and Human Services (HHS)
EXPIRED
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-07-342
Update: The following updates relating to this announcement have been issued:
Request for Applications (RFA) Number: RFA-RR-10-011
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 (4) weeks prior to the grant submission date. See Section IV.
Catalog of Federal
Domestic Assistance Number(s)
93.389
Key Dates
Release/Posted Date: September
2, 2010
Opening Date: October 4, 2010 (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 Due Date(s): November 4, 2010
AIDS Application
Due Date(s): Not Applicable
Peer Review
Date(s): February/March 2011
Council Review Date(s): May
2011
Earliest Anticipated Start Date(s): July 1, 2011
Additional
Information To Be Available Date (Activation Date): Not Applicable
Expiration
Date:November 5, 2010
Due Dates for
E.O. 12372
Not Applicable
Additional
Overview Content
Executive Summary
Table of Contents
Part I Overview Information
Part
II Full Text of Announcement
Section
I. Funding Opportunity Description
1. Research
Objectives
1. Mechanism of Support
2. Funds Available
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. Receipt, 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
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
Contacts
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 that have one or more active PHS supported
award(s). The major objective of this program is to upgrade animal facilities
to support the conduct of biomedical and/or 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 biomedical and/or behavioral research.
No facilities and administrative (F&A) costs or continuation costs will be awarded. The NIH reserves the right to conduct site visits when deemed essential. This may include site visits during the application/proposal evaluation process and/or visits during the renovation at the completion of the project.
Sustainable Design
In keeping with requirements for federally funded facilities, grantees are encouraged to implement the following listed primary elements of sustainable design in federally funded facilities. Sustainability is the outcome of an integrated process of facility development and operation incorporating a balance of life-cycle cost, environmental impact and occupant health and safety, security, and productivity. At a minimum, the following primary elements of sustainable design shall be considered in all projects, as applicable.
1. Integrated design.
2. Commissioning.
3. Optimization of energy performance.
4. Energy efficiency.
5. Measurement and verification.
6. Protection and conservation of water.
7. Indoor water.
8. Outdoor water.
9. Enhancement of indoor environmental quality.
10. Ventilation and thermal comfort.
11. Moisture control.
12. Day lighting.
13. Low-emitting materials.
14. Protection of indoor air quality during renovation.
15. Reducing the environmental impact of materials.
16. Maximizing recycled and bio-based content.
17. Construction waste reuse and recycling.
18. Minimizing use of ozone depleting compounds.
Sustainable Design References
Department of Health and Human Services. HHS Policy for Sustainable and High Performance Buildings. December 2007. http://www.hhs.gov/asam/ofmp/hiperfbldngpol.pdf
Department of Health and Human Services. HHS Real Property Asset Management Plan. http://www.hhs.gov/asam/ofmp/ramp.doc
Executive Order 13101: Greening the Government through Waste Prevention, Recycling, and Federal Acquisition http://frwebgate.access.gpo.gov/cgibin/getdoc.cgi?dbname=1998_register&docid=fr16se98-113.pdf
Executive Order 13123: Greening the Government through Efficient Energy Management. http://frwebgate.access.gpo.gov/cgibin/getdoc.cgi?dbname=1999_register&docid=fr08jn99-171.pdf
Executive Order 13134: Developing and Promoting Biobased Products and Bioenergy. http://www.archives.gov/federal-register/executive-orders/1999.html#13134
Executive Order 13148: Greening the Government through Leadership in Environmental Management. http://frwebgate.access.gpo.gov/cgibin/getdoc.cgi?dbname=2000_register&docid=fr26ap00-129.pdf
OMB Circular
A-11, Section 55-Energy and Transportation Efficiency Management.
http://www.whitehouse.gov/omb/circulars/a11/current_year/s300.pdf#search=%22
OMB%20Circular%20A-11%20Part%207%22
OMB Circular
A-11, Part 7 (Section 300), Planning, Budgeting, Acquisition, and Management of
Capital Assets.
http://www.whitehouse.gov/omb/circulars/a11/current_year/s300.pdf#search=%22
OMB%20Circular%20A-11%20Part%207%22
The Federal Leadership in High Performance and Sustainable Buildings, Memorandum of Understanding. http://www.energystar.gov/ia/business/Guiding_Principles.pdf
Green Building Initiative Green Globes System. http://www.thegbi.org
US Green Building Council. http://www.usgbc.org
Whole Building Design Guide http://www.wbdg.org
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 Announcement (FOA) will use the G20 award mechanism. The applicant
will be solely responsible for planning, directing, and executing the proposed
project.
