Part I Overview Information

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), (http://www2.niddk.nih.gov)

Title: Recovery Act Limited Competition: Research On Biosamples From Selected Diabetes Clinical Studies (RC4)

Announcement Type

New

Update: The following update relating to this announcement has been issued:

Request for Applications (RFA) Number: RFA-OD-10-010

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number
93.701

Key Dates
Release/Posted Date: January 4, 2010
Opening Date: February 11, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): February 11, 2010
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Date: March 11, 2010
Peer Review Date: June/July 2010
Council Review Date: August 2010
Earliest Anticipated Start Date: September 30, 2010
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: March 12, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description

Section II. Award Information

Section III. Eligibility Information

Section IV. Application and Submission Information

Section V. Application Review Information

Section VI. Award Administration Information

Section VII. Agency Contacts

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Purpose

The goal of this activity is to provide a mechanism for funding to investigators for laboratory tests on non-renewable (non-DNA) samples generated by selected studies and clinical trials. There are two ways to access samples. One is through the NIDDK Biosamples Repository which contains samples from the following clinical trials: Type 1 Diabetes Prevention Trial- 1 (DPT-1), Diabetes Prevention Program Type 2 Diabetes (DPP), Diabetes Control and Complications Trial / Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC samples collected though 2001).

This FOA also applies separately to investigators who wish to apply for funding for assays using samples from one of the following NIDDK-funded consortia:

1) Type 1 Diabetes TrialNet, (http://www.diabetestrialnet.org/index.htm);

2) Diabetes Control and Complications Trial / Epidemiology of Diabetes Interventions and Complications DCCT/EDIC (samples collected before and after 2001),

(http://www.t1diabetes.nih.gov/investigator/details.asp?ConsortiumID=36);

3) Targeting INflammation using SALsalate for Type 2 Diabetes (TINSAL-T2D), (http://www.tinsal-t2d.org);

4) Look AHEAD (Action for Health in Diabetes), (www.lookaheadtrial.org);

5) Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) www.todaystudy.org; and

6) HEALTHY study for school-based intervention for Type 2 Diabetes risk.

This opportunity is limited to samples from the clinical consortia listed above. Funding or access to samples will not be provided for assay development or exploratory animal models research, or any research utilizing samples other than those that derive from studies listed above. Investigators should propose to test scientifically meritorious hypotheses related to the clinical trial’s goals, and within the intent of the signed consent form for each study or trial. Applications should explain in what ways the study is meritorious, the assay technique is validated, and that the laboratory is able to carry out the assays with the highest quality standards.

Applicants for consortium-controlled samples must provide their requests for access to samples approved in writing and documentation received at the NIDDK Review branch at least 2 weeks prior to the review date. In the case of consortium controlled samples, successful applications will be clearly collaborative with scientific input from the clinical consortium’s clinical or laboratory scientists and biostatisticians.

NIDDK Repository-held samples will be reviewed for both access and funding at the same time through this FOA.

Nature of the Research Opportunity

The FOA is expected to promote scientific discoveries on disease mechanisms, disease pathogenic processes, and biomarkers of disease progression or clinical responses. This FOA will provide funding to support scientific collaboration among assay providers from outside of the clinical trials networks and clinical and laboratory scientists and biostatisticians within NIDDK’s consortia listed above. Consortia member scientists are encouraged to come in with responsive applications, but they must also have documented access to consortium-controlled samples through the relevant process. Responsive applications will include:

Applicants must explain how the proposed research will take advantage of the associated clinical and phenotypic data, and why the proposed research specifically requires samples from the selected trial or clinical study. See Section 6. Other Submission Requirements below for detailed application instructions specific to this FOA.

The following is a brief description of clinical trials and studies with opportunities for samples access and testing.

CONSORTIUM APPROVAL NEEDED

Applicants for consortium-held samples are required to contact the relevant study groups in advance to gain access to the samples and study data and to determine whether there is sufficient quantity of the samples that will be required for the proposed study.

