EXPIRED
ESTABLISHMENT OF SPECIFIC PATHOGEN FREE RHESUS AND PIGTAILED MACAQUE COLONIES Release Date: February 28, 2002 RFA: RR-02-005 National Center for Research Resources (NCRR) (http://www.ncrr.nih.gov) LETTER OF INTENT RECEIPT DATE: March 25, 2002 APPLICATION RECEIPT DATE: April 25, 2002 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquires o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA This RFA is a re-issuance of RFA RR-00-004 released on February 10, 2000. It is reissued to solicit applications for the establishment of ADDITIONAL colonies of SPF rhesus macaques. (Colonies already being supported through the previous solicitation are eligible to apply). Increased numbers of rhesus macaques particularly of Indian ancestry are needed for AIDS vaccine and pathogenesis studies. The purpose of this Request for Applications (RFA) is to solicit proposals from prospective grantees who can breed rhesus and pigtailed macaques that are Specific Pathogen Free (SPF) and provide them to NIH grantees for AIDS-related research. The term SPF in the context of this solicitation is defined as animals free (antibody negative) of herpes B virus, simian immunodeficiency virus (SIV), Type D simian retrovirus (SRV), and simian T-lymphotropic virus (STLV-1). The presence of the retroviral infections makes the infected animals unsuitable for AIDS- related research projects. Thus, for the purposes of testing potential AIDS vaccines as well as studies regarding the pathogenesis of AIDS, investigators must have animals free of viruses that might compromise their research findings. Although the herpes B virus does not appear to compromise AIDS-related investigations, the potential health risks for personnel dictates that the breeding colonies must be free of this virus as well. Providing such animals for NIH grantees to do AIDS- related research is the topmost priority of this RFA. RESEARCH OBJECTIVES Background In response to the critical need for providing rhesus macaques with specific qualities, the NCRR will establish breeding colonies through a Cooperative Agreement Grant mechanism. The rhesus and pigtailed macaques must be free of the following retroviruses: simian immunodeficiency virus (SIV), Type D simian retrovirus (SRV), and simian T-lymphoyte virus (STLV-1). Because of prospective health risks to personnel, a further requirement is for these animals to be free of Herpesvirus simiae (herpes B virus). It is also recognized that there is a special need for Major Histocompatability Complex (MHC) defined rhesus macaques for certain types of AIDS-related research. A major component of the evaluation of AIDS vaccines in non-human primates, and in humans, is the measurement of virus-specific T-cell immune responses. The majority of immunogenic Cytotoxic T Lymphocytes (CTL) bind to MHC class I molecules. Mamu-A *01 is an example of one MHC class I haplotype that is important in controlling viral replication. Thus, the screening of such animals should be included as a component of the application. This may involve establishing a collaborative arrangement with facilities that are capable of providing MHC screening. Selected pedigree breeding for specific MHC type I haplotypes could then be initiated. A specific example is if collaborative arrangements have been established for the screening of MHC-1 haplotype, such an arrangement would facilitate the genetic management of the colonies to provide genetically-defined animals for AIDS research. Such animals could be invaluable for the AIDS research community. MECHANISM OF SUPPORT The NIH (U24) RFA "Animal Model and Animal and Biological Material Resource" uses a cooperative agreement award mechanism in which the Private Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the section "Cooperative Agreement Terms and Conditions of Award". The total project period for an application submitted in response to this RFA may not exceed 5 years. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator- initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE The NCRR anticipates making several awards to new or existing SPF colonies for project periods of up to five years. NCRR intends to commit approximately $8.4 million total costs is expected to be set aside for funding these activities in the initial year. The number of awards and the level of support will depend upon receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCRR, awards pursuant to this RFA are contingent upon the availability of funds for this purpose in fiscal year 2002. The anticipated award date is August 30, 2002. ELIGIBLE INSTITUTIONS You may submit an application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic institutions Current SPF colony grantees may use this solicitation to apply for additional funds to expand their colonies and increase their screening capabilities. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS The cooperative agreements (U24s) will require cooperation between the NCRR representative (NCRR Program Administrator) and the Principal Investigators (PIs) of the individual projects in order to assure smooth interactions among cooperating organizations. The NCRR Program Administrator will assist in coordinating the activities of the awardees and in facilitating exchange of animals. COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD The following terms and conditions will be incorporated into the U24 award statement, and will be provided to the PI and the awardee institutional official at the time of award. These special Terms of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. (Part 92 applies when state and local governments are eligible to apply as a "domestic organization.") 1. COLLABORATIVE RESPONSIBILITIES Coordinating Committee (CC) In response to the previous RFA (RR-00-004), six SPF Colonies were established. As part of the award conditions, a Coordinating Committee (CC) consisting of the NCRR and the principal investigator (P.I.) of the grants was formed. The Program Administrator and P.I.s of any new awards will automatically become active members of the CC. The CC is expected to meet at least twice a year. The CC is responsible for implementation oversight and coordination in the establishment and operation of the SPF colonies as proposed in the individual applications of the awardees. They CC develops uniform procedures for quality control in animal husbandry and in the maintenance of the animal facilities. The CC is responsible for the oversight to ensure standardization of the viral screening assays. The CC continually reviews and monitors the operating procedures proposed by individual awardee organizations in order to ensure that they are compatible with the overall goals of the RFA. The CC consists of the PI of each SPF colony and NCRR Program Administrator. Additional members may be added by action of the CC. The structure of the CC was established at the first meeting. The Chair of the CC is responsible for coordinating the Committee activities, for preparing meeting agendas, and for scheduling and chairing meetings. The NCRR Program Administrator attends and participates in all meetings of the CC and should be informed of any major interactions. The CC prepares an annual progress report which will include individual reports from each awardee. Each awardee is responsible for timely preparation of this report. The NCRR Program Administrator, as a member of the CC, will assure that operating policies are acceptable to the NCRR. An arbitration system, as detailed below, will be available to resolve disagreements between awardees and NCRR staff. 