REGIONAL BIOCONTAINMENT LABORATORIES (RBL) CONSTRUCTION PROGRAM

RELEASE DATE:  June 29, 2004

RFA Number:  RFA-AI-04-032 
 
EXPIRATION DATE:  December 30, 2004

Department of Health and Human Services (DHHS)

PARTICIPATNG ORGANIZATION:
National Institutes of Health (NIH) 
 (http://www.nih.gov)

COMPONENT OF PARTICIPATING ORGANIZATION:
National Institute of Allergy and Infectious Diseases (NIAID) 
 (http://www.niaid.nih.gov)

CATALOGUE OF FEDERAL DOMESTIC ASSISTANCE NUMBERS:
No. 93.389, NIH Construction

LETTER OF INTENT RECEIPT DATE: November 29, 2004 
APPLICATION RECEIPT DATE: December 29, 2004 

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Background and Objectives
o Mechanism of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA

The National Institute of Allergy and Infectious Diseases (NIAID) invites 
applications for Construction Cooperative Agreement (UC6) funds to support the 
construction of new Regional Biocontainment Laboratories (RBLs) to be used for 
biomedical research and research training.  Funds will be provided to program, 
design, construct, and commission comprehensive state-of-the-art laboratories 
that will support research on the NIAID Category A, B and C priority pathogens 
and emerging infectious diseases.  At a minimum, the facility must include 
biosafety level-3 (BSL-3) and biosafety level-2 (BSL-2) biomedical research 
laboratories, a vivarium for small animals, and support space for research, 
administration, and building operations.  The RBLs must preferentially support 
NIAID-funded biodefense and emerging infectious diseases research and will be 
members of the NIAID Biodefense Network.  Additionally, the RBLs will serve as 
a regional resource for research institutions in the area, and must be 
available and prepared to assist national, state, and local public health 
efforts in the event of a bioterrorism emergency.

PUBLIC BRIEFING

The NIAID will hold an informational session for individuals representing 
institutions considering submission of applications in response to this RFA. 
The session will be held on Tuesday, July 27, 2004 from 9:00AM to 12:00noon in 
Room 1205, 6700B Rockledge Drive, Bethesda, Maryland 20817. Staff rom the 
NIAID Biocontainment Laboratories Program and from the Division of Extramural 
Activities will provide information about the program and will be available to 
answer questions pertinent to preparing applications. Advance registration is 
not required.

BACKGROUND AND OBJECTIVES

To focus attention on the agents that pose great risks in the event of a 
bioterrorist attack, the NIAID compiled a list of the Category A, B, and C 
priority pathogens (http://www.niaid.nih.gov/biodefense/bandc_priority.htm).  
A strategic plan defining short and long-term goals aimed at protecting the 
United States against attacks using these agents was developed in consultation 
with a Blue Ribbon Panel on Bioterrorism and Its Implications for Biomedical 
Research (http://www.niaid.nih.gov/biodefense/research/strat_plan.htm).  The 
NIAID strategic plan emphasizes basic and translational research that will 
lead to the development of new diagnostics, therapeutics and vaccines.

The Blue Ribbon Panel further identified a critical need to expand the 
availability of research resources to support implementation of the Biodefense 
Research Agenda of NIAID.  Since a major challenge in meeting the goals of the 
Agenda is the serious shortage of high-containment laboratories, NIAID has 
established the Regional Biocontainment Laboratories Construction Program.  
The objective of this Program is to build new, stand-alone, state-of-the-art 
laboratory facilities to expand the national capacity to conduct biomedical 
research requiring BSL-3 biocontainment.  Funds will be provided to support 
programming, design, construction, commissioning, and installation of fixed 
equipment into new, comprehensive biocontainment facilities containing BSL-3 
laboratories, BSL-2 laboratories, vivarium, and research support 
(administration, operations, etc.) space.  The RBLs must include small animal 
facilities and must meet minimum size requirements (see below).  GLP 
compliance capabilities are encouraged, as are facilities to conduct non-human 
primate studies and aerobiology.  These RBL facilities are intended to provide 
support for NIAID-funded research in biodefense and emerging infectious 
diseases, and are to serve as a regional resource to all NIAID-approved 
research organizations in the area.  The RBLs also will participate in the 
NIAID Biodefense Network, and must be available and prepared to support public 
health efforts in the event of a biodefense emergency.  

The NIAID Biodefense Network is comprised of the Regional Centers of 
Excellence for Biodefense and Emerging Infectious Diseases (RCEs), as well as 
the National and Regional Biocontainment Laboratories (NBL/RBLs).  Awards were 
made in 2003 to establish eight RCEs 
(http://www.niaid.nih.gov/biodefense/research/rce.htm).  Each RCE consists of 
a consortium of universities and complementary research institutions serving a 
particular geographical region.  The RCEs support research and development 
activities that promote scientific discovery and translational research to 
create the next generation of therapeutics, vaccines, and diagnostics for the 
NIAID Category A, B and C priority pathogens.  In 2003, NIAID also awarded 
funds for the construction of two National Biocontainment Laboratories (NBLs) 
and nine Regional Biocontainment Laboratories (RBLs) 
(http://www.niaid.nih.gov/biodefense/research/rblnbl_awards.htm).  The NBLs 
will serve as a national and regional resource for research on biodefense and 
emerging infectious disease agents that require BSL-4/3/2 biocontainment, 
while the RBLs will serve as a regional resource for research requiring BSL-
3/2 biocontainment.  The NBLs and RBLs will be available to assist public 
health officials in the event of a bioterrorism emergency.  Participants in 
the NIAID Biodefense Network will include NIAID Program staff, and 
representatives from the RCEs, NBLs, and RBLs.  The Network will help define 
the direction and scope of biodefense and emerging infectious disease research 
activities within the RCEs and NBL/RBLs, with centralized coordination through 
the RCE Program Office at NIAID.  The current solicitation will augment the 
Network by providing additional BSL-3 biocontainment capacity to support the 
NIAID biodefense and emerging infectious diseases research efforts, however 
association with an RCE is not required.  

MECHANISM OF SUPPORT

This RFA will use the NIH Construction Cooperative Agreement (UC6), an 
"assistance" mechanism, rather than an "acquisition" mechanism, in which 
substantial NIH scientific and/or programmatic involvement with the awardee is 
anticipated during the performance of the activity. The applicant will be 
solely responsible for planning, directing, and executing the proposed 
project. This RFA is a one-time solicitation.  The anticipated award date is 
August, 2005. 

