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)

Title:   Short Term Career Development Award in the Environmental Health Sciences   for Established Investigators (K18)

Announcement Type
New

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

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. For general information on this transition, please see the electronic submission website at http://era.nih.gov/ElectronicReceipt/ and the transition timeline at http://era.nih.gov/ElectronicReceipt/files/Electronic_Receipt_Timeline_Ext.pdf.  NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html).

Program Announcement (PA) Number: PAR-07-402

Catalog of Federal Domestic Assistance Number(s)
93.113

Key Dates
Release Date:  July 12, 2007
Letters of Intent Receipt Date(s): Not Applicable.
Application Submission Date(s): Standard dates apply; please see http://grants1.nih.gov/grants/funding/submissionschedule.htm for details
AIDS Application Receipt Date(s): Not Applicable.
Peer Review Date(s): Standard dates apply; please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for guidance on dates.
Council Review Date(s): Standard dates apply; please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for guidance on dates.
Earliest Anticipated Start Date(s): Standard dates apply; please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for guidance on dates.
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date:  New Date January 24, 2009 (per issuance of PAR-09-090) Original Expiration Date: July 13, 2010

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
  1. Research Objectives

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

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

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

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

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

Section VII. Agency Contact(s)
  1. Scientific/Research Contact(s)
  2. Peer Review Contact(s)
  3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


Background:

A perceived gap in the career development opportunities funded by the NIEHS is a program which would provide the flexibility to allow established, well-funded mid-career level investigators the support and protected time to get the necessary training and research experience to expand their already productive research programs to address the goals of the Strategic Plan and to take advantage of the anticipated new research opportunities being developed to move the Strategic Plan forward.

A primary goal of the NIEHS, elaborated in the Strategic Plan announced in 2006, is to expand the role of clinical and translational research in the environmental health sciences in the programs supported by the Institute and to enhance the role of clinical investigators in environmental health sciences research.  The Strategic Plan also addresses the need for increased training and career development opportunities in clinical and translational research and recognizes the advantages of the increased integration of environmental health sciences research with the overall NIH research enterprise.

Within the past year the NIEHS has announced a number of new and restructured programs to address these goals, including the DISCOVER program and the K12 Institutional Patient Oriented Career Development Program in the Environmental Health Sciences.  Other programs, including the program of Institutional T32 Training Grants and the P30 Core Centers, have been restructured to increase the participation of translational scientists and the representation of disease-oriented research.

The NIEHS also intends to continue and further emphasize its traditional support mechanisms for training and career development of junior scientists with clinical backgrounds through the funding of F30 Individual Fellowships for Dual Degree MD/PhD students, K08 and K23 Career Development Awards for Clinical Investigators, and further encouragement of the support of physician scientist in the training programs.  Mid-career patient oriented researchers who have active, well-supported research in the environmental health sciences may apply for K24 Career Development Awards which provide up to five years of salary support release time to further their research goals and mentor new clinician scientists.

Purpose and Objectives:

This funding opportunity announcement establishes a program of short-term mentored career development awards, using the K18 mechanism, with a range of 3 months to 1 year duration, aimed at established, well-funded mid-career level investigators, to support their development of research capability in the environmental health sciences or in translational research.  The program would be directed to two groups of investigators:

a.  Physician Scientists and others with clinical training who have research funding from other Institutes and essentially no experience in research applicable to the environmental health sciences, who wish to spend time in the laboratory or research program of a well funded and NIEHS supported investigator in order to explore the introduction of research involving environmental stressors of importance to the mission of the NIEHS into their experimental systems and disease oriented research programs; and

b.  Investigators in the basic sciences with active research funding from NIEHS who wish to gain experience in a relevant, disease oriented translational program in order to extend their basic knowledge to a more translational problem.

The intent of this FOA is to provide candidates with protected time to achieve a shift in the focus of their research direction, or to learn exposure biology relevant to their ongoing research projects; it is not intended as a substitute for research project support.

Applicants will be expected to hold the rank of Associate Professor or Professor, or their equivalent in non-academic settings, and propose a mentored career development and career enhancement program, along with a research project, to be conducted in a different institutional setting from the location where they hold the primary appointment.  These career development awards will typically coincide with academic sabbatical years.

The host mentoring laboratory is expected to demonstrate appropriate research and resources to provide a new research direction.  In most cases, the applicant and the proposed host laboratory will not have any previous research collaborations.

In most cases, the host mentoring laboratory may not be within the School or academic institutional setting where the applicant has a primary appointment, and applications which propose an experience at a location which is geographically and physically separate from the applicant organization are encouraged.  With strong justification, under unusual circumstances, and with strong evidence of institutional support and release time (to be assessed by the peer review), an applicant who is a member of a medical school faculty may propose a research and career development experience in a physically distinct and different department of the Medical School from that in which he/she has an appointment.  Departmental and School administrators for the Departments and Schools of the applicants should describe any institutional commitments the applicant will maintain during the period of the research career enhancement and any special provisions which will be made to provide appropriate release time.  In particular, the administration should demonstrate their commitment to the candidate’s separation from current responsibilities during the sabbatical period.

