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EXPIRED

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: Programs of Excellence in Glycosciences (P01)

Announcement Type
New

Request For Applications (RFA) Number: RFA-HL-10-026

Catalog of Federal Domestic Assistance Number(s)
93.839

Key Dates
Release Date: December 8, 2009
Letters of Intent Receipt Date: April 9, 2010
Application Receipt Date: May 10, 2010
Peer Review Date(s): October November 2010
Council Review Date: January 2011
Earliest Anticipated Start Date: April 1, 2011
Additional Information To Be Available Date (Url Activation Date): http://www.nhlbi.nih.gov/funding/inits/faq-hl-10-026.htm
Expiration Date: May 11, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

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

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

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
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 goal of the Programs of Excellence in Glycosciences (PEG) is to translate emerging discoveries in glycosciences into new diagnostics and clinical applications and to build research capacity in glycosciences relevent to heart, lung, and blood research. The National Heart, Lung, and Blood Institute (NHLBI) solicits applications to support new partnerships that promote multidisciplinary research, provide skills development in glycosciences, and generate glyco-analytical tools for heart, lung, and blood research, thereby creating a cadre of investigators fluent and skillful in glycan chemistry and biology applicable to NHLBI’s research interests. Despite technological advances in glycosciences, there is a gap between the chemists/biochemists having glycoscience expertise and biomedical researchers. The proposed FOA is meant to bridge the gap between glycoscience technologies and the biological sciences by supporting partnerships between the two disciplines through shared goals, fostering research, generating relevant resources, and providing skills development to a new generation of investigators that will sustain and advance the application of glycosciences as it relates to heart, lung and blood research.

Background

Glycans and glycan-binding proteins (GBPs) play crucial roles in physiology and disease processes affecting heart, lung, and blood systems, yet they remain understudied. Understanding the roles of glycans in biological processes has become increasingly urgent as they have been shown to serve as modulators of DNA/RNA activities and also to mediate multiple functions both independently and through post-translational modifications of proteins and of linkages to lipids. In light of these important roles and the potential opportunities for future discoveries, there is a need to establish more scientific investigators who have the necessary carbohydrate chemistry skills to enhance our understanding of biological processes in heart, lung and blood research. An important challenge for biomedical researchers in the early 21st century is to utilize available genomic data to gain a better understanding of physiologic and pathologic processes. This FOA is targeted at filling the gap in existing programs by placing emphasis on glycosciences and thereby increasing the potential of the genomic and proteomic tools and knowledge bases recently generated with NHLBI support.

In keeping with the NHLBI Strategic Plan Goals 1, 2 and 3, The Division of Blood Diseases and Resources of the National Heart, Lung, and Blood Institute (NHLBI) convened a working Group of scientific investigators in February 2008, in Bethesda, Maryland, to identify scientific opportunities emerging from the recent technological advances in glycosciences. The committee identified many research opportunities and priorities regarding the impact of glycans in hemostasis, inflammation, and vascular biology, and recommended developing new initiatives to catalyze research involving glycosciences. They emphasized that multi-PI collaborative research projects between investigators having expertise in glycan chemistry and those who address biological questions in blood and vascular diseases will be the key to success in translational studies. The committee also recommended the need to provide strong skills development in glycosciences to young investigators in order to build research capacity that is self-sustaining and advances the application of glycosciences to heart, lung, and blood research. This initiative aims to create programs that bring together investigators from complementary disciplines namely, glycan chemistry and biomedical sciences, through the NHLBI Programs of Excellence in Glycosciences (PEG).

