CHALLENGE GRANTS: BIODEFENSE PRODUCT DEVELOPMENT RELEASE DATE: June 15, 2004 RFA Number: RFA-AI-04-029 EXPIRATION DATE: January 19, 2005 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov) CATALOGUE OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: No. 93.855, Immunology, Allergy, and Transplantation Research No. 93.856, Microbiology and Infectious Diseases Research LETTER OF INTENT RECEIPT DATE: December 17, 2004 APPLICATION RECEIPT DATE: January 18, 2005 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, strives to understand, treat and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) and the Division of Allergy, Immunology and Transplantation (DAIT) support extramural research to control and prevent diseases caused by virtually all infectious agents. This includes basic biomedical research, such as studies of microbial physiology and antigenic structure; immunity; applied research, including the development of diagnostic tests; and clinical trials to evaluate experimental drugs and vaccines. In response to growing concerns about the use of biological agents in acts of terrorism, the further clinical development of new vaccines, therapeutics, adjuvants, and diagnostics against NIAID Category A, B, and C priority pathogens (see http://www.niaid.nih.gov/biodefense/bandc_priority.htm) is a high priority. This program, CHALLENGE GRANTS: BIODEFENSE PRODUCT DEVELOPMENT, will support further development of previously identified products against NIAID Category A, B, and C high priority pathogens including vaccines, adjuvants, therapeutics, and diagnostics. To be responsive to this program for the development of biodefense products, the applicant must have already demonstrated proof-of-principle for a candidate vaccine, therapeutic, adjuvant, or diagnostic method for biodefense. Phases of further development eligible for support include, but are not limited to: early validation; pre- clinical stages; scale-up; production; and fulfilling regulatory requirements. NOTE: While clinical development strategies may be included within an overall development plan, this RFA will NOT support clinical trials; applications requesting support for clinical trials will be viewed as unresponsive to this RFA and will be returned without review. Utilization of human derived material in pre-clinical studies in support of complying with regulatory requirements is considered responsive. NOTE: Applications to support basic research or the "discovery" of new targets or the identification and validation of protective epitopes for NIAID Category A, B, and C priority pathogens will NOT be supported under this RFA, but are supported by other NIAID programs (see http://www.niaid.nih.gov/biodefense/research/funding.htm). In addition, ancillary research studies that are not directly relevant to development of the selected product will not be supported. Challenge Grants Under this program, Challenge (UC1) grant awards will be performance based for a period of up to three years. That is, funds can be requested and will be awarded in increments based on the attainment of interim research objectives (milestones) defined by the applicant and approved following peer review by the NIAID. Because funding will be tied to the attainment of interim research objectives (milestones), funding will not be provided annually as is traditional for NIH grants, but will be linked to project timelines and interim objectives. Initial release of funds will be to support achievement of the first interim objective/milestone. Release of the next funding increment will be based on the achievement of the previous interim objective, as determined by NIAID staff. Partnerships A key component of this initiative is the development of partnerships between the government and industry. For the purpose of this program, "industry" is defined as large and small, domestic or foreign, pharmaceutical, biotechnology, bioengineering, and chemical companies. Since academic organizations are often the source of new candidate products, this program can also support a partnership between industry and collaborator(s) as necessary from academic and non-profit research organizations. The involvement of an academic or non-profit research organization is NOT a requirement; therefore, industry does not need an academic collaborator to submit an application to this program. All projects must demonstrate substantive investment by industry participant(s). "Substantive investment" is defined, for the purposes of this program, as substantive commitment of any one or more of the following resources: personnel, in kind contributions of materials and/or reagents, including but not limited to chemical libraries, innovative biotechnology platforms (i.e., for screening of drugs and inhibitors), scale up of GMP chemical synthesis or production, provision of animal or other laboratory models for evaluation, subcontracts, data management resources, regulatory support, and alterations/renovations of facilities or provision of equipment to address biohazard concerns. The Principal Investigator of the project may be affiliated with either industry or an academic organization (if academia is part of a partnership with industry). See information under ELIGIBLE INSTITUTIONS below. RESEARCH OBJECTIVES Background The National Institutes of Health and other agencies in the Department of Health and Human Services (DHHS) are currently supporting research to develop new products to protect the public from the health consequences resulting from the use of biological threat agents. NIAID has recently convened three separate Blue Ribbon Panels to address research priorities. The three NIAID Panels focused on: o NIAID Category A Priority Pathogens (February 4-5, 2002; the full report is available at http://www.niaid.nih.gov/biodefense/research/biotresearchagenda.pdf o NIAID Category B and C Priority Pathogens (October 22-23, 2002; the full report is available at http://www.niaid.nih.gov/biodefense/research/categorybandc.pdf) o Immunity and Biodefense (June 17, 2002; the full report is available at http://www.niaid.nih.gov/publications/pdf/biodimmunpan.pdf) These Panels identified the development of new vaccines, adjuvants, therapeutics, and diagnostics as one of the highest priorities. In addition to the NIAID research agenda, the DHHS has identified the highest priority products for biodefense preparedness (http://www.niaid.nih.gov/biodefense/research/high_priority.htm). Potential