The Type 1 Diabetes TrialNet is an international network of investigators, clinical centers, and core support facilities that recruits patients and conducts research to advance knowledge about type 1 diabetes and to test strategies for its prevention and early treatment. TrialNet supports the development and implementation of clinical trials of agents aimed at preventing the disease in at-risk patients and slowing the progression of type 1 diabetes in new onset patients. The network’s Natural History Study enhances understanding of how the disease develops in individuals at risk and thus helps in the formulation of future trials. The Natural History study provides the basis for risk assessment and recruitment of at-risk subjects into clinical trials aimed at preventing the disease in susceptible individuals. For this FOA, serum, RNA, and PBMC samples collected from selected subjects within the Natural History study will be made available. Check the TrialNet website for specific information about the available collection. Samples from completed clinical trials are available for collaborators under this FOA. The completed clinical trials are briefly described below but more information about them can be found in publications and on the TrialNet website. Ancillary studies application procedures may be found at: http://www.diabetestrialnet.org/researchers/ancillary.htm.

Targeting INflammation using SALsalate for Type 2 Diabetes (TINSAL-T2D) study is a multi-center, randomized, double-blinded, placebo-controlled, parallel-group clinical trial. The primary objective of the study is to determine whether salicylates represent a new pharmacological option for glycemic control in patients with type 2 diabetes. The primary outcome for the study is change in HbA1c level from baseline to week 26 in the intent-to-treat (ITT) population with last observation carried forward. The study is conducted in two stages. The first stage is to select a dose of salsalate that is both well-tolerated and demonstrates a trend toward improvement in glycemic control. The second stage is to evaluate (1) the effects of salsalate on glycemic control (HbA1c), (2) the tolerability of salsalate use, and (3) the effects of salsalate on measures of inflammation, the metabolic syndrome, and cardiac risk. Small amounts of serum, plasma and urine have been collected over the trial period (up to 3 months). The ancillary studies policy can be found at: http://www2.niddk.nih.gov/NR/rdonlyres/DA26D281-E47A-4FF0-84EC-6D3A95DA5760/0/TINSALT2DAncillaryStudyPolicy.pdf. Additional information can be obtained at: http://www.tinsal-t2d.org.

Look AHEAD (Action for Health in Diabetes): Look AHEAD is a 16-center randomized, controlled clinical trial examining, in overweight and obese volunteers with type 2 diabetes, the long-term effects of an intensive lifestyle intervention program designed to achieve and maintain weight loss by decreased caloric intake and increased physical activity. This program is being compared to a control condition involving a program of diabetes support and education. The primary hypothesis of Look AHEAD is that the incidence rate of the first post-randomization occurrence of a composite outcome, which includes cardiovascular death (including fatal myocardial infarction and stroke), non-fatal myocardial infarction, hospitalized angina, and non-fatal stroke, over a planned follow-up period of up to 13.5 years will be reduced among participants assigned to the Lifestyle Intervention compared to those assigned to the control condition, Diabetes Support and Education. The Look AHEAD cohort comprises approximately 5,000 overweight or obese participants with type 2 diabetes, aged 45-76 at baseline. The consortium has stored serum and plasma samples collected at baseline, year 1, and year 4 annual visits. The study has a well-defined ancillary study policy and process for submission of ancillary studies to be approved by the Ancillary Studies Committee. All applications must be approved by Look AHEAD prior to submission. Additional study information, including the ancillary study policy and online proposal submission materials, can be found on the study website: http://www.lookaheadtrial.org

Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) is a 15-site clinical trial to assess the best treatment for type 2 diabetes in the pediatric population. The TODAY cohort consists of 704 youth diagnosed with type 2 diabetes between the ages of 10 and 17 years, who were randomized to one of three arms: (1) metformin alone; (2) metformin plus rosiglitazone; and (3) metformin plus an intensive lifestyle intervention. All participants received standardized diabetes education. The primary outcome is time to rescue, defined as a hemoglobin A1c > 8.0 percent for 6 months. Secondary outcomes include beta cell function, co-morbidities (dyslipidemia, hypertension), microvascular complications, side effects/QOL, and cost analysis. Enrollment is complete and the intervention will end in February 2011. Serum and plasma samples were collected at baseline, six months, and annually up to 5 years. The ancillary study policy for TODAY can be found at: http://www.todaystudy.org.