The NIH UC6 is a cooperative agreement award mechanism in which the Principal 
Investigator retains the primary responsibility and dominant role for 
planning, directing, and executing the proposed project, with NIH staff being 
substantially involved as a partner with the Principal Investigator, as 
described under the section "Cooperative Agreement Terms and Conditions of 
Award".  This RFA uses just-in-time concepts and non-modular budgeting 
formats.  This program does require cost sharing as defined in the current NIH 
Grants Policy Statement at 
http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.  The total 
project period for applications submitted in response to this RFA may not 
exceed five years.

FUNDS AVAILABLE 

The NIAID intends to commit approximately $125 million in FY 2005 to fund 5 to 
8 new awards in response to this RFA.  Only applications requesting funds to 
build stand-alone facilities at a single site will be considered responsive to 
this RFA.  An applicant may request a project period of up to 5 years (with 
all funds to be obligated within 5 years of the date of award).  No facilities 
and administrative (F&A) costs will be awarded.  NIAID will not provide 
funding to support the operation of the facility.  Because the nature and 
scope of the proposed facility will vary from application to application, it 
is anticipated that the size and duration of each award will vary.  Each award 
will have a Federal share of $15 to $25 million.  Matching funds of at least 
25% of the total allowable costs of the project must be provided by the 
applicant institution.  Although the financial plans of the NIAID include 
support for this program, awards pursuant to this RFA are contingent upon the 
availability of appropriated funds, NIAID appropriations authority provided at 
the discretion of Congress, and the receipt of a sufficient number of 
meritorious applications.  At this time, it is not known if this RFA will be 
reissued. 

ELIGIBLE INSTITUTIONS

The applicant may submit (an) application(s) if the institution has any of the 
following characteristics: 
o Non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories

Foreign and Federal institutions are not eligible to apply.  
Current NBL and RBL awardees are not eligible to apply.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed project is invited to work with his/her institution to 
develop an application for support. Individuals from underrepresented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs.  It is advisable that the Principal 
Investigator be a highly placed institutional official, at the level of Dean 
or equivalent, who has responsibility and authority for research activities at 
the applicant organization, as well as the authority to commit institutional 
funds and resources.

SPECIAL REQUIREMENTS

1. Sources of Funding:  A description of the anticipated sources of the non-
Federal funding for the project (both matching funds and funds needed to 
complete the total project) must be provided with the application, including a 
letter from an appropriate institutional official (authorized to commit funds 
at the institution) committing the matching funds and assuring that they will 
be “in-hand” prior to an award.  The minimum match requirement will be $1 
(awardee) to $3 (Federal).  Only applications proposing a Federal share of $15 
to 25 million will be accepted.  No facilities and administrative (F&A) costs 
may be requested, nor will any facilities and administrative costs be awarded.  
Organizations may contribute more than the required matching funds to allow 
for larger projects.  Existing assets may not be used as matching funds; 
examples of unallowable existing assets include the value of currently owned 
land, land acquisition costs, existing infrastructure, existing buildings, 
equipment, and off-site improvements (see unallowable costs, 
http://grants.nih.gov/archive/grants/policy/nihgps_2001/part_iib_1.htm).  

2. Overall Facility Requirements:  The proposed facility must be a stand-alone 
comprehensive research laboratory building at a single site with a single 
project footprint.  It must have a minimum size of 30,000 gross square feet 
(GSF) that will provide flexibility and adaptability in meeting the needs of 
the NIAID Biodefense Agenda.  The RBL must incorporate defined public, 
laboratory, vivarium (limited to small animal and non-human primate 
facilities), and support zones including appropriate research, information 
technology, administrative support, and conference space.  Additions to 
existing buildings, completion of uninhabitable “shell” space in new or 
existing buildings, and major alterations and renovations are not allowed.  
Major renovations and alterations may be funded through other initiatives 
(http://www.ncrr.nih.gov/resinfra/ri_rfip.asp).  The acquisition and 
installation of fixed equipment, such as casework, fume hoods, large 
autoclaves, or biological safety cabinets, is allowed.  

3. Animal Facility Requirements:  High-level biocontainment animal facilities 
for multiple small species are required, while those for non-human primate 
models are encouraged.  The facilities must be planned and designed to allow 
for maximum flexibility and adaptability for protocols requiring work with 
both infected and uninfected animals.  The facilities shall include all 
required program spaces to support the mission of the RBL, i.e., animal 
holding areas, procedure rooms, surgical suites, necropsy room, and all other 
required vivarium support such as a cage wash, autoclaves, a tissue digester, 
food and bedding storage, medical pathological waste storage, and a 
loading/receiving area; as appropriate.  The design also should include BSL-2 
laboratory space, as appropriate, to support the BSL-3 laboratories.  
Facilities to conduct aerobiology work and capability for GLP compliance also 
are encouraged.  Facilities for large animals (bovine, equine, ovine, etc.) 
and BSL-3AG facilities will not be supported.  

4. Overall Facility Design:  The RBL design should maximize operational 
effectiveness, efficiency and space utilization, and create a high-quality, 
state-of-the-art work environment that is appropriate for biomedical and 
microbial research.  The facility must be reliable, adaptable, and 
sufficiently flexible to serve multiple users and their unique user 
requirements related to biocontainment, and should accommodate changing future 
research needs.  

5. Utilities Infrastructure:  The existing site utilities infrastructure must 
be adequate to ensure reliability in supporting the proposed facility.  
Emergency and standby power and 100% redundant mechanical, electrical, and 
plumbing systems must be provided to meet the safety needs of the occupants 
and the surrounding community.  The redundancy requirement includes site 
utilities, primary mechanical and electrical equipment, and distribution 
systems.  Each piece of equipment and its related components should be capable 
of being totally isolated from the remaining operational units to accommodate 
routine maintenance and emergency repairs, as well as designed to ensure 
continuous operation during equipment failure and scheduled maintenance 
outages.  The equipment serving these systems shall be designed to a minimum 
of "N+1" redundancy.  Piping systems shall be designed for flexibility and 
have redundant components and risers to provide reliable and continuous 
operation.  Emergency/stand-by generators and distribution systems must be 
provided to support the intended use and critical nature of the facility.

