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Part I Overview Information


Department of Health and Human Services

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

Components of Participating Organizations
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov)

Title: Data Coordinating Center for the Collaborative Pediatric Critical Care Research Network (U01)

Announcement Type
This is a reissue of RFA-HD-04-015.

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

Request For Applications (RFA) Number: RFA-HD-08-027

Catalog of Federal Domestic Assistance Number(s)
93.865

Key Dates
Release Date: August 4, 2008
Letters of Intent Receipt Date): February 28, 2009
Application Receipt Date): March 31, 2009
Peer Review Date(s): June/July 2009
Council Review Date(s): October 2009
Earliest Anticipated Start Date: December 1, 2009
Additional Information to Be Available Date (Url Activation Date): Not applicable
Expiration Date: April 1, 2009

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
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
D. Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Arbitration Process
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Purpose

The purpose of this FOA is to solicit applications for a centralized Data Coordinating Center (DCC) that will support the activities of the Collaborative Pediatric Critical Care Research Network (CPCCRN). The funded DCC will cooperate with the NICHD CPCCRN Principal Investigators and the NICHD Project Scientist in identifying research topics of high priority and in designing protocols appropriate to the evaluation of optimal management in these areas. The DCC will have primary responsibility for data management and analysis for Network research in collaboration with the CPCCRN Steering Committee.

Background

In order to respond to the need for well-designed clinical trials, translational and descriptive studies in pediatric critical care, as well as research to enhance understanding of the pathophysiology of critical illness in childhood and its relationship to morbidity, disability and rehabilitation needs in childhood, NICHD established the CPCCRN in 2005, following the competition announced in RFA HD-04-014 (see http://grants.nih.gov/grants/guide/rfa-files/RFA-HD-04-004.html). This Network approach increases the number of comparative trials and meaningful translational and descriptive studies that are conducted by providing a framework for rapid initiation of important studies as their public health significance for children becomes apparent, through the efficient use of pooled scientific and clinical expertise and data management resources.

The NICHD CPCCRN’s mission is to develop and maintain infrastructure to pursue well-designed collaborative clinical trials and important descriptive studies in pediatric critical care. The Network seeks to reduce morbidity and mortality in pediatric critical illness and injury, and to provide a framework for the development of the scientific basis of pediatric critical care practice. Collaboration with professionals in pediatric rehabilitation, general pediatrics, and pediatric subspecialty disciplines providing care to children with special health care needs will be an integral part of Network activities. Currently, the CPCCRN consists of six core Clinical Centers that are responsible for carrying out research projects. The research network includes a DCC that serves as the central biostatistical resource for the network. The network is directed by a Steering Committee with standing committees and subcommittees. An Advisory Board and a Data and Safety Monitoring Board oversee all activities.

Objectives and Scope

The DCC will support six to eight core Clinical Centers in clinical, translational, and descriptive research to investigate the safety and efficacy of treatment and management strategies in the care of critically ill children, and to carry out research in the pathophysiology and consequences of childhood critical illness and injury.

Applicants for the DCC should be familiar with RFA-HD-08-025, announcing the re-competition of the Collaborative Pediatric Critical Care Research Network to learn more about the scope, structure, and function of the CPCCRN.

The functions of the DCC will include developing protocol data management aspects, devising novel comparative study designs, providing sample size calculations and statistical advice, developing data forms and protocol tools, performing data analyses, coordinating and providing logistical support for the activities of the Steering Committee (four times a year, in the Washington, DC area), Data and Safety Monitoring Board, Advisory Board (annually) and overall study coordination and quality assurance. While the DCC is not required to have offices in the Washington, DC area, the logistical support required for the Network will require a minimum 80% Principal Investigator commitment, and such an application should document in detail how logistical support for the CPCCRN and its activities will be provided without an office in the Washington area.

