Department of Health and Human Services

Participating Organizations
National Institute 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 Coordination and Analyses Center (DCAC) [U01]

Announcement Type:
New

Request For Applications (RFA) Number: RFA-HD-06-001

Catalog of Federal Domestic Assistance Number(s)
93.865

Key Dates
Release Date: December 9, 2005
Letters of Intent Receipt Date(s): January 20, 2006 
Application Receipt Dates(s):  February 21, 2006
Peer Review Date(s):  April-May 2006
Council Review Date(s): June 8, 2006
Earliest Anticipated Start Date: July 1, 2006
Additional Information: To Be Available Date (Url Activation Date): Not applicable
Expiration Date: February 22, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

• The National Institute of Child Health and Human Development (NICHD) invites applications for a Cooperative Agreement (U01) to establish a Data Coordinating and Analyses Center (DCAC) for the Community and Child Health Network (CCHN).
• The NICHD intends to commit approximately $500,000 in Total Costs in FY 2006 to fund one new grant in response to this RFA.
• An applicant may request a project period of up to five years and a budget for direct costs up to $325,000 dollars per year.
• This RFA will use the National Institutes of Health (NIH) Cooperative Research Project Grant (U01) award mechanism.
• Investigators may submit an application if his/her institution has any of the following characteristics: For-profit or non-profit organizations; public or private institutions, such as universities, colleges, hospitals, and laboratories; units of State and local governments; eligible agencies of the Federal government; domestic organizations.
• Eligible principal investigators include any individual with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.
• An institution may submit only one application in response to this RFA.
• Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 09/2004). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, email: GrantsInfo@nih.gov. Applications must be received by the date listed under Key Dates, above.
• See Section IV.1 for application materials.
• Telecommunications for the hearing impaired is available at: TTY 301-451-5936.

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

1. Research Objectives

Nature of the Research Opportunity

The National Institute of Child Health and Human Development (NCHD) invites applications for a Cooperative Agreement (U01) to establish a Data Coordinating and Analyses Center (DCAC) for the Community and Child Health Network (CCHN). The CCHN consists of three-to-five clinical research sites to be funded by the NICHD to carry out Phase II projects to explore the causes of racial and ethnic disparities in perinatal and early pediatric health outcomes. The five clinical sites eligible to apply for Phase II award are those that were funded for Phase I by NICHD and fulfilled Phase I objectives. A coherent structure for the Phase II study will be developed by the end of Phase I.

The DCAC will interact with Phase II CCHN clinical sites, the CCHN Steering Committee and related subcommittees, the biological specimen repository, the Data and Safety Monitoring Board (DSMB) and the NICHD Program Administrators.

Background

In spite of remarkable progress in perinatal and pediatric care, there remain significant racial and ethnic disparities in health outcomes in the United States. Perinatal interventions to improve outcomes and reduce disparities have resulted in small or transient benefits, at best. To address this issue, five Research Centers were funded in 2002 to develop a community-linked research collaboration for maternal and child health. The purpose of the 2-1/2 year funding was to develop a multi-site, multi-level study design that will examine how community-, family-, and individual-level influences interact with biological influences and result in health disparities in pregnancy outcome and infant and early childhood mortality and morbidity.

The Phase II clinical sites and the DCAC will be awarded at the same time. The Phase II study will be based on strong theoretical foundations, incorporating rigorous measurement regimes, and using study designs found in the biomedical, social, and behavioral sciences. Such a multi-disciplinary approach was considered necessary to improve our understanding of the complicated interplay of environmental and genetic factors that produce biological outcomes. The Phase II study will be designed to enroll a cohort of 4000 5000 subjects in the perinatal period and follow them until a subsequent pregnancy ensues. Infants from the index and the subsequent pregnancy will be studied for health outcomes. The activities will include screening and recruitment of subjects, follow-up and measurements of social and biological indicators, and assessments of outcome variables in the mothers and infants. The Phase II study is planned as a five-year study. A standardized protocol will be used to collect common measures across sites (Common Data Set). Information in the Common Data Set will be used in studies involving comparisons among sites and/or studies that require aggregation of data from multiple sites. In addition to the common protocol with minor local variation, each research site may conduct independently, or with limited collaboration with other research sites, additional site-specific studies, depending upon securing funds from other sources.

