PLANNING GRANTS FOR REGIONAL CENTERS OF EXCELLENCE FOR BIODEFENSE AND 
EMERGING INFECTIOUS DISEASES RESEARCH (P-RCE) 

RELEASE DATE:  October 1, 2002 (see amendment NOT-AI-03-005)

RFA:  AI-02-050

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

LETTER OF INTENT RECEIPT DATE:  November 15, 2002 

APPLICATION RECEIPT DATE:  January 15, 2003

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Regional Definitions
o Individuals Eligible to Become Principal Investigators
o Terms and Conditions of Award
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
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 
planning grant applications (U56) to support planning for and development of 
applications (U54) to the Regional Centers of Excellence for Biodefense and 
Emerging Infectious Diseases Research (RCE) Program.
  
The overall goal of this RFA is to support planning, research program 
initiation, and resource acquisition that could lead to the establishment of 
a regional center, whose purpose is to develop and maintain the research and 
development response capacity to rapidly evaluate and counter new 
bioterrorism or emerging infectious disease events.  It is expected that at 
the end of this planning grant, the principal investigator and the team of 
researchers that has been assembled will submit an application for a RCE 
award.

The RCE Program is detailed in RFA AI-02-031.  Briefly, the RCE program's 
goal is to develop and maintain strong infrastructure and multifaceted 
research and development activities that will provide the scientific 
information and translational research capacity to make the next generation 
of therapeutics, vaccines and diagnostics against the NIAID Category A-C 
Agents http://www2.niaid.nih.gov/Biodefense/bandc_priority.htm
with particular emphasis on Category A.  To accomplish this, the Centers will 
be provided with support 1) to develop and conduct programs of investigator-
directed research; 2) to train researchers and other personnel for biodefense 
activities; 3) to develop and maintain comprehensive core facilities to 
support the research and training activities of the RCE; 4) to develop 
translational research capacity for testing and validating vaccine, 
therapeutic and diagnostic concepts for biodefense and emerging infectious 
diseases; 5) to maintain and make available core facilities and other support 
to approved investigators from academia, biotech companies, the 
pharmaceutical industry, and other appropriate entities in the region for the 
purpose of performing basic research and for testing and evaluating vaccines, 
therapeutics and diagnostics for NIAID Category A-C Agents; 6) to be ready 
and available to provide facilities and scientific support to first-line 
responders in the event of a national biodefense emergency.

The RCE RFA invites research institutions and groups of investigators to form 
consortia or collaborations and develop applications for programs that will 
address the fundamental research and development questions that will provide 
the information needed to counter the threat of bioterrorism.  Diverse 
research and development approaches are encouraged, as long as they include 
the following essential features: a biodefense research focus on NIAID 
Category A-C Agents, particularly Category A, which incorporates a 
translational component with the long term goal of developing testable 
products.  Additionally, the consortium must document: institutional 
commitment, organizational capabilities, ability to develop and expand 
facilities, plans for training of new investigators and other participants in 
the national biodefense effort, and interdisciplinary coordination and 
collaboration, particularly linkages to federal, state, and local agencies.  
The consortium must have a lead team of individuals responsible for the 
overall management and direction of the RCE.  A group of Center member 
researchers, with expertise in biodefense and emerging infectious diseases 
research, is essential to lead the research thrust, which underlies all the 
other activities of the RCE. 

Successful applicants for Planning Grants for Regional Centers of Excellence 
for Biodefense and Emerging Infectious Diseases (P-RCE) will become part of a 
national, NIAID-managed Biodefense/emerging infectious diseases network that 
will be coordinated by the NIAID RCE Management and Oversight Committee.

RESEARCH OBJECTIVES  

Background

As identified by the recently convened NIAID Blue Ribbon Panel on 
Bioterrorism and Its Implications for Biomedical Research, there is a 
critical need for the establishment of highly developed research and 
development infrastructure with strong translational research capacity to 
implement the Biodefense Research Agenda of NIAID 
(http://www2.niaid.nih.gov/biodefense/).   

To facilitate this initiative, the NIAID has established The Regional Centers 
of Excellence for Biodefense and Emerging Infectious Diseases Research (RCE) 
Program.  Additionally, NIAID is establishing this planning grant activity to 
assist interested investigators and institutions in developing plans for a 
Regional Center of Excellence. 