applicants should also be aware of other biodefense research programs at NIAID that have different research scopes and requirements from those solicited in this program. A complete list of the biodefense funding opportunities currently supported by NIAID can be found at: http://www.niaid.nih.gov/biodefense/research/funding.htm. To be responsive to this Program: CHALLENGE GRANTS: BIODEFENSE PRODUCT DEVELOPMENT, the application must: o Propose the development of a previously identified candidate vaccine, therapeutic, adjuvant, or diagnostic product that has demonstrated proof-of- concept against any of the NIAID Category A, B, and C priority pathogens (listed at http://www.niaid.nih.gov/biodefense/bandc_priority.htm o Demonstrate substantial investment by a commercial sector (industry) component; and o Focus on further development of the candidate product(s) or strategy for product development by specifying the proposed overall project goal(s) and interim objectives (milestones), a detailed timeline for milestone and goal attainment, and a detailed budget for each milestone. It is recommended that an applicant propose no more than four interim objectives/milestones and a final objective (or product). Ancillary research studies that are not directly relevant to development of the selected product will not be supported. VACCINES FOR BIODEFENSE Vaccines are the most effective method of protecting the public against infectious diseases. The development of vaccines against biological threat agents that can be administered quickly and can safely elicit a protective response in a broad range of recipients is a high priority. Research approaches should begin with an identified and characterized vaccine candidate that has demonstrated proof-of-concept against a NIAID Category A, B, or C priority pathogen. Only applications for vaccine development against one of these priority pathogens are responsive to this program. NOTE: Applications proposing the development of a vaccine that does not focus on a NIAID Category A, B, or C priority pathogen will be deemed unresponsive and will be returned to the applicant without review. All applicants must develop a sound scientific rationale for the forward progression of the target or vaccine candidate through the product development pathway. A research and development plan must be included that defines the potential ultimate product, proposed project goal, interim objectives (development milestones), identifies alternative approaches, and provides a timeline for milestone and goal attainment. Development activities that can be supported under this program include, but are not limited to, the following areas: o Optimization of production methodology including process development; o Scale up and production of candidate vaccines including GMP production; o Evaluation of vaccine candidates against a NIAID Category A, B, or C priority pathogen formulated with or without adjuvants or immunomodulators; o Optimization of dose and route of delivery in pre-clinical evaluation; and o Performing pre-clinical testing for safety and toxicity and efficacy in animal models and other benchmarks required for moving candidate vaccines into Phase I clinical trials. NOTE: Clinical trials for vaccines will NOT be supported. Note: All NIAID Category A, B, and C priority pathogens are responsive to this RFA. For applications for vaccine development for Bacillus anthracis, of particular interest are projects involving the development of vaccines that affect the persistence, germination, clearance, and inactivation (host immune response mechanisms) of spores in the lung and/or mediastinal lymph nodes. For applications for vaccine development for influenza, of particular interest are projects involving the development of vaccines that address pandemic influenza issues. ADJUVANTS FOR BIODEFENSE The development of an enhanced immune response may require the administration or co-administration of an adjuvant or immunostimulatory compound. Applications to support the further development or evaluation of molecules with documented ability to enhance the immune response are responsive to this program, and products capable of safely enhancing an innate immune response are particularly encouraged. This program supports the further development and evaluation of vaccine adjuvants and immunomodulators against all NIAID Category A, B, and C priority pathogens (see http://www.niaid.nih.gov/biodefense/bandc_priority.htm) that have previously demonstrated proof-of-concept. Applications may propose the further development of an adjuvant or immunomodulator as either a stand-alone product or in conjunction with a licensed or an investigational vaccine against a NIAID Category A, B, or C priority pathogen only. NOTE: Applications proposing the development of an adjuvant or immunomodulator in conjunction with a vaccine that does not focus on a NIAID Category A, B, or C priority pathogen will be deemed unresponsive and returned to the applicant without review. Development activities supported under this program may include, but are not limited to, one or more of the following areas: o Testing of previously evaluated adjuvants for their capacity to stimulate enhanced immune responses toward specific NIAID category A, B or C priority pathogens/toxins; o Testing mixtures of adjuvants to evaluate additive or synergistic potential to safely stimulate desired immune responses; o GLP or GMP production; o Optimization of delivery platform(s), including antigen and adjuvant combinations/formulations; o Optimization of dose, dosing interval, and route of delivery in pre- clinical evaluation; and o Performing pre-clinical testing for safety and efficacy in animal models and other benchmarks required for moving candidate adjuvants into Phase I clinical trials. NOTE: Clinical trials for adjuvants will NOT be supported. The application should comprise a development plan that begins with an identified and characterized adjuvant or immunostimulatory compound and develops a sound scientific rationale for its forward progression through the product development pathway. A research and development plan must be included that defines the potential ultimate product, proposed project goal and interim objectives (development milestones); identifies alternative approaches; and provides a schedule for milestone and goal attainment. THERAPEUTICS FOR BIODEFENSE The need for