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 Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov/)(http://www.niehs.nih.gov/careers/hazmat/)

Title: Hazmat Training at Doe Nuclear Weapons Complex (U45)

Announcement Type
This is a reissue of RFA-ES-04-006

Update: The following update relating to this announcement has been issued:

Request For Applications (RFA) Number: RFA-ES-09-003

Catalog of Federal Domestic Assistance Number(s)
93.142

Key Dates
Release Date: July 9, 2009
Letters of Intent Receipt Date: October 23, 2009
Application Receipt Date: November 23, 2009
Peer Review Date: February/March 2010
Council Review Date: May 2010
Earliest Anticipated Start Date: September 1, 2010
Additional Information To Be Available Date (Url Activation Date): not applicable
Expiration Date: November 24, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

The major objective of this solicitation is to prevent work related harm by assisting in the training and education of workers in the DOE nuclear weapons complex. Safety and health training will transmit skills and knowledge to workers in how best to protect themselves and their communities from exposure to hazardous materials encountered during hazardous waste operations, facility decommissioning and decontamination, hazardous materials transportation, environmental restoration of contaminated facilities or chemical emergency response. Currently, tens of thousands of DOE employees require safety and health training to help reduce the risk of their being exposed in the course of their work to hazardous materials and hazardous waste products. One effort to enhance training capabilities at these sites has been through the National Institute of Environmental Health Sciences (NIEHS) Worker Education and Training Program (WETP).

A major goal of this program is to provide assistance to organizations in developing their institutional competency to provide appropriate model training and education programs to hazardous materials and waste workers in the DOE nuclear weapons complex. Both NIEHS and DOE recognize the importance of effectively managing training resources to maintain and improve federal and contractor workforce competencies. Proper use of resources will result in federal and contractor employees who are highly skilled and capable of carrying out our critical missions in a safe and reliable manner consistent with recognized standards of excellence. Continuing improvements will assist in planning and conduct of training programs to ensure that these programs are closely aligned with mission priorities and administered efficiently.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

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

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

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Dispute Resolution
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 OF THIS FOA

The National Institute of Environmental Health Sciences (NIEHS) invites applications for cooperative agreements to support the development of model programs for the training and education of workers engaged in activities related to hazardous materials and waste generation, removal, containment, transportation and emergency response within the Department of Energy (DOE) Nuclear Weapons Complex.

The major objective of this solicitation is to prevent work related harm by assisting in the training and education of workers in the DOE nuclear weapons complex. Safety and health training will transmit skills and knowledge to workers in how best to protect themselves and their communities from exposure to hazardous materials encountered during hazardous waste operations, facility decommissioning and decontamination, hazardous materials transportation, environmental restoration of contaminated facilities or chemical emergency response. Currently, tens of thousands of DOE employees require safety and health training to help reduce the risk of their being exposed in the course of their work to hazardous materials and hazardous waste products. One effort to enhance training capabilities at these sites has been through the National Institute of Environmental Health Sciences (NIEHS) Worker Education and Training Program (WETP).

A major goal of this program is to provide assistance to organizations in developing their institutional competency to provide appropriate model training and education programs to hazardous materials and waste workers in the DOE nuclear weapons complex. Both NIEHS and DOE recognize the importance of effectively managing training resources to maintain and improve federal and contractor workforce competencies. Proper use of resources will result in federal and contractor employees who are highly skilled and capable of carrying out our critical missions in a safe and reliable manner consistent with recognized standards of excellence. Continuing improvements will assist in planning and conduct of training programs to ensure that these programs are closely aligned with mission priorities and administered efficiently.

BACKGROUND INFORMATION

The Superfund Amendments and Reauthorization Act of 1986 (SARA), Section 126(g), authorizes an assistance program for training and education of workers engaged in activities related to hazardous waste generation, removal, containment or emergency response and hazardous materials transportation and emergency response. The Congress assigned responsibility for administering this program to the National Institute of Environmental Health Sciences (NIEHS), an Institute of the National Institutes of Health (NIH) within the Public Health Service (PHS) of the US Department of Health and Human Services (DHHS).

