and Human Services (HHS)
EXPIRED
SYSTEMS AND METHODS FOR SMALL ANIMAL IMAGING (SBIR/STTR) RELEASE DATE: November 18, 2002 PA NUMBER: PA-03-031 EXPIRATION DATE: November 1, 2005, unless reissued. National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov/) National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/) National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov) National Center for Research Resources (NCRR) (http://www.ncrr.nih.gov) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov) National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.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 The National Institute of Biomedical Imaging and Bioengineering (NIBIB), the National Heart, Lung, and Blood Institute (NHLBI), the National Institute of Environmental Health Sciences (NIEHS), the National Center for Research Resources (NCRR), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and the National Institute of Neurological Disorders and Stroke (NINDS) invite grant applications for Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) awards to support research and development of small animal imaging devices and methods that can be applied broadly to research on diverse biological or disease processes. A similar Request for Applications (RFA) for small animal imaging research and development to be supported by individual Research Project Grant (R01) awards can be found at (http://grants.nih.gov/grants/guide/rfa-files/RFA-EB-03-002.html). The primary focus of this Program Announcement (PA) is research and development related to devices, methods, and imaging agents for the investigation of biological and disease processes in small animals. The integration of systems and methods with complementary imaging and/or spectroscopy modalities is also included as appropriate to provide anatomic, physiologic, metabolic, and molecular-level information in small animal models of disease. The motivation for this PA is that recent discoveries in genomics and molecular and cell biology have led to the development and wide use of small animal models of human disease. One of the limitations with the use of these models is the need to sacrifice large numbers of animals for ex vivo tissue and molecular analysis. Imaging instrumentation and methods that permit imaging on the scale of small animals offer an opportunity to address this problem by enabling noninvasive investigations of biological processes in vivo. This capability provides the potential for longitudinal studies in the same animal. The coupling of animal models of human disease with advances in imaging technology presents an extraordinary opportunity for biomedical imaging to play an important role in the early detection, diagnosis, and treatment of disease. Several dedicated small animal imaging systems have been developed and a few commercialized, although technological hurdles still exist that limit the realization of the full potential of small animal imaging for biomedical research and drug development. Progress is needed to improve throughput, sensitivity, and spatial and temporal resolution of small animal imaging devices, to provide quantitative information through improved reconstruction methods that incorporate models of physical effects, and to provide improved methods for system validation. System optimization incorporating the design of molecular probes that serve as links to particular biological processes in vivo is also a focus. Further improvements in system design, image processing and analysis software, and data sharing technology, coupled with improvements and innovations in animal handling techniques during imaging, are needed to make small animal imaging technology more accessible to molecular biologists and pharmaceutical scientists desiring to use animal models as tools for biomedical research and drug discovery and development. RESEARCH OBJECTIVES The need to support the discovery and development of biomedical imaging methods has been identified at several NIH workshops and conferences on biomedical imaging, including a June 25-26, 1999 symposium entitled "Biomedical Imaging Symposium: Visualizing the Future of Biology and Medicine" which was coordinated by the NIH Bioengineering Consortium (BECON). Three scientific areas were addressed at the symposium: (1) imaging at the cellular- and molecular-levels such as required for the early detection of disease; (2) imaging for the clinical diagnosis, staging, and recurrence of disease; and (3) imaging applied to therapeutic applications and monitoring for various disease processes. Additionally, small animal models of human disease, in particular mouse models, have been identified as valuable resources for the investigation of the underlying mechanisms of human disease. Small animal imaging provides the means to address all three priority areas through the noninvasive monitoring of biological processes, disease progression, and response to