safe and effective, broad-spectrum and specific antimicrobials for biodefense against highly pathogenic agents or their toxins is a key national priority. Applications for development of novel antivirals, antitoxins, immunotherapies, and antibiotics against NIAID Category A, B, and C priority pathogens are responsive to this RFA. The further characterization of immunotherapeutics such as antimicrobial peptides, antibodies, lectins, or immune modulators that provide either broad protection or pathogen specific protection against antigens from NIAID category A, B, or C priority pathogens are also responsive. Activities to support the further development of previously identified therapeutics may include, but are not limited to, one or more of the following areas: o Lead optimization by structure activity studies, medicinal chemistry, molecular modeling and/or library screening to improve the antimicrobial activity, pharmacology, and safety of the drug candidate; o Synthesis of sufficient quantities of a lead compound(s) for further characterization, including efficacy and toxicity in in vitro or in vivo models; o Performing preliminary pharmacokinetic and pharmacodynamic analyses; assessing bioavailability and mechanism of action; o Evaluating the potential for the emergence of drug resistance in model systems; o Determining drug interactions in host molecular processes; and o Performing required benchmarks for moving a drug candidate into Phase I clinical trials (http://www.fda.gov/cder/regulatory/default.htm). NOTE: Clinical trials for therapeutics will NOT be supported. Applications should focus on the further development and testing of the therapeutic identified in one of the above areas deemed responsive to this program. The application should include a sound scientific rationale for the further development of the product. A research and development plan must be included that defines the proposed project goal, interim objectives (development milestones) and potential ultimate product, and provides a timeline for milestone and goal attainment. NOTE: All NIAID Category A, B, and C priority pathogens are responsive to this RFA. For applications for development of therapeutics for Bacillus anthracis, of particular interest are projects involving the development of therapeutics that affect the persistence, germination, clearance, and inactivation (host immune response mechanisms) of spores in the lung and/or mediastinal lymph nodes. For applications for development of therapeutics for influenza, of particular interest are projects involving the development of therapeutics that address pandemic influenza issues. DIAGNOSTICS FOR BIODEFENSE There is an urgent need for rapid, highly sensitive, specific, easy to use, and cost-effective diagnostics for public health laboratories, hospital-based clinical laboratories, and point-of-care use to identify or diagnose individuals exposed to biological threat agents or their toxins. Diagnostic tools that will rapidly distinguish whether an individual is infected by a biological threat agent or a common infection with similar, generalized symptoms and determine drug sensitivities are of high priority, as are diagnostic tools for the simultaneous detection and identification of a broad range of infectious agents in clinical specimens. This program supports the further development of sensitive, specific, and rapid diagnostics against all NIAID Category A, B, and C priority pathogens. To be responsive to this program, applications must focus on diagnostic assays and technologies that previously have demonstrated proof-of-concept in early stages of development. Applications should focus on the further development and validation of assays and technologies for NIAID Category A, B, or C priority pathogens and include a description of the capabilities of the diagnostics; a description of how the diagnostic/technology will be used; and plans for determining the sensitivity, specificity and validation of the diagnostic. NOTE: This program does NOT support applications for the development of environmental detection devices or their deployment. As such, applications for the development of environmental detection devices and/or their deployment will be deemed unresponsive and returned to the applicant without review. Activities to support the further development of diagnostics may include, but are not limited to, one or more of the following areas: (we agree this is fine and have removed the prior language). o Technologies capable of high throughput screening using multiple biomarkers to identify multiple pathogens simultaneously and/or human immune or other physiological response to infection (e.g. platform-based technologies); o Tests to evaluate antimicrobial resistance, enhanced virulence, or genetic manipulation; o Technologies that integrate multiple methods of parallel measurements for detection in the same platform, such as detecting nucleic acids and proteins from multiple agents in the same assay; o Technologies for multiplex rapid nucleic acid or antigen detection using novel and improved methodologies and reagents; and o In vivo imaging methods and development of contrast reagents for visualization of pathogens or host immune responses in vivo. MECHANISM OF SUPPORT This RFA will use the NIH Challenge Grant - Cooperative Agreement (UC1), an "assistance" mechanism, rather than an "acquisition" mechanism, in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. The applicant will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is July, 2005. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator-initiated applications using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application. The NIH UC1 is a cooperative agreement award mechanism in which the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the section "Cooperative Agreement Terms and Conditions of Award." Essential elements of the challenge grant cooperative agreement mechanism include: (1) a single Principal Investigator who will be scientifically and administratively responsible for the research and development effort; (2) a single applicant organization that will be legally and financially responsible for the use and disposition of funds awarded; and (3) interim research and development targets upon whose achievement the next increment of funds will be released to the awardee. Recognizing that product development is often an iterative and sequential process, and that steps early in the process may not be successful and may need to be modified or reworked, NIAID staff, through the cooperative agreement grant mechanism, will be actively involved as a member of the partnership by evaluating the milestones of awardees and determining whether additional investment in the development of the product is warranted. Awards will be made for a period of up to three years and will be performance-based. That is, funds will be awarded in increments based on the attainment of interim research objectives defined by the applicant and approved by the NIAID (See APPLICATION INSTRUCTIONS and TERMS AND CONDITIONS OF AWARD below). Because funding will be tied to the attainment of interim research objectives/milestones, funding will not be provided annually as is traditional for NIH grants, but will be linked to the interim research objectives. A separate budget is required for each interim research objective/milestone proposed. Initial release of funds will be to support achievement of the first interim objective/milestone. Release of the next funding increment will be based on the achievement of the previous interim objective as determined by NIAID staff. The total project period for applications submitted in response to this RFA may not exceed three years. At this time, the NIAID has not determined whether and how this solicitation will be continued beyond the present RFA. This RFA uses just-in-time concepts, but not modular grant budgets. FUNDS AVAILABLE The estimated total funds [direct and facilities and administrative (F&A) costs] available for all awards for the entire length of the program will be $30 million to be awarded in fiscal year 2005. As a result, in FY2005, the NIAID plans to fund approximately 4-8 awards. It is anticipated that award budgets will vary widely in amount from hundreds of thousands to millions of dollars. The NIAID is seeking to fund a range of product development projects based on scientific merit and public health needs and priorities. An applicant may request up to $300,000 for major equipment. 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 and the receipt of a sufficient number of applications of high scientific merit. Continued funding will be contingent upon satisfactory progress on timelines and milestones. At this time, the NIAID has not determined whether and how this solicitation will be continued beyond this present program. ELIGIBLE INSTITUTIONS The applicant may submit (an) application(s) if the institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic and foreign institutions/organizations o Faith-based or community-based organizations FOREIGN ORGANIZATIONS Several special provisions apply to applications submitted by foreign organizations. o Charge back of customs and import fees is not allowed. o Format: every effort should be made to comply with the format specifications, which are based upon a standard US paper size of 8.5" x 11." o Funds for up to 8% administrative costs can now be requested, (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html) o Organizations must comply with federal/NIH policies on human subjects, animals, and biohazards. o Organizations must comply with federal/NIH biosafety and biosecurity regulations. See TERMS AND CONDITIONS OF AWARD below. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS This program responds to the urgent public health need to advance new and promising high-priority products for biodefense by supporting partnerships between the private sector and the Federal Government. Applications in response to this program are limited to the development of vaccines, adjuvants, therapeutics and diagnostics against NIAID Category A, B, and C priority pathogens that have demonstrated proof-of-concept. Each application must propose a milestone-driven, timeline-based project whose goal is to further the development of that product as specified above. Ancillary research studies that are not directly relevant to the development of the selected product will not be supported. 1. Budget Because awards made under this program will be performance-based and milestone-driven, funding will be tied to the successful attainment of interim research objectives (milestones), and may not be provided annually as is traditional for NIH grants. Budget submissions must be linked to the interim objectives/milestones and final product(s) rather than the traditional annual budget periods requested in NIH grants. Applicants must include separate, complete budget pages (Form Page 4 - Detailed Budget for Initial Budget Period) for each interim research objective/milestone, for each project. The initial budget period is defined as the time period needed to complete the first interim objective/milestone, and the funds requested should be those needed to attain the first interim milestone. In the upper right-hand corner of the first Form Page 4, enter the proposed "From" and "Through" dates for research to complete the first interim objective. Complete the balance of the form based on the efforts to be performed during this interval. Initial release of funds will be to support achievement of the first interim objective/milestone. The budgets for the second budget period should be that needed to attain the second interim objective (or the final product if there is no second interim objective), and the third budget period shows the funds needed to complete the R&D effort (if there were two interim objectives). Each additional Form Page 4 submitted in support of each milestone must also state proposed From and Through dates for that specific milestone. Release of subsequent funding increments will be based on the achievement of the previous interim objective as determined by NIAID staff. Form Page 5 - Budget for Entire Proposed Period of Support The budgets for each budget period must indicate the funds needed to attain the interim objectives/milestones and should not be annually-based on an annual basis. Since these budget periods are tied to performance and not to the calendar, the budgets can be for periods of more than or less than one year. 2. Product Development Plan Applicants MUST include a section entitled Product Development Plan in the application which may not exceed 5 pages. The Product Development Plan does not count towards the page limits for the Research Plan. This section must describe a plan for the further commercial development of the candidate