Part I Overview Information


Department of Health and Human Services

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

Components of Participating Organizations
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov)

Title: National NeuroAIDS Tissue Consortium (NNTC) Data Coordinating Center (DCC) (U01)

Announcement Type
New

Request For Applications (RFA) Number:  RFA-MH-08-020

Catalog of Federal Domestic Assistance Number(s)
93.242

Key Dates
Release Date: May 18, 2007
Letters of Intent Receipt Date(s): August 4, 2007
Application Receipt Date(s): September 4, 2007
Peer Review Date(s): November 2007
Council Review Date(s): January 2008
Earliest Anticipated Start Date(s): April 1, 2008
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: September 5, 2007

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
  1. Research Objectives

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

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

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

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

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Purpose

The purpose of this Request for Applications (RFA) is to solicit applications for the Data Coordinating Center (DCC) that will serve the four National NeuroAIDS Tissue Consortium (NNTC) Network sites.   The DCC will provide for two functions:  1) the database and coordinating center support functions to the NNTC research community, and 2) the development of an NNTC-related scientific agenda in large part based upon the NNTC database.  (The NNTC awards will directly and indirectly support ongoing neuroAIDS research projects and the initiation of new projects concerning the long-term effects of HIV infection and treatments on brain function (see RFA-MH-08-021). The future collection of well-characterized brains and fluids from HIV+ populations will continue to be an important resource for the community. The restructuring of the NNTC from serving as a research resource for the scientific community to being a cooperative research project reflects a changed emphasis from primarily serving as clinical and brain bank collection sites toward being a resource that also provides a scientific research agenda for the research community based upon the current collections in hand and upon the associated data in the NNTC database. The database harboring the NNTC common data set is an increasingly valuable resource for epidemiology studies due to the uniqueness of the NNTC cohort.  It will be able to provide descriptive statistics on demographics and epidemiology-related information that is increasingly valuable as diagnosable end-stage patients are surviving and living longer lives, and it will be able to shape future recruitment and collections strategies based upon analyses of current holdings and scientific agendas.  To ensure that the maximal scientific benefit is derived from this significant public investment and is consistent with the goals of proposed NIH policy on data and resource sharing, this funding opportunity aims to support rapid sharing of data and research resources with the broad scientific community for research use.

Background

The NNTC was established in 1998 with the purpose of providing neuroAIDS researchers with high-quality brain and fluids samples from well-characterized HIV-infected patients in terms of their neuromedical and neuropsychiatric antemortem status.  NNTC participants have been evaluated at 6-month intervals and researchers can now request tissues from persons who have been characterized by: degree of neurobehavioral impairment, neurological, neuropsychiatric, and other clinical diagnoses, history of drug use, antiretroviral treatments, blood and CSF viral load, and neuropathological diagnosis. Currently, more than 2000 subjects are enrolled and the NNTC banks contain approximately 641 brains, thousands of plasma samples, over 600 CSF samples, and additional organs and nerves of interest. More than 200 publications have credited the resource as being instrumental in their research findings. The four clinical and brain banking sites are located at Mt. Sinai, New York; University of Texas, Galveston; University of California, San Diego; and University of California, Los Angeles.  (Also see RFA-MH-08-021).

Data Management: In 1999 the NNTC steering committee determined that the consortium and its users would benefit from the creation of a centralized facility which would converge the specimen and clinical information from the 4 sites. After funding the preliminary effort through supplements, the NIMH released a request for proposals (RFP) for a National Coordinating Office (NCO) to take a larger role in database operations. The NCO contract began effectively in April, 2003. The contractor currently maintains and expands the centralized inventory databases on a secure network server; maintains and monitors a password-protected and public website; serves as an information conduit between the consortium and the public; produces appropriate public relations materials including a public NNTC website (http://www.nntc.org/); provides toll-free telephone access by which researchers can request specimens; collects and distributes requests to individual NNTC sites; coordinates the shipments of samples; follows-up on receipt of tissue and fluid delivery; trains NNTC staff in any new database entry methods and provides them with technical assistance related to data transfer; and generates descriptive statistics based on the cohort.

The unexpected number of “end stage disease” (an enrollment criteria) survivors offers unique opportunities for basic science and database-related epidemiology research. In the future, it is expected that the scientific leader of the DCC (DCCsPI) will help drive the scientific agenda by providing the appropriate HIV, biostatistical, epidemiological, and neuroAIDS-related expertise to guide the NNTC PIs to fully appreciate the capabilities of the database in terms of its contributions to an “internal” NNTC and “external” scientific agenda.