therapy, with the potential to provide a natural bridge to the clinical environment and contribute substantially to the development of human medicine. This BECON symposium also emphasized the need to support fundamental discovery and technical development of imaging technologies before specific disease- or organ-oriented applications are determined. These challenges can be accomplished effectively by multi-disciplinary teams from academia, national laboratories, and industry, with expertise in the quantitative, computational, and biomedical sciences. In addition, the need for appropriate research support mechanisms and NIH study section reviews that emphasize technology development with less emphasis on organ- or disease-specific clinical applications were identified. Consistent with the recommendations of the BECON symposium and the mission of the NIBIB, the goals of this PA are directed at basic research and/or development of small animal imaging systems and methods. Research areas of interest include the improvement of existing devices and methods and the development of novel approaches to small animal imaging that enhance spatial or temporal resolution, measurement sensitivity, specificity, and throughput as required for the detection, diagnosis, or measurement of treatment efficacy for different disease processes. The scope of the PA includes the integration of molecular imaging systems and methods with anatomical or other functional imaging and/or spectroscopy methods to provide more effective tools for biomedical research. The development of imaging or spectroscopy systems that have the flexibility to accommodate a variety of protocols for investigations of different diseases, and the development of platform- independent imaging methods for multi-center research is also a focus. The following research areas are examples of appropriate topics for applications in response to this PA. This list is meant to be representative and not all-inclusive: o Development of small animal imaging systems that extend the capabilities of existing devices through improved spatial and temporal resolution, sensitivity, and throughput for screening applications. This research scope includes improvements to dedicated small animal imaging devices and adaptation of existing clinical devices, in addition to high-risk, high- gain research objectives such as new in vivo imaging and/or spectroscopy paradigms. Development of multi-modality imaging approaches that increase the range of information provided for enhanced image interpretation and improved quantification of biological processes in vivo are also within the scope of this PA. Mathematical modeling of such systems and their performance is included as required for system optimization. o Development of improved methods for image reconstruction and processing, and the development of analytical tools for image analysis. An emphasis of the PA is on technological advances that might enhance the capabilities of existing devices and increase the availability of small animal imaging devices and methods for biological research, drug discovery and development, and screening of toxic chemicals for disease processes. o Development of complementary devices and methods for improved animal handling including motion compensation and correction, imaging agent administration, blood sampling, anesthesia delivery, and animal maintenance and monitoring during imaging. Implantable sensor devices that take advantage of microelectromechanical (MEMS) and nanoelectromechanical (NEMS) systems, and techniques or devices that are designed for immobilization of the head for functional neuroimaging in awake animals, are also included. o In vivo investigations of imaging agents and high-affinity molecular probes for the imaging of biological processes in small animals, including improved methods for probe delivery and targeting. These studies may include the development of molecular probes for gene expression, cell tracking, enzyme action or other metabolic processes, or blood flow or drug distribution and action, with the potential to impact the study of several disease processes. Single or multiple imaging agents or multifunctional probes suitable for multi-modality imaging and/or spectroscopy are included. System optimization for imaging agents and molecular probes can be addressed where appropriate. Studies involving in vitro characterization of imaging agents and probes, and/or in vivo testing in human subjects, are not within the scope of this PA. o Within each of the areas highlighted above, applications specific to studies of the cardiovascular, pulmonary, and blood systems and to the treatment and diagnosis of heart, lung and blood diseases will be directed to the National Heart, Lung and Blood Institute. o Within each of the areas highlighted above, applications specific to studies of the effects of toxic environmental exposures on organ systems, especially the nervous system, will