product(s). It must include: o A clear description of the goal(s) of the project, including one (or more) final product(s) or stage(s) of development to be completed during the award period. Some examples could be: an Ebola vaccine candidate requiring scale- up or an anthrax drug needing toxicity testing. This section must also state all interim milestones to be achieved during the course of the project and identify any impediments that could require a revision in the work plan or milestones with alternative approaches. Some examples of interim objectives could be: completion of a prototype of a diagnostic tool or animal immunogenicity studies. It is suggested that an applicant propose no more than four interim objectives/milestones and a final objective. An example of an interim milestone could be the production of a GMP vaccine candidate or a decision as to which drug candidate will advance to pre-clinical testing. This section should include information that demonstrates that the applicant understands the steps that are required for advancing a candidate product as proposed in the application. For additional details on vaccines, see: http://www.fda.gov/cber/vaccine/vacappr.htm. For additional details on therapeutics, see: http://www.fda.gov/cder/regulatory/default.htm. For additional details on diagnostics, see: http://www.fda.gov/cdrh. o A detailed schedule or timeline for the anticipated attainment of each milestone and the overall goal(s). o Criteria that clearly describe how decisions will be made to advance a product through the proposed product development pathway. In other words, provide criteria by which "go" or "no go" decisions will be made for each milestone. 3. Physical and/or Facility Security Applicants must address issues related to physical or facility security and biocontainment and biosafety pertinent to the specific pathogens of interest in a Biosafety and Biocontainment section of the application. In addition, biosafety procedures and personnel biosafety training should be addressed. 4. Good Laboratory Practice When appropriate, research plans should include an awareness of the guidelines that govern GLP as defined by 21 CRF (58) and GMP, as defined by 21 CRF (211), manufacturing and/or IND enabling studies that will be performed with this award as they would be applicable to eventual product licensure in the U.S. 5. Intellectual Property The successful development of high priority products for biodefense will require substantial investment and support of private sector industries and may also involve collaborations with multiple organizations, including academic and/or non-profit research institutions. It is the intent of this initiative to support the formation of the appropriate public-private partnerships that are essential to meet these urgent public health needs. NIAID recognizes that intellectual property rights are likely to play an important role in achieving the goals of this program. To this end, the NIAID requires that at the time of application, all applicants provide a letter ("Proprietary Rights Assurance Letter") containing the following assurances, which is signed by a representative who is duly authorized to provide such assurances on behalf of the applicant organization: o Applicant is solely responsible for the timely acquisition of all proprietary rights, including intellectual property rights, and all materials needed for applicant to perform the project; o Applicant acknowledges that prior to, during, and subsequent to the award, the U.S. Government is not required to obtain for applicant any proprietary rights, including intellectual property rights, or any materials needed by applicant to perform the project; o Applicant acknowledges the requirement to report to the U.S. Government all inventions made in the performance of the project, as specified at 35 U.S.C. Sect. 202 (Bayh-Dole Act). The Proprietary Rights Assurance Letter should be included with the application preceding the checklist page. Apart from the Proprietary Rights Assurance Letter, applicants are encouraged to reach early consensus with their proposed partners regarding intellectual property and other legal matters that may arise during the project. In addition, applicants are expected to exercise their Bayh-Dole rights in a manner that does not conflict with the goals of this award or the intent of the Bayh-Dole Act to promote the utilization, commercialization and availability of U.S. Government-funded inventions for public benefit. Finally, applicants are expected to make new information and materials known to the research community in a timely manner through publications, web announcements, and reports to the NIAID or other mechanisms. 6. Select Agents All awardee institutions, foreign and domestic, must confirm that they are in compliance with Select Agent regulations (http://www.cdc.gov/od/sap/) and NIH Guidelines for Research Involving Recombinant DNA Molecules (http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html) to receive funding from NIAID. See COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD below. 7. Meetings A critical determinant of success of the project is likely to be the degree of communication among the grantee organization, any collaborating institutions (if applicable), and the NIH and/or other U.S. government agencies. It is mandatory that the Principal Investigator, one or two key personnel designated by the Principal Investigator, two external advisors, and the NIAID Program Officer meet once a year to review progress and aid program development. To facilitate this mandatory meeting, proposed budgets must include funds for travel of the Principal Investigator, key personnel, and two external advisors (to be named after award by NIAID in consultation with the Principal Investigator) to an annual two-day meeting in Bethesda, Maryland, or at a relevant scientific meeting, as determined by NIAID Program staff. Names of suggested external advisors should not be included in the application. Where scientifically appropriate, NIAID may ask grant recipients to collaborate or cooperate with other NIAID-funded projects and/or US government agencies, for example, the Food and Drug Administration, the Centers for Disease Control and Prevention, and the United States Department of Agriculture. COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD The following terms and conditions will be incorporated into the award statement and provided to the Principal Investigator as well as the 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 part 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used for this program is the challenge grant cooperative agreement (UC1), an assistance rather than an acquisition mechanism, in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. Under the cooperative agreement, the NIH 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, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the research will be shared among the awardees and the NIAID Program Officer. 