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- Subject: NIH Guide, vol. 22, no. 3, pt. 3, 22 January 1993
- Message-ID: <CMM.0.90.2.727661905.kristoff@net.bio.net>
- Date: 22 Jan 93 00:18:25 GMT
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- $$XID RFA AI9304 AI-93-04 P1O1 *****************************************
-
- NATIONAL COOPERATIVE VACCINE DEVELOPMENT GROUPS FOR ACQUIRED
- IMMUNODEFICIENCY SYNDROME
-
- NIH GUIDE, Volume 22, Number 3, January 22, 1993
-
- RFA: AI-93-04
-
- P.T. 34; K.W. 0715008, 0740075
-
- National Institute of Allergy and Infectious Diseases
-
- Letter of Intent Receipt Date: February 26, 1993
- Application Receipt Date: April 22, 1993
-
- PURPOSE
-
- It is the intention of this Request for Applications (RFA) to
- encourage investigators to collaborate on new approaches for Acquired
- Immunodeficiency Syndrome (AIDS) vaccine research and development
- through the National Cooperative Vaccine Development Groups (NCVDG)
- Program, and to complement and balance the efforts presently being
- pursued by existing NCVDGs. It is recognized that the ultimate
- objective of developing efficacious AIDS vaccines requires a solid
- knowledge base of the immunology, virology, adjuvants, molecular
- biology, and host interactions of infectious agents. The objective
- of this RFA is to stimulate original, novel and innovative research
- of sound scientific rationale, requiring comprehensive team effort,
- that is likely to result in AIDS vaccines effective in prevention
- and/or used as immunotherapy against AIDS.
-
- The National Institute of Allergy and Infectious Diseases (NIAID)
- invites applications aimed at the conceptualization, development, and
- evaluation of vaccines designed to effectively prevent (AIDS). This
- research should stress creative, novel approaches to the development
- of effective AIDS vaccines and should have the capacity to translate
- these concepts rapidly into improved candidate vaccines. The NCVDG
- can be focused in one or more vaccine areas and may pursue studies of
- HIV-based vaccines or studies of relevant model viruses (e.g., the
- Simian Immunodeficiency Viruses (SIV)). The Group must possess the
- expertise necessary to conduct adequate evaluation of the proposed
- approach(s) in preclinical situations. Further studies required for
- development of new vaccines to bring them to clinical trial may be a
- part of the work proposed by an applicant. Alternatively, an NCVDG
- may request that the NIAID conduct these developmental tasks using
- contracts now in place (SIV Evaluation Units, Chimpanzee Access via
- Interagency Agreement with the National Cancer Institute, and AIDS
- Resources and Reagents Contract). An NCVDG must form a cohesive
- team, and is encouraged to include scientists from a combination of
- academic, non-profit research, and commercial organizations.
-
- Applications that include research projects from the private sector
- (e.g., pharmaceutical, chemical, or biotechnological companies) are
- encouraged.
-
- HEALTHY PEOPLE 2000
-
- The Public Health Service (PHS) is committed to achieving the health
- promotion and disease prevention objectives of "Healthy People 2000,"
- a PHS-led national activity for setting priority areas. This RFA,
- National Cooperative Vaccine Development Groups for AIDS, is related
- to the priority area of HIV infection. Potential applicants may
- obtain a copy of "Healthy People 2000" (Full Report: Stock No.
- 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No.
- 017-001-00473-1) through the Superintendent of Documents, Government
- Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238).
-
- 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, companies, units of State and
- local governments, and eligible agencies of the Federal government.
- Applications from minority individuals and women are encouraged.
-
- MECHANISM OF SUPPORT
-
- Awards will be made as cooperative agreements (U01s). The
- cooperative agreement is an assistance mechanism in which substantial
- NIAID programmatic involvement with the recipient during the
- performance of the planned activity is anticipated. The nature of
- NIAID staff participation is described in SPECIAL REQUIREMENTS -
- Terms and Conditions of Award. The awardee will be responsible for
- the planning, direction, and execution of the proposed project and
- interrelated activities. A minimum of two interrelated research
- projects per Group is required. While no maximum number of projects
- is stipulated, it has been observed that when a multidisciplinary
- grant or award exceeds six component projects the program becomes
- less coordinated and more difficult to manage.
-
- The total project period for applications submitted in response to
- this RFA may not exceed four years. Because the nature and scope of
- the research proposed in response to this RFA may vary, it is
- anticipated that the size of the award will vary also. However,
- applications with first-year budgets in excess of $1,000,000 total
- (direct and indirect) should contact the NIAID Scientific
- Coordinator, listed under INQUIRIES, for written approval. Budget
- requests should be carefully justified and commensurate with the
- complexity of the project.
-
- This RFA may be a one-time solicitation. If by the end of the third
- year of the award, the NIAID has not announced its intent to re-issue
- the RFA, incumbents should contact NIAID program staff and consider
- submitting investigator-initiated (R01) applications which will
- compete with all investigator-initiated applications and be reviewed
- according to the customary peer review procedures.
-
- While the number of applications cannot be determined, both new and
- competitive renewal applications are anticipated.
-
- All policies and requirements that govern the grant program of the
- PHS, and the National Institutes of Health (NIH) apply.
-
- FUNDS AVAILABLE
-
- The NIAID anticipates making four to eight awards for project periods
- up to four years. The NIAID has set aside $4.2 million total costs
- for the first year of funding. This level of support is dependent on
- the receipt of a sufficient number and diversity of applications of
- high scientific merit. Although this program is provided for in the
- financial plans of the NIAID, awards pursuant to this RFA are
- contingent upon the availability of funds for this purpose.
-
- RESEARCH OBJECTIVES
-
- Background
-
- The NIH and other agencies in the PHS are currently supporting
- extramural and intramural projects for the study of the etiology,
- natural history, and demographics of AIDS; for the screening of
- high-risk individuals; for determining means of diminishing the risk
- of infection; and for the development of vaccines and other methods
- of prevention. Notwithstanding these efforts, the rapidity of the
- increase in diagnosed cases of AIDS and the morbidity from this
- disease require the mobilization of the most creative scientific
- talents -- regardless of their scientific discipline or
- organizational affiliations -- into groups whose objective is to
- pursue aggressively a concerted research effort to discover and
- develop vaccines for preventing AIDS. Recent surveillance studies
- indicate that the total number of AIDS cases in the U.S. reported
- through March 1992 was 218,301, with projections by WHO of 30 to 40
- million HIV infections worldwide in men, women, and children by the
- year 2000. Moreover, more than 90 percent of these cases will be in
- developing countries. It has been predicted that all infected
- persons will progress to develop AIDS.
