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 Center for Research Resources (NCRR) (http://www.ncrr.nih.gov)

Title:  Training Clinical Veterinarians in Nonhuman Primate Clinical Medicine(R25)

Announcement Type

New

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide. 

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Request For Applications (RFA) Number: RFA-RR-06-006

Catalog of Federal Domestic Assistance Number(s)
93.389

Key Dates
Release/Posted Date: September 15, 2006
Opening Date:  September 22, 2006 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): September 25, 2006 and January 22, 2007. NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). 
Application Submission/Receipt Date(s):  October 24, 2006 and February 22, 2007
AIDS Application Submission/Receipt Date(s): N\A
Peer Review Date(s): February 2007 and June 2007   
Council Review Date(s): May 2007 and September 2007
Earliest Anticipated Start Date(s): July 2007 (for October 2007 submissions) and December 2007 (for February 2007 submissions)
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: February 23, 2007

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism 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. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Submission, Review, and Anticipated Start Dates
          1. Letter of Intent
    B. Submitting an Application Electronically to the NIH
    C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

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

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

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)

2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives  

Nonhuman Primates (NHP) are critical to biomedical/behavioral research and offer unique animal models for human diseases and conditions.  Their importance in biomedical and behavioral research is well documented.  NHPs’ close molecular, immunological, reproductive, and neurological relationship to humans makes them essential surrogates for humans in biomedical studies related to major human diseases (e.g., AIDS, cancer, Alzheimer’s disease, Parkinson’s disease, and cardiovascular diseases).  The National Center for Research Resources (NCRR) and other NIH Institutes and Centers (IC) invest substantial resources in support of the National Primate Research Centers (NPRC) and other publicly funded NHP resources.  Major support is also provided for basic and translational research using these species. Clinical veterinarians providing NHP veterinary medical care must receive additional clinical education and experience beyond the professional training received in veterinary school or college in order to provide appropriate and quality clinical care and colony management.  The increased demand for the use of NHPs in biomedical investigations, and the emergence and spread of potentially deadly human diseases such as SARS, influenza, and hepatitis that will be studied using NHP models is expected to exacerbate the shortage of veterinarians who are properly educated in NHP clinical care and colony management, especially within current NPRC network and the other specialized resource centers.

The NCRR will provide funding for post-doctoral clinical education for veterinarians in NHP clinical medicine utilizing the federally-funded programs at the NPRCs and specialized breeding and research colonies.  This funding opportunity will provide an educational environment for veterinarians interested in pursuing a career in NHP clinical medicine to develop competence in this area. Each participant resident position will be funded for two years and each participant resident is expected to receive supervised, practical experience in all aspects of veterinary medical care and management of NHP colonies. A participant resident is defined as a veterinarian who graduated from an AVMA accredited or AVMA listed school or college of veterinary medicine, who is accepted by the eligible institution to receive clinical experience in NHP clinical care and colony management. A comprehensive and complete education program should be proposed by the applicant.  The program should include but is not limited to didactic and clinical components. Following completion of this program, participant residents are expected to have acquired knowledge and professional skills in NHP taxonomy, biology and care, disease recognition and management (diagnosis, treatment, prevention, etc.), clinical skills, use in biomedical/behavioral and translational research, animal welfare, animal model selection criteria, ethical use of NHPs in research, and any additional training the institution deems appropriate for this program.  The participant resident is expected to also acquire administrative skills needed for NHP colony management; however, they will not be primarily responsible for performing functions normally done by the institution’s regular administrative or veterinary care staff members.  The objective is to educate veterinarians to be competent and proficient in the clinical management of NHPs.