Program Structure

Each program must include a minimum of three research projects and two mandatory cores: The Research Projects will perform cutting-edge multidisciplinary research in glycosciences that applies to problems in heart, lung, and blood; the Glycosciences Skills Development Core will provide high-quality skills development to M.D., M.D./Ph.D., and Ph.D. scientists through hands-on experience and formal lectures focusing on advanced skill development in glycosciences; and the Shared Resources Core will develop and supply glyco-analytical tools and resources, such as glycoconjugates analysis, glycan synthesis, and understanding and detecting glycan interactions to accelerate the pace of research. Each PEG should include an administrative core. There will also be one Administrative Center to serve all the PEGs to coordinate shared Program activities. The Administrative Center will serve all the PEGs and will perform a range of administrative functions including organizing investigator meetings and External Review Panel meetings, arranging conference calls, and designing and maintaining a website to support the PEGs.

PEG team members do not necessarily have to be located in the same institution or geographical location since desired combinations of expertise and technologies may not reside at a single institution or even a particular region of the country. Each PEG must provide a multidisciplinary structure that will coordinate research activities between glycan chemistry and biomedical sciences related to heart, lung, and blood. Research projects may be preclinical, basic, mechanistic or translational. The inclusion of new and early stage investigators in this program is encouraged. PEGs should be dynamic, and be able to change and adapt as research and the field progress. Inclusion of industrial partners is allowable when the relevant expertise and partnership opportunities are available.

Research Scope

Glycoconjugates and/or glycan-binding proteins are known to be involved in physiology and disease processes. Therefore, the application of glycosciences to heart, lung, and blood research offers a wealth of opportunities for translational breakthroughs leading to improved diagnosis, treatment, and prevention of disease. Exploiting advances in structural analysis of glycans will promote analysis and manipulation of these complex sugars and effective evaluation of their roles as mediators in physiology, disease processes, diagnostics and therapeutics.

Possible areas of research include but are not limited to dissecting the molecular nature of heparin/heparan sulfate, assessing the bioactivity and regulation of glycans, and recognizing how these molecules contribute to cellular activities; elucidating biosynthetic pathways of vascular heparin/heparan sulfates through chemoenzymatic synthesis; and harvesting the therapeutic potential of endogenous glycosaminoglycans for treatment of blood, pulmonary, and vascular diseases through stimulation, modulation and inhibition of their biosynthesis using novel tools.

Another area of interest is inflammation as it is related to blood, vascular, and pulmonary diseases. Topics of research may include understanding how glycoproteins and glycan-binding proteins, including selectins, siglecs, galectins, glycoconjugate ligands, integrins and related molecules, together regulate inflammation and inflammatory responses. Other unexplored areas of research include the impact of glycans on platelet function in adhesion or platelet aggregation via serotonin and the resulting effect on cardiovascular diseases, systemic and pulmonary hypertension and stroke.

It is also of interest to define the roles of terminal glycosylation of glycoproteins, including mucins, and of glycolipids, especially in regard to sialylation and modification of sialic acids, fucosylation and sulfation, in biological recognition, autoimmunity, and turnover of glycoconjugates. In cystic fibrosis, altered terminal glycosylation of airway epithelium glycoproteins contributes to chronic infection and robust inflammatory response in the lung. However, little is understood about the overall contributions of glycoproteins to the inflammatory component of cystic fibrosis.

It is important to emphasize that PEGs are expected to bring together investigators with expertise in glycosciences and investigators from biomedical sciences relevant to heart, lung, and blood research to form collaborative programs. The following areas would represent appropriate topics for proposed projects. This list is not intended to be all-inclusive, and other glycan-focused topics can be considered.

Projects outside the scope of this FOA:

Glycosciences Skills Development Core

An interdisciplinary skills development core in glycosciences is mandatory. Full implementation of a nationwide effort to create and sustain the application of glycosciences in heart, lung, and blood research requires building research capacity through high quality glycosciences skills development of participants with M.D., M.D./Ph.D., and Ph.D. degrees. These participants will be associated with one of the research projects but will obtain additional skills development through the Glycosciences Skills Development Core. Each PEG will be required to train at least four scientists who need to acquire the necessary skills and knowledge to apply glycoscience tools and solutions to basic and translational research relevant to heart, lung, and blood. Skills development participants will be required to obtain hands-on experience with technologies such as analytical methods for glycan structure determination, analytical techniques for glycosaminoglycans, separation of glycans, mass spectrometry of glycoproteins, measurement of glycan-protein interaction, modeling of glycan-protein interactions, glycan histopathology and glycoconjugates isolation and purification. Also, formal didactic lectures in glycobiology, glycan chemistry and the relevance of glycans to human biology and disease processes should be provided to complement laboratory/technical experiences.