HEALTHY is a recently completed study testing whether a school-based intervention can decrease risk factors for type 2 diabetes. Conducted in 42 schools at seven sites, HEALTHY delivered a three-year intervention, starting in 6th grade, with three components: 1) enhanced physical activity in the school by increasing the time devoted to moderate-vigorous activity in gym class; 2) environmental change in the school targeting the total food service environment; and 3) behavior curriculum aimed at increasing physical activity in and out of school, decreasing sedentary behavior out of school, and changing dietary habits. The primary objective of the trial is to determine if, at the end of the 8th grade, the intervention significantly impacts BMI, fasting glucose and fasting insulin in the intervention schools compared to control schools. Over 4600 students were assessed in 6th and 8th grade. Serum and plasma samples were collected at the baseline (6th grade) and the endpoint (8th grade). The ancillary study policy for HEALTHY can be obtained from Dr. Barbara Linder (linderb@mail.nih.gov).

CONSORTIUM AND REPOSITORY HELD SAMPLES

The Diabetes Control and Complications Trial (DCCT) recruited 1,441 type 1 diabetic participants who were randomly assigned to 2 treatment groups, intensive and conventional for an average of 6.5 years of randomized treatment time. The DCCT ended in 1993 after demonstrating conclusively that intensive treatment reduced the development and progression of diabetic retinopathy, nephropathy and neuropathy, compared to conventional treatment. Subsequently, the Epidemiology of Diabetes Interventions and Complications Study (EDIC) recruited 96 percent of the living participants from DCCT for regular observational follow-up of metabolic and complications status, using similar methods as in the DCCT. The former intensive treatment group continues to exhibit the same reduction in the risks of diabetic complications, starting from a new baseline. This carry-over effect of prior glycemic exposure on the later course of complications (superimposed on the effect of concurrent glycemic exposure) has been called "metabolic memory" or "metabolic imprinting". Serum, plasma and urine samples have been obtained annually since the DCCT baseline and stored frozen at -70 C. Samples collected through 2001 are available through the NIDDK Repository and may be applied for under this FOA. The ongoing DCCT/EDIC research group also welcomes proposals for collaborative studies from any investigator who believes he/she has a research idea that could utilize some of the stored sample collection (serum, plasma and urine) and clinical phenotypic data in an ancillary study. Any proposal would receive initial review by the relevant DCCT/EDIC committees, and would have to abide by the policies and procedures for data sharing and publications described here: http://www.niddk.nih.gov/patient/EDIC/edic.htm.

REPOSITORY ONLY

Applicants for repository-held samples are required to contact the NIDDK Central Repositories in advance to determine whether there is sufficient quantity of the samples that will be required for the proposed study. Applicants are required to provide detailed information about which samples are needed and the necessary volumes as part of the application. In addition, applicants must consult with the Repositories to determine whether the proposed use of samples is consistent with the limitations of the subjects informed consents. For each of these clinical studies, data sets are available and applicants are urged to obtain and review the data to assist in their preparation of the application. Information for obtaining data from these studies is available on the NIDDK Repository Website: https://www.niddkrepository.org/niddk/home.do.

Diabetes Prevention Program (DPP): the Diabetes Prevention Program (DPP), was initiated in 1996 and ended one year early (May 2001) as a result of highly significant and positive study outcomes. These results demonstrated that lifestyle and drug interventions could markedly reduce the risk for developing type 2 diabetes in a group at high risk due to the presence of impaired glucose tolerance, by 58 percent for lifestyle and 31 percent for metformin. Importantly, it was shown that interventions were similarly effective in men and women and in all of the ethnic-racial, gender and age groups that were included in the study. While the primary goal of the DPP was to prevent the development of diabetes, an important secondary goal was to decrease the rate of cardiovascular disease and its risk factors, which are being measured in the ongoing follow-up study DPPOS. Serum samples were collected from DPP subjects annually.

