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 Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov)

Title: Longitudinal Studies of HIV-Associated Lung Infections and Complications (R01)

Announcement Type
New

Request For Applications (RFA) Number: RFA-HL-07-008

Catalog of Federal Domestic Assistance Number(s)
93.838

Key Dates
Release Date: September 14, 2006
Letters of Intent Receipt Date(s): November 20, 2006
Application Receipt Dates(s): December 19, 2006
Peer Review Date(s): June-July 2007
Council Review Date(s): September 12, 2007
Earliest Anticipated Start Date(s): September 28, 2007 http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: December 20, 2006

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

• Purpose: Accelerate research on lung complications associated with HIV-infection by characterizing lung infections, other HIV-associated lung complications, and their consequences in longitudinal studies in existing HIV-infected cohorts and other established groups of HIV-infected patients.
• The National Heart, Lung, and Blood Institute (NHLBI) invites applications for 4-6 clinical research sites and a supporting Data Coordinating Center (DCC).
• The total cost of the program is estimated at $30 million over 5 years ($6 million a year). We anticipate making 5-7 awards (1 DCC, 4-6 clinical sites) starting in FY 2007.
• The clinical research sites will conduct individual protocols, and after they are funded may be possible to develop and conduct some cooperative projects with other grantees participating in this Funding Opportunity Announcement (FOA). The PIs must demonstrate that they have access to HIV-infected cohorts suitable to the project(s) being proposed. In addition to clinical research, they must have the capability for doing basic research. The PIs must provide a written statement agreeing to cooperate, and they must agree to share samples and data.
• The DCC will be responsible for arranging meetings and conference calls, preparing reports, implementing a web-based system to coordinate joint program activities, and facilitating the sharing of data and specimens. The DCC will provide data management, quality control, develop forms, and maintain common data sets. The DCC will be expected to provide statistical support in designing and conducting collaborative protocols and in analyzing data. The DCC will also support specimen banking activities and activities associated with preparing and submitting presentations and publications. The DCC staff will need appropriate expertise and experience in project management, biostatistics, epidemiology, database management, sample collections, informatics, and expertise in web-based data management.
• An important function of the program will be to collect and store biological specimens for future mechanistic studies of the underlying pathogenesis of pulmonary complications associated with HIV-infection.
• As part of this FOA the clinical site investigators will be expected to form collaborations with basic investigators to plan the collection and storage of specimens and data with future mechanistic studies in mind.
• Applicants are strongly encouraged to include a small-scale hypothesis driven specific aim that will use samples and data from the clinical protocol(s) to explore possible directions for later basic science proposals that are beyond the scope of the FOA.
• The clinical investigators are also strongly encouraged to form collaborations with basic scientists and to submit R21 and R01 grant applications for mechanistic ancillary studies that are beyond the scope of this FOA.
• It is anticipated that the data obtained by this program will be used to plan future clinical trials and basic research studies.
• This initiative will use the investigator-initiated research project grant (R01) mechanism.
• Lung cancer as a complication of HIV infection is an area of overlapping interest of NHLBI and the National Cancer Institute (NCI).
• Eligible organizations include:
• For profit organizations
• Non-profit organizations
• Public or private institutions such as universities, colleges, hospitals, and laboratories
• Units of state government
• Units of local government
• Eligible agencies of the federal government
• Although foreign organizations are not eligible, subcontracts with foreign institutions to study foreign populations are acceptable.
• Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
• Each applicant may submit only one application. However, an institution may submit more than one application, provided they are scientifically distinct and have different PIs.
• The principal investigators and research teams will need to have appropriate experience and expertise in pulmonary disease, managing HIV infection, and the planning and performance of longitudinal studies. Expertise and disciplines that may be especially important for this project include: epidemiology, biostatistics, multicenter studies, pulmonology, infectious diseases, immunology, virology, microbiology, lung pathology, biomedical/clinical informatics, and tissue repositories. The PI must be able to assemble and provide strong leadership for a multidisciplinary group.
• Applications must be prepared using the PHS 398 research grant application instructions and forms (rev 5/2001). The application instructions for PHS 398 are available at http://grants.nih.gov/grants/funding/phs398/phs398.html.

