PA-00-044: INNOVATION GRANT PROGRAM FOR AIDS VACCINE RESEARCH

Department of Health
and Human Services (HHS)

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INNOVATION GRANT PROGRAM FOR AIDS VACCINE RESEARCH Release Date: January 10, 2000 PA NUMBER: PA-00-044 National Institute of Allergy and Infectious Diseases Application Receipt Date: THIS PA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA. PURPOSE This program announcement (PA) is a continuation of the Innovation Grant Program for Approaches in HIV Vaccine Research, implemented by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), on the recommendation of the AIDS Vaccine Research Committee (AVRC). This program encourages the entrance of novel and innovative vaccine discovery and development concepts into the research pipeline. As such, the emphasis of this program is on supporting prophylactic vaccine research projects that are particularly innovative, novel, may be high risk/high impact, and that exhibit the potential to advance AIDS prophylactic vaccine design or evaluation. Applications are especially welcome from young investigators and those not currently active in the field of AIDS research. The Innovation Grant Program utilizes a grant mechanism that provides funding for projects of an exploratory nature to generate preliminary data for further studies. Applications targeting any scientific area(s) related to AIDS prophylactic vaccine research are encouraged. Before each application receipt date, scientific areas of particular importance will be posted on the NIAID website http://www.niaid.nih.gov/daids/vaccine/innovation.htm. These areas are chosen based on advice received from the AIDS Vaccine Research Committee (AVRC) as a result of its meetings and workshops. Applicants are strongly encouraged to contact program staff and visit the website before submitting an application. Applications for research aimed at these targeted areas are especially encouraged, but as explained above, will not be required to focus on those areas. NIH SUPPORT OF RESEARCH ON THIS TOPIC Although this PA is being issued by NIAID, other components of NIH mentioned below also have an interest in, and support research on, the topics covered. Applicants may wish to contact each of the NIH components listed in INQUIRIES to find out about other funding opportunities. The National Institute for Dental and Craniofacial Research (NIDCR) has no set-aside funds for this PA but will consider supporting highly meritorious applications meeting the mission of the Institute. 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 Program Announcement (PA), Innovation Grant Program for AIDS Vaccine Research , is related to the priority areas of immunization and infectious diseases, HIV infection, and sexually transmitted diseases. Potential applicants may obtain a copy of "Healthy People 2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at http://grants.nih.gov/grants/funding/modular/modular.htm Research projects will be supported with the Exploratory/Developmental Research Grant mechanism (R21). This mechanism provides short-duration support for preliminary studies of a highly speculative nature, which are expected to yield, within this time frame, sufficient information upon which to base a well-planned and rigorous series of further investigations. Applications will request direct costs in $25,000 modules, up to a total direct cost of $150,000 per year. Current policy limits support under the R21 grant to two years with no extensions or supplements. However, awardees may request no-cost extensions if they so desire. A typical modular grant application requests the same number of modules in each year. Applicants may request up to two years of support and up to $150,000 per annum in direct costs, although with compelling justification exceptions can be made if specific costly reagents, animals, specimens or laboratory modifications are needed to perform these studies. Program staff may be able to advise prospective applicants concerning NIAID-sponsored resources that may be available to them. Contact the program staff listed under INQUIRIES for further information. This award is non-renewable. However, it is hoped that successful grantees funded through this exploratory phase program will elect to seek continuing support for research further along the development pipeline through the R01 or P01 grant mechanisms. The applicant will have full responsibility for the planning, direction, and execution of the proposed research. RESEARCH OBJECTIVES All pertinent areas of investigation that will contribute toward development of an efficacious HIV/AIDS vaccine are welcome. These might include but are not limited to: methods to enhance antigen presentation/processing, structural studies of HIV proteins as related to their antigenicity, nucleic acid vaccination, non-HIV live virus vaccine vectors, pseudovirion approaches, analysis of correlates of immunity, approaches to enhance HIV vaccine-induced immunologic memory, and, development of improved assays for antibody neutralization, CTL or other immune responses. To help meet the research objectives defined by NIAID and the AIDS Vaccine Research Committee, research applications intended to produce preliminary data or precedent for an idea or a concept are particularly encouraged. Vaccine research solely focused on therapeutic applications is not within the scope of this program announcement. The safety evaluation of immunogens in infected animals or people can be included if these studies directly support the development of a prophylactic vaccine. For information on programs that support therapeutic vaccine development please contact program staff. SPECIAL REQUIREMENTS Awardees will be expected to attend a meeting convened by NIAID to showcase the progress of the work funded under this program. Details of this meeting will be provided post-award. Thus, applicants should include in their budget request funds for the PI to attend one two-day meeting in the Washington, DC area. