NCI COMPETING CONTINUATION SBIR/STTR PHASE II GRANTS FOR CANCER DIAGNOSIS, PREVENTION AND TREATMENT RELEASE DATE: January 5, 2004 PA NUMBER: PA-04-047 (This PA has been reissued, see PA-06-051 and PA-06-052) EXPIRATION DATE: November 3, 2005 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Cancer Institute (NCI/NIH) (http://www.nci.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.393. 93,394, 93.395, 93.396, 93.399 LETTER OF INTENT RECEIPT DATES: March 1, July 1, November 1 of each year APPLICATION RECEIPT DATE(S): Applications submitted in response to this program announcement will be accepted at the standard application deadlines (April 1, August 1, and December 1). THIS PA CONTAINS THE FOLLOWING INFORMATION: o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Project Period and Amount of Award o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Letter of Intent o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Award Criteria o Receipt and Review Schedule o Required Federal Citations NOTICE: This program announcement (PA) 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 http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf) or http://grants.nih.gov/grants/funding/sbirsttr1/index.doc (MS Word] contains information about the SBIR and STTR programs, regulations governing the programs, and instructional information for submission. All of the instructions within the current SBIR/STTR Omnibus Solicitation apply with the following exceptions: o Additional grant submission instructions o Additional review considerations o Extended project period and amount of award PURPOSE OF THE PA The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs were initiated as a means for government agencies to use small businesses to stimulate technological innovation and to help agencies meet their research and development (R&D) needs. An additional provision of these programs is the expected commercialization of the research. Certain types of research require clinical evaluation and Federal regulatory approvals before the Phase III part of the small business research pathway can ever be realized. A recipient of a 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, biologic or diagnostic assay, the $1 million often represents a small fraction of the funds necessary to complete the studies required for approval and licensing by the Food and Drug Administration (FDA) or other Federal agencies and for clinical evaluation. While a recipient of an NIH SBIR/STTR Phase I and Phase II award normally receives less than three years of support, the process of moving promising new products from bench to bedside typically may take more than a decade. The drug discovery timeline, for example, starts with identification of an agent or class of agents with particular activities; 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 various aspects of the agent, including safety, toxicity, effectiveness, and dosage determination. Similarly, long timelines are required 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 products with potential to contribute significantly to the economy of the nation and to the health of her people. The intent of the competing continuation SBIR/STTR Phase II grants is to support such research and development and its translation into the clinic. The purpose of this Program Announcement (PA) is to solicit grant applications for the competing continuation of previously funded Phase II SBIR/STTR grants that propose to continue the process of developing products for commercialization that ultimately require: 1) approval of a Federal regulatory agency and 2) clinical evaluation up to "proof of principle" demonstration, generally only through a Phase II clinical trial. Such products include, but are not limited to: drugs, vaccines, radioligands, biomarkers, medical implants or devices, imaging protocols proposed for clinical use, new software for instrument performance, and diagnostic or predictive assays applicable for cancer diagnosis, prevention, and treatment. RESEARCH OBJECTIVES The small business community has been very active in the innovative development and production of a variety of commercializable biomedical research and technology products since the inception of the SBIR and STTR programs in 1982 and 1992, respectively. However, the progress made by the SBIR/STTR recipient businesses in translating their new discoveries and technologies into clinical benefit for the cancer patient may be hampered by the lengthy process and costs required before commercialization. As a way to alleviate some of these issues, this PA will provide competing continuation funds for up to 3 additional years to Phase II grantees that have developed promising anticancer agents or biologics, new diagnostic or treatment devices, or biological assays for diagnosis or treatment, etc. These funds will help businesses to complete the necessary preclinical research and development needed for Investigational New Drug (IND) or Investigational Device Exemption (IDE) filing and other processes needed to meet the requirements and expectations of Federal regulatory agencies prior to clinical evaluation for safety, toxicity, and effectiveness. The products may include, but are not limited to: drugs, vaccines, radioligands, medical implants, imaging protocols proposed for clinical use, instrumentation software, medical devices, etc. The competing continuation SBIR/STTR Phase II application should represent a continuation of support for research and development of the previous work funded by the original Phase II grant. It is expected that promising results