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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov)
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov)

Title: Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) [U01]  

Announcement Type
This is a reissue of RFA-HD-04-025.

Request For Applications (RFA) Number:  RFA-HD-10-015

Catalog of Federal Domestic Assistance Number(s)
93.865, 93.242, 93.279

Key Dates
Release Date: Jnuary 20, 2010
Letters of Intent Receipt Date(s): March 14, 2010
Application Receipt Dates(s): April 14, 2010
Peer Review Date(s): June/July 2010
Council Review Date(s): October, 2010
Earliest Anticipated Start Date: December 1, 2010
Additional Information to Be Available Date (Url Activation Date): Not applicable
Expiration Date: April 15, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary  

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

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

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

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives     

Purpose

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA), and National Institute of Mental Health (NIMH) invite applications from investigators willing to participate under a cooperative agreement to support the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN). This network will have the capacity for developing and conducting selected behavioral, community-based translational, prophylactic, therapeutic, microbicide and vaccine trials based on and adding to the information developed through the Adolescent Medicine HIV/AIDS Research Network (1994-2001) and the current Adolescent Medicine Trials Network (2001-2011). The primary mission of the ATN will be to conduct research, both independently and in collaboration with existing research networks and individual investigators, in HIV-infected and HIV-at-risk pre-adolescents, adolescents, and young adults up to age 25 years. Prevention research and not the development of antiretroviral therapy trials will remain a large focus of research for pre-adolescents. Much of the research activity of the ATN will focus on collaboration with the Clinical Trials Networks supported by other institutes of the National Institutes of Health (NIH), including but not limited to the Division of AIDS, National Institute of Allergy and Infectious Diseases (NIAID) and the National Cancer Institute (NCI) through coordination of research. The ATN will bring expertise and resources to collaborative protocol development that will ensure feasible and acceptable study design as well as experience in recruiting and retaining this unique population. This initiative calls for a broad array of intervention studies aimed at the primary, secondary, and tertiary prevention of HIV infection in pre-adolescents, adolescents, and young adults at clinical sites and in their surrounding communities. These include pilot phase and formative studies as well as selected larger efficacy level interventions, with appropriate collaboration from other networks when needed. Comparative effectiveness and operational research, including program evaluation research, may also be conducted when necessary and feasible. The objectives of this Request for Applications (RFA) are to continue the research and expand the infrastructure required for a network of 17-19 clinical sites, one data and operations center, and one scientific leadership group with discipline-specific subgroups. This network will design, develop, and conduct multiple common clinical trials as well as pertinent formative and translational research studies collaboratively or independently when needed. This network will bring the required numbers of subjects into rigorously designed common protocols and thus address pressing research questions in youth more quickly than individual centers acting alone.

Background

An estimated 1.2 million new HIV infections occur among 15 to 24 year olds annually in the world, a number that represents a staggering 45% of all annual new infections. Each day another 3,300 young people are newly infected. In the US, the HIV incidence rate in youth is among the highest with 34% of all new infections occurring among 13-29 year olds in 2006. These infections are disproportionately distributed among ethnic/racial minorities and men who have sex with men (MSM), with 62% of new infections among African American and Hispanic populations and 53% of new infections among MSM in 2006. These groups are also unique compared to all others in that longitudinal trends of infection over the last decade have continued to increase. The relative disproportion of youth (60-80%) who are unaware of their infection compared to adults (25%) is also alarming. Adding to these are significant numbers of HIV positive children, infected from birth, and entering adolescence with its attendant developmental issues. Recent CDC guidelines for routine HIV testing across the US are increasing the numbers of people identified with undiagnosed HIV infection.  However, establishing a durable linkage to care, an activity associated with improved outcomes, remains an elusive challenge for many providers.  Linkage to care is defined as a medical assessment by a licensed medical practitioner occurring within 6-12 months since diagnosis followed by at least one, if not more, similar additional medical assessments in the ensuing 3-6 month period and thereafter. This issue is of particular relevance among vulnerable populations like youth, who encounter many more obstacles and challenges than adults.  