This FOA uses Just-in-Time information concepts (see SF424 (R&R) Application Guide).
U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit budget requests using the Research & Related Budget component (i.e., SF 424 C Construction Budget Information Sheet).
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 IC(s) provide support for this
program, awards pursuant to this funding opportunity are contingent upon the
availability of funds.
Facilities
and Administrative (F&A) costs requested by consortium participants are not
included in the direct cost limitation. See NOT-OD-05-004.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1.
Eligible Applicants
1.A.
Eligible Institutions
The following
organizations/institutions are eligible to apply:
Individuals with the skills, knowledge, and resources necessary to carry out the proposed project are invited to work with their institution/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.
All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
2. Cost
Sharing or Matching
This program does not require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special
Eligibility Criteria
Number of Applications. Applicants may submit one application.
Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).
Renewals. Renewal applications are not permitted in response to this FOA.
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, use the Apply for
Grant Electronically button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions
provided on that Web site.
Registration:
Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. 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 with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered on-time (see 3.C.1 for more information about on-time submission).
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 NIH eRA Commons.
Several additional separate actions are required before an applicant can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Registered
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.
Both the PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.
1.
Request Application Information
Applicants must
download the SF424 (R&R) application forms and the 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 301-710-0267; Email: [email protected].
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 for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, 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 has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in 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 Profile (Expanded)
Budget Information for Construction Programs (SF-424C)
PHS398 Cover Page Supplement
PHS398 Checklist
Optional
Components:
PHS398 Cover Letter File
3.
Submission Dates and Times
See Section IV.3.A. for details.
3.A. Submission, Review, and Anticipated Start Dates
Opening
Date: October 4, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not Applicable
Application Due Date(s): November 4, 2010
Peer Review Date(s): February/March 2011
Council Review Date(s): May 2011
Earliest Anticipated Start Date(s): July
1, 2011
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/applicants/apply_for_grants.jsp and follow Steps 1-4. Note: Applications must
only be submitted electronically. PAPER APPLICATIONS WILL NOT BE
ACCEPTED. 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.
3.C.
Application Processing
3.C.1
Submitting On-Time
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 due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered on-time :
Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.
Submission to Grants.gov is not the last step applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!
3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings
IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.
Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.
Please note that the following caveats apply:
3.C.3 Viewing an Application in the eRA Commons
Once any eRA identified 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 weekdays (Monday Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.
Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the IC. Incomplete and/or non-responsive applications will not be reviewed.
There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. 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 the application status in the Commons.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.
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.
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: 1) are necessary to conduct the project, and 2) would be allowable under
the grant, if awarded, without NIH prior approval. If specific expenditures
would otherwise require prior approval, the grantee must obtain NIH approval
before incurring the cost. NIH prior approval is required for any costs to be
incurred more than 90 days before the beginning date of the initial budget
period of a new 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
Face Page
You MUST provide an entry for the Total Estimated Project Funding , Total Federal and non-Federal Funds , and Estimated Program Income , all on the SF424 RR Cover.
PD/PI Credential (e.g., Agency Login)
The NIH requires the PD(s)/PI(s) 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.
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.
Research & Related Senior/Key Person Component
Include information about the PD/PI, the Animal Facility Director, the Project Manager, and any other key persons in this component. G20 applications must specify a Facilities Person/Project Manager in the R&R Senior/Key Person Profile component or applicant will receive the following error message: A Facilities Person/Project Manager must be identified for this application . Please provide the information for this person after the PD/PI on the Senior/Key Person page. Specify a project role of Other or Other Professional , and an Other Project Role Category of Facilities Person/Project Manager .
