NHLBI COMPETITIVE SUPPLEMENTS FOR HUMAN EMBRYONIC STEM CELL RESEARCH RELEASE DATE: December 12, 2003 PA NUMBER: PAR-04-037 (This PA has been reissued, see PAR-05-047) EXPIRATION DATE: February 13, 2004. Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.837, 93.838, 93.839 LETTER OF INTENT RECEIPT DATE: January 13, 2004 APPLICATION RECEIPT DATE: February 13, 2004 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Supplemental Instructions o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The purpose of these supplements is to enable NHLBI grantees with little or no prior experience working with human embryonic stem (ES) cell lines to conduct research with these cell lines that is directly related to the aims of an existing, funded NHLBI grant. The research proposed in the supplement should be within the scope of the existing NHLBI grant and may not expand the original scope of the parent grant. Only research using human ES cell lines listed in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov/). RESEARCH OBJECTIVES On August 9, 2001 President Bush announced his decision to allow Federal funds to be used for research on existing eligible human ES cell lines. In order to facilitate research, the NIH Human Embryonic Stem Cell Registry lists the human ES cell lines that meet the eligibility criteria (see http://escr.nih.gov/). The availability of human ES cell lines for Federally funded research affords a unique opportunity for investigators to use these cell lines to address fundamental biomedical research questions. However, most investigators have had little or no prior experience in working with human ES cells and have not had the opportunity to propose research aims utilizing human ES cells in their grant applications. This notice provides the opportunity for NHLBI grantees to incorporate the use of human ES cells into their experimental plan when the proposed supplemental research falls within the original scope of the parent grant and is a logical extension of the goals and objectives. MECHANISM OF SUPPORT This PA will use the NIH competitive supplement to an existing NHLBI award. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This PA is a one-time solicitation. This PA uses just-in-time concepts. It also uses the modular budgeting as well as the non-modular budgeting formats (see https://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 https://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm. FUNDS AVAILABLE The NHLBI intends to commit approximately $1,125,000 in FY 2003 to fund up to 15 competitive supplements in response to this PA. An applicant may request a project period of 1 or 2 years and a budget for direct costs of up to $50,000 per year. The supplement award period cannot extend beyond the project end date of the parent grant. Although the financial plans of the NHLBI provide support for this program, awards pursuant to this PA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. 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 applicant must be the principal investigator on an existing NHLBI funded Research Project (R01, R37, or U01), Exploratory/Developmental Project (R03 or R21), Phase II SBIR (R44), Program Project (P01), or Specialized Center (P50, P60, U10 or U54) award. Competitive supplements are available to NHLBI grantees to conduct research using human embryonic stem (ES) cell lines. All human ES cell lines used must be listed on the NIH Human Embryonic Stem Cell Registry (http://escr.nih.gov/). Additional guidance on Federal funding of human embryonic stem cell research is listed in the citations at the end of this announcement. Competitive supplements can only be awarded for research that is within the scope of an existing funded NHLBI Research Project (R01, R37, or U01), Exploratory/Developmental Project (R03 or R21), Phase II SBIR (R44), Program Project (P01), or Specialized Center (P50, P60, U10, or U54) award. The Principal Investigator must be the same person as is the current Principal Investigator on the original application. A supplemental application will not be accepted until after the original application has been awarded, and may not extend beyond the term of the current grant. Investigators carrying out murine ES cell work may elect to request funding to extend their investigations to human ES cell lines. Other investigators carrying out stem cell research, developmental studies, or other related studies are also encouraged to apply. In all cases, a careful explanation and justification for the supplement as a logical extension of the ongoing research must be included. Investigators must contact the human ES cell line providers listed on the NIH Registry independently and make arrangements to obtain the cell lines, including any required material transfer agreements (MTA). Applicants must indicate which human ES cell line or lines will be used. The NIH registry number for all ES cell lines to be used must be in the Description on Page 2. A letter or agreement indicating the provider will supply the human ES cell line must be furnished either with the application or prior to issuance of the award. The investigators should also demonstrate prior ability to work with human ES cell lines or outline their plans for obtaining training in the culture of human ES cells. The human ES cell line providers, other laboratories with ES cell experience, or laboratory training courses on ES cell methods are potential means of obtaining this training. Other means for acquiring human ES cell expertise may also be proposed. 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: Dr. John W. Thomas Division of Blood Diseases and Resources / NHLBI 6701 Rockledge Drive / Room 10154 /Mail Stop 7950 Bethesda, MD 20892-7950 Telephone: (301) 435-0050 FAX: (301) 451-5453 E-mail: ThomasJ@nhlbi.nih.gov John Fakunding, Ph.D. Division of Heart and Vascular Diseases / NHLBI 6701 Rockledge Drive / Room 9170 / Mail Stop 7940 Bethesda, MD 20892-7940 Telephone: (301) 435-0544 FAX: (301) 480-1336 E-mail: FakundiJ@nhlbi.nih.gov Dr. Mary Ann Berberich Division of Lung Diseases / NHLBI 6701 Rockledge Drive /Room 10102 / Mail Stop 7952 Bethesda, MD 20892-7952 Telephone: (301) 435-0222 FAX: (301) 480-3557 E-mail: BerberiM@nhlbi.nih.gov o Direct your questions about peer review issues to: Sherry Dupere, Ph.D. Center for Scientific Review National Institutes of Health 6701 Rockledge Drive MSC 7843, Room 5136 Bethesda, MD 20892 (for express mail use zip 20817 and remove MSC 7843) Tel. (301) 435-1021 Fax (301) 480-1677 Email: DupereS@csr.nih.gov o Direct your questions about financial or grants management matters to: Marsha Mathis National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7158, MSC 7926 Bethesda, MD 20892-7926 Telephone: (301) 435-0170 FAX: (301) 480-3310 Email: MathisM@nhlbi.