Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Environmental Health Sciences (NIEHS)
Funding Opportunity Title	Research Consortium for 2-Year Bisphenol A Toxicity Study (U01)
Activity Code	U01 Research Project Cooperative Agreements
Announcement Type	New
Related Notices	January 10, 2011 - See Notice NOT-ES-11-005 Notice of Informational Web Seminar.
Funding Opportunity Announcement (FOA) Number	RFA-ES-10-009
Companion FOA	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestics Assistance (CFDA) Number(s)	93.113
FOA Purpose	This Funding Opportunity Announcement (FOA), issued by the National Institute of Environmental Health Sciences (NIEHS), solicits cooperative agreement grant applications to develop a research consortium to assess disease endpoints in a chronic BPA toxicity study. Applications must show expertise in specific disease areas and hypothesis driven scientific ideas and approaches to add specific endpoints based on the literature on BPA toxicity.

Posted Date	December 6, 2010
Letter of Intent Due Date	January 19, 2011
Application Due Date(s)	February 18, 2011
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	May 2011
Advisory Council Review	August 2011
Earliest Start Date(s)	August 2011
Expiration Date	February 19, 2011
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The purpose of this FOA is to develop a consortium of researchers with expertise in specific disease endpoints in animal studies in order to work with the National Toxicology Program/Food and Drug Administration (NTP/FDA) in the final design and execution of a chronic toxicity study of BPA in SD rats.

Bisphenol A (BPA) is the monomer that is polymerized to make a multitude of polycarbonate plastic products. It is also used in epoxy resins that line many different kinds of metal cans and in heat sensitive receipts as well as a in a multitude of polycarbonate products. Monomeric BPA has been reported to induce a range of toxic effects that may be associated with its estrogenic properties or interactions with other targets and signaling systems. Human exposure results from release of the monomeric BPA which has been shown to have estrogenic properties. Detectable levels of BPA have been found in 93% of urine samples collected from people 6yrs and older. Infants have been shown to have almost 10x higher levels than adults.

While there are numerous rodent studies assessing the toxicity of BPA, including GLP-compliant studies (Good Laboratory Practices-GLP), there would be considerable value toward resolving outstanding issues with a GLP-compliant chronic study that includes developmental exposure, with direct rather than lactational exposure of pups, includes assessment of a variety of endpoints related to diseases linked to BPA exposure by animal and human investigations, and evaluates the internal doses of BPA associated with effects.

To this end the NTP/FDA has proposed a study where the strain of animal, animal diet and housing conditions, numbers of animals, dosing regimen and route of exposure to BPA are all controlled and carried out according to GLP guidelines. The NTP-FDA will also assess landmarks of sexual development and histological and clinical chemistry endpoints appropriate to the study as is typical for GLP-compliant chronic toxicity assays. Internal blood levels of total BPA and, where technically feasible, BPA aglycone will also be monitored at appropriate time points during the study. The study will be carried out with Sprague Dawley rats from the National Center for Toxicological Research (NCTR) colony and fed a low phytoestrogen diet. Dosing will be by gavage to the dam from gestation day 6 through parturition. Pups will be directly dosed orally from postnatal day 1 through termination at 2 years of age. The actual doses of BPA will depend on the results of an on-going subchronic study which includes 7 doses between 2.5 and 2,700 g/kg body weight per day. Ethinyl estradiol, at doses to be determined, may be used as a reference estrogen depending on the results of the ongoing 90 day study. One animal per sex from half of the litters will be taken for an interim evaluation at 1 year, and one animal per sex per litter (all) will be taken at 2 years for the standard evaluation. Other animals from the litter would be available for supplementary study, and breeding of additional animals for treatment could also be considered.

The actual study will be carried out at the FDA research facility, NCTR, in Arkansas.

The objective of this research program is to take advantage of scientific expertise in the extramural community to develop a consortium of investigators who will propose hypothesis driven mechanistic studies focusing on disease/dysfunction endpoints which can be added to the chronic study design. The independent scientific ideas and approaches will either use animals generated from the core study or if needed to add additional animals to the core study in order to assess the effects of BPA on specific diseases/dysfunctions over a lifetime.