Applicants should also describe any clinical, administrative, research, or grant related commitments they intend to maintain during the period of the award, and arrangements which will be made to provide protected release time.

Candidates may propose a career development program of three month, six months, nine months or one year duration.

Research projects proposed in response to this FOA will be expected to have a defined impact on the environmental health sciences and be responsive to the mission of the NIEHS, which is distinguished from that of other Institutes by its focus on research programs seeking to link the effects of environmental exposures to the cause, mechanisms, moderation, or prevention of a human disease or disorder or relevant pathophysiologic process. For purposes of this announcement, all applications must focus on a specific human disease, dysfunction, pathophysiologic condition, or relevant human biologic process and propose to study a specific environmentally relevant toxicant.  Examples of environmentally relevant toxicants include industrial chemicals or manufacturing byproducts, metals, pesticides, herbicides, air pollutants and other inhaled toxicants, particulates or fibers, fungal, and bacterial or biologically derived toxins. Agents considered non-responsive to this announcement include, but are not limited to: alcohol, chemotherapeutic agents, radiation which is not a result of an ambient environmental exposure, smoking, except when considered as a secondary smoke exposure as a component in the indoor environment (particularly in children),  drugs of abuse, pharmaceuticals, and infectious or parasitic agents, except when these are disease co-factors to an environmental toxicant exposure to produce the biological effect.  Research on model compounds is not considered responsive.  Ecologic, biomonitoring, biotransformation or biodegradation studies are also not responsive, except when these elements are incidental to the study of the disease endpoint.

Application proposing research projects which fit the NIH definition of patient oriented or clinical research are encouraged.  Applications involving animal or in vitro exposures must include a justification of how the exposure paradigm is relevant to human exposure and clearly discuss the link between the exposure and the relevant human disease in the Background and Significance section of the application. In addition, the applicant should discuss the potential for translation of the research, which is defined as applying the ideas, insights, and discoveries generated through the basic inquiry to the treatment or prevention of human disease.

It is hoped that a benefit of this award to the goals of the NIEHS will be the stimulation of innovative, new projects in clinical and translational research in the environmental health sciences.  Therefore, investigators who receive support through this FOA will be invited to the NIEHS campus in Research Triangle Park, NC, to present an open seminar on their research results.

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

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the NIH K18 grant award mechanism.

The applicant and his/her mentor are jointly responsible for planning, directing, and executing the proposed project and career enhancement activities.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

2. Funds Available

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 NIEHS plans to provide up to $500,00 per year in 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.

The total project period for an application submitted in response to this funding opportunity shall be between three and twelve months.  All applicants must devote a minimum of 50 percent effort to the environmental health sciences career development and research activities, although a full-time commitment for the three to twelve-month period of time is encouraged.  For information regarding NIH policy in determining full-time professional effort for career awards, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-056.html.

The actual salary provided by the award will be prorated based on the applicant’s full-time, 12-month salary and the support period requested, up to the maximum legislated salary level.  This program will provide up to $40,000 in direct costs per year for research development support to cover career enhancement training experiences, such as tuition and fees for short-term courses, consultant fees, travel to scientific meetings, and research related costs, primarily supplies and technical services.  The award will also provide fringe benefits on the calculated base salary at the established institutional rate.

Facilities and Administrative (F&A) Costs, which were formally called indirect costs, will be reimbursed at eight percent of modified total direct costs. 

The candidate’s institution may supplement the salary received from the K18 award to a level consistent with the institution’s salary scale.  Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the conduct of the K18 program.  No PHS funds may be used for supplementation.

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

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

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

Foreign Institutions are not eligible to apply.

1.B. Eligible Individuals

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

This award is intended for mid-career and senior investigators holding a research or health professional doctorate who are at the academic rank of Associate Professor or Professor, or the equivalent in nonacademic settings, who have established records of independent, peer-reviewed Federal or private research grant funding, primarily from NIH, who seek an intense, mentored career development experience which will substantially impact upon their ability to pursue future research in the environmental health sciences.   Targeted applicants include physician scientists with disease oriented research and research funding who wish to explore applications of their research to the environmental health sciences and  expand their knowledge of exposure biology; and conversely, individuals with research funding from the NIEHS who propose to move their research to the translational or clinical arena. 

Applicants must identify one or more mentors with extensive research experience and an active, funded research program in an appropriate domain or discipline, who is well-qualified and willing to sponsor the short term research career development experience.  Applicants who do not have research grant support from the NIEHS must propose to work with a mentor who has active research project grant support from the NIEHS during the period of the career development experience.   It is expected that the career development proposal will represent a novel extension of the research of the applicants, and therefore, applications proposing to work in areas where there is significant evidence of previous collaborations will not be considered responsive.

At the time of the award, applicants must be citizens or noncitizen nationals of the United States, or must have been lawfully admitted to the United States for permanent residence (i.e., in possession of a currently valid Alien Registration Receipt Card I-551, or other legal verification of such status).  Noncitizen nationals are generally persons born in outlying territories of the United State (e.g., American Samoa and Swan’s Island).  Individuals on temporary or student visas are not eligible. 

