LIMITED COMPETITION FOR EQUIPMENT SUPPLEMENTS TO MBRS RISE OR IMSD AWARDS Release Date: December 3, 2001 RFA: RFA-GM-02-005 National Institute of General Medical Sciences (NIGMS) Letter of Intent Receipt Date: January 9, 2002 Application Receipt Date: February 12, 2002 PURPOSE Minority Opportunity for Research (MORE) Division, Minority Biomedical Research Support (MBRS) Branch of The National Institute of General Medical Sciences (NIGMS) announces a limited initiative to solicit competing supplemental applications to acquire laboratory equipment. Although equipment is an allowable cost in the Research Initiative for Scientific Enhancement (RISE) and Initiative for Minority Student Development (IMSD) grants, these supplements should provide the research and training faculty with equipment that is either not readily available or is lacking but that is essential to conducting their research. The supplemental funds may be used to purchase new equipment or to upgrade existing equipment for use by students and faculty in the biological, behavioral or biomedical related sciences in research education and training. 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 Request for Applications (RFA), Limited Competition for Equipment Supplements to MBRS RISE or IMSD Awards, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Eligible institutions are those with current MBRS RISE grants or IMSD grants. Institutions must have at least one year of support remaining at the time of award and the supplemental award may not extend beyond the parent grant. MECHANISM OF SUPPORT Support will be offered as a competing supplemental (Type 3) award to an existing R25 award. For equipment, this is a one-time solicitation and awards are not renewable. However, if a technical assistant is requested in a RISE application, these costs may be requested for the duration of the grant period. IMSD grantees may not request a technical assistant. FUNDS AVAILABLE NIGMS intends to commit approximately $1-2 million in FY 2002 to fund supplemental equipment grants in response to this RFA. Because the nature and cost of the equipment may vary, it is anticipated that the size of each award will also vary. Although the financial plans of NIGMS provide support for this supplement program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. At this time, it is not known if this RFA will be reissued. RESEARCH OBJECTIVES Background In the NIH Revitalization Act of 1993, NIH was encouraged to increase the number of underrepresented minorities participating in biomedical and behavioral research. In response to the Act, the NIGMS established the MBRS program which includes the RISE and IMSD initiatives. The purpose of the MBRS program is to assist biomedical and behavioral research faculty to develop competitive research programs at minority-serving institutions, and to increase the number of underrepresented minority scientists professionally engaged in biomedical research. In addition, the MBRS Branch recognizes that eligible institutions are diverse in institutional environment and mission. Therefore, with respect to evaluation, the RISE and IMSD initiatives require that each institution set its own goals and measurable objectives that are based on its self assessment and that it identify anticipated milestones for achievements. Types of Equipment Requests Applicants may request costs for individual pieces of equipment necessary to facilitate progress in a particular research training activity. Justification for the equipment should be based on its utility to drive the activity forward and its present unavailability at that institution. SPECIAL REQUIREMENTS Although requests for equipment should be justified with regard to enhancing the progress of the research, it should not change the scope of the program. For applications requesting an equipment supplement to RISE grants, support for equipment in direct support of research education and training activities may be requested. In addition, when fully justified, support for a technical assistant to maintain and teach others in the use of the equipment is allowed. For applications requesting an equipment supplement to IMSD grants, support for equipment in direct support of research education and training activities may be requested. The minimum aggregate cost allowable for either RISE or IMSD applications is $50,000 and the maximum is $150,000. A progress report will be required as a part of a subsequent non-competing application (Type 5), competing renewal (Type 2) application, or of the close- out package if a competing renewal application is not awarded. This progress report should describe the benefits derived from institution-wide use of the equipment and provide specific information on overall use of the equipment. Unallowable Costs Unallowable costs include: o Computers for individual use; o Computers and audiovisual equipment for general classroom use; o Supplies and other laboratory items whose cost is less than $5,000. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN 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 RFA 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. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that contains the title and grant number of the parent grant, the name, address, and telephone number of the Principal Investigator (Program Director), and the number and title of the RFA in response to which the application is being submitted. If possible, provide a description of the equipment that will be requested. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIGMS staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to Dr. Ernest D. Marquez listed under INQUIRIES. The letter of intent receipt date is listed above in the heading of this RFA. APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html must be used in applying for these grants. This version of the PHS 398 is available in an interactive, searchable format. For further assistance contact GrantsInfo, Telephone 301/435-0714, Email: GrantsInfo@nih.gov. The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Helen R. Sunshine, Ph.D. Chief, Office of Scientific Review National Institute of General Medical Sciences, NIH Building 45, Room 1 AS.13 45 Center Drive, MSC 6200 Bethesda, Maryland 20892-6200 Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already 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. APPLICATION CONTENT Under the Experimental Plan, the PI should provide the information requested below. This section may not exceed five pages. Equipment quotations, letters from collaborators and consultants, and the checklist are excluded from the five-page limit. Section 1: Describe how the requested equipment has (1) relevance to the institution's goals and specific objectives, (2) immediate utility to specific research education/training activities, and (3) how the investigator will take advantage of unique features of the equipment to enhance progress of the research education/training activity. Describe how the requested equipment will provide an innovative approach to the research education/training activities. Describe how the equipment will significantly enhance the scientific environment in which the research /development activities are being conducted and how it will contribute to the probability of success. Section 2: Describe the plan for maintenance of the requested equipment and how the institution will assist in support of the equipment requested. Section 3: Describe your plans to share data generated from the requested equipment (if applicable). Section 4: Complete Section 3 ("Facilities and Administrative Costs") of the PHS 398 Form Checklist. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NIGMS. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIGMS in accordance with the review criteria stated below. 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 the applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory General Medical Sciences Council 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 requested equipment 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. Applications submitted in response to this RFA are supplemental to an existing award. The following review criteria will be used to determine the merit of the supplemental application for equipment: Significance: o Does the requested equipment have relevance and immediate utility and will the investigator take advantage of unique features of the equipment to enhance progress of his/her research education/training activity? Approach: o Is there a plan for its maintenance? o For RISE applications, is there a plan its maintenance and, if technical assistance is requested, does the technician have the appropriate background and skills to maintain the equipment and instruct others in its use? Innovation: o Has the investigator shown that the equipment will provide an innovative approach to accomplishing the original aims of the research education/training activities? Investigator: o Has the investigator been productive in documenting his/her progress of the research education/training activities and will this equipment enhance its progress? Environment: o Will the equipment significantly enhance the scientific environment in which the research education/training is being conducted and contribute to the probability of success? o Is there evidence of institutional support of the program and of the equipment to be acquired? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The reasonableness of the proposed budget o The adequacy of the proposed plan to share data, if appropriate 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 concerning this RFA are encouraged. The opportunity to clarify any issues or answer questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Ernest D. Marquez, Ph.D. Chief, MBRS Branch National Institute of General Medical Sciences 45 Center Drive, Room Number 2As.37, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-3900 FAX: (301) 480-2753 E-mail: marqueze@nigms.nih.gov Direct inquiries regarding review issues to: Helen R. Sunshine, Ph.D. Chief, Office of Scientific Review National Institute of General Medical Sciences, NIH Building 45, Room 1 AS.13 45 Center Drive, MSC 6200 Bethesda, Maryland 20892-6200 Telephone: (301) 594-2881 FAX: (301) 480-8506 E -mail: sunshinh@nigms.nih.gov Direct inquiries regarding fiscal matters to: Antoinette Holland Grants Management Officer Grants Management Branch Division of Extramural Activities National Institute of General Medical Sciences, NIH Building 45, Room 2AN.50 45 Center Drive, MSC 6200 Bethesda, Maryland 20892-6200 Telephone: (301) 594-5132 FAX: (301) 480-2554 E-mail: hollanda@nigms.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.375. 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 PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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