be directed to the National Institute of Environmental Health Sciences. o Within each of the areas highlighted above, applications specific to the studies of the nervous system and to the treatment and diagnosis of neurological diseases will be directed to the National Institute of Neurological Disorders and Stroke. MECHANISM(S) OF SUPPORT This PA will use the NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. Applications can be submitted for support as Phase I STTR (R41) or Phase I SBIR (R43) grants; Phase II STTR (R42) or Phase II SBIR (R44) grants; or under the SBIR/STTR FAST-TRACK option as described in the SBIR/STTR Omnibus Solicitation. Phase II applications in response to this PA will only be accepted as competing continuations of previously funded NIH Phase I SBIR/STTR awards. The Phase II proposal must be a logical extension of the Phase I research. The SBIR/STTR Omnibus Solicitation and information on the FAST-TRACK process are available at http://grants.nih.gov/grants/funding/sbir.htm. ELIGIBILITY REQUIREMENTS Eligibility requirements are described in the SBIR/STTR Omnibus Solicitation. 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 following criteria: o is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor; o is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture (as defined in this section) there can be no more than 49 percent participation by foreign business entities in the joint venture; o is at least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States; has, including its affiliates, not more than 500 employees, and meets the other regulatory requirements found in 13 CFR Part 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both. Control can be exercised through common ownership, common management, and contractual relationships. The term "affiliates" is defined in greater detail in 13 CFR 121.3-2(a). The term "number of employees" is defined in 13 CFR 121.3-2(t). Business concerns include, but are not limited to, any individual (sole proprietorship), partnership, corporation, joint venture, association, or cooperative. Further information may be obtained by contacting the Small Business Administration Size District Office at http://www.sba.gov/size/. 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. On an SBIR, routinely the principal investigator must have his/her primary employment with the small business at the time of award and for the duration of the project. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research and financial or grants management issues: o Direct questions regarding programmatic issues to: Brenda J. Korte, Ph.D. Program Director Division of Biomedical Imaging National Institute of Biomedical Imaging and Bioengineering NIH/DHHS 6707 Democracy Blvd. Suite 200 Bethesda, MD 20892-5469 Telephone: 301-451-4772 Fax: 301-480-4973 Email: kortebr@mail.nih.gov Denis B. Buxton, Ph.D. Division of Heart and Vascular Diseases National Heart, Lung and Blood Institute NIH/DHHS 2 Rockledge Center, Suite 9044 6701 Rockledge Drive Bethesda, MD 20892-7940 Telephone: 301-435-0516 Fax: 301-480-1335 Email: db225a@nih.gov Jerrold Heindel, Ph.D. Health Science Administrator Organs and Systems Toxicology Branch Division of Extramural Research and Training National Institute of Environmental Health Sciences NIH/DHHS P.O. Box 12233 MD EC-23 Research Triangle Park, NC 27709 Telephone: 919-541-0781 Fax: 919-541-5064 Email: heindelj@niehs.nih.gov Amy Swain, Ph.D. Program Director Division of Biomedical Technology National Center for Research Resources NIH/DHHS Rockledge 1, Room 6154 6705 Rockledge Drive Bethesda, MD 20892 Telephone: 301-435-0755 Fax: 301-480-3659 Email: as387d@nih.gov Leroy M. Nyberg, Ph.D., M.D. Urology Program Director Division of Kidney, Urologic and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Two Democracy Plaza, Room 617 6707 Democracy Boulevard Bethesda, MD 20892-5458 Telephone: 301-594-7717 Fax: 301-480-3510 Email: ln10f@nih.gov Daofen Chen, Ph.D. Program Director, Channels/Synapses/Circuits National Institute of Neurological Disorders and Stroke, NIH/DHHS Neuroscience Center, Room 2131 6001 Executive Boulevard Bethesda, MD 20892-9523 Rockville, MD 20852 (courier service only) Phone: (301) 496-1917 FAX: (301) 402-1501 Email: daofen_chen@nih.gov The National Institute of Mental Health, while not a sponsor of this program announcement, supports research and development similar to that solicited here, with particular interest in such projects relevant to brain research. Dr. Michael Huerta (mhuerta@helix.nih.gov, 301-443-3563) is an appropriate contact at NIMH for such research interests. o Direct questions regarding financial or grants management matters to: Ms. Lisa Moeller Grants Management Specialist National Institute of Biomedical Imaging and Bioengineering NIH/DHHS 6707 Democracy Blvd., Suite 900 Bethesda, MD 20892-5469 Telephone: 301-451-4782 Fax: 301-480-4974 Email: moellerl@mail.nih.gov Ms. Carol