Budget Information for Construction Programs (SF424C)
The Budget Information for Construction Programs (SF424C) must be used to attach an overall application budget page for the total requested funds.
Project Narrative Sections
Page limitations of the Project Narrative Sections are listed below. All attachments must be provided to NIH in PDF format, filenames must be included and have no spaces or special characters, and a .pdf extension must be used.
Applications will be unresponsive if: (1) Line drawings are not included for the project; (2) Additional text is added to the line drawings in order to defeat the 13 page limit for the Project Narrative section; or (3) The Project Narrative is greater than 13 pages. An application that is unresponsive will not be reviewed.
PROJECT NARRATIVE (assemble in order shown below): The entire project narrative (including the Specific Aims, Background, and Renovation and/or Equipment plans through the project timeline) is limited to 13 pages. Line drawings and tables do not count toward this limit. Upload this information using the Project Narrative Attachment in the Other Project Information Component.
Specific Aims: This section must not exceed one page and should summarize any request for alterations and renovation including the associated square footage.
Background: The Background and Significance section should not exceed two pages. This section must:
(1) Identify the animal facilities for which funds are requested and provide information about the usage of these facilities. This is best done in a table or in a bulleted list.
(2) Describe the overall management of animal facilities at the institution, and discuss how this proposal fits into that overall vision.
(3) Describe past institutional support of this animal facility. This might include support for technicians, equipment purchased by the institution, support for animal facility director, and previous alterations and renovations supported by the institution.
(4) Animal Program Data - Provide a brief description of all on-campus and off-campus animal facilities, including sites where experimental surgery is performed. Indicate who manages each facility. Indicate the average daily census (by species) for each facility. Indicate whether the institution is accredited by the American Association for Accreditation of Laboratory Animal Care (AAALAC), and if not, describe plans for obtaining accreditation. It is not mandatory that applicant’s institution be AAALAC accredited to apply to this FOA. If equipment is requested for surgical or diagnostic facilities, the caseload, species, types and numbers of surgeries or diagnostic tests must be documented.
Renovation and/or Equipment Plans: The Renovation/Equipment Plan can be up to 10 pages (or more) as long as the number of pages in the Specific Aims, Background, and Renovation/Equipment through the project timeline sections totals no more than 13 pages. The Renovation/Equipment Plan includes the following subsections: Significance and Need, Project Management and Institutional Commitment, Design Considerations, Equipment and Project Timeline. The page limits in this section do NOT include the requested tables or line drawings.
Significance and Need: Begin with two tables containing (1) active and (2) pending grants (from the NIH and other sources) that will be affected by the renovation. These tables should have the following columns: grant title, principal investigator, grant number, funding source, annual amount of funding, start and end dates. These tables do not count toward the 13 page limit.
Justify the need for the renovation. Describe how the requested alterations and renovations will correct these deficiencies and problems. Explain how the proposed improvements will expand, improve, or maintain existing research and research support activities. Describe the modifications to the existing facility to accommodate the proposed functions and the requested equipment. Future scientific needs that would be accommodated as part of the improvement also should be described.
Describe the administrative structure and oversight for the project. Describe the ongoing institutional commitment to the animal facility.
If alterations and renovations are requested, list in tabular format the size (dimensions) and square footage of each component (e.g., room, alcove, cubicle, laboratory etc.) that will be directly affected by the renovation project. This table will not count against the 13 page project narrative limit.
Provide information about the mechanical, electrical, plumbing (MEP) systems and utilities in each component. Include information about the number of air changes per hour, electrical power, light levels, hot and cold water, steam, MEP requirements, fire protection requirements, biohazard and radiation safety requirements, chemicals used, major scientific equipment to be installed including environmental rooms, density of fume hoods, building population, number of workstations, security/surveillance and building automation systems.
