NIAID COMPETING CONTINUATION OF SBIR/STTR PH II AWARDS RELEASE DATE: October 31, 2003 RFA Number: RFA-AI-04-005 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) ( COMPONENTS OF PARTICIPATING ORGANIZATION: National Institute of Allergy and Infectious Diseases (NIAID) ( CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): No. 93.855, Immunology, Allergy, and Transplantation Research No. 93.856, Microbiology and Infectious Diseases Research LETTER OF INTENT RECEIPT DATE: December 14, 2003 APPLICATION RECEIPT DATE: January 16, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Notice of Additional Instructions o Purpose of the RFA o Research Objectives o Eligible Applications o Mechanism(s) of Support o Project Period and Amount of Award 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 Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations NOTICE: This Request for Application (RFA) must be read in conjunction with the current OMNIBUS SOLICITATION OF THE NATIONAL INSTITUTES OF HEALTH, CENTERS FOR DISEASE CONTROL AND PREVENTION, and FOOD AND DRUG ADMINISTRATION FOR SMALL BUSINESS INNOVATION RESEARCH (SBIR) AND SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) GRANT APPLICATIONS. The solicitation (see (see contains information about the SBIR and STTR programs, regulations governing the programs, and instructional information for submission. All of the instructions within the SBIR/STTR Omnibus Solicitation apply with the following exceptions: o Special receipt date and mailing instructions o Additional eligibility and significance requirements o Extended project period and amount of award o Requirement for critical path and annual milestones o Mandatory NIAID "Clinical Terms of Award" for clinical research o Initial review convened by the NIAID Division of Extramural Activities o Additional review considerations PURPOSE OF THIS RFA This RFA invites applications for the competing continuation of eligible SBIR or STTR Phase II awardees to continue the process of developing a product that requires clinical evaluation and FDA approval. An "eligible application" must develop one of the following products: therapeutics (drugs or antibodies) to treat HIV or HIV-related opportunistic infections, anti- inflammatory therapeutics, improved transplantation strategies, or other new or improved vaccines, antiviral or antimicrobial agents for infectious diseases. The progress from an eligible SBIR/STTR Phase II grant should be commensurate with previous support and indicate the merit of continued NIH research and development (R&D) funding. Activities supported by a competing continuation of a Phase II SBIR/STTR grant may include additional pre-clinical R&D, clinical testing, and other R&D activities needed to meet requirements of the FDA. A competing continuation SBIR/STTR Phase II award may not be used to conduct early stage research (e.g., identifying targets for drugs, initial identification of lead compounds, etc.). RESEARCH OBJECTIVES The SBIR/STTR programs were initiated as a means for government agencies to use small businesses to stimulate technological innovation and to help agencies meet their R&D needs. An additional provision of these programs is the expected commercialization of the research. Certain types of research require clinical evaluation and FDA approvals before the Phase III of the small business research pathway can be realized. A recipient of an NIH SBIR/STTR Phase I and Phase II award normally receives no more than $1 million. If the intended commercialized product is a medical device, drug, or biologic, the $1 million often represents a small fraction of the funds necessary to complete the studies required for approval and licensing by the FDA. A recipient of an NIH SBIR/STTR Phase I and Phase II award normally receives less than three years of support. Yet, the process of moving promising new products from research to commercialization typically takes more than a decade. The drug discovery timeline, for example, starts with identification of an agent or class of agents with particular activity, identification and optimization of lead compounds, and subsequent pre-clinical testing of these compounds for safety and toxicity. 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. Similarly long timelines obtain for other products intended to understand, diagnose, prevent, or treat human health disorders (e.g., medical devices, vaccines). Despite the cost and the length of time required to move such products from the laboratory to the patient, these are precisely the products with potential to contribute significantly to the economy of the nation and to the improvement of public health. The intent of the NIAID SBIR/STTR Phase II competing continuation awards is to support such R&D. ELIGIBLE APPLICATIONS Eligible to apply for NIAID SBIR/STTR Phase II competing continuation awards under this RFA are NIH SBIR/STTR Phase II awardees that meet the definition of a small business concern (as described in the NIH SBIR/STTR Phase II instructions) and whose projects are developing a product that requires clinical evaluation and FDA approval. Only applications on one of the following products will be considered responsive to this RFA: o therapeutics (drugs or antibodies) to treat HIV infections o therapeutics (drugs or antibodies) for HIV-related opportunistic infections o anti-inflammatory therapeutics o improved transplantation strategies o new or improved vaccines, antiviral or antimicrobial agents for infectious diseases Applications that are not considered responsive to one of these topics will be returned without review. Applications may be submitted either before or after expiration of the eligible Phase II budget period. MECHANISM(S) OF