PAR-04-018: NATIONAL CENTERS FOR NEUROFIBROMATOSIS RESEARCH

Department of Health
and Human Services (HHS)

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NATIONAL CENTERS FOR NEUROFIBROMATOSIS RESEARCH RELEASE DATE: November 5, 2003 PA NUMBER: PAR-04-018 EXPIRATION DATE: February 1, 2007, unless reissued Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENTS OF PARTICIPATING ORGANIZATION: National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov) National Institute of Deafness and Other Communication Disorders (NIDCD) (http://www.nidcd.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.853 (NINDS), 93.173 (NIDCD) THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of this 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 The National Institute of Neurological Disorders and Stroke (NINDS) and the National Institute of Deafness and Other Communication Disorders (NIDCD) invite qualified investigators to submit grant applications for the establishment of National Centers for Neurofibromatosis Research. Recent discoveries have created important opportunities for basic, translational, and clinical research on the neurofibromatoses. The purpose of this Program Announcement (PA) is to encourage the formation and development of research centers that can capitalize on these opportunities, and ultimately develop therapeutic interventions for neurofibromatosis patients. These centers are intended to provide focused expertise and resources, and establish a multi-disciplinary environment that will accelerate research progress. RESEARCH OBJECTIVES Background The neurofibromatoses (NF) are autosomal dominant genetic disorders that cause tumors to grow along peripheral nerves. NF also often affects the development of other tissues (including bones, skin, heart, blood, and brain) and causes learning disabilities in approximately one-third of patients. There are three distinct forms of NF - NF1, NF2, and the recently identified subtype schwannomatosis. Patients with these disorders experience a wide range of symptoms, which range from mild to devastating. Over a decade ago, investigators identified the genes that cause NF1 and NF2 (neurofibromin and merlin/schwannomin respectively) and began to characterize their protein products. NF has served as an important paradigm for understanding how mutations in single genes can affect the development of multiple tissues. A great deal of information is now available regarding the functions of the NF1 and NF2 gene products, as well as about the signaling pathways in which they participate. These advances in basic research are providing hope that rational therapeutics will be developed to block the aberrant cell proliferation and other abnormalities associated with these diseases. In addition, sophisticated cell and animal models now exist that can be used to test candidate therapeutics. The goal of NF research is the development of more effective therapies for patients with these disorders. Current treatment modalities, such as surgery and radiation, are at best designed to ameliorate specific symptoms. Developing more effective pharmaceutical or biological interventions will require further basic research, pre-clinical therapy development, and clinical studies and trials. Much of this research will require centralized resources and interdisciplinary collaborations. For example, testing candidate therapeutics can be done more efficiently in an environment where the appropriate cell and animal models are assembled, and screening technologies are optimized. Centralized tissue repositories, clinical databases, and other resources will greatly facilitate genetic and epidemiological studies. Effective clinical trials require both infrastructure and sufficient numbers of well- characterized patients. Interaction between basic scientists and clinicians will also be critical for translating research discoveries into interventions that can be tested in the clinic. Scope NF centers are intended to provide an interdisciplinary, interactive environment that will accelerate research progress and permit studies that could not be done as effectively in individual laboratories. Proposals should include a minimum of three research projects, which can be basic, translational, or clinical in focus. However, at least one project in each center application should focus specifically on preclinical therapy development or clinical research, and all centers should be designed to enhance progress towards the goal of treating NF. Projects should be designed to take advantage of the interactive, centralized facilities provided by the proposed center. In addition, a strong case must be made that the individual projects are synergistic in nature. Finally, every center should include at least one project focusing on NF1, the most common of the three forms of NF. Proposed research projects should relate directly to the etiology, pathogenesis or treatment of NF. Examples of possible projects include: o Molecular and cell biological studies of NF1, NF2, or schwannomatosis that will be accelerated by the centralized availability of research and clinical expertise, patient DNAs and tissues, or other resources. o Investigation of the pathogenesis of neurofibromas, gliomas, malignant peripheral nerve sheath tumors, skeletal and cardiovascular abnormalities, learning disabilities, and other manifestations of NF. o High-throughput preclinical screening of candidate NF therapeutics. o Development of improved cell and animal models for preclinical screening. o Genotype-phenotype studies of NF patients. o Identification of NF modifier genes and analysis of their effects on patient phenotype. o Natural History studies, particularly those that will guide therapeutic interventions or establish a baseline for future clinical trials. o Phase I or II Clinical Trials of potential therapeutic interventions for NF. o Development of improved and standardized methods for assessing outcome in NF clinical trials and clinical research (e.g. measurement tools for tumors, NF-specific microarrays, cognitive measures). In addition to describing the proposed research projects, applicants must explain how establishing a research center will either accelerate research progress or permit research that would be difficult or impossible in an individual laboratory. Such justification could, for example, include how a center will permit: o Centralization of resources (e.g. tissues, DNAs, genotypic or phenotypic information derived from patients) required for the proposed research projects. o More efficient preclinical testing of potential therapeutics. o Pooling of patient populations, without which a specific clinical study or trial could not be achieved. o Interaction between basic researchers and clinicians. o Training of potential NF researchers directly involved in center activities or visiting the center from other sites. Applicants can propose the establishment of core facilities necessary for the proposed research. For example, cores designed to collect tissue or DNA samples, store genotypic or phenotypic