This Program Announcement expires on September 1, 2004 unless reissued. MECHANISMS IN NUTRITION AND INFECTION Release Date: August 29, 2001 PA NUMBER: PA-01-133 National Institute of Dental and Craniofacial Research National Institute of Allergy and Infectious Diseases National Institute of Diabetes and Digestive and Kidney Diseases Office of Dietary Supplements THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. MODULAR INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS UP TO $250,000 PER YEAR. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT http://grants.nih.gov/grants/funding/phs398/phs398.html. PURPOSE The National Institute of Dental and Craniofacial Research (NIDCR), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and NIH Office of Dietary Supplements (ODS) invite grant applications to investigate basic, epidemiological and clinical research on nutrition (including dietary supplements) and infection. The relationship between infection and nutrition is bi-directional in that infection can result in malnutrition, and malnutrition can contribute to infection. Applicants are encouraged to assemble research expertise in the areas of nutrition, microbiology and immunology to explore these complex interrelationships between nutrition and infection. Mechanistic studies aimed at understanding the molecular and cellular connections between nutrition and infections, immunity and inflammation are especially needed. 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), Mechanisms in Nutrition and Infection, is related to the priority areas of Nutrition and Infectious Diseases. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) research project grant (R01) award and the developmental grant (R21)award mechanisms. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this PA may not exceed five years for R01 projects and two years for R21 projects. R21 applications cannot exceed $100,000 in direct costs per year. Applicants with budget requests that exceed $500,000 in direct costs in any year of the project should refer to the NIH policy on such applications: http://grants.nih.gov/grants/guide/notice-files/not98-030.html. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts that have been adopted by the NIH. Complete and detailed instructions and information on Modular Grant applications have been incorporated into the PHS 398 (rev. 5/2001). Additional information on Modular Grants can be found at http://grants.nih.gov/grants/funding/modular/modular.htm R01s greater than $250,000 per year require detailed budgets and do not follow Modular Grant format. RESEARCH OBJECTIVES Background information Globally, infectious diseases manifested either as acute or chronic illnesses are responsible for high morbidity and mortality. Epidemiological studies show that poor nutritional status can influence the incidence and the severity of infectious diseases. Other studies show a strong association between nutritional impairment and the development of chronic diseases with potential infectious etiologies such as cardiovascular diseases, cancer, and diabetes. However, there are still major gaps in our understanding of the interrelationships between nutrition and infection. For instance, very little is known about the mechanisms by which nutrition-related immunosuppression leads to increased susceptibility to infection. Clearly, this is a multifactorial issue and there are several interacting variables including host genetics, pathogen virulence, environmental factors, age, and gender. Moreover, the complexity of each independent variable makes it difficult to understand the underlying mechanisms. Thus, there is a need to address current concepts such as the role of nutrition on immunity and the related impact on infection and newer concepts such as the direct effects of nutrients on the genetic composition of microbes. It is expected that recent advances in molecular technology and the availability of human as well as several microbial genomes should enhance the progress in this area. Because of the strong association between nutrient depletion and increased susceptibility to infection, national and international agencies have been very supportive of nutritional supplementation programs. However, a greater understanding of the cellular and molecular mechanisms involved will facilitate the optimal clinical use of nutrients in the reduction of the morbidity and mortality associated with infection. Recent workshops sponsored by the National Institutes of Health on nutrition and infectious diseases, nutrition and oral diseases and the effects of specific nutrients on immune-mediated diseases, which included participants with expertise in nutrition, immunology, molecular biology, and infectious disease, emphasized the need to continue to examine the potential mechanisms by which specific nutrients may contribute to poor clinical conditions. Summary Research Objectives and scope The intent of this program announcement is to advance our understanding of the cellular and molecular mechanisms involved in the relationships between nutrition and infection. It is anticipated that applicants will take advantage of the availability of new technologies and the availability of recent genomic data. Examples of research topics include, but are not limited to: o Determination of the role of nutritional factors in microbial pathogenesis and host susceptibility to infection using appropriate animal model and in vitro systems. These studies should also include elucidation of the molecular regulatory mechanisms involved in the pathogenesis of infectious diseases within the context of nutrition, o Examination of the interplay between microbial pathogens as well as between specific nutritional components on the pathogenesis of microbial infections, o Examination of the impact of nutrition on the capacity of microbial pathogens to invade and grow in vascular and connective tissue, o Examination of the role of inflammatory mediators in the pathogenesis of infectious diseases within the context of nutrition, o Investigation of the potential mechanisms by which specific micronutrients interfere with the beneficial effects of other micronutrients during infection, o Examination of the direct effects of nutrients on pathogen virulence, o Examination of the effects of dietary intervention with specific nutrients on the immune system, and, o Examination of the link between nutritional status in early life and the development of infection later in adult life. TERMS AND CONDITIONS OF AWARD When clinical studies or trials are a component of the research proposed, studies must be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study. Terms and Conditions of Award will be included with awards. 