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:  Developing And Improving Institutional Animal Resources (G20)

Announcement Type
This is a reissue of PAR-03-077, which was previously released March 18, 2003.

Update: The following updates related to this announcement have been issued:

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.

Program Announcement (PA) Number: PAR-07-342

Catalog of Federal Domestic Assistance Number(s)
93.389

Key Dates
Release/Posted Date: March 29, 2007
Opening Date: April 25, 2007, (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not Applicable
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): May 25, 2007; May 25, 2008; May 25, 2009 - (Changed to May 28, 2008 and May 28, 2009 per NOT-RR-08-007)
Peer Review Date(s): October 2007; October 2008; October 2009
Council Review Date(s): January 2008; January 2009; January 2010
Earliest Anticipated Start Date(s): April 1, 2008; April 1, 2009; April 1, 2010
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: May 29, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Purpose. The National Center for Research Resources (NCRR) encourages the submission of individual animal resource improvement grant applications from biomedical research institutions. The major objective of this program is to upgrade animal facilities to support the conduct of Public Health Service (PHS) supported biomedical and behavioral research. This program announcement (PA) replaces PAR-03-077.

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
    A. Cooperative Agreement Terms and Conditions of Award
3. Reporting

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

The National Center for Research Resources (NCRR) encourages the submission of individual animal resource improvement grant applications from biomedical research institutions. The major objective of this program is to upgrade animal facilities to support the conduct of Public Health Service (PHS) supported biomedical and behavioral research. A related objective is to assist institutions in complying with the USDA Animal Welfare Act and DHHS policies related to the care and use of laboratory animals. Support is limited to alterations and renovations (A&R) to improve laboratory animal facilities, and the purchase of major equipment items for animal resources,diagnostic laboratories, transgenic animal resources, or similar associated activities.

Animal resource improvement grants are awarded to assist biomedical research institutions in upgrading animal facilities and developing administratively centralized and uniformly effective programs of research animal care in support of PHS-funded research. Another major objective is to assist institutions in complying, and maintaining compliance, with provisions of the USDA Animal Welfare Act and DHHS policies related to the care and use of laboratory animals.

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

Section II. Award Information


Applications will compete with all others in the G20 category for available funds. An institution must have current PHS funding for research involving laboratory animals to be eligible for an award. The following will also be considered when making funding decisions:

Evidence of continued PHS research funding will be verified prior to award.

Following the award, funds for A&R will not be released until final architectural drawings, specifications, and updated cost estimates are approved by NCRR. The grantee will begin a process of design approval with the Division of Policy and Program Assessment (DPPA) immediately upon receipt of the Notice of Grant Award. No requests to initiate the bidding process for alterations or renovations will be entertained prior to receipt of the grant award from NIH and subsequent approval of working drawings and specifications by NIH staff. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this PA may not exceed five years and no indirect costs or continuation costs will be awarded. The initial budget period is for one year. All funds must be obligated within 5 years from the date of award.

1. Mechanism of Support

This Funding Opportunity Announcement (FOA) will use the G20 award mechanism. The applicant will be solely responsible for planning, directing, and executing the proposed project.

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 financial plans of the NCRR provides 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.

This FOA will use the NIH G20 award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The mechanism available for the support of these improvement projects is the grant for repair, renovation, and modernization of existing research facilities.  The total budget request for the improvement grant application and award is limited to $500,000 (direct costs).  This is a change from the previous PAR-03-077.  The $500,000 request may be used (a) entirely for movable equipment (e.g., cages, static racks); (b) for renovation, repair or modernizing the facility and for fixed equipment; and (c) in any combination of option (a) and (b) to reach the $500,000 maximum request limit of the award. 

Facilities and administrative costs are not allowed. The matching requirement for all applicants has been eliminated. Since the nature and scope of the projects proposed in response to this FOA might vary, it is anticipated that the size of an award will vary also.

NIH grants policies as described in the NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Institutions or eligible entities, including Primate Centers, may submit one application for developing and improving institutional animal resources (G20) in the same Federal fiscal year.       

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:

PDs/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 for this FOA through Grants.gov/APPLY.

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 “Frequently Asked Questions – Application Guide, 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)
Research & Related Other Project Information
Research & Related Senior/Key Person Profile (Expanded)
Budget Information for Construction Programs (SF-424C)
PHS 398 Cover Page Supplement
PHS398 Checklist 

Optional:

PHS 398 Cover Letter File

Foreign Organizations (Non-domestic (non-U.S.) Entity)

Foreign organizations are not eligible to submit an application in response to the FOA.

SPECIAL INSTRUCTIONS  

Applications Involving a Single Institution

When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

The SF 424 (R&R) application forms have PHS 398 components that closely resemble the old PHS 398 application forms in content and function.