Objectives and Functions of the Data Coordinating and Analyses Center

This RFA is to establish a DCAC to provide coordination, organizational, informational, logistic, and analytical support to the CCHN during the implementation of the Phase II study. Several activities are requested as part of DCAC functions and responsibilities. These activities require the DCAC to closely work with the CCHN Steering Committee (the main decision-making body) and subcommittees, biological specimen repository site (see below), Data and Safety Monitoring Board (DSMB), and the Program Administrators from NICHD. The Principal Investigator (PI) of the DCAC will participate as a voting member of the Steering Committee.

Biological Specimen Repository: The clinical sites will obtain biological specimens from subjects enrolled in the Phase II study. These specimens may include, but are not limited to, placenta, blood, and salivary specimens. Some or all of such specimens collected may need to be stored until batch processing or measurement of biological variables at a later date. The NICHD will be negotiating with Federal and non-federal sites and repositories to facilitate storage of biological specimens. The DCAC is expected to interact with the clinical research sites and the repository site(s) at several levels. These include coordinating the collection process, safe and expedited transportation of the samples collected, documentation and logging of information related to the specimens, and entry of results of analyses of biological data, when they become available, into the research data base.

Additional specific responsibilities of the DCAC are listed below.

• Cooperate with the Clinical Sites and NICHD in all design, collection, and analysis functions.
• Arrange and participate in CCHN Steering Committee and DSMB meetings and conference calls, and CCHN Subcommittee conference calls as needed.
• Prepare and distribute the minutes and action items from the CCHN Steering Committee and DSMB meetings and conference calls, site visits, and CCHN Subcommittee meetings, and provide timelines for the completion of action items and updates on the status of action items as required.
• Coordinate with the Steering Committee while developing data collection tools; develop and maintain data entry systems for the creation and maintenance the Common Data Set.
• Prepare, disseminate, and update the Common Data Set Manual of Procedures (MOP), data collection forms, databases, and results reporting summaries for the sites, and maintain and verify for correctness the resulting Common Data Set.
• Work with the Steering Committee to design and implement computer-assisted personal interviews and geo-coding data.
• Coordinate activities related to collection of biological specimens (e.g., placenta, blood, and salivary samples) and transporting them to the Federal or non-federal repositories.
• Provide or arrange for training of all site personnel as needed on data management and analysis, and quality control and quality assurance.
• Provide the NICHD Program Administrators, the DSMB, and the Steering Committee with reports based on statistical and other analyses of issues related to the Common Data Set, or other needs arising during the course of studies.
• Assist the NICHD Program Administrators in written, telephone, and electronic communications with the study sites and with various committees as requested.
• Analyze data for publication, and work with the Clinical Site and the NICHD staff in publication efforts. Establish a catalogue of, and disseminate information concerning, all CCHN publications.
• Report quarterly to the NICHD and to the Steering Committee prior to and at each meeting regarding accumulated data and research center performance. The applicant should document the ability to meet such reporting deadlines.
• Develop and maintain a public and private (secured, password-protected) CCHN Web page.
• The DCAC, in collaboration with the Steering Committee, will develop and implement plans to create a database that is accessible to the public within a year of study completion.

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

1. Mechanism(s) of Support

This RFA will use the National Institutes of Health (NIH) Cooperative Research Project Grant (U01) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

The NIH U01 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 $500,000 in Total Costs [Direct plus Facilities and Administrative (F&A) costs] in FY 2006 to fund one new grant in response to this RFA. An applicant may request a project period of up to five years and a budget for direct costs up to $325,000 per year. The earliest anticipated start date is July 1, 2006.

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

1. Eligible Applicants

1.A. Eligible Institutions

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

• For-profit organizations
• Non-profit organizations
• Public or private institutions, such as universities, colleges, hospitals, and laboratories
• Domestic Institutions

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 programs.

