of intent.

Contact: George S. Johnson, Division of Cancer Treatment and Diagnosis, NCI, Executive Plaza North, Room 8152, MSC 7456, 6130 Executive Boulevard, Bethesda, MD 20892-7456 USA, 301-496-8783, fax: [phone], e-mail: johnsong@ exchange.nih.gov. Reference: PA No. PA-01-091

Research on Research Integrity

The Office of Research Integrity, the National Institute of Neurological Disorders and Stroke, and the National Institute of Nursing Research invite applications to support research on research integrity. Research integrity is a vital component of both the reliability of the research record and the trust that underlies public support for research. Therefore, the responsible expenditure of public funds for research must include attention to research integrity. The purpose of the proposed grant program is to foster empirical research on the institutions, processes, and values that affect integrity in research. The sponsoring agencies are particularly interested in studies that will inform policy making at the Department of Health and Human Services, the NIH, and research institutions, with the goal of fostering appropriate attention to integrity in publicly funded research programs.

This request for applications seeks to address the need for more and better information on the factors that encourage and/or discourage integrity in publicly funded research. For our purposes, research is defined broadly to include societal, institutional, and individual aspects of the enterprise. Integrity is understood as adherence to rules, regulations, guidelines, and commonly accepted professional codes or norms. Applicants are encouraged to submit proposals that will provide generalizable empirical knowledge about the ways in which researchers and research institutions meet or fail to meet their professional responsibilities in the conduct, evaluation, and reporting of research. Particular areas of interest include but are not limited to 1) research norms and/or practices, 2) institutional climate and responsibility, 3) education on the responsible conduct of research, 4) mentor/trainee relationships, 5) data acquisition, management, sharing, and ownership, 6) responsible authorship, 7) integrity of publication practices and the research record, 8) research collaborations and issues that may arise from such collaborations, 9) conflicts of interest, and 10) the meaning of research misconduct and the regulations, policies, and guidelines that govern research misconduct in Public Health Service-funded institutions.

Applicants should use the NIH individual research project grant (R01) award mechanism. Prospective applicants are asked to submit a letter of intent by 15 October 2001, with final applications due 19 November 2001. More information is available on the Internet at http://grants.nih.gov/grants/ guide/rfa-files/RFA-NS-02-005.html.

Contact: Mary D. Scheetz, Division of Education & Integrity, ORI, 5515 Security Lane, Suite 700, Rockville, MD 20852 USA, 301-443-5302, e-mail: [e-mail]; Mary Ellen Cheung, Neuroscience Center, NINDS, Room 2209, MSC 9525, 6001 Executive Boulevard, Bethesda, MD 20892-9525 USA, 301-496-1447, e-mail: [e-mail]; Karin Helmers, Office of Extramural Programs, NINR, Building 45, Room 3AN12, MSC 6300, Bethesda, MD 20892-6300 USA, 301-594-2177, fax: [phone], e-mail: [e-mail]. Reference: RFA No. RFA-NS-02-005