1. Monitoring Clinical Studies When clinical studies are a component of the research proposed, NIAID policy requires that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study. AN UPDATED NIAID policy was published in the NIH Guide on July 8, 2002 and is available at: http://grants.nih.gov/grants/guide/notice-files/NOT-AI-02-032.html. The full policy, including terms and conditions of award, is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf. 2. Awardee Rights and Responsibilities Awardees will have primary responsibility for defining the research objectives, approaches and details of the projects within the guidelines of the RFA and for performing the scientific activity. Specifically, awardees have primary responsibility as described below. Awardees may be from industry or academia; however, the industrial portion of the partnership is critical for compliance and substantive investment by industry directed to the specific project being proposed must be clearly defined. The awardee must be in compliance with Select Agent Rule (http://www.cdc.gov/od/sap/) and NIH Guidelines for Research Involving Recombinant DNA Molecules (http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html). The NIH has established a new policy regarding the use of NIH funds for research involving Select Agents. This policy is being implemented using Terms of Award that are to be included in any grant, cooperative agreement, or contract in which select agents are or will be used. Award to a U.S. Institution: This award includes research involving Select Agents (see 42 CFR 73 for the Select Agent list; and 7 CFR 331 and 9 CFR 121 for the relevant animal and plant pathogens). Before using NIH funds, the awardee must complete registration with CDC (or USDA, depending on the agent). No funds can be used for research involving Select Agents if the final registration certificate is denied. Award to Foreign Institution: This award includes research involving Select Agents (see 42 CFR 73 for the Select Agent list; and 7 CFR 331 and 9 CFR 121 for the relevant animal and plant pathogens). Before using NIH funds for any work directly involving the Select Agents, the awardee must provide information satisfactory to the NIH that a process equivalent to that described in 42 CFR 73 for US institutions is in place and will be administered on behalf of all Select Agent work sponsored by these funds. The awardee must be willing to address the following key elements appropriate for their institutions: safety, security, training, procedures for ensuring that only approved/appropriate individuals have access to the Select Agents, and any applicable laws, regulations and policies equivalent to 42 CFR 73. Award to U.S. Institution with Foreign Institution Participation: This award includes research involving Select Agents (see 42 CFR 73 for the Select Agent list; and 7 CFR 331 and 9 CFR 121 for the relevant animal and plant pathogens). Before using NIH funds for any work directly involving the Select Agent at the US institution, the awardee must complete registration with CDC or USDA, depending on the agent). No funds can be used for research involving Select Agents if the final registration certificate is denied. Before using NIH funds for any work directly involving the Select Agents at the foreign institution, the US awardee must provide information from the foreign institution satisfactory to the NIH that a process equivalent to that described in 42 CFR 73 for US institutions is in place and will be administered on behalf of all Select Agent work sponsored by these funds. The awardee must be willing to address the following key elements appropriate for the foreign institution: safety, security, training, procedures for ensuring that only approved/appropriate individuals have access to the Select Agents, and any applicable laws, regulations and policies equivalent to 42 CFR 73. The Principal Investigator 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 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 Principal Investigator. Meetings: One mandatory progress review meeting of the awardees will be held annually at the NIAID, or at a site designated by the NIAID Program Officer, during which the Principal Investigator and Project Leaders will present significant findings. The NIAID Program Officer and External Advisors (when applicable) will be present. A critical determinant of success will be the degree of communication between the Principal Investigator, Project Leaders and other significantly involved parties. Therefore, in addition to the one meeting listed above, additional meetings, which may be necessary for coordination of cooperative agreement activities, may be scheduled if justified. Regular telephone and written communication with the NIAID Program Officer is considered to be very important and is strongly encouraged. Publications: The Principal Investigator will be responsible for the timely submission of all abstracts, manuscripts and reviews (co)authored by members of the grant and supported in part or in total under this Agreement. The Principal Investigator and Project Leaders are requested to submit manuscripts to the Program Officer within two weeks of acceptance for publication so that an up-to-date summary of program accomplishments can be maintained and joint press conferences and press releases prepared. Publications or oral presentations of work performed under this Agreement are the responsibility of the Principal Investigator and appropriate Project Leaders and will require appropriate acknowledgement of NIAID support. Timely publication of major findings is encouraged. While the NIAID Program Officer has a right of access to the data (see NIAID staff responsibilities below) the awardee will retain custody of and right to the data. For more information on data sharing go