information, facilitate clinical studies or trials, or coordinate administrative functions can be included within each center proposal. Applicants must describe in detail why each core facility is required for the research described in the application. MECHANISM OF SUPPORT The mechanism of support for this solicitation will be the Research Center Grant (P50). Responsibility for planning, direction, and execution of the proposed research centers will rest solely with the applicant. Because the nature and scope of the research proposed in response to this PA may vary, it is anticipated that the size of the award may also vary. NINDS P50 grants are generally limited to $1 million dollars per year direct costs for five years. However, high quality patient-oriented research requires resources devoted to training personnel, ensuring appropriate inclusion and follow-up of subjects, monitoring patient safety, and coordinating activities among participating sites (see http://www.nih.gov/news/crp/97report/execsum.htm). Therefore, NINDS recently published a notice raising the budget ceiling for specific solicited P50 applications to $1.5 million per year direct costs (see http://grants.nih.gov/grants/guide/notice-files/NOT-NS-03-020.html). This increased ceiling will also apply to center applications received through this PA that have significant clinical components. Applicants requesting additional funds must explain clearly why they are required for the proposed clinical studies. Any future unsolicited competing continuation applications based on this project will compete with all NIH investigator-initiated applications and be reviewed according to the customary peer review procedures. This PA uses just-in-time concepts. Investigators seeking to carry out pilot studies of therapies in preparation for a clinical trial should apply under the auspices of the Preliminary Investigations Leading to Optimal Trials in Neurology program announcement PAR-03-174. Since such applications must conform to the intent of both program announcements, including the additional review criteria of PAR-03-174 (http://grants.nih.gov/grants/guide/pa-files/PAR-03-174.html), potential applicants are strongly encouraged to contact NINDS program staff for guidance. Close collaboration and integration between research center activities and clinical trials is encouraged. 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 institutions/organizations o Foreign institutions are not eligible to apply o Faith-based or community based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage 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: Direct your questions about scientific/research issues to: Robert Finkelstein, Ph.D. Neurogenetics Cluster National Institute of Neurological Disorders and Stroke Neuroscience Center, RM 2143 6001 Executive Blvd MSC 9525 Bethesda, MD 20892-9525 Phone: 301-496-5745 FAX: 301-402-1501 Email: rf45c@nih.gov Amy M. Donahue, Ph.D. Division of Scientific Programs National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard RM 400C, MSC-7180 Bethesda, MD 20892-7180 Phone: 301-402-3458 FAX: 301-402-6251 Email: donahuea@nidcd.nih.gov Direct your questions about peer review issues to: Alan Willard, Ph.D. Chief, Scientific Review Branch National Institute of Neurological Disorders and Stroke Neuroscience Center, RM 3208 6001 Executive Blvd MSC 9529 Bethesda, MD 20892-9529 Phone: 301-496-9223 FAX: 301-402-0182 Email: aw135y@nih.gov Direct your questions about financial or grants management matters to: Kathleen Howe Grants Management Branch National Institute of Neurological Disorders and Stroke 6001 Executive Boulevard, Room 3266 Bethesda, MD 20892 Phone: (301) 496-9231 FAX: (301) 402-0219 Email: kh52x@nih.gov Sara Stone Division of Extramural Activities National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400B, MSC-7180 Bethesda, MD 20892-7180 Telephone: 301-402-0909 FAX: 301-402-1758 Email: stones@nidcd.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at 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 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. The title and number of this PAR must be typed in line 2 of the face page of the application form and the YES box must be checked. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. 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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. 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 must be sent to: Alan Willard, Ph.D. Chief, Scientific Review Branch National Institute of Neurological Disorders and Stroke Neuroscience Center, RM 3208 6001 Executive Blvd MSC 9529 Bethesda, MD 20892-9529 Phone: 301-496-9223 FAX: 301-402-0182 Email: aw135y@nih.gov 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. The NINDS Guidelines for the development of Program Project and Center Applications should be followed when preparing the application. They are available on the NINDS home page at: http://www.ninds.nih.gov/index.htm. 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 by NINDS 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 the 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 your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. 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. o Significance o Approach o Innovation o Investigator o Environment 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. 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? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? (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? (3) 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? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your 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, your application will also be reviewed with respect to the following: INTEGRATION AND COLLABORATION: The ability of the proposed Center to promote integration across research projects and collaboration across laboratories including basic, translational, and clinical approaches. Activities in each project should inform and advance the others and the proposed collaborative activities should provide synergy to the proposed Center. 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). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm o 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 Inclusion Criteria included in the section 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 REVIEW CONSIDERATIONS 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. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. 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. 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). SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible. http://grants.nih.gov/grants/policy/data_sharing Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH- defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://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, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at 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.

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