6. Security System Requirements:  Biocontainment facilities and research 
support laboratories must be designed to maximize safety in the work space and 
surroundings.  Stringent security and access control must be provided for the 
building and coordinated with existing security system infrastructure and 
operations, as appropriate.  The NIAID’s primary security objectives for the 
RBL program are the safety and protection of the general public and 
environment, security of the select agents, and preserving the integrity of 
biocontainment.  The safety and security of personnel; protection of the 
property, research and animals; and potential damage or destruction to the 
facility, must all be addressed.  It is the awardee’s responsibility to ensure 
that these objectives are satisfied.  In preparation for submitting an 
application, the applicant institution should conduct a preliminary security 
assessment to be utilized in developing security measures for the proposed 
building.  

Post-award, each grantee will be required to perform a site-specific and 
project-specific Threat and Risk Assessment (TRA) to develop a security plan.  
This TRA shall include using the services of a qualified TRA professional. The 
TRA will become the basis for addressing individual security issues. The TRA 
should identify and quantify potential threats, both internal and external to 
the building, its contents, the personnel working in it, and the general 
public. The analysis should include a thorough examination and evaluation of 
the physical aspects of the proposed facility, along with operational issues.  
Based on the TRA, the awardee shall establish security measures to ensure that 
the security objectives of the NIAID’s National Biodefense Program are 
achieved.  A copy of the TRA along with a list of the proposed security 
measures shall be submitted to the NIAID.

The security measures, as established by the TRA, for each RBL will be 
incorporated into the design and operation plan for the facility. The NIAID 
will review these documents during the regular design submittals for 
compliance.  NIAID also will monitor construction and the certification 
process for conformance with the security measures established by the awardee 
to assure the facility is safe and secure when completed and in operation.  

7. Requirements for Meeting Local, State and Federal Codes and Guidelines:  
Design features shall meet or exceed: current codes (local, state, Federal); 
current certification standards; standards in the latest version of the NIH 
Design Policy and Guidelines 
(http://orf.od.nih.gov/policy/pdf/NIHDesignManual_6.04.pdf); biosafety requirements 
and standard procedures found in the CDC/NIH Biosafety in Microbiological and 
Biomedical Laboratories (BMBL), most current edition 
(http://bmbl.od.nih.gov/); and the requirements resulting from the Select 
Agent Rule and related issues 
(http://www.niaid.nih.gov/dmid/select_agent/default.htm).  Plans must provide 
facilities that will allow for adherence to the most stringent interpretation 
of the BSL-3 biosafety requirements in the BMBL.  The design must allow for 
work with radioactive isotopes in accordance with applicable rules and 
standards.

8. The awardee institution must work effectively, efficiently and in a 
cooperative manner with government personnel, government contractors and all 
necessary subcontractors (e.g. architect/engineers, designers, general 
contractors, consultants, construction managers) involved in development, 
planning, design, construction and commissioning activities to complete the 
project on an aggressive schedule, as approved by NIAID.  Consistent with 
applicable laws and award terms, the project will be completed at the most 
reasonable cost to the government by bringing the best available commercial 
practices to the project in collaboration with NIAID.

9. Design Review and Approval Process:  Following award notification, the 
awardee will begin a process of design review and approval with NIAID program 
staff and other designated NIH personnel.  This process consists of the 
following required stages of design document submission.
a.  programming, schematic design (15%), and basis of design 
documentation
b.  design development (35%)
c.  construction document (75%)
d.  final construction document (100%)
Approximately twenty sets each of documentation will be required at each stage 
of design document submission.  Additionally, a formal conceptual design (15%) 
presentation will be required.
For each submission stage, the documents will include detailed cost estimates 
that are required for final review and approval by NIAID staff before bids and 
proposals can be solicited by the awardee for the construction activities of 
the project.  Advertisement for construction bids and construction may be 
initiated only after approval of the final construction documents (100%) by 
NIAID staff.  Please note that the NIAID must approve any plans that include a 
construction management contract with a guaranteed maximum price (GMP) clause.  
In addition, advertisement for construction bids and construction can be 
initiated only after receipt of the construction grant award and subsequent 
approval of the working drawings and specifications by NIH staff.  Early in 
the project development process, applicants are encouraged to review the NIH 
Grants Policy Statement 
(http://grants.nih.gov/archive/grants/policy/nihgps/policy_stmt.htm).  The sections 
related to public policy requirements and construction (i.e., Part III) are 
particularly relevant.  Consistent with NIH policy, no requests to initiate 
construction will be entertained prior to receipt of a construction award from 
NIH and subsequent approval of working drawings and specifications by NIAID 
staff.

10. The RBL shall be commissioned in accordance with the NIH Model 
Commissioning Guide: 
http://des.od.nih.gov/eWeb/research/farhad2/Commissioning/nih_cx_guide/ComGuideTitle.htm.

11. Facility Usage Requirements:  The facility must be utilized for biomedical 
research purposes as determined by NIAID program needs for at least 20 years 
beginning 90 days following the completion of the project.  Any land lease 
agreement must cover a time period sufficient for the usage requirement and be 
a minimum of 20 years in length from the completion of the facility.  Federal 
interest in the facility must be acknowledged as a condition of this award.  
An annual progress report is required for 20 years and must include a list of 
publications “originating from the use” of this facility.  This list should be 
limited to those scientific papers acknowledging NIAID support including 
grant/or contract numbers.  Failure to comply with the 20-year utilization 
requirement will result in recovery of the Federal share of the value of the 
facility in accordance with Federal Regulations at 45 CFR 74.32.  The NIAID 
will not provide funds for the operation of the facility.  Additionally, RBLs 
must be ready and available to provide facilities, scientific support and 
expertise to first-line responders and be available and prepared to support 
public health efforts in the event of a national biodefense or emerging 
infectious diseases emergency.

12.  Community Relations Plan:  The RBL applicants must have a plan to 
establish and maintain a strong community relations effort throughout the 
planning, design, construction and operation of the facility.   Proactive 
positive relations will be developed and maintained with the research 
community, the award recipient’s community, surrounding residential/commercial 
communities, and the general public throughout the application process, 
construction and operation of the facility.  A detailed description of the 
plan must be provided as part of the application.

13. Research Base:  The applicant organization must be associated with 
investigators funded by NIAID to conduct biodefense and emerging infectious 
diseases research and training.  Association with an existing RCE is not 
required.  Applications should document a research base of currently funded 
and/or planned research activities and the involved personnel and institutions 
that will make use of the proposed biocontainment facilities.  This may 
include a consortium of institutions, including industry partners.  However, 
there can be only one applicant institution, which will be responsible for 
construction, ownership, and operation of the facility under this RFA.