The National Defense Authorization Act for fiscal years 1992 and 1993 (42 USC 7274(d)) authorized the Secretary of Energy in section 3131(a)(1)(A)-(B) to make awards: "to provide training and education to persons who are or may be engaged in hazardous substance response or emergency at Department of Energy nuclear weapons facilities; and to develop response curricula for such training and education." The Secretary was further authorized in Section 3131(a)(2)(A)-(B) to make the training awards to non-profit organizations demonstrating capabilities in: "implementing and conducting effective training and education programs relating to the general health and safety of workers; and identifying, and involving in training, groups of workers whose duties include hazardous substance response or emergency response."

As stated above, under Section 126(g) of Superfund Amendments and Reauthorization Act (SARA), NIEHS developed and administers a Worker Education and Training Program. During 1992, the DOE evaluated this program developed by NIEHS for suitability of adaptation to its own program and training needs, and determined that the program was suitable. In an effort to rapidly move to the implementation stage and to leverage program resources, DOE entered into an agreement with NIEHS to award and administer the grants and to adapt its existing program to meet the needs of the DOE nuclear weapons complex.

Protecting worker health and safety through the delivery of safety and health training is a priority of the Secretary of Energy and is a primary goal of the Office of Environmental Management (EM). As the DOE mission has shifted from weapons production to environmental restoration, the site worker will be exposed to new operations and hazards while conducting restoration activities, many of which will be associated with potential exposure to hazardous substances and wastes.

To provide protection to workers' health and safety, all workers at DOE sites engaged or potentially engaged in environmental restoration activities, including hazardous substance response or emergency response, are required by CERCLA and respective DOE Orders to meet the requirements of the Occupational Safety and Health Administration's (OSHA) regulations 20 CFR 1910.120 and the EPA Hazardous Waste Operations and Emergency Response (HAZWOPER) training requirements (40 CFR 300.150).

Environmental cleanup is a complex undertaking, which may often pose significant dangers to remediation workers as well as to residents of the surrounding community. Throughout the Department of Energy (DOE) complex, contamination issues resulting from the historic mission of weapons production, as well as from extensive use of radioactive materials and highly toxic chemicals - have created a unique challenge for those managing environmental cleanups. There is clearly a need for highly trained workersto carry out the actual remediation work.

Model training programs for hazardous waste workers and emergency responders shall satisfy minimum requirements as specified in Federal OSHA rules and other related regulations which have been or may be promulgated. Training programs shall also meet the minimum requirements specified in the Minimum Criteria for Worker Health and Safety Training for Hazardous Waste Operations and Emergency Response, updated in 2006 as a result of an NIEHS sponsored technical workshop on training quality. Originally issued in 1991 and expanded in 1994, the latest document incorporates training issues such as the emergence of computer-based training and the training of workers to deal with the aftermath of terrorist actions. The Final Version of the Minimum Health and Safety Training Criteria: Guidance for Hazardous Waste Operations and Emergency Response (HAZWOPER) Supporting and All-Hazards Disaster Prevention, Preparedness, and Response can be found at http://tools.niehs.nih.gov/wetp/public/hasl_get_blob.cfm?ID=2465.

Consideration should also be given to Appendix E of 29 CFR 1910.120 (59 FR 43268, August 22, 1994), which references much of the NIEHS Minimum Criteria Worker Health and Safety Training for Hazardous Waste Operations and Emergency Response. This OSHA guidance is available at: http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=9770.

During 2006, the Department of Energy (DOE) established a new safety and health program under Rule 10 CFR 851, Worker Safety and Health Program. This rule established worker safety and health requirements that govern the conduct of contractor activities at non-nuclear, as well as nuclear, sites. The Rule requires that DOE contractor workers are provided with a workplace that is free from recognized hazards that can cause death or serious physical harm.

To accomplish this objective, the Rule establishes management responsibilities, worker rights, safety and health standards, and required training. The Rule incorporates DOE Order 440.1A that provides the basic foundation for a worker protection program to protect workers from hazards associated with their activities. Rule 10 CFR 851 should be a central part of any training activities at DOE sites and may be referenced at http://www.hss.energy.gov/HealthSafety/WSHP/rule851/851final.html.

