TECHNOLOGY DEVELOPMENT FOR BIOMEDICAL APPLICATIONS RELEASE DATE: February 27, 2003 PA NUMBER: PAR-03-075 (see replacement RFA-RR-04-005) EXPIRATION DATE: November 1, 2003 APPLICATION RECEIPT DATES: June 1, and October 1 National Center for Research Resources (NCRR) (http://www.ncrr.nih.gov) National Human Genome Research Institute (NHGRI) (http://www.nhgri.nih.gov) National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov) National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): This program is described in the Catalog of Federal Domestic Assistance in the following citations: No. 93.389 (NCRR), 93.172 (NHGRI), 93.113 (NIEHS), 93.114 (NIEHS), 93.115 (NIEHS), 93.286 (NIBIB) and 93.287 (NIBIB). 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 Special Requirements o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA This PA replaces PAR-02-091. The purpose of this program announcement (PA) is to invite innovative applications for (1) the development of new and improved instruments or devices, (2) the development of new methodologies using existing instruments, or (3) the development of software related to instrumentation. Any of these projects should propose tools, methodologies, or software that can be used by a wide range of biomedical or clinical researchers; projects that focus on specific organs or diseases are not responsive to this announcement. Awards made for applications received in response to this announcement will employ the R21 and the R21/R33 mechanisms that are designed to support high-risk applications for which few if any preliminary findings are available. Investigators with substantial preliminary data should seek an R01 grant by submitting an unsolicited application at the standard receipt date or by responding to a particular program announcement. Questions about the suitability of proposals should be addressed to program staff listed in the "Where to Send Inquiries" section well before submission. Proposals that are focused on a specific organ or disease will be returned without review; however, proposals may use a specific organ or disease as a model system. Investigators may also want to look at the NIBIB (http://www.nibib1.nih.gov/research/investigators.htm) and BECON (http://www.becon.nih.gov/becon_funding.htm) web pages for funding opportunities in bioengineering research or biomedical imaging research. The proposed research may involve conceptualization, design, fabrication, and/or testing of new instruments or devices. Applications to develop new experimental techniques and protocols using existing instrumentation are also welcome. Applications to develop new software related to instrumentation are encouraged, with the exception of proposals with a primary focus in the area of medical informatics. The overall objective of applications for new instruments, techniques, or software should be the development of more powerful and more precise technology with broad applicability to biomedical research. RESEARCH OBJECTIVES The primary intent of this PA is to stimulate the development of new techniques for biomedical research that will allow scientists to achieve the biomedical breakthroughs of tomorrow. High-risk applications are encouraged, and the innovative nature of the application will be part of the review criteria. For some high-risk applications, it may be appropriate to use the R21 mechanism alone to generate preliminary data. The NCRR is interested in supporting new tools and techniques in areas such as optical spectroscopy, mass spectrometry, electrophoresis and other separation techniques, microscopy, lasers and optics, x-ray techniques, nuclear magnetic resonance spectroscopy, bioreactors and other forms of cell culture, centrifugation, and microarrays. The NHGRI is interested in supporting technological advances in the following areas of research: (1) genomic sequencing; (2) human sequence variation (e.g., genotyping); (3) functional genomics; (4) comparative genomics; and (5) bioinformatics and computational biology directly related to instrumentation for 1-4, above. Applicants developing a proposal in the areas of bioinformatics and computational biology may want to consider applying to the BISTI program, http://www.bisti.nih.gov/. The highest priority is for technologies that will support comprehensive analyses of entire genomes or their products in cells and tissues. The NIBIB is especially interested in proposals in the areas of biomedical engineering, biomedical imaging, and technologies for the study of structure and function of biological systems at all levels of complexity. Specific areas of research include: surgical tool and technique development; imaging device development; image-guided therapies and interventions; image computation, displays, perception, and screening; imaging informatics; imaging technology assessment; medical devices and implant science; biosensor technology, algorithms, and telemetry development and biosensor technology assessment; remote diagnosis and therapy; computer-assisted surgery; and telemedicine. This program announcement is similar in spirit to the "Instrument Development for Biological Research" program in the Directorate for Biological Sciences at the National Science Foundation (http://www.nsf.gov/cgi-bin/ getpub?nsf98119). The major difference between the two programs is that instrumentation for the conduct of disease-oriented research is specifically excluded from the NSF program, although some instrument development proposals could be considered either under this program announcement or by NSF. Applicants are encouraged to contact program staff at either NSF or NIH to discuss which program is more appropriate. MECHANISM(S) OF SUPPORT This PA will use the NIH R21 and R21/R33 award mechanism(s). