Part I Overview Information


Department of Health and Human Services

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

Components of Participating Organizations
National Institute of Allergy and Infectious Diseases (NIAID), ( http://www.niaid.nih.gov/)

Title: Medical Countermeasures to Restore Gastrointestinal Function after Radiation Exposure: Project Bioshield (RC1)

Note: The Project BioShield Act of 2004, enacted on July 21, 2004, authorizes the Secretary, Department of Health and Human Services (DHHS), through the program carried out by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), to expedite peer review and award of grants, contracts, and cooperative agreements to perform, administer, or support research and development of countermeasures determined by the Secretary to be a priority to treat, identify, or prevent harm from any biological, chemical, radiological, or nuclear agent that may cause a public health emergency affecting national security, or adverse health consequences that may arise from using such a countermeasure. Consistent with this authority, the NIAID is announcing a new grant initiative focused on the development of novel medical countermeasures to restore gastrointestinal function after radiation exposure.

For this special program applications are to be sent directly to NIAID, not to the Division of Receipt and Referral in CSR (see Section IV 3.B).

Announcement Type
New

Request For Applications (RFA) Number: RFA-AI-07-013

Catalog of Federal Domestic Assistance Number(s)
93.855

Key Dates
Release/Posted Date: December 29,2006
Letters of Intent Receipt Date(s): February 13, 2007
Application Receipt Date(s): April 19, 2007
Peer Review Date(s): May, 2007
Council Review Date(s): August, 2007
Earliest Anticipated Start Date(s): September, 2007
Additional Information To Be Available Date (Url Activation Date): http://www.niaid.nih.gov/ncn/budget/qa/
Expiration Date: April 20, 2007

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

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

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

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
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

The Department of Health and Human Services (DHHS) has assigned the NIH the responsibility to identify, characterize, and develop new medical countermeasures against radiological or nuclear attacks. A robust research and development program in this area will begin to yield new diagnostic tools, radioprotectors and mitigators and therapeutic agents to facilitate an effective response against radiological injury. On October 14, 2004, the NIH convened an expert panel to review the NIH Strategic Plan and Research Agenda for Medical Countermeasures against Radiological and Nuclear Threats (http://www3.niaid.nih.gov/research/topics/radnuc/default.htm). This strategic plan and research agenda outlines a flexible, collaborative, and comprehensive NIH research and product development program focused on medical therapies and diagnostics to counter radiation injury. On behalf of the NIH, the NIAID is charged with implementing this research agenda.

In most radiation scenarios, injury to the hematopoietic system and gastrointestinal tract are the main determinants of survival. There are currently some medical countermeasures for the management of hematopoietic injury, and additional approaches are in the pipeline. However, there is an urgent need to develop specific countermeasures against the lethality caused by intestinal exposure to radiation and against the pathophysiological manifestations of radiation-induced gastrointestinal injury. The availability of new products that can restore gastrointestinal function after radiation will change the medical management options and outcomes of exposure for a potentially large number of casualties.

The goal of this funding opportunity is to develop medical products that will rapidly and efficiently prevent, mitigate and treat gastrointestinal injury after radiation exposure. This program will support research on mechanisms of radiation-induced injury as well as development of products that will mitigate and treat radiation damage to gastrointestinal system by preventing enterocyte depletion, mucosal barrier break down, mucositis, bacterial translocation, and adverse tissue regeneration with the ultimate goal of increasing survival. The program will also focus on products and methods that will restore gastrointestinal function in terms of barrier protection from microbes, re-equilibration with commensal bacteria, and/or restoration of nutritional transport, reconstitution of mucosal innate and adaptive immunity. Applicants may propose the development of previously identified candidate products relevant to these goals. Product development under this initiative must directly involve the protection or restoration of gastrointestinal function in the context of radiation damage, and be relevant to radiation damage caused by terrorist acts or accidental exposures. For the purpose of this initiative, products are defined as drugs, biologics or other compounds with protective or therapeutic potential, as well as new procedures that result in protection or restoration of the gastrointestinal system using existing compounds.

It is anticipated that candidates that prove efficacious will be advanced towards Food and Drug Administration (FDA) licensure through follow-on support from industry or other government-funded programs. The NIAID will place a high priority on projects that demonstrate advantages over current treatments (such as ease of use in mass casualty settings, ability to deliver treatment post-exposure, and/or reduced toxicity) and have a feasible product development plan for FDA licensure. Studies in animal models will be required to demonstrate efficacy of the products to minimize damage and restore normal function. Clinical studies using human tissue samples or data from irradiated patients may be included, if the results are likely to be relevant to the treatment of humans exposed to terrorist or accidental radiological or nuclear attack. Clinical trials will not be supported under this initiative.

Areas of research and development that are responsive may include, but are not limited to, the following:

This program will not support the following:

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 NIH Challenge grant (RC1) award mechanism. The RC1 grant is used by NIAID to support accelerated product research and development efforts in targeted areas. 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

NIAID intends to commit up to $4.0 million in FY 2006 to support research and development projects under this initiative. Applicants may request up to $1 million in total costs for a project period not to exceed eighteen (18) months.

Although the financial plans of NIAID 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.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

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

1.B. Eligible Individuals

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

2. Cost Sharing or Matching

Not applicable. The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria

A Principal Investigator (PI) may submit only one application. A Principal Investigator can serve as a collaborator in another application provided there is no scientific overlap. An institution may submit more than one application.