Personnel:  Only key personnel, investigators who will benefit from or use the proposed facilities, the principal investigator and the program director should be listed, although salary support may not be requested. This must include the chief or consulting veterinarian and a facility renovation contact for the project.

Biographical Sketch Page:  Provide a biographical sketch (4-pages including research support) for key personnel and only those investigators who will benefit and or use the proposed facilities, the principal investigator, the program director, as well as the chief or consulting veterinarian.

Specific Instructions:  

Follow the PHS SF424 instructions for this section of the application including appropriate font size and margin requirements. Resubmission applications must include an introduction (1-3 pages) which responds to critiques from the previous application review. The introduction must be placed at the beginning of the Project Narrative section of the application, and it must address criticisms and highlight the specific changes in the application as described in the instructions for PHS SF424. The Project Narrative section of the application must strictly adhere to a limit of 40 pages (new for the G20 mechanism) not including the 1-3 pages for the Introduction. This 40 page limit is specific for the G20 mechanism as well as the C06 mechanism. The outline suggested below should be followed in describing the program. All information critical to the review must be in the Project Narrative or the Research & Related Other Project Information (#7, Equipment and #11-Other Attachments) of the application, not in the Appendix.

The following sample SF 424 application face page format is suggested:

SF 424 Application Face Page:

(1) Item #13, Proposed Period: Start Date: March 1, 2008, End Date:  February 28, 2009

(2) Item #17, Is application subject to review by state executive order 12372 process? Enter No, Program is not covered by E.O. 12372

The Project Summary/Abstract (#6) of the SF424, Research & Related Other Project Information must be used to attach a 250 word project summary/abstract.

Project Narrative (SF424, Research & Related Other Project Information):

Each of the following must be inserted as an attachment at the Project Narrative Research & Related Other Project Information (#7):

1.  Introduction to Application - It must address criticisms from the previous summary statement and highlight the specific changes in the application.

2. Specific Aims  - Clearly present the aims of the animal resource improvement project and relate them to the short- and long-term goals of the institution's animal resource program, and the research needs of the institution.

3. Background and Significance Project Information - This section should address the overall animal care and use program, and the need for improvements to meet current and future laboratory animal needs for biomedical research.

Provide an overall description of the institution's animal care and use program. Give relevant background information and describe the current status of the institution's animal resource facilities and program as they relate to biomedical research and research training. Describe the institution's overall involvement in animal-related research. This section should include a description of the following aspects of the animal resource:

Provide an overall description of the institution's animal care and use program. Give relevant background information and describe the current status of the institution's animal resource facilities and program as they relate to biomedical research and research training. Describe the institution's overall involvement in animal-related research. This section should include a description of the following aspects of the animal resource:

Clearly show how the proposed improvements will expand, improve or maintain existing research and research support activities. Briefly describe major research projects using the resource should be provided including source, time period, and amount of funding and level of animal usage. Future scientific needs to be addressed as part of the improvement should also be described. It is important to describe how the requested improvements will correct the deficiencies and problems described in the Background section. Demonstrate how the proposed facility improvement program fits into the institution's overall plan to meet or maintain PHS standards for animal care and use. If the project is part of an overall (larger) facility improvement plan, the application should describe the larger plan and how the project fits into that plan.

Describe and provide detailed justifications for the requested equipment items. The manufacturer, model number, size, capacity, or design criteria, total unit cost and facility where it will be used should be included.

Requests for surgical equipment must be justified by listing the number of investigators and PHS grant support received (can be provided in tabular form), the caseload, and the types of surgical procedures performed. Failure to adequately justify each requested item will likely result in its deletion from the recommended budget. For any proposed A&R, a narrative summary (as outlined below), line drawings, and cost estimates must be provided.

Project Narrative Summary:

(1) Relate the proposed renovations to the projected animal populations (by species) and research projects that will use the facility.

(2) List the functional components, including the size (dimensions) and square footage of each component (e.g., room, alcove, cubicle etc.) that will be directly affected by the renovation project.

(3) List engineering criteria applicable to each component (e.g., mechanical, electrical and plumbing, and utilities). Include information such as the number of air changes per hour, electrical power, light levels, hot and cold water, and steam.

(4) List appropriate architectural criteria such as width of corridors and doors, and surface finishes.

(5) List and justify all fixed and movable equipment items requested for the renovated area.

The Research & Related Other Project Information - #7 must be use to attach a list of movable and fixed equipment.