In addition, in order to hasten accrual in Network studies, the DCC, along with NICHD and the site Principal Investigators, will have the responsibility to identify qualified and interested investigators at non-Network centers who wish to enroll patients in these studies. Arrangements for data collection and reimbursement of trial-related data collection costs at non-Network centers will be the responsibility of the DCC.

The Data Coordinating Center will:

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

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the U01 award mechanism(s).

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. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

2. Funds Available

The estimated amount of funds available for support of one project awarded as a result of this announcement is $3.52 million direct costs for fiscal year 2010, (including the $1.5 million in patient and protocol costs to be administered by the DCC). An applicant may request up to $850, 000 in direct costs to support the DCC for each year, and duration of award of five years. Future year amounts will depend on annual appropriations.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation see NOT-OD-05-004.

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:

1.B. Eligible Individuals

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

The Principal Investigator(s) for the DCC must have appropriate expertise and capability in biostatistics, data management, informatics, data analysis and project management, and strong skills and experience in the design, execution and analysis of pediatric research.

More than one PD/PI, or 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, 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 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. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, 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

Applicants are permitted to submit a renewal application in response to this FOA.

Applicants are not permitted to submit a resubmission application in response to this FOA.

Applicants may submit more than one application, provided they are scientifically distinct.

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: February 28, 2009
Application Receipt Date: March 31, 2009
Peer Review Date(s): June/July 2009
Council Review Date: October 2009
Earliest Anticipated Start Date: December 1, 2009

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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 in Section IV.3.A.

The letter of intent should be sent to:

Carol Nicholson, MD, MS
National Center for Medical Rehabilitation Research (NCMRR)
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)
6100 Executive Boulevard, Room 2A03, MSC 7510
Bethesda, MD 20892 -7510 (US Postal Service Express or regular mail)
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 435-6843
Email: [email protected]

3.B. Sending an Application to the NIH

Applications must be prepared using the forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Robert Stretch, Ph.D.
Director, Division of Scientific Review
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 5B01D, MSC 7510
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-1485
Fax: (301) 402-4104
Email: [email protected]

3.C. Application Processing

Applications must be received on or before the application receipt date) described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute Incomplete and/or non-responsive applications will not be reviewed.

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.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

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. The Grants Policy Statement can be found at 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 or renewal 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 or renewal 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 NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)

6. Other Submission Requirements and Information

The NICHD invites applications from qualified investigators. The following eligibility requirements should be met to be considered eligible as a DCC for the CPCCRN.

Minimum Requirements: Data Coordinating Center

In addition, the Research Plan section of the application should include the following information: (1) Description of relevant capabilities (including the minimum requirements above) and experience to be used in executing the responsibilities of the Data Coordinating Center and (2) Concept Proposal and Budget Preparation Example (below). The concept and budget preparation proposal is limited to a maximum of 10 pages. Both (1) and (2) must be included within the 25 page limit for the Research Plan as specified in the PHS 398 application instructions.

The NICHD expects that ongoing studies will continue into the continuation award period for existing CPCCRN sites. New protocols may be implemented before the start of continuation. Centers that join the Network for the first time in the next award period (beginning December 1, 2009) will participate in protocols ongoing at that time. The NICHD intends to enable the Network to initiate new protocols within the first year of the next award period. The topics of these protocols will be decided cooperatively by the Steering Committee with advice from the Advisory Board.

Concept Proposal and Budget Preparation Example

Concept Proposal

A concept proposal for potential conduct in the CPCCRN should be described. The concept proposal should describe one study, including hypothesis, specific aim(s), background, methods, data analysis (including a consideration of power, sample size, and feasibility), and consideration of potential difficulties or ease of implementation across the CPCCRN. The DCC concept proposal should be one that would utilize informatics technology and advanced communication to enhance planning and execution, enabling efficient arrival at the desired scientific conclusion. The concept proposal is limited to a maximum of 10 pages. The proposed concept will serve as an indicator of the applicant’s ability to participate in the development and design of multi-center protocols and how the DCC supports the scientific functions of the CPCCRN. The concept should be one that requires multi-center design. Since follow-up is prioritized in NICHD studies, plans to use DCC capabilities to ensure information is gathered about the consequences of critical illness and injury in childhood are specifically solicited. The concept proposal may or may not actually be performed in the Network; it is anticipated that the funded DCC Principal Investigator will be invited to submit the concept proposal included in their application to the CPCCRN Steering Committee.