14. NIAID Biodefense Network Participation:  RBLs will participate in the 
NIAID Biodefense Network, which consists of the NIAID Regional Centers of 
Excellence for Biodefense and Emerging Infectious Diseases Research Program, 
the National Biocontainment Laboratories, and the Regional Biocontainment 
Laboratories.  Representatives will be required to attend regular meetings of 
Network members, and additional meetings, as needed, in the event of a 
bioterrorism emergency.

15. Site Visits:  The NIH reserves the right to conduct site visits when 
deemed necessary.  This may include site visits during the application 
evaluation process, post-review and prior to award, during the design and 
construction process, and during operation of the laboratory.  Alternatively, 
or in addition, visits to NIH by representatives of the awardee institution 
may be required.  Any site visits may involve other government officials or 
contractors representing NIH.

16. National Environmental Policy Act Requirements:  The National Institutes 
of Health (NIH) is required to follow The National Environmental Policy Act 
(NEPA) process for any major action that utilizes federal funds or federal 
property.  Due to the nature of these projects, the NIH is requiring the 
applicants to complete and submit the NIH NEPA checklist.  The determination 
of whether an Environmental Impact Statement (EIS) or Environmental Assessment 
(EA) is completed, or No Further Action is required, is the responsibility of 
NIH. The NIH will have full review, recommendation, and approval of the 
process and/or reports; however, the awardee will be required to initiate the 
environmental review and provide backup documentation. The NIH will act as a 
source of reference and assistance in the procedures and retains the final 
decision for the NEPA process.
 
The NIH will assess the level of environmental impact of proposed projects 
using the information submitted as described in 
http://www.niaid.nih.gov/biodefense/research/enviroanalysis.pdf.  All 
applications must be accompanied by an analysis; applicants may use the 
suggested sample format.  The analysis is intended to convey available 
environmental information with the initial grant application and does not 
require expenditure of funds for extensive consultant services prior to a 
grant award.  Therefore, the hiring of special consultants for developing 
detailed data and elaborate presentations is discouraged.   
 
The analysis should be accompanied by a current listing of all relevant 
licenses, permits, and/or other approvals required.  Copies of all such 
documents should be submitted with the environmental analysis. This would 
include, but not be limited to, the state and local air, water quality, and 
zoning board reports. Also, indicate the state, local, and regional planning 
authorities contacted or consulted regarding the application and briefly 
discuss the proposed facility with respect to regional development plans.  The 
awardee will complete any further required environmental assessments or impact 
statements as determined by the NIH.

17. State and Local Government Review Requirements:  Applicants are required 
to comply with Executive Order (E.O.) 12372 as supplemented by DHHS 45 CFR 
Part 100, Intergovernmental Review of Department of Health and Human Services 
Programs and Activities.  E.O. 12372 sets up a system for State and local 
government review of proposed Federal assistance applications.  Applicants 
(other than federally-recognized Indian tribal governments) should contact 
their State Single Point of Contact (SPOCs) as early as possible to alert them 
about the prospective application and receive any necessary instructions on 
the State process. (See http://www.whitehouse.gov/omb/grants/spoc.html.)   For 
proposed projects serving more than one State, the applicant is advised to 
contact the SPOC of each affected State.  The SPOC must be given at least 60 
days to review a construction grant application.

Applicants are to provide the SPOC with a copy of the application NOT LATER 
THAN the time the application is submitted to the Center for Scientific 
Review, NIH.  Include, as appendix material to the application, all comments 
received from the SPOC during pre-application coordination.  Applications 
submitted to NIH in response to this solicitation must contain either SPOC 
comments or documentation indicating the date on which the application was 
submitted to the SPOC for review.

The SPOC comment period ends 60 days after the application receipt date.  The 
granting agency does not guarantee to "accommodate or explain" for State 
process recommendations it receives after that date.  All SPOC comments must 
be forwarded to the applicant and to the NIAID fiscal contact given in the 
RFA.  If comments are provided by the SPOC, the applicant may wish to submit 
to the NIH a statement of its reaction to the comments and any appropriate 
changes to its application.  If no response is received from the SPOC by the 
end of the 60 days allotted for review of the application, the applicant must 
notify the NIH that no response was received.

18. Public Disclosure Requirements:  Applicants also must make a public 
disclosure of the project by publication and describe its environmental impact 
at the time the SPOC is notified.  It is suggested that the notice be 
published in a large-circulation newspaper in the area.  This public 
disclosure is required by Section 102 of the National Environmental Policy Act 
(NEPA) of 1969 and by Federal Executive Order 11514.

One example of a suitable disclosure statement follows; however, the choice of 
presentation is at the discretion of the applicant:

"PUBLIC NOTICE"

"Notice is hereby given that the Uptown Medical School proposes to construct 
additional space, partially utilizing Federal funds. The proposed construction 
project is the addition of 2,700 square feet connected to the existing Allen 
Building, which is located at 5333 Main Street, Downtown, Ohio.

"The Medical School has evaluated the environmental and community impact of 
the proposed construction. There will be construction noise and increased 
construction traffic during the construction period. No significant permanent 
environmental impacts are foreseen. All building permits and zoning approvals 
have been obtained.  "In accordance with Federal Executive Order 11514, which 
implements the NEPA of 1969, any individual or group may comment on, or 
request information concerning, the environmental implications of the proposed 
project. Communications should be addressed to the Office of Planning, Uptown 
Medical School, and be received by (date). The Federal grant application may 
be reviewed at the Office of the Dean, School of Medicine, 5333 Main Street, 
during working hours."

COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD

The following terms and conditions will be incorporated into the award 
statement and provided to the Principal Investigator as well as the 
institutional official at the time of award.

These special Terms of Award are in addition to, and not in lieu of, otherwise 
applicable OMB administrative guidelines, HHS Grant Administration Regulations 
at 45 CFR part 74 and 92, and other HHS, PHS, and NIH Grant Administration 
policy statements.

The administrative and funding instrument used for this program is the 
Construction Cooperative Agreement (UC6), an "assistance" rather than an 
"acquisition" mechanism, in which substantial NIH scientific and/or 
programmatic involvement with the awardee is anticipated during the 
performance of the activity. Under the cooperative agreement, the NIH purpose 
is to support and/or stimulate the recipient's activity by involvement in and 
otherwise working jointly with the award recipient in a partner role, but it 
is not to assume direction, prime responsibility, or a dominant role in the 
activity. Consistent with this concept, the dominant role and prime 
responsibility for the activity resides with the awardees for the project as a 
whole, although specific tasks and activities in carrying out the research 
will be shared among the awardees and the NIAID Program Coordinator.