2. Cost Sharing or Matching

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

Applicants to this program may not concurrently apply for any other PHS award that duplicates the provisions of the award.  Current PIs on NIH career awards are not eligible.

Applicants may submit only one application per receipt date in response to this FOA, and may accept only one award resulting from applications to this FOA.  In addition, the NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization.

Each short term career enhancement program in the environmental health sciences must be tailored to meet the individual needs of the candidate.  The candidate and mentor are jointly responsible for the preparation of the career development plan.  The sponsoring institution must demonstrate a commitment to provide the environment and resources needed for the candidate to perform the activities included in the career enhancement program that maximize the use of relevant research and educational resources and propose qualified investigators as mentors.

A Resources Format page (PHS 398) for the host laboratory must be included in the application.

Candidates for the K18 award are likely to have been principal investigators on NIH research or career development awards.  The research and career development experience proposed in the K18 must be in a fundamentally new field of study or research. 

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) 435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

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

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

3. Submission Dates and Times

See  Section IV.3.A for details.

3.A. Submission, Review and Anticipated Start Dates

Application Submission Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm for details
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for guidance on dates.
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for guidance on dates.

Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for guidance on dates.

3.A.1. Letter of Intent

Not Applicable


3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application 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 five 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).

3.C. Application Processing

Applications must be submitted on or before the application receipt/submission dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.

Upon receipt applications will be evaluated for completeness by CSR. Incomplete 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 merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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

Salary support:  The salary requested for the candidate must be consistent with both the established salary structure for full-time staff appointments and with salaries actually provided by the sponsoring institution from its own funds to other staff members of equivalent qualifications, rank and responsibilities in the applicant department.  The candidate is required to devote between 50% and 100% effort to this career enhancement program for a period of three to twelve months.

Research Development Support:  The research development support costs must be justified and be consistent with the project proposed and the proportion of time spent in research and career enhancement activities.  Salary for ancillary personnel support, such as mentors, secretarial, and administrative assistants is not allowed.

The K18 is not renewable and may not be transferred to another individual.   Due to the short-term nature of the award, it may not be transferred to another institution.

6. Other Submission Requirements

The total number of pages for Item 1 (The Candidate) and A-D of Item 4 (Research Plan) combined may not exceed 15 pages.

Supplementary instructions for Career Development awards are located in the PHS 398, Section III, starting on page 44.

The following information must be included in the application:

Candidate:

Career Enhancement Plan

Research Plan

Training in the Responsible Conduct of Research

Statement(s) by Mentor(s)/Consultant(s)/Collaborator(s)

Environment and Institutional Commitment to the Candidate

Letters of Reference

Budget for the Entire Proposed Period of Support

Plan for Sharing Research Data

Not Applicable
.

Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information


1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

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

2. Review and Selection Process

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

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

The following will be considered in making funding decisions:

The goals of NIH-supported career development programs are to help insure that diverse pools of highly trained scientists are available in adequate numbers and in appropriate research areas to address the Nation’s biomedical, behavioral and clinical research needs.  In the written comments, reviewers will be asked to discuss the following aspects of applications in order to judge the likelihood that the proposed training will have a substantial impact on the pursuit of these goals.  Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application:

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score.  These criteria are listed in logical order and not in order of priority.

Candidate:

Career Enhancement/Development Plan

Research Plan

Training in the Responsible Conduct of Research

Statements by Mentor/Co-Mentor(s), Consultant(s), and Collaborator(s)

Environment and Institutional Commitment

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Resubmission Applications (formerly “revised/amended” applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

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

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

2.B. Additional Review Considerations

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

2.C. Sharing Research Data

Not applicable.


2.D. Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://ott.od.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates

Not Applicable.

Section VI. Award Administration Information


1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

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

3. Reporting

The final progress report for this short-term career development award in the Environmental Health Sciences for Established Investigators should include the following information:

A final progress report, invention statement, and Financial Status Report are required 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:

Carol Shreffler, Ph.D.
Division of Extramural Research
National Institute of Environmental health Sciences, EC-23
Building 4401, Room 3411
P.O. Box 12233

Research Triangle Park, NC  27709
Telephone: (919) 541-1445
Fax:  919-541-5064
Email:  shreffl1@niehs.nih.gov

2. Peer Review Contacts:

Linda K. Bass, Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
Building 4401, Room 3172
79 TW Alexander Drive
Research Triangle Park, NC  27709-2233
Telephone: (919) 541-1307
Fax:  (919) 541-2503
Email:  bass@niehs.nih.gov

3. Financial or Grants Management Contacts:

Donald Ellis
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
Building 4401, Room 3444B
P.O. Box 12233
Research Triangle Park, NC 27709
Telephone: (919) 541-1874
Fax: (919) 541-2843
Email:  donaldellis@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.

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

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

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

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

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

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

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

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov/) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).

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

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

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

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

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

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

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


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