The ATN is the first clinical research group to address the particular challenges and unique clinical management demands of HIV-infected adolescents and the prevention needs of at-risk youth through common protocols. The ATN has undertaken studies to interrupt HIV transmission in uninfected youth. The Connect-to-Protect® (C2P) Program has established and continues to develop the primary prevention infrastructure called for in an NIH-Community Consultation (January 11-12, 2001) on what racial and ethnic minority youth and their caregivers will require to accept HIV prevention vaccine research. This is expected to buttress the foundation for research efforts on other primary biomedical prevention modalities including microbicides and pre-exposure prophylaxis (PrEP) among this vulnerable population. The C2P program has been successfully implemented at all ATN sites across the US and Puerto Rico, and preliminary evidence shows that community mobilization (engagement in prevention efforts) has effected positive changes in behaviors, which are ultimate determinants of HIV transmission and acquisition.

Secondary prevention studies examine ways to preserve health in HIV-infected populations, including management strategies like earlier initiation of highly active antiretroviral therapy (HAART) with subsequent de-intensification, vitamin D supplementation to mitigate renal and bone co-morbidities associated with HAART, and the evaluation of human papillomavirus (HPV) immunization safety and immunogenicity. Studies are needed in key areas: effects of HIV infection and of HAART on neurocognitive and other neurologic outcomes; long-term effects of newer therapies administered during growth and sexual maturation periods; adolescent-specific HIV pathogenesis; and the potential for immune recovery mediated by therapeutic vaccines or immune-based therapies. As more effective agents are used widely to treat HIV disease in youth, improved survival may permit serious non-AIDS events (SNAEs) associated with ongoing immune dysregulation and activation to emerge.  These include malignancies, particularly those resulting from co-infection with HPV, hepatitis B virus (HBV) or hepatitis C virus (HCV), cardiovascular and central nervous system events, as well as renal and hepatic diseases.  Relevant studies on immunopathogenesis and therapeutic strategies to address these possible co-morbidities are needed. Furthermore, as efforts increase to identify youth with unknown HIV infection, interventions to address the needs of newly diagnosed youth will be important.  Studies that address co-morbidities with HIV infection such as mental health disorders and substance abuse issues are also of paramount importance.

Tertiary prevention studies are needed to restore ill HIV-positive youth to full or better function. All HIV-infected youth are faced with social and physical developmental challenges of puberty that make coming to terms with chronic illness, complex drug regimens, and disclosure to peers an intensely more complicated endeavor. There are few innovative adolescent-specific studies to improve treatment adherence and to prevent or minimize the negative consequences of HIV infection, particularly during the critical developmental periods of adolescence. The ATN is systematically evaluating the major difficulties adolescents have with adherence to antiretroviral regimens. Special attention is needed for the emerging behavioral problems of perinatally-infected adolescents who experience all of the socio-behavioral difficulties of their sexually-infected peers, but also face unique clinical management problems given past multiple drug regimen failures. The ATN is addressing these special needs through studies designed with chronic disease specialists and collaborations with other AIDS clinical trials networks.

The ATN's current agenda needs to be sustained and expanded to meet the emerging needs of this population. The ATN has been able to identify, develop, and implement a broad research agenda consisting of formative and adaptive behavioral research studies, community-based epidemiologic needs assessments, and therapeutic pilot studies and trials. NICHD, NIDA, and NIMH intend to work with ATN investigators to further the HIV research agenda for American youth in three major ways: (1) by meeting the clinical management and behavioral needs of HIV-infected youth, (2) by further strengthening and developing the community-based primary prevention infrastructure that might support HIV preventive biomedical clinical trials, including vaccines, microbicides, PrEP and integrated biomedical and behavioral trials, and (3) by collaborating with the Centers for Disease Control and Prevention (CDC) and their local health department grantees to improve the identification, linkage and engagement to care of youth with undiagnosed HIV infection. To accomplish these goals fully, NICHD, NIDA, and NIMH will coordinate the development of the ATN's research agenda and the use of its available resources with the Clinical Trials Networks supported by the Division of AIDS, NIAID and the NCI.