SUPPORT This RFA usually uses the Phase II SBIR (R44) and STTR (R42) grant mechanisms, which are set-aside programs. The application for the competing continuation must propose R&D that represents a logical extension of the previously supported Phase II research. When awarded as a grant, the applicant is responsible for planning, directing, and executing the proposed project. When appropriate, NIAID may offer to award Phase II SBIR/STTR competing continuation applications using a small business cooperative agreement SBIR (U44) or STTR (U42) mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIAID staff being substantially involved as a partner with the Principal Investigator. This RFA uses just-in-time concepts. This RFA does not use modular budget format. Cost-sharing arrangements are strongly encouraged since the SBIR/STTR programs cannot support all activities that may be required to advance a project to feasibility demonstration in a clinical trial. Except as otherwise stated in this RFA, awards will be administered according to the NIH Grants Policy Statement (NIHGPS), currently available at PROJECT PERIOD AND AMOUNT OF AWARD The SBIR/STTR Omnibus Solicitation indicates the statutory guidelines of funding support and project duration periods for SBIR and STTR Phase I and Phase II awards. Competing continuation applications for SBIR/STTR Phase II awards may be for a project period of up to three years and a budget not to exceed a total cost of $1 million per year (including direct cost, F&A, and fee/profit) provided the time period and amount are well justified. FUNDS AVAILABLE NIAID intends to commit approximately $4 million to fund 4-6 SBIR competing continuation awards and $1 million to fund 1-2 STTR competing continuation awards in FY2004 or FY2005. Although the financial plans of the NIAID provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. 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 initial SBIR Phase II applications. SBIR Phase II competing continuation grant applications submitted under this RFA may exceed this guideline, however, when well justified and when those costs are necessary to support clinical studies or trials and related expenses. Examples of well founded reasons for exceeding this guideline include, but are not limited to, subcontracts for safety, toxicity, or efficacy testing in animals, 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. For STTR competing Phase II applications, the small business MUST perform at least 30% of the R&D and the partnering research institution must perform at least 40% of the proposed R&D. ELIGIBLE INSTITUTIONS: Eligibility requirements are described in the SBIR/STTR Omnibus Solicitation. See (PDF) or (MS Word). Only small business concerns are eligible to submit applications. A small business concern is one that, on the date of award for both Phase I and Phase II agreements, meets ALL of the criteria as described in the SBIR/STTR Omnibus Solicitation. The competing continuation application must be a continuation of a previously funded Phase II (R44) SBIR or Phase II STTR (R42) grant focusing on R&D of a product or products ultimately requiring clinical testing and Federal regulatory approval. 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. Individuals from underrepresented racial and ethnic groups, as well as individuals with disabilities, are encouraged to apply for NIH programs. The Principal Investigator (PI) on an SBIR application must have his/her primary employment (more than 50 percent) with the small business at the time of award and for the duration of the project. The PI on an STTR application may be employed with the small business concern or the participating non-profit research institution as long as she or he has a formal appointment with or commitment to the applicant small business concern, which is characterized by an official relationship between the small business concern and that individual. SPECIAL REQUIREMENTS Follow the Instructions for the Significance Section of an NIH SBIR/STTR Phase II Application. In addition, include the following in this section: Item b. Significance Section o Describe what makes the project eligible for a competing continuation Phase II award. o Describe a critical path(s) to product approval with detailed milestones to be reached during each year of the proposed project period. A milestone is defined as a specific R&D achievement that either demonstrates an essential product attribute or completes a step necessary to advance the product towards completion. Examples of milestones include, but are not limited to: passing toxicity studies; demonstrating sufficient bio-availability; showing efficacy in an animal model; completion of a prototype of a diagnostic tool; FDA submission and acceptance of an Investigational New Drug Application (IND) or an Investigational Device Exemptions (IDE); initiation of a clinical trial; and follow-on funding. o List in table format the milestones that have been achieved to date and those for each grant year of the proposed project. Include in the table the remaining milestones after the proposed grant period and estimated timeline to complete the product R&D. Additional milestones may be suggested by the review committee. The review committee may also suggest which, if any, of the milestones should be identified in the Terms of Award as essential for annual non-competitive renewal. Failure to achieve annual milestones may be grounds for not continuing future years of an award. Item c. Phase II Final Report Label this section, "Phase II Final Report." Follow the Instructions for the Phase I Final Report of an NIH SBIR/STTR Phase II Application except replace all references to "Phase I" with "Phase II." Clinical Terms of Award When human 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. AN UPDATED NIAID policy was published in the NIH Guide on July 8, 2002 and is available at: The full policy, including terms and conditions of award, is available at: A mandatory milestone for projects involving humans is the approval of the final clinical protocol by NIAID prior to the accrual of subjects into the trial. 