The SF 424 Research & Related Other Project Information, # 11-Other Attachments must include only information relevant to the proposed renovation of the animal facility for which NCRR-support is sought. Do not submit general institutional reports and strategic plans not directly related to the facility described in the application. Each of the following information must be submitted as a separate PDF file at  # 11-Other Attachments (e.g., all Line Drawings must be a single PDF attachment; a separate active and separate pending Grant Support Table attachments must  be include and so forth through the list below). It is important that these Other Attachment names be used in the file name (e.g., the Line Drawings file must be named Line Drawings) in order to appropriately set the Bookmarks and Table of Contents entries for the application.  The attachments will be arranged alphabetically by file name when the grant image is produced following the application submission.  A total of 10 Other Attachments are permitted.  If an item listed below is not applicable, omit it from the application:

Line Drawings (Research & Related Other Project Information, # 11-Other Attachments):

(1) Submit line drawings that will fit on an 8-1/2" x 11" sheet of paper. (DO NOT SUBMIT BLUEPRINTS). All floor plans must be legible, with the scale clearly indicated. Reviewers require the scale of the floor plans in order to determine whether equipment and clearances are appropriate. If applicable, submit both existing and proposed drawings.

(2) The line drawings of the proposed renovation must be at a scale adequate to explain the project. The drawings should indicate size dimensions, function, and net and gross square feet of space for each room. The total net and gross square feet of space to be renovated should also be given.

(3) The plan should indicate the location of the proposed renovation area in the building.

(4) Include the as-built drawings of the proposed renovation area and indicate any areas which will be demolished.

(5) Changes or additions to existing mechanical and electrical systems should be clearly described in notes made directly on the plan or attached to the plan.

(6) Indicate the type(s) of new finishes to be applied to room surfaces.

(7) Detailed cost estimates must be included. Provide vendor quotes when available.

The Budget Information for Construction Programs (SF-424C) must be used to attach an overall application budget page for the total request funds.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date:  April 25, 2007 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not Applicable
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):  May 25, 2007, May 25, 2008, May 25, 2009 - (Changed to May 28, 2008 and May 28, 2009 per NOT-RR-08-007)
Peer Review Date(s): October 2007; October 2008; October 2009
Council Review Date(s): January 2008; January 2009; January 2010
Earliest Anticipated Start Date(s): April 1, 2008; April 1, 2009; April 1, 2010
Expiration Date: May 29, 2009

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.

This replaces the former mode of sending an extra copy to the IC review/referral office.

In order to expedite the review, applicants are requested to notify the NCRR Referral Office by email nelsonbj@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.

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.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status 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” 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.

Award funds are restricted. Funds will be release for use by the grantee following the NCRR approval of institutional design documents. Design documents must be submitted to evaluate the placement of fixed equipment such as ventilated cages, cage and rack washers, autoclaves etc. even though alteration and renovation (A&R) component is small or not requested in the application. Following NCRR approval, funds are release through a revised notice of grant award.               

ALLOWABLE COSTS: Items that may be requested under this grant mechanism include:

UNALLOWABLE COSTS: Improvement grants are not intended to provide support for:

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.

6. Other Submission Requirements

PD/PI Credential (e.g., Agency Login)

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 “Registration FAQs – Important Tips -- Electronic Submission of Grant Applications.”

Organizational DUNS

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 “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

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.

Research Plan Component Sections

While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component 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.  

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following requirements for G20 applications:

Appendix Materials

This FOA does not allow appendix material.

Plan for Sharing Research Data

Not Applicable to the G20 mechanism.

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.

Applications will be reviewed for completeness by the Office of Review, NCRR. Those applications judged to be incomplete or ineligible will be returned to the applicant. Applications that are complete will be reviewed for scientific and technical merit by the Scientific and Technical Review Board (STRB) on Biomedical and Behavioral Research Facilities established for this purpose by the NCRR. As part of the initial merit review, all applications will receive a written critique and receive a second level review by the National Advisory Research Resources Council.

Factors considered in the appraisal of an animal resource improvement project include:

A. The Improvement Request

1. Research to be supported - The overall scope of the ongoing PHS-supported biomedical and behavioral research involving laboratory animals, which will be affected by the proposed improvements, will be considered. The specific impact of the proposed construction on existing and future PHS-supported biomedical and behavioral research, research training and/or research support activities related to only the NCRR-supported construction project described in the application for the proposed facility. In addition, the resulting expanded or proposed future biomedical and behavioral research activities will be considered.

2. Need - The applicant should show how the grant support will meet current and future laboratory animal research needs, particularly for smaller or developing institutions, and how this will help the institution meet or maintain standards of the Animal Welfare Act and PHS policies concerning the care and use of laboratory animals.

3. Design Considerations - The proposed project will be judged for technical soundness, appropriateness and suitability of the proposed renovation project for addressing current and future needs of the institution.

4. Budget - The budget will be evaluated in relationship to the applicant's responsiveness to these guidelines, justification provided for each of the requested items, cost effectiveness, and the institution's perceived commitment to the animal care program.  Justify the budget and include vendor quotes if available.

B. The Animal Care Program: The scope of the animal care and use program to be enhanced by this facility improvement request should be carefully defined. For the purpose of this application, the animal care program should cover the entire applicant institution.