1. Awardee Rights and Responsibilities

a.  Awardees will have primary responsibility for the project as a whole, 
including all phases of design and construction, and working with NIH staff 
and contractors as needed.

b.  Awardees agree to participate in projects identified by the NIAID 
Biodefense Network that include common research interests and address a 
specific biodefense problem or threat.

c.  The Principal Investigator must attend and participate as a voting member 
in regular meetings of the NIAID Biodefense Network to discuss progress and 
directions of research and to ensure that overall NIAID Biodefense Agenda 
goals are being met.

d.  The Principal Investigator must participate, as needed, in regular, local 
meetings of the RBL and its research partners to discuss progress and 
directions of research and to ensure that the necessary interdisciplinary 
interactions are taking place.  Additionally, the Principal investigator must 
ensure that the facilities of the RBL are utilized to the fullest extent 
possible and that procedures remain in place to make facilities available to 
qualified users in the region.

e.  Each RBL will submit an annual progress report to the NIAID that describe 
activities and accomplishments during the previous funding/reporting period 
and attend an annual program meeting.

f.  All awardees must adhere to the Principles and Guidelines for Recipients 
of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical 
Research Resources (64 Federal Register 72090).
The Principles and Guidelines can be accessed electronically at: 
http://ott.od.nih.gov/.

2. NIAID Program Staff responsibilities: 

a.  The role of NIH staff in the cooperative agreement arrangement is to 
support and stimulate the recipient's activities by substantial involvement as 
facilitators in the process without assuming responsibilities that remain with 
the Principal Investigator.  The RBL Program Staff members from the NIAID 
Division of Microbiology and Infectious Diseases assigned to each RBL as NIAID 
Program Coordinator(s) will work closely with the Principal Investigator to 
develop and approve plans for construction of the facility, facilitate the 
collaborations with other NIAID-funded research groups and to leverage the 
resources available in the RBL.  

b. The NIAID Program Coordinator(s) will monitor the progress of the RBL 
program, assist in coordinating activities between the RBLs, and contribute to 
the adjustment of research projects or approaches as warranted. The NIAID 
Program Coordinator(s) will assist and facilitate this process and not direct 
it.  The NIAID Program Coordinator(s) will also provide assistance with all 
major transitional changes of RBL activities prior to implementation to assure 
consistency with the overall goals of the RBL Program and the NIAID biodefense 
mission.  When appropriate, issues may be brought to the NIAID Biodefense 
Network for discussion.

c. The NIAID RBL Program Coordinator(s) will assist in organizing an annual 
meeting of investigators from all funded RCE/RBL/NBLs to share progress and 
research insights that may benefit all of the projects. 

d. Other NIAID staff will be responsible for normal program stewardship and 
monitoring of award.

3. Collaborative responsibilities:

a. The NIAID Biodefense Network will provide overall scientific coordination 
of the RBL Program; RCE Principal Investigators, Directors of the RBL/NBLs, 
and the NIAID two RCE/NBL/RBL Program Coordinator(s) will be members. 
Additional NIAID Program Staff and scientists other than Principal 
Investigators may attend as non-voting members of the committee, when 
additional expertise may be required.

b. The NIAID Biodefense Network will meet at least once a year, or as needed 
in the event of a bio-terrorism emergency event.  The purpose of these 
meetings is to share scientific information, to assess scientific progress, to 
identify new research and development opportunities and potential avenues of 
collaborations such as with industry, private foundations, NIH intramural 
scientists, and other federal government agencies, and to establish priorities 
that will accelerate the translation of preclinical findings into clinical 
applications, reallocate resources and conduct other business of the 
RCE/RBL/NBL Programs.

c. The Network will be called upon to make recommendations regarding 
approaches to specific threat agents and emerging infectious diseases that 
require new attention as the need arises.  The Network will seek input from 
the scientific research communities, and assist the NIAID in determining 
initiatives that will have an impact on the health and safety of the nation.  
The Network will also provide a forum for coordinating RCE/RBL/NBL activities 
that require a liaison function with other federal agencies such as FDA, USDA, 
and CDC.

4. Arbitration

Any disagreement that may arise on scientific/programmatic matters (within the 
scope of the award), between award recipients and IC may be brought to 
arbitration. An arbitration panel will be composed of three members – one 
chosen by the awardee, a second member selected by the IC, and the third 
member selected by the two prior selected members. This special arbitration 
procedure in no way affects the awardee's right to appeal an adverse action 
that is otherwise appealable in accordance with the PHS regulations at 42 CFR 
Part 50, Subpart D and HHS regulation at 45 CFR Part 16.

These special Terms of Award are in addition to and not in lieu of otherwise 
applicable OMB administrative guidelines, HHS Grant Administration Regulations 
at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant Administration 
policy statements.

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA and welcome the opportunity to 
answer questions from potential applicants. Inquiries may fall into several 
areas: design/construction, scientific/research, peer review, and financial or 
grants management issues.

It is highly recommended that appropriate NIAID program staff be consulted 
before submitting the letter of intent and during the early stages of 
preparation of the application. (See program contacts under INQUIRIES).
o Direct questions about design/construction issues to:

Nancy Boyd
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room 5015, MSC-6603
6610 Rockledge Drive
Bethesda, MD  20892-6603
Telephone:  (301) 402-8585
FAX:  (301) 480-1263
Email: nb142q@nih.gov

o Direct questions about scientific/research issues to:

Alicia Dombroski, Ph.D.
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room 5005, MSC-6603
6610 Rockledge Drive
Bethesda, MD  20892-6603
Telephone:  (301) 402-8561
FAX:  (301) 480-1263
Email: ad211y@nih.gov

o Direct questions about peer review issues to:

John Bogdan
Division of Extramural Activities 
National Institute of Allergy and Infectious Diseases
Room 3258, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Telephone:  (301) 402-7372
FAX:  (301) 402-2638
Email:  jb753c@nih.gov

o Direct questions about financial or grants management matters to:

Lesia Norwood
Division of Extramural Activities 
National Institute of Allergy and Infectious Diseases
Room 2117, MSC-7614
6700-B Rockledge Drive
Bethesda, MD 20892-7614
Telephone:  (301) 402-7146
FAX: (301) 480-3780
Email: ln5t@nih.gov

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes 
the following information:

o Descriptive title of the proposed project
o Name, address, e-mail address, and telephone number of the Principal 
Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA

Although a letter of intent is not required, is not binding, and does not 
enter into the review of a subsequent application, the information that it 
contains allows NIAID staff to estimate the potential review workload and plan 
the review.