While the investigators are asked to propose additional disease-related endpoints to be included in the chronic study, the NIEHS staff will evaluate and determine the feasibility of including the endpoints.

Each application should focus only on one disease/dysfunction. The following diseases/dysfunctions are relevant to this solicitation: cardiopulmonary diseases, obesity/diabetes/metabolic syndrome, immune dysfunction, hepatotoxicity, breast and prostate and other cancers, thyroid dysfunction, reproductive toxicity (male and female, together or separately), learning and behavioral assessment including assessment of sexually dimorphic changes in brain structure/biochemistry. It is expected that investigators will propose state-of-the-art assessment of disease onset and etiology which will include but not be limited to the use of genomic, proteomic and epigenetic analysis of the link between BPA exposure and the disease/dysfunction studied over dose, time and sex.

The following information is requested and must be part of the research strategy section of the application.

What is the hypothesis tested? What is the Disease or dysfunction focused endpoint proposed to be added to the study? What data provide the rationale for study of the disease/dysfunction in relation to BPA exposure during development? What is the expertise of the investigator in the specific disease/dysfunctions examined? Note that expertise in BPA research is not required.

What state of the art methods and approaches will be used to assess the disease/dysfunction endpoints? Details of the number of animals, actual protocol and approach including timing and any need for special animal care or handling or tissue preparation must be included. It is critical to explain how the proposed study can be incorporated into the core GLP backbone study. Note that it is possible to use the NCTR facilities to assess endpoints that may require continued assessment, for example, behavioral assessments. It is also possible to participate in tissue collection on site or have tissues prepared and sent to the investigator's lab. Applicants should detail how they plan to both obtain the tissues as well as assess the endpoints.

A timeline of proposed studies should be included. Funds to attend yearly grantee meetings should be included in the budget.

Since the goal is to develop a consortium of investigators that would both contribute to the final study design and in the state-of-the-art assessment of disease/dysfunction endpoints, the NIEHS plans to fund one award in each of the various disease endpoints, depending on review outcomes. The funded investigators will then work with the NTP/FDA to finalize the study protocol including the inclusion and assessment of their particular endpoints. This will be accomplished by a meeting of all parties prior to study start of the study and continued interactions between NTP/FDA scientists and the investigators funded as part of the consortium. Investigators funded as part of this consortium will have the ability to publish data related to their specific endpoints individually and as part of the consortium. Also, it is understood that all data generated, positive or negative, will be reported and made available to the FDA for review if requested in the course of evaluations related to regulatory decisions.

It is expected that this GLP-compliant study design with the addition of state-of-the -art investigator-initiated disease/dysfunction endpoints will provide a significant new and robust dataset on BPA toxicity that would be useful to regulatory agencies. This new collaborative approach to risk assessment could result in new guidelines on how to coordinate toxicology studies in the future.

Funding Instrument	Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.
Application Types Allowed	New The OER Glossary and the PHS398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications. NIEHS intends to commit an estimated total of $2 million for 7-10 awards.
Award Budget	Application budgets are limited to $150,000 direct cost per year and need to reflect actual needs of proposed project. Because of the nature of the research program, budgets may vary across the 4 years.
Award Project Period	The maximum period is 4 years.

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.

Higher Education Institutions:

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American tribal organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are not allowed.

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• eRA Commons

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization 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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to:

Janice B. Allen, Ph.D.
Scientific Review Officer
National Institute of Environmental Health Sciences
Division of Extramural Research and Training
P.O. Box 12233; Mail drop K3-03
Research Triangle Park, NC 27709-2233

For Courier delivery:

530 Davis Drive, Room 3080
Research Triangle Park, NC 27709-2233
Telephone: 919-541-7556
Fax: 919-316-4606
Email: Allen9@niehs.nih.gov

Applications must be prepared using the PHS 398 research grant application forms and 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)

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

Janice B. Allen, Ph.D.
Scientific Review Officer
National Institute of Environmental Health Sciences
Division of Extramural Research and Training
P.O. Box 12233; Mail drop K3-03
Research Triangle Park, NC 27709-2233

For Courier delivery:

530 Davis Drive, Room 3080
Research Triangle Park, NC 27709-2233
Telephone: 919-541-7556
Fax: 919-316-4606
Email: Allen9@niehs.nih.gov

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed.