Clinical education provided under this FOA must involve more than one NHP species. Efforts should be made to include as many of the commonly used species as possible. The Program Director/Principal Investigator (PD/PI) must be a veterinarian with NHP clinical experienceThe qualifications and experience of the PD/PI must be adequately described in the application. Methods should be incorporated within the proposal outlining plans for receiving such instruction and experience if diverse species are not present at the applicant institution.  Under this initiative, applicant institutions may partner with other institutions to enhance the depth and breadth of clinical knowledge and experience for the Participant residents and increases the number of NHP species available to the program. The proposed research education program may complement other, ongoing research training and education occurring at the applicant institution, but the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. The R25 is not a substitute for an institutional research training program (T32) and can not be used to circumvent or supplement Ruth L. Kirschstein National Research Service Award (NRSA) mechanisms.  Where applicable and desirable, clinical participants funded through this program may participate in a structured comparative medicine training program, provided the training conducted under this FOA is acceptable for credit toward board certification by an AVMA recognized specialty, i.e., American College of Laboratory Medicine (ACLAM),  American College of Veterinary Pathology (ACVP), American College of Veterinary Internal Medicine (ACVIM), etc. However, participant residents may not receive additional salary and benefits. Applicants planning to use other facilities for clinical educational activities, or expecting to incorporate this program into existing comparative medicine training programs must provide letters of agreement signed by all participating institutions.

Funds from this program are restricted to support PI/PD veterinarians and other authorized personnel participating in this clinical education initiative. The total direct cost per participant resident shall not exceed $138K/year for two years (includes PD/PI and participant resident compensation and benefits, other support, and participant resident travel; participant resident travel may not exceed $1200/participant resident).  Total cost (directs and F&A)/participant resident/year may not exceed $150K and for the two year period may not exceed $300K.  Applicants may request 1-3 participant residents based upon factors such as recruitment potential, capacity, or past record of providing educational opportunities or training for veterinarians in NHP clinical care; however, consideration will be given to providing an equitable distribution of participant residents among eligible institutions submitting meritorious R25 applications.   

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 utilizes the R25 Education Program funding mechanism.  The NCRR Education Program grants (i.e. R25s) support the development and implementation of curriculum-dependent programs that may focus on educational activities after the completion of a Doctor of Veterinary Medicine Degree (e.g., D.V.M, V.M.D., or equivalent) as long as they address a need that is not fulfilled adequately by any other grant mechanism available from the NIH and are dedicated to areas of high priority to the NCRR.  The R25 grant may not be used to conduct traditional biomedical research or as a research training grant.  This mechanism is used strictly as a clinical education tool.  Applicants whose programs cannot meet the Special Requirements stated in these guidelines should refer to the traditional National Research Service Award (NRSA) Institutional (T32) http://grants.nih.gov/grants/guide/pa-files/PA-06-468.html for Short-Term (T35) http://grants.nih.gov/grants/guide/pa-files/PA-05-117.html Training Grants as possible alternative sources of support.

Applicants may request up to five years of support in a single grant period in order to develop an evidence based education program. Applicants will be solely responsible for planning, directing, and executing the proposed project. This funding opportunity is subject to "Just-in-time" application procedures but it is not subject to the Streamlined Non-competing Application Process (SNAP). Independently from the amount requested, this funding opportunity uses Research & Related Budget described in the SF424 electronic application procedures available at Grants.gov/APPLY.

Research education grant support is for new projects only. At this time, it is not known if competing renewal (formerly “competing continuation”) applications will be accepted and/or if this FOA will be reissued.

2. Funds Available

Because the nature and scope of the proposed research education program 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 NCRR provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

The total number of eligible institutions will vary and depends upon the number holding eligible grants or cooperative agreements (P51, P40, U42, U24) funded by NCRR)

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

Facilities and Administrative (F&A) costs requested by consortium participants, if applicable, 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 in response to this FOA.  Further, eligible institutions are limited to those funded by NCRR as a National Primate Research Center, or specialized NHP Animal Models and Animal Biological Materials Resources using the P51, P40, U42, or U24 mechanisms. The applicant institution must have a strong NHP research or breeding program involving more than one NHP species linked to biomedical research.

In many cases, it is anticipated that the proposed research education program will complement other ongoing research training occurring at the applicant institution and that a substantial number of program faculty will have active research projects in which participant residents may gain relevant experiences consistent with their research interests and goals. Institutions with existing Ruth L. Kirschstein National Research Service Award (NRSA) institutional training grants (e.g., T32) or other federally funded training programs may apply for a research education grant provided that the proposed educational experiences are distinct from those training programs receiving NIH support.  Moreover, the R25 mechanism is not intended to support long-term training by NRSA-eligible individuals and may not be used to circumvent or supplement Ruth L. Kirschstein NRSA research training mechanisms. 