2. AWARDEE RIGHTS AND RESPONSIBILITIES o Awardees will have primary and lead responsibilities for the project as a whole, including selection and maintenance of rhesus macaques, husbandry, microbiological and genetic monitoring, data quality control and reporting to the CC, any research to enhance the resource, preparation of publications, as well as collaboration with the other awardees with assistance from the NCRR Program Administrator. o Awardees must comply with the operating policies and procedures developed by the CC. o Awardees will retain custody of, and have primary rights to, the data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. Investigators conducting biomedical research frequently develop unique research resources. The policy of the PHS is to make available to the public the results and accomplishments of the activities that it funds. All awardees must adhere to PHS policy for the distribution of unique research resources produced with PHS funding and is available at the following internet address: http://grants2.nih.gov/grants/policy/nihgps_2001/part_iia_6.htm #AvailabilityofResearchResults 3. NCRR PROGRAM ADMINISTRATOR RESPONSIBILITIES o The NCRR Program Administrator will coordinate and facilitate the programs supported by these cooperative agreements, will attend and participate as a voting member in all meetings of the CC and SPF Colony Directors, and will provide liaison between them and the NCRR. o The NCRR Program Administrator will ensure that there is effective communication between the CC and NCRR. o The NCRR Program Administrator will assist the CC in developing and drafting operating policies and procedures for dealing with recurring situations that require coordinated action, e.g., standardized genetic and microbiological monitoring. o The NCRR Program Administrator in conjunction with CC activities will play a significant role in ensuring the equitable distribution of SPF animals to NIH grantees. o The NCRR Program Administrator may review the operations of individual U24 grants for compliance with the operating policies developed by the CC and may recommend withholding of support, suspension, or termination of an award for lack of progress or failure to adhere to policies established by the CC. 4. ARBITRATION PROCEDURES An arbitration panel of external consultants will be created as needed to resolve any irreconcilable differences of opinion related to scientific/programmatic matters between the NCRR Program Administrator and the CC with respect to implementation of a proposed operating policy. The panel will include one member selected by the CC, one member selected by NCRR, and a third member chosen by the other two members of the arbitration procedures in no way affect the awardee"s right to appeal an adverse determination in accordance with PHS regulations at 42 CFR Part 50, subpart D and HHS regulations at 45 CFR Part 16. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Jerry A. Robinson, Ph.D. Division of Comparative Medicine National Center for Research Resources One Rockledge Centre, Room 6164 6705 Rockledge Drive Bethesda, MD 20892 Telephone: (301) 435-0744 FAX: (301) 480-3819 e-mail: jerryr@ncrr.nih.gov o Direct your questions about per review issues to: Camille M. King, Ph.D. Scientific Review Administrator Division of Office of Review National Center for Research Resources One Rockledge Centre, Room 6114 6705 Rockledge Drive, Bethesda, MD 20892 Telephone: (301) 435-0811 FAX: (301) 480-3660 e-mail: kingc@ncrr.nih.gov o Direct your questions about financial or grants management matters to: Paul Karadbil Office of Grants Management National Center for Research Resources 6705 Rockledge Drive, Room 6086 Bethesda, MD 20892-7965 Telephone: (301) 435-0840 Email: paulk@ncrr.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA 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 IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent is to be sent to: Jerry A. Robinson, Ph.D. Division of Comparative Medicine National Center for Research Resources One Rockledge Centre, Room 6164 6705 Rockledge Drive Bethesda, MD 20892 Telephone: (301) 435-0744 FAX: (301) 480-3819 e-mail: jerryr@ncrr.nih.gov Applicants who wish to use express mail or courier service should change the zip code to 20817. SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact Grants Info, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. The RFA label available in the PHS 398 application (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. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Center for Scientific Review (CSR) National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817-7710 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Camille M. King, Ph.D. Scientific Review Administrator Division of Office of Review National Center for Research Resources One Rockledge Centre, Room 6114 6705 Rockledge Drive, MSC 7965 Bethesda, MD 20892-7965 (Zip Code 20817-7965 for express mail) APPLICATION PROCESSING: Applications must be received by April 25, 2002. 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. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by CSR and for responsiveness by the NCRR. Incomplete 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 the NCRR in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o 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 and assigned a priority score o Receive a second level review of the NCRR National Advisory Research Resource 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 your application in order to judge the likelihood the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application"s overall score, weighting them as appropriate for each application. Your 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, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. o Significance. What will be the impact of this resource on the AIDS biomedical research community? o Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Is the resource designed to effectively provide the required service to the research community? Is the approach sufficient to ensure that the types of animals specified with the appropriate "SPF" validation will be made available. Does the applicant acknowledge potential problem areas and consider alternative tactics? Timelines and available number projections will be review considerations. Documentation of the animal"s housing history will also be required. o Innovation. Is the design of the resource and the method of providing service innovative? o 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? o Environment. Does the environment contribute to the probability of success of the resource? Is there evidence of institutional support for the resource? ADDITIONAL REVIEW CRITERIA In addition to the above criteria, your application will also be reviewed with respect to the following: o Protections. 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. o Inclusion. The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and 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 Budget. The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: March 25, 2002 Application Receipt Date: April 25, 2002 Peer Review Date: May/June 2002 Council Review: September 2002 Earliest Anticipated Start Date: September 30, 2002 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 REQUIRED FEDERAL CITATIONS 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 URLs IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified pages 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. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving he health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of the "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.306. Awards are made under authorization of the 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 grants policies and Federal Regulations 42 CFR 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. 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 come 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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