-
- An NCVDG may consist of scientists from academic and/or non-profit
- research institutions and commercial organizations. The NIAID has
- awarded thirteen NCVDGs, some of which already have terminated. The
- purpose of this current initiative is to maintain the total NCVDG
- network to ten Groups aimed at facilitating and accelerating efforts
- in AIDS vaccine development. A listing of the active NCVDGs can be
- found in Appendix I.
-
- Research Goals and Objectives of the NCVDG Program
-
- 1. The principal goal of the NCVDG Program for AIDS is the
- conceptualization, development, and evaluation of vaccines designed
- to effectively prevent AIDS in humans. This research can focus on
- HIV or other lentiviruses (e.g., SIV) that are appropriate models for
- AIDS vaccine development and that may involve animal model studies of
- vaccine immunogenicity and efficacy.
-
- 2. Applications for funding as an NCVDG should stress creative,
- novel approaches to the development of effective AIDS vaccines and
- may emphasize one or more of the general approaches outlined below.
- Since the currently funded NCVDGs are also pursuing research in many
- of these areas, potential applicants are strongly encouraged to
- contact program staff to determine if their proposed studies address
- vaccine strategies not currently being funded. Applications for
- research on novel vaccine vectors, immunogen processing and
- presentation, mucosal immunity, and creative methods to enhance
- immunogenicity are encouraged.
-
- Approaches may include, but are not limited to:
-
- o live attenuated vaccines;
- o whole inactivated vaccines;
- o recombinant proteins or protein fragments;
- o novel recombinant viruses or other vectors (e.g., yeast Ty
- elements, hepatitis B virus, bacteria);
- o synthetic peptides;
- o combination approaches;
- o DNA immunization.
-
- 3. Applications should address all aspects of research, from basic
- research to subsequent developmental studies, scale-up and
- production, evaluation in laboratory animals, protection of
- appropriate species from infection or disease following virulent
- challenge, and other considerations that relate to the acceptability
- and utility of candidate vaccines for clinical trials.
-
- Applicants should describe their plans to accommodate the stated
- program requirements, criteria, and staff involvement.
-
- 4. The Group's objectives and goals should be relevant and
- compatible with NIAID program's missions and directions as stated in
- this RFA.
-
- 5. For small pilot studies involving a few animals, the Principal
- Investigator is expected to have access to a small number of animals
- and to primate facilities. For larger animal studies the applicant
- may use NIAID resources such as the SIV Evaluation Units, Chimpanzees
- via Interagency Agreement with the National Cancer Institute, and the
- Resources and the Reagents Contract. The Principal Investigator
- should contact the program official on how these resources may be
- accessed.
-
- Definitions
-
- COOPERATIVE AGREEMENT - An assistance mechanism in which substantial
- NIAID programmatic involvement with the recipient organization during
- the performance of the planned activity is anticipated.
-
- NATIONAL COOPERATIVE VACCINE DEVELOPMENT GROUP (NCVDG) - In this RFA
- the terms National Cooperative Vaccine Development Group, NCVDG, and
- "Group" are synonymous. Each Group may be composed of a number of
- scientific investigators from academic and/or non-profit research
- institutions as well as scientists from commercial organizations,
- performing research on interrelated projects whose central focus is
- development of vaccine(s) for AIDS.
-
- RESEARCH PROJECT - A discrete, specified, circumscribed project that
- must relate to the overall theme of the NCVDG.
-
- SCIENTIFIC CORE COMPONENTS - Facilities for equipment and services
- that are shared by two or more projects of the Group. Examples of
- Scientific Core components are: vaccine production facility, reagent
- production, animal model evaluations. The Scientific Core can be
- defined as a component with established techniques and assays that
- perform a service function resulting in an economy of effort and
- savings in the overall costs. The Scientific Core unit is to be
- described in the same detail as research projects to enable the
- evaluation of its scientific expertise and technical merit. (See
- details for preparation of the budgets under Preparation and
- Organization of the Application).
-
- ADMINISTRATIVE CORE - An administrative facility that provides
- central operations and support for the overall management of the
- cooperative agreement and services shared by the Group as a whole.
- The Administrative Core should have a budget separate from that of
- the Principal Investigator's, but administered by the Principal
- Investigator's organization.
-
- PROJECT LEADER - The leader of one of the scientific research
- projects of the NCVDG, who is responsible for the scientific conduct
- of that project.
-
- CORE LEADER - The leader of one of the Scientific or Administrative
- Cores of the NCVDG
-
- PRINCIPAL INVESTIGATOR - The person who assembles the NCVDG, who is
- responsible for the performance of the Group as a whole and for that
- of each of the Project Leaders, and who submits the single
- application in response to this RFA. The Principal Investigator will
- coordinate Group activities scientifically and administratively and
- should preferably also be project leader of one of the Research
- Projects of the Group. The awardee institution establishes and
- operates the Central Operations Office that funds Group members and
- is legally and fiscally accountable for the disposition of funds
- awarded. While the Principal Investigator need not be an employee of
- the awardee institution, for this Program NIAID strongly prefers that
- the Principal Investigator be an employee of the awardee institution.
-
- NIAID SCIENTIFIC COORDINATOR - A scientist of the extramural staff of
- the NIAID who functions as a peer with the Principal Investigators
- and Project Leaders and facilitates the partnership relationship
- between NIAID and the Groups.
-
- INVENTION - A new vaccine that is or may be patentable under Title 35
- of the United States Code.
-
- ARBITRATION PANEL - A panel that is formed to review any scientific
- or programmatic activity that is impeding progress within a Group.
- It will be composed of a "Group" designee, one NIAID designee, and a
- third designee with expertise in the relevant area and chosen by the
- other two. Such panels may help resolve both scientific and
- programmatic issues that develop during the course of work that
- restrict progress.
-
- SPECIAL REQUIREMENTS
-
- Terms and Conditions of Award
-
- NOTE: Failure to abide by any of the Terms of Award pertaining to
- awardee responsibilities stipulated in this Section may result in the
- withholding of funds by the NIAID until compliance with the terms is
- restored.
-
- Working Relationships Within a Cooperative Agreement
-
- Under the Cooperative Agreement, a partner relationship exists
- between the recipient of the award and NIAID in which the Group is
- responsive to the requirements and conditions set forth in this RFA.
- The participation of the Government through the NIAID extramural
- staff is intended to facilitate a concerted effort by all members of
- the network of Groups by providing appropriate scientific input, by
- coordinating efforts among Groups, by making available to Groups
- biological materials for testing, by accessing appropriate data
- bases, and by providing ancillary testing and other resources, such
- as reagents, samples or experimental animals, available under
- existing Government contracts. The interaction of academic and
- non-profit research institutions with commercial organizations and
- Government is strongly encouraged and is expected to favor
- expeditious preclinical development of AIDS vaccines to prevent
- transmission of HIV.