If multiple sites are involved in the research education program, the applicant institution must be the primary site for the program.  The need for and use of multiple sites must be justified.   

1.B. Eligible Individuals

Any Veterinarian with the skills, knowledge, and resources necessary to carry out the proposed research education program as the Project Director/Principal Investigator (PD/PI) is invited to work with an eligible 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.  The PD/PI will be expected to monitor and assess the program, submitting annual reports as required. (See Section VI.3., “Reporting.”)

The PD/PI must be a veterinarian experienced in NHP clinical medicine with the demonstrated  ability to direct, manage, and administer the proposed training program and are currently managing or providing clinical support to NHP clinical programs at eligible institutions.  The PD/PI must be able to assure that the participant residents will receive the breadth and depth of clinical education in NHP clinical medicine required by this FOA.

Participant residents eligible for support under this funding opportunity must have a DVM/VMD awarded by a school or college of veterinary medicine accredited or listed by the AVMA.  Participants must be citizens or non-citizen 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 1-551, or some other legal admission document.  Non-citizen nationals are generally persons born in outlying possessions of the United States ( e.g., American Samoa and Swan Island).  Individuals on temporary or student visas are not eligible.

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

Applicants are required to include a plan for Training in the Responsible Conduct of Research (see Section IV.6).

An eligible institution may submit only a single R25 application in response to this funding opportunity, regardless of the number of eligible NCRR funded mechanisms held.

The intent of this FOA is to establish education programs in NHP clinical medicine designed to prepare veterinarians for clinical management of a variety of NHP species used in NIH supported research projects. It is incumbent upon the applicant institution to clearly demonstrate the institutional capabilities and resources to provide a program that is broadly based, such that participant residents will be prepared to independently provide clinical support for NHPs bred or purchased for use in biomedical, behavioral, and translational research.

Participant residents receiving support under this FOA may not receive concurrent support from other NIH sponsored training programs (i.e., T32, F32, K01).  Veterinarians supported under this FOA must devote at least 75% and no more than 85% effort (9-10.2 person months) to this program. Participation in a structured, NIH or other funded comparative medicine training program is permissible under the conditions described in Section I.1.  Participant residents are not eligible for any salary support from these other programs since salary support is provided by this funding opportunity. 

Applicants must describe the methods they will use to recruit qualified individuals from diverse population groups

Participant residents appointed to this clinical education program should have the ability and opportunity to carry out supervised NHP clinical education with the primary objective of developing or enhancing their clinical skills and knowledge in preparation for a career in NHP clinical medicine and colony management. The individual must also demonstrate a willingness to work with NHPs in a biomedical, behavioral, or translational research environment.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

Applicants’ failure to meet the eligibility criteria by the application deadline will result in non-review of the application or even though the application may be reviewed will preclude the agency from making an award.

Evaluation Plan: Applications must contain an evaluation plan.  Applications submitted without these sections may be delayed in the review process or not reviewed.

Section IV. Application and Submission Information


To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

PD/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Started

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

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

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

Research Education Program

While the proposed research education program may complement other, ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support.

If multiple sites are involved in the research education program, the applicant institution must be the primary site for the program.  The need for and use of multiple sites must be justified. 

Although research education grants are not typical research instruments, they do involve experiments in education and/or dissemination of research knowledge that require an evaluation plan in order to determine the degree of success or failure. A plan must be provided for program evaluation. Benchmarks should be specified, and specific plans and procedures must be described to capture, analyze and report outcome measures that would determine the success of the research education program in achieving its objectives. 

Allowable Costs 

Allowable costs must be consistent with NIH policy and be reasonable, allocable, well documented and fully justified for the research education program proposed in the application. Grant funds may not be used to supplant funds otherwise available at the applicant institution.