The 398 forms have been changed. Here is the Link to the recently revised PHS-398 form and instructions (NOT-OD-06-056, "NIH Announces Interim Changes to the PHS398 Application and Instructions"): http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-06-056.html

All PIs /Institutions must be registered in NIH eRA Commons Must be reflected on Face Page of application; if not, application will not be accepted by the NIH.

For further assistance, contact Grantsinfo at (301) 710-0267, email: [email protected].

• Telecommunications for the hearing impaired is available at: TTY 301-451-5936

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
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: Accelerate research on lung complications associated with HIV-infection by characterizing lung infections, other HIV-associated lung complications, and their consequences in longitudinal studies in existing HIV-infected cohorts and other established groups of HIV-infected patients.
• Nature of the research opportunity: The National Heart, Lung, and Blood Institute (NHLBI) invites applications for a data coordinating center and 4-6 clinical sites to characterize HIV-associated lung infections, other HIV-associated lung complications and their consequences by conducting longitudinal studies in existing HIV-infected cohorts.
• An important function of the program will be to collect and store biological specimens for future mechanistic studies of the underlying pathogenesis.
• As part of this FOA the clinical site investigators will be expected to form collaborations with basic investigators to plan the collection and storage of specimens and data with future mechanistic studies in mind.
• Applicants are strongly encouraged to include a small-scale hypothesis driven specific aim that will use samples and data from the clinical study to explore possible directions for later basic science proposals that are beyond the scope of the FOA.
• The clinical investigators are also strongly encouraged to form collaborations with basic scientists and to submit R21 and R01 grant applications for mechanistic studies that are beyond the scope of this FOA.
• It is anticipated that the data obtained by this program will be used to plan future clinical trials and basic research studies.
• It is expected that data, specimens, and other resources generated by the program will be shared by the investigators and that they can be easily shared and integrated into other projects in the future.
• Controlled vocabulary and agreed upon data elements for interoperability should be addressed in plans for procedures, specimens, and associated metadata (including images) resulting from this program to create resources that can be easily shared and integrated with other projects.
• Need and Justification: The HIV epidemic in developing countries affects millions of people, many of whom have serious or fatal lung complications. These have never been well characterized. HIV-associated lung complications are also frequent causes of illness and death in industrialized nations, where the greatly improved prognosis of HIV patients due to multi-drug antiretroviral therapy has turned HIV into a chronic disease. The nature and prevalence of lung complications was characterized by the Pulmonary Complications of HIV Infection Study (PACS) more than 15 years ago before highly effective multi-drug regimens increased life expectancy. They have not been systematically reassessed since. Moreover, the long-term consequences of HIV infection and HIV-associated lung infections are unknown. Wide gaps in our understanding of HIV in the lung continue to exist.
• In developing countries with high rates of tuberculosis and HIV infection, dual HIV-TB infection acts synergistically, accelerating the course of HIV and the course and spread of tuberculosis with devastating results. The most urgent need in this setting is to gain a better understanding of both diseases and their interactions to improve diagnosis, monitoring and treatment. Little is known about the role of other respiratory co-infections, e.g., Pneumocystis jiroveci and bacterial pneumonias, and how to manage them in developing countries with very limited resources.
• In industrialized countries, lung complications need to be re-examined. For example, to what extent is drug resistant Pneumocystis a problem? The prevalence, pathogenesis, and management of serious lung complications such as HIV-associated pulmonary hypertension, which may be rapidly fatal, HIV-associated emphysema, and lung cancer need to be determined. How is sarcoidosis manifested in patients receiving multi-drug antiretroviral regimens? How do immune reconstitution syndromes affect the lung?