Provide architectural criteria such as the width of corridors and doors and surface finishes. Architectural criteria should also address quality of life issues (e.g., natural lighting, noise, vibration) and functional relationships and zoning of the renovated area. Sufficient information must be provided to allow the evaluation of plans for BSL-3/ABSL-3 animal facility design documents.
The line drawings do not count toward the 13 page limits and must be included for all applications submitted in response to this FOA. Additional text must not be included in the line drawings to defeat the page limit. Include floor plans for alterations and renovations including the location of fixed equipment and placement of racks and cages. The line drawings must fit on an 8.5 x 11 sheet of paper. Do not submit blueprints. All floor plans must be legible with the scale clearly indicated. The floor plans must indicate the location of fixed equipment and illustrate safety clearances and workspace. Submit both existing and proposed drawings. The drawings should indicate size dimensions, function, and the net and gross square feet for each room. The total net and gross square feet of space to be renovated should also be given. The plan should indicate the location of the proposed renovation area in the existing building. 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. The line drawings must indicate egress routes. The drawings must indicate the functional layout of the proposed facility showing the location of entries and exits, clearances, and the location of fixed equipment.
List and justify all fixed equipment. A list of eligible fixed equipment can be found at http://ncrr.nih.gov/research_funding/instruments. Equipment should be relevant to the function of the animal facility. Information such as the manufacturer, model number, size, capacity, total cost, and location in the facility should be included. Quotes for equipment should be provided in the Other Attachments section below.
Provide a project timeline for the proposed alteration and renovation.
OTHER ATTACHMENTS
In the Other Attachments section, include the following, each as a separate attachment. NOTE: Each attachment must be given a file name using the headings below (e.g., Environmental_Analysis_Form).
(1) Environmental Analysis Form (http://www.ncrr.nih.gov/resinfra/environmental_Analysis_Form.pdf ).
(2) Budget Justification, List of Equipment and Vendor Quotes: The next attachment should be all vendor quotes, list of equipment and the budget justification. List and justify each piece of equipment. These quotes may include delivery costs, but should not contain service contract costs.
(3) In a separate brief attachment, applicants must include information about the Institutional Occupational Health Program as it pertains to animal care staff.
(4) Applicants must include IACUC and if accredited, AAALAC summary reports, and/or sections of these reports that describe deficiencies of the facility and the animal care program.
The following documents are likely to be useful when responding to this FOA. NIH Grants Policy Statement (03/01/01) Part II- Subpart B (construction grants) http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part9.htm#_Toc54600155 and the NIH Office of Research Facilities is also helpful. (See http://orf.od.nih.gov/PoliciesAndGuidelines/FacilitiesPoliciesandGuidelines/DesignRequirementsManualPDF.htm)
Please refer to this document for a representative list of allowable and unallowable costs.
Biosafety in Microbiological and Biomedical Laboratories, CDC/NIH, 5th Edition, http://www.cdc.gov/OD/ohs/biosfty/bmbl5/bmbl5toc.htm. Appendix A is particularly useful.
Information about the Select Agent Rule and related matters. http://www.selectagents.gov/
NIH Model Commissioning guide http://des.od.nih.gov/eWeb/research/farhad2/Commissioning/nih_cx_guide/ComGuideTitle.htm
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 additional requirements:
Appendix Materials
This FOA does not allow appendix material. Additional supplementary material will not be accepted after the receipt of the application.
Resource Sharing Plan(s)
Not Applicable
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
Review
Process
Applications that are complete and responsive to
this FOA will be evaluated for scientific and technical merit by
an appropriate peer review group convened by NCRR and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria
stated below.
As part of the scientific peer review, all applications will:
The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Applications will receive an impact/priority score based, among other pertinent factors, including those below, on the following criteria: (1) The scientific merit of the of the research supported by the improvement project; (2) The need for the project; (3) The project design; and (4) The ability of the PI to carry out the proposed project to completion.
Overall Impact
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project proposed).
Scored Review Criteria
Reviewers will consider each of the five review criteria below (Significance; Investigator(s); Innovation; Approach and Environment) in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance. Is there sufficient justification for improving this facility? To what extent will the proposed change in the research environment facilitate the applicant institution’s ability to conduct, expand, improve, or maintain biomedical and/or behavioral research?
