DEVELOPMENT OF ASSAYS FOR HIGH THROUGHPUT DRUG SCREENING 

RELEASE DATE:  February 25, 2004

PA NUMBER:  PA-04-068 
November 21, 2006 - The R01 portion of this funding 
opportunity has been replaced by PA-07-054, which now uses the electronic SF424 (R&R) application for February 5, 2007 submission dates and beyond.

EXPIRATION DATE:  Expiration Date for R01 Non-AIDS Applications: November 2, 2006 
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007

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 Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov/) National Cancer Institute (NCI) (http://www.nci.nih.gov/) National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.273, 93.849 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 Requirement o Where to Send Inquiries o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The purpose of this PA is to encourage the use of high throughput small molecule screening for use in both research and drug discovery programs by funding the development of innovative assays that may be adapted for automated screening. The assays would aim to identify new tools for basic research and promising new avenues for therapeutics development, especially in areas related to the missions of NIDDK, NCI and NIAID. RESEARCH OBJECTIVES The Molecular Libraries Initiative (http://nihroadmap.nih.gov/molecularlibraries/index.asp) is one part of the NIH roadmap for medical research in the 21st century that outlines ways of translating basic scientific knowledge into tangible benefits for human health. The overall goal of the Molecular Libraries Initiative is to offer public sector researchers opportunities to screen small molecules with the high throughput chemical screening (HTS) methods commonly used by the private sector to develop therapeutic agents. HTS uses robotics to simultaneously test thousands of distinct compounds in functional and/or binding assays. Compounds identified through HTS can provide powerful research tools to elucidate biological processes or form the basis for drug discovery. HTS links knowledge of biological processes to industrial scale screening, and is one way to expedite efforts that translate basic research into clinical applications. There are academic and private sector facilities for carrying out HTS, and there are plans to establish several NIH-funded HTS screening centers (http://nihroadmap.nih.gov/molecularlibraries/index.asp). These facilities typically provide access to a large compound library, robotics to carry out the assays, and informatics to interpret the results. The goal of this PA is to establish a continuously evolving stream of scientifically and technologically outstanding assays that can be automated for HTS in one of these facilities. Funding will enable investigators to translate promising protocols into assays suitable for HTS. Emphasis will be placed on assays that provide new insight into important targets. For example, assays may involve targets indirectly related to disease, but which might provide insight into the biology of relevant diseases. Other targets might be associated with rare diseases. One important criterion for this initiative is novelty, so the proposed assays should avoid focus on areas and approaches that have been extensively targeted in other settings. Assays should be relevant to the scope of research for at least one of the sponsoring NIH Institutes (see below for Institute specific interests), focusing on specific diseases or on relevant basic physiology, cell biology, or developmental processes. Many of the in vitro biological and disease models currently used to study the effects of specific compounds or molecular perturbations can be adapted to high throughput formats. There are a number of characteristics that make an assay suitable for high throughput approaches. The assay must be robust, reproducible and have a simple readout that is amenable to automated analysis. Importantly, it must be possible to miniaturize the assay to a 96- well format or smaller. A broad range of models share these features, including molecular and biochemical assays, cellular models and simple model organisms. Relevant topics include, but are not limited to: o Assays for molecular chaperones or molecules that improve the post- translational targeting, folding, or assembly of proteins, especially involving mutant proteins responsible for inborn errors of metabolism, cancers, or other rare diseases. o Screens involving immunological targets, especially in the context of research that focuses on autoimmune diseases or areas where specific antibodies stimulate or inhibit relevant processes. o Model organism-based assays, such as those using bacteria, yeast, Drosophila, C. elegans, zebrafish, etc. that have relevance to the research areas of the sponsoring Institutes. o Assays for compounds that identify multi-protein signaling complexes, or that modify the function of signaling complexes, regulatory networks and sorting machinery. o Assays to identify highly specific molecular markers that might be useful for identifying or tracking a particular cell or function. o Biochemical or cell-based assays of activity, behavior or interaction of proteins and other molecules of interest. o Assays of cellular or molecular phenotypes. o Modulation of expression of genes of interest, including effects on transcription factors, transcription, translation or RNA splicing. o Assays that biochemically incorporate an entire metabolic or macromolecular biosynthetic pathway from an organism. o Whole cell assays that employ engineered cells rendered hypersensitive to a targeted pathway. Proposals should include assay development plans sufficient to demonstrate reproducibility in a low-to-moderate throughput setting and should be feasible for adaptation to an automated, high-throughput screening approach. Demonstration of feasibility for HTS must include: o Demonstration of highly predictable and reproducible responses to known compounds or other