RFA-RR-00-004: ESTABLISHMENT OF SPECIFIC PATHOGEN FREE RHESUS MACAQUE COLONIES

Department of Health
and Human Services (HHS)

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ESTABLISHMENT OF SPECIFIC PATHOGEN FREE RHESUS MACAQUE COLONIES Release Date: February 10, 2000 RFA: RR-00-004 National Center for Research Resources Letter of Intent Receipt Date: March 15, 2000 Application Receipt Date: April 26, 2000 PURPOSE Increased numbers of rhesus macaques 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 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 immundeficiency 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. 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 RFA, Establishment of Specific Pathogen Free Rhesus Macaque Colonies , is related to several priority areas, including AIDS, cancer, heart disease and stroke, diabetes and chronic disability conditions, maternal and infant health, and others. Potential applicants may obtain a copy of "Healthy People 2010" at http://odphp.osophs.dhhs.gov/pubs/hp2000. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, 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. Foreign institutions are not eligible. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use an Animal Model and Animal and Biological Material Resource Cooperative Agreement(U42)Grant mechanism. 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 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. The administrative and funding instrument to be used for this program will be an Animal (Mammalian and Non-Mammalian) Model, and Animal and Biological Materials Resource Cooperative Agreement (U42), an assistance mechanism (rather than an acquisition mechanism), in which substantial NCRR scientific and/or programmatic involvement with the awardees is anticipated during the performance of the activity. Under the cooperative agreement, the NCRR’s purpose is to support and/or stimulate the recipient’s activity by involvement in, and otherwise working jointly with the award recipient in a partnership role, but it is not to assume direction, primary responsibility, or a dominant role in the activity. Details of the responsibilities, relationships and governance of the activities to be funded under cooperative agreements are discussed later in this document. FUNDS AVAILABLE The NCRR anticipates making awards for three or four SPF colonies for project periods of up to five years. Approximately $3.0 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 2000. The anticipated award date is September 29, 2000. 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 macaques must be of Asian Indian desent. In addition, these animals 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 (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, although the screening of such animals is not within the purview of this RFA, special consideration will be given to those colonies whose programs are targeted toward selected pedigree breeding for these MHC type I haplotypes. 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. SPECIAL REQUIREMENTS The cooperative agreements (U42s) will require cooperation between the NCRR representative (NCRR Program Administrator) and the Principle 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. TERMS AND CONDITIONS OF AWARD The following terms and conditions will be incorporated into the U42 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) The NCRR Program Administrator and awardees are responsible for forming a CC as defined below. 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 will develop uniform procedures for quality control in animal husbandry and in the maintenance of the animal facilities. The CC will be responsible for the oversight to ensure standardization of the viral screening assays. The CC will continually review and monitor 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 will initially consist of the PI of each SPF colony and NCRR Program Administrator. Additional members can be added by action of the CC. The structure of the CC should be established at the first meeting as noted below. The Chair of the CC will be 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 must prepare an annual progress report which will include individual reports from each awardee. Each awardee is responsible for timely preparation of this report. At its initial meeting, the Committee will elect a chairperson (who may not be the NCRR Program Administrator). The CC will determine whether additional CC representation is required. The CC will meet three times in the first year to map strategies, to develop operating procedures and to evaluate progress. The initial meeting will be held as soon as possible after funding. Two additional meetings will be held during the first year of operation and there will be at least two meetings per year thereafter. Meetings may be held at any of the participating organizations or at another convenient location. These meetings are aimed at coordinating the activities of the participating facilities, establishing new policies and priorities, reviewing progress and providing oversight for the distribution of SPF animals to NIH grantees. The NCRR Program Administrator will participate in the discussions at these meetings. 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://grants.nih.gov/grants/policy/nihgps/policy_stmt.htm 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 U42 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. LETTER OF INTENT Prospective applicants are asked to submit, by March 15, 2000, a letter of intent that includes a descriptive title of the proposed project, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of this RFA in response to which the application may be submitted. 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 NCRR staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Jerry A. Robinson, Ph.D. 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 APPLICATION PROCEDURES The research grant application form PHS 398 (revised 4/98)is to be used in applying for this grant. These forms are available at most institutional offices of sponsored research, from the Division of Extramural Outreach and Information Resources, NIH, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267 or E-mail grantsinfo@nih.gov, and from the program administrator listed under INQUIRIES. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page of the application. 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 2a of the face page of the application form and the YES box must be marked. The sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. 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 Suite 1040 6701 Rockledge Drive MSC 7710 Bethesda, MD 20892-7710 Applicants who wish to use express mail or courier service should change the zip code to 20817. At the time of submission, two additional copies of the application must be sent to: Jerry A. Robinson, Ph.D. Comparative Medicine National Center for Research Resources One Rockledge Centre, Room 6164 6705 Rockledge Drive, MSC 7965 Bethesda, MD 20892 (Zip Code 20817 for express mail) Applications must be received by April 26, 2000. If an application is received after that date, it will be returned to the applicant without review. The 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. REVIEW CONSIDERATIONS 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 will be evaluated for scientific and technical merit by an NCRR peer review committee convened in accordance with NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit, generally the top one half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Research Resources Council, NCRR. Review Criteria 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? In addition to the above criteria, in accordance with NIH policy, all applications will be reviewed with respect to the following: o The reasonableness of the proposed budget and duration in relation to the proposed research. o The adequacy of the proposed protection for animals or the environment, to the extent they may be adversely affected by the project proposed in the application. Schedule Letter of Intent Receipt Date: March 15, 2000 Application Receipt Date: April 26, 2000 Peer Review Date: June 2000 Council Review: September 2000 Earliest Anticipated Start Date: September 29, 2000 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 questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Jerry A. Robinson, Ph.D. 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 Direct inquiries regarding fiscal 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 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.849. 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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