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 subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided 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" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: 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. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. This policy announcement is found in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000, at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at: http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in applying for these grants and will be accepted at the standard application deadlines (http://grants.nih.gov/grants/dates.htm) as indicated in the application kit. This version of the PHS 398 is available in an interactive, searchable PDF format. Although applicants are encouraged to begin using the 5/2001 revision of the PHS 398 as soon as possible, the NIH will continue to accept applications prepared using the 4/1998 revision until January 9, 2002. Beginning January 10, 2002, however, the NIH will return applications that are not submitted on the 5/2001 version. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. Applications will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained 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, email: GrantsInfo@nih.gov. In addition, the application kits can be found on the following URL: http://grants.nih.gov/grants/forms.htm. 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 are advised that he or she must contact the Institute program staff before submitting the application, i.e., as plans for the study are being developed. Furthermore, the application must obtain agreement from the program staff that the Institute will accept the application for consideration for award. 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. This policy requires an applicant to obtain agreement for acceptance of any such application and any such subsequent amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at http://grants.nih.gov/grants/guide/notice-files/not98-030.html SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and NIH staff. The research grant application form PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in applying for these grants, with modular budget instructions provided in Section C of the application instructions. Applicants are permitted, however, to use the 4/1998 revision of the PHS 398 for scheduled application receipt dates until January 9, 2002. If you are preparing an application using the 4/1998 version, please refer to the step-by-step instructions for Modular Grants available at http://grants.nih.gov/grants/funding/modular/modular.htm. Additional information about Modular Grants is also available on this site. The title and number of the 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 five 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 (for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established NIH referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the Principal Investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. AWARD CRITERIA Award criteria that will be used to make award decisions include: o scientific merit (as determined by peer review) o availability of funds o programmatic priorities. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dennis Mangan, Ph.D. Infectious Diseases and Immunity Branch Division of Basic and Translational Sciences National Institute of Dental and Craniofacial Research Natcher Bldg, Room 4AN-32F Bethesda, MD 20892-6402 Telephone: 301-594-2421 FAX: 301-480-8318 E-mail: Dennis.Mangan@nih.gov Christopher E. Taylor, Sc.D. Division of Microbiology & Infectious Diseases National Institute of Allergy and Infectious Diseases Room 3128, MSC-7630 6700-B Rockledge Drive Bethesda, MD 20892-7630 Telephone: (301) 496-5305 FAX: (301) 496-8030 E-mail: ct18m@nih.gov Michael K. May, Ph.D. DDDN/NIDDK 6707 Democracy Blvd. 2 Democracy Plaza Room 663, MSC 5450 Bethesda, MD 20892-5450 (For UPS & Fed EX use 20817) Tel: 301-594-8884 Fax: 301-480-8300 E-mail: mm102i@nih.gov Becky Costello, Ph.D. Office of Dietary Supplements National Institutes of Health 31 Center Drive, Room 1B29 Bethesda, MD 20892-2086 phone: 301-435-2920 fax: 301-480-1845 email: CostellB@od.nih.gov Direct inquiries regarding fiscal matters to: Mr. William Powell Grants Management Branch National Institute of Dental and Craniofacial Research Bg 45, Room 4AN-44A Bethesda, MD 20892-6402 Telephone: 301-594-4800 FAX: 301-402-1517 E-mail: William.Powell@nih.gov Ms Annette Hanapole Grants Management Specialist Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 2122, MSC-7614 6700-B Rockledge Drive Bethesda, MD 20892-7614 Telephone: 301-402-5937 FAX: 301-480-3780 E-mail: ahanapole@niaid.nih.gov Ms Desiree Johnson Division of Extramural Activities NIDDK 6707 Democracy Blvd. 2 Democracy Plaza Room 713B, MSC 5456 Bethesda, MD 20892-5456 Telephone: 301-594-8844 FAX: 301-480-3504 E-mail: JohnsonD@extra.niddk.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.121, Oral Diseases and Disorders Research Awards, 93.856, Microbiology and Infectious Diseases, and 93.847, 93.848, and 93.849, Diabetes and Digestive and Kidney Diseases. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Office of Dietary Supplements (ODS) was mandated by Congress in 1994 and established within the Office of the Director, National Institutes of Health (NIH). The Dietary Supplement Health and Education Act (DSHEA) [Public Law 103-417, Section 3.a] amended the Federal Food, Drug, and Cosmetic Act to establish standards with respect to dietary supplements. This law authorized the establishment of the ODS. 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, and 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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