The letter of intent is to be sent by the date listed at the beginning of this 
document. The letter of intent should be sent to:

John Bogdan
Division of Extramural Activities 
National Institute of Allergy and Infectious Diseases
Room 3258, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616 (20817 for express mail or courier service)
Telephone:  (301) 402-7372
FAX:  (301) 402-2638
Email:  jb753c@nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using Standard Form (SF) 424 and 424C 
(http://www.whitehouse.gov/omb/grants/grants_forms.html), as well as continuation pages 
and other materials described in the supplementary instructions noted below. 
Complete the application following the instructions included with the 424 
application form, except as noted below.  Applications must have a DUN and 
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the 
Universal Identifier when applying for Federal grants or cooperative 
agreements. The DUNS number can be obtained by calling (866) 705-5711 or 
through the web site at http://www.dunandbradstreet.com/. The DUNS number 
should be entered in item 5 on the SF424 cover page. The PHS 398 document is 
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an 
interactive format. For further assistance contact Grants Info, Telephone 
(301) 435-0714, Email: GrantsInfo@nih.gov.

SUPPLEMENTARY INSTRUCTIONS: The sections of the application must be presented 
and numbered in the following order:

1.  SF 424 Face-sheet (page 1 of the application)

Item 5. Person to be contacted - Identify the Principal Investigator. The 
Principal Investigator should be an institutional official, at the level of 
Dean or equivalent, who has the responsibility for allocation of space and 
resources for the project addressed in this application, and can provide the 
necessary assurances and commitments.  In addition, an institutional business 
official contact should also be provided, as described in Section 5, below, of 
these instructions, "Budget (Additional information required)."

Item 9. Enter "National Institutes of Health."

Item 10. Program - The CFDA number for this program is 93.389; Type "NIH 
Construction" as the title.

Item 11. Descriptive Title of Applicant's Project; Enter " RFA-AI-04-032  
Regional Biocontainment Laboratory.”  

Item 13. Enter xx/xx/2005 through xx/xx/20xx.  The entire project period may 
not exceed five years.

Item 15. Estimated Funding -
a. Enter the amount from item 17 on application page SF 424C.  A Federal share 
of $15 million to $25 million is required.
b. Applicant: Use this line to indicate the difference between item 15a. above 
and 15g. below.
g. TOTAL: Enter the amount shown on line 16, column "a" on page SF 424C.

Item 16. The research facilities construction programs of the NIH are subject 
to Executive Order 12372. 

2.  SF 424C, Budget Information (Page 2 of the application)

Note that costs associated with purchase of land or offsite improvements are 
not eligible for Federal funding, nor may these costs be used to satisfy 
matching requirements under this initiative 
(http://grants.nih.gov/archive/grants/policy/nihgps_2001/part_iib_1.htm).  
Line 10. Equipment -Enter the total cost of only fixed equipment such as 
cabinets, sinks, fume hoods, and other built in equipment items that are 
essential to this project. 

Line 11. Miscellaneous -Enter the amount requested for all other costs in the 
appropriate columns.

Line 13. Contingencies - The PHS allowable contingency is limited to five 
percent of the eligible project costs as defined above. The contingency fund 
is established to provide for unforeseen problems. Following the award of the 
construction contract by the grantee institution, the PHS funded contingency 
is reduced to two percent of the eligible project costs.

Line 17. Federal Assistance Requested. The Federal percentage share is up to 
75 percent for all applications submitted in response to this RFA.  However, 
the amount of Federal assistance requested may not be less than $15 million or 
more than $25 million.

3.  Table of Contents (page 3 of the application)

4.  Program Overview (page 4 of the application.)

Provide a concise (250 words or less) overview description of the proposed 
project stating long-term objectives and specific aims.

5.  Budget (additional information required)

Use a blank continuation sheet(s) to provide the following information which 
should be numbered beginning as Page 5 of the application.

Indicate the composition of funds shown in Item 15.b. on the SF 424 face-sheet 
broken down as follows:

(1) bonds authorized but not yet sold; (2) net amount of cash available free 
from claims; (3) cash value of pledges already made but unpaid (i.e., the face 
value) and the amount for which the pledges can be discounted by a bank or 
lending agency (i.e., the discounted value). A statement from the bank or 
lending agency should be attached giving the bank's estimate of the discounted 
value of the pledges; (4) total amount of contingent gifts and bequests with a 
description of the contingency; and (5) other proposed methods of applicant 
financing.

This section should sufficiently detail the source(s) of non-Federal funding 
for the project (both matching funds and those funds that are necessary to 
complete the total project). An applicant must provide an assurance that 
required matching funds are available, and that additional funds have been 
secured to meet project costs in excess of the Federal award and non-Federal 
matching amounts before an award may be made.

Provide an itemized listing of the costs included on Line 11, Miscellaneous, 
on Form Page SF424C.

Include a detailed justification of the cost of the construction, providing 
precise cost estimates and vendor quotes when available. 

6. Biographical Sketches

Using the Biographical Sketch format & instructions provided in the PHS 398 
(http://grants.nih.gov/grants/funding/phs398/phs398.html) provide biographical 
sketches (2 pages) for the Principal Investigator and key personnel for this 
project.  Do not provide biosketches for anticipated users of the facilities. 

7. Description of Planned Facility and Design Plan Justification ( weight:  
65%)  

The following information about the facility design must be included: 

a. Provide a functional layout of the proposed facility including conceptual 
drawings to show: the location of the proposed facility in relation to 
existing buildings and research facilities at the institution, (indicate all 
building names and addresses); existing utility infrastructure as well as new 
utility infrastructure required to support the proposed facility; and the 
layout of each laboratory, office, animal room, or other space including 
entries and exits, clearances, and location of fixed equipment items such as 
hoods and autoclaves. Generic laboratory descriptions are not sufficient for 
technical evaluation. The plans must indicate biosafety level (e.g., BSL-2 or 
BSL-3) and utilization of space by name or by specific function, e.g., 
instrument room.  Safety and security features must be indicated clearly in 
the design, as well as egress routes and the relationship of rooms.  All 
related specialized facilities and the location of major equipment must be 
shown.  The conceptual plans must be supported by sufficient descriptions and 
information to allow evaluation of plans regarding:  laboratory design, animal 
facility design, architectural, structural, mechanical, plumbing, electrical, 
fire safety, research computer, security/surveillance and building automation 
systems. 