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 ( Potential applicants are encouraged to contact appropriate NIAID program staff concerning this policy. Commercialization Plan All Phase II SBIR/STTR grant applications, including Phase II competing continuation applications, require a Commercialization Plan, described in item J of the Instructions for Preparation of Phase II Applications. These Instructions describe the contents to be included in the following sections: 1. Value of the SBIR/STTR Project, Expected Outcomes, and Impact. 2. Company. 3. Market, Customer, and Competition. 4. Intellectual Property (IP) Protection. 5. Finance Plan. 6. Production and Marketing Plan. 7. Revenue Stream. If relevant, applicants may replace sections 5 with licensing, mergers or acquisition plans, section 6 with the milestones necessary for one of the section 5 events, and section 7 with a description of commitments, if any, from potential partners or buyers. Although applicants may consider this new section 7 too confidential to include, when provided it may enhance the enthusiasm of reviewers. 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: general SBIR issues, specific scientific research and development issues, review issues, and financial or grants management issues. Frequently asked "Questions and Answers" about this RFA may be found at General SBIR Issues Potential applicants are strongly encouraged to contact Dr. Gregory Milman before proceeding with an NIAID competing continuation SBIR/STTR Phase II application. Gregory Milman, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 2153, MSC-7610 6700-B Rockledge Drive Bethesda, MD 20892-7610 (US Mail) Rockville, MD 20817-7610 (Delivery Services) Telephone (301) 496-8666 Fax: (301) 402-0369 Email: Specific Scientific Research and Development Issues Applicants are directed to a list of research areas and program staff for each area at Review Issues Madelon Halula, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 3116, MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 (US Mail) Rockville, MD 20817-7616 (Delivery Services) Telephone (301) 402-2636 Fax: (301) 402-2638 Email: Financial or Grants Management Issues 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 Bethesda, (MD 20817-7614 for express/courier service) Telephone: (301) 402-6580 FAX: (301) 480-3780 Email: 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 institution(s) 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 NIAID 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: Madelon Halula, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 3116, MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 (US Mail) Rockville, MD 20817-7616 (Delivery Services) Telephone (301) 402-2636 Fax: (301) 402-2638 Email: SUBMITTING AN APPLICATION The PHS 398 research grant application must be used for all SBIR/STTR Phase I, Phase II and Fast-Track applications (new and revised.) Effective October 1, 2003, 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 The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 is available at Prepare your application in accordance with the SBIR/STTR Omnibus Solicitation and the PHS 398. Helpful information for advice and preparation of the application can be obtained at: The NIH will return applications that are not submitted on the 5/2001 version of the PHS 398. For further assistance contact GrantsInfo, Telephone: (301) 710-0267, Email: USING THE RFA LABEL: The RFA label available in the PHS 398 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: or 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 (for USPS EXPRESS or REGULAR MAIL) Bethesda, MD 20817 (for EXPRESS/COURIER NON-USPS SERVICE) At the time of submission, two additional copies of the application must be sent to: Madelon Halula, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 3116, MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 (US Mail) Rockville, MD 20817-7616 (Delivery Services) Telephone (301) 402-2636 Fax: (301) 402-2638 Email: RECEIPT OF APPLICATIONS. Applications must be received on or before the receipt date listed on the first page of this announcement. If an application is received after that date, it will be returned to the applicant without review. APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO NIAID WILL NOT BE ACCEPTED. This policy does not apply to courier deliveries (i.e. FEDEX, UPS, DHL, etc.) ( This policy is similar to and consistent with the policy for applications addressed to Centers for Scientific Review as published in the NIH Guide Notice 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. The Center for Scientific Research (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. The CSR will not accept any application that is essentially the same as one already reviewed. 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. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIAID. Incomplete and/or nonresponsive applications will not be reviewed. 