Research Objectives

The NNTC has a unique mission, cohort, and subpopulation of enrollees who have survived several years after being diagnosed as having end stage disease. The consortium will be poised to serve as a resource by providing human tissue for other scientists to initiate or replicate research projects such as the identification/validation of potential biomarkers for HIV (or other – e.g., HCV, PML, JCV) disease progression in brain (or potentially liver, heart, etc.) tissue. Additionally, the resource may be able to rapidly respond to new findings in the field by validating potential biomarkers or other findings via its consortium related scientific agenda and priorities. The consortium is to provide important, novel information regarding the epidemiology of neuroAIDS and make additional inroads, through its resource and internal scientific agenda functions, into the pathogenesis of brain disease in the context of HIV infection. The value of the NNTC clinical and brain banking operations will continue to be important to researchers in the future as the disease evolves and new treatments are brought to patients.

Our objectives for the future include restructuring current operations such that the consortium can incorporate a scientific agenda into its operations by integrating individuals with expertise in all disciplines necessary to address a NNTC scientific agenda (i.e. neuropathology, virology, immunology, neuroscience (molecular, cellular and integrative), genetics, genetic epidemiology, and biostatistical) into the operations of the consortium. The NNTC will be managed by an Executive Committee (EC) (see Section VI.2.A.3) whose voting membership will consist of the site Principal Investigators (PIs) and the scientific PI of the DCC (DCCsPI).  In addition, a Scientific Leadership Group (SLG) will be formed, consisting of the EC, a Project Collaborator representing the NIMH and a Project Collaborator for the NINDS, as well as lead scientific discipline experts in the areas identified by the EC as important to the development of the scientific agenda. The SLG will be charged with identifying best practices regarding optimal recruitment (practices, numbers at sites, demographics, and scientific value in the context of the NNTC mission, etc), and methodologies (clinical and laboratory), as well as explicitly defining and promulgating a NNTC-based scientific agenda and research resource for the larger neuroAIDS scientific community.

Applications for the DCC should address how the Center plans to fulfill the primary objectives which include: (1) maintaining and expanding the centralized inventory databases on a secure network server that contains unidentifiable patient-related information (such as cognitive status, drug-use history, neuropsychological history, CD4 count) and general demographics, pathological data, specimen inventory and researchers’ requests; (2) maintaining  and monitoring a password-protected website accessible to authorized users; (3) serving as an information conduit between the consortium and the scientific and layman public audiences, producing appropriate public-relations materials on behalf of the NNTC including maintaining and updating a public NNTC website, and providing toll-free telephone access by which researchers can contact the DCC; (4) collecting requests from researchers for specimens, distributing requests to individual NNTC sites, coordinating the shipments of samples, and following up on receipt of tissue and fluid delivery; and (5) training NNTC staff in any new database entry methods as a result of approved changes in current database operations and providing technical assistance related to data transfer. 

The DCC should also address a scientific agenda.  In terms of the scientific agenda, the DCCsPI should formulate and address what s/he sees as being key research opportunities that could be implemented with the current and prospective database studies. The DCCsPI should develop potential internal scientific agenda-related projects that could be epidemiology-based and database oriented.  S/he should describe how they anticipate contributing to the development of a scientific agenda considering factors such as how alterations in current and future recruitment strategies will affect data analyses and longitudinal value (i.e., how many subjects will be maintained at each site; how long sites anticipate following a subject; between-site differences in recruitment number and length of patient enrollment be handled; the rationale for between-site variability regarding recruitment, length of follow up, and procedural differences; how will future NNTC recruitment occur such that subject demographics and the scientific value/utilization of tissues is taken into account before additional recruitment and collections continue, such that the scientific value is maximized and cost is minimized). The DCCsPI should also discuss how s/he will contribute to discussions and the development of an external scientific agenda, which should provide the research community with a better understanding of the limitations and possibilities associated with research projects based upon NNTC collections.

The DCCs PI should address how s/he can fill a leadership role in biostatistical neuroAIDS-related research (see PAS-07-XXX).

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

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the U01 Cooperative Agreement award mechanism(s).   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". The NIMH intends to reissue the funding opportunity near the end of the projects’ awarded term.