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. Specific features of this mechanism include: o Single submission and evaluation of both a feasibility/pilot phase (R21) and an expanded development phase (R33) as one application. o Expedited transition of the R21 feasibility phase to a R33 development phase for combined applications. o Flexible budgets. o Flexible staging of feasibility and development phases. Applications under this program announcement will use either the combined R21/R33 mechanism or the R21 mechanism alone. Applications using just the R33 mechanism will not be considered. An application using the R21 mechanism alone is appropriate when the possible outcomes of the proposed research are unclear; under these conditions, it would not be possible to propose quantitative milestones or describe the R33 phase of the research. Applicants are strongly encouraged to contact program staff with any questions about the appropriate mechanism. Refer to the "Where to send Inquiries" section of this program announcement for program staff contacts. This PA uses just-in-time concepts. It also uses only the non-modular budgeting format. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign 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. SPECIAL REQUIREMENTS Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The applicant can choose to submit an independent R21 application, or a combined R21/R33 application. The advantage of the combined R21/R33 mechanism is that it offers a seamless transition between the exploratory phase and the development phase of a project. Transition from the R21 to the R33 is dependent on completion of negotiated milestones. Once these milestones have been achieved, the investigator will submit a progress report to the program. Upon determination that the milestones have been accomplished, the R33 phase can begin. 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, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Gregory K. Farber, Ph.D. Division of Biomedical Technology National Center for Research Resources 6701 Democracy Boulevard, MSC 4874 Bethesda, MD 20892-4874 TEL: (301) 435-0755 FAX: (301) 480-3659 Email: gf48a@nih.gov o Direct your questions about peer review issues to: Bo Hong, Ph.D. Office of Review National Center for Research Resources 6701 Democracy Boulevard, MSC 4874 Bethesda, MD 20892-4874 TEL: (301) 435-0813 FAX: (301) 480-3660 Email: mv10f@nih.gov o Direct your questions about financial or grants management matters to: Mary Niemiec Team Leader Office of Grants Management National Center for Research Resources 6701 Democracy Boulevard, MSC 4874 Bethesda, MD 20892-4874 TEL: (301) 435-0842 FAX: (301) 480-3777 Email: mn20z@nih.gov If you are unsure whom to contact, direct your questions to Dr. Farber. SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted on June 1 and October 1 annually. Both new applications and revisions to previously reviewed applications are due on the same date. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SPECIFIC INSTRUCTIONS FOR THE APPENDIX The only items that may be included in the appendix are original glossy photographs or color images of gels, micrographs, etc., provided that a black and white photocopy of the same size is included within the research plan. SPECIFIC INSTRUCTIONS FOR PREPARING A COMBINED R21/R33 PHASED INNOVATION AWARD APPLICATION The combined R21/R33 application must include the specific aims for each phase and the feasibility milestones that would justify transition to the R33 phase. Applications must include a specific section labeled Milestones following the Research Plan of the R21 phase. Milestones should be well described, quantifiable and scientifically justified. A discussion of the milestones relative to the progress of the R21 phase, as well as, the implications of successful completion of the milestones for the R33 phase should be included. The milestone section should be indicated in the Table of Contents. Applications lacking this information, as determined by the NIH program staff, will be returned to the applicant without review. Prior to funding an application, the Program Director will contact the applicant to discuss the proposed milestones and any changes suggested by the review panel as indicated in the Summary Statement. The Program Director and the applicant will negotiate and agree on a final set of milestones. These will be the basis for judging the success of the R21 work. For funded applications, the PI will submit a progress report to the program upon completion of the R21 milestones. Receipt of this progress report will trigger a review that will determine whether or not the R33 should be awarded. The release of R33 funds will be based on successful completion of negotiated scientific milestones, program priorities, and on the availability of funds. The R21/R33 Phased Innovation Award application must be submitted as a single application with one face page. Although it is submitted as a single application, it should be clearly organized into two phases. To accomplish a clear distinction between