Scope

This initiative calls for a broad array of interventional studies, conducted collaboratively and independently when needed, aimed at the primary, secondary, and tertiary prevention of HIV infection in pre-adolescents, adolescents, and young adults at the trials units associated with the network. A significant portion of these youth will include populations that are medically disenfranchised, of low socio-economic status and/or of racial/ethnic minority constituency (e.g. African American and Hispanic youth, substance abusing youth, etc.).

Studies on all three prevention levels should be interdisciplinary collaborations to address the complexity of the population and co-occurring health problems, such as sexually transmitted disease infection, alcohol and substance abuse (including levels and patterns of use), and mental, psychiatric and neurocognitive disorders. Behavioral, biomedical, and integrated modalities should be considered in the context of available infrastructure and utilizing the unique capabilities of the network. Research that employs an integrated biomedical and behavioral approach is encouraged where possible.

Primary prevention studies will focus on efforts to interrupt HIV transmission in uninfected populations. This will be accomplished by establishing a community-based primary prevention infrastructure that will be able to support clinical trials evaluating HIV preventive vaccines, microbicides, PrEP and other biomedical modalities as part of its menu of prevention strategies tailored for youth at greatest risk for HIV infection or transmission. These strategies include, but are not limited to, interventions in the following areas:

Secondary prevention studies examine behavioral and therapeutic interventions, ideally at earlier stages of infection, in order to preserve health and function toward preventing disease progression in HIV-infected populations. These include, but are not limited to, studies in the following areas:

Tertiary prevention studies evaluate strategies to restore ill HIV-positive adolescents and young people to full or better function. These studies include, but are not limited to, the following areas:

Organizational Components and Responsibilities

The ATN will consist of the Adolescent Medicine Coordinating Center (ACC), a Data and Operations Center (DOC), and Adolescent Medicine Trials Units (ATUs). Responsibilities of these components are described in the sections below.   The ACC will establish and support the Adolescent Medicine Leadership Group (AMLG), which may have subgroups.  The structure of these subgroups should be driven by the nature of the research proposed in the application. Currently, the AMLG is comprised of three subgroups to implement the research agenda (Therapeutics, Behavior, and Community Prevention). Any organized ancillary groups that support the development or review of the proposed research should be described in the application. Current ancillary groups include the Study Coordinator Group, the Community (Connect-to-Protect) Coordinators Group, the Community Advisory Board, Data and Safety Monitoring Board(s) (DSMB), and the Ethics Advisory Panel. ATN Network governance and coordination will be provided by an Executive Committee, comprised of the Principal Investigator and Project Director of the ACC, the Vice Chair(s) for any AMLG subgroup, the Principal Investigator and Project Director of the DOC, the Chair and Vice Chair of the Adolescent Medicine Trials Units Principal Investigators, and the NICHD Project Scientist. Other NIH scientists, Chairs and Vice Chairs of ancillary clinical and community coordinator groups, and the staff person of the Community Advisory Board serve as non-voting ad hoc members. The Executive Committee will enforce the established policies and procedures of the ATN. The ATN policies can be retrieved at http://www.atnonline.org/, a website operated by the currently-funded ATN.

Adolescent Medicine Coordinating Center (ACC)

The ACC is the component that provides the necessary scientific leadership and infrastructure support for the ATN.  The Principal Investigator (PI) of the ACC is responsible for assembling, through performance-based subcontracts, the necessary multidisciplinary team of established investigators from within and outside of the PI's home institution to participate in the Adolescent Medicine Leadership Group (AMLG) and to set the research agenda for the network, and clearly outline the priority areas, plans, processes, and timelines for achieving the implementation of the proposed agenda. The proposed research agenda should address the full spectrum of trials included in the purpose for establishing the ATN (viz. behavioral, therapeutic, vaccine, microbicidal, PrEP and community prevention trials). The AMLG is responsible for the peer review of studies proposed for implementation within the ATN, with additional review at the NICHD Program level. NICHD will specify when a study requires a DSMB to oversee the research activities. The AMLG establishes and maintains collaborative relationships with other research networks in order to implement the full research agenda. Members of the AMLG groups are expected to attend monthly group calls, scheduled specific study calls, and semi-annual network and ad hoc group meetings. In addition to enforcement of ATN policies and procedures, the Executive Committee will also be responsible for the fiscal management and tracking of all network resources, either directly or through establishment of a specific subcommittee tasked with this function. Members are expected to attend monthly committee calls, semi-annual network and ad hoc committee meetings; network resources are expected to be tracked and managed on at least a quarterly basis.