Investigator(s). Does the PI have the appropriate experience and background suited to the proposed project? Is the Facility Person/Project Manager identified for the project? Does the Facility Person/Project Manager have the skills necessary to complete the project on time and within budget?
Innovation. Does the design implement sustainable design principles? Are innovative strategies used in the design? Does the proposed A&R increase efficiency in the use of energy, water, or materials to reduce adverse impacts on the environment?
Approach. Are potential problems, alternative strategies, and benchmarks for success presented? Does the plan indicate the proposed renovation area in the building, including associated room adjacencies, traffic patterns for the movement of people, animals, and materials (clean and dirty) through the facility, and relative location of needed ancillary areas (e.g., changing rooms for animal facilities)? Is the total net and gross square feet of space to be renovated provided? Are the proposed timeline and sequence of construction reasonable?
Engineering Criteria: Do the engineering criteria include information about the mechanical, electrical, plumbing systems, and utilities in the renovation? Are the number of air changes per hour, electrical power, light levels, hot and cold water, and steam appropriate for the project?
Architectural Criteria: Are the architectural criteria such as the width of corridors and doors and surface finishes appropriate for the project?
Line Drawings: Is the function of the space indicated? Do the line drawings indicate the size dimensions, function, and net and gross square feet for each component? Are the line drawings at a scale adequate to explain the project? Do the plans indicate the changes to be made to the space? Are the line drawings drawn to scale to indicate adjacencies and operational relationships of equipment? Is the location of major equipment, fume hoods, sinks, showers, and other major items indicated in the drawings? Are areas to be demolished indicated?
Are changes or additions to existing mechanical and electrical systems clearly described and adequate to the project? Are requests for equipment justified? Will the requested equipment remedy identified deficiencies or fill gaps in the animal facility?
Environment. Is the institution committed to using the renovated space for biomedical or behavioral research? Does the institution have a history of adequate support for this facility? Has the institution provided evidence of future commitments to this animal facility?
Additional Review Criteria
As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.
Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Additional Review Considerations
As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.
Budget and Period of Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Selection Process
Applications submitted in response to this FOA will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:
Other factors which the awarding IC considers appropriate in light of its particular statutory mission. Funds for alteration and renovation will be restricted and will only be released after project final construction documents are approved by the NCRR.
3. Anticipated Announcement and Award Dates
Not Applicable
Section VI. Award Administration Information
1.
Award Notices
After the peer review of the application
is completed, the PD/PI will be able to access his or her Summary Statement
(written critique) via the 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
The NIH Extramural
Developing and Improving Institutional Animal Resources grant (G20) requires
all funds to be obligated within four years after the design phase is concluded.
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.
In particular, the Public Policy Requirements for Construction Awards set forth in the NIH Grants Policy Statement apply to all awards under this FOA. Those requirements include but are not limited to:
1 Elimination of Architectural Barriers to the Handicapped: The Architectural Barriers Act of 1968, as amended, the Federal Property Management Regulations 101-19.6 (41 CFR 101-19.6), and the Uniform Federal Accessibility Standards issued by the General Services Administration (41 CFR 101-19.6, Appendix A) set forth requirements to make facilities accessible to, and usable by, the physically handicapped and include minimum design standards. All new facilities constructed with NIH grant support must comply with these requirements.
2 Historic Properties/Archaeological Sites: under the provisions of the National Historic Preservation Act, as amended, and the Archeological and Historical Preservation Act of 1960, as amended, the Secretary of the Interior has compiled a National Register of Historic Places sites and buildings of significant importance to U.S. history. The statutes require that, before approval of a construction grant application (or other applications as specified by NIH), NIH take into account the effect on these sites of the proposed construction (or other) project. The applicant must determine whether activities using NIH financial assistance will affect a property listed in the National Register. If a designated historic property will be affected, the applicant must obtain clearance from the appropriate State Historic Preservation Office before submitting the application. Failure to obtain this clearance will delay NIH action on an application.
