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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
National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/)

Title: Data Coordinating Center for the NICHD Cooperative Multicenter Neonatal Research Network (U10)

Announcement Type
This announcement for the Data Coordinating Center for the NICHD Neonatal Research Network (NRN) is a reissue with modifications of LOI-HD-02-106, released on June 3, 2002.

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

Request for Applications (RFA) Number: RFA-HD-07-002

Catalog of Federal Domestic Assistance Number(s)
93.865

Key Dates
Release Date: January 19, 2007
Letters of Intent Receipt Date(s): June 15, 2007
Application Receipt Date(s): July 17, 2007
Peer Review Date(s): October/November 2007
Council Review Date(s): January 2008
Earliest Anticipated Start Date(s): April 1, 2008
Additional Information to Be Available Date (Url Activation Date): Not applicable
Expiration Date: July 18, 2007

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 and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
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

The National Institute of Child Health and Human Development (NICHD) invites applications from investigators willing to participate as the Data Coordinating Center for the NICHD Neonatal Research Network under a cooperative agreement in an ongoing multicenter clinical research program designed to perform interventional and observational clinical studies in newborn infants, particularly low birth weight infants. The model of multi-site clinical centers for research is well established. The objective of this program is to facilitate the advancement of neonatal care by establishing a network of academic centers that, by rigorous patient evaluation using common protocols, can study the required numbers of patients and can provide answers more rapidly that individual centers acting alone.

The infrastructure is set up for carefully designed randomized double-blinded placebo controlled trials with the ability to follow both short-term (clinical effect) and long-term (neurodevelopmental outcome) measures. The infrastructure is also set up for observational, longitudinal studies in the neonatal intensive care unit setting. Many randomized clinical trials involve the need for baseline information regarding disease incidence and outcome, which is available from the generic database of neonates <1,500 grams birth weight in the current Neonatal Research Network. This initiative will foster support of the DCC in collaboratively conducting multicenter trials in the neonatal population.

Currently there are 16 NICHD NRN Clinical sites and four collaborating sites (sites who conducted trials within the Network that are continuing follow up of study subjects). The NICHD NRN is currently conducting the Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT), Phase II Randomized, Double Blind, Placebo Controlled, Safety and Pharmacokinetic Study of a Single Dose of Inositol in Premature Infants (INS-1), shortly to be followed by INS-2 (multiple dose pharmacokinetic study), and a large multicenter trial of Inositol for retinopathy of prematurity, each of which are randomized trials. Ongoing studies include The Generic Data Base Study (GDB): Survey of Morbidity and Mortality in Very Low Birth Weight (VLBW) Infants, Follow-up of Extremely Low Birth Weight (ELBW) Infants at 18-22 months, Neurodiagnostic Evaluations that Assist in the Prediction of Adverse Outcomes Following Acute Perinatal Asphyxia, Early Diagnosis of Nosocomial Candidiasis Study, and Early-Onset Sepsis.

The NICHD Neonatal Research Network's mission is to investigate the safety and efficacy of treatment and management strategies for newborn infants. The clinical sites for the network were re-competed in 2005 and 16 sites were awarded for the 2006-2011 cycle for membership. The data coordinating center plays a pivotal role in data management and analysis, statistical expertise, and logistical services required for the neonatal research network. In support of the activities of the Neonatal Research Network, the data center will (1) collaborate in the development, implementation and monitoring of common Network protocols; (2) provide data management, including preparation of data and safety reports for the Data Monitoring Committee and preparation of data reports for Network subcommittees, centers and public data files; (3) collaborate in the analysis of data and publication of results of the Neonatal Research Network trials and studies; (4) provide the logistical support necessary to running an efficient and productive network.

A responsive application must provide strong evidence of the applicant’s ability to cooperate with multiple sites involved in clinical trials in design, execution, data collection and data analysis resulting in publication for multicenter randomized and observational clinical trials, particularly in the area of neonatal-perinatal medicine. The data center must provide logistical support for meetings, teleconferences, and the steering committee. Experience with the Investigational New Drug (IND) Application procedures is essential. A website is required and maintained by the data coordinating center. The Data Coordinating Center is the primary liaison to the data safety and monitoring committee (DSMC) and is responsible for coordination of DSMC activities.

Scope

There are a number of controversial issues in neonatology that might be clarified by multicenter collaborative research. The funded Data Coordinating Center will cooperate with the NICHD NRN Principal Investigators and the Program Scientist in identifying research topics of high priority and in designing protocols appropriate to the evaluation of superior or even optimal management in these areas. The participating DCC will have primary responsibility for data management and analysis for Network research in collaboration with the Steering Committee.

The NICHD expects 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. Areas of potential projects include but are not limited to:

Ongoing protocols such as the generic data base and follow-up study will continue.

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

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the NIH Cooperative Clinical Research (U10) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The anticipated award date is April 1, 2008.