The Diabetes Prevention Type 1 (DPT-1) trial was a NIDDK-funded multi-center randomized clinical trial to determine if treatment with a common beta-cell auto-antigen (insulin) can delay the onset of Type 1 Diabetes Mellitus (Type 1 DM) in relatives of persons with type 1 diabetes. The protocol for high risk subjects used daily subcutaneous insulin injections and an annual course of intravenous insulin treatment, while the protocol for intermediate risk subjects used daily doses of insulin or placebo administered orally. There were over 100,000 relatives of persons with type 1 diabetes screened, and 711 subjects entered either the parenteral or oral arm of the study. Serum samples were collected and will be available from subjects who enrolled in the trial(s), some of whom later developed type 1 diabetes, plus samples from a selection of subjects (over 10,000) who were autoantibody negative at screening.

See Section VIII, Other Information - Required Federal Citations, for laws and policies related to this announcement.

Section II. Award Information

1. Mechanism of Support

This FOA will use the RC4 award mechanism. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses Just-in-Time information concepts (see SF424 (R&R) Application Guide). It also uses the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm).

2. Funds Available

This initiative is supported by funds provided to the NIH under the American Recovery & Reinvestment Act of 2009 ( Recovery Act or ARRA ), Public Law 111-5. NIDDK has designated up to $3,000,000 in FY 2010 to fund 5-10 grants, contingent upon the submission of a sufficient number of scientifically meritorious applications.

The total project period for an application submitted in response to this funding opportunity may not exceed 2 years. Although the size of award may vary with the scope of research proposed, applications must stay within the budgetary guidelines of $400,000 total costs for the project. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004.

This program is supported by funds provided to the NIH under the Recovery Act. The purpose of the Recovery Act is to stimulate the American economy through job preservation and creation, infrastructure investment, energy efficiency and science, and other means. Consistent with these goals, domestic (United States) institutions/organizations planning to submit applications that include foreign components should be aware that requested funding for any foreign component should not exceed 10% of the total requested direct costs or $25,000 per year (aggregate total for a subcontract or multiple subcontracts), whichever is less.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply. Consistent with the purposes of the Recovery Act (in particular, to preserve and create jobs and promote economic recovery in the United States, and to provide investments needed to increase economic efficiency by spurring technological advances in science and health), applicants must be a domestic (United States) institution/organization. The United States institution/organization must be located in the 50 states, territories and possessions of the U.S., Commonwealth of Puerto Rico, Trust Territory of the Pacific Islands, or District of Columbia. NIH encourages applications from all interested organizations/institutions, including those from Institutional Development Award (IDeA) states and Academic Research Enhancement Award (AREA)-eligible institutions. Foreign organizations/institutions are not permitted as the applicant organization.

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization 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 support.

More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct.

Resubmissions. Resubmission applications are not permitted in response to this FOA.

Renewals. Renewal applications are not permitted in response to this FOA.

Section IV. Application and Submission Information

To download a current SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the Apply for Grant Electronically button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered on-time (see 3.C.1 for more information about on-time submission).

A one-time registration is required for institutions/organizations at both:

PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.

Several additional separate actions are required before an applicant can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Registered

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Both the PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo -- Telephone 301-710-0267; Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY: (301) 451-5936

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are necessary for processing (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

The SF424 (R&R) application has several components. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
Research & Related Budget

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs

When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

Information for the Contact PD/PI should be entered in item 15 of the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the Research Plan section and Multiple PD/PI Leadership Plan must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award (NoA).

Applications Involving a Single Institution

When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.

When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 5.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: February 11, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date: February 11, 2010
Application Due Date: March 11, 2010
Peer Review Date: June/July 2010
Council Review Date: August 2010
Earliest Anticipated Start Date: September 30, 2010

3.A.1. Letter of Intent

Although the Letter of Intent (LOI) is not required, not binding and does not enter into the review of the subsequent application, an applicant may choose to submit one. The information that the LOI contains allows IC staff to estimate and plan for the potential review workload. Prospective applicants are asked to submit a LOI that includes the following information:

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Francisco O. Calvo, Ph.D.

Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
6707 Democracy Boulevard, Room 752, MSC 5452
Bethesda, MD 20892-5452
(Courier use 20817)
Telephone: 301-594-8897
Fax: 301-480-4126
Email: FC15Y@NIH.GOV

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow Steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

3.C. Application Processing

3.C.1 Submitting On-Time

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed.

All applications must meet the following criteria to be considered on-time :

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Once an application package has been successfully submitted through Grants.gov,

NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.

Please note that the following caveats apply:

3.C.3 Viewing an Application in the eRA Commons

Once any eRA identified errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.

Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the IC. Incomplete and/or non-responsive applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review, as indicated in the NIH Grants Policy Statement.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see the NIH Grants Policy Statement).

6. Other Submission Requirements

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD(s)/PI(s) to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Special Instructions for PHS398 Research Plan Component (Section 5.5 of SF424 (R&R) Application)

Research Strategy Page Limitation: The Research Strategy is limited to a total of 6 pages.

In addition to the specific elements described in the NIH SF424 (R&R) application instructions (e.g., Specific Aims, Research Strategy Significance, Innovation), the applicant should provide the following additional information within the Approach section:

Approach

1. Justification for requesting these specific samples, and why other sources of similar samples are not appropriate. This section should explain how the proposed use relates to the design and outcomes of the study that produced the requested samples. The question being posed by the investigator must be appropriate to the source of the biospecimens, how they were collected, prepared, analyzed, and stored, their age, and the phenotypic and other accompanying data. Include detailed information about what samples are requested. If you will be combining the results from the proposed study with those obtained from other samples, be sure to explain how the requested samples will fit in with your overall study design ( (e.g., from which study and stage of the study the specimens are requested, whether random samples or specific selection of those with subjects with or without specified clinical events and laboratory or imaging findings are sought, etc.)

2. Include a clear justification for the amount of sample being requested. In all cases, applicants should only request the minimum volume needed for the study.

3. State whether the relevant NIDDK clinical consortium as needed has approved access and confirmed the availability of the samples being requested. Documentation in the form of a Letter of Support from the consortium is expected to arrive at the NIDDK Review Branch on or before two weeks prior to the review date.

4. Methodology: Relevant preliminary data demonstrating the applicant’s experience with the assay or technique that will be used with the requested samples. Describe how the requested samples will be used, including a description of the specific procedures by which the samples will be tested and analyzed.

5. Power and effect size: Describe the power of the project and the anticipated size of a detectable effect.

6. Data analysis: Provide a detailed plan for data analysis. Include a brief summary of the team’s expertise and experience and evidence that they can handle the analysis proposed.

7. Data management: Describe how the accompanying phenotypic data as well as the data from sample analysis will be managed. For example, who will have the main responsibility for organizing, storing, and archiving the data? Who will maintain computer data files and make needed work files available to those who will analyze the data? How will the privacy of information of beneficiaries in the files be guarded and guaranteed? Highlight experience with data management for large data sets, such as those to be produced by the proposed project. Applicants are expected to return data derived from analysis of samples to the data coordinating center for the relevant NIDDK consortium, or the NIDDK Data Repository, along with appropriate quality measures. The plan should acknowledge the expectation to follow NIDDK instructions to return the phenotypic data and unused samples to the relevant NIDDK consortium or repository by one year after the period of award of this project.

8. Sample management: Explicitly address how the samples will be held, managed, and processed. For example, who will have the main responsibility for storing and testing the samples?

9. Plans for the next phase: Describe plans for follow up studies and, if relevant, further biomarker or assay development. If collaborations have been established for follow up, include these letters of collaboration.

In addition to the above special instructions for the Research Strategy component of the application, please address these additional considerations in the Human Subjects sections (see below).

Human Subjects: Applicants must include in this section a statement of how the proposed research fits within the limitations of the subjects informed consent. Information about the informed consents for each study can be obtained from the relevant NIDDK clinical consortium or the NIDDK repository.