Lander Grants Management Specialist Division of Extramural Affairs National Heart, Lung and Blood Institute NIH/DHHS Rockledge Building 2 6701 Rockledge Drive Bethesda MD 20892-7926 Federal Express Zip: 20817 Telephone: 301-435-0150 Fax: 301-480-3310 Email: landerc@nhlbi.nih.gov Ms. Carolyn Winters Grants Management Specialist Division of Extramural Research and Training National Institute of Environmental Health Sciences NIH/DHHS P.O. Box 12233 Research Triangle Park, NC 17709 Telephone: 919-541-7823 Fax: 919-541-2860 Email: winters@niehs.nih.gov Ms. Kimberly Pendleton Office of Grants Management National Center for Research Resources NIH/DHHS Rockledge I, Rm 6216 6705 Rockledge Dr. MSC 7965 Bethesda, MD 20892-7965 Telephone: 301-435-0844 Email: PendletonK@ncrr.nih.gov Ms. Helen Ling Senior Grants Management Specialist Grants Management Branch, DEA National Institutes of Diabetes and Digestive and Kidney Diseases NIH/DHHS 6707 Democracy Blvd., Room 732 MSC 5456 Bethesda, MD 20892-5456 (For Express Mail Use Zip Code 20817) Telephone: (301) 594-8857 FAX: (301) 480-3504 Email: LingH@extra.niddk.nih.gov Ms. Aricia Cottman Grants Specialist National Institute of Neurological Disorders and Stroke NIH/DHHS 6001 Executive Boulevard, Room 3290, MSC 9537 Bethesda, MD 20892-9537 Telephone: (301) 496-8072 FAX: (301) 402-0219 Email: ac195q@nih.gov SUBMITTING AN APPLICATION You may submit your application as a Phase I or Phase II application or as a Fast Track pair of Phase I and Phase II applications. See "Specific Instructions" below. The PHS 398 research grant application (rev. 5/2001) must be used. Instructions and forms are available at http://grants.nih.gov/grants/funding/phs398/phs398.html. PHS 398 forms specific to SBIR applications are available at http://grants.nih.gov/grants/funding/phs398/398_SBIRSTTRforms.doc. Refer to Chapter VI of the PHS 398 for specific instructions for SBIR and STTR applications. This version of PHS 398 is available in an interactive, searchable PDF and HTML format. The NIH will return applications that are not submitted on the 5/2001 version. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email:GrantsInfo@nih.gov. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted on the standard SBIR/STTR application deadlines (April 1, August 1, December 1). SPECIFIC INSTRUCTIONS FOR PHASE I APPLICATIONS: Application forms, requirements, and procedures are the same as listed in the Omnibus Solicitation for Phase I SBIR/STTR Grant applications (http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf), except for the following: o Type the title and number of this PA on line 2 on the face page of the application. o The Omnibus Solicitation states levels for Phase I and Phase II budgets that are guidelines, not ceilings. For this PA, we will consider larger budgets for longer periods of time, if they are well justified and necessary to complete the proposed research and development. SBIR applications requesting up to $100,000 per year in total costs direct costs, indirect costs and fee) must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Section VI of the research grant application instructions for the PHS 398 at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on SBIR modular grants is available at http://grants.nih.gov/grants/funding/phs398/instructions2/p1_SBIRSTTR _general_instructions.htm. Applications for over $100,000 total costs must include a detailed budget and budget justification (Form Pages 4 and 5). SPECIFIC INSTRUCTIONS FOR Phase II Applications: We will only accept Phase II applications as competing continuations of previously funded NIH Phase I SBIR or STTR awards. The Phase II application must be for developmental work that is a logical extension of the feasibility research conducted during Phase I. When preparing an application for a Phase II award, you should follow the instructions for NIH Phase II SBIR or STTR applications. The instructions and forms for a Phase II SBIR and STTR award are available at http://grants.nih.gov/grants/funding/phs398/phs398.html. SPECIFIC INSTRUCTIONS FOR Fast Track Applications: The NIH Fast-Track mechanism expedites the decision and award of SBIR and STTR Phase II funding for scientifically meritorious applications that have a high potential for commercialization. Fast Track incorporates a submission and review process, in which complete Phase I and Phase II grant applications are submitted simultaneously and reviewed together. The FAST-TRACK must have a section labeled Milestones at the end of the Phase I Research Plan. This section must include well-defined quantifiable milestones for completion of Phase I, a discussion of the suitability of the proposed milestones for assessing the success in Phase I, and a discussion of the implications of successful completion of these milestones on the proposed Phase II. Failure to provide such information in the Phase I application and/or sufficient detail in the Phase II application may be sufficient reason for the peer review committee to exclude the Phase II from consideration. If so, the applicant may apply later for Phase II support. Such applications will be reviewed by an appropriate scientific review group convened by the NIH. In addition, the Phase II portion of a Fast Track application must include a concise Product Development Plan (limited to ten pages). Label this section clearly and include it in Section J of the Phase II Research Plan. More detailed instructions on the preparation of a Fast Track application are described in the PHS 398 at http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf#page=21. 