PAS-02-149: SMALL BUSINESS BIODEFENSE PROGRAM

Department of Health
and Human Services (HHS)

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SMALL BUSINESS BIODEFENSE PROGRAM RELEASE DATE: August 15, 2002 PA NUMBER: PAS-02-149 RECEIPT DATES: (http://grants.nih.gov/grants/funding/sbirsttr_receipt_dates.htm) EXPIRATION DATE: August 2, 2005 National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov) THIS PROGRAM ANNOUNCEMENT (PA) CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements (if included) o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA To support SBIR/STTR grants to develop therapeutics, vaccines, diagnostics, adjuvants/immunostimulants, and selected resources for biodefense. This PA provides instructions relating to total cost and dates of project period for these applications. RESEARCH OBJECTIVES NIAID has identified specific products for biodefense that are of highest priority for rapid development. These products are listed at: http://www2.niaid.nih.gov/Biodefense/Research/high_priority.htm. The list may be updated regularly based on changing priorities. Due to the urgent need to advance research involving Biodefense and concern that the time and cost of these projects may exceed that routinely awarded for SBIR or STTR grants, NIAID will entertain well- justified applications focused on NIAID High Priority Biodefense Products with the following expanded duration and award limits: 1) SBIR and STTR Phase I applications up to 2 years and $500,000 total cost per year. 2) SBIR and STTR Phase II applications up to 3 years and $2,000,000 total cost per year. The total amount of all consultant costs and contractual costs normally may not exceed 50% of the total costs requested for Phase II SBIR applications. However, NIAID will entertain well-justified Phase II applications for an SBIR Biodefense award with greater than 50% contractual costs when those costs are necessary to support clinical studies and trials or product development. MECHANISM(S) OF SUPPORT This PA will use the NIH Small Business Innovation Research (SBIR R43/R44) and Small Business Technology Transfer (STTR R41/R42) applications to stimulate technological innovations in areas that are within its mission. The total requested project period for an application submitted in response to this PA may not exceed two years for Phase I (R43 or R41) grant and three years for a Phase II (R44 or R42) grant. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This PA must be read in conjunction with the Omnibus Solicitation of the Public Health Service for Phase I SBIR/STTR Grant Applications found at http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf and the instructions for Phase II Grant Applications found at http://grants.nih.gov/grants/funding/sbir2/index.htm. Except as noted below, all instructions and information in these documents apply. FUNDS AVAILABLE The estimated budget available for support of SBIR/STTR grants in Biodefense and Emerging Infectious Diseases is $35,000,000 for Fiscal Year 2003. Future year amounts will depend on annual appropriations. ELIGIBLE INSTITUTIONS Eligibility requirements for Phase I and Phase II grants are found at http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf and http://grants.nih.gov/grants/funding/sbir2/index.htm respectively. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Eligibility criteria for principal investigators can be found at http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf and http://grants.nih.gov/grants/funding/sbir2/index.htm SPECIAL REQUIREMENTS MILESTONES As consistent with the Omnibus Solicitation, Phase II SBIR and STTR applications must be performance based, and include a critical path and scientific milestones for product development to be completed during the project period. A milestone is defined as a specific area of research that must be completed before additional research endeavors can be started. Examples of milestones include, but are not limited to: completion of a prototype of a diagnostic tool; submission of an IND to FDA; initiation of a clinical trial. CLINICAL TERMS OF AWARD When clinical studies or trials 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. Terms and Conditions of Award will be included with awards. When clinical studies or trials 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://grants2.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. A mandatory milestone is the approval of the final clinical protocol by NIAID prior to the start of the clinical trial. Phase I applicants, who anticipate that their Phase I application will contain or comprise a clinical trial, can include a budget item in the Phase I application to assist in the preparation of the clinical protocol for the Phase II application. Phase II applications that contain or comprise a clinical trial should also include a budget item for preparation of a clinical protocol. Protocol development must be consistent with Federal and NIAID specific regulations governing the conduct of human subjects research (http://www.hhs.gov/ohrp/assurances/assurances_index.html). Potential applicants are encouraged to contact appropriate NIAID program staff concerning this policy. WHERE TO SEND INQUIRIES We strongly encourage your inquiries concerning this PA and welcome the opportunity to clarify any issues or questions from potential applicants. o Direct inquires regarding scientific, technical and programmatic issues to: Dr. Barbara Mulach Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Room 3266, MSC-7630 6700-B Rockledge Drive Bethesda, MD 20892-7630 Telephone: (301) 496-1884 FAX: (301) 480-4528 Email: bmulach@niaid.nih.gov o Direct inquires regarding fiscal matters to: Ms. Theresa Mercogliano Grants Management Specialist Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6700-B Rockledge Drive, Rm. 2261, MSC 7614 Bethesda, MD 20892-7614 Bethesda, MD 20817-7614 (for express/courier service) Telephone: (301) 402-5512 FAX: (301) 480-3780 Email: tmercoglia@niaid.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Please refer to Chapter VI of the PHS 398 instructions when preparing an SBIR or STTR application. PHS 398 forms specific to SBIR/STTR applications are available at: http://grants.nih.gov/grants/funding/phs398/398_SBIRSTTRforms.doc. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, 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) APPLICATION PROCESSING: Applications must be received by or mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/sbirsttr_receipt_dates.htm. The 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 a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique 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 second level review by an appropriate National Advisory Council (there is no guarantee that all will be assigned to NIAID, hence "assigned on the basis of established PHS guidelines" above) REVIEW CRITERIA The review criteria for SBIR and STTR applications are found at: http://grants.nih.gov/grants/funding/phs398/instructions2/p1_preparing_SBIR _STTR_app.htm. PHASE I APPLICATION REVIEW CRITERIA SIGNIFICANCE Does the proposed project have commercial potential to lead to a marketable product or process? Does this study address an important problem? What may be the anticipated commercial and societal benefits of the proposed activity? If the aims of the application are achieved, how will scientific knowledge be advanced? Does the proposal lead to enabling technologies (e.g., instrumentation, software) for further discoveries? Will the technology have a competitive advantage over existing/alternate technologies that can meet the market needs? APPROACH Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Is the proposed plan a sound approach for establishing technical and commercial feasibility Does the applicant acknowledge potential problem areas and consider alternative strategies? Are the milestones and evaluation procedures appropriate? INNOVATION Does the project challenge existing paradigms or employ novel technologies, approaches or methodologies? Are the aims original and innovative? INVESTIGATORS Is the Principal Investigator capable of coordinating and managing the proposed SBIR/STTR? Is the work proposed appropriate to the experience level of the Principal Investigator and other researchers, including consultants and subcontractors (if any)? Are the relationships of the key personnel to the small business and to other institutions appropriate for the work proposed?" ENVIRONMENT Is there sufficient access to resources (e.g., equipment, facilities)? Does the scientific and technological 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? IN ACCORDANCE WITH NIH POLICY, THE FOLLOWING CRITERIA WILL BE APPLIED TO ALL APPLICATIONS: BIOHAZARDS Is the use of materials or procedures that are potentially hazardous to research personnel and/or the environment proposed? Is the proposed protection adequate? ANIMAL WELFARE If vertebrate animals are involved, are adequate plans proposed for their care and use? Are the applicant's responses to the five required points appropriate? Will the procedures be limited to those that are unavoidable in the conduct of scientifically sound research? BUDGET For all applications, is the percent effort listed for the PI appropriate for the work proposed? On applications requesting up to $100,000 total costs, is the overall budget realistic and justified in terms of the aims and methods proposed? On applications requesting over $100,000 in total costs, is each budget category realistic and justified in terms of the aims and methods? In accordance with NIH policy, all applications will also be reviewed with respect to the following: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISKS - for all studies involving human subjects. See "Guidance for Preparing the Human Subjects Research Section." If an exemption is claimed, is it appropriate for the work proposed? If no exemption is claimed, are the applicant's responses to the six required points appropriate? Are human subjects placed at risk by the proposed study? If so, are the risks reasonable in relation to the anticipated benefits to the subjects and others? Are the risks reasonable in relation to the importance of the knowledge that reasonably may be expected to be gained? Are the plans proposed for the protection of human subjects adequate? INCLUSION OF WOMEN PLAN - for clinical research only. See instructions. Does the applicant propose a plan for the inclusion of both genders that will provide their appropriate representation? Does the applicant provide appropriate justification when representation is limited or absent? Does the applicant propose appropriate and acceptable plans for recruitment/outreach and retention of study participants? INCLUSION OF MINORITIES PLAN - for clinical research only. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html Does the applicant propose a plan for the inclusion of minorities that will provide their appropriate representation? Does the applicant provide appropriate justification when representation is limited or absent? Does the applicant propose appropriate and acceptable plans for recruitment/outreach and retention of study participants? INCLUSION OF CHILDREN PLAN- for all studies involving human subjects Does the applicant describe an acceptable plan in which the representation of children of all ages (under the age of 21) is scientifically appropriate and recruitment/retention is addressed realistically? If not, does the applicant provide an appropriate justification for their exclusion? DATA AND SAFETY MONITORING PLAN - for clinical trials only Does the applicant describe a Data and Safety Monitoring Plan that defines the general structure of the monitoring entity and mechanisms for reporting Adverse Events to the NIH and the IRB? PHASE II APPLICATION REVIEW CRITERIA In addition to the above criteria: How well did the applicant demonstrate progress toward meeting the Phase I objectives, demonstrating feasibility, and providing a solid foundation for the proposed Phase II activity? Did the applicant submit a concise Product Development Plan that adequately addresses the four areas described in Section I, item 9, J? Does the project carry a high degree of commercial potential, as described in the Product Development Plan? AMENDED APPLICATIONS In addition to the above criteria, the following criteria will be applied to revised applications. Are the responses to comments from the previous SRG review adequate? Are the improvements in the revised application appropriate? PHASE I/PHASE II FAST-TRACK APPLICATION REVIEW CRITERIA For Phase I/Phase II Fast Track applications, the following criteria also will be applied: Does the Phase I application specify clear, appropriate, measurable goals (milestones) that should be achieved prior to initiating Phase II? Did the applicant submit a concise Product Development Plan that adequately addresses the four areas described in Section I, item 9, J? To what extent was the applicant able to obtain letters of interest, additional funding commitments, and/or resources from the private sector or non-SBIR/STTR funding sources that would enhance the likelihood for commercialization? Does the project carry a high degree of commercial potential, as described in the Product Development Plan? Phase I and Phase II Fast-Track applications that satisfy all of the review criteria will receive a single rating. Failure to provide clear, measurable goals may be sufficient reason for the scientific review group to exclude the Phase II application from Fast-Track review. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). 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. 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 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. You will find this policy announcement 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://grants.nih.gov/grants/stem_cells.htm 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 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 PA 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. 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 PA 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 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. 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.

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