The NIH U10 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator 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 NICHD intends to commit approximately $3 million in total costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2008 to fund one new or competing continuation grant in response to this RFA. An applicant may request a project period of up to five years and a budget for direct costs of $1.8 - 2.2 million per year. The anticipated start date is April 1, 2008.

Although the financial plans of the NICHD 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. At this time, it is not known if this RFA will be reissued.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

The Data Coordinating Center must have an office in the Washington, DC metropolitan area, preferably in close proximity to NIH. The need for continuous and active communication between NICHD and the DCC dictates that only institutions with an office in the Washington, DC metropolitan area (or those who are willing to establish an office within the first 60 days following award) are eligible to apply. The DCC must work cooperatively with the NICHD NRN and collaborating centers.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

This RFA requires a senior investigator with an appropriate doctoral degree with skills, knowledge and resources necessary in biostatistics, data management, data analysis, project management, and ability to interact with the broad and diverse group of neonatal clinical investigators who are in the NICHD NRN.

2. Cost Sharing or Matching

Not applicable

3. Other-Special Eligibility Criteria

An applicant institution may submit only one application in response to this RFA.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants1.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 on line 2 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(s): June 15, 2007
Application Receipt Date(s): July 17, 2007
Peer Review Date(s): October/November 2007
Council Review Date(s): January 2008
Earliest Anticipated Start Date(s): April 1, 2008

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 at the beginning of this document.

The letter of intent should be sent to:

Rosemary D. Higgins, M.D.
Program Scientist for the Neonatal Research Network
Pregnancy and Perinatology Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B03B, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 435-7909
FAX: (301) 496-3790
Email: [email protected]

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications 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
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service, non-USPS service)
Telephone: (301) 496-1485
FAX: (301) 402-4104
Email: [email protected]

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NICHD. Incomplete and 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 http://grants.nih.gov/grants/policy/policy.htm.

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 competing continuation award if such costs: are necessary to conduct the project, and 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 competing continuation 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

The NICHD invites applications from qualified investigators. The following items must be addressed satisfactorily for an applicant to be eligible for consideration as a DCC for the NICHD NRN.

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 neonatal-perinatal medicine, and provide evidence of successful performance as a DCC for multi-site studies within the past three to five years. Further, the applicants need to show evidence of monitoring of trials including the ability to generate monthly reports of the NICHD NRN clinical centers and subcommittees, safety reports for Data Safety and Monitoring Committee, and provision of support of data files.

Academic Productivity

DCC applicants must provide evidence of research productivity by the data coordinating center in previous or ongoing clinical trials, especially those of a cooperative or multicenter design in the field of neonatal-perinatal medicine. 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 participation in the studies should be listed.

Clinical Trials and Statistical Expertise

A Principal investigator with a doctoral degree in a relevant field such as statistics, biostatistics, epidemiology or other relevant area, is required to commit 100 percent effort to the DCC activities of the NICHD NRN. The PI must have clinical trials and statistical expertise.

The PI is expected to provide input on study design, data collection, data analysis, and publication of NICHD NRN studies. Active participation of the PI is expected during all phases of a clinical research study. One individual must be designated as an alternate principal investigator who is able to serve in the absence of the PI. An alternate PI with a doctoral degree in a relevant field such as statistics, biostatistics, or other relevant area is should commit at least 10 percent effort to the project.

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 neonatal-perinatal medicine, 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 the changing needs and seasonal variation in work effort of the NICHD NRN. 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:

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 website system for participants of the NICHD NRN. The website should have public and private access links available. Previous experience in neonatal-perinatal medicine 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 DSMC and 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 in the DC metropolitan area) and conference calls, Data Safety and Monitoring Committee meetings (one per year and as needed) and conference calls, and other meetings as needed by the NICHD NRN. On occasion, the DCC handles travel arrangements for selected consultants as needed. The NRN communicates on an ongoing basis via email and teleconference; these activities are supported by the DCC. The DCC is responsible for supporting the infrastructure for meetings and teleconferences. 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 NRN 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 communication 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 the NICHD NRN studies (e.g., developmental tests, standardized physician examinations, follow up), 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 and ability 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, DSMC 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.

Special Strengths of the PI or Institution

Applicants are encouraged to describe special or unique strengths that may be relevant to NRN 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 NRN.

In addition, special administrative strengths or experience as well as participation in administrative aspects of clinical research (institutional review board, data safety monitoring committee, 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 perinatal 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 NRN clinical centers, the NICHD, DSMC and advisory board in all aspects of research as outlined in this RFA. NRN projects are given priority at awarded clinical sites. Clinical sites are expected to participate in all trials unless they describe trials that currently conflict with ongoing network trials as part of their application for this RFA 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. Support in areas of grants management, personnel management; space allocation, data coordination and confidentiality, procurement, and equipment as well as general support of the research should be described as well as evidence of past research support.