Participants will be supported by the PEGs for up to four years during which time they will be expected to become conversant in glycan chemistry and molecular aspects of glycosciences and be able to integrate the information with basic, translational and/or clinical research in heart, lung, and blood diseases.

Plans for establishing, leading, and managing the skills development core and how it will function within the PEG must be described in the application. Each application should identify a Skills Development Coordinator, whose relevant experience in glycobiology as well as training is well documented in the Research Plan.

Shared Resources Core

All PEG participants must be committed to collaboration and resource sharing, including data, reagents, and bio-specimens. Each PEG responding to this RFA should provide resources addressing one or more major areas such as analysis of glycoconjugates, glycan synthesis, detection and analysis of glycan interactions thereby enabling the application of glycan technology to translational research in heart, lung, and blood disease and physiology. The Cores will be responsible for determining appropriate technologies involving, for example, chromatography, mass spectrometry, nuclear magnetic resonance or a combination of these as well as interpretation of data. Targets may be selected in collaboration with participating investigators for defining glycoconjugate structures, synthesis or detection of glycans or identifying glycan interactions.

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

Section II. Award Information

1. Mechanism of Support

This funding opportunity will use the P01 award mechanism(s). This is a one-time solicitation to fund the Programs of Excellence in Glycobiology for seven years. The PEGs will undergo a mid-course review by the External Review Panel during the fourth year of funding to determine how well the PEG program is meeting its goals.

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

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

2. Funds Available

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.

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

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

1.B. Eligible Individuals

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

The principal investigator must devote a minimum of 20 percent time commitment to the program and must also be the project leader of one of the component research projects. Project leaders must commit at least a 20 percent effort to the research project for which they are responsible.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may not submit more than one application.

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

Renewals. Renewal applications are not permitted in response to this FOA.

Section IV. Application and Submission Information

1. Address to Request Application Information

The most current PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 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 in item (box) 2 only of the face page of the application form, and the YES box must be checked.

3. Submission Dates and Times

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

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: April 9, 2010
Application Receipt Date: May 10, 2010
Peer Review Date: October November 2010
Council Review Date: January 2011
Earliest Anticipated Start Date: April 1, 2011

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 in Section IV.3.A.

The letter of intent should be sent to:

Director, Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Room 7214, MSC 7924
Bethesda, MD 20892-7924 (Express zip: 20817)
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 forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

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

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

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

Director, Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Room 7214, MSC 7924
Bethesda, MD 20892-7924 (Express zip: 20817)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: [email protected]

3.C. Application Processing

Applications must be received on or before the application receipt date) described above (Section IV.3.A.). If an application is received after that date, the application may be returned without review. Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute Incomplete and/or non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. In addition, applicants who submitted applications prior to January 25, 2009, and are not funded, may resubmit in accord with NIH Resubmission policies, but must utilize the new application forms and instructions with a restructured and shorter Research Strategy. Also note there are changes in other parts of the application including the Biographical Sketch and Resources sections.

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

Characteristics of Programs of Excellence in Glycosciences (PEG)

A. A clearly defined, unifying, central theme to which each component project relates and to which each research investigator contributes.

B. Component research projects that are interrelated and contribute scientifically to the central theme of the program.

C. A principal investigator must devote a minimum of 20 percent time commitment to the grant.

D. Project leaders who provide expertise from several disciplines.

E. Core leaders who have appropriate expertise

F. A plan to ensure extensive interaction among all participants and the communication of ideas and results.

G. A section titled "Synergy and Interactions Among Projects and Project Leaders." The section must address:

Guidelines for the Preparation of Programs of Excellence In Glycosciences (PEG)

This section supplements instructions in PHS Form 398 that are available at the NIH Web site (http://grants2.nih.gov/grants/funding/phs398/phs398.html ).