Budget Preparation Example

Since new applicants for the DCC will not be aware of detailed Network activities, for the purposes of providing peer reviewers with an example of the applicant’s ability to formulate a staffing plan and budget, all DCC applicants (both new and competing continuations) should complete a hypothetical staffing plan and budget based on the following information. Assume that two new protocols, including one randomized clinical trial and one observational descriptive study, were planned but not yet implemented. Assume, for this exercise, that the two studies will generate data on 500 items for each of 300 subjects in the randomized trial, and on 300 items for each of 1000 subjects in the observational study during the first year of the Network. Assume seven clinical sites will enroll approximately equal numbers of subjects each for both the randomized trial and the observational study and that enrollment is completed in the first year. Using these assumptions, estimate the minimal base costs associated with providing professional and support staffing and logistics as described above, and with the preparations necessary to receive and process data from the two studies during the first year. Using these assumptions, estimate the minimal base costs associated with providing professional and support staffing, and with preparations necessary to receive and process data from the two studies during the first year, as well as costs associated with distributing and accounting for per-protocol funds to the Clinical Sites for these hypothetical studies.

DCC applicants should NOT provide a budget for the concept proposal in their application.

The Research Plan section of the application should include the following information: an overview or summary of capabilities and commitment, a detailed description of relevant expertise and capabilities, and a research plan detailing the strategy to be used in executing the responsibilities of the DCC. All information must be included within the page limit for the Research Plan as specified in the PHS 398 application instructions.

Overview

The overview to the application should provide a summary of the capabilities and commitment of the applicant DCC to collaborative, multicenter research involving vulnerable populations. If the applicant DCC has substantial experience with, or staff expertise in, research involving vulnerable populations outside the pediatric age group, special sensitivity to the issues of informed consent in the critically ill, research under emergency circumstances, or experience in multicenter research in children, it should be summarized here. Additionally, a statement of intent to collaborate in a manner consistent with the terms and conditions of award should be included in the Introduction.

Evidence of Successful Past Performance

DCC applicants must demonstrate prior experience in the design, conduct, data analysis and management of major collaborative clinical research projects, preferably in pediatric critical care, and provide evidence of successful performance as a DCC for multicenter studies within the past five years. Further, the applicants need to show evidence of monitoring of trials including the ability to generate monthly reports of the NICHD CPCCRN clinical centers and subcommittees, safety reports for Data and Safety Monitoring Board, and provision of support of data files.

Academic Productivity

Applicants must provide evidence of research productivity by the DCC in previous or ongoing clinical trials, especially those of a cooperative or multicenter design in the field of pediatric critical care. Contributions in key areas of research development and design, data collection and analysis, monitoring of trial progress, and track record of publications that resulted from participating in the studies should be listed.

Clinical Trials and Statistical Expertise

The DCC PI is expected to provide input on study design, data collection, data analysis, and publication of NICHD CPCCRN studies. Active participation of the PI is expected during all phases of a clinical research study. The applicant must demonstrate staff expertise in biostatistics, data management, data analysis, and project management in multicenter research.