Adolescent Medicine Data and Operations Center (DOC) 

The Adolescent Medicine Data and Operations Center (DOC) has the responsibility to provide the ATN's infrastructure and organizational support including the funding of study needs and subject accrual to protocols at the clinical sites, staff and site training, quality assurance procedures including site monitoring, ATN study development and support, the operation and integrity of the study databases, analytic capacity, and regulatory adherence through protocol and site registrations procedures. Members of the DOC are expected to attend monthly group calls, scheduled specific study calls, and semi-annual network and ad hoc group meetings. Funds for travel should be requested within the proposed budget.

It is important to note that most funds for study protocols to be conducted by the individual Adolescent Medicine Trials Units (ATUs) will be awarded in the ATN DOC Notice of Grant Award (NGA) rather than each ATU NGA. The use of these funds will require prior approval from NICHD program.  Approval will release these funds for studies either in increments or full amounts for approved ATU protocols to the ATN DOC. The ATN DOC is responsible for the monitoring and distribution of protocol funds to the ATU as a fee for service arrangement. This mechanism will provide a centralized, equitable, and efficient method for coordinating the distribution of funds with actual subject accrual.

Adolescent Medicine Trials Units (ATUs)

The Adolescent Medicine Trials Units (ATUs) provide the clinical research site infrastructure for subject recruitment, retention, and safety through their capacity to provide a wide array of adolescent-specific services by multidisciplinary clinical staffs in well-established adolescent medicine, HIV-care experienced clinical sites. The ATUs enroll and monitor subjects in ATN-supported studies, and provide guidance and counsel on the acceptability and feasibility of proposed network research. ATUs are required to cooperate with site monitoring teams, to discharge remote data capture responsibilities and adhere to ATN policies and procedures. Principal investigators, and clinical and community study coordinators are expected to attend monthly group calls, scheduled specific study calls, and semi-annual network and ad hoc group meetings. Funds for travel should be requested within the proposed budget.

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

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the NIH Cooperative Research Project Grant (U01) award mechanism(s).

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

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

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

2. Funds Available

NICHD intends to commit an approximate minimum of $22.5 million, NIDA intends to commit $1 million, and NIMH intends to commit $1 million in total costs [direct costs plus Facilities and Administrative (F & A) costs] in FY 2011 to support 17 to 19 new and/or competing continuation grants in response to this FOA. An applicant for the ATN Coordinating Center (ACC) may request a project period of up to five years and budget for direct costs of up to $5 million per year. An applicant for the ATN Data and Operations Center (DOC) may request a project period of up to five years and budget for direct costs of up to $2 million per year. An applicant for a re-competing ATN Trials Unit may request a project period of up to five years and a core budget limited to support salary plus benefits for the PI (up to 25% effort), 2 study coordinators and 1 community coordinator to maintain the infrastructure required to perform multiple protocols. A new applicant for an ATN Trials Unit may request a project period of up to five years and core budget limited to support salary plus benefits for the PI (up to 25% effort) and 2 study coordinators to establish the infrastructure required to perform multiple protocols. Future year budgets may be escalated at three percent for recurring costs. Funds to support actual protocol accrual will be managed and distributed by the Adolescent Medicine Data and Operations Center (DOC) to each participating ATN Trials Unit as a fee-for-service arrangement after a protocol has been approved by the ATN and the NICHD has approved the funds for distribution. Requests for protocol funds should not be included in the application, but will be negotiated at a later date. Because the nature and scope of the proposed research activities will vary from site application to site application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NICHD, NIDA, and NIMH provide support for this program, awards pursuant to this FOA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

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

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

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

1.B. Eligible Individuals

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

Individuals may submit an application for one or more structural components of the ATN: the ATN Coordinating Center, the ATN Data and Operations Center, or the ATN Trials Units.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Individuals are eligible to submit an application for one or more structural components of the ATN: the ATN Coordinating Center (ACC), the ATN Data and Operations Center, or the ATN Trials Units. Given the scope of responsibilities for the principal investigator of the ACC in generating a cutting edge basic science and clinical biomedical, behavioral and community prevention research agenda for the network, the applicant must be a physician (M.D., D.O. or equivalent) with subspecialty training in either infectious diseases or immunology, and having expertise and experience in providing comprehensive care for HIV infected adolescents and young adults.