The exceptions and additions noted below are the only changes from the general requirements provided in the instructions for PHS Form 398. Page limitations specified in PHS Form 398 apply to each project and core unit of a PEG application.

Specific Instructions

1. Table of Contents: Provide a detailed table of contents that will enable readers to find specific information readily. List each project, the budget for each project, each core unit, and the budget for each core unit, and supply the page number for each item. Identify each project by title, assign each project a number that reflects the order in which the projects are presented in the application, and provide the name of the project leader or responsible investigator.

2. Detailed Budget for Initial Budget Period

3. Budget for Entire Proposed Period of Support.

4. Research Plan

Additional Format Instructions - The following sections must precede the portion of the application that contains the details of the individual projects.

1. Program Introduction and Statement of Objectives (Limit of 12 pages.)

2. Organizational and Administrative Structure of the PEG

Individual Projects Should Include

  1. Title and number for each research project so that it can be readily distinguished from any other project in the program. An individual description should be prepared for each project in the PEG application as would be required for an R01 application.
  2. Provide the name and academic title of the project leader and each participating investigator. This request is being made pursuant to the basic authority of the NHLBI to award research project grants (see Title 42, United States Code, Section 241).
  3. Present the budget for each research project according to the instructions for PHS Form 398. A detailed categorical budget is required for the first and all subsequent years. Include budget requests and explicit detailed budget justifications for all years.
  4. Describe in detail the facilities to be used by each project. This is to be accomplished by completing the "Resource and Environment" page included in the PHS Form 398 grant application packet.
  5. Research Plan: State the overall objective for each proposed research project and explain how it relates to the central theme of the PEG and how it interrelates with and complements and/or supplements, the other research projects and core units of the PEG. In addition, describe the overall expected biomedical significance of the proposed research.

Individual Core Units (Limited to 6 pages per Core unit.)

In addition to the two mandatory cores, a core unit is defined as a resource for the PEG that provides centralized services to more than one of the research projects.

1. Title and assign a LETTER designation to each core unit so that it can be readily distinguished from any other core unit.

2. Provide the name and academic title of the core unit leader and each participating investigator.

3. Describe the function of the core unit as a resource to the PEG. This section must present clearly the facilities, techniques, and professional skills that the core unit would provide to the program and explain why its inclusion is essential to two or more of the individual research projects and to the overall research program.

4. Describe in detail the facilities to be used by EACH core unit. This is to be accomplished by completing the "Resource and Environment" page included in the PHS Form 398 grant application packet.

5. Present the budget for each core unit in the format and according to the instructions for Form 398. A budget for the entire proposed project period is required for all subsequent years of support (direct costs only). Include explicit and detailed categorical budget justifications for all years and fully describe how the costs interrelate with those of the projects serviced by the core unit.

6. Relation of the Core Units to the Research Projects: Provide in tabular form information concerning the research projects that each core unit would serve and the proportion of the cost of the core unit associated with each research project involved.

Research Strategy Page Limitations

NIH requires that applications submitted for January 25, 2010, due dates and beyond have shortened Research Strategy page limits. Standard page lengths for the new Research Strategy section (part of the Research Plan) of the application are now 12 pages, with an additional page for Specific Aims for each Research Project. In addition, the Glycosciences Skills Development Core and Shared Resources Core each have a 12-page limitation. The other program specific cores are limited to 6 pages for the Research Strategy plan.

Summary Table of PEG page limits

Summary Table of PEG page limits

Applications must be submitted utilizing current forms and instructions.