-
- Patent Coverage
-
- Inasmuch as the development of effective AIDS vaccines is the
- objective of this effort, and since active involvement by industrial
- laboratories is facilitated by the existence of adequate patent
- coverage, it is essential that applicants provide plans to ensure
- such coverage. Since several institutions may be involved, the
- situation could be complicated. Each applicant Group must,
- therefore, provide a detailed description of the approach to be used
- for obtaining patent coverage and for licensing where appropriate, in
- particular where the invention may involve investigators from more
- than one institution. In addition, each Group must provide a
- detailed description of the procedures to be followed for the
- resolution of legal problems that may develop. Your attention is
- drawn to P.L. 96-517 as amended by P.L. 98-620 and instructions
- published by the Office of Management and Budget in the Federal
- Register (OMB Circular A-124), Volume 47, Number 34, Friday, February
- 19, 1982, pp. 7556-7566. Note that non-profit organizations
- (including universities) and small business firms retain the rights
- to any patent resulting from Government contracts, grants or
- Cooperative Agreements.
-
- Also, a Presidential memorandum of February 18, 1983 extended to all
- business concerns, regardless of size, the first option to the
- ownership of rights to inventions as provided in P.L. 96-517. As a
- result of this memorandum, the relationships among industrial
- organizations and other participants are simplified, since all Group
- members can now be full partners in the research and in any
- inventions resulting therefrom. The specific patenting arrangements
- among the institutions may vary, and could include joint patent
- ownership, exclusive licensing arrangements, etc. Applicants are
- encouraged to develop an arrangement that is most suitable for their
- own particular circumstances.
-
- The proposed patent plan among the institutions comprising the Group
- must be submitted with the application. This patent agreement,
- signed and dated by the organizational officials authorized to enter
- into patent arrangements for each Group member and member
- institution, must be sent prior to peer review to Dr. Alan Schultz at
- the address listed under INQUIRIES.
-
- Federal regulation clause 37 CFR 401 and HHS Inventions regulations
- at 45 CFR Parts 6 and 8 require that NIH be informed of inventions
- and licensing occurring under NIH funded research. Invention and
- licensing reports must be submitted to Extramural Invention Reports
- office, Office of Extramural Research, Building 31, Room 5B41, NIH,
- with a copy to Dr. Alan Schultz at the address listed under
- INQUIRIES.
-
- Awardee Rights and Responsibilities
-
- The applying Group must define its objectives in accord with its own
- interests and perceptions of novel and exploitable approaches and
- must develop the detail of the research design following the guidance
- given in this RFA. It is the primary responsibility of the Principal
- Investigator to clearly state the objectives of the Group, to perform
- the research stipulated in the proposal and to ensure that the
- results obtained are published in a timely manner. The data obtained
- will be the property of the awardee.
-
- Specifically, the Principal Investigator defines the details for the
- project within the guidelines of the RFA, retains primary
- responsibility for the performance of the scientific activity, and
- agrees to accept close assistance in coordination, cooperation, and
- participation of NIAID staff in all aspects of scientific and
- technical management of the project in accordance with the terms
- formally and mutually agreed upon prior to the award. The
- responsibility for the planning, direction, and execution of the
- proposed project will be solely that of the applicant.
-
- 1. Meetings
-
- o Two mandatory Group meetings. The Principal Investigator and
- Project Leaders of the Group, and the NIAID Scientific Coordinator,
- must meet twice per year to review progress, plan and design research
- activities, and establish priorities within the Group. The Principal
- Investigator will be responsible for scheduling the time and place
- (generally at one of the performance sites) and for preparing concise
- proceedings or minutes which will be delivered to the members of the
- group within sixty days of the meeting. The agenda for this meeting
- will be determined by agreement between the Principal Investigator
- and the NIAID Scientific Coordinator. NIAID staff may not chair
- Group meetings.
-
- o One mandatory meeting of the awardees will be held annually at the
- NIH or at a site designated by the NIAID during which the Principal
- Investigators and Project Leaders of all the Groups will present
- significant findings in symposium format.
-
- Applicants should include requests for travel funds specifically for
- the above meetings when preparing the budget.
-
- o Informal meetings. A critical determinant of Group success will
- be the degree of communication among its members. Therefore, in
- addition to the three meetings listed above, two additional meetings
- which may be necessary for coordination of Group activities may be
- scheduled if justified and should be included in the budget. Regular
- telephone and written communication will be important and are
- encouraged.
-
- 2. The Principal Investigator will be responsible for the timely
- submission of all abstracts, manuscripts and reviews (co)authored by
- members of the Group and supported in part or in total under this
- Agreement. The Principal Investigator and Project Leaders are
- requested to submit manuscripts to the Scientific Coordinator within
- three weeks of acceptance for publication so that an up-to-date
- summary of program accomplishments can be maintained.
-
- 3. An annual Progress Report should be submitted, which should
- include a complete and cumulative list of all publications
- (abstracts, manuscripts, reviews) (co)authored by Group members and
- supported in part or in total under this Agreement.
-
- Each Progress Report should also include a brief section outlining
- intra-Group interactions that have augmented activities, citing
- specific occurrences (e.g., construct X was made under Project 1 and
- transferred to Project 2 for analysis). Inter-Group collaboration
- with other NCVDGs should be specified, where applicable. Interaction
- with the Scientific Coordinator and the NIAID during the reporting
- period should be described.
-
- The Progress Report should routinely include basic information.
- Please refer to PHS 2590 noncompeting continuation application form,
- which includes the basic information required by NIH for preparation
- of the progress report.
-
- 4 Publications or oral presentations of work done under this
- Agreement are the responsibility of the Principal Investigator and
- appropriate Project Leaders and will require appropriate
- acknowledgement of NIAID support.
-
- 5. All published (abstracts, peer reviewed manuscripts, reviews) and
- oral presentations of work supported in part or in total by the NCVDG
- cooperative agreement must acknowledge the award by including the
- mechanism, cooperative agreement number, and Institute, i.e., "This
- work was supported in whole (or in part) by the NCVDG program,
- cooperative agreement number U01-AI-12345, NIAID.
-
- 6. While the NIAID Scientific Coordinator has a right of access to
- the data (see NIAID staff responsibilities below), the applicant will
- retain custody of and rights to the data. Timely publication of
- major findings is encouraged.
-
- 7. The applicant institution and the Principal Investigator will be
- responsible for the Group's application. The award will be made to
- the applicant institution on behalf of the Group as a whole and not
- to individual research projects within the Group. The applicant
- institution will provide a Central Operations Office for the Group,
- will be responsible for the performance of the entire Group, and will
- be accountable for the funds awarded.