DOE Order 440.1A may be referenced at http://www.directives.doe.gov/pdfs/doe/doetext/neword/440/o4401a.pdf

The DOE HAZWOPER Handbook has been an important resource for DOE training program development and provides tools and guidance to establish and implement comprehensive, cost-effective, hazard-based worker health and safety programs that are an integral part of accomplishing work on time and within budget. This Handbook has been developed to assist Department of Energy (DOE) and contractor. It is available at:http://www.hss.doe.gov/HealthSafety/WSHP/chem_safety/docs/haz_waste_activity_handbook/hwa_handbook.pdf

In February 2007, WETP updated its strategic plan to be consistent with the NIEHS vision, which includes identification and prevention of hazardous exposures. The WETP uses the environmental sciences to reduce risk and protect worker and public health through training. The strategic plan outlines the directions that the program seeks to take during the next 5 years. It includes information on the development of the plan, partnerships, roles of advanced training technologies, and the central role of 29 CFR 1910.120 in environmental response and cleanup whether at traditional superfund sites, uncontrolled hazardous waste sites, or sites emanating from a natural disaster or an act of terrorism. The 2008-2013 WETP Strategic Plan can be found at http://www.niehs.nih.gov/careers/hazmat/wetp_strategic_plan_2008.pdf.

PROGRAM DESCRIPTION

The NIEHS Worker Education and Training Program, in partnership with the DOE Environmental Management Program, has supported qualified domestic nonprofit organizations to develop and administer model health and safety education programs for hazardous materials or waste workers within the nuclear weapons complex. In 2009, the DOE Office of Health, Safety and Security (HSS) and the NIEHS Worker Education and Training Program signed a memorandum of understanding in an expanded effort to communicate and improve relationships with those elements that train, manage, and represent the DOE workforce and to improve the safety culture at DOE sites. The objective of this collaboration will be to seek areas/topics where HSS, the NIEHS and its grantees can collaborate with site programs to enhance the safety of site operations through training.

Target populations for training in the DOE nuclear weapons complex include those covered by requirements of Federal Occupational Health and Safety Administration (CFR, Title 29, Part 1910, which is found at:http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=9765) and Environmental Protection Agency (CFR, Title 40, Part 311) standards for Hazardous Waste Operations and Emergency Response, regulations governing the NIEHS Hazardous Waste Worker Training Program (CFR, Title 42, Part 65), as well as hazardous materials transportation workers regulated by the US Department of Transportation. Further guidance on DOT Hazmat Employees is available at: http://www.fmcsa.dot.gov/rules-regulations/administration/fmcsr/fmcsrruletext.asp?chunkKey=090163348004751d

Congress recognized this need and authorized the Secretary of Energy, through the National Defense Authorization Act for Fiscal Years 1992 and 1993, Section 3131, to award grants for training and education for persons engaged in hazardous substance response or emergency response at DOE nuclear weapons facilities. For purposes of Section 3131, the term "hazardous substance" in addition to its definition under CERCLA includes radioactive waste, mixed radioactive and hazardous waste.

In an effort to rapidly move to the implementation stage and to leverage program resources, DOE studied the suitability of NIEHS as awards administrator for the DOE program. Based on a review of the NIEHS program, DOE entered into an agreement with NIEHS to award and administer the grants and to adapt the HAZWOPER program to meet the needs of DOE.

The goal of the DOE/NIEHS Worker Training Program has been to provide site-specific, quality training to workers in a timely and cost-effective manner, through a partnership involving government, contractors, and labor organizations. A cornerstone of the program is the use of "worker-trainers," employees well-versed in performing a given task in a hazardous environment who are trained to instruct other workers. Benefits of the partnership include fostering cooperation between management and workers, improving efficiency and quality of training, improving the ability to address worker concerns, and empowering all stakeholders to address site-specific safety and health needs.

NIEHS, through its awardees, has provided high quality hazardous substance response or emergency response training to ensure that: (1) DOE site workers are aware of the hazards that exist at DOE sites; (2) workers are prepared to work safely in such hazardous environments to prevent accidents from occurring; and (3) workers have sufficient knowledge of their work environment and hazardous conditions to identify hazardous situations and to take appropriate actions to protect themselves, fellow workers, and the environment.