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. As part of the initial merit review, all applications will: o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the 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 within the context of the SBIR/STTR Program. The scientific review group will address and consider each of the following criteria in assigning the application’s overall score: o Significance o Approach o Innovation o Investigator o Environment 1. Significance: Does this study address an important public health problem? Is the proposed project in one of the NIAID Small Business Highest Priority Areas? Does the proposed project have commercial potential to lead to a marketable product or process that requires FDA approval? 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., vaccine platforms) for further discoveries? Will the technology have a competitive advantage over existing/alternate technologies or products. 2. Approach: Does the proposed project describe a critical path for FDA approval and licensing with milestones and a timeline for those milestones to be achieved during each year of the proposed project period; milestones that will remain after the proposed funding period to complete the product R&D? Are there additional milestones that the review committee suggests be included? The review committee may suggest which, if any, of the milestones and timelines should be included in the Terms of Award. 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? 3. Innovation: Does the project challenge existing paradigms or employ novel technologies, approaches or methodologies? Are the aims and/or products original and innovative? 4. Investigators: Is the Principal Investigator capable of coordinating and managing the proposed R&D? Are the work and management activities proposed appropriate to the experience level of the Principal Investigator and other researchers, including consultants and subcontractors (if any)? Are the roles and relationships of the Principal Investigator, key personnel, consultants, and contractors appropriate for the work proposed? 5. Environment: Do the proposed contracts, if any, have the capability of producing the expected product or service in the time frame proposed? 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? 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 (cost-sharing) that would enhance the likelihood for commercialization? 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: COMMERCIALIZATION PLAN: The Commercialization Plan (formerly the Product Development Plan) should be used to evaluate the probability that the product will eventually receive FDA approval and become available. If licensing, mergers or acquisition plans are anticipated in order to produce the product, are the milestones for these events described and reasonable? 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 additional information and 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 additional information and Inclusion Criteria in the sections on Federal Citations, below). Human Subjects: Protection of Human Subjects from Research Risks - for all studies involving human subjects. See instructions and "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. 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. 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? CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the required five items described under Vertebrate Animals (section f of the Research Plan instructions) will be assessed. 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? 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? ADDITIONAL REVIEW CONSIDERATIONS: The following items may be also be considered by reviewers but will not be included in the determination of scientific merit. SHARING RESEARCH DATA: Applicants requesting more than $500,000 in direct costs in any year of the proposed research must 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. BUDGET: The reasonableness of the proposed budget may be considered. 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? PERIOD OF SUPPORT: The appropriateness of the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: December 14, 2003 Application Receipt Date: January 16, 2004 Peer Review Date: June/July 2004 Council Review: September 2004 Earliest Anticipated Start Date: September/October 2004 AWARD CRITERIA Applications submitted in response to a RFA will compete for available funds with all other recommended SBIR and STTR applications but NIAID paylines for other SBIR or STTR applications do not apply to applications in response to this RFA. 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 for applications in response to this RFA o Relevance to NIAID priorities 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. DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose- finding studies (phase I); efficacy studies (phase II); efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, investigators submitting an NIH application seeking $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. 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 "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 (; a complete copy of the updated Guidelines are available at 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 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 HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at and at Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see 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 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). Those who must comply with the Privacy Rule (classified under the Rule as covered entities ) must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website ( 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 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 AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at 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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