-
- NIAID Staff Responsibilities: Nature of NIAID Participation
-
- Assistance via a Cooperative Agreement differs from the traditional
- research grant in that, in addition to the normal programmatic and
- administrative stewardship responsibilities, the awarding component
- (NIAID) anticipates substantial programmatic involvement during
- performance of the research program. NIAID shall work with the Group
- and shall be represented by a NIAID Scientific Coordinator. The
- coordinator shall be a member of the professional staff of the
- Vaccine Research and Development Branch, Basic Research and
- Development Program, Division of AIDS.
-
- During performance of the award, the NIAID Scientific Coordinator,
- Dr. Alan M. Schultz, Acting Preclinical Section Chief, may provide
- appropriate assistance, advice, and guidance by performing the
- following: participating in the design of Group activities; advising
- in the selection of sources or resources; coordinating or
- participating in collection and/or analysis of data; advising in
- management and technical performance; or participating in the
- preparation of publications. However, the role of the NIAID will be
- to facilitate and not to direct the activities. It is anticipated
- that decisions in all activities will be reached by consensus of the
- Group and that NIAID staff will be given the opportunity to offer
- input to this process. The manner of reaching this consensus and the
- final decision-making authority will rest with the Principal
- Investigator.
-
- 1. NIAID Participation in Design of Group Activities, Development of
- Research Protocols and Evaluation of Results
-
- o The NIAID Scientific Coordinator, like other Group members, may
- suggest studies within the scope of the Group's objectives and
- research activities; may present to the Group experimental findings
- from published sources or from contract projects in support of these
- suggestions; may participate in the design, but not in the execution,
- of experiments agreed to by the Group; and may participate in the
- analysis of results.
-
- o The NIAID Scientific Coordinator may assist the Group or other
- individual members in research planning, particularly by:
-
- o provision of needed resources and information that may not be
- otherwise be available to the Group;
-
- o provision of data from testing conducted in resource contract
- laboratories;
-
- o provision of information concerning work being conducted in other
- NIAID-supported extramural projects, in order to reduce or prevent
- duplication of efforts.
-
- 2. NIAID Participation in Collection and Analysis of Data,
- Procedures for Submission of Results to NIAID, and Preparation of
- Group Findings for Presentation and Publication
-
- In addition to the special reports and stipulations described below,
- reporting requirements will be identical to those currently in
- existence for awardees of traditional NIH research project grants.
-
- o The principal end product of NCVDG activities will be the
- development of promising AIDS vaccines for testing in clinical
- trials. Subsequent developmental work through private resources is
- encouraged. Alternatively, the Group may recommend that development
- be sponsored by the NIAID. In the latter case, it will be necessary
- for the Principal Investigator (s), appropriate Project Leaders and
- the NIAID Scientific Coordinator to collaborate in the analysis,
- summarization, preparation, and presentation of data to the
- appropriate NIAID staff and NIH advisory committees (including the
- AIDS Research Advisory Committee and NIAID Council) and other working
- groups (such as the Animal Model Operating Committee or the AIDS
- Vaccine Selection Committee).
-
- o NIAID will retain the option to cross-file or independently file
- an application for investigational clinical trial; i.e., an
- Investigational New Drug Application (INDA), to the United States
- Food and Drug Administration of any invention resulting from these
- NIAID supported Cooperative Agreements. Reports of data generated by
- the Group or any of its members required for inclusion in INDA's and
- Clinical Brochures and for cross-filing purposes will be submitted by
- the Principal Investigator to the Scientific Coordinator upon
- request. Such reports will be in final draft form and include
- background information, methods, results, and conclusions. They will
- be subject to approval and revision by the NIAID and may be augmented
- with test results from other Government sponsored projects prior to
- submission to the appropriate regulatory agency.
-
- o The NIAID, via the NIAID Scientific Coordinator, will have access
- to data generated under this Cooperative Agreement. Information
- obtained from the data may be used by the NIAID Scientific
- Coordinator for the preparation of internal reports on the Group's
- activities.
-
- Arbitration Process
-
- Inasmuch as certain activities require approval by NIAID staff during
- performance of this Cooperative Agreement, specifically, reports
- intended for inclusion in INDA's and Clinical Brochures,
- redistribution of biological materials received from the Government,
- and dissemination of research findings resulting from the use of
- these materials, NIAID will establish an arbitration process to
- resolve any differences of opinion between the awardee and NIAID, on
- scientific-technical matters. An arbitration panel, composed of one
- Group designee, one NIAID designee, and a third designee with
- expertise in the relevant area and chosen by the other two, will be
- formed to review any scientific or programmatic issue that is
- significantly restricting progress. These special arbitration
- procedures in no way affect the awardee's right to appeal an adverse
- action in accordance with PHS regulations at 42 CFR Part 50, Subpart
- D, and HHS regulations at 45 CFR Part 16.
-
- The special "Terms and Conditions of Award: Nature of NIAID
- Participation" described in this Section 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 policies.
-
- Preparation and Organization of the Application: Special
- Instructions for Preparing the Group Application
-
- 1. General Instructions: Overall Application
-
- For preparing the NCVDG application this Section supplements the
- instructions found in form PHS 398 (rev. 9/91), which is available as
- an application kit at most grantee institutions and from the Office
- of Research Grants Inquiries, Division of Research Grants, National
- Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD
- 20892, telephone 301-496-7441. Additional instructions are required
- because the form PHS 398 is designed primarily for individual
- research grant (R01) applications, whereas the Group application
- consists of several research projects interrelated by a common theme.
- Items that require modification for multi-project applications, in
- addition to other information not requested in form PHS 398, are
- detailed below:
-
- o PHS 398 Instructions - Pages 1-10: General Information and
- General Instructions. No modification.
-
- o PHS 398 Instructions - Pages 10-16: Specific instructions for
- filling form page 1 (Face Page of Form 398) of the application.
-
- o Page 1 of Form PHS 398
-
- Complete items 1 through 18 as instructed. Please note that this
- should be Page 1 of the entire application; all succeeding pages
- should be numbered consecutively. Since the application is in
- response to an RFA, mark the "Yes" box in item 2a and enter the
- number and title of this RFA.
-
- For item 3a to 3h, enter the name of the Principal Investigator of
- the Group along with other required information concerning him or
- her. The applicant (awardee) institution and the Principal
- Investigator will be responsible for the application, for Group
- research activities, and the awardee institution will be responsible
- for the support of Group activities through a Central Operations
- Office.
-
- For item 11, name the applicant organization and its address. The
- applicant organization (awardee institution) will provide the Central
- Operations Office and be legally and financially responsible and be
- accountable for the use and disposition of funds awarded on the basis
- of this RFA; show availability of personnel and facilities capable of
- performing and supporting the administrative functions of the Group.