GENERAL TRAINING GOALS AND OBJECTIVES

Major program objectives for the future of the DOE/NIEHS Worker Education and Training Program include:

Awards will be made for direct student and worker trainer training, technical support of training, and training program evaluation. It is believed that adequate curricula and training materials exist for worker training that can be adapted with minimal effort. Means of multiplying training are also encouraged to meet the need; thus, programs such as effective train the trainer programs are encouraged. Programs targeted to multi-state and nationwide coverage to reach wider worker populations will be given preference in review and funding. Applications will not be considered that cover municipalities or other jurisdictions covering less than two states. Applicants are also encouraged to develop plans for independently continuing the program.

Applicants should refer to SARA Section 126 requirements for training. Coverage of all hazardous waste and emergency response workers is based on potential exposure and health risk. The language of section 126 (d)(1) and (g) is clear that training scope be broad. Section 126 states that the training be required for personnel engaged in hazardous substance removal or other activities, such as those involved in transportation, which expose or potentially expose such workers to hazardous substances. The same section later requires that special training be provided to workers who may be exposed to unique or special hazards. Section (g)(1) authorizes this training assistance program for the training of workers who are or may be engaged in activities related to hazardous waste removal or containment or emergency response.

The training scope covers worker health protection from hazardous waste work and exposure to hazardous substances in the broadest sense. The applicant shall identify workers or groups of workers who need to be trained in hazardous substance response or emergency response to ensure their health and safety. These target populations may include the existing DOE workforce; those likely to perform DOE environmental clean-up and waste management work within 120 days following the completion of training; those involved in waste transportation on, to, and from DOE sites; appropriate supervisors and managers of contractor and subcontractor activities; emergency response personnel with site mutual aid agreements; and appropriate Federal, State, and local government officials who are involved in compliance efforts.

Cooperative agreement applicants are expected to make a reasonable effort to develop cooperative relationships with DOE training managers to: (1) identify what training courses are needed to ensure that applicable health and safety training requirements are met; (2) accurately determine the number of employees who need training; and (3) ensure that training meets site-specific needs and is consistent with established quality standards. Such arrangements should be described in detail in the training plan.

An applicant may join with one or more nonprofit organizations in a single application and share resources in order to maximize worker group coverage, enhance the effectiveness of training, and bring together appropriate academic disciplines and talents. Such arrangements are strongly encouraged. The application must have specific plans to implement the cooperative arrangements necessary for program integration and to insure effectiveness. These plans must be contained in the prime applicant’s submission as well as budgets to implement these plans. Specific expertise, facilities or services to be provided by each participating member must be identified. Awardees submitting competing continuation applications should also describe how they have met special cooperative agreement terms and conditions of their awards, including their interaction with other investigators and NIEHS program staff.

Essential components of health and safety programs for those who work with hazardous materials are appropriate education and training. The Superfund Amendments and Reauthorization Act of 1986 addresses this in Section 126 which requires the Occupational Safety and Health Administration (OSHA) to promulgate standards for the health and safety protection of employees in this area. OSHA final rule 29 CFR 1910.120 Hazardous Waste and Emergency Response Operations was promulgated on March 6, 1989 with an effective date of March 6 1990. Further information about OSHA resources and interpretations of HAZWOPER training requirements can be found at:http://www.osha.gov/SLTC/hazardouswaste/index.html

The immediate goal of worker health and safety training is educational in nature, designed to provide students with relevant information, problem- solving skills, and the confidence needed to use these tools. Long-term goals of the model training programs should be to assure that workers become and remain active participants in determining and improving the health and safety conditions under which they work and that avenues for collaborative employer-employee relationships in creating safe workplaces are established.

Worker safety and health training is adult-based, action-oriented, and result-centered. The goals and objectives of worker training focus on outcomes rather than on learning for its own sake. Workers come to training with a great volume of experience, and are, in many ways, the richest resources of a training class. Experience shows that successful adulteducation often emphasizes peer-sharing activities, such as problem-solving and simulation exercises, that tap the experience of the learner. Successful worker training often mirrors the way people learn at work -- from each other. After training, workers should be able to bring what they have learned in the classroom or work-site training back to their jobs.