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: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

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

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

3. Submission Dates and Times

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

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): February 13, 2007
Application Receipt Date(s): April 19, 2007
Peer Review Date(s): May, 2007
Council Review Date(s): August, 2007
Earliest Anticipated Start Date(s): September, 2007

3.A.1. Letter of Intent

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

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

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

The letter of intent should be sent to:

Dr. Priti Mehrotra
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3138, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892 (USPS Express or regular mail)
Bethesda, MD 20817 (for express/courier service)
Telephone: (301) 496-2550
FAX: (301) 402-2638
Email: pm158b@nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared as instructed in 6. Other Submission Requirements below.

Send the signed original application, five (5) paper copies, and one (1) CD with a faithful PDF file copy to:

Dr. Priti Mehrotra
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3138, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892 (USPS Express or regular mail)
Bethesda, MD 20817 (for express/courier service)
Telephone: (301) 496-2550
FAX: (301) 402-2638
Email: pm158b@nih.gov

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

NOTE: Applications must be sent to the above address and not to the Division of Receipt and Referral, Center for Scientific Review, NIH.

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 and responsiveness by the NIAID. Incomplete and non-responsive applications will not be reviewed.

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

An application with a research plan of no more than fifteen (15) pages must be submitted by April 19, 2007. The application must include the following sections, in the order listed:

*PHS 398 FACE PAGE Must be completed and signed by the appropriate institutional officials (does not count against the page limit). The Face Page form requires a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number. Organizations that do not have a DUNS number may receive one at no cost by calling the dedicated toll-free DUNS number request line at 1-866-705-5711 or via URL http://www.dunandbradstreet.com/. Additional information on this requirement is provided at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-055.html.

*PHS 398 PAGE 2 DESCRIPTION, KEY PERSONNEL, PERFORMANCE SITES, etc. (does not count against page limit).

*PHS 398 PAGES 4 AND 5 BUDGET PAGES (does not count against page limit).

Within the 15 page limit:

Letters of Support For applications that include the use of a specific candidate for basic or regulated studies, applicants must also include letters of support from any collaborators and consultants participating in the proposed research, and corporate sponsors or individuals providing the candidate for the project (does not count against page limit).

Biographical Sketches Provide biographical sketches, not to exceed one (1) page each, for each individual proposed on the project. Provide evidence that the Principal Investigator is qualified to direct this product development effort (does not count against page limit)

*The PHS 398 Face Page form and the PHS 398 Page 2, and the PHS 398 Pages 4 and 5 Budget Pages, along with instructions for completing these forms, can be found at http://www3.niaid.nih.gov/biodefense/bioshield_forms.html.

Appendix Materials

Stop SignIMPORTANT NOTE: Appendix materials are not allowed. Applications that contain appendix materials will not be reviewed. Applications must be complete. No materials will be accepted after the application receipt deadline.

The letter application must be single-spaced and single-sided, using type no smaller than 11 pt. font and margins no smaller than 0.5 inches on each side, top and bottom.

Additional Instructions and Information

Intellectual Property

NIAID recognizes that intellectual property rights are likely to play an important role in achieving the goals of this program. To this end, the NIAID reminds the applicant that:

To the extent that the project will involve partners, applicants are encouraged to reach early consensus with their proposed partners regarding intellectual property and other legal matters that may arise during the project. In addition, applicants are expected to exercise their Bayh-Dole rights in a manner that does not conflict with the goals of this award or the intent of the Bayh-Dole Act to promote the utilization, commercialization and availability of U.S. Government-funded inventions for public benefit. Finally, applicants are expected to make new information and materials known to the research community in a timely manner through publications, web announcements, and reports to the NIAID or other mechanisms.

Plan for Sharing Research Data

Not applicable.

Sharing Research Resources

Not applicable.

Section V. Application Review Information


1. Criteria

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

The following will be considered in making funding decisions:

2. Review and Selection Process

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

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

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

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)?

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?

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:

Applications will be reviewed on the basis of: the scientific rationale and technical feasibility of the proposed project to develop medical countermeasures to restore gastrointestinal function after radiation exposure, as well as the probability of technical success; the experience, expertise, and qualification of the project team; and the scientific environment and research facilities. Appropriateness in terms of the overall proposed project and stage of development, as well as the potential for further product development beyond that proposed in order to produce an FDA licensable radiation medical countermeasure, will also be assessed.

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

Not applicable.

2.D. Sharing Research Resources

Not applicable.

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, a successful PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

Awards will be made on the basis of scientific merit as determined by peer review, availability of funds, as well as programmatic priorities.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

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

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

2. Administrative and National Policy Requirements

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

3. Reporting

Not applicable.

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:

Narayani Ramakrishnan, Ph.D.
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases
Room 4059, MSC-6601
6610 Rockledge Drive
Bethesda, MD 20892-6601

Telephone: (301) 451-3101
Fax: (301) 480-6597
Email: nramakrishnan@niaid.nih.gov

2. Peer Review Contacts:

Dr. Priti Mehrotra
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3138, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892
Telephone: (301) 496-2550
FAX: (301) 402-2638
Email: pm158b@nih.gov

3. Financial or Grants Management Contacts:

Dawn Mitchum, MPH
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2241, MSC-7610
6700-B Rockledge Drive
Bethesda, MD 20892-7610
Tel: 301-451-2667
Fax: 301-493-0597
Email: dmitchum@niaid.nih.gov

Section VIII. Other Information


Required Federal Citations

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

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.

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).

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ in the following citation: No. 93.855, Immunology, Allergy, and Transplantation Research, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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

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


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