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/grants/policy/nihgps_2003/NIHGPS_Part2.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/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/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) 710-0267, 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/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
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