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Sherry Dupere, Ph.D. Center for Scientific Review National Institutes of Health 6701 Rockledge Drive MSC 7843, Room 5136 Bethesda, MD 20892 (for express mail use zip 20817 and remove MSC 7843) Tel. (301) 435-1021 Fax (301) 480-1677 Email: DupereS@csr.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 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. 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 only for the date listed at the beginning of this document. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at https://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 https://grants.nih.gov/grants/funding/modular/modular.htm. SUPPLEMENTARY INSTRUCTIONS Overview A competing supplemental application may be submitted to request support for a significant expansion of a project's scope or research protocol. The Principal Investigator must be the same person as is the current Principal Investigator on the original application. Applications for competitive supplements are not appropriate when the sole purpose is to restore awards, administratively reduced by the funding agency, to the full SRG-recommended level. A supplemental application will not be accepted until after the original application has been awarded, and may not extend beyond the term of the current grant. Introduction The Introduction to the supplemental application should provide an overall description of the nature of the supplement and how it will influence the specific aims, research design, and methods of the current grant. If the supplemental application relates to a specific line of investigation presented in the original application that was not recommended for approval by the SRG, then the applicant must respond to the criticisms in the prior summary statement, and substantial revisions must be clearly evident and summarized in the introduction. The introduction should not exceed one page. Research Plan The body of the application should contain sufficient information from the original grant application to allow evaluation of the proposed supplement in relation to the goals of the original application. The regular Research Plan format should be followed but is limited to 10 pages excluding references. The research plan includes specific aims, background and significance, preliminary studies, and research design and methods (Sections A to D). Progress Report A progress report is required for supplemental applications. Provide the beginning and ending dates for the period covered since the project was last reviewed competitively. Summarize the previous application's specific aims and the importance of the findings. Discuss any changes in the specific aims as a result of budget reductions for the current grant. Modular Budget If the original application used a modular budget, then Modular Budget Procedures apply to competing supplemental applications. Otherwise follow the instructions for non-modular budget research grant applications. The modules requested should reflect the total direct costs only of items for which additional funds are requested. If the initial budget period of the supplemental application is less than 12 months, prorate the personnel costs and other appropriate items of the detailed budget. Any budgetary changes for the remainder of the project period of the current grant should be discussed under the budget justification. In summary, the application should include: o A one page Introduction o The 10-page research plan, excluding references, which includes specific aims, background and significance, preliminary studies, and research design and methods (Sections A to D). o A description of the proposed supplemental activity and how it is related to the specific aims and objectives of the parent grant o The significance and potential impact of the supplement on ongoing research in the field o A summary of the expected overall impact of the requested supplement on ongoing research results o The NIH registry number for all ES cell lines to be used must be in the Description on Page 2. o A description of prior experiences working with human ES cell lines or an outline of plans for obtaining training on human ES cell culture methods. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be received by the application receipt date listed at the beginning of this document. If an application is received after that date, it will be returned to the applicant without review. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o 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 the National Heart, Lung, and Blood Advisory Council. 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? Is the proposed supplemental activity related to the specific aims and objectives of the parent grant? (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)? Is a description of prior experience working with human ES cell lines or an outline of plans for obtaining training on human ES cell culture methods provided? (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: PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. INCLUSION: 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) BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: January 13, 2004 Application Receipt Date: February 13, 2004 Peer Review Date: June 2004 Council Review: Not Applicable Earliest Anticipated Start Date: July 1, 2004 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 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 http://stemcells.nih.gov/index.asp 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, 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 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 No. 93.839, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at https://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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