Personnel: Individuals participating in the design and implementation of the research education program may request salary and fringe benefits appropriate for the person months devoted to the program.  These expenses must be itemized in Sections A and B, as appropriate, of the Research & Related Budget.  Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. (If mentoring interactions and other activities with students/participants are considered a regular part of an individual's academic duties, then mentoring and other interactions with students/participants are non-reimbursable from grant funds). Limited administrative and clerical salary costs associated distinctly with the program that are not normally provided by the applicant organization may be direct charges to the grant only when specifically identified and justified. 

Other Program-Related Expenses: Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses must be justified as specifically required by the proposed research education program and must not duplicate items generally available for educational programs at the applicant institution. These expenses must be itemized, as appropriate, in Sections C. (Equipment), D. (Travel), and F. (Other Direct Costs) of the Research & Related Budget. Up to $1,200 annually is allowed for relevant travel for the PD/PI and each participant.

Participant Resident Costs: Participant residents are those individuals who benefit from the proposed research education program.  Participant resident costs must be justified as specifically required for the proposed research education program.  Participant resident costs must be itemized in Section E. (Participant Resident/Trainee Support Costs) of the Research & Related Budget. 

Because this is an educational and not a training mechanism, non-U.S. citizens may participate in this program. However, requests for participation of non-U.S. citizens under the auspices of this FOA should be made with the understanding that this mechanism is not to be used to circumvent or supplement NRSA training mechanisms. Unless strongly justified on the basis of exceptional relevance to the NIH/IC mission, research education programs should be used primarily for the education of U.S. citizens.  Applicants are strongly encouraged to contact Program staff (see Section VII) to discuss the appropriate utilization of this mechanism with respect to the eligibility, appointment, and participation of non-U.S. citizens.

Each participant resident may receive compensation not to exceed $65,000 per year. Each participant resident may also receive funds to defray partial tuition, supplies, equipment, other education-related expenses, and up to $1,200 annually for travel expenses. Expenses for foreign travel must be exceptionally well justified. Funds will not be provided for fringe benefits or health insurance for participant residents in any research education program. Individuals supported by NIH training and career development mechanisms (K, T, or F awards) may receive, and indeed are encouraged to receive, educational experiences supported by the R25 mechanism, as participant residents, but may not receive salary or stipend supplementation from a research education program.

Because the R25 mechanism is not intended as a substitute for an NRSA institutional training program (T32), costs to support full-time participant residents are not allowable. A full-time participant resident is defined for the research education program as an individual supported for 40 hours/week for a continuous, 12-month period. Participants in this FOA are not full-time employees and are therefore eligible for support since they are graduate health professionals.

Institutional Commitment: Evidence of institutional commitment to the research educational program is strongly encouraged. 

Facilities and Administrative (F&A) Costs: F&A costs for the applicant organization and consortium participants will be reimbursed at 8 percent of modified total direct costs.   

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: September 22, 2006 (Earliest date an application may be submitted to Grants.gov)
Application Submission/Receipt Date(s): October 24, 2006 and February 22, 2007
AIDS Application Submission/Receipt Date(s): N/A
Peer Review Date(s): February 2007 and June 2007
Council Review Date(s): May 2007 and September 2007
Earliest Anticipated Start Date: July 2007 (for October 2006 submission), October 2007(for February 2007 submission)

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note:  Applications must only be submitted electronically.  PAPER APPLICATIONS WILL NOT BE ACCEPTED. 

In order to expedite the review, applicants are requested to notify the (NCRR) Referral Office by email (glowaj@mail.nih.gov) when the application has been submitted.  Please include the FOA number and title, PD/PI name, and title of the application.
 
3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.

Upon receipt, applications will be transferred from Grants.gov to the NIH Electronic Research Administration process for validation. 

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to a Scientific Review Group is also in the Commons. 

The NIH will not accept any application in response to this FOA 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 an application already reviewed with substantial changes, but such application must include an “Introduction” (3 pages maximum) addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).

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.
Funds awarded under this FOA may only be used for educating veterinarians in NHP clinical medicine and may not be reprogrammed for other use without written permission from NCRR. Total direct costs shall not exceed $138K/participant resident/year.  