A list of curricula developed by current NIEHS awardees is available on the web at http://tools.niehs.nih.gov/wetp/index.cfm?id=603

ONGOING PROGRAM INITIATIVES

Due to the complexity and the number of new emerging training innovations and technologies occurring in the worker health and safety arena, NIEHS identified several training opportunities in the previous RFA (ES-04-006) that were specifically related to the advancement of the Worker Education and Training Program. It was important that these new emerging training technologies and approaches be woven and integrated into the framework of the program. NIEHS had learned that successful examples of training partnerships involve the creation of clear mechanisms for assuring avenues for input and collaboration by labor, management, local government officials and other stakeholders, as well as a vision for integrating training into other workplace programs and initiatives. In addition, it was clear that the context and technical approaches to safety and health training had undergone a rapid transition since 1990, as computer and telecommunications technology had unleashed a wealth of technical information resources and established innovative modes of training development, delivery and evaluation. Applicants should refer to http://www.niehs.nih.gov/careers/hazmat/funding/doe2009_rfa_links.cfmfor a list of these important ongoing program initiatives.

Applications should include plans for reaching underserved workers in the proposed target populations especially those disadvantaged in education, language skills or limited in literacy. The inclusion of institutions and organizations that have historical involvement and expertise in responding to environmental justice issues is also strongly encouraged.

Participation of minority institutions and community-based organizations from people of color communities may include the:

Considering the emergence of new health and safety concerns for workers in the areas of green remediation/worker, green chemistry, nanotechnology, new industrial processes and chemicals, combustible dust, and the storage of nuclear waste, it is clear that additional health and safety training approaches are necessary to address these new hazards to the hazardous waste workforce.

For example, WETP focused hazardous waste training has long been recognized as protecting the environment and the health of surrounding communities. In today's terminology, the jobs supported by this training are "green" jobs. Proper training assures that green jobs are safe jobs. In October, 2008, the WETP held the conference, Implications for Safety and Health Training in a Green Economy, which confirmed that the WETP was taking the correct course of action in developing training that prepares workers for green-collar jobs. In the current state of affairs, green job training is important because of the toxicity that is present in our work places, communities, and homes. Thus, green job training is a public health imperative. Applicants should consider how green job principles focused on safety and health training for hazardous materials and waste may be incorporated into hazmat training at DOE nuclear weapons sites through existing or new training programs and curricula.

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 U45 Cooperative Agreement award mechanism.

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

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

2. Funds Available

The estimated amount of funds available for support of 7 - 10 cooperative agreements awarded as a result of this announcement is $9.5 million for fiscal year 2010. Future year amounts will depend on annual appropriations.

The total project period for an application submitted in response to this funding opportunity must be 5 years. A new applicant may request a budget for direct costs of up to $700,000 dollars for the first year. Applicants submitting renewal (competing continuation) applications may request up to a ten percent increase above the budget level (direct cost) of the last year of their continuation project (non-competitive renewal). Renewal (competing continuation) applicants who intend to request more than a ten percent increase above the budget level must request in writing to the Program staff prior approval to submit the application

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.

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. Only one application per institution/organization will be accepted.

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

Renewals. Renewal applications are permitted in response to this FOA

Section IV. Application and Submission Information

1. Address to Request Application Information

The 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 in item (box) 2 only of the face page of the application form and the YES box must be checked.

The title of this FOA is Hazmat Training at DOE Nuclear Weapons Complex (U45). The number of this FOA is RFA-ES-09-003.

Additional information is available in the PHS 398 grant application instructions.

3. Submission Dates and Times

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

3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date: October 23, 2009
Application Receipt Date: November 23, 2009
Peer Review Date: February/March 2010
Council Review Date: May 2010
Earliest Anticipated Start Date: September 1, 2010

Applicant Information Meeting Date: September 2, 2009.