Applicant institutions for ATUs must be providing multidisciplinary, youth-friendly, primary health care to HIV-infected young people grounded in the principles and practice of adolescent medicine.  Applications for ATUs should include a primary site only; consortium or sub-site arrangements will not be accepted and such applications will be considered non-responsive to the FOA. Multiple practice sites for the research staff at the primary site are acceptable; future direct funding of these secondary sites is possible and will follow evidence of accrual to ATN studies.

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

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

Renewals. Renewal applications are permitted in response to this FOA.

Section IV. Application and Submission Information


1. Address to Request Application Information

The current 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) 435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

Prepare all applications using the PHS 398 application forms in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html). 

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

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

3. Submission Dates and Times

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

3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date(s): March 14, 2010
Application Receipt Date(s): April 14, 2010
Peer Review Date(s): June/July 2010
Council Review Date(s): September 2010
Earliest Anticipated Start Date(s): December 1, 2010

3.A.1. Letter of Intent

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

The letter of intent should be sent to:

Bill G. Kapogiannis, M.D.
Pediatric, Adolescent and Maternal AIDS Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B11J, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 402-0698
FAX: (301) 496-8678
Email: kapogiannisb@mail.nih.gov  

3.B. Sending an Application to the NIH

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

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

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

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

Director, Division of Scientific Review
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)
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

3.C. Application Processing

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

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)

6. Other Submission Requirements

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

Applications will be considered non-responsive to this solicitation if they fail to address all component-specific elements delineated in this Section.

Specific Application Requirement for ATN Coordinating Center (ACC)

An application for the ACC is submitted by an institution on behalf of the Principal Investigator of the ACC who should propose a research agenda for the ATN in the application, clearly outlining the priority areas in depth, discussing plans, processes, and timelines for achieving the implementation of the proposed agenda, and assembling the necessary multidisciplinary team of established investigators from within and outside of the PI's home institution. Disciplines should be included as required to support the proposed research agenda. The proposed research agenda should address the full spectrum of trials listed in the NICHD's, NIDA's, and NIMH's purpose for establishing the ATN (viz. behavioral, prophylactic, therapeutic, vaccine, and microbicidal trials). The ACC application should also include a strategic planning process to ensure the integrity and innovation of the research agenda.

Evidence of potential collaborative relationships with other research networks should be provided. Applicants are encouraged to consider, in particular, relationships with research networks supported by the Division of AIDS, National Institute of Allergy and Infectious Diseases and with the National Cancer Institute’s AIDS Malignancy Consortium. The budget for the ACC should include, at a minimum, salary and administrative support for the Coordinating Center, AMLG and its operations, and travel to two three-day ATN meetings per year. Future year budgets may be escalated at 3 percent for recurring costs.

The ACC PI should also request a discretionary budget in this application; to be used for the completion of open ATN studies, for the funding of new innovative pilot studies, for supporting collaboration or co-endorsement agreements with other research networks, and for accommodating central protocol-mandated requirements (e.g., specimen processing costs) on an as-needed basis.

Requests for discretionary funds may not exceed $1,000,000 direct costs in the first year of the project period. Similar requests may be made in subsequent years of the project period. The application must describe the review procedures that will guide the Executive Committee in distributing discretionary funds.