control conditions, and of a clear threshold between positive and negative responses. o Demonstrated suitability and reproducibility of the assay for high- throughput screening using a diverse collection of at least a few hundred compounds, such as a collection of FDA approved drugs or other bioactive molecules. o Demonstration of reagent availability necessary to perform HTS, such as enzyme indicators, chemicals necessary for reagent readout, and capacity to generate sufficient reaction substrates (DNA, RNA, protein, or enzyme substrates). There must also be a clear plan for evaluating the significance of the ‘hits’ obtained in a primary high throughput screen. This plan should be feasible for the evaluation of multiple hit compounds that may be identified in a primary HTS effort. The plan should also include secondary screens to rule out artifacts and appropriate counterscreens in order to prioritize compounds for further testing. The overall goals for the use of the assay in an HTS effort should be well defined and clearly presented. This discussion should include the expected use of the compounds in the context of a larger research program. Applications that propose interaction with existing research consortia funded by one of the sponsoring NIH Institutes are encouraged (see below for Institute-specific interests). However, experiments proposed in response to this PA need not include the use of assays in high throughput screens or even the final stages of miniaturization for HTS. Rather, the emphasis is on designing and validating creative approaches to assaying biological and disease processes that can potentially be used for chemical genetics and drug discovery. Assays developed under this PA will be eligible for consideration by the NIH Molecular Library screening centers (http://nihroadmap.nih.gov/molecularlibraries/index.asp), although funding under this PA does not constitute a commitment by NIH to screen the assay at a center or an obligation on the part of funded investigators to apply for consideration by the centers. It is anticipated that assays developed through this initiative will be submitted to HTS facilities, although funding for the screening is outside the scope of this initiative. Researchers are expected to use the results from HTS as the basis for seeking additional funding from appropriate entities for lead compound development. Institute Specific Interests NCI: The NCI is especially interested in proposals related to cancer prevention, treatment or treatment monitoring with imaging agents. Assays pertinent to the mission of NCI should be justified as relevant to cancer and may include any physiology, cell biology or developmental process with the goal of identifying molecules that either perturb the system (e.g., drugs for cancer prevention or treatment) or yield molecular information (e.g., imaging agents). Applicants may find the NCI drug discovery and development resources helpful, such as the availability of individual and plated samples and data mining tools (http://dtp.nci.nih.gov/). NCI encourages collaborations with existing NCI funded projects, and especially invites participation by chemists who can provide chemical libraries on a pilot basis to assist with assay validation. NIAID: NIAID is particularly interested in proposals directly addressing infectious or immune-mediated disease or basic immunology. Proposals may focus on assays targeting etiologic agents of human infectious disease including, but not limited to, potential agents of biodefense (categories A, B, and C), as well as other newly emerging infectious agents. Pathogens with abnormally high global burdens of disease such as HIV, tuberculosis, and malaria, as well as toxins or arthropod vectors of infectious agents as targets will also be included. Additionally, proposals may focus on augmenting immune responses towards infectious agents, including early innate immune responses and the induction or prolongation of immunological memory to vaccination. Also of prime interest is the prevention, amelioration, or reversal of immune-mediated diseases by small molecules. Targets relevant to asthma, allergy, inflammatory diseases, transplant rejection, and all types of autoimmune diseases may be proposed. Assays that facilitate studies on basic immunological mechanisms are also appropriate. NIDDK: In order to be supported by NIDDK through this PA, proposed assays should be relevant to NIDDK’s scope of research, which includes obesity, diabetes, diabetic complications, endocrine disease, liver and digestive diseases, kidney and urological diseases, hematology and inborn errors of metabolism. Alternatively, proposals may focus on NIDDK-relevant basic physiology, such as glucose and lipid homeostasis, cell biology, or developmental processes. Finally, applications may propose interaction with NIDDK-funded existing research consortia, such as the Beta Cell Biology Consortium (http://www.betacell.org/), Stem Cell Genome Anatomy Projects Consortium (http://www.scgap.org/), or Animal Models of Diabetic Complications Consortium (http://www.amdcc.org/). MECHANISM(S) OF SUPPORT This PA will use the NIH R01 award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. An applicant may request a project period of up to 3 years. This PA uses just-in-time concepts. It also uses the modular budgeting as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format. Otherwise follow the instructions for non-modular budget research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm. 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 institutions/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. SPECIAL REQUIREMENTS The applicants must describe their willingness to submit data generated through this project to relevant publicly available databases (see section below entitled “SHARING RESEARCH DATA”) and submit a plan to address the sharing of research resources generated under this PA consistent with the programmatic goals of this project and NIH policies (see section below entitle “SHARING OF MATERIALS GENERATED UNDER THIS PA”). 