A briefing for applicants will be held at NIEHS on Wednesday, September 2, 2009 from 1:00-5:00 PM on the NIEHS Main Campus, Rall Building, Rodbell Conference Room B at 111 T.W. Alexander Drive, Research Triangle Park, NC USA 27709. NIEHS staff will use this "Applicant Information Meeting" (AIM) to explain the purpose of the Program, provide instructions about the application process, and answer questions. A summary of responses from the briefing, all relevant information for potential applicants and Supplementary Instructions will be available upon request from NIEHS (wetp@niehs.nih.gov) and will be posted on the NIEHS Worker Education and Training Program (WETP) home page at: http://www.niehs.nih.gov/careers/hazmat.

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:

Sally Eckert-Tilotta, Ph.D.
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
530 Davis Drive
Keystone Building, Room 3076
P.O. Box 12233, K3-03
Research Triangle Park, North Carolina 27709
Fax: 919-541-2503
E-mail: eckertt1@niehs.nih.gov

Please note that email submission of letters of intent is preferred.

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 5CDs of the appendix material must be sent to:

Sally Eckert-Tilotta, Ph.D.
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
530 Davis Drive
Keystone Building, Room 3076
P.O. Box 12233, K3-03
Research Triangle Park, North Carolina 27709
Telephone: 919-541-1446
Fax: 919-541-2503
E-mail: eckertt1@niehs.nih.gov

3.C. Application Processing

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

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

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

6. Other Submission Requirements

SUPPLEMENTAL INSTRUCTIONS

Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information". The applications submitted in response to this FOA are complex, and the training and programmatic information needed to adequately assess a grant proposal is not fully accommodated within the instructions accompanying the PHS 398 form. Therefore, applicants need to follow the detailed guidelines "Application Guidelines for Hazmat Training at DOE Nuclear Weapons Complex that can be found on: http://www.niehs.nih.gov/careers/hazmat/funding/docs/ES-09-003supplementalinstructions.pdf

Research Plan Page Limitations

The narrative is limited to 25 pages.

Appendix Materials

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

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

Resource Sharing Plan(s)

The following resource sharing policies do not apply to this FOA:

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

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 National Institute of Environmental Health Sciences 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 following will be considered in making funding decisions:

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).

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 training workers? If the aims of the project are achieved, how will training be improved? How will successful completion of the aims change the concepts, methods, technologies, services associated with training that drive this field?

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Are lines of responsibility and accountability clearly delineated when two or more organizations are collaborating on an activity? Is there adequate evidence of experienced and technically qualified key personnel? Does the Principal Investigator strongly demonstrate the capacity for providing leadership and assuring productivity of appropriate worker health and safety training and education programs and for overall management of the training programs including quality assurance and program evaluation? Is there sufficient evidence of an applicant’s organizational structure or consortium, if applicable, that provides adequate knowledge and oversight of resources and administrative management of the program?

Innovation. Does the application challenge and seek to shift current training 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 training or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or training interventions proposed? Is there evidence of inclusion of worker training initiatives and innovations?

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

Are the methods and techniques to be used for identifying, describing, and accessing target specific worker populations for worker health and safety training and anticipated impact of the proposed program adequate?

Does the applicant provide detailed program plans for adapting existing curricula, training of instructors, distributing course materials, directing worker training, and conducting program evaluations?

Is there documentation of the program's achievement of compliance with the requirements of the NIEHS Minimum Criteria for Worker Health and Safety Training for Hazardous Waste Operations and Emergency Response found at http://tools.niehs.nih.gov/wetp/public/hasl_get_blob.cfm?ID=2465?

Are the combinations of classroom instruction and hands on demonstration and instruction appropriate to simulate worker site activities and conditions?

Are there plans for independently continuing the program; for the generation of program income, if applicable; and for assuring the long-term viability of the program?

Is the training plan adequate for reaching underserved worker populations especially those disadvantaged in education, culture, or language or limited in literacy and access to training?

For a prior awardee, has the awardee demonstrated meeting established terms and conditions of prior awards; attainment of program goals and objectives of prior awards; and ability to manage and expend funds in a timely manner in prior budget periods?

Has the organization or consortia demonstrated effectiveness in planning, implementing and operating appropriate worker health and safety training and education programs?

Are they able to immediately initiate direct worker health and safety training, program evaluation, and related support activities?