Specific Application Requirements for the ATN Data and Operations Center (DOC)

An application for the DOC is submitted by an institution on behalf of the Principal Investigator of the DOC who should propose an infrastructure and organizational support plan for the ATN in the application, clearly outlining the mechanisms proposed for staff and site training, site-specific subject accrual reimbursement, quality assurance procedures, the operation and integrity of the ATN study databases, ATN study development and support, and analytic capacity. These responsibilities should be presented with plans, processes, and timelines. It is important to note that funds for study protocols to be conducted by the individual Adolescent Medicine Trials Units (ATUs) will be awarded in the ATN DOC Notice of Grant Award (NGA) rather than each ATU NGA. The use of these funds will require prior approval from NICHD.  Approval will release these funds for studies either in increments or full amounts for approved ATU protocols to the ATN DOC. The ATN DOC is responsible for the monitoring and distribution of protocol funds to the ATU as a fee for service arrangement. This mechanism will provide a centralized, equitable, and efficient method for coordinating the distribution of funds with actual subject accrual.

The DOC applicant should be able to respond flexibly to the changing needs of the ATN as the project unfolds, adding and deleting staff as the requirements dictate. The application should reflect an understanding of these processes. An application for the DOC must provide evidence of data management capabilities by describing standard operating procedures that address: (1) plans for database design and administration; (2) plans for data collection (the ATN uses remote data capture (RDC) and this capability must be maintained), management, analysis, and data quality control for internally-developed studies; (3) plans for the management of external data collected and/or analyzed by AMLG or other collaborating investigators themselves and (4) plans for providing an electronic communication system to participants of the ATN.

The budget for the DOC should include, at a minimum, salary and administrative support for the PI, Project Director, and staff required to efficiently support open ATN studies as well as staff to support studies to be developed, and travel to two three-day ATN meetings per year. The capacity of data analytic staff should be noted, with the ability to accommodate a range of study designs, data collection modalities, and variable types. The DOC budget should also include a funding request for Community Advisory Board (CAB) staff support and travel of CAB representatives (one from each ATU) to one annual meeting. Future year budgets may be escalated at 3 percent for recurring costs.

Specific Capacity-Based Application Requirements for Newly-Applying Adolescent Medicine Trials Unit (ATUs)

An application for an ATU is submitted by an institution on behalf of the Principal Investigator of the ATU who should present evidence of the following in the application:

(1) personal expertise, experience, and capacity to contribute to the implementation of the ATN research agenda as outlined in the duties of ATU PIs; (2) personal expertise in clinical research site administration and organization as evidenced by retention of trained research staff (all existing research staff must have been employed in their current capacity for at least 2 years at the time of application); (3) an interdisciplinary health team providing a wide array of adolescent-specific clinical services on site; (4) successful past research participation, with documentation of recruitment and retention rates; (5) the availability of experienced study coordinator(s); (6) clinic and health department numerical and rate data attesting to the presence of adolescents and youth between the ages of 12 and 24 years, with HIV infection rates or rates of high-risk behavioral activity in the clinic catchment's area; (7) ability to recruit and retain at least 75 HIV-positive youth and at least 125 HIV-negative but HIV-at-risk youth in the target age range; (8) documentation of local CLIA-certified laboratory support; and (9) capacity for engaging community infrastructure to supplement the site’s clinical and research capabilities, including linkages to community-based organizations, AIDS service organizations, and venues associated with health and psychosocial services for adolescents and young adults. Past performance on outreach for research and clinical activities should be noted, along with efforts to contribute to local infrastructure building such as coalitions, partnerships, and participation in planning groups related to Ryan White, substance use treatment and prevention, and HIV prevention.

Applications should describe the applicant's clinical research organization and should include plans, information, and documentation that describe the site's ability to accomplish the work successfully. To assist with responding to selected aspects of the evidence required above, applicants should request the appropriate reporting tables from the NICHD program official listed below to include in the application. Applications from newly applying institutions will be considered non-responsive to the FOA if these tables are missing from the application.

The budget for an ATU should include salary support for the Principal Investigator, study coordinator, outreach/recruiting worker, and support staff; all with appropriate justification. Local laboratory costs for open ATN studies will be negotiated with successful applicants prior to the award. Costs for travel to two two-day ATN meetings for the PI and primary study coordinator, communications, supplies, and equipment should be included. Future year budgets may be escalated at 3 percent for recurring costs. Funds for actual protocols should not be included in the application but will be negotiated at a later date on a per subject total cost basis. These funds will be managed and distributed to each participating ATU via the DOC as a fee for service arrangement after a protocol has been approved by the ATN and the NICHD has approved the funds for distribution. Applications should include a primary site only; consortium or sub-site arrangements will not be accepted and such applications will be considered non-responsive to the FOA. Multiple practice sites for research staff at the primary site are acceptable; future direct funding of these secondary sites is possible and will follow evidence of accrual to ATN studies.