-
- o Page 2 of form PHS 398 - This section represents an abstract of
- the overall program. It should briefly state the overall goals of
- the NCVDG and give an indication of the research emphasis of
- component projects and cores. Do not exceed space provided. This
- section should be written in such a manner that it can be adapted by
- NIH staff to be the Overall Description portion of the Summary
- Statement.
-
- Under "Key Personnel Engaged on Project," list the Principal
- Investigator of the overall NCVDG and the Project Leader for each
- component project and the Core Leader for each core.
-
- o Page 3 of form PHS 398: Table of Contents (modification necessary)
-
- The NCVDG application should be assembled and paginated as one
- complete application. Following the complete table of contents for
- the entire document, the applicant should provide a separate table of
- contents for each project similar in detail to the table of contents
- in the PHS 398. Bearing in mind that the application will be
- reviewed project by project and core by core, prepare a detailed
- table of contents that will enable reviewers to readily find specific
- information. A page reference should be included for the budget that
- is associated with each project/core. Further, each project should
- be identified by number, title and responsible Project Leader.
-
- o Summary Budget Information Required for the Group Application.
-
- Summary budgets should be prepared for the total Group application.
-
- 1. Present a composite budget for the first year according to the
- format shown in Table I in Appendix II of this RFA.
-
- 2. Use page 5 from the form PHS 398 to prepare a summary budget by
- category for all years of requested support. Requests for unusual
- increases in any of the succeeding years must be justified in the
- individual project budgets.
-
- 3. Detailed budgets for each category for each research project and
- each core are requested for the first year only.
-
- Personnel
-
- List all professional and non-professional participants (including
- those with no salary requested) in the Group for the first year of
- requested support utilizing the format shown in Table II and the
- distribution of professional effort (%) for other support as shown in
- Table III. Sample tables labeled I, II, and III are found in
- Appendix II attached to this RFA.
-
- o Page 6 of Form 398: Biographical Sketches
-
- Prepare biographical sketches for all professional personnel
- participating in individual projects and cores, using page 6 of the
- form PHS 398 application kit and applying the same page limitations.
- The biographical sketches, with that of the PI first and those of the
- other key professional personnel following in alphabetical order,
- should be placed at the end of the application, appropriately
- numbered and referenced in the table of contents.
-
- Research Plan
-
- As an introduction to the component elements of the NCVDG provide the
- information detailed below, using continuation pages as needed. Name
- this section "OVERALL PROGRAM". Since this Section will constitute
- the Research Plan for the overall program a total of up to 25 pages
- may be used in its presentation (Introduction, Organizational and
- Administrative Structure). The Facilities pages should not be
- included in the 25-page limitation.
-
- 1. Program Introduction - Statement of Objectives
-
- The NCVDG should be viewed as a confederation of interrelated
- research projects -- each capable of standing on its own scientific
- merit, but complementary to one another. It is very important to
- establish the programmatic theme in the first few sentences of a
- general introduction.
-
- The introduction is an important section, for it provides the
- investigator an opportunity to give conceptual wholeness to the
- overall program -- by giving a statement of the general problem area
- and by laying out a broad strategy for attacking the problems. As
- the strategy develops, each project and core should be cited briefly
- as to its place in the overall scheme.
-
- The introductory section should briefly state the rationale of the
- research proposed in each project describing how it relates to
- vaccine development and/or the anticipated approach to achieve and/or
- evaluate the work proposed.
-
- It is essential to demonstrate that each component research project
- contributes to the attainment of the Group's objectives and that each
- has available the professional and technical personnel to permit
- efficient and successful conduct of the proposed research; i.e., it
- is important to show that the total personnel of the Group are
- sufficient in quality and quantity to assure successful conduct of
- the proposed research.
-
- It is useful to provide a clear, concise plan in narrative and
- diagrammatic form that depicts the interrelationships among the
- members of the NCVDG and the contribution of each to fulfillment of
- Group objectives; provide an organizational chart of the NCVDG
- showing the name, organization, and scientific discipline of the
- Principal Investigator and Project Leaders; provide an organizational
- chart for each laboratory project within the Group showing
- relationships among the key personnel.
-
- To assure the maintenance of close collaboration and effective
- communication among members of the Group include letters of
- commitment to this plan and also a letter accepting the participation
- of the NIAID Scientific Coordinator, defined under Terms and
- Conditions of Award.
-
- It also is appropriate in this section to indicate the prior
- collaborative arrangements between investigators in the Group. It is
- important to reveal the anticipated unique advantages to be expected
- from the Group operating within the proposed collaborative efforts;
- how the projects are mutually reinforcing; and how collectively they
- will further the stated goals of the proposed research.
-
- NOTE: The Principal Investigator should provide a narrative,
- supported by diagrammatic presentation(s) as needed, addressing the
- points raised under the above items. This description should clearly
- demonstrate the interactive, cooperative, integrated and
- interdependent nature of each proposed project and core to the Group
- activities as a whole. The narrative is to be included under the
- Administrative Core: it will serve as one of the criteria used by
- the peer review group to evaluate and rate the ability of the
- Principal Investigator to assemble a comprehensive, interactive
- Group.
-
- 2. Facilities: use page 8 of PHS 398, using continuation pages as
- necessary
-
- Demonstrate that each component laboratory project, Scientific Core
- facilities, and the NCVDG as a whole have available the facilities
- required for conduct of the proposed research; demonstrate that
- appropriate biohazard facilities and safety procedures are in place
- for activities involving HIV or SIV and other pathogens and
- pathogen-producing cell lines as outlined in The Federal Register,
- Volume 49, Number 201, Tuesday, October 16, 1984, p. 40556; include a
- description of the Institutional Safety Guidelines and approval
- procedures for each proposed laboratory project. This information
- should be conveyed on page HH of the PHS 398 under Resources and
- Environment.
-
- 3. Organizational and Administrative Structure of the NCVDG
-
- Describe in detail and by diagram the chain of responsibility for
- decision-making and administration beginning at the level of
- Principal Investigator and including the different research project
- leaders and core leaders. Indicate where in the chain of
- responsibility advisory groups (local or outside consultants) will be
- used. Describe their role in establishing quality control of the
- research efforts.
-
- o Consortium Arrangements.
-
- If an application includes research activity involving institutions
- other than the sponsoring organization, the program is considered a
- consortium effort. Such activity may be included in a
- multi-component (such as a U01) application, but it is imperative
- that care be taken in preparing any consortium application so that
- the programmatic, fiscal, and administrative considerations are fully
- explained. The policy governing consortia is described in the NIH
- Guide for Grants and Contracts (Vol. 14, No. 7, June 21, 1985), which
- should be available at your institution's business office, or use the
- Office of Grants Inquiries' publication entitled, "Guidelines for
- Establishing and Operating Consortium Grants," January 1989, which
- may be obtained by calling 301-496-7441. These guidelines should be
- read carefully before such an application is developed. If
- clarification of the guidelines is needed, the applicant is
- encouraged to contact grants management staff, Ms. Jane Unsworth, at
- 301-496-7075.