PHS398 Research Plan Component Sections

Item Number and Title

Instructions

1. Introduction to Application

Omit (N/A: Resubmissions and Revisions not allowable)

2. Specific Aims

One page maximum. Separate PDF attachment

3. Research Strategy

Limited to 6 pages. Attach the 6- page Research Strategy as a single PDF document. Figures and illustrations may be included but must fit within the 6-page limit. Do not include links to Web sites for further information. Do not include animations.

Excluded from the 6-page Research Strategy limitation are the following items:

Appendix Materials

Appendices are not permitted.

No supplemental/update information will be accepted, other than the notification that the relevant consortium has approved the request for access to samples, by two weeks prior to the review date

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm).

(a) Data Sharing Plan: Applicants are expected to return data derived from analysis of samples to the NIDDK clinical consortium or repository, along with appropriate quality measures. The plan should acknowledge the requirement to follow NIDDK instructions to return the phenotypic data and unused samples to the NIDDK clinical consortium by one year after the period of award of this project.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (e.g., blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (go to NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.)

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Review Process

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Applications that are complete and responsive to this FOA will be evaluated for scientific and technical merit by an appropriate peer review groups convened by NIDDK and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project proposed).

Scored Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technological advances, technical capability, clinical practice, and/or health be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Are the proposed studies likely to increase understanding of disease progression or therapeutic responses observed (or not observed) in the clinical trial? Are the proposed studies likely to help establish a biomarker of clinical response or disease progression in the studied population?

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, technological developments, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Does the project effectively utilize the clinical trial context of the sample collection? Are there enough samples in the collection and reproducibility of the assay to draw conclusions about the utility of the measurement as a biomarker of clinical or therapeutic response, or disease progression? Does the quantity of sample requested match the intended use?

Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

In addition to the above review criteria, the following criteria will be addressed and considered in the determination of scientific merit and the rating.

Consent: Is the project consistent with the informed consent for the clinical trial or study in which the samples were collected?

Access: Does the application include a statement that grants access to the samples by the NIDDK clinical consortium if needed? Does the application include an acceptable samples management plan which includes storage of the samples under appropriate conditions and includes a plan to return any unused residual sample material?

2.A. Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

2.B. Additional Review Considerations

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession, use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:

Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Selection Process

Applications submitted in response to this FOA will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:

Appeals will not be permitted. See NOT-OD-09-054, Recovery Act of 2009: NIH Review Criteria, Scoring System, and Suspension of Appeals Process.

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General. In addition, as part of just-in-time information for those Recovery Act awards, for any modular budget application, a detailed budget will be required prior to award.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

The terms of the NoA will reference the requirements of the Recovery Act.

In addition to the standard NIH terms of award, all awards will be subject to the HHS Standard Terms and Conditions for Recovery Act awards. The full text of these terms approved for NIH awards can be found in the following document: Standard Terms and Conditions for AARA Awards.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Section IV.5., Funding Restrictions.

2. Administrative and National Policy Requirements

. All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.

3. Reporting

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

In addition, grantees must comply with the requirements set forth in the Recovery Act, including, but not limited to, the reporting requirements described in Section 1512 of the Act, as well as applicable OMB guidance regarding the use of Recovery Act funds. As noted above, grantees must also comply with the HHS Standard Terms and Conditions for Recovery Act awards. The full text of these terms approved for NIH awards can be found in the following document: Standard Terms and Conditions for AARA Awards.

Recovery Act-related reporting requirements will be incorporated as a special term of award.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated. Until such time as HHS has migrated to the SF 425 FFR, award recipients will utilize the SF 269 FSR.

Section VII. Agency Contacts

This funding announcement is subject to restrictions on oral conversations during the period of time commencing with the submission of a formal application[1] by an individual or entity and ending with the award of the competitive funds. Federal officials may not participate in oral communications initiated by any person or entity concerning a pending application for a Recovery Act competitive grant or other competitive form of Federal financial assistance, whether or not the initiating party is a federally registered lobbyist[1]. This restriction applies unless:

(i) the communication is purely logistical;

(ii) the communication is made at a widely attended gathering;

(iii) the communication is to or from a Federal agency official and another Federal Government employee;

(iv) the communication is to or from a Federal agency official and an elected chief executive of a state, local or tribal government, or to or from a Federal agency

official and the Presiding Officer or Majority Leader in each chamber of a state legislature; or

(v) the communication is initiated by the Federal agency official.