2. Funds Available

The NIMH intends to commit approximately $450,000 in direct costs in FY 2008 to fund 1 DCC in response to this RFA.  An applicant may request a project period of up to 5 years.  Although the financial plans of NIMH provide support for this program, an award pursuant to this RFA is contingent upon the availability of funds. Funding beyond the first year of the grant will be contingent upon satisfactory progress during the preceding years and availability of funds.  

The anticipated start date is April 1, 2008. The periods of performance for new awards will continue for 5 years after the start date.

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

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics and is independent of the current NNTC brain banks, except in the collaborative efforts to established in this RFA

Although foreign institutions may apply, they must demonstrate superior capabilities over domestic competitors. They need to detail cost containment strategies regarding travel to the annual EC meetings and potentially to the NNTC sites, if necessary, in order to test, troubleshoot or provide training to site staff.

1.B. Eligible Individuals

The principal investigator of the DCC site must possess the skills, knowledge, resources, and professional experience needed to carry out the proposed data coordinating center activities and a willingness to share in the goals and objectives established by the consortium and executive committee. In addition, s/he should have established a demonstrably productive working relationship as a scientific collaborator. The Principal Investigator must be able to commit at least 10% effort to the DCC.

The DCCsPI must fulfill the functions of managing a DCC and serving a scientific leadership role by showing expertise in biostatistical issues as well as strong neuroAIDS experience.  S/he must be capable of facilitating the development of a NNTC-based scientific agenda particularly as pertains to the current and prospective collections of data in the database.  The DCCsPI must be able to commit at least 10 percent effort to the NNTC cooperative effort.

2. Cost Sharing or Matching

Not applicable.

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

None

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, 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.


SUPPLEMENTAL INSTRUCTIONS

PART A: Data Coordinating Center Functions (NTE 15 Pages)

Description of the operations of the DCC and how it will meet the data management, communications and other functions in support of the NNTC

PART B: Scientific Leadership and Agenda Setting (NTE 15 Pages)

Description of DCCs PI plan for developing scientific agenda.


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): August 4, 2007
Application Receipt Date(s): September 4, 2007
Peer Review Date(s): November 2007
Council Review Date(s): January 2008
Earliest Anticipated Start Date(s): April 1, 2008

3.A.1. Letter of Intent

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

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Kathy L. Kopnisky, Ph.D.
Division of AIDS, Health and Behavior Research
Center for Mental Health Research on AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6205, MSC 9619
Bethesda, MD 20892-9619
Telephone:  (301) 443-7726
FAX:  (301) 443-9719
Email:  kkopnisk@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 five copies of the appendix material must be sent to:

Shuang-Bao Hu, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Blvd., Room 6156, MSC 9609
Bethesda, MD 20892-9606
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-5160
FAX: 301-594-0702
Email: shuangbaohu@email.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 National Institute of Mental Health. Incomplete and non-responsive applications will not be reviewed.

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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

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

6. Other Submission Requirements

PART A: Data Coordinating Center Functions (15 pages total)

The application should address how the Center will achieve the objectives to: 1) maintain and expand the centralized inventory databases on a secure network server that contains unidentifiable patient-related information (such as cognitive status, drug use history, neuropsychological history, CD4 count) and general demographics, pathological data, specimen inventory, and researchers’ requests; (2) maintain and monitor a password-protected website accessible to authorized users; (3) serve as an information conduit between the consortium and the public, producing appropriate public-relations materials on behalf of the NNTC including maintaining and updating a public NNTC website, and providing toll-free telephone access by which researchers can contact the DCC; (4) collect requests from researchers for specimens, distribute requests to individual NNTC sites, coordinate the shipments of samples, and follow-up on receipt of tissue and fluid delivery; (5) train NNTC staff in any new database entry methods as a result of approved changes in current database operation and provide technical assistance related to data transfer; (6) coordinating and archiving information regarding NNTC and EC meetings, calls, activities; and (7) generate descriptive statistics and for the public website and for the NNTC PIs or EC; perform EC-approved database-derived scientific analyses.  Applicant should demonstrate progress or achievements at similar efforts. In general, the applicant must demonstrate the capabilities to meet the objectives of the DCC and show an understanding and knowledge of the relationship between the NIH and the NNTC, and how the DCC will contribute to the NNTC mission.  