Staffing Expertise and Capabilities

Appropriate biographical sketches should be submitted with the application for the key personnel. Personnel involvement and evidence of multicenter collaboration on recent clinical trials, especially those in pediatric critical care, should be noted including publications resulting from these studies. The DCC should have some degree of flexibility in staffing to be able to respond to changing needs and seasonal variation in work effort of the NICHD CPCCRN. For instance, meeting deadlines, trial startup and completion, and other variables occur which necessitate increases and decreases in staff effort from the DCC. The following categories of personnel are needed to insure excellence in the day-to-day activities of the DCC:

The applicant should propose an idealized staffing pattern for providing DCC functions from protocol design through analysis. This should include provisions for adjusting staff time commitments during the life of a study.

Capacity and Ability to Manage Data and Communications

Ability to assist in protocol development with respect to design of manual of procedures, data collection forms, data collection systems, electronic technology, and data entry systems must be demonstrated in the application. Prior experience in data quality assurance is required. Applicants should provide evidence of data management and program support capabilities by describing their standard operating procedures to include data collection, management, analysis and quality control. Applicants must include plans for support of electronic mail and communication as well as plans for a web-based system for participants of the NICHD CPCCRN. Previous experience in pediatric critical care studies and FDA IND (Food and Drug Administration Investigational New Drug) protocols are preferred. Knowledge of federal patient-privacy and data confidentiality requirements and appropriate experience in ensuring that relevant mechanisms and procedures are in place must be provided in the application.

Evidence of Reporting Capabilities

Evidence of experience with generation of monthly reports on subject enrollment for multiple concurrent studies, reports for use by the Data Safety Monitoring Board (DSMB) and the Advisory Board, and reports for Steering Committee meetings is required. Documentation and dissemination of meeting minutes and minutes of conference call meetings are required. The applicant should delineate previous history of such activities in the application. Further, experience in preparing data and manuscripts for publication is to be described in the Research Plan. The DCC PI will give a report to the Steering Committee quarterly at the Steering Committee meetings.

Expertise and Experience in Logistical and Other Support Services

The DCC provides arrangements for logistical support associated with Steering Committee meetings (four per year) and conference calls, DSMB meetings (one per year and as needed) and conference calls, and other meetings as needed by the NICHD CPCCRN, and the annual external Advisory Board meeting. On occasion, the DCC may handle travel arrangements for selected consultants as needed. The DCC will also provide infrastructure and support the ongoing communication of the CPCCRN via email and teleconference. Expertise in coordinating sample storage and study drug/equipment assignment is required.

Evidence and Experience of On-Site and Off-Site Monitoring Ability

The DCC must have experience in organizing and conducting both on-site and off-site monitoring for clinical research studies. Generation of data errors and needed edits is required. The DCC needs to ensure that the CPCCRN sites fully comply with NIH regulatory requirements, including Human Subjects Protections, informed consent, reporting of adverse events, human and animal safety and welfare provisions, and FDA requirements as indicated by specific studies.

Evidence of Technology Transfer, Data Management and Protocol Training Capabilities

The DCC must be able to assist the clinical sites in data management and communications activities. Training and technical expertise as well as experience and resources must be delineated in the Research Plan. Training sessions for scientific protocols, ongoing yearly certifications necessary for any NICHD CPCCRN studies and data entry are arranged through the DCC.

Evidence of Management Capabilities

The Principal Investigator should delineate his/her skills as a manager for a Data Coordinating Center. The DCC must provide evidence of experience, ability, and organizational systems used to estimate the appropriateness and reasonableness of resources needed for individual projects and ability to manage those resources efficiently during the course of the research. Flexibility among personnel based on effort needed is required. Prior experience with meeting deadlines (e.g., FDA reporting requirements, national meetings, Steering Committee meetings, DSMB meetings, Advisory Board meetings, and so forth) should be delineated in the application. Experience with subcontracts is required as there is occasional need to supplement resources through arrangements with outside organizations based on individual protocol requirements.

The Principal Investigator must also demonstrate evidence of financial administrative capability.

The applicant should propose an operational structure for providing and coordinating all DCC functions for several Network protocols simultaneously (including lines of responsibility/authority for professional staff), and propose an administrative and management structure that would support and enhance the operational structure. Further, he/she should describe any modifications in the current processes/operational structure used to provide DCC functions that may be made if the applicant were to be selected as the CPCCRN DCC.

