PA-02-173: COMPETING CONTINUATION AWARDS OF SBIR PHASE II GRANTS FOR PHARMACOLOGIC AGENTS AND DRUGS FOR MENTAL DISORDERS

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COMPETING CONTINUATION AWARDS OF SBIR PHASE II GRANTS FOR PHARMACOLOGIC AGENTS AND DRUGS FOR MENTAL DISORDERS RELEASE DATE: September 27, 2002 PA NUMBER: PA-02-173 (This PA has been reissued, see PA-06-079) EXPIRATION DATE: October 2005 National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov) THIS 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 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 This Program Announcement (PA) solicits Small Business Innovation Research (SBIR) grant applications that propose to continue the process of developing pharmacologic agents for brain research related to mental disorders, including research aimed at discovering new drugs for these disorders. This PA specifically invites applications for the competing continuation of previously funded Phase II SBIR grants, to take existing, promising compounds through the next step of drug discovery and development. Only SBIR Phase II awardees are eligible to submit a competing continuation application. The previously funded Phase II SBIR grant need not have been submitted in response to a particular solicitation, as long as the research is appropriate to the purpose of this solicitation. This PA does not support early stage drug development such as the identification of new targets or lead compounds. Rather, the expectation is that as a result of support from previous SBIR Phase I (R43) and Phase II (R44) grants, promising pharmacologic agents have already been identified and some preclinical pharmacology has been conducted. The competing continuation would represent a continuation of support for research/research and development of such previous work funded by the original Phase II R44 grant. Activities supported by a competing continuation of a Phase II SBIR grant may include an extension and expansion of preclinical research and development, clinical testing, and other scientific research and development activities that would ultimately be useful in meeting the requirements and expectations of Federal regulatory processes. A Phase II competing continuation award should not, however, be used to conduct very early stage research (e.g., identifying targets for drugs, initial identification of lead compounds, etc.). In addition, like Phase I and initial Phase II grants, the Phase II competing continuation award will not support costs for legal consultation, marketing efforts, etc. This PA must be read in conjunction with the current Phase II Grant Application (http://grants.nih.gov/grants/funding/sbir2/index.htm) and in conjunction with Chapter VI of the PHS 398 http://grants.nih.gov/grants/funding/phs398/phs398.html. RESEARCH OBJECTIVES Background Pharmacologic therapeutics represent the single most important commercial product of biomedical research, and they have an unsurpassed track record of improving human health. Nevertheless, drug discovery and development is a costly, time consuming, and high risk activity. The process starts with the discovery of an agent or class of agents with particular activity. Lead compounds must then be identified, optimized, and only then tested in preclinical conditions for safety, toxicity, etc. Those agents still considered viable after such rigorous scrutiny are then brought to human subjects for clinical evaluation of a variety of aspects of the agent, including safety, effectiveness, and dosage determination. In recent years, with the advent of biotechnology, small businesses have played an increasingly important role in drug discovery and development, typically, but not entirely, focusing their efforts on the earlier stages of this process rather than clinical trial evaluation. SBIR support has heretofore only allowed for a Phase I and single Phase II grant for such research. A recipient of an NIH SBIR Phase I and Phase II award normally receives no more than $1 million. If the intended commercialization product is a drug or biologic, the $1 million is probably less than 1% of the funds necessary to complete the studies required for licensing by the Food and Drug Administration (FDA.). Moreover, a recipient of an NIH SBIR Phase I and Phase II award normally receives less than three years of support. Yet, the process of moving promising new products from bench to bedside typically takes more than a decade. This program announcement aims to add up to another 3 years of support to small businesses for drug research and development by providing a second epoch of Phase II SBIR funding through the award of an SBIR Phase II competing continuation grant. It is recognized that even with a competing continuation grant, this entire timeline will not be supported by the SBIR Program for any given drug. The competing continuation grant will, however, allow small businesses to carry further the fruits of their research to advance science and to attract interest and investment in their research programs by third parties. This Phase II competing continuation support will also allow small businesses to address clinical issues, and other important issues relevant to regulatory approval by agencies such as the federal Food and Drug Administration. Thus, competitive continuation awards of Phase II grants will contribute to the strength of this nation"s economy and to the health of her people. Research topics The following examples would make appropriate topics for proposed SBIR Phase II competing continuation projects. These are meant for illustrative purposes only and are not exclusive of other appropriate activities: o Preclinical studies, including pharmacology and toxicology, beyond those conducted under the Phase I (R43) and initial Phase II (R44) grants. Some in vivo or in vitro studies would be expected to have been carried out in Phase I or the initial Phase II grant. o Completion of studies as required by the Food and Drug Administration (FDA) for Investigational New Drug (IND) or Radioactive Drug Research Committee (RDRC) application. o Studies in normal healthy volunteers to determine a drug"s safety profile, metabolism, etc. o Clinical studies in patient/disease population to assess the drug"s effectiveness MECHANISM OF SUPPORT SBIR PHASE II Competing Continuation