Part B: Scientific Leadership and Agenda Setting (15 pages total)

Section 1: Demonstration of Scientific Leadership and Appropriate Expertise 

Section 2: Scientific Agenda and Development Plan

The overall objective of this section is to develop a scientific agenda based upon the current data in the NNTC database. The DCCsPI should discuss the development of an NNTC “internal” and “external” scientific agenda and propose agendas that seem appropriate based upon public information regarding the NNTC, its cohort, demographics, and purpose.  The “internal” NNTC scientific agenda should be an agenda that the 4 brain banks and the DCCsPI actively foster and are in a unique position to develop due to their familiarity with the data in the database, the volume (8+ years) of accumulated data, the clinical population, and their collective access to tissue for multisite studies. The internal scientific agenda should also address issues related to clinical and laboratory protocol changes. For instance, how will the internal committee determine if/when to alter the clinical methodologies or protocol schedules from bi-annual to annual visits; how will the DCCs PI determine if protocol changes affect data analyses?

The “external” agenda should provide the research community with a better understanding of the limitations and possibilities associated with research projects based upon NNTC collections. The external agenda should speak to the issue of the feasibility of the resource for certain types of scientific projects, such as host genetics and biomarkers related research, taking into consideration the numbers of individuals in the cohort who have specific diagnoses (i.e., HAD, MCMD, HCV/HIV coinfections, depression or other psychiatric illness, drug/alcohol abuse, etc.). The DCCsPI should provide a timeline for:  1) the development of the agendas based primarily on the data in the common database, but also on the potential capabilities if the database can be expanded; and 2) the posting of the external NNTC agenda to their website, among other places.

The applicant should also address how s/he anticipates being able to increase the value of the resource and its data. The applicant should address how s/he will approach quality data management, study design, and biostatistical and analytical methodologies related to a NNTC-based research agenda. The applicant should discuss plans to produce high quality data and research that are well-managed and coordinated.

Plan for Sharing Research Data

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

The sharing of biomaterials, data, and software in a timely manner has been an essential element in the rapid progress that has been made in the analysis of human diseases. To address the joint interests of the government in the availability of, and access to, the results of publicly funded research and in the opportunity for economic development based on these results, NIH expects applicants who respond to this FOA to develop and propose detailed plans for data sharing.

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

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

Sharing Research Resources

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

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

Section V. Application Review Information


1. Criteria

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

The following will be considered in making funding decisions:

2. Review and Selection Process

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

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

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

Additionally, the review criteria listed below should be considered in the context of the synergy that is possible in a multi-site project such as the DCC and NNTC where the whole aims to be  greater than the sum of the parts.

Part A: Data Coordinating Center Functions

Significance.  Has the proposed DCC successfully served as a data management and analysis center in the past?  Does it fulfill other roles and duties that are critical to the success of research studies and to the work of external collaborators?  Are the roles of the DCC generally and the DCCsPI, in particular, in the design of future NNTC analyses, adequate and appropriate? 

Approach.  Are the approaches for managing NNTC data and ensuring its security appropriate and optimal?  Are the approaches to ensuring a clear means of communication between EC members optimal? Does the application propose appropriate means of coordination regarding the handling and shaping of tissue/fluid requests? Is the approach for managing monthly calls and regular NNTC-wide activities adequate?  Does the application acknowledge potential problem areas and consider alternative tactics? 

Innovation. Is the applicant proposing current technologies and innovative practices in data management systems, communications, and statistical analyses approaches in support of clinical and banking operations?

Investigators.  Are the PI and key personnel appropriately trained and well suited to perform the data management, data analyses, study design, and NNTC-wide coordinating roles central to the functioning of the NNTC?  Are key personnel in place, and is their effort sufficient, to conduct NNTC research including study design, analysis, and development of novel epidemiologic and statistical methods?  Is the work proposed appropriate to the experience level of the personnel?  Has sufficient time been budgeted to the Principal Investigator(s) and key personnel to ensure that adequate attention is paid to the NNTC-wide scientific issues?

Environment.  Does the environment in which the work will be done contribute to the probability of the success of the DCC and DCCsPI in addressing the multifaceted responsibilities? 

Special Review Criterion.

Feasibility and Logistics.  Has the application appropriately addressed the responsibility of developing the logistics and communications that are necessary to coordinate the NNTC activities?  Has the application demonstrated how appropriate training is conducted to ensure consistent data collection?

Part B: Scientific Leadership and Agenda

Significance.  Does the application propose cutting edge analytical methods to optimize the use of a variety of data (on tissue collections and neurobehavioral impairment, neurological and other clinical diagnoses, drug use, treatments, blood and CSF viral load, neuropathological diagnosis) to inform on key questions? Is an important and credible scientific agenda proposed given the limitations of not having the complete database in hand?