The policies of R25 awards apply to this program. Awards are contingent upon the availability of funds.  Furthermore, the duration of the award and the number of funded training positions may be less than the level recommended by the peer review group based on programmatic and budgetary considerations.  Funds for continuation support beyond the initial year are determined by the success as described in the annual progress report, the timely submission of required forms, and the availability of funds for continuation programs.

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: 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 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 the NIH Grants Policy Statement.

In general, allowable costs on R25 grants must be consistent with NIH policy and the recommendations of peer reviewers. The direct costs include but are not limited to the following: limited personnel costs (PI/PD, commensurate with person months devoted to the program), participant resident compensation (not to exceed $65K/participant resident/year), supplies, other participant resident costs (e.g.; tuition), consultant costs, equipment, travel (limit-$1200/participant resident/year), sub-contractual costs and other expenses. Total direct cost may not exceed $138K/year/participant resident.  It is recommended that potential applicants consult NCRR staff if there are any questions regarding allowable costs. The R25 remains under "Expanded Authorities."

Facilities and administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation; see NOT-OD-04-040. F&A costs for grantee institutions and third party institutions will be budgeted and reimbursed at a rate of 8 percent of modified total direct costs, exclusive of tuition and fees, expenditures for equipment, and sub-grants and contracts in excess of $25,000. State and local governmental agencies, except State universities or hospitals, and Indian tribal governments may receive full F&A cost reimbursement.

Concurrent Awards: A participant resident veterinarian receiving support from this R25 may not hold another federally sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of this R25 award.

6. Other Submission Requirements

The NIH requires the PD/PI to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”

Renewal (formerly “competing continuation” or “Type 2”) applications are not permitted. 

All application instructions outlined in the SF424 (R&R) Application Guide (MS Word or PDF) are to be followed, with the following requirements for R25 applications:

Videos, CDs, and/or DVDs specifically related to the science education program.  Applicants should contact the SRA for submission instructions after application assignment.

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

Warning: Please be sure that you observe the direct cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.

Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.   

Supplementary Research Education Program Application Instructions

Applicants should use the following guidance, in addition to the instructions accompanying the SF 424 (R&R) form.  Applications that do not conform to the specific instructions detailed below will not be reviewed.  

1. SF 424 Research & Related Project/Performance Site Location(s): Include collaborating sites if appropriate.

If multiple sites are involved in the research education program, the applicant institution must be the primary site for the program. A justification must be included for sites other than the applicant institution in the program narrative.   

2.  SF 424 Research & Related Other Project Information, Item 9 (Facilities & Other Resources):  Describe the educational environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program. 

3.  SF 424 Research & Related Senior/Key Person Profile: Key Personnel must include the PD/PI as well as any other key persons (such as those involved in the development, implementing, directing, monitoring, evaluating, etc., who are integral to the proposed research education program) participating in the research education program. 

4.  Research & Related Budget:  Complete for each budget period requested.

A.  Senior/Key Person: complete for all senior/key persons associated with the research education program.  The PD/PI must be included here.

B.  Other Personnel: complete for all other personnel (including clerical and administrative staff) associated with the research education program.

C.  Equipment: self-explanatory.

D.  Travel: include here any travel funds requested for senior/key persons and other personnel (i.e. those persons identified in Sections A. and B.) associated with the research education program.  Travel funds for the PD to attend education program related meeting may not exceed $1200/year.  Travel funds for participant resident veterinarians will not exceed $1200/year/participant resident.

E.  Participant Resident/Trainee Support Costs: include here all allowable categories of funds requested to support participant residents in the research education program.  If categories in addition to those listed in this section of the 424R&R form are needed, describe in Other. State the number of Participant Residents/Trainees to be supported by the proposed research education program.

F.  Other Direct Costs: itemize as appropriate and allowed for the research education program.

K.  Budget Justification: provide a detailed justification for each category for which funds are requested.  For Section E, itemize each category of support costs per participant resident and justify. 

5.  PHS 398 Research Plan Attachments:

Part 4 of this section (Preliminary Studies/Progress Report) should contain information on steps that have led to the proposed research education program.