• Multicenter longitudinal clinical studies and access to biological specimens are needed to answer questions that cannot be answered in theoretical and animal models of disease. This initiative will encourage rigorous epidemiologic and clinical studies aimed at identifying and characterizing HIV-associated pulmonary complications in existing cohorts of HIV-infected patients and the collection and storage of human specimens and microbial isolates.
• Types of research and experimental approaches that are being sought to achieve the objectives:
• This FOA will support longitudinal observational studies in existing HIV-infected cohorts to obtain data and specimens. Establishment of studies that are ancillary to ongoing research in HIV-infected cohorts is encouraged.
• Once grants are funded, investigators are encouraged to collaborate with other grantees funded under this FOA and pool resources and data.
• Applicants are strongly encouraged to include one aim that proposes preliminary mechanistic work.
• Investigators would be expected to characterize HIV-associated lung infections and/or other conditions and to collect and store biological specimens for future mechanistic studies of the underlying pathogenesis.
• More fully developed mechanistic studies to elucidate pathogenesis, identify possible targets for treatment and conduct research on novel strategies to prevent or minimize lung damage could be pursued in the future using the human data and specimens obtained by this program.
• Clinical measures will be obtained as appropriate, e.g., chest radiographs, computed x ray tomography of the chest, echocardiograms to evaluate pulmonary hypertension and right heart function, and lung function studies. Biological specimens e.g., blood, sputum cultures, bronchoalveolar lavage specimens, lung biopsy specimens (when clinically indicated), surgically resected lung neoplasms, other surgical specimens, and post mortem specimens would be collected, and stored to be shared and analyzed.
• The clinical sites will need strong multidisciplinary groups with expertise in clinical research, epidemiology, multicenter studies, pulmonology including research bronchoalveolar lavage and pulmonary function testing, infectious diseases, immunology, virology, microbiology, oncology, lung pathology, lung imaging, and collecting and processing biological specimens.
• The Data Coordinating Center site will need expertise in data coordination and management of multicenter clinical and epidemiological studies, maintaining web-based data sets and other web-based resources, biostatistics, pulmonology, infectious diseases, and in particular HIV infection, informed consent, tissue repositories and biomedical/clinical informatics.
• It is anticipated that pulmonary projects associated with this FOA may be ancillary to existing programs supported by the National Institute of Allergy and Infectious Diseases (NIAID), for example, AIDS Clinical Trials Groups (ACTGs), studies like the Multicenter AIDS Cohort Study (MACS), and existing Centers for AIDS Research (CFARs). Other HIV-infected populations may also be appropriate for these studies, for example, clinic, hospital and Veterans Affairs based populations. However, some projects may require new recruitment of additional subjects and controls.
• Some examples of research topics for investigation may include but are not limited to the following - for all these examples investigators would be expected to obtain and bank relevant specimens and data for future use:
• Determine prevalence of HIV-associated complications e.g., pulmonary hypertension, HIV-associated emphysema, HIV-associated lung cancer, characterize the course, effects of antiretroviral therapy.
• Investigate occurrence of acute and chronic lung dysfunction and injury resulting from HIV infection and or HIV-associated infections, e.g., S. pneumoniae, Mtb, P. jiroveci, C. neoformans, HHV8, etc.
• Investigate relationships between the actual load of virus or immune dysfunction in the lung and development and course of infections, e.g., Pneumocystis, TB or bacterial pneumonias or lung malignancies.
• Determine prevalence and characterize immune reconstitution syndromes affecting the lung.
• Investigate sarcoidosis in the setting of HIV-infection and antiretroviral therapy and characterize clinical manifestations and course of the disease.