Specific Performance-Based Application Requirements for Re-Competing Adolescent Medicine Trials Unit (ATUs)

An application for an ATU is submitted by an institution on behalf of the Principal Investigator of the ATU who should present evidence of the following in the application:

(1) the experience of the ATN staff in contributing to the development of the ATN research agenda through evidence of attendance at ATN meetings and conference calls, and service on protocol teams and committees; (2) the capacity of the site through a brief description of the site's interdisciplinary health team providing care and the array of adolescent-specific clinical services on site; (3) documentation of local CLIA certified laboratory support; and (4) the experience of the site in implementing the ATN research agenda. Related to this last requirement, it is the intention of NICHD to standardize the reporting of past performance in recruitment and retention of subjects to the ATN trials open to all sites. To achieve this, re-competing applicants are instructed to request the appropriate reporting tables from the NICHD program official listed below to include in the application. Applications from re-competing institutions will be considered non-responsive to the FOA if these tables are missing from the application. Separate from the reporting tables, capacity for engaging community infrastructure to supplement the primary site’s clinical and research capabilities should be documented, including linkages to community-based organizations, AIDS service organizations, and venues associated with health and psychosocial services for adolescents and young adults. Past performance on outreach for research and clinical activities should be noted, along with efforts to contribute to local infrastructure building such as coalitions, partnerships, and participation in planning groups related to Ryan White, substance use treatment and prevention, and HIV prevention.

The budget for an ATU should include salary support for the Principal Investigator, study coordinator(s), outreach/recruiting workers, and support staff; all with appropriate justification. Local laboratory costs for open ATN studies will be negotiated with successful applicants prior to the award. Costs for travel to two two-day ATN meetings for the PI and primary study coordinator, communications, supplies, and equipment should be included. Future year budgets may be escalated at 3 percent for recurring costs. Funds for actual protocols should not be included in the application but will be negotiated at a later date on a per subject total cost basis. These funds will be managed and distributed to each participating ATU via the DOC as a fee for service arrangement after a protocol has been approved by the ATN and the NICHD has approved the funds for distribution. Applications should include a primary site only; consortium or sub-site funding arrangements will not be accepted and such applications will be considered non-responsive to the FOA. Multiple practice sites for research staff at the primary site are acceptable; future direct funding of these secondary sites is possible and will follow evidence of enrollment into studies.

Research Plan Page Limitations

Applications for the ACC – 30 pages

Applications for the DOC – 30 pages

Applications for the ATUs – 12 pages

Appendix Materials

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

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

Resource Sharing Plan(s)

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

(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

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

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

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.

In submitting a plan, all applicants to the ACC component of the ATN should 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). Applicants to all other organizational components need only note their intention to adhere to ATN policy; this will be considered responsive to the requirement to provide a data sharing plan.

All investigators responding to this funding opportunity should include a statement of intention to adhere to ATN policy for the storage and use of study biologic specimens in the ATN Repository.

Section V. Application Review Information


1. Criteria

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

2. Review and Selection Process

Review Process

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

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

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

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

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

Specific Review Criteria for the ATN Coordinating Center (ACC)

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

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

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

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

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

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

Specific Review Criteria for Adolescent Medicine Data and Operations Center (DOC)

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

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

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

Approach.  Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  Are potential problems, alternative strategies, and benchmarks for success presented?   If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

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

Specific Review Criteria for Newly-Applying Adolescent Medicine Trials Unit (ATUs)

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

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

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

Approach.  Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  Are potential problems, alternative strategies, and benchmarks for success presented?   If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

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

Specific Review Criteria for Re-competing Adolescent Medicine Trials Unit (ATUs)

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

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

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

Approach.  Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  Are potential problems, alternative strategies, and benchmarks for success presented?   If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

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

In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the impact/priority score.