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994 available on the web at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application for PHS 398 (rev. 4/98) and will be accepted on the standard AIDS-related application receipt dates as indicated in the application kit. These forms are available at most institutional offices of sponsored research, from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: grantsinfo@nih.gov, and on the internet at http://grants.nih.gov/grants/funding/phs398/phs398.html The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in- time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $150,000 per year. The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $150,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Use a Modular Grant Budget Narrative page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested for each year. o Under Personnel, list key project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm - Complete the educational block at the top of the form page, - List current position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years, - List selected peer-reviewed publications, with full citations, o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. It is important to identify all exclusions that were used in the calculation of the F&A costs for the initial budget period and all future budget years. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. APPLICATIONS NOT CONFORMING TO THESE GUIDELINES WILL BE CONSIDERED UNRESPONSIVE TO THIS PA AND WILL BE RETURNED WITHOUT FURTHER REVIEW. For purposes of identification and processing the application, mark "YES" in item 2 on the face page and enter the PA number and the title "Innovation Grant Program for AIDS Vaccine Research". The research plan will be strictly limited to 10 pages total. Applications that exceed the page limit will be returned without review. An appendix may be included in the application, however, the appendix is not to be used to circumvent the page limit of the research plan. Explicit instructions concerning what may be included in an appendix can be found in Section 1B "General Instructions" for the PHS 398 Grant Application. Late or incomplete applications will not be accepted. Submit a signed, typewritten original of the application and five signed, photocopies, in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) The Center for Scientific Review (CSR) will not accept any application in response to this PA 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 Applications will be assigned on the basis of established PHS referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique. Only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Procedures The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. Review Criteria (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. AWARD CRITERIA Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: the scientific and technical merit of the proposed project as determined by peer review, and the availability of funds. In the final selection of applications to be funded, consideration will be given to achieving balanced coverage of all AIDS vaccine areas of investigation. INQUIRIES Inquiries are strongly encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. The Division of AIDS now has a website: http://www.niaid.nih.gov/daids/vaccine/default.htm for AIDS vaccine research with an emphasis on facilitating participation in applying for AIDS vaccine research funds and accessing other resources available to AIDS vaccine investigators through the Division. The website has information describing the various programs targeting AIDS vaccine research and listings of currently active AIDS vaccine-related program announcements and contracts and their associated deadlines. Updates concerning the continuing Innovation Grant Program will also be posted there. Applicants new to the field of AIDS research are encouraged to explore the NIH AIDS Research and Reference Reagent Program and availability of human specimens at http://www.niaid.nih.gov/reposit/default.htm. These programs make available small quantities of viruses, antibodies, HIV proteins, plasmids, and other reagents to researchers. Direct inquiries regarding programmatic issues to: Dr. Steve Bende Division of AIDS National Institute of Allergy and Infectious Diseases 6700-B Rockledge Dr, Room 4107, MSC 7628 Bethesda, MD 20892-7628 Rockville, MD 20817 (for express/courier service) Telephone: (301) 435-3756 FAX: (301) 435-6511 Email: sb22k@nih.gov Direct inquiries regarding fiscal matters to: Ms. Jeanette Gordon Grants Management Branch Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6700-B Rockledge Drive, Room 2234 - MSC 7614 Bethesda, MD 20892-7614 Telephone: (301) 402-6580 FAX: (301) 480-3780 Email: pf49e@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.855 and 93.856. 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 NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, and portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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