Part 5 of this section (Research Design and Methods) should be retitled "Research Education Program Plan" and should contain material organized under the following subheadings in a single attachment and as appropriate to the specific program.

Program Director(s): Describe arrangements for administration of the program, provide evidence that the Program Director is actively engaged in research and/or teaching in an area related to the mission of the NCRR, and can organize, administer, monitor, and evaluate the research education program, as well as evidence of institutional and community commitment and support for the proposed program.

Program Faculty/Staff: Describe the characteristics and responsibilities of the participating faculty; provide evidence that the participating faculty and preceptors are actively engaged in research or other scholarly activities related to the mission of theNCRR. These individuals should have the activities described as a part of their regular duties and therefore will not normally receive monetary support from this FOA.

Proposed Research Education Program: Provide programmatic detail on the special activities proposed (e.g., courses, curricula, seminars, workshops). Describe in detail the rationale, approach, and the clinical education program for the participant residents and how it relates to one or more of the areas of interest to the NCRR.

Responsible Conduct of Research: Describe plans to provide formal and informal instruction to participant residents on scientific integrity and ethical principles in research. The plan should be appropriate for the duration and content of the proposed research education program.  Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, and policies regarding the use of human and animal subjects. Plans must address: 1) the subject matter of the instruction, the format of the instruction, the degree of program faculty participation, participant resident attendance, and the frequency of instruction; and 2) the rationale for the proposed plan of instruction.

If such training is not appropriate for the proposed research education program, then the PD/PI must provide a strong justification for its exclusion.

Program Participant Residents: Provide details about the pool of proposed participant residents, their qualifications, recruitment strategies and sources of applicant pool, etc. 

Diversity Recruitment and Retention Plan:  Provide a detailed diversity recruitment and retention plan for the research education program.  Renewal applications must detail experiences in recruiting and retaining individuals from underrepresented groups during the previous award period.  Include, in a table, the total numbers of individuals who applied, were interviewed, admitted, and participated in the research education program as well as the total number of individuals from the three classes defined below.  For those programs where individuals are not participating, e.g. a program requesting support to develop a curriculum, the PD/PI must explain why this information is not appropriate. 

The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation's capacity to address and eliminate health disparities.

Accordingly, the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups; individuals with disabilities; and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis. The NIH is particularly interested in encouraging the recruitment and retention of the following classes of participant residents:

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see http://www.nsf.gov/sbe/srs/women/start.htm). In addition, it is recognized that under representation can vary from setting to setting; individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program.

B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.

C. Individuals from disadvantaged backgrounds who are defined as:

1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size; published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml. For individuals from low income backgrounds, the institution must be able to demonstrate that such participant residents have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professions Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

2. Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.  Recruitment and retention plans related to a disadvantaged background are most applicable to high school and perhaps to undergraduate candidates, but would be more difficult to justify for individuals beyond that level of academic achievement.

Peer reviewers will separately evaluate the diversity recruitment and retention plan after the overall score has been determined.  Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds.  The review panel’s evaluation will be included in an administrative note in the summary statement.  If the diversity recruitment and retention plan is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received.  Staff within the NCRR, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable.

Evaluation Plan: Include evaluation plans for assessing the success of the program in achieving its goals and objectives. Benchmarks should be specified and specific plans and procedures must be described to capture, analyze and report outcome measures that would determine the success of the research education program in achieving its objectives. The inclusion of evaluation instruments is encouraged.  Applications that lack an evaluation plan will be returned. Describe the information that will be collected, the periods for, and criteria to be used in evaluating the success of this Program.

Plan for Sharing Research Data

N/A

Sharing Research Resources

NIH policy requires that grant awardee 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/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131). 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.

Research education programs are not generally expected to generate research resources. However, applications are expected to include a software dissemination plan if support for development, maintenance, or enhancement of software is requested in the application. There is no prescribed single license for software produced. However, the software dissemination plan should address, as appropriate, the following goals:

•           Software source code should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories. Users should be permitted to modify the code and share their modifications with others.

•           The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.

•           To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

The initial review group will comment on the appropriateness of the proposed software dissemination plan.  Program staff will also consider the adequacy of the software dissemination plan as one of the criteria for award.