SBIR Phase II competing continuation applications in response to this PA will only be accepted as competing continuations of previously funded NIH Phase II SBIR awards (R44 mechanisms). The expectation is that as a result of support from previous SBIR Phase I (R43) and Phase II (R44) grants, promising findings had been produced that indicate not only the merit of further research and development, but also that clinical investigations and Federal regulatory approvals will ultimately be required to realize the potential of the product being researched and developed. The previously funded NIH Phase II grant need not have been submitted in response to any particular solicitation, but the application for the competing continuation must propose research and development of pharmacologic agents and drugs for the treatment of mental disorders, and must be a logical extension of the previously supported Phase II research. Applicants will be solely responsible for planning, directing, and executing the proposed project. Project Period and Amount of Award Because the length of time and cost of drug discovery and development represents a long term research and development commitment, a project period of up to three years and a budget not to exceed total costs of $800,000 per year (including direct costs, indirect costs and fee/profit) will be considered under this PA if the time period and amount are well justified. Consultant and Contractual Costs The total amount of all consultant costs and contractual costs normally may not exceed 50% of the total costs requested for R44 Phase II SBIR applications. Competing continuation grant applications submitted under this PA may exceed this guideline, however, when well justified. Examples of well founded reasons for exceeding this guideline include, but are not limited to, subcontracts to clinical research organizations to carry out aspects of clinical evaluation or subcontracts to assure compliance with Good Manufacturing Practices (GMPs) expectations of the FDA. This PA uses just-in-time concepts. Also, applicants must follow the instructions for non-modular research grant applications. ELIGIBLE INSTITUTIONS The competing continuation application must be a continuation and logical extension of a previously completed Phase II (R44) SBIR grant focusing on drug development of pharmacologic agents. To maintain eligibility to seek a Phase II competing continuation grant, a Phase II grantee organization should submit an application for the Phase II competing continuation grant within the first six receipt dates following the expiration of the initial Phase II budget. Other eligibility requirements for a Phase II competing continuation grant are identical to those for the initial Phase II (R44) applications and can be found at http://grants.nih.gov/grants/funding/sbir2/index.htm and in the PHS 398 http://grants.nih.gov/grants/funding/phs398/phs398.html. 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. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. o Direct your questions about scientific/research issues to: Margaret Grabb, Ph.D. Division of Basic and Clinical Neuroscience Research National Institute of Mental Health 6001 Executive Boulevard, Room 7201, MSC 9645 Bethesda, MD 20892-9645 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-3563 FAX: (301) 443-1731 Email: mgrabb@mail.nih.gov o Direct your questions about financial or grants management matters to: Ms. Kathy Hancock Grants Management Branch National Institute of Child Health and Human Development 6001 Executive Boulevard, Room 8A17M Bethesda, MD 20892-7510 Telephone: (301) 496-5482 FAX: (301) 402-0915 Email: hancockk@mail.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using Chapter VI of 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. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. All Phase II grant applications, including this competing continuation application, require a "Product Development Plan," as described at http://grants.nih.gov/grants/funding/phs398/instructions2/ p1_specific_instructions.htm#8_Appendix. The Product Development Plan is meant in part to demonstrate the commercial viability of the product researched and developed with SBIR support. Since this Phase II competing continuation application mechanism supports a more advanced stage of research and development than the R44 Phase II mechanism, the Product Development Plan should reflect more advanced plans and arrangements for commercialization than what might be submitted for an R44 application. For example, part of a Product Development Plan that would be appropriate to drug development supported by a Competing Continuation application would be a clear indication of an arrangement (e.g., strategic alliance, letters of support)) with another party through which the final stages of the work might be supported or carried out, including additional clinical trials, FDA submissions, drug manufacturing and drug commercialization. This example is meant for illustrative purposes, the details of any Product Development Plan will depend upon the particular circumstances represented in a given application. For purposes of identification and processing, enter the following title and number of this PA in item 2 on the face page of the application: COMPETING CONTINUATION AWARDS OF SBIR PHASE II GRANTS FOR PHARMACOLOGIC AGENTS AND DRUGS FOR MENTAL DISORDERS," PA-02-173) APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. 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/submissionschedule.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 the appropriate national advisory council or board REVIEW CRITERIA In addition to the five subcomponents of the Significance review criterion described in Chapter VI of the PHS 398 (http://grants.nih.gov/grants/funding/phs398/instructions2/ p1_peer_review.htm#Research_Project), a sixth subcomponent will be assessed by reviewers: Does the activity as proposed address issues related to Federal regulatory approval processes? 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 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 Catalog of Federal Domestic Assistance No. 93.242, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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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