to: http://grants.nih.gov/grants/policy/data_sharing/index.htm. 3. NIAID Staff Responsibilities The NIAID Program Officer will provide normal stewardship and will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice and coordination above and beyond normal program stewardship for grants, as described below. The NIAID Program Officer will serve as a liaison/facilitator between the awardee, pharmaceutical and biotechnology industries, and other government agencies (e.g., FDA, USDA, CDC), and will serve as a resource of scientific and policy information related to the goals of the awardee's research. The NIAID Program Officer will facilitate coordination of project activities during the course of the project. The NIAID Program Officer will assist the awardee with access to other NIAID- supported resources and services, including resources for preclinical development such as animal models, screening facilities, standardized research reagents, and a genomics resource center, where available. 4. Collaborative Responsibilities The specific timelines, interim objectives and funding levels agreed to by the awardee and the NIAID shall be included in the terms and conditions of award. Given the nature of product development, it is recognized that timelines and interim objectives may require revision and renegotiation during the course of the project period. The Principal Investigator and NIAID must agree to all such revisions. Release of each funding increment by NIAID will be based on a NIAID review of progress towards achieving the previously agreed upon interim objective. Where scientifically appropriate, NIAID may ask awardees to collaborate or cooperate with other NIAID-funded projects and/or US government agencies, for example CDC, FDA, and/or USDA. 5. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and IC may be brought to arbitration. An arbitration panel will be composed of three members one chosen by the awardee, a second member selected by the IC, and the third member selected by the two prior selected members. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16. 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. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct inquires regarding general scientific, technical, and programmatic issues to: Dr. Michael Kurilla Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Room 5030, MSC-6603 6610 Rockledge Drive Bethesda, MD 20892-6603 Telephone: (301) 496-5305 FAX: (301) 496-8030 E-Mail: mk486x@nih.gov o Direct your questions about scientific/research issues on VACCINES to: Dr. Cristina Cassetti Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Room 5032, MSC-6603 6610 Rockledge Drive Bethesda, MD 20892-6603 Telephone: (301) 451-3745 FAX: (301) 496-8030 E-Mail: cc125b@nih.gov o Direct your questions about scientific/research issues on ADJUVANTS to: Dr. David Winter Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Room 3014, MSC-6601 6610 Rockledge Drive Bethesda, MD 20892-6601 Telephone: (301) 496-7551 FAX: (301) 480-2381 E-Mail: dw322u@nih.gov o Direct your questions about scientific/research issues on THERAPEUTICS to: Dr. Mark Challberg Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Room 4095, MSC-6603 6610 Rockledge Drive Bethesda, MD 20892-6603 Telephone: (301) 496-7453 FAX: (301) 480-1594 E-Mail: mc37e@nih.gov o Direct your questions about scientific/research issues on IMMUNOTHERAPEUTICS to: Dr. Alison Deckhut Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Room 3007, MSC-6601 6610-B Rockledge Drive Bethesda, MD 20892-6601 Telephone: (301) 496-7551 FAX: (301) 402-2571 E-Mail: ad122x@nih.gov o Direct your questions about scientific/research issues on DIAGNOSTICS to: Dr. Maria Giovanni Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Room 6007, MSC-6603 6610 Rockledge Drive Bethesda, MD 20892-6603 Telephone: (301) 496-5305 FAX: (301) 496-8030 E-Mail: mg37u@nih.gov Direct your questions about peer review issues to: Dianne Tingley, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 3133, MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 (20817 for express mail or courier service) Telephone: (301) 496-0818 FAX: (301) 402-2638 Email: mh30x@nih.gov o Direct your questions about financial or grants management matters to: Ms. Pamela Fleming Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 2119, MSC-7614 6700-B Rockledge Drive Bethesda, MD 20892-7614 Telephone: (301) 496-7075 FAX: (301) 480-3780 E-Mail: pf49e@nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Dianne Tingley, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 3133, MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 (20817 for express mail or courier service) Telephone: (301) 496-0818 FAX: (301) 402-2638 Email: mh30x@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must be submitted as new applications; revised applications previously submitted in response to former RFAs will not be viewed as responsive to this RFA and will be returned. Applications must have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. SUPPLEMENTARY INSTRUCTIONS: Applications must address each item described under the SPECIAL REQUIREMENTS section, as applicable. In addition, responses to this RFA should follow the PHS 398 instructions with the following modifications: o Form Page 2 Description The first sentence of the description should identify the primary focus of the work proposed as either Vaccines for Biodefense, Adjuvants for Biodefense, Therapeutics for Biodefense, or Diagnostics for Biodefense. o Form Page(s) 4 - Given the anticipated complexity of applications and the likelihood for multi-organizational arrangements, applicants should pay special attention to the preparation of a detailed budget which provides a thorough justification for all key personnel, equipment, consultant costs, and travel expenses. Separate budgets must be submitted for each interim objective/milestone (See SPECIAL REQUIREMENTS Section). Budget materials do not count against the page limitations. Continuation pages should be used when necessary to provide a complete budget justification. This RFA does not use the modular budget format. o Research Plan: Must have the following four sections and may not exceed 25 pages: 1. Specific Aims - What do you intend to do? What product or products will be developed? 2. Background and Significance - Why is the R&D important? What is the potential public health benefit? What is the probability of a beneficial product? 