3 National Environmental Policy Act (including Public Disclosure): The NIH shall determine the amount of review, if any, required under NEPA to assess the potential environmental impacts of the actions taken under the grant. If NEPA applies, the application must be accompanied by the applicant’s own separately bound environmental analysis to facilitate review and evaluation for environmental concerns before approval or other action on the application. The NIH shall inform the grantee what additional reviews, if any, are required.
4 Flood Insurance: The Flood Disaster Protection Act of 1973, as amended (Public Law 93-234), provides that no Federal financial assistance to acquire, modernize, or construct property may be provided in identified flood-prone communities in the United States, unless the community participates in the National Flood Insurance Program and flood insurance is purchased within 1 year of the identification. The flood insurance purchase requirement applies to both public and private applicants for NIH support.
5 Clean Air and Clean Water Act: 42 U.S.C. 7401 et seq. and EO 11738 provide for the protection and enhancement of the quality of the nation’s air resources to promote public health and welfare and for restoring and maintaining the chemical, physical, and biological integrity of the nation’s waters.
6 Safe Drinking Water Act: 42 U.S.C. 300h-3 provides for the protection of underground sources of drinking water that have an aquifer, which is the sole source of drinking water. Specifically, no grant may be entered into for any project that the EPA Administrator determines may contaminate such aquifer.
Immediately upon completion of the alteration and renovation, the grantee shall, at a minimum, provide the same type of insurance coverage as it maintains for other property it owns, consistent with the minimum coverage specified in the NIH Grants Policy Statement.
2.A. Cooperative Agreement Terms
and Conditions of Award
Not Applicable
3.
Reporting
A final progress report, invention statement, and
Financial Status Report are required when an award is completed, relinquished
or terminated.
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 (program), peer review, and financial or grants management issues:
1. Scientific/Research Contact(s):
Direct inquiries about scientific and programmatic issues to:
Willie D. McCullough, Ph.D.
Office of Construction Grants
National Center for Research Resources
Democracy One, Room 940
6701 Democracy Boulevard
Bethesda, MD 20892-4874
Telephone: (301) 435-0766
Fax: (301) 480-3770
Email: [email protected]
Direct inquiries regarding technical programmatic issues (engineering and architectural) to:
Esmail Torkashvan, P.E.
Division of Research Infrastructure
National Center for Research Resources
National Institutes of Health/DHHS
6701 Democracy Blvd., Room 928
Bethesda, MD 20892-4874
Telephone: (301) 435-0766
FAX: (301) 480-3770
Email: [email protected]
2. Peer Review Contact(s):
Barbara J. Nelson, Ph.D.
Office of Review
National Center for Research Resources
Democracy One, Room 1080
6701 Democracy Boulevard
Bethesda, MD 20892-4874
Telephone: (301) 435-0806
Fax: (301) 480-3660
Email: [email protected]
3. Financial/Grants Management Contact(s):
Irene
Grissom
Office of Grants Management
National Center for Research Resources
Democracy One, Room 1036
6701 Democracy Boulevard
Bethesda, MD 20892-4874
Telephone: (301) 435-0836
Fax: (301) 480-3777
Email: [email protected]
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 institutional review board (IRB) rules, as well as local, State and
Federal laws and regulations, including the Privacy Rule.
Policy for Genome-Wide
Association Studies (GWAS):
NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH
Guide NOT-OD-07-088. For additional information,
see http://grants.nih.gov/grants/gwas/.
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.
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.
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-09-116.html. Only research using hESC
lines that are registered in the NIH Human Embryonic Stem Cell Registry will be
eligible for Federal funding (http://escr.nih.gov/). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research.
NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators
funded by the NIH must submit or have submitted for them to the National
Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final,
peer-reviewed manuscripts upon acceptance for publication, to be made publicly
available no later than 12 months after the official date of publication. The
NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more
information, see the Public Access webpage at http://publicaccess.nih.gov/.
Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (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. 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/.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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