The line or schematic drawing(s) must be easy to read, no larger than 8-
1/2"x11", and reproducible by photocopy or similar process.  Scales must be 
clearly indicated on all line drawings. Legibility of the drawings is 
important.  Architect's design development documents and drawings will be 
requested ONLY if a decision is made to fund the project.  They should NOT be 
submitted with the application.  The appropriateness of the proposed physical 
location and layout of the new facility will be evaluated by scientific and 
technical reviewers. 

b.  A table showing:
o The net square feet in the proposed facility with breakdown by function and 
biosafety level. The format should encourage the identification of space in 
relation to the science and the program activity. Where this is not possible, 
space may be identified as animal research areas (examination rooms, etc.), 
equipment areas, or centralized/core facilities. 
o The gross square feet of the new facility.
o A summary of space by room type (basic research, office space, etc.).

Use the AIA Document D101 Method for Calculating the Areas and Volumes of 
Buildings (American Institute of Architects, 1735 New York Avenue, N.W., 
Washington, DC 20006-5292).

c.  An itemized listing of fixed equipment including cost.

d.  Design Plan Justification (maximum of 10 pages of text)
Include written statements that provide justification for the space 
allocations and descriptions of design features for each type of laboratory 
space/area included for the project (BSL-3 facilities, BSL-2 facilities, 
animal facilities, etc.).  

e.  Projected Time Line 
Provide a proposed timetable with milestones and associated costs for the 
project.

8.  Project Strategic Plan (weight:  35%; maximum of 20 pages of text)  

This section must clearly describe the scientific rationale and justification 
for the proposed facilities, the organizational structure of the institution 
with specific attention to who will be responsible for this project, and 
management plans for the design, construction and operation of the RBL. This 
section has the purpose of providing NIAID staff and the reviewers with the 
information necessary to judge the overall scope and scientific and technical 
merit of the project including examples of research activities that would make 
use of the facility, the appropriateness of the proposed facility for 
supporting those activities, and the capability of the applicant to pursue the 
project successfully.  

The major sections of the narrative must address the following points:

a.  Provide an organizational chart of the institution and accompanying 
description that defines the administrative authority of the applicant 
organization as related to the conduct of this construction project and 
subsequent operations of the facility.  Include an overall plan for the 
management of the facility construction that describes plans for prioritizing, 
scheduling and granting access to the facility to investigators in the region, 
for training personnel to work in the biocontainment facilities, and for 
fiscal management of the operation of the facility.

c. Describe how the facility would support NIAID-funded biodefense and 
emerging infectious diseases research.  Provide succinct descriptions of 
specific funded or planned research activities/projects that will benefit 
from the proposed construction (a limit of 15 lines per activity/project 
described applies to this section). Do not provide a description of global 
research activities at the institution or consortium.  Include a description 
of regional interactions or relationships that have been established with 
investigators conducting NIAID-funded research in biodefense and emerging 
infectious diseases. Supporting documentation should be provided in the form 
of tables that list current and pending biodefense-related research 
grants/contracts, including the name of the principal investigator, the 
title, and the source, amount of funding, and start and end dates. For funded 
projects, also include the grant/contract number.  

d. Describe how the facility would contribute to the availability of 
biodefense research resources at the institution(s) and in the region/nation.  
Identify unique opportunities for the RBL to contribute to biodefense and 
emerging infectious diseases research, and identify unmet needs that may be 
addressed by the planned resources.

e. Describe how the facility will develop plans for, and serve as, a regional 
and/or national resource and be prepared to respond in the event of a national 
bioterrorism emergency, and how maximum use of the facility will be promoted 
and implemented.

f. Provide a detailed community relations plan outlining initial and ongoing 
community outreach and involvement related to the intended research activities 
to be conducted at the RBL.  Documentation of community outreach must be 
provided to the NIAID before award/construction can begin.  

9.  Applicants must include an opinion from acceptable title counsel 
describing the interest the applicant organization has in the site and the 
building and certifying that the estate or interest is legal and valid. If 
there is a lease, the legal opinion must provide evidence of the existence of 
a lease agreement which covers a time period sufficient for the usage 
requirement (20 years beyond completion or occupancy of the project) and that 
a Federal interest in the building will be recorded for the period of the 
usage requirement. (Refer also to assurances.)

10. Certification 

Provide a written certification that the facility will be utilized exclusively 
for the specific purpose for which it was constructed for at least 20 years 
beginning 90 days following the completion of the project.  Any land lease 
agreement must cover a time period sufficient for the usage requirement and be 
a minimum of 20 years in length from the completion of the facility.  Federal 
interest in the facility must be acknowledged as a condition of this award.  
An annual progress report is required for 20 years and must include a list of 
publications “originating from the use” of this facility.  This list should be 
limited to those scientific papers acknowledging NIAID support including 
grant/or contract numbers.  Failure to comply with the 20-year utilization 
requirement will result in recovery of the Federal share of the value of the 
facility in accordance with Federal Regulations at 45 CFR 74.32.  The NIAID 
will not provide funds for the operation of the facility.  Additionally, RBLs 
must be ready and available to provide facilities, scientific support and 
expertise to first-line responders and be available and prepared to support 
public health efforts in the event of a national biodefense or emerging 
infectious diseases emergency.

11.  Personal Data on Principal Investigator 

Complete and submit the Personal Data form page for the Principal Investigator 
(http://grants.nih.gov/grants/funding/phs398/personal.pdf), following the 
instructions on the form page.  In accordance with the instructions provided 
on the form page, do not attach copies of the Personal Data form page to the 
duplicated copies of the application. Upon receipt of the application by NIH, 
this page is separated from the application and the data, including the SSN, 
are encrypted in the NIH database. A partially completed Personal Data form 
page is acceptable to NIH, i.e., applicants may elect to provide some items 
but not all. (The Social Security Number is requested for the purpose of 
accurate identification, referral, and review of applications and for 
efficient management of PHS grant programs. Provision of the Social Security 
Number is voluntary. No individual will be denied any right, benefit, or 
privilege provided by law because of refusal to disclose his or her Social 
Security Number.)

12.  Appendix Materials

Photographs, oversized documents, or materials that cannot be photocopied in 
the body of the application may be submitted as appendices.  Also include any 
comments received from the SPOC during pre-application coordination.  