Budget preparation

The instructions for the budget requests provided with the research grant application (PHS 398) should be followed. F&A costs will be awarded in the same manner as for research project grants. Budgets will be reviewed on the basis of appropriateness for the work proposed. Allowable costs and policies governing the research grants programs of the NIH will prevail. In planning the budget section of your application, each applicant should submit the base budget estimates for all years. The budget is limited to $1.8 - 2.2 million in direct costs and must not exceed $3 million in total costs for any given year.

The first year budget at the time of application will be limited to a BASE BUDGET with maximum allowances as follows:

Appendix Materials

Stop SignIMPORTANT NOTE: NIH has published new limitations on grant application appendix materials to encourage application.ns to be as concise as possible while containing the information needed for expert scientific review. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.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.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

The data sharing plan should be in accordance with current NRN Policies.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria

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

The following will be considered in making funding decisions:

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by (NICHD) in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

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 high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge 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?

Applications will be reviewed based on their ability to meet overall requirements of the RFA and to cooperatively participate as the Data Coordinating Center for the NRN.

Qualifications and Commitment of Key Personnel

Protocols and Procedures

Facilities and Management

Logistics and Support Capabilities

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 priority score:

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

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 E on Human Subjects in the PHS Form 398).

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. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates

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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

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 NoA 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).

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 (U10), 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.

The NICHD Neonatal Research Network (NRN) consists of 16 NRN Clinical sites, collaborating clinical sites, and the Data Coordinating Center (DCC)(this award under RFA HD-07-002).

2.A.1. DCC Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for:

The PI will be a voting member of the Steering Committee.

The Clinical sites are funded through a separate solicitation as cooperative agreements (U10).

All parties will agree to accept the coordinating role of the group and the participatory and cooperative nature of the group process, and the decisions of the steering committee.

The NRN Steering Committee will retain custody and have primary rights to the NRN combined data that is submitted to the data coordinating center from the NRN awardees, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

NRN clinical site awardees will retain custody of and have primary rights to the data and software developed under their awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

2.A.2. NIH Responsibilities

NICHD Program Scientist

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

1. Assistance with the identification of important areas of study.

2. Assistance in the development of study protocols.

3. Assistance in the development and review of capitation-based budgets, including the identification of study costs and special institutional needs.

4. Assistance in the review and evaluation of each stage of the program before subsequent stages are started, in conjunction with the Steering Committee and the Advisory Board.

5. Assistance in reporting results in the community of investigators and health care recipients.

6. Assistance in the conduct of the trials, including ongoing review of progress; possible redirection of activities to improve performance and cooperation; and frequent communication with other members of the Steering Committee.

7. Participation on the Steering Committee and all active subcommittees.

NICHD Program Official

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.

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

2.A.3. Collaborative Responsibilities

The management of the Neonatal Research Network includes committees with the following functions:

Steering Committee

A Steering Committee will be responsible for protocol development, assisted by the Advisory Board and the Data Safety and Monitoring Committee. The Steering Committee will have primary responsibility for the conduct of protocols and the preparation of publications. The Steering Committee will be composed of all Principal Investigators from the clinical sites, the Principal Investigator from the data center, and two NICHD staff. The Clinical Centers are supported through separate cooperative agreements solicited in a separate RFA. Participating NICHD staff will include the Pregnancy and Perinatology Branch NRN Program Scientist. The NRN Program Scientist will be the only voting NICHD staff member of the Steering Committee. A member of the NICHD Grants Management Branch advises the Steering Committee on funding matters. An outside chairperson, who is not participating as a Principal Investigator, will be selected by the NICHD.

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.

Advisory Board

The Advisory Board assists the Steering Committee in the identification and prioritization of topics for perinatal research. The advisory board is selected by the NICHD and consists of individuals with expertise in clinical trials, biostatistics, epidemiology, perinatology, and neonatology, and the Chairperson of the Steering Committee. Additional members will participate based on the need for specific expertise.

Data Safety and Monitoring Committee

A Data Safety and Monitoring Committee (DSMC) monitors the safety of ongoing clinical trials. The DSMC is established by the NICHD and reports to the Director of NICHD. The DCC is the liaison with the DSMC. The DSMC is composed of individuals with expertise in clinical trial design and conduct, perinatology, neonatology, basic science, and ethics.

In addition, the NICHD Neonatal Research Network 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.

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 PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

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:

Rosemary D. Higgins, M.D.
Pregnancy and Perinatology Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B03B, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service, non-USPS service)
Telephone: (301) 435-7909
FAX: (301) 496-3790
Email: [email protected]

2. Peer Review Contacts:

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service, non-USPS service)
Telephone: (301) 496-1485
FAX: (301) 402-4104
Email: [email protected]

3. Financial or Grants Management Contacts:

Grace Poe
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17J, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service, non-USPS service)
Telephone: 301-435-7011
FAX: 301-451-5510
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

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

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). 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.

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 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.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).

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 RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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

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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