Special Strengths of the PI or Institution

Applicants are encouraged to describe special or unique strengths that may be relevant to CPCCRN research. This can include state-of-the-art data management systems, which may be shared or may be available to develop and expand the scientific productivity of the CPCCRN.

In addition, special administrative strengths or experience as well as participation in administrative aspects of clinical research (Institutional Review Board, Data and Safety Monitoring Board, Advisory Board for clinical research, clinical research committees, and so forth) for the PI and additional staff members should be highlighted. Level and support of clinical trials can be described.

Applications from institutions that have a General Clinical Research Center (GCRC) funded by NIH or other funded pediatric critical care research centers as resources for conducting the proposed research should provide a letter of agreement that identifies the level of support from the PI or the GCRC program director.

Intent to Participate

There must be a clearly expressed intent to participate in a cooperative manner with other CPCCRN Clinical Centers, the NICHD, DSMB and Advisory Board in all aspects of research in a manner consistent with the terms of the award. CPCCRN projects are given priority at awarded clinical sites. CPCCRN Clinical Centers are expected to participate in all trials, and the DCC provides logistic and data support for the trials.

Departmental and/or Institutional Commitment

The departmental and/or institutional commitments to participate in research should be clearly documented with letters of support from appropriate individuals. Evidence of past support can also be cited. A description of the available and/or planned facility and how it has been used for multicenter clinical research as well as coordination of basic and translational studies should be included. Support in areas of grants management, personnel management; space allocation, data coordination and confidentiality (including electronic data systems, such as hardware, software, maintenance and informatics technology), procurement, and equipment as well as general support of the research should be described (as well as evidence of past research support), and letters of support from appropriate leaders of institutional component services should be included in the application.

Budget Preparation and Management

The applicant DCC should demonstrate ability to calculate costs for the proposed contribution to a specific research protocol conducted in a multicenter setting during the past five years. The applicant should be able to describe procedures to increase operational efficiency and decrease costs while protecting the integrity of the data and the quality of the analyses, and describe the method to be used to calculate all operational costs per protocol and per enrolled patient for all DCC functions.

Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information".

Research Plan Page Limitations

The Research Plan is limited to 25 pages (see above), as per the PHS 398 instructions.

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. (See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance 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 Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(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 (such as 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, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Section V. Application Review Information


1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

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

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NICHD 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:

The following will be considered in making funding decisions:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

Qualifications and Commitment of Key Personnel

Protocols and Procedures

Facilities and Management

Logistics and Support Capabilities

Evidence of Successful Past Performance

Qualifications and commitment of key personnel:

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the rating:

Scientific Review of the Concept Proposal

Scientific review of the concept proposal and budget preparation example for a randomized interventional trial or an observational study appropriate for the CPCCRN will be carried out in order to evaluate the quality of the hypotheses and specific aim(s), background, methods, data analysis (including consideration of power, sample size, and feasibility). Consideration will also be given to the applicant s demonstrated awareness of study design drawbacks, and how such problems might be addressed with the expertise of the DCC PI and staff.

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan section on Human Subjects in the PHS 398 instructions).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan section on Human Subjects in the PHS 398 instructions).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five points described in the Vertebrate Animals section of the Research Plan will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Resource Sharing Plan(s)

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.

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 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.

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 (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the Notice of Award will be mailed to the business official.

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 Also 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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

Applications recommended by the National Advisory Child Health and Human Development Council (NACHHD) will be considered for award based primarily on scientific and technical merit of the relevant capabilities and experience to be used in executing the responsibilities of the Data Coordinating Center as well as, although to a lesser extent, the evaluation of the concept proposal, as determined by peer review. Program balance, that is, the scope and variety of research strengths to enable a successful collaborative program, will be considered. Availability of funds will also determine the award made.