All instructions in the PHS398 Application Guide must be followed.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the PHS398 Application Guide, with the following modifications:

• Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, GWAS Sharing Plan) are expected, but they are not applicable for this FOA.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

Not Applicable.

Part I. Overview Information contains information about Key Dates.

Information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

This initiative is not subject to intergovernmental review.

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by NIEHS, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Not applicable.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

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 review criteria and additional review criteria (as applicable for the project proposed).

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do the investigators have sufficient experience with the disease endpoints and technology proposed as evidenced by research publications (Experience with BPA toxicity is not a prerequisite.)?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

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? Can the research proposed be accomplished within the GLP-compliant study design? .

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, 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. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

As applicable for the project proposed, reviewers will consider 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.

Applications from Foreign Organizations

Not applicable.

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

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIEHS (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review), will be discussed and assigned an overall impact/priority score.
• Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications submitted in response to this FOA . Following initial peer review, recommended applications will receive a second level of review by the National Advisory Environmental Health Sciences . The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Ability of the study design to be incorporated into the GLP-compliant study backbone.

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.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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 and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. . More information is provided at Award Conditions and Information for NIH Grants.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) 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.

• Overseeing the budget and specific activities related to their specific research component of the consortium. The PI will agree to accept the participatory and cooperative nature of the collaborative research process.
• The PI will participate as a member of the consortium steering committee.
• The PI will comply with the consortium needs including periodic meetings and reports.
• The PI will fully comply with federal regulatory requirements, including but not limited to those relating reporting of adverse events.
• The PI agrees to independently publish study results in a timely manner.
• The PI agrees to be willing to integrate data across research projects for consortium publications.
• The PI agrees to provide raw data from the study to regulatory agencies or other interested parties upon written request.
• 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 DHHS, PHS, and NIH policies.

• Develop the core GLP-compliant study design.
• Have substantial involvement in determining the final research consortium and disease endpoints and protocols to be included in the study design.
• Coordinate and facilitate the interactions among consortium researchers.
• Review the scientific progress of individual U01 grants and their compliance with the operating policies of the steering committee.
• May advise in the design of research activities, advise on the availability of resources pertinent to the project, and advise on the management and technical performance.
• Serve as a liaison between the steering committee, and other federal agencies as needed. In addition to the Project Scientist(s), a designated NIEHS Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NIEHS Program Official may recommend withholding support, suspension, or termination of a U01 award for lack of scientific progress or failure to adhere to policies established by the Steering Committee. 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.

• A steering committee will serve as the governing board of the research consortium. The steering committee will monitor and assess progress of the investigator-initiated studies and determine the need for redirection in scientific focus in order to accommodate new knowledge and recommend new opportunities and directions.
  
  
• The steering committee will be comprised of the Principal Investigator of each consortium project,the Principal Investigator at NTP/FDA that is responsible for the core GLP-compliant study, one representative from NIEHS Division of Extramural Research and Training and the NTP project officer.
  
  
• The steering committee will serve as the governing board of the research consortium. It will monitor progress, share and review progress, recommend activities in need of budget adjustments and opportunities for further research. Although the steering committee will will make recommendations the NIEHS/NTP/FDA staff will have final approval and all proposed changes must comply with NIH, DHHS, and Federal Guidelines.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH 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 dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

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

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Jerrold (Jerry) Heindel, Ph.D.
Program Officer
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-0781
Email: heindelj@niehs.nih.gov

Retha Newbold
NTP/Extramural BPA Coordinator
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-0738
Email: Newbold1@niehs.nih.gov

Janice B. Allen, Ph.D.
National Institute of Environmental Health Sciences
Telephone: 919-541-7556
Email: Allen9@niehs.nih.gov

Wanda Boggs
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-316-4638
Email: boggsw@niehs.nih.gov

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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 Part 52 and 45 CFR Parts 74 and 92.