-
- o Patent Coverage
-
- Provide a description of the Group's plan for assuring adequate
- patent coverage of new inventions that may issue as a result of
- Government funding of this U01.
-
- NOTE: A formal statement of Patent Agreement among all Group members
- and their institutions as well as a detailed description of
- procedures to be followed for the resolution of legal problems which
- may develop, signed and dated by the organizational official
- authorized to enter into patent arrangements for each Group member
- and member institution, is to be submitted to Dr. Alan Schultz at the
- address listed under INQUIRIES.
-
- Core Units
-
- Since the cores are designated to provide resources for two or more
- of the component research projects, all pages on cores should be part
- of the "OVERALL Program".
-
- 1 Use letters to designate individual core units and give each a
- title.
-
- 2 Provide the name and academic title of the core leader and key
- participating investigators.
-
- 3. Administrative Core: The Administrative Core component should be
- at the awardee Institution and should provide BOTH travel funding
- for: (a) personnel to participate in two required annual intra-Group
- meetings, and any additional justified intra-Group meetings, (b)
- Principal Investigator and project leaders for a NIAID-specified
- annual U.S. meeting with NCVDG Principal Investigators and project
- leaders of other Groups; AND other funding including secretarial
- and/or administrative services, expenses for Group publications and
- communication expenses such as conference calls, facsimiles, and
- postage.
-
- 4. Description of Scientific Core(s): Describe the role and
- importance of the core as a resource to the NCVDG as a whole and
- indicate the specific projects it will serve, e.g., Production of
- monoclonal antibodies and distribution to research projects 1, 2, and
- 4. This section should present a clear picture of the facilities,
- techniques, and professional skills that the core will provide. The
- role of the core leader and each of the key participants should be
- described. Each core request should include a chart which apportions
- the dollars, or percentage of dollars, that will be required to
- support each component research project which will use the resource.
- (See Table IV in Appendix II of this RFA).
-
- For presentation of each Core budget request and justifications the
- following PHS Form 398 pages should be used:
-
- o Face Page. Enter a descriptive name of the requested core (e.g.,
- Administrative Core, Monoclonal Antibody Production Core) in item 1,
- Title of Project. Complete data items 3a (Name of Core Leader), 4,
- 5, 6, 7, 8, and 9.
-
- o Pages 4 and 5: Budget for Core(s): Fill these pages for each
- core request, providing justifications with the same detail as in
- research projects.
-
- o The budget for each core unit should be presented according to the
- instructions indicated on pages 16-19 of the PHS 398 Instructions. A
- detailed budget is required for the first year (PHS 398, page 4) and
- a budget summary for all additional years (PHS 398, page 5). Explicit
- detailed budget justifications for all years should be included.
- Budget pages should be clearly labeled so that they can be accurately
- associated with the individual cores.
-
- o Other activities which are essential to maintaining or achieving
- the objectives of the stated research projects (e.g., large scale
- production of reagents, animal maintenance) should be included as
- subcontracts under the budget for the Scientific Core.
-
- Individual Research Projects
-
- 1. General Information.
-
- The strength of the multiproject application will be judged on the
- basis of the research it will support. Therefore, the reviewers will
- expect each project and core unit to be described in the same detail
- as for a regular research grant application to enable the scientific
- merit to be judged from the written application.
-
- 2. Format for Presentation of Individual Research Projects
-
- Each project leader should present his or her individual project
- using the Form 398, REV. 9/91 and following the application kit
- instructions, except as modified below.
-
- o Face Page of Form PHS 398. Complete items 1, 3a, 3d, 4, and 5
- ONLY. In item 1, enter Project Number and a descriptive project
- title. In items 3a and 3d, enter the name and academic title of the
- project leader. Items 4 and 5 are self-explanatory.
-
- o Page 2 of Form PHS 398. Provide an abstract of the research
- proposed in the project. Prepare the abstract according to the
- instructions provided on page 2 of PHS 398. This abstract should be
- written in such a manner that it could be adapted by NIH staff to
- constitute the Description portion of the project in the Summary
- Statement.
-
- o Pages 4 and 5 of Form PHS 398. Detailed first year budget and
- budget for entire project period: follow instructions on pages 16-19
- of the form PHS 398 instructions. The budget pages should have the
- project number and the project leader's name in the upper left hand
- of each budget page.
-
- o Page 7 of Form PHS 398: Other Support: FOLLOW INSTRUCTIONS
- CAREFULLY. If a duplicate R0l or R29 is submitted concurrently or is
- pending, it should be so stated in this section. Incomplete,
- inaccurate or ambiguous information about OTHER SUPPORT, whether
- active or pending, may lead to delays in the review of the
- application.
-
- 3. Research Plan: Follow the instructions indicated in IV. C.,
- pages 19 through 22 of the PHS 398 Instructions, completing items 1
- through 4 in detail. In addition, attention should be given to
- integration of the component project into the overall Group project.
- As with a regular research grant application, the overall research
- plan for each project should not exceed 25 pages (from Specific Aims
- through Research Design and Methods). The following points should be
- addressed in the appropriate sections.
-
- o Specific Aims: In addition to listing the specific objectives for
- the total period of requested support for the component, state the
- overall objective or long-term goal of the research and its
- relationship to the goals of the NCVDG and how it relates to other
- projects or cores in the Group.
-
- o Significance: In addition to the overall biological significance
- of the proposed research, this section should indicate the relevance
- of the project to the primary theme of the NCVDG.
-
- o Collaborative Arrangements: Describe the collaboration between
- investigators in this project and other investigators within the
- NCVDG. Describe in detail any other collaborative arrangements
- anticipated, either internal or external to the institution. Include
- letters from collaborating investigators indicating their agreement
- with the collaborative arrangements.
-
- STUDY POPULATIONS
-
- SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
- POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
- RESEARCH STUDY POPULATIONS
-
- NIH policy is that applicants for NIH clinical research grants and
- cooperative agreements will be required to include minorities and
- women in study populations so that research findings can be of
- benefit to all persons at risk of the disease, disorder or condition
- under study; special emphasis should be placed on the need for
- inclusion of minorities and women in studies of diseases, disorders
- and conditions which disproportionately affect them. This policy is
- intended to apply to males and females of all ages. If women or
- minorities are excluded or inadequately represented in clinical
- research, particularly in proposed population-based studies, a clear
- compelling rationale should be provided.