The proposed sharing plan, after negotiation with the applicant when necessary, will be made a condition of the award.  Evaluation of annual non-competing progress reports will include assessment of the dissemination practice by the grantee.  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). See Section VI.3., “Reporting.”

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

Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.

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

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

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

This NIH supported clinical training will help ensure that veterinarians in adequate numbers are trained in NHP clinical medicine and are available to support the NIH funded primate centers and resources in order to meet the Nation’s biomedical, behavioral, and translational research needs.   In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed training program will have a substantial impact on the pursuit of these goals.  The scientific review group will determine the quality of the proposed training program, the qualifications of the PD/PI, and consider whether the number of trainee positions proposed is appropriate for the program.  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.

Applications for this funding opportunity will be evaluated using the following criteria:

Research education program grant applications submitted in response to this funding opportunity announcement should be characterized by innovation, scholarship and responsiveness to the priorities and/or changing needs of the NCRR in meeting its objectives.  Applicants are strongly encouraged to contact NCRR program staff for current information about targeted priorities and policies before preparing an application (see Section VII).

Significance: Does the proposed research education program address scientific/education areas and/or topics important to the mission of the NCRR? How will implementation of the proposed program advance the objectives of this funding opportunity announcement as well as the mission of the NCRR?

Will the quality of the clinical education proposed to meet the stated objectives of preparing participant residents to function as independent NHP clinical veterinarians?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Is the research education program original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? 

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the proposed program appropriate to the experience level of the PD/PI and other researchers? Does the investigative team bring complementary and integrated expertise to the program (if applicable)? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's objectives?

Environment: Does the scientific/educational environment in which the program will be conducted contribute to the probability of success? Does the proposed research education program benefit from unique features of the scientific environment, subject populations, or employ useful collaborative arrangements? Is there evidence of appropriate collaboration among participating programs, departments, and institutions? Is the institutional commitment to the proposed program appropriate? If multiple sites are participating, is this adequately justified in terms of the research education experiences provided? Are adequate plans provided for coordination and communication between multiple sites (if appropriate)?

Evaluation Plan:  Is the required "Evaluation Plan" to assess the effectiveness of the Program in achieving its objectives, and the degree of portability of the proposed program adequate? Are the plans to recruit individuals from under represented and diverse populations adequate?

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:

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, the adequacy of the proposed protection will be assessed.

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research education program will be assessed by the reviewers. Is the number of person months listed for the effort of the PD/PI appropriate for the work proposed? Is each budget category realistic and justified in terms of the aims and methods? Are other aspects of the budget appropriately justified? The priority score should not be affected by the evaluation of the budget.

Training in the Responsible Conduct of Research: Peer reviewers will assess the applicant's plans for training in the responsible conduct of research on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction.

The plan will be discussed after the overall determination of merit, and the review panel's evaluation of the plan will not be a factor in the determination of the priority score. Plans will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note on the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until the applicant provides a revised, acceptable plan. Program staff will judge the acceptability of the revised plan.

Diversity Recruitment and Retention Plan:The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce.  The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation’s capacity to address and eliminate health disparities.

Accordingly, the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups; individuals with disabilities; and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research.  Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis.

Peer reviewers will separately evaluate the diversity recruitment and retention plan after the overall score has been determined.  Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds.  The review panel’s evaluation will be included in an administrative note in the summary statement.  If the diversity recruitment and retention plan is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received.  Staff within the NCRR, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable.

2.C. Sharing Research Data

Not Applicable

2.D. Sharing Research Resources

NIH policy requires that grant awardee 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/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131). 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 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), See Section VI.3., “Reporting.”

3. Anticipated Announcement and Award Dates

N/A

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 NIH 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.

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

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 NCRR to the grantee business official. 

2. Administrative and National Policy Requirements

Termination of Award: When a grantee institution plans to terminate an award, program and grants management staff at the NIH funding component must be notified in writing as soon as possible.

Change of Institution:  The research education program may not be transferred from one institution to another, unless strongly justified.