Other Special Requirements:

Multidisciplinary Scientific Team: Each PEG application should focus on bringing together a multidisciplinary team with expertise in glycan chemistry and biomedical science interested in applying this integrated knowledge to advance heart, lung, and blood research. Scientific partnerships between investigators who have not collaborated in the past are encouraged so that new interdisciplinary research teams can be formed that will have the required capacity to address common goals in heart, lung, and blood research. Investigators new to the glycosciences who are trying to incorporate glycan studies into their research programs are strongly encouraged to participate in these programs. Research goals should be sufficiently long term and comprehensive enough to justify organizing a PEG and adaptable enough to permit change as the research proceeds. The integrative team approach and its appropriateness for the proposed project should be described including plans for collecting, analyzing, and interpreting data. Plans for enhancing the abilities and opportunities for investigators to work across disciplinary boundaries should also be included.

Glycosciences Skills Development: Applications must include a description of plans to develop and direct a skills development component in glycosciences. The goal of this component is to produce independent investigators conversant in glycan chemistry and biology with the skills to apply glycosciences to heart, lung, and blood research. An investigator with responsibility for overseeing the skills development component should be identified. Each PEG must budget for providing skills development for at least four postdoctoral fellows.

Shared Resources Core: The translation of glycan research into new diagnostics and clinical applications will depend on the availability of relevant glyco-analytical tools necessary for heart, lung, and blood research applications. For example, the difficulty in obtaining the necessary knowledge and having access to core facilities such as synthesis of glycans, analysis of glycoconjugates, detection of glycan interactions, identification and detection of new glycans in normal and diseased tissues is currently a major obstacle to scientific progress. Therefore, the establishment of shared glycan-core resources for PEG investigators would significantly accelerate the research pace. Each PEG application must include a description of the proposed cores (of the types cited above) and a description of how resources will be shared.

Administrative Core: Each PEG should have an administrative core to coordinate activities within the program and with the Administrative Center.

Administrative Center: The Administrative Center will serve all the PEGs and will perform a range of functions including organizing investigator meetings and External Review Panel meetings, arranging conference calls, and designing and maintaining a website to support the PEGs. The Administrative Center site will be selected from the PEGs and will receive additional funds to support these activities. Applicants should indicate whether they wish to be considered for the Administrative Center site and submit a description of how they would carry out the functions of the Center.

PEG Budget Items: A separate budget for research projects, resource core, skills development core and administrative core must be included. With regard to projected funding by source, some PEG applicants may anticipate or receive commitments for significant funding from sources other than the NIH; e.g., from a collaborating company. In this case, applications should describe the source, annual amount, and the use of other funding.

Investigators Meeting: Investigators from individual PEGs will meet annually in Bethesda, MD, to present updates on progress, to exchange ideas, and to discuss problems encountered. The agenda for the meetings will be determined by an Executive Committee composed of the Principal Investigators of the PEGs and the NHLBI Program Director. The annual meeting will include an oral and/or poster presentation as a part of the skills development program. The PEG budget should include provisions for investigators to attend the investigators meeting.

Internal Advisory Committee: Each PEG will establish its own Internal Advisory Committee to evaluate progress and the effectiveness of interaction among participants.

External Advisory Committee: Each PEG may choose to establish an External Advisory Committee to evaluate program progress. PEG applications should not constitute their external advisory board prior to or during the review of their application because individuals identified in an application cannot participate in its peer review.

Investigators Subcommittee: The Investigators Subcommittee, composed of the PEG Principal Investigators or their representative and the NHLBI Program Director, will meet quarterly by conference call. The Investigators Subcommittee will plan the annual investigators meeting, and designate and determine areas of shared interest and potential for collaboration in order to further the goals of the program.

External Review Panel: In order to maintain close scientific oversight of the PEGs, an External Review Panel (ERP) consisting of eminent scientists in appropriate fields will be established by NHLBI. The ERP will meet periodically to review the progress of each PEG and to assess the overall programmatic goals of the initiative. In addition, the ERP will carry out a formal review of progress in the fourth year and make recommendations to the Director, NHLBI on continued support; and on structural and functional changes that should be made to enhance the scientific directions of the PEGs and their interactions with the scientific community.