3. Preliminary Studies - What has already been done? How does this support the proposed R&D effort? 4. Research Methods - How are you going to perform the R&D effort? o The Proprietary Rights Assurance Letter should be included with the application preceding the checklist page. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional exact copies of the grant application and all five sets of any appendix material must be sent to: Dianne Tingley, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 3133, MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 (20817 for express/courier service) Applications must be received on or before January 18, 2005. Applications that are not received as a single package on the receipt date will be judged non-responsive and will be returned to the applicant. It is highly recommended that the appropriate NIAID program contact be consulted before submitting the letter of intent and during the early stages of preparation of the application. (See program contact under INQUIRIES). APPLICATION PROCESSING: The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. While the investigator may still benefit from the previous review, the RFA application is not to state explicitly how. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NIAID. Incomplete and/or nonresponsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAID in accordance with the review criteria stated below. Depending on the total number and research topics of applications received in response to this RFA, applications may be separated into subgroups for review by different peer review committees. As part of the initial merit review, all applications will: o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the National Advisory Allergy and Infectious Diseases Council REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application's overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment 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. o SIGNIFICANCE: Is this project likely to significantly advance the development of a vaccine, adjuvant, therapeutic, or diagnostic against the specific biologic threat agent identified in this initiative? If the aims of the application are achieved, are important biomedical agents or products likely to result? What will be the effect of these studies on the concepts or methods that drive this field? o APPROACH: Does the application clearly articulate the development of a candidate product? 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? Is the industry commitment adequate to have an impact on the success of the proposed research objectives? Is the likelihood of successful project completion high given the current state of research and development and the technical approach? Does the application clearly delineate appropriate timelines and interim milestones and are they appropriate, feasible and technically sound? o INNOVATION: If appropriate, 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? NOTE: The NIAID recognizes that the inherent nature and demands of the product development process may require funding large, complex grants with interdependent specific aims. Furthermore, some aspects of the product development process (e.g., large-scale production) are inherently not innovative. o INVESTIGATOR: Is the research and development team appropriately trained and experienced 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)? Is there strong evidence of substantive industrial commitment? o ENVIRONMENT: Does the 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 environments, including partnerships with industry, or employ useful collaborative arrangements? Is there adequate evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below) INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS RFA-specific review criteria: o The scientific rationale and basis for the candidate product, including the strength of existing data on product feasibility, safety, and potential efficacy o The appropriateness of the proposed project in terms of the stage of development of the candidate product o The appropriateness and feasibility of defined objectives/milestones o Feasibility of future product development o The appropriateness and feasibility of conducting or field evaluation during the period of award. SHARING RESEARCH DATA: Applicants requesting more than $500,000 in direct costs in any year of the proposed research are expected to include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data-sharing plan into the determination of scientific merit or priority score. (See instructions and URL to policy in the Federal Citations, below.) BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: December 17, 2004 Application Receipt Date: January 18, 2005 Peer Review Date: May, 2005 Council Review: June, 2005 Earliest Anticipated Start Date: July, 2005 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Programmatic priorities o High priority public health needs In addition, to achieve program balance, NIAID reserves the right to make awards to the most meritorious applications in various priority categories, including vaccines, therapeutics, adjuvants and diagnostics. REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm SHARING RESEARCH DATA: Investigators submitting an NIH application seeking more than $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy 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. 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 is available at http://grants.nih.gov/grants/funding/children/children.htm REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. This policy announcement is in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance at http://www.cfda.gov/ in the following citations: No. 93.855, Immunology, Allergy, and Transplantation Research and No. 93.856, Microbiology and Infectious Diseases Research. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The NIH Grants Policy Statement is available at http://grants.nih.gov/grants/policy/policy.htm. This document includes general information about the grant application and review process; information on the terms and conditions that apply to NIH Grants and cooperative agreements; and a listing of pertinent offices and officials at the NIH. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people performed during this interval.


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