Consultation with the NCRR program staff is strongly encouraged when a change of institution is being considered.  In reviewing a request to transfer a grant, NIH will consider whether there is a continued need for the grant-supported project or activity and the impact of any proposed changes in the scope of the project. A change may be made without peer review, provided the PI plans no significant change in the original objectives, and the facilities and resources at the new organization will allow for successful performance of the project or activity. If these conditions or other programmatic or administrative requirements are not met, the NCRR may require peer review or may disapprove the request and, if appropriate, terminate the award.

The applicant must provide the following information to the NCRR for review:

Change of Program:  Awards are made for a specific program under the guidance and leadership of a particular PD/PI.  A change in any of these parameters requires prior approval by the responsible program officer in the NIH funding component.  A rationale must be provided for any proposed changes in the aims of the original, peer-reviewed program.  If the new program does not satisfy this requirement, the award will be terminated.

Change of PD/PI: If change of the PD/PI is necessary, support of the award is not automatic but may be continued with prior written approval by the NIH funding component, provided that the following conditions are met.  The current PD/PI or the grantee institution must submit a written request for the change, signed by the appropriate institutional business official, to the responsible program officer of the NIH funding component that describes the reasons for the change.  The Biographical Sketch of the proposed PD/PI, including a complete listing of active research grant support, must be provided.  The information in the request must establish that the Specific Aims of the original peer-reviewed research education program will remain unchanged under the direction of the new PD/PI and that the new PD/PI has the appropriate research and administrative expertise to lead the program.  This request must be submitted sufficiently in advance of the requested effective date to allow the necessary time for review. 

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.

3. Reporting

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

 The annual progress report should provide information about the number of participant residents currently in the program, level of progress, number and name of NHP species available for training participant residents, summary of clinical training activities for the year, overview of plans for the coming year including recommendations for changes if any, and effectiveness of recruiting strategies. The report must also include an account of experiences in recruiting from under-represented minorities including a report outlining the number applicants and number accepted, and the racial/ethnic distribution of both.  A brief description of qualifications of residency training staff participant residents, include additions or reductions in staff, tracking of /participant residents having completed the program must also be included if applicable. Any other information that complete a description of program progress for the period covered should also be included.

The continuation budget should be responsive to the funding request approved by the NCRR.  The non-competing budget should show detail breakdown of expenses by participant resident compensation and benefits, F&A cost, and other expenses.

Evaluation:  In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program.  Accordingly, award recipients are hereby notified that they may be contacted during and after completion of this award for periodic updates on various aspects of program development, implementation, dissemination, and other information helpful in evaluating the impact of this program.

Publication and Sharing of Research Results:  Investigators are encouraged to submit reports of their findings for publication to the journals of their choice.  For each publication that results from this award, NIH support should be acknowledged by a footnote in language similar to the following: “This project was supported by NIH grant number ________.  Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.”

Final Reports: A final Progress Report 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:

William T. Watson, D.V.M., M.S., DACLAM
Division of Comparative Medicine
National Center for Research Resources
Democracy Plaza 1, Room 954
6701 Democracy Boulevard
Bethesda, MD 20892
Telephone: (301) 435-0744
Email: watsonwm@mail.nih.gov

2. Peer Review Contacts:

John R. Glowa, Ph.D.
Scientific Review Administrator
Office of Review
National Center for Research Resources
National Institutes of Health, DHHS
6701 Democracy Boulevard, Room 1072
Bethesda MD 20892-4874
Courier Service Zip: 20817
Internal: Democracy 1, Room 1072, MSC 4874
Office of Review: 301-435-0844
Fax: 301-480-3660
Email: sb44k@nih.gov

3. Financial or Grants Management Contacts:

Irene Haas Grissom
Chief Grants Management Offices
National Center for Research Resources
Office of Grants Management
6701 Democracy Boulevard
Room 1036-MSC 4874
Bethesda, MD  20892-4874
Phone: 301-435-0836
Fax: 301-480-3777
Email: ig3y@nih.gov

Section VIII. Other Information


Required Federal Citations

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

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

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

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

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

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 PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in
the Catalog of Federal Domestic Assistance 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 Part 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 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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