1. Animal Care - The quality of the animal husbandry program at the applicant institution will be assessed. The extent to which the project will enhance the welfare of animals maintained in the facility will be evaluated, including advances in the humane treatment of the animals due to husbandry changes allowed by the improvements.

2. Personnel - The technical and professional staff will be evaluated. The institution should have a sufficient number of professional staff with appropriate qualifications and experience to operate the animal resource in a competent manner. The facility should also have qualified non-professional staff and supporting services.

3. Administrative Arrangements - An evaluation will be made of the administrative arrangements for routine management of the animal resource.

The institutional plan to assure a comprehensive and acceptable animal care and use program will be evaluated. The institution should have a record of commitment and a sound plan for financial support of the resource, through a recharge system, per diem charges, institutional support, etc.

4. Resources and environment - The suitability of the institutional setting for achieving the goals of the program will be considered. This will include an appraisal of the academic environment and the support for the animal resource by the administration and faculty.

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by the Scientific and Technical Review Board, an appropriate peer 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:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Awards will assist institutions in complying with the USDA Animal Welfare Act and DHHS policies related to the care and use of laboratory animals.  

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?   The major objective of this program is to upgrade animal facilities to support the conduct of Public Health Service (PHS) supported biomedical and behavioral research. Applicants must clearly demonstrate how the animal improvement project will achieve this major objective.   

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? Not applicable to the G20 mechanism. 

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?
Applicants must clearly demonstrate that the Principal Investigator is appropriately trained and well suited to carry out the improvement project.

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?
Not applicable to the G20 mechanism. 

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?

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 will be considered during the review of the application. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Not applicable to the G20 mechanism. 

2.D. Sharing Research Resources

Not applicable to the G20 mechanism. 

3. Anticipated Announcement and Award Dates

Not applicable to the G20 mechanism. 

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/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.

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.

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 Section IV.5., “Funding Restrictions.”       

2. Administrative and National Policy Requirements

Award funds are restricted. Funds will be release for use by the grantee following the NCRR approval of institutional construction documents. Construction documents must be submitted to evaluate the placement of fixed equipment such as ventilated cages, cage and rack washers, autoclaves etc. and must be completed within the first 24 months following the initial notice of grant award. Following NCRR approval of the construction documents, funds are release by the NCRR Office of Grants Management by issuing a revised notice of grant award.

Design Schedule Requirements: The NIH Extramural Developing and Improving Institutional Animal Resources grant (G20) requires all funds to be obligated within five years after the a grant award is made. Following the receipt of a Notice of Grant award, the institution must sign and return the Terms and Conditions of the award to the Office of Grants Management, NCRR, to begin the design phase of the award. Because the award has a five-year time limit for the obligation of all grant award funds, the grantee is required to begin the design phase immediately following the return of the signed Terms and Conditions. The grantee must develop the design document within the first two years of the award (completion of the designs in less than two years is acceptable).

Grantees should allow four to six weeks for the NIH review of each design submission. All submitted design documents must be approved by the NCRR/NIH and the grantees must adhere to the following design document approval schedule:

The design documents must be completed with the first 24 months of initial award budget period.  

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the Notice of Award (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

Not applicable to the G20 mechanism. 

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:

Direct inquiries about scientific and programmatic issues to:

Willie D. McCullough, Ph.D.
Director, Facilities Improvement Programs
Division of Research Infrastructure
National Center for Research Resources

Democracy One, Room 940
6701 Democracy Boulevard
Bethesda, MD 20892

Telephone: (301) 435-0766
Fax: (301) 480-3770
Email: mccullow@mail.nih.gov

Direct inquiries about project design and technical programmatic issues  (engineering and architectural) to:

Esmail Torkashvan, P.E.
Division of Research Infrastructure
National Center for Research Resources

Division of Research Infrastructure
Democracy One, Room 928
6701 Democracy Boulevard
Bethesda, MD 20892

Telephone: (301) 435-0766
Fax: (301) 480-3770
Email: torkashv@mail.nih.gov
 
2. Peer Review Contacts:

Barbara J. Nelson, Ph.D.
Office of Review
National Center for Research Resources

Democracy One, Room 1080
6701 Democracy Boulevard
Bethesda, MD 20892

Telephone: (301) 435-0806
Fax: (301) 480-3660
Email: nelsonbj@mail.nih.gov

3. Financial or Grants Management Contacts:

Holly Atherton
Office of Grants Management
National Center for Research Resources

Democracy One, Room 1040
6701 Democracy Boulevard
Bethesda, MD 20892
Telephone: (301) 435-0840
Fax: (301) 480-3777
Email: athertoh@mail.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 (45 CFR 46) 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. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal 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 SF424 (R&R) application; 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.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) 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 HHS 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) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 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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