Objective and Scope

The U56 planning grant supports the establishment of a structure and a 
program that is focused on multidisciplinary approaches to understanding, 
preventing, diagnosing and treating infections caused by the NIAID category 
A-C agents and other emerging infectious diseases.  Applicants for this 
Planning Grant for Regional Centers of Excellence for Bioterrorism and 
Emerging Infectious Diseases Research (P-RCE) will be expected to work toward 
the following objectives during the course of an award: 1) establish the 
leadership team for the RCE; 2) establish the long-range strategic plan for 
the proposed Center; 3) define research objectives and projects, as well as 
cores for the RCE; 4) initiate research projects and begin facilities 
development; and 5) submit an application to the RCE program (U54). 

1. Defining the Principal Investigator, applicant organization and consortium 
partners.   A key issue in planning a regional center is the selection of the 
PI, consortium partners, and applicant organization.  The group considering 
formation of a Regional Center must assess the potential PI and other 
researchers with regard to commitment of sufficient effort, prior experience 
of the PI and the applicant organization with large multi-institutional 
research projects, and the ability to lead.  The applicant institution must 
be willing to provide the necessary space as well as managerial and fiscal 
support for the Center.  The PI and leadership team should be tentatively 
identified at the time of application for the P-RCE grant although the team 
may change before an RCE application is developed.

2. Developing a Strategic Plan.  A major goal of the planning process is the 
establishment of a strategic plan to identify the most significant 
opportunities and gaps in science that would be addressed by a Regional 
Center of Excellence in the short and long term, and to identify objective 
milestones to measure success or failure.  The outlines of the strategic plan 
should be defined at the time of applying for the P-RCE, although complete 
development would occur during the period of the award. The following process 
and organization is suggested for the strategic plan:

a) Summary of current research of P-RCE participants and the current 
facilities and resources available.  Outline the major infectious disease, 
immunity, and biodefense related studies to be assisted by P-RCE, and 
eventually, if successful, RCE funding. 

b) Opportunities - Identify and evaluate potential opportunities for use of 
P-RCE resources. This analysis will require outreach for suggestions from all 
members of the consortium. The NIAID strongly encourages the planning group 
to form associations with other federal agencies, such as intramural NIH, 
CDC, DoD, Dept of Agriculture, DOE National Laboratories, and with state and 
local health departments.  As part of this process the planning group should 
document the collaborations with the institutions in their region that were 
considered and which will be further developed to both utilize their unique 
strengths and address the mission of the RCE Program. 

c) Action Plan - Choose the highest priority opportunities and develop a 
detailed plan for the two years of funding. As part of the planning process, 
an overall research theme should emerge.  This should help provide a measure 
to determine if planned activities contribute to the overall theme. Examples 
of action plan steps include: determining which cores will be established; 
determining how existing BSL2/3 resources will be utilized; planning for 
leveraging of resources for renovation/expansion if needed; developing 
support for new research projects; establishing channels for communication 
and outreach.   

d) Outcome Measurements - Determine how progress on action plans will be 
measured.  Include justification of ways that P-RCE funding would provide 
unique contributions that cannot be provided by other types of research 
awards.  Define criteria for measuring progress on long-term goals for the 
entire funding period, and include semi-annual milestones for the each year.  
Specifically, address the timetable and milestones for submitting an RCE 
application.

e) Emergency Response Plan - Determine who the partners and contacts would be 
in the case of a local, regional or national biodefense crisis.  This should 
include plans for working with potential partners to establish procedures and 
systems for the planned center's regional research role in assisting in the 
response.
 
3. Planning the Research Projects.  As part of the planning process, the 
leadership team should begin to develop independent, competitive, research 
projects, addressing the research agenda for the NIAID category A-C agents.   
Each P-RCE application must include a detailed proposal and budget for one 
new meritorious research project; a second one may be included.  In addition, 
the application must describe how other research projects will be identified 
during the award period so that the required five projects are in place for 
the RCE application.  

4. Planning the Career Development Projects.  As part of the action plan, 
describe how the highest priority training needs will be identified and how 
plans for implementing them will be developed and established.  

5.  Planning a Developmental Projects system.  Describe how the P-RCE will 
establish a process for the selection, monitoring and evaluating of 
developmental projects.  These will be small-scale, untested research 
activities that would, if successful, contribute to the goal of developing a 