Standard NHLBI PPG

PEG

NHLBI approval for submission

Required

(only via $500k approval)

Not Required

PI Effort Level

25%

20%

Structure

Research Projects and Core(s)

Research Projects and Core(s) (Skills Development Core, Shared Resources Core)

Multi-disciplinary team

Not required

Required

Prior collaboration among team members

Expected

Not required

Clinical research

Not required

Phase III clinical trials not allowed

Not Required

Phase II and/or III clinical trials not allowed

Maximum allowable direct costs

$1,515 million per year

$1.6 million per year

Duration

Not limited

1 grant cycle with 7 years maximum

Review Criteria

Standard

Standard

Review Process

2-stage: Tailored Review Committee, NHLBI PPG Review Committee

1-stage: Special Emphasis Panel for all PEG applications

Appendix Materials

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

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

Resource Sharing Plan(s)

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

(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

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

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

Section V. Application Review Information

1. Criteria

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

2. Review and Selection Process

Review Process

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

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

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

Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed). Each application will be reviewed in its entirety and receive a single impact/priority score. The individual research projects will not receive separate scores.

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

Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? What is the potential for the Program to enhance glycoscience research and provide novel information about the roles of glycosylation, glycans and/or glycan binding proteins in disease or disorders or in biological processes relevant to heart, lung, and blood? Will the Program provide needed glycosciences skills development for the next generation of glycoscientists?

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

Do the PIs form multidisciplinary teams? Does the designated Glycosciences Skills Development Coordinator have well documented relevant experience?

Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Does the program show evidence of being dynamic and able to change and adapt as research and the field progress? What is the potential for the Program to generate innovative glyco-analytical tools and resources applicable to heart, lung, and blood research? Will the Program provide novel skills development opportunities for investigators new to the field of glycosciences?

Approach. Are the overall strategy, methodology, and analyses well reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves clinical research, are the plans for (1) protection of human subjects well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Does the overall strategy include a multidisciplinary approach with leading researchers, junior investigators, and cutting-edge technologies in the glycosciences?

Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Does the environment support interactive collaborations and sharing of resources among PEG investigators? Does the research plan include an environment for appropriate skills development in the glycosciences?

Additional Review Criteria

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

Administrative Center: The Administrative Center, if present in the application, will receive a separate impact/priority score based on the review criteria below, but that score will not be factored into the overall impact/priority score for the project.

Review Criteria for the Administrative Center.

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

(5) data and safety monitoring for clinical trials.

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

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

Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: (1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; (2) justifications for the use of animals and for the appropriateness of the species and numbers proposed;

(3) adequacy of veterinary care; (4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and (5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.

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

Additional Review Considerations

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

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

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

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

Selection Process

The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

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

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

Section VII. Agency Contacts

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

1. Scientific/Research Contacts:

Rita Sarkar, Ph.D.
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 9161
Bethesda MD 20892-7950
Bethesda, MD 20817 (for courier service)
Telephone: 301-435-1324
Fax: 301-480-1046
Email: [email protected]

Narasimhan Danthi, Ph.D.
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 8218
Bethesda, MD 20892-7940
Telephone: (301) 435-0513
Fax: (301)-480-1454
Email: [email protected]

Dorothy Gail, Ph.D.
Division of Lung Diseases
National Heart, Lung, and Blood Diseases
6701 Rockledge Drive, Room 10178
Bethesda, MD 20892-7952
Telephone: (301) 435-0222
Fax: (301) 480-3557
Email: [email protected]

2. Peer Review Contacts:

Director, Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Room 7214, MSC 7924
Bethesda, MD 20892-7924 (Express zip: 20817)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: [email protected]

3. Financial or Grants Management Contacts:

Ms. Marsha Mathis
Division of Extramural Research Activities
Office of Grants Management
6701 Rockledge Drive, Room 7169
Bethesda, MD 20892-7926
Telephone: (301) 435-0166
Fax: (301) 480-1948
Email: [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.

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

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-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

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

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

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

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

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

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

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

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

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