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 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 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 your 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 Milestones and Proof of Principle o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Does your study address an important problem? Does the proposed project have commercial potential to lead to a marketable product or process? What may be the anticipated commercial and societal benefits of the proposed activity? If the aims of your application are achieved, how do they advance scientific knowledge? Does the proposal lead to technologies (e.g., instrumentation, software) that will enable further discoveries? Will the technology have a competitive advantage over existing/alternate technologies that can meet market needs? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? What is the time frame for developing the proposed technologies, and is this time frame suitable for meeting the community's needs? How easy will it be to use the proposed technology? Are your plans adequate for the proposed technology, its integration as an effective solution for implementation, and dissemination? If you are proposing industrial partnerships, how will they facilitate the development and integration of system components? (3) MILESTONES (for Phase I R41 or R43 or Fast Track applications) AND PROOF OF PRINCIPLE (for Phase II applications): If you are submitting a Phase I application, how appropriate are your proposed milestones for evaluating demonstration of feasibility for transition to the R42 or R44 Phase II development work? Do the milestones provide an objective target for evaluating results? If you are submitting a Phase II application, how well has the feasibility or proof of principle been demonstrated? (4) INNOVATION: Does your project employ novel concepts, approaches, or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? What is the throughput and cost-effectiveness of your proposed technology? What additional uses can be projected for your proposed technology? (5) INVESTIGATOR: Are you appropriately trained and well suited to direct this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (6) ENVIRONMENT: Is there sufficient access to resources (e.g., equipment, facilities)? Does the technical and scientific environment in which your work will be done contribute to the probability of success? Does the proposed work take advantage of unique features of the technical and scientific environment or employ useful collaborative arrangements? In accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of the proposed protection for humans, animals or the environment to the extent they may be adversely affected by the project proposed in the application. o The appropriateness of the proposed budget and duration in relation to the proposed research. The following evaluation criterion will be presented in an administrative note in the Summary Statement and will not factor into the numerical score: o The adequacy of plans to make the methods and materials generated in the project widely available in a timely fashion to the scientific community, given the proposed plan to exercise (or not to exercise) intellectual property rights. AWARD CRITERIA Applications will compete for available funds with all other recommended SBIR and STTR applications. Funding decisions for Phase I or Phase II applications will be based on quality of the proposed project as determined by peer review, availability of funds, and relevance to program priorities. Phase II applications will be selected for funding based on the initial priority score, assessment of the Phase I progress and determination that Phase I goals were achieved, the project's potential for commercial success, and the availability of funds. FAST-TRACK Phase II applications may be funded following submission of the Phase I progress report and other documents necessary for continuation. REQUIRED FEDERAL CITATIONS 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. 93.286 & 93.287 (NIBIB), 93.849 (NIDDK), 93.113 (NIEHS), 93.837, 93.838, & 93.839 (NHLBI), 93.853 (NINDS), and 93.371 (NCRR) 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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