from a previous SBIR/STTR Phase I and Phase II grant will indicate the merit and need for further research and development. Clinical investigations and Federal regulatory approvals will ultimately be required before the potential of the product being researched and developed can be translated into the clinic. Activities supported by a competing continuation of an SBIR/STTR Phase II grant may include an extension and expansion of preclinical research and development, clinical testing, and other scientific research and development activities needed to meet the requirements and expectations of Federal regulatory agencies. It is expected that some in vitro or in vivo studies will have been carried out in Phase I or the initial Phase II grants. A competing continuation Phase II award should not, however, be used to conduct early stage research (e.g., identifying targets for drugs, identification of new and more effective compounds or potential diagnostic markers, initial device/software development, initial assay testing, etc.). Listed below are examples of research that would be considered responsive to this program announcement. These are listed for illustrative purposes and are not exclusive of other appropriate activities. o Preclinical studies, including pharmacology and toxicology, and other clinical studies beyond those conducted under the NCI Phase I (R41, R43) and initial NCI Phase II (R42, R44) grants. o Completion of studies as required by the Food and Drug Administration (FDA) for Investigational New Drug (IND), Investigational Device Exemption (IDE), Premarketing Approval (PMA), or Radioactive Drug Research Committee (RDRC) applications. o Assessment of devices, including clinical laboratory assays and/or software with regard to performance standards related to the FDA approval process, including possible in vivo animal studies and clinical evaluation through Phase II trials only. o Safety and effectiveness studies of novel medical devices and/or software. o Biocompatibility studies of surface materials of putative medical implants. o Evaluation of imaging technologies for screening, diagnostic or therapeutic purposes. o Evaluation of novel genetic, proteomic, and epigenetic technologies for diagnostic or therapeutic purposes. o Clinical studies up through Phase II trials in normal and patient/disease populations in support of New Drug Application approval by the FDA. o Clinical studies in normal and patient/disease populations in support of Pre- Market Approval for medical devices, diagnostic assays and/or instrumentation software by the FDA. MECHANISM(S) OF SUPPORT This PA uses the SBIR and STTR mechanisms, which are set-aside programs. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. Future unsolicited, competing continuation applications based on this project will compete with all SBIR/STTR applications and will be reviewed according to the customary peer review procedures. This PA uses just-in-time concepts. Applicants must follow the instructions for non-modular budget research grant application format and instructions as described in the current SBIR/STTR Omnibus Solicitation. Cost-sharing arrangements are encouraged because SBIR/STTR programs cannot support all activities that may be required to advance a project to feasibility demonstration in a clinical trial. An NCI competing continuation SBIR/STTR Phase II application must be in response to this PA, and the application will only be accepted as a competing continuation of a previously funded NCI Phase II SBIR or STTR award or other NIH Phase II SBIR or STTR award that now has cancer relevance. The expectation is that, as a result of support from a previous SBIR/STTR Phase I (R43/R41) and Phase II (R44/R42) grant, promising results have 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 for translation into the clinic. The previously funded NIH Phase II grant need not have been submitted in response to any specific solicitation, but the application for the competing continuation must propose specific aims and development that represent a logical extension of the previously supported Phase II R44/R42 research that will be translated into the clinic. Activities supported by a competing continuation SBIR/STTR Phase II grant may include expansion of preclinical development, clinical testing, and other scientific activities that would ultimately be necessary in meeting the requirements and expectations of Federal regulatory approval processes. PROJECT PERIOD AND AMOUNT OF AWARD Because the length of time and cost of drug, device or assay/biomarker development represent a long- term research and development commitment, a maximum project period of up to three years and a budget not to exceed total costs of $750,000 per year (including direct costs, F & A and a fee/profit) will be considered under this PA if the time period and amount are well justified. However, for those Phase II applications that include support for expensive studies required for IND filing with the FDA and/or clinical trials up through only Phase II trials, applicants may request up to $1 million per year total costs if the time periods and amounts are well justified. ELIGIBLE INSTITUTIONS: Eligibility requirements are described in the SBIR/STTR Omnibus Solicitation. Only small business concerns are eligible to submit applications. A small business concern is one that, on the date of award for the Phase II agreement, meets ALL of the criteria as described in the SBIR/STTR Omnibus Solicitation. The competing continuation application must be a continuation of an on-going or a previously completed Phase II (R44) SBIR or Phase II STTR (R42) grant submitted by an SBIR/STTR-eligible small business concern that focuses on research and development of a product or products ultimately requiring Federal regulatory approval and clinical testing before licensing. To maintain eligibility to seek a competing continuation Phase II grant, a Phase II grantee organization should submit an application for the competing continuation Phase II grant within the first six receipt dates following the expiration of the initial Phase II award. Other eligibility requirements for a competing continuation Phase II grant are identical to those for the initial Phase II (R44/R42) applications and can be found at http://grants.nih.gov/grants/funding/sbirsttr2/PhaseII_SBIRSTTR.pdf (PDF) or http://grants.nih.gov/grants/funding/sbirsttr2/PhaseII_SBIRSTTR.doc (MS Word) INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed continuing research is invited to work with his/her 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. On an SBIR application, the Principal Investigator 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 by the small business concern or the participating non-profit research institution as long as s/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. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. It is highly recommended that prospective competing continuation applicants first contact their respective Phase II Program Director at the various NCI programs to discuss their eligibility and qualification before beginning the process of putting together a competing continuation Phase II application in response to this PA. Inquiries may fall into two areas: scientific/research, and financial or grants management issues: o Direct other questions about scientific/research issues to: Rosemary S. L. Wong, Ph.D. Radiotherapy Development Branch Division of Cancer Treatment and Diagnosis National Cancer Institute 6130 Executive Boulevard, EPN Room 6015A, MSC 7440 Bethesda, MD 20892-7440 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-9360 FAX: 301-480-5785 Email: rw26f@nih.gov o Direct your questions about financial or grants management matters to: Mr. Ted Williams Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, EPS Room 243 Bethesda, MD 20892-1750 Telephone: (301) 496-8785 FAX: (301) 496-8601 Email: williate@mail.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 PA 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 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: Rosemary S. L. Wong, Ph.D. Radiotherapy Development Branch Division of Cancer Treatment and Diagnosis National Cancer Institute 6130 Executive Boulevard, EPN Room 6015A, MSC 7440 Bethesda, MD 20892-7440 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-9360 FAX: 301-480-5785 Email: rw26f@nih.gov SUBMITTING AN APPLICATION The PHS 398 research grant application must be used for these competing continuation SBIR/STTR Phase II 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 accessing 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. Prepare your application in accordance with the SBIR/STTR Omnibus Solicitation and the PHS 398. Helpful information on the preparation of the application can be obtained at: http://grants.nih.gov/grants/funding/sbirgrantsmanship.pdf. The NIH will return applications that are not submitted using the 5/2001 version of the PHS 398 guidelines. For further assistance contact GrantsInfo, Telephone: (301) 710-0267, Email:GrantsInfo@nih.gov. The title and number of this PA must be typed on line 2 of the face page of the application. SUPPLEMENTARY INSTRUCTIONS: CONSULTANT AND CONTRACTUAL COSTS SBIR: 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. Competing continuation SBIR Phase II grant applications submitted under this PA may exceed this guideline, however, when well justified and when those costs are necessary to support required IND/IDE/PMA filing activities, clinical studies or trials, and related expenses not available at the awardee institution. 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). STTR: By law, for STTR Phase II applications, the small business MUST perform at least 40% of the research/R&D and the partnering research institution MUST perform at least 30% of the proposed research/R&D. The content of the Research Plan in response to Items a-d is limited to 25 pages. Part of the Specific Aims (Item a) of the Research Plan should include a Gantt chart or equivalent representation of the tasks including the stages at which interaction with the regulatory agencies will occur. In the Preliminary Studies section (Item c), include a Phase II Final Report that describes the accomplishments of the Phase II efforts that justify this request for competing continuation funds. Those applicants requesting funds for clinical evaluation must follow the instructions applicable for Human Subjects Research (Item e) as described in the SBIR/STTR Omnibus Solicitation. COMMERCIALIZATION PLAN All Phase II grant applications, including these competing continuation Phase II applications, require a "Commercialization Plan" as described in Item j of the SBIR/STTR Phase II instructions at http://grants.nih.gov/grants/funding/phs398/instructions2/p1_specific _instructions.htm#8_Appendix. The Commercialization Plan is meant in part to demonstrate the commercial viability of the product to be researched and developed with SBIR/STTR support. Since this competing continuation Phase II application mechanism supports a more advanced stage of research and development activities relative to the original R44/R42 Phase II mechanism, the Commercialization Plan should provide a timeline describing more advanced plans and arrangements for commercialization following the completion of the research, as well as Federal regulatory issues to be addressed with the competing continuation funds. Part of a Commercialization Plan could be a clear indication of an arrangement (e.g., strategic alliance, letter 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 Commercialization Plan will depend upon the particular circumstances represented in a given application. 