2. Cost Sharing or Matching

Cost sharing is not required.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria

Minimum Requirements

• The applicant must have demonstrated prior experience as a coordinating and statistical center in multi-center clinical and epidemiological studies. Previous experience with studies related to perinatal and/or pediatric trail is desirable, but not mandatory.
• The DCAC will report quarterly to NICHD, and to the Steering Committee prior to and at each meeting regarding accumulated data and clinical unit performance. The applicant should document the ability to meet such reporting deadlines.
• The investigators should be prepared to meet as a Steering Committee about four times per year for each of the five years of the funding period.
• The applicant must be prepared to assist the NICHD in securing services of research sub-specialties to supplement the expertise of members of the Steering Committee.
• The PI, with other staff, must have appropriate biostatistical, computational, data management, and data coordination expertise and capability.
• The applicant must have the ability to assist in designing protocols, study manuals, and data collection systems.
• The applicant must have experience in developing and maintaining a quality control system, and should demonstrate experience in monitoring quality assurance of data.
• The applicant must have demonstrated experience in developing logistical support to handle collection, transportation, and data logging activities related to biological specimens.
• The applicant must have demonstrated experience in collecting and analyzing computer-assisted personal interviews and must possess the necessary software/hardware systems for this purpose, as well as for analyzing data on geo-coding.
• The applicant must have experience in data monitoring, patient tracking systems, and coordination.
• The applicant must demonstrate the willingness and ability to cooperate with the CCHN sites and NICHD staff in all design, data collection, and analysis functions. The applicant should provide a plan for developing a cooperative relationship among the CCHN sites and between the various organizational components.
• The applicant must be prepared to assist the NICHD in securing services of research sub-specialties to supplement the expertise of members of the Steering Committee.
• The applicant must be prepared to cooperate with the CCHN sites and the NICHD Program Scientist in all design, collection, and analysis functions.

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: GrantsInfo@nih.gov.

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): January 20, 2006 
Application Receipt Dates(s):  February 21, 2006
Peer Review Date(s):  April-May 2006
Council Review Date(s): June 8, 2006
Earliest Anticipated Start Date: July 1, 2006

3.A.1. Letter of Intent

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

• Descriptive title of proposed research
• Name, address, and telephone number of the Principal Investigator
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

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 NICHD 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:

Tonse N. K. Raju, M.D.
Medical Officer
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B03, MSC 7510
Bethesda, MD 20892-7510
(Rockville, MD 20852 for courier or express services)
Telephone: (301) 402-1872
Fax: (301) 496-3790
Email: rajut@mail.nih.gov

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 H. Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01. MSC 7501
Bethesda, MD 20892-7510
(Rockville MD 20852 for courier or express service)
Telephone: (301) 496-1485
Fax: (301) 402-4104
E-mail: stretchr@mail.nih.gov

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.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

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

Please address the following in your application:

Research Experience

• Description of previous experience in managing multi-center clinical research studies, including experience in coordinating specimen repository activities.
• Description of applicant's perception of the DCAC role in the study.

Staffing and Procedures

• Description of staff and computing, data processing, and analytic capability.
• A plan detailing methods of data receipt, quality control, analysis, and reporting, including communication with clinical and administrative personnel. This plan should be based on the assumption that there will be a patient tracking system, and a database that will include information from medical records and specialized laboratory studies (genetics, pathology, and maternal interview).

Intent to Participate

• There must be a clearly expressed intent to participate in a cooperative manner with the Clinical Sites and the NICHD in all aspects of Network research as outlined in this RFA.

Budget Preparation

The instructions for the preparation of the budget provided in the application form PHS 398 (rev 9/2004) should be followed. 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 the application, each applicant should submit budget estimates for all years.

The budget should include components for efforts for all key personnel. The effort level can be up to 100 percent for the Principal Investigator and up to 100 percent for the Study Coordinator/Administrative assistant. Similar effort levels can be requested for other key personnel including (but not limited to), the Project Director, Computer Systems Developer(s)/programmer(s); Data Manager and/or Management Specialist(s); Administrative Assistant(s); and consultant(s). Percentage effort for each key personnel should match their unique role(s) in the project explained fully under budget justification. In addition, budget can include costs for 12 person trips annually to Bethesda, MD for steering committee meetings, and up to $10,000 for supplies and equipment as needed. All line-item budget requests should be justified. Direct costs in any year should not exceed $325,000. The F&A cost of consortium institutions does not count toward the $325,000 cap.