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

2. A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for:

The awardee will agree to accept the coordinating role of the group and the participatory and cooperative nature of the collaborative research process, and the decisions of the Steering Committee. The DCC grant will provide research support services to the Clinical Sites comprising the CPCCRN. These will include establishment and maintenance of a centralized information management system to help the Network Centers, the Steering Committee, and the NICHD to edit store, analyze, publish, and disseminate results from the shared research. The DCC will serves as a central repository for data on all collaborative Network projects. The DCC will assist the NICHD Project Scientist, Project Officer, and the Steering Committee in monitoring research progress, and will work to ensure data integrity, accuracy, security, and accessibility.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

2. A.2. NIH Responsibilities

An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

NICHD Project Scientist Responsibilities

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

NICHD Project Officer Responsibilities

Traditional program management/stewardship responsibility for review and oversight of the cooperative agreement award will reside with the CPCCRN Project Officer. This role is separate from the Program Scientist, and will include the following:

2.A.3. Collaborative Responsibilities

The management of the CPCCRN includes committees whose functions are as follows:

Steering Committee

A Steering Committee will be responsible for protocol development, assisted by the Advisory Board and the Data and Safety Monitoring Board for each study. The Steering committee will have primary responsibility for development and conduct of protocols and the preparation of publications. The Steering Committee will be composed of all Principal Investigators, the Principal Investigator for the DCC, and two NICHD staff. The NICHD Project Scientist will be the only voting NICHD staff member of the Steering Committee. An outside chairperson, who is not participating as a Principal Investigator will be selected by the NICHD.

Meetings of the Steering Committee will ordinarily be held in the Washington, D.C. metropolitan area or by telephone conference call. Logistics of both conference calls and Steering Committee meetings are the responsibility of the DCC. The Steering Committee, with the assistance of the DCC, is responsible for coordinating protocol development, descriptive study design, protocol submission, study conduct, quality control and study monitoring, trial adjudication, drug ordering, data management , statistical analysis, protocol amendments/status changes, adherence to requirements regarding investigational drug management and Federally mandated regulations, and protocol and performance reporting. The DCC will be responsible for direct communication with the NICHD Project Scientist.

Advisory Board

The Advisory Board assists the Steering Committee in the identification and prioritization of topics for pediatric critical care research. The Advisory Board is selected by the NICHD and consists of individuals with expertise in clinical trials, biostatistics, epidemiology, and pediatric critical care. Additional members with specific scientific expertise may be appointed. A parent of an affected child may also serve on the Advisory Board.

Policies and Procedures

In addition, the NICHD CPCCRN has established policies and procedures that govern its operations, including publications. These policies and procedures can be amended by the Steering Committee and the NICHD. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee. The NICHD-appointed Chairperson will vote in the case of a tie vote. All major scientific decisions will be determined by majority vote of the Steering Committee.

2.A.4. Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

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.

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.

Section VII. Agency Contacts


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, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Carol Nicholson, MD, MS
National Center for Medical Rehabilitation Research (NCMRR)
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)
6100 Executive Boulevard, Room 2A03, MSC 7510
Bethesda, MD 20892 -7510 (US Postal Service Express or regular mail)
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 435-6843
Email: [email protected]

2. Peer Review Contacts:

Robert Stretch, Ph.D.
Director, Division of Scientific Review
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 5B01D, MSC 7510
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-1485
Fax: (301) 402-4104
Email: [email protected]

3. Financial or Grants Management Contacts:

Bryan S. Clark, M.B.A.
Chief Grant Managements Officer
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 8A01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 435-6975
FAX: (301) 402-0915
Email: [email protected]

Section VIII. Other Information


Required Federal Citations

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 (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). 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 IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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/

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.

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 http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, 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.

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 new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in 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-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 (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.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award. 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 (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

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) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for 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 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 the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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.


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