Approach.  Is the approach for the research and projects described in the application appropriate? Is the approach for working with the other NNTC PIs and SLG members reasonable?  Does the application acknowledge potential problem areas and consider alternative tactics?

Innovation. Does the application propose current technologies and innovative practices in data management systems, communications, and statistical analyses approaches in support of clinical and banking operations?

Investigators.  Is the DCCsPI appropriately trained and well suited to perform the data management, data analyses, study design, and NNTC scientific agenda building effort?  Has the applicant served in a data management and analysis scientific leadership role?  Is the role of the applicant in the design of the future NNTC analyses adequate and appropriate?  Are there key personnel in place, and is their effort sufficient, to conduct NNTC research including study design, analysis, and development of novel epidemiologic and statistical methods?  Is the work proposed appropriate to the experience level of the DCCsPI and the key personnel?  Has sufficient time been budgeted to the Principal Investigator and key personnel to ensure that adequate attention was paid to the NNTC-wide scientific issues?

Environment.  Does the scientific environment in which the work will be done contribute to the probability of the success of the DCC and DCCsPI in addressing its multifaceted responsibilities? 

Special Review Criterion.

Feasibility and Logistics.  Does the proposed scientific agenda appear feasible? Do the lines of communication between the DCCsPI and DCC staff appear straightforward?  Do the proposed methods of communication between the DCCsPI and DCC staff as well as between the DCC/DCCsPI and the EC appear straightforward?

2.A. Additional Review Criteria:

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

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

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

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

2.B. Additional Review Considerations

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

2.C. Sharing Research Data

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

2.D. Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and

http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

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

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

3. Anticipated Announcement and Award Dates

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

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

2.A. Cooperative Agreement Terms and Conditions of Award

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

The administrative and funding instrument used for this program will be the cooperative agreement (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.

Annual NNTC SLG meetings are required.  The meeting will always be held in the Washington, DC area, unless NIH Collaborators approve otherwise.  A substantial portion of each meeting should be devoted to assessing scientific progress and establishing scientific priorities and timelines. The Data Coordinating Center should ensure the availability of updated summary data for these meetings.

2.A.1. Project Director/Principal Investigator Rights and Responsibilities

The Project Director/Principal Investigator will have the primary responsibility for: Defining the research objectives, approaches and details of the projects within the guidelines of the RFA.

A.  Responsibilities of the DCCsPI and the DCC site:

The quality of the internal (and partially external) NNTC-based research will largely depend on the degree of collaboration among the 5 site PIs and key personnel of the DCC.  The generation of high-quality data in a multi-center setting will require continuous feedback by the sites to the DCC for data management and protocol implementation.  The timely responsiveness of the DCC in providing information to the sites will be the responsibility of the DCC and DCCsPI.  In particular, the DCC and DCCsPI will be responsible for:

The DCC and the DCCsPI will also be responsible for maintaining an optimal collaboration with the NNTC PIs.  In particular they will be responsible for:

The PD/PI will retain custody of, and have primary rights to the data information and software developed under the cooperative agreement, subject to Government rights of access consistent with the current HHS, PHS, and NIH policies. Publication and copyright agreements and the requirements for financial status reports, retention of records, and terminal progress reports will be as stated in the NIH Grants Policy Statement:

B. Responsibilities of the NNTC PIs (see Part 2.A.1. of RFA-MH-08-021):

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

NIMH staff assistance will be provided by the NIMH Project Officer who will serve as the NIMH Project Collaborator.  NINDS staff assistance will be provided by the NINDS Project Officer who will serve as NINDS’s Project Collaborator. The Project Collaborators will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice, and coordination above and beyond normal program stewardship for grants, as described below.

In addition to the standard program stewardship, NIH Project Collaborator will:

In the event that an NIH Project Collaborator is not available, an alternate Project Collaborator will be named and have the same rights and responsibilities.

2.A.3. Collaborative Responsibilities

EXECUTIVE COMMITTEE:  All activities of the DCC and NNTC sites are coordinated and supervised by the Executive Committee (EC) whose voting membership will consist of Principal Investigators (NNTC site PIs, each with one vote) and the DCC Principal Investigator (one vote). The EC collaboratively decides all scientific policy and organizational issues concerning development and implementation of research agendas, structure, working group memberships, publications, access to data and interim data monitoring, and access to biological specimens.