Additional Review Criteria

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

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

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

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

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

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

Renewal Applications.  When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

Revision Applications.  When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project.  If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

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

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

Resource Sharing Plans.  Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:  1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

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

Selection Process

The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information


1. Award Notices

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

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

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 awardees are required to submit annual progress reports to the co-sponsoring Institutes providing study and site performance information as stipulated by the institutes and to respond to and address performance issues identified during the budget year.

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

2. A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for:

Adolescent Medicine Coordinating Center (ACC)

The ACC consists of the Principal Investigator, Project Director, and supporting staff of the institution receiving the award for the AMLG. The duties of the ACC include, but are not limited to, the following:

Adolescent Medicine Leadership Group (AMLG)

The AMLG will consist of the Principal Investigator of the ATN Coordinating Center (ACC) and the Principal Investigator of the ATN Data and Operations Center (DOC), the project directors of the ACC and DOC, the collaborating investigators comprising the AMLG subgroups, and the NIH project scientists. The Principal Investigator of the ACC will serve as chair of the group. A vice-chair will be elected by the members and from among the members of each leadership subgroup. The ACC project director will coordinate the activities of the AMLG at the direction of its officers. The AMLG will have the primary responsibility for defining the research agenda and its implementation in the network, and initiating and maintaining collaboration with other NIH-funded HIV-related research networks within the guidelines of this FOA. The AMLG will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

Specifically, the AMLG will:

Data and Operations Center

The Data and Operations Center (DOC) will consist of the Principal Investigator, DOC project director, and staff deemed necessary to carry out the mission of the DOC. The DOC project director will coordinate the activities of the DOC at the direction of the principal investigator.

The DOC will:

The Adolescent Medicine Trials Principal Investigators (ATP) Group

The ATP Group will consist of the Principal Investigators of the ATN-funded sites. The ATP Group will have a chair and vice chair elected from among and by the ATP Principal Investigators.

Specifically, the ATP Group will:

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

2. A.2. NIH Responsibilities

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

NIH Project Scientists will represent each of the institutes co-sponsoring the FOA.

The NIH Project Scientists will:

In addition to the Project Scientist, a separate 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.

The duties of the agency Program Official include:

2.A.3. Collaborative Responsibilities (optional)

The Executive Committee

The Executive Committee is the main governing body of the ATN. The Committee is composed of the Chair of the AMLG, the Vice Chair(s) of the AMLG subgroups, and Project Director of ACC; the Principal Investigator and Project Director of the DOC; the Chair and Vice Chair of the ATP Group; and the NICHD project scientist. Other NIH project scientists are non-voting members. The Chair(s) and Vice Chair(s) of ancillary study groups and the CAB Staff Person are non-voting and ad hoc members of the Executive Committee. A quorum must exist for Executive Committee action; a quorum consists of five voting members. Voting members will have one vote each, and motions will carry with a simple majority. The Chair of the AMLG will also chair the Executive Committee. The Vice Chair of the Executive Committee will be elected by the entire committee from among the committee members; none of the NIH project scientists are eligible to serve as Chair or Vice Chair of the Executive Committee.

The Executive Committee will:

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.

2.A.3. Collaborative Responsibilities (optional)

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.

2.A.4. Dispute Resolution

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. A Dispute resolution 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 dispute resolutionprocedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

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

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts


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

1. Scientific/Research Contacts:

Bill G. Kapogiannis, M.D.
Pediatric, Adolescent and Maternal AIDS Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard , Room 4B11J, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 402-0698
FAX: (301) 496-8678
Email: kapogiannisb@mail.nih.gov

2. Peer Review Contacts:

Robert Stretch, Ph.D.
Director, Division of Scientific Review
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)
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: stretchr@mail.nih.gov

3. Financial or Grants Management Contacts:

Bryan S. Clark, M.B.A.
Chief Grants Management Officer
Grants Management Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A01A, MSC 7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Phone: 301-435-6975
E-Fax: 301-451-5510
E-mail: clarkb1@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

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

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

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

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

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

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.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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

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

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

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


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