Projects that are outside the scope of this announcement are:

• Basic research solely focused on studies in animal models. However, very limited use of an animal model would be permissible in a basic research aim that also uses human samples from the clinical studies to aide in elucidating pathogenetic mechanisms.
• Applications that focus only on basic mechanisms.
• Applications that focus only on HIV-associated lung cancer or other lung neoplasms. However, research on HIV-associated lung cancer or other lung neoplasms may be included as one aspect of an application that also addresses other HIV-related lung complications.
• Applications that focus only on the upper airway (e.g., nose, sinuses). However, upper airway complications could be relevant if they are being studied in the context of their contribution to lung disease.

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 regular research grant (R01) 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.

2. Funds Available

• The NHLBI intends to commit approximately $30 million in total costs over 5 years ($6 million in FY 2007).
• The NHLBI anticipates funding 5-7 new grants (this includes 1 Data Coordinating Center, and 4-6 Clinical Centers).
• Applicants for the Data Coordinating Center should request a project period of 5 years. Applicants may request up to $600,000 in direct costs in any given year.
• Applicants for the clinical sites may request a project period of up to 5 years. Applicants may request up to $550,000 in direct costs in any given year.
• The anticipated start date for new awards is September 28, 2007. The expected period of performance is 5 years.

HIV infection is an area of overlapping interest of NHLBI and the National Institute of Allergy and Infectious Diseases (NIAID). Populations of patients proposed for studies in this program may also be enrolled in studies supported by NIAID. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

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

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:

• For-profit organizations
• Non-profit organizations
• Public or private institutions, such as universities, colleges, hospitals, and laboratories
• Units of state government
• Units of local government
• Eligible agencies of the federal government
• Domestic Institutions
• Faith-based or community-based organizations

Subcontracts with foreign institutions to study foreign populations are acceptable.

1.B. Eligible Individuals

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

2. Cost Sharing or Matching

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

Each applicant may submit one application for this FOA. An institution may submit more than one application provided the applications are submitted by different principal investigators and the applications address different scientific questions.

Section IV. Application and Submission Information

1. Address to Request Application Information

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

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

2. Content and Form of Application Submission

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

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form, and the YES box must be checked.

3. Submission Dates and Times

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

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): November 17, 2006
Application Submission Date(s): December 19, 2006
Peer Review Date(s): June-July 2007
Council Review Date(s): September 12, 2007
Earliest Anticipated Start Date(s): September 28, 2007

3.A.1. Letter of Intent

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

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

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows 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:

Chief, Review Branch
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Rockledge II, Room 7214
Bethesda, MD 20892-7924
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: [email protected]

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application.

The 398 forms have been changed. Here is the Link to the recently revised PHS-398 form and instructions (NOT-OD-06-056, "NIH Announces Interim Changes to the PHS398 Application and Instructions"): http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-06-056.html

All PIs /Institutions must be registered in NIH eRA Commons Must be reflected on Face Page of application; if not, application will not be accepted by the NIH.

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:

Chief, Review Branch
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Rockledge II, Room 7214
Bethesda, MD 20892-7924
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: [email protected]

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

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NHLBI. 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

Grantee Meetings: Upon initiation of the program, the NHLBI together with the Data Coordinating Center will arrange for up to three meetings in the first year and up to two meetings in years 2-5 to encourage the exchange of information among the investigators who participate in this program. In preparation of the budget for the grant application, applicants should include travel funds for three 1 day meetings for year one and two 1 day meetings in years 2-5 to be held in or near Bethesda, MD for the principal investigators and up to 2 additional key collaborators. At these meetings awardees will be expected to share their results, coordinate joint projects and to help evaluate the progress of the overall program and the individual centers. Applicants should also include a statement in their applications indicating their willingness to participate in these meetings.

The Data Coordinating Center should also include funds pay for up to two meetings a year in Bethesda, Maryland of an Observational Study Monitoring Board (OSMB) that would review and follow protocols conducted at the clinical sites in. This would include funds to pay for travel of the Board members (at government rates), and/or to set up teleconferences and to provide honoraria.

Each clinical site must demonstrate that they have access to sufficient HIV-infected patients and any controls that may be needed for the studies they are proposing.

Both the clinical site and staff and the DCC staff must have appropriate training and experience for working safely with biologically hazardous specimens that may contain HIV and other dangerous microbial agents. They must indicate what steps they will take to safely acquire, process, ship, store, and distribute biologically hazardous specimens that contain HIV and other infectious agents.

Each clinical site applicant must propose longitudinal clinical or epidemiological research. In addition, we strongly encourage inclusion of one or more small-scale basic science, hypothesis driven or generating aim(s) that use samples and data obtained from the clinical/epidemiological protocol to elucidate pathogenetic mechanisms associated with the lung condition under investigation.

Each R01 application must be independent. Applicants should propose protocols that can be accomplished at their site alone (their institution and subcontracts or collaborations that they have formed that can be supported by the funds provided in their R01 application budget within the 5 year window of the grant.

Clinical Center applications must include multidisciplinary research collaboration(s) and partnerships between basic and clinical investigators.

Ancillary projects proposed in the applications must be planned in such a way as to be feasible and be able to fit smoothly into the context of the ongoing programs.