-
- The composition of the proposed study population must be described in
- terms of gender and racial/ethnic group, together with a rationale
- for its choice. In addition, gender and racial/ethnic issues should
- be addressed in developing a research design and sample size
- appropriate for the scientific objectives of the study. This
- information must be included in the form PHS 398 (rev. 9/91) in
- Sections 1-4 of the Research Plan AND summarized in Section 5, Human
- Subjects. Applicants are urged to assess carefully the feasibility
- of including the broadest possible representation of minority groups.
- However, NIH recognizes that it may not be feasible or appropriate in
- all research projects to include representation of the full array of
- United States racial/ethnic minority populations (i.e., native
- Americans [including American Indians or Alaskan Natives],
- Asian/Pacific Islanders, Blacks, Hispanics).
-
- The rationale for studies on single minority population groups should
- be provided.
-
- For the purpose of this policy, clinical research is defined as human
- biomedical and behavioral studies of etiology, epidemiology,
- prevention (and preventive strategies), diagnosis, or treatment of
- diseases, disorders or conditions, including but limited to clinical
- studies.
-
- The usual NIH policies concerning research on human subjects also
- apply. Basic research or clinical studies in which human tissue
- cannot be identified or linked to individuals are excluded. However,
- every effort should be made to include human tissues from women and
- racial/ethnic minorities when it is important to apply the results of
- the study broadly, and this should be addressed by applicants.
-
- For foreign awards, the policy on inclusion of women applies fully;
- since the definition of minority differs in other countries, the
- applicant must discuss the relevance of research involving foreign
- population groups to the United States' populations, including
- minorities.
-
- If the required information is not contained within the application,
- the application will be returned.
-
- Peer reviewers will address specifically whether the research plan in
- the application conforms to these policies. If the representation of
- women or minorities in the study design is inadequate to answer the
- scientific question(s) addressed AND the justification for the
- selected study population is inadequate, it will be considered a
- scientific weakness or deficiency in the study design and will be
- reflected in assigning the priority score to the application.
-
- All applications for clinical research submitted to NIH are required
- to address these policies. NIH funding components will not award
- grants or cooperative agreements that do not comply with these
- policies.
-
- LETTER OF INTENT
-
- Prospective applicants are asked to submit, by February 26, 1993, a
- letter of intent that includes a descriptive title of the overall
- proposed research; the name, address, telephone number, and
- institution of the Principal Investigator; names of prospective
- project leaders and other key investigators and their respective
- institutions; title, project leader, and institution for each
- component research project, and the 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 applications, the information that it
- contains is helpful in planning for the review of applications. It
- allows NIAID staff to estimate the potential review workload and to
- take early steps to avoid conflict of interest in the review.
-
- The letter of intent is to be sent to Dr. Alan Schultz at the address
- listed under INQUIRIES.
-
- APPLICATION PROCEDURES
-
- The research grant application form PHS 398 (rev. 9/91) is to be used
- in applying for these cooperative agreements. These forms are
- available at most institutional offices of sponsored research and may
- be obtained from the Office of Grants Inquiries, Division of Research
- Grants, National Institutes of Health, 5333 Westbard Avenue, Room
- 449, Bethesda, MD 20892, telephone 301/496-7441.
-
- The RFA label available in the PHS 398 (rev. 9/91) 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, to assure the identification of your
- application with this RFA the "Yes" box must be marked in item 2a of
- the face page of the application form and the title and number of
- this RFA typed.
-
- Applications that are not received as a single package from the
- Principal Investigator and that do not conform to the instructions
- contained in PHS 398 (rev. 9/91) application kit will be judged
- non-responsive and will be returned to the applicant.
-
- Applicants from institutions that have a General Clinical Research
- Center (GCRC) funded by the NIH National Center for Research
- Resources may wish to identify the GCRC as a resource for conducting
- the proposed research. If so, a letter of agreement from either the
- GCRC program director or principal investigator could be included
- with the application.
-
- Submit a signed, typewritten original of the application, including
- the Checklist, and three signed, photocopies, in one package to
-
- Division of Research Grants
- National Institutes of Health
- Westwood Building, Room 240
- Bethesda, MD 20892**
-
- At the time of submission, also submit two exact copies of the
- application directly to Dr. Dianne Tingley at the address listed
- under INQUIRIES.
-
- Applications must be received by April 22, 1993. If an application
- is received after that date, it will be returned to the applicant
- without review. If the application submitted in response to this RFA
- is substantially similar to a grant application already submitted to
- the NIH for review, the applicant will be asked to withdraw either
- the pending application or the new one. Simultaneous submission of
- identical applications will not be allowed, nor will essentially
- identical applications be reviewed by different review committees.
- Therefore, an application cannot be submitted in response to this RFA
- that is essentially identical to one that has already been 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.
-
- This restriction is superseded by an NIH policy permitting concurrent
- submission of a duplicate R01 and a component of a multi-project
- application. The NIH policy however, further stipulates that should
- both the R01 and the multi-project application be considered for
- funding, the R01 will be relinquished in favor of the multi-project
- application.
-
- REVIEW CONSIDERATIONS
-
- Review Procedures
-
- Applications will be reviewed by DRG staff for completeness and by
- NIAID staff to determine administrative and programmatic
- responsiveness to this RFA; those judged to be incomplete or
- non-responsive will be returned to the applicant without review.
- Applications with budgets in excess of $1,000,000 total (direct and
- indirect) first year costs that do not have the written approval of
- the program contact (see INQUIRIES) will be returned without review.
-
- Those applications that are complete and responsive may be subjected
- to a triage by an NIAID peer review group to determine their
- scientific merit relative to the other applications received in
- response to this RFA. The NIAID will remove from further competition
- those applications judged to be noncompetitive for award and will
- notify the applicant and institutional business official.
-
- Those applications judged to be competitive for award will be further
- reviewed for scientific and technical merit by a Review Committee
- convened by the Scientific Review Branch, Division of Extramural
- Activities. A second level of review will be provided by the
- National Advisory Allergy and Infectious Diseases Council. In the
- event of multiple highly qualified applications, final funding
- recommendations will be based on highest Program priorities. Review
- date, Council meeting date, and earliest award date are listed under
- Schedule, below.
-
- Review Criteria
-
- The application must be directed towards the attainment of the stated
- programmatic goals (see Research Objectives). The following factors
- are the criteria used by peer review groups in the scientific and
- technical review of multicomponent applications:
-
- o The scientific merit of the program as a whole, as well as that of
- each individual project. Each project must be supportable on its own
- merit.
-
- o The significance of the overall program goals and the development
- of a well-defined central research focus.
-
- o The cohesiveness and multidisciplinary or multifaceted scope of
- the program and the coordination and interrelationships among the
- individual projects and core(s).
-
- o The justification and usefulness to the various research projects
- of the core facilities. The relationship of each core to the central
- focus of the overall program. Each core unit must provide essential
- facilities or service for two or more approved individual projects.