Future years budgets should be limited to annual increments of base salary not to exceed three percent, while all other costs will remain flat.

Plan for Sharing Research Data

Because the data elements and study design will be developed after award, the data-details of the sharing plan need not be presented; but an intent to develop such a plan should be specified.

The reasonableness of the outlines of the data sharing plan 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.

1. Criteria

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

The following will be considered in making funding decisions:

• Scientific merit of the proposed project as determined by peer review
• Availability of funds
• Relevance of program priorities

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:

• Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.
• Receive a written critique.
• Receive a second level of review by National Advisory Child Health and Human Development Council.

Criteria for Evaluation

Qualifications and Commitment of Key Personnel:

• Experience of the PI and Co-investigators in working with networks conducting observational and interventional clinical trials;
• Evidence of prior successful scientific collaboration involving federally-funded investigators;
• PI and Co-investigator’s expertise in leading successful data coordinating center(s);
• Appropriate biostatistical, computational, data management and coordination expertise and capabilities by the PI and by the related key personnel.
• Adequacy and breadth of understanding of the existing research on the health of women and infants during perinatal and postpartum periods in the United States; an awareness of the ethical and cultural issues and concerns related to community involvement and participation in health care research projects similar to the CCHN Phase II study; and an understanding of the complexities of fielding community based studies in subject population from a diverse socio-economic background;
• Demonstrated prior experience as a coordinating and statistical center in multi-center randomized clinical trials and studies;

Facilities

• Documented adequacy of administrative office facilities including space, computer and related office supplies and other infrastructure;
• Documented availability of facilities for collecting and analyzing computer-assisted personal interviews; and the availability of software/hardware systems for this purpose including for the analyses of geo-coding data.
• Multilingual capability to facilitate document translation and protocol implementation is an advantage;

Other Specific Criteria

• Commitment to work collaboratively with the NICHD, the academic and community PIs within the CCHN network and their respective co-investigators and sub-contractors to achieve the goals of CCHN Phase II study described earlier;
• Evidence of support and commitment by sub-contractors for collaboration.
• Demonstrated ability and adequacy of plans to assist in designing protocols, study manuals, and data collection systems, including distributed data entry.
• Documented ability and adequacy of plans to develop central data collection, management, and analysis for the network;
• Demonstrated experience and adequacy of plans to develop and implement data monitoring and patient tracking systems;
• Demonstrated experience and adequacy of plans to develop and maintain quality control systems, and guarantee the quality and integrity of collected data;
• Commitment to cooperate with the CCHN sites investigators (academic and community) and the NICHD Program staff in all design, collection, and analyses functions;
• Plans to respond to potential changes in the protocols as developed by the CCHN Steering committee;
• Documented ability and adequacy of plans to organize and coordinate the Data and Safety Monitoring Board, teleconferences and face-to-face meetings of the Steering Committee (the latter, up to 4 times a year), and other CCHN-related meetings as necessary. Commitment to attend all CCHN meetings;
• Documented ability and adequacy of plans to report monthly to the NICHD, and the CCHN Steering Committee, as well as providing to NICHD and members of the Steering Committee, up-to-date data on the performance by each of the research sites prior to each Steering Committee meetings;
• Commitment and capacity to develop and implement plans for a future database from the common protocol that is accessible to the public within two years of study completion, in collaboration with the Steering Committee and NICHD.

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. Although DCAC will not enroll research subjects, it will have an access to all aspects of research information, including the confidential and sensitive data. The applicant organization should address how they will handle and safeguard all confidential research data collected in the CCHN studies. Adequate documentation should be provided about the training of key personnel in regards to protection of human subject from research risks (see the Research Plan, Section E on Human Subjects in the PHS Form 398 for more details).

Inclusion of Women, Minorities and Children in Research: Not applicable

Care and Use of Vertebrate Animals in Research: Not applicable

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 applicant organization should address issues related to human subject protection including confidentiality and community needs, and data sharing with investigators outside of the awardees. Since there will be a central data collection, management, and analyses system in this study, the DCAC, in collaboration with the Steering Committee, will develop and implement plans to create a database that is accessible to the public within a year of study completion. Because the data elements and study design will be developed after award, the data-details of the sharing plan need not be presented; but an intent to develop such a plan should be specified.