Applicants for the centralized Data Coordinating Center (DCC) should present a description of plans to: (1) provide data management, including quality control and development of forms; (2) maintain a common data set; (3) develop needed databases and implement a web-based system to coordinate program activities; (4) provide statistical support (5) provide support in designing and conducting joint protocols; (6) support specimen banking activities; (7) provide support for preparing and submitting joint presentations and joint publications; and (8) provide coordination of meetings and reports as needed (7) provide administrative support services for an Observational Study Monitoring Board (OSMB) for all the clinical R01s (estimate 4-6 grants).

The DCC staff should have appropriate expertise and experience in project management, biostatistics, informatics and expertise in web-based data management. Prior experience in complex collaborative studies is desired. The DCC Principal Investigator and other key staff should have knowledge of HIV/AIDS and pulmonary clinical studies and repositories.

Applications for the DCC may be submitted by individuals located at the same institution as an applicant for a clinical site grant submitted under this FOA, but an individual may not be the Principal Investigator of a research grant and the DCC.

Applicants are encouraged to establish links and utilize existing resources including those listed below, but other resources not mentioned here may also be appropriate:

Multicenter AIDS Cohort Study (MACS) and Women's Interagency HIV Study (WIHS)
MACS/WIHS
http://www.statepi.jhsph.edu

AIDS repository
http://www.aidsreagent.org

AIDS and Cancer Specimen Resource
http://acsb.ucsf.edu/

Centers for AIDS Research (CFAR)
http://www3.niaid.nih.gov/research/cfar/

AIDS Clinical Trials Group (ACTG)
http://www.aactg.org/index.asp

NHLBI shared microarray facilities
http://www.nhlbi.nih.gov/resources/medres/microarray.htm

AIDS information
http://aidsinfo.nih.gov/Guidelines/Default.aspx?MenuItem=Guidelines

Programs for Genomic Applications (PGA) which include resources for animal modeling and phenotyping, clinical and physiological studies, databases and software tools, bioinformatics, expression profiling, mutagenesis, proteomics, SNP’s and genotypes, comparative sequence analysis, educational programs, biomedical topics, and biochemical pathways (http://www.nhlbi.nih.gov/resources/pga/).

Roadmap project http://nihroadmap.nih.gov/

Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator should be included with the application. (http://www.ncrr.nih.gov/clinical/cr_gcrc.asp)

Specific Instructions for Modular Grant applications
Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398.

Domestic institutions submitting applications for grant mechanisms that use the modular budget (R01, R03, R15, R21, and R34) that request $250,000 in direct costs or less for all years must continue to use the modular format even if the application includes a subaward with a foreign (non-U.S.) institution.

Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.

Plan for Sharing Research Data

All applications responsive to this FOA must include a plan for sharing research data along with a statement that the plan will be followed unless it is superseded by an NIH- or NHLBI-wide policy on sharing research data that is established prior to the date of award, in which case the NIH- or NHLBI-wide policy will be followed. The precise content of the plan may vary, depending upon the data being collected and how the data are to be shared, but elements to consider include: the expected schedule for data sharing; the format of the final dataset; the documentation to be provided; what, if any, analytical tools will be provided, whether or not a data-sharing agreement will be required and, if so, a brief outline of the likely terms of an agreement that addresses the criteria for determining who can receive the data and what, if any, conditions will be imposed 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).

For applications requesting more than $500,000 in direct costs in any year of the proposed research, the NHLBI will monitor compliance with the data sharing plan and/or the NIH or NHLBI-wide policy as appropriate.

Although the reasonableness of the plan for sharing research data will not influence the determination of scientific merit or the priority score, it may be assessed as part of the scientific review and will definitely be an important consideration in selection of applications for funding.

Sharing Research Resources

NIH policy requires that grant awardee 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.

Important functions of the program will be to conduct studies in such a way that data and biological samples can be easily shared and to collect data and store biological specimens for future mechanistic studies of the underlying pathogenesis of pulmonary complications associated with HIV-infection. The PIs must provide a written statement agreeing to cooperate, and they must agree to share samples and data. In addition to sharing the resources during the course of the program, it is expected that data, specimens, and other resources generated by the program will be shared with outside investigators (who are not part of the original program) and that the resources can be easily shared and integrated into other projects in the future. The NIH-wide policy for sharing data and biological samples is being updated at this time and once developed the new NIH guidelines will be applicable to grants funded under this program.