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 (FOR USPS EXPRESS or REGULAR MAIL) Bethesda, MD 20817 (FOR EXPRESS/COURIER NON-USPS SERVICE) APPLICATION PROCESSING: Applications must be received by or mailed on or before the receipt dates described on the first page of this program announcement. The Center for Scientific Review (CSR) will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an unfunded version of an application already reviewed, but such application must include an Introduction addressing the previous critique. 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 Applications submitted for this PA that are complete will be assigned on the basis of established PHS referral guidelines. Appropriate scientific review groups 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 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 an appropriate national advisory council or board. 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 discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment ALL SBIR/STTR APPLICATIONS 1. 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? 2. 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? 3. Innovation: Does the project challenge existing paradigms or employ novel technologies, approaches or methodologies? Are the aims original and innovative? 4. 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? 5. 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? ADDITIONAL REVIEW CRITERIA: In addition to the above review criteria, the following items will be applied to ALL Type 2 Competing Continuation Phase II applications in the determination of scientific merit and the priority score: o Does the activity as proposed address issues related to Federal regulatory approval processes? o Did the applicant submit a concise Commercialization Plan that adequately addresses the specific areas described in Item j of the Phase II research plan? O Does the project carry a high degree of commercial potential as described in the Commercialization Plan? 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: 1. 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? 2. 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? 3. 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? 4. 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? 5. 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 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 http://grants.nih.gov/grants/policy/data_sharing) 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, and 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. AWARD CRITERIA Applications submitted in response to this PA will compete for available funds with all other submitted SBIR and STTR 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 RECEIPT AND REVIEW SCHEDULE See http://grants.nih.gov/grants/funding/sbirsttr_receipt_dates.htm 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 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: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). Clinical trials supported or performed by NCI require special considerations. The method and degree of monitoring should be commensurate with the degree of risk involved in participation and the size and complexity of the clinical trial. Monitoring exists on a continuum from monitoring by the principal investigator/project manager or NCI program staff or a Data and Safety Monitoring Board (DSMB). These monitoring activities are distinct from the requirement for study review and approval by an Institutional review Board (IRB). For details about the Policy for the NCI for Data and Safety Monitoring of Clinical trials see: http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm. For Phase I and II clinical trials, investigators must submit a general description of the data and safety monitoring plan as part of the research application. See NIH Guide Notice on Further Guidance on a Data and Safety Monitoring for Phase I and II Trials for additional information: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html. Information concerning essential elements of data safety monitoring plans for clinical trials funded by the NCI is available: http://www.cancer.gov/clinical_trials/ 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 (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. A continuing education program in the protection of human participants in research is available online at: http://cme.nci.nih.gov/ 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 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. 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 (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 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 at http://www.cfda.gov/ 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 http://grants.nih.gov/grants/policy/policy.htm 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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices



NIH Office of Extramural Research Logo
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®



Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.