The reasonableness of the outlines of the data sharing plan 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
Not applicable

1. Award Notices

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 e-mail notification from the awarding component to the grantee business official (designated in Item 14 on the Application Face Page). If a grantee is not e-mail 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 notice of grant award. 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 ( NIH U01), 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 has the primary responsibility for coordinating activities with the clinical and other research sites of the Community and Child Health Network (CCHN), as well as with the NICHD staff, and collection and analyses of research data, as developed by the Steering Committee. It is anticipated that these activities will contribute to the successful completion of CCHN studies. The Principal Investigators from the DCAC and the CCHN Clinical Sites will retain custody of, and primary rights to their data developed under this award, subject to Government rights of access, consistent with the current HHS, PHS, and NIH Policies, and according to the publication policies developed by the Steering Committee.

2.A.2. NIH Responsibilities

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

The NICHD Project Scientists include staff from the Pregnancy and Perinatology Branch (PPB) and from the Demographic and Behavioral Sciences Branch (DBSB), NICHD. These scientists will have substantial involvement above and beyond the normal program stewardship of the award. The Project Scientist is a partner within the research team representing the government's interest in the substantive work of the research team. The primary role of the Project Scientists is to facilitate the work of the awardees and the Steering Committee. They will:

• Assist in all functions of the Steering Committee, including: reviewing and commenting on each stage of the program before subsequent stages are started; recommending the options of adding, modifying or terminating aspects of the program.
• Recommend consultants for appointment to the Steering Committee on an as-needed basis.
• Assist with accomplishing the objectives of the CCHN.
• Assist in the analysis, interpretation, and reporting of findings in the scientific literature and other media to the community at large and the public policy community within the Federal government.
• NICHD will appoint a Project Officer, apart from the Project Scientists, who will:
• Have the option to withhold support to a participating institution if technical performance requirements, such as compliance with the protocol, are not met.
• Carry out continuous review of all activities to ensure objectives are being met.
• Exercise the normal stewardship responsibilities of an NIH Program Officer.

2.A.3. Collaborative Responsibilities

Steering Committee

The overall guidance and management of the research team will be provided by a Steering Committee. The responsibilities of the Steering Committee will include planning and implementation of the cooperative aspects of the study. Membership of the Steering Committee will include the two Principal Investigators from each site (one academic PI and the other a Community PI); a chair appointed by NICHD who will have no direct ties to any of the sites; the NICHD Project Scientists; and the PI of the DCAC. Each full member will have one vote; the NICHD Project Scientists will have a total of one vote. All members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee. The Steering Committee will:

• Plan the design and implementation of the plan of action for the CCHN;
• Participate in decision-making regarding study design issues, developing study implementation processes at the participating sites, and key constructs regarding the conduct and completion of the CCHN studies;
• Formulate publication policy and appoint a Publication Subcommittee; and
• Publish results, conclusions, and interpretations of the cooperative research; due publication credit will be given to all work done cooperatively.

All CCHN clinical site and DCAC awardees agree to accept the coordinating role of the Steering committee and the cooperative nature of the group process.

Data Safety and Monitoring Committee

A Data Safety and Monitoring Committee (DSMC) will be established by the NICHD, and will advise the Steering Committee on research design issues, data quality and analysis, and ethical and human subject issues.

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.

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:

Tonse N. K. Raju, M.D.
Medical Officer
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B03, MSC 7510
Bethesda, MD 20892-7510
(Rockville MD 20852 for express/courier service)
Telephone: (301) 402-1872
Email: rajut@mail.nih.gov

2. Peer Review Contacts:

Robert H. 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 courier or express service)
Telephone: (301) 496-1485
Fax: (301) 402-4104
Email: stretch@nih.gov

3. Financial or Grants Management Contacts:

Myrtle A. Coleman
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A01, MSC 7510
Bethesda MD 20892-7510
(Rockville MD 20852 for express/courier service)
Telephone: (301) 402-4572
Fax: (301) 482-7827
Email: colemama@mail.nih.gov

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. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations: This program is described in the Catalog of Federal Domestic Assistance 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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