Specimens collected in the course of the lung research protocols may be stored at the NHLBI Biological Specimen Repository, currently managed by the Division of Blood Diseases and Resources through a contractor, SeraCare. It is also possible that specimens or aliquots will be kept in other repositories e.g., those being used by ongoing studies of HIV-infected cohorts.

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:

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

2. Review and Selection Process

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

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

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

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

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

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

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

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? Has the investigative team at the data coordinating center or the clinical site documented specific competence and their knowledge concerning HIV research and pulmonary research?

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

Review Criteria for the Data Coordinating Center (DCC) Facility

For evaluation purposes of DCC Applications, the following technical criteria will be considered:

PERSONNEL: Does the Principal Investigator have the training, expertise, experience, and availability necessary for planning and directing the Data Coordinating Center facility? Does the PI and the other staff members have expertise and previous experience in preparation of data forms, electronic transmission of data, data management, biostatistics, informatics, designing and conducting multi-site clinical studies, consent procedures, and collecting and storing human samples for future use? Does the administrative staff have documented training, experience, competence, and availability? Do the personnel proposed for website development have documented experience in website development and maintenance? Has their availability been documented? Have the PI and professional staff documented specific competence and previous knowledge concerning HIV research and pulmonary research? What is the past experience of the proposed DCC team, as a whole, in supporting multisite clinical studies - including collection and management of data, data analysis and the collection, banking and distribution of biological specimens?

METHODS AND PROCEDURES: Are the proposed plans for coordination and for data collection, processing, entry, transmission, storage, statistical analysis, and reporting meritorious? Are the plans adequately developed? Are the proposed plans for training of Data Coordinating Center personnel in data collection and handling meritorious and adequately developed? Are plans for quality control and quality assurance and plans for monitoring the Data Coordinating Center performance meritorious and adequately developed? Are the proposed plans for collecting, storing, and making human samples available meritorious and adequately developed? Are plans for protecting the privacy of human research subjects adequately addressed?

FACILITIES AND ORGANIZATIONS: Are the facilities and resources necessary to carry out the proposed functions of the Data Coordinating Center available and adequate? How adequate is the organizational and administrative structure, including the means of assuring quality control of data, data entry, confidentiality of data, and plans for day-to-day coordination? What is the institutional commitment to the Data Coordinating Center for the proposed program? Is this adequate?

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).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

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

2.B. Additional Review Considerations

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

2.C. 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 requires that grant awardee 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), sent by electronic mail to the principal investigator and the sponsored projects office of the applicant institution, 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).

3. Reporting

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

Section VII. Agency Contacts

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

1. Scientific/Research Contacts:

Hannah H. Peavy, M.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Rockledge II, Suite 10018
Bethesda, MD 20892
Telephone: (301) 435-0222
FAX: (301) 480-3557
Email: [email protected]

For questions regarding NIAID AIDS Programs

Robin E. Huebner, Ph.D., M.P.H.
Epidemiologist, Epidemiology Branch
Basic Sciences Program (BSP), Division of AIDS (DAIDS)
NIAID, NIH, DHHS
6700-B Rockledge Drive, Rm 4104 MSC 7626
Bethesda, MD 20892-7626
(use 20817 zip code for overnight or courier mail)
Telephone: 301-402-4239
FAX: 301-402-3211
Email: [email protected]

2. Peer Review Contacts:

Chief, Review Branch
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Rockledge II, Room 7214
Bethesda, MD 20892-7924
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: [email protected]

3. Financial or Grants Management Contacts:

Robert Pike
Grants Operations Branch
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Rockledge II, Room 7214
Bethesda, MD 20892
Telephone: (301) 435-0171
FAX: (301) 435-480-3059
Emai:[email protected]

Section VIII. Other Information

Required Federal Citations

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

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

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

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

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

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

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

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

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

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

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.

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

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

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

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

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

			Department of Health and Human Services (HHS)
NIH... Turning Discovery Into Health®