-
- o The leadership, scientific ability, and administrative competence
- of the Principal Investigator for the development, implementation,
- and management of a comprehensive research program; and the Principal
- Investigator's commitment to devote substantial time and effort to
- the program.
-
- o The qualifications, experience, and commitment of the
- investigators responsible for the individual research projects or
- core(s) (Project Leaders) and their contribution to the program,
- including their ability to devote adequate time and effort to the
- program. It is anticipated that, due to the complexity and time
- required to maintain a well-coordinated and productive research
- effort, a minimum 20 percent (time) effort by the Principal
- Investigator and each Project Leader should be devoted to the study,
- unless there is compelling evidence to the contrary.
-
- o Accomplishments of the program to date (for renewal applications),
- and research experiences and accomplishments of investigators in the
- Group in the research areas outlined in the RFA (for new
- applications).
-
- o The academic and physical environment in which the research will
- be conducted, including the adequacy of space, equipment, animal
- facilities, biohazard containment facilities; and the potential for
- interaction with active scientists in disciplines including
- infectious diseases, reproductive biology, virology, molecular
- biology and/or immunology from other departments and/or institutions.
-
- o A sound institutional administrative and organizational structure
- that facilitates attainment of the objective(s) of the program,
- including fiscal responsibility and management capability to assist
- the PI and staff in following PHS policy.
-
- o Arrangements for internal quality control of on-going research,
- allocation of funds, day-to-day management, internal communications
- and cooperation among the investigators involved in the program,
- contractual agreements, and replacement of the Principal
- Investigator, if required, on an interim or permanent basis.
-
- o The ethical and hazardous aspects of the project(s).
-
- In addition the following criteria which are more specific for this
- RFA also will be considered by the review group:
-
- o Documented commitment of Institutions represented by Group
- members; documented capability of Principal Investigator's
- Institution to serve as the Central Operations Office for the Group;
-
- o Likelihood that new strategies and vaccine approaches will be
- identified during the course of the proposed study;
-
- o Plans for effective intra-Group communication and for assuring
- cohesiveness within the Group as a whole;
-
- o Including a mechanism for selecting and replacing key professional
- or technical personnel using the framework of the RFA.
-
- AWARD CRITERIA
-
- Award criteria will be based on scientific merit as reflected in the
- priority score, program priorities, and the availability of funds.
-
- INQUIRIES
-
- The opportunity to clarify issues or questions about the RFA from
- potential applicants are welcome. Please send the letter of intent
- and direct inquiries regarding the RFA and programmatic issues to:
-
- Alan Schultz, Ph.D.
- Acting Chief, Preclinical Section,
- Vaccine Research and Development Branch
- National Institute of Allergy and Infectious Diseases
- Solar Building, Room 2B-01
- Bethesda, MD 20892
- Telephone: (301) 496-8200
- FAX: (301) 402-1506
-
- Direct inquiries regarding application preparation and review to:
-
- Dr. Dianne Tingley
- Chief, DAIDS Scientific Review Section
- Scientific Review Branch
- National Institute of Allergy and Infectious Diseases
- Solar Building, Room 4C-16
- Bethesda, MD 20892
- Telephone: (301) 496-0818
-
- Direct inquiries regarding fiscal matters to:
-
- Ms. Jane Unsworth
- Chief, AIDS Grants Management Section
- Grants Management Branch
- National Institute of Allergy and Infectious Diseases
- Solar Building, Room 4B-22
- Bethesda, MD 20892
- Telephone: (301) 496-7075
-
- Applicants who use express mail or courier services are advised to
- follow the carrier's requirements for showing a street address. The
- address of the Solar Building is:
-
- 6003 Executive Boulevard
- Rockville, MD 20852
-
- Schedule
-
- Letter of Intent Receipt Date: February 26, 1993
- Application Receipt Date: April 22, 1993
- Scientific Review Date: June 1993
- Council Meeting Date: September 1993
- Earliest Award Date: December 1993
-
- AUTHORITY AND REGULATIONS
-
- This program is described in the catalog of Federal Domestic
- Assistance, 93.856 - Microbiology and Infectious Diseases Research
- and 93.855 - Immunology, Allergy and Transplantation Research.
- Awards are made under the authority 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 Part 52 and 45 CFR Parts 74 and 92. This
- program is not subject to the intergovernmental review requirements
- of Executive Order 122372 or Health Systems Agency review.
-
- Appendix I
-
- List of Active NCVDGs
-
- Ronald C. Kennedy, Ph.D.*
- Southwest Foundation for Biomedical Research
- P.O. Box 28147
- (W. Loop 410 at Military Drive)
- San Antonio, TX 78284
- Telephone: (512) 674-1410
-
- Richard Allen Young, Ph.D.*
- Whitehead Institute for Biomedical Research
- Nine Cambridge Center
- Cambridge, MA 02142
- Telephone: (617) 258-5218
-
- Murray B. Gardner, M.D.*
- Department of Medical Pathology
- School of Medicine
- University of California
- Davis, CA 95616
- Telephone: (916) 752-2710
-
- Lawrence Corey, M.D.*
- c/o Virology, D536
- Children's Hospital and Medical Center
- 4800 Sand Point Way, NE
- Seattle, WA 98105
- Telephone: (206) 526-2117
-
- Dennis L. Panicali, Ph.D.
- Therion Biologics, Inc.
- 76 Rogers Street
- Cambridge, MA 02142
- Telephone: (617) 876-7779
-
- Arsene L. Burny, Ph.D.
- Department of Molecular Biology
- University of Brussels
- 67, Rue Des Chevauz
- 1640 Rhode-St-Genese BELGIUM
- Telephone: 32-2-650-9824
-
- Richard W. Compans, Ph.D.
- University Alabama at Birmingham
- Department of Microbiology
- University Station
- Birmingham, AL 35294
- Telephone: (205) 934-3049
-
- James Young, Ph.D.
- Medimmune, Inc.
- 35 West Watkins Mill Road
- Gaithersburg, MD 20878
- Telephone: (301) 417-0770
-
- Michael A. Murphey-Corb, Ph.D.
- Tulane Regional Primate Research Center
- Three Rivers Road
- Covington, LA 70433
- Telephone: (504) 892-2040, Ext. 275
-
- Flossie Wong-Staal, Ph.D.
- Department of Medicine M-023-F
- University of California, San Diego
- La Jolla, CA 92093
- Telephone: (619) 534-7957
-
- Mark Newman, Ph.D.
- Cambridge Biotech Corporation
- 365 Plantation Street
- Worcester, MA 01605
- Telephone: (508) 797-5777
-
- * Award ends in 1993
-
- For Sample Tables listed in Appendix II, please request a copy of
- this RFA.
-