the two phases, applicants should submit Sections a-d (Specific Aims, Background and Significance, Preliminary Studies, Research Design) for the R21 phase, then the milestones, and then sections a and d (Specific Aims, Research Design) for the R33 phase. The Form 398 Table of Contents should be modified to show the sections for each phase as well as the milestones. There is a page limit of 25 pages for the composite research plan. Section a-d of the R21 research plan must not be longer than 15 pages. The milestones, and the a and d sections for the R33 application can take, at most, an additional 10 pages. The clarity and completeness of the R21/R33 application with regard to specific goals and feasibility milestones is critical. The presentation of milestones that are not sufficiently scientifically rigorous to be valid for assessing progress in the R21 phase will reflect upon the scientific judgment of the applicant. 1. Face Page of the application: Item 2. Check the box marked "YES" and type the number and title of this program announcement. Also indicate that the application is R21/R33 in the title. Items 7 and 8: Costs Requested For the R21 phase of the application, direct costs are limited to a maximum of $125,000 per year for no more than three years. R21 budgets can only exceed this cap to accommodate F&A costs of subcontracts to the project. The combined R21/R33 application is limited to five years in duration, and the R33 phase may not exceed three years in duration. 2. Page 2 - Description: As part of the description, identify concisely the fundamental research and/or technology or tool to be developed, its innovative nature, its relationship to presently available capabilities, and its expected impact on biomedical research. 3. Budget: The application should provide a detailed budget for Initial Budget Period (form page 4) for the first year of the R21 phase and a second detailed budget (form page 4) for the first year of the R33 phase. Form page 5 should be used to provide a budget for the entire proposed period of support. Form pages should indicate which years are R21 and which are R33. All budgets should include a written justification. The modular budget format should not be used. 4. Research Plan: Item a: Specific Aims Specific aims must be presented which the applicant considers to be scientifically appropriate for the relevant phases of the project. Research that develops new technologies or tools is likely to require application of principles from fields such as analytical chemistry, mathematics, physics, and engineering. Clear statements of the underlying principles should be made within this section. Item b: Background and Significance Elaborate on the innovative nature of the proposed research. Clarify how the fundamental tools or technologies to be developed will result in a significant improvement over existing approaches. Explain the potential of the proposed technology for having an impact on a compelling area of biomedical research. Clearly identify how the project, if successful, will result in new capabilities for biomedical research, the immediacy of the opportunity, and how any proposed technologies or tools differ from existing technologies or tools. This item should not be included in the R33 portion of the application. Item c: Preliminary Studies/Progress Report While preliminary data are not required for submission of the R21 phase, this section should provide current thinking or evidence in the field to substantiate feasibility of the R21 phase. If the applicant does have preliminary data, it should be presented in this section. This item should not be included in the R33 portion of the application. Item d: Research Design and Methods Follow the instructions in the PHS 398 booklet. Applicants should also address plans to make the products, tools, or technologies forthcoming from this research available to the relevant biomedical research user community. 5. Milestones: For combined R21/R33 applications, a specific section labeled Milestones must be included following the Research Design and Methods of the R21 phase. Milestones should be well described, quantifiable, and scientifically justified. Applicants should write the milestones assuming that a scientifically literate non-expert will use them to evaluate the progress that has been achieved. Milestones should not be simply a restatement of the specific aims or a timeline. The milestones section should be indicated in the Table of Contents. Applications lacking this information will be returned to the applicant without review. For funded proposals, peer review is not likely between the two phases of the project. When the R21 milestones have been achieved, the PI must submit a progress report to the program. Receipt of this progress report will elicit a review that will determine whether or not the R33 should be awarded. The release of R33 funds will be based on successful completion of milestones, program priorities, and on the availability of funds. SPECIFIC INSTRUCTIONS FOR PREPARATION OF THE R21 APPLICATION WHEN SUBMITTED WITHOUT THE R33 PHASE 1. Face Page of the application: Item 2. Check the box marked "YES" and type the number and title of this program announcement and indicate R21 in the title. Item 7a: DIRECT COSTS REQUESTED FOR INITIAL PERIOD OF SUPPORT For the R21 application, direct costs are limited to a maximum of $125,000 per year for a maximum of three years. R21 budgets can only exceed this cap to accommodate F&A costs of subcontracts to the project. 