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 two areas: scientific/research, and financial or grants management issues: o Direct your questions about scientific/research issues to: Rebekah S. Rasooly, Ph.D. Division of Kidney, Urologic, and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Room 643 Bethesda, MD 20892-5458 Telephone: (301) 594-6007 FAX: (301) 480-3510 Email: rr185i@nih.gov Ronald J. Dubois, Ph.D. Division of Cancer Treatment National Cancer Institute 6130 Executive Boulevard, Room 8150 Bethesda, MD 20892-7456 Telephone: (301) 496-8783 FAX: (301) 402-5200 Email: rd41n@nih.gov Michael G. Kurilla, M.D., Ph.D. Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases 6610 Rockledge Drive, Room 5030 Bethesda, MD 20892-6604 Telephone: 301-496-5305 FAX: 301-496-8030 Email: mk486x@nih.gov o Direct your questions about financial or grants management matters to: Donald Ellis Grant Management Branch National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Room 709A Bethesda, MD 20892-5456 Telephone: (301) 594-8849 FAX: (301) 480-3504 Email: de30z@nih.gov Barbara Fisher Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Room 243 Bethesda, MD 20892-7150 Telephone: (301) 846-1015 FAX: (301) 846-5720 Email: bf18m@nih.gov Lesia A. Norwood Grant Management Branch National Institute of Allergy and Infectious Diseases 6700B Rockledge Drive, Room 2117 Bethesda, MD 20892-7614 Telephone: (301) 402-7146 Fax: (301) 480-3780 Email: ln5t@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) 435-0714, Email: GrantsInfo@nih.gov. The title and number of this program announcement must be typed on 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 MODULAR BUDGET GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget grant format. The modular budget grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. 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 five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be 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 unfunded version of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by an appropriate national advisory council or board. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to evaluate 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 the following criteria in assigning the 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, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. 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). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 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 REVIEW CONSIDERATIONS Applicants must describe their willingness to share data and research resources generated under this PA consistent with the programmatic goals of this project and NIH policies SHARING RESEARCH DATA Applicants must describe their willingness to submit data generated through this project to relevant publicly available databases (http://grants.nih.gov/grants/policy/data_sharing/). The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed in all proposals by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score SHARING OF MATERIALS GENERATED UNDER THIS PA Restricted availability of unique research resources, upon which further studies are dependent, can impede the advancement of research. The NIH is interested in ensuring that the research resources developed through this grant become readily available to the broader research community in a timely manner for further research, development, and application, in the expectation that this will lead to products and knowledge of benefit to the public health. It is expected that resources to be shared will include, among others, the assay protocol and materials. PLANS. To address this interest in assuring research resources are accessible, NIH requires applicants who respond to this PA to submit a plan: (1) for sharing the research resources generated through the grant; and (2) addressing how they will exercise intellectual property rights, should any be generated through this grant, while making such research resources available to the broader scientific community. The sharing of research resources plan and intellectual property plan must make unique research resources readily available for research purposes to qualified individuals within the scientific community in accordance with the NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/nihgps/) and the Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources: Final Notice, December 1999 (http://www.ott.nih.gov/policy/rt_guide_final.html) and (http://ott.od.nih.gov/NewPages/64FR72090.pdf)].). These documents also define terms, parties, responsibilities, prescribe the order of disposition of rights, prescribe a chronology of reporting requirements, and delineate the basis for and extent of government actions to retain rights. Patent rights clauses may be found at 37 CFR Part 401.14 and are accessible from the Interagency Edison web page, http://www.iedison.gov. REVIEW. Reviewers will comment, as appropriate, on the adequacy and feasibility of the sharing of research resources plan and the intellectual property plan. Comments on the plans and any concerns will be presented in an administrative note in the Summary Statement. These comments will not affect the priority score of the proposal. NIH program staff will consider the adequacy of the plans in determining whether to recommend an application for award. The approved plans will become a condition of the grant award and Progress Reports must contain information on activities for the sharing of research resources and intellectual property. 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 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 "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.healthypeople.gov/. 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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