For additional information see http://www.whitehouse.gov/omb/assets/memoranda_fy2009/m09-24.pdf

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research (program), peer review, and financial or grants management issues:

1. Scientific/Research Contact(s):

Type-1 Diabetes TrialNet and Diabetes Prevention Trial Type 1 (DPT-1)

Lisa M. Spain, Ph.D.
Immunobiology Of Type 1 Diabetes And Autoimmune Endocrine Diseases
Division of Diabetes, Endocrinology, and Metabolism
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 695
Bethesda, MD 20817
Telephone: (301) 451-9871
Email: spainl@mail.nih.gov

Diabetes Control and Complications Trial / Epidemiology of Diabetes Interventions and Complications DCCT/EDIC

Catherine Cowie, Ph. D.
Diabetes Epidemiology Program
Division of Diabetes, Endocrinology, and Metabolism
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 691
Bethesda, MD 20817
Telephone: (301) 594-8804
Email: cowiec@mail.nih.gov

Diabetes Prevention Program (DPP)

Sanford Garfield, Ph.D.
Biometry and Behavioral Research Program
Division of Diabetes, Endocrinology, and Metabolism
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 685
Bethesda, MD 20817
Telephone: (301) 594-8803
Email: garfields@mail.nih.gov

Targeting INflammation using SALsalate for Type 2 Diabetes (TINSAL-T2D)

Myrlene Staten, M.D.
Diabetes Research Translation
Division of Diabetes, Endocrinology, and Metabolism
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 6107
Bethesda, MD 20817
Telephone: (301) 402-7886
Email: statenm@mail.nih.gov

Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) and HEALTHY

Barbara Linder, M.D., Ph.D.
Senior Advisor for Childhood Diabetes Research
Division of Diabetes, Endocrinology, and Metabolism
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 699
Bethesda, MD 20817
Telephone: (301) 594-0021
Email: linderb@mail.nih.gov

LookAHEAD (Action for Health in Diabetes)

Mary Evans, Ph.D.
Director, Special Projects in Nutrition, Obesity, and Digestive Diseases
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 681
Bethesda, MD 20817
Telephone: (301) 594-4578
Email: evansmary@mail.nih.gov

2. Peer Review Contact:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd, Room 752, MSC 5452
Bethesda, MD 20892-5452
(Courier use 20817)
Telephone: (301) 594-8897
Fax: (301) 480-4126
Email: fc15y@nih.gov

3. Financial/Grants Management Contact:

Elizabeth Gutierrez
Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 712B
Bethesda, MD 20892-5455
Telephone: (301) 594-8844
Email: gutierrezel@mail.nih.gov

Section VIII. Other Information

Required Federal Citations

The American Recovery And Reinvestment Act of 2009 (Pub. L. No. 111-5): http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h1enr.pdf

Standard Terms and Conditions for Recovery Act Awards: The full text of these terms approved for NIH awards can be found in the following document: http://grants.nih.gov/grants/policy/NIH_HHS_ARRA_Award_Terms.pdf

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45 CFR 46) 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). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants ( NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
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 and local institutional review board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh-Dole Act (see the NIH Grants Policy Statement. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

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 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 funding opportunity 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.

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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is 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 SF424 (R&R) application; 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 Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. 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 (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 applications for research involving human subjects and individuals designated as key personnel. The policy is available 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-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (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.

NIH Public Access Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) 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 HHS Office for Civil Rights (OCR).

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. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

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 FOA 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. Awards are made under Sections 301 and 405 of the PHS Act, as amended (42 USC 241 and 284) and are subject to 42 CFR Part 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 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.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.

[1] Formal application includes the preliminary application and letter of intent phases of the program.

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NIH Funding Opportunities and Notices


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