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application. Type the RFA number on the label. Failure to use this label could 
result in delayed processing of the application such that it may not reach the 
review committee in time for review. In addition, the RFA title and number 
must be typed on line 2 of the face page of the application form and the YES 
box must be marked. The RFA label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. 

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the Checklist, and three signed, photocopies, in 
one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive
Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)

At the time of submission, two additional exact copies of the grant 
application and all five sets of any appendix material must be sent to:

John Bogdan
Division of Extramural Activities 
National Institute of Allergy and Infectious Diseases
Room 3258, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616 (20817 for express mail or courier service)
Telephone:  (301) 402-7372
FAX:  (301) 402-2638
Email:  jb753c@nih.gov

Applications must be received on or before December 29, 2004.  Applications 
that are not received as a single package on the receipt date will be judged 
non-responsive and will be returned to the applicant.

APPLICATION PROCESSING:  Applications must be received by the application 
receipt date listed in the heading of this RFA.  If an application is received 
after that date, it will be returned to the applicant without review.

The NIH will not accept any application in response to this RFA that is 
essentially the same as one currently pending initial review unless the 
applicant withdraws the pending application. The NIH will not accept any 
application that is essentially the same as one already reviewed. This does 
not preclude the submission of a substantial revision of an unfunded version 
of an application already reviewed, but such application must include an 
Introduction addressing the previous critique.   

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NIAID. 

Incomplete and/or non-responsive applications will be returned to the 
applicant without further consideration or review.

Applications that are complete and responsive to the RFA will be evaluated for 
scientific and technical merit by an appropriate peer review group convened by 
the NIAID in accordance with the review criteria stated below.  As part of the 
initial merit review, all applications will:

o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the National Advisory Allergy and 
Infectious Diseases Council

The NIH reserves the right to conduct site visits or reverse site visits when 
deemed necessary.

REVIEW CRITERIA

The scientific review group will address and consider these criteria in 
assigning the application’s overall score. 

Description of Planned Facility and Design Plan Justification (weight:  65%)

1. Adequacy, feasibility and technical merit of the chosen site; and the plans 
for design, construction and commissioning of the biocontainment facility.  
This includes the plans for specialized facilities such as vivarium (including 
non-human primate facilities), aerobiology, GLP, and other components of the 
RBL.   

2. Adequacy, appropriateness, and suitability of the approaches and methods 
for ensuring safety, security and biohazard control at the proposed 
biocontainment facilities.  This includes plans for maintaining containment, 
waste management, compliance with select agent regulations, and 
safety/security operations plans.

3. Adequacy and feasibility of the plans for the applicant to construct a 
high-level containment facility in a timely manner including the 
reasonableness of the proposed schedule for the construction.

Project Strategic Plan (weight:  35%)

1. Adequacy, feasibility and merit of the proposed administrative and 
organizational structure, administrative arrangements, operations plans, 
financial resources and commitments from institutions within the region to 
meet the objectives of the project.  Adequacy and suitability of the position, 
training, proposed effort, capabilities and experience of the Principal 
Investigator and other proposed key personnel for the management and 
administration of the design, construction, and certification of the proposed 
facility (this does not include evaluation of future personnel who will be 
required to operate and maintain the facility).

2. Scientific/technical merit of the local and regional scientific environment 
with respect to the number and quality of biomedical research investigators 
and their anticipated needs for the facility.  The anticipated effect(s) of 
the proposed construction on existing and future NIAID supported, research 
training and /or research support activities.  Appropriateness of the plans to 
make the RBL and its resources available to investigators and institutions 
throughout the region; to meet current and future local, regional and national 
needs for facilities to support NIAID funded biodefense and emerging 
infectious diseases research; and to function as a regional resource and as 
part of a national response in the event of a biodefense emergency.

3. Adequacy and merit of the proposed community relations plan, including an 
evaluation of the current status and plans for educating and informing the 
community.

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

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human 
subjects and protections from research risk relating to their participation in 
the proposed research will be assessed. (See criteria included in the section 
on Federal Citations, below)
 
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans 
to include subjects from both genders, all racial and ethnic groups (and 
subgroups), and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects will also be 
evaluated. (See Inclusion Criteria in the sections on Federal Citations, 
below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to 
be used in the project, the five items described under Section f of the PHS 
398 research grant application instructions (rev. 5/2001) will be assessed.
  
ADDITIONAL REVIEW CONSIDERATIONS

SHARING RESEARCH DATA: Applicants requesting more than $500,000 in direct 
costs in any year of the proposed research are expected to include a data 
sharing plan in their application. The reasonableness of the data sharing plan 
or the rationale for not sharing research data will be assessed by the 
reviewers. However, reviewers will not factor the proposed data-sharing plan 
into the determination of scientific merit or priority score. (See 
instructions and URL to policy in the Federal Citations, below.)
 
BUDGET:  The reasonableness of the proposed budget and the requested period of 
support in relation to the proposed research.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:      November 29, 2004
Application Receipt Date:           December 29, 2004
Peer Review Date:                   May, 2005
Council Review:                     June, 2005
Earliest Anticipated Start Date:    September, 2005

AWARD CRITERIA

In addition to Scientific and Technical Merit, other criteria that will be 
used to make award decisions include:

o Availability of funds
o Ability to support the desired scope of work
o Programmatic priorities
o Regional distribution of meritorious applications

Prior to award, NIAID may also negotiate to modify the scope of the proposed 
construction project to meet overall program needs.

REQUIRED FEDERAL CITATIONS

ANIMAL WELFARE PROTECTION:  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.

PUBLIC 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 public 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 RFA 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.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals 
for NIH funding must be self-contained within specified page limitations. 
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) 
should not be used to provide information necessary to the review because 
reviewers are under no obligation to view the Internet sites. Furthermore, we 
caution reviewers that their anonymity may be compromised when they directly 
access an Internet site.

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving 
the health promotion and disease prevention objectives of "Healthy People 
2010," a PHS-led national activity for setting priority areas. This RFA 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 Catalogue of Federal Domestic Assistance at 
http://www.cfda.gov/ in the following citation: No. 93.389, NIH Construction.  
Awards are made under authorization of Sections 301 and 405 of the Public 
Health Service Act as amended (42 USC 241 and 284) and administered under NIH 
grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  
The NIH Grants Policy Statement is available at 
http://grants.nih.gov/grants/policy/policy.htm. This document includes general 
information about the grant application and review process; information on the 
terms and conditions that apply to NIH Grants and cooperative agreements; and 
a listing of pertinent offices and officials at the NIH. 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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


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