2. Page 2 - Description: As part of the description, identify concisely the fundamental research and/or technology or tool to be developed, its innovative nature, its relationship to presently available capabilities, and its expected impact on biomedical research. 3. Budget: The application should provide a detailed budget for Initial Budget Period (form page 4), as well as a budget for the entire proposed period of support (form page 5). All budgets should include a written justification. The modular budget format is not to be used. 4. Research Plan: The research plan for an R21 application is limited to 15 pages. Item a: Specific Aims Specific aims that the applicant considers to be scientifically appropriate for the relevant phases of the project must be presented. Research that develops new technologies or tools is likely to require the application of principles from fields such as analytical chemistry, mathematics, physics, and engineering. Clear statements of the underlying principles should be made within this section. Item b: Background and Significance Elaborate on the innovative nature of the proposed research. Clarify how the fundamental tools or technologies to be developed in this project will result in a significant improvement over existing approaches. Explain the potential of the proposed technology for having an impact on a compelling area of biomedical research. Clearly identify how the project, if successful, would result in new capabilities for biomedical research, the immediacy of the opportunity, and how any proposed technologies or tools would differ from existing technologies or tools. Item c: Preliminary Studies/Progress Report While preliminary data are not required for submission of the R21 phase, this section should provide current thinking or evidence in the field to substantiate feasibility of the R21 phase. If the applicant does have preliminary data, it should be presented in this section. Item d: Research Design and Methods Follow the instructions in the PHS 398 booklet. 5. Milestones: Applications using the R21 mechanism without the R33 phase should not have milestones. 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 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application, and five copies of the Appendix, are to be sent to: Office of Review National Center For Research Resources 6701 Democracy Boulevard, MSC 4874 Bethesda, MD 20892-4874 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be received by June 1 or October 1 annually. Both new applications and resubmissions of previously reviewed proposals are due on those dates. 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. Instructions for preparing a revised application can be found at https://grants.nih.gov/grants/funding/phs398/instructions2/p1_specific _instructions.htm#7_Research_Plan. 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 will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a second level review by the appropriate national advisory council or board. REVIEW CRITERIA 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 The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application. The 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. SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? ENVIRONMENT: Does the scientific 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? Is there evidence of institutional support? 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: 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 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 will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL CONSIDERATIONS DATA SHARING: The adequacy of the proposed plan to share data. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. OTHER REVIEW CRITERIA: o How appropriate are the proposed milestones for judging the success of the proposed R21 work? o How appropriate are the proposed milestones in determining whether the R33 phase should be awarded? o Are the milestones quantitative? o To what degree does the research or development of technologies or tools support the needs of the targeted biomedical research community? o What is the time frame for developing the proposed approaches, tools, or technologies? Is this time frame suitable for meeting the relevant biomedical research community's needs? o Are the plans for dissemination of the proposed endpoints, tools or technologies of the project adequate? AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS 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. MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: https://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "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 (https://grants.nih.gov/grants/guide/notice-files/ NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at https://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 https://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 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at https://grants.nih.gov/grants/stem_cells.htm and at https://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 https://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 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 https://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.

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