SCIENTIFIC LEADERSHIP GROUP:  The NNTC Scientific Leadership Group SLG is charged with assuring that the overall NNTC operations are in keeping with high standards of scientific and programmatic achievement and that adequate mechanisms for systematic assessment of clinical and banking quality and scientific agenda building processes are in place. While the scientific discipline experts (e.g. host genetics, immunology, HIV epidemiology, behavioral genomics, etc) of the SLG, who are retained by the site PIs, do not have voting rights on the EC, their participation at annual EC meetings and subsequent written recommendations are required in order to help shape the resource and scientific agenda setting such that it is maximally valuable to the scientific and patient community. 

NNTC site PIs and the DCCsPI will be required to accept and implement policies approved by the EC majority.

INTERACTION WITH THE COMMUNITY:  An optimal interaction between the NNTC sites and the communities from which the participants are drawn will be critical for the long-term success of the study.  The NNTC PIs will be responsible for ensuring that individual NNTC sites maintain ties to their patient communities and interact in a spirit of collaboration that is mutually responsive.  Each NNTC site will be responsible for budgeting appropriate expenses for the support of these interactions.

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.  The three members will be: a designee of the Executive Committee, chosen without the NIH Project Collaborators’ input; one NIH designee; and a third designee with expertise in the relevant area who is chosen by the other two designees.  In the case of an individual site disagreement, the first member of the arbitration panel may be chosen by the individual awardee with the disagreement. 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.

2.A.5. Access to Data

The EC, in collaboration with DCC, will be responsible for optimizing the mechanism for rapid access to data for exploratory work or manuscript preparation.  Requests by investigators for raw and summary data will be managed by DCC after clearance and prioritization by the EC.  The combined NNTC data will be kept at DCC, with copies of the dataset being sent to each NNTC site and to NIH Project Collaborators each NIH institute funding the NNTC.  Prior to approval and release of data, research plans submitted to the EC will be evaluated to determine if it is in accordance with the informed consent signed by the NNTC participants.  A NNTC public-use data set will be created by the DCC and will be updated within 90 days of each monthly upload.

2.A.6. Access to Biological Specimens

In view of the importance of biological specimens for current and future studies, their number and volume should be regularly monitored by the DCC and reported to the EC.  Each site's annual report to NIMH/NINDS should include a DCC summary report on biological specimens and a detailed status report of any local repository.  Problems with specimen collection at individual sites should be brought to the attention of the EC, through the DCC and the working groups, for appropriate remedial measures.  Requests for specimens by NNTC (internal) investigators or independent (external) investigators should describe in detail the study for which specimens are sought, their number and volume, in accordance with a standardized NNTC Data and Specimen request form. The five NNTC PIs especially, as well as the other EC members, will actively promote wider and optimal utilization of NNTC specimens by outside investigators.  Prior to approval and release of specimens, research plans submitted to the EC will be evaluated to determine if the research is in accordance with the informed consent and that necessary approvals have been obtained.  EC approval is not necessarily applicable to specimens in local repositories; however, EC notification about studies being conducted on local repository specimens is expected, and compliance with human subjects regulations is required.

2.A.7. Dissemination of Study Results

The existing NNTC publication policy should be followed.  The policy will be reviewed in the first 6 months of the next competitive renewal funding cycle, and amended by the EC if necessary, to achieve overall fairness and timeliness in the formal reporting of research results.  The timely dissemination of study results to the communities involved is strongly emphasized.  The support of the NIH Institutes in funding the NNTC should be acknowledged and the NIH grant numbers included in all publications.

3. Reporting

The DCCsPI should submit in electronic format an annual progress report to the NIH Project Collaborators at the NIH institutes funding the NNTC that includes the following:

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

Section VII. Agency Contacts


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

1. Scientific/Research Contacts:

Kathy L. Kopnisky, Ph.D.
Division of AIDS, Health and Behavior Research
Center for Mental Health Research on AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6205, MSC 9619
Bethesda, MD 20892-9619
Telephone: (301) 443-7726
FAX: (301) 443-9719
Email: kkopnisk@mail.nih.gov

2. Peer Review Contacts:

David Armstrong, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6138, MSC 9606
Bethesda, MD 20892-9609
Telephone: (301) 443-3534
FAX: 301-443-4720
Email: armstrda@mail.nih.gov

3. Financial or Grants Management Contacts:

Rita V. Sisco
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6122, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2805
FAX: (301) 443-6885 
Email: siscor@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

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

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

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

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

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

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

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

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

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

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

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

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

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

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

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

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


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