Environment. Will the 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 environment, subject populations, or collaborative arrangements? Are the facilities and equipment appropriate to support the described worker health and safety training and education activities, including hands on instruction? Is there evidence that the operation of training facilities assures the protection of prospective trainees during program delivery? Are there appropriate policies and procedures for assuring fitness for training and medical clearance?

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

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

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

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

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

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

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 Agent 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. 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, 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 (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 Notice of Award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

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

2.A. Cooperative Agreement Terms and Conditions of Award

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

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

2. A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator of each awardee has primary authorities and responsibilities to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their studies and training activities. It is the responsibility of each awardee to develop the details of the training plan, which will be required to describe the technical approaches, target population access and recruitment, curricula modification, training methodology, and program evaluation procedures.

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

2. A.2. NIH Responsibilities

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

The role of the NIEHS Program Coordinator will be to facilitate, not to direct, the development of a high quality national worker training resource. These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements.

The NIEHS Program Coordinator will coordinate activities of mutual interest and benefit to awardees and the Institute. The primary objective of the Worker Education and Training Program will be to stimulate collaborative work between NIEHS and the awardees in the creation of model worker safety and health training programs. Substantial programmatic involvement by the NIEHS Program Coordinator will assure that there is not duplication of efforts or overlap in worker safety and health training delivery and program development by the awardees.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

2.A.3. Collaborative Responsibilities

Conflict of Interest Management: An NIEHS program official or NIEHS program director will be responsible for the normal scientific and programmatic stewardship of the cooperative agreement award including evaluation of non-competing applications, supplemental requests, etc and will be named in the award notice. When the Project Coordinator also serves as the Program Official, the policy of the NIEHS WETP Program is that the Program Official will not publish with awardees, on activities specifically associated with the cooperative agreement unless it is an introduction or editorial regarding the basic information on the NIEHS WETP role in managing the technical and administrative aspects of the program.

2.A.4. Dispute Resolution

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIEHS may be brought to arbitration. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Awardee, one NIEHS designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

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.

Each awardee is required to submit an annual progress report to the NIEHS Program Administrator, which describes the number, location and nature of all training activities and the characteristics of the trainees reached during a particular fiscal year. Results and findings from training program evaluations will be summarized by each awardee and submitted to the NIEHS Program Administrator on an annual basis. Program evaluation reports shall quantitatively describe the current status of instructor effectiveness, trainee retention of knowledge and skills, and positive impacts of training activities on work practices, workplace safety and health conditions, and overall worker protection from on the job hazards.

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:

Joseph Hughes, Director
Worker Education and Training Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
Keystone Building, Room 3039
P.O. Box 12233, MD K3-14
Research Triangle Park, NC 27709-2233
Telephone: 919-541-0217
Fax: 919-541-0462
Email: hughes3@niehs.nih.gov

Sharon Beard, Industrial Hygienist
Worker Education and Training Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
Keystone Building, Room 3038
P.O. Box 12233, MD K3-14
Research Triangle Park, NC 27709-2233
Telephone: 919-541-1863
Fax: 301-451-5595
Email: beard1@niehs.nih.gov

Ted Outwater, Public Health Educator
Worker Education and Training Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
Keystone Building, Room 3050
P.O. Box 12233, MD K3-14
Research Triangle Park, NC 27709
Phone: 919-541-2972
Fax: 919-541-0462
E-mail:outwater@niehs.nih.gov

2. Peer Review Contacts:

Sally Eckert-Tilotta, Ph.D.
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
530 Davis Drive
Keystone Building, Room 3076
P.O. Box 12233, K3-03
Research Triangle Park, North Carolina 27709
Telephone: 919-541-1446
Fax: 919-541-2503
E-mail: eckertt1@niehs.nih.gov

3. Financial or Grants Management Contacts:

Carolyn Mason, Deputy Grants Management Officer
Grants Management Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
Keystone Building, Room 3060
P.O. Box 12233, MD K3-11
Research Triangle Park, NC 27709-2233
Telephone: 919-541-1373
Fax: 919-541-2860
Email: mason6@niehs.nih.gov

Section VIII. Other Information

Required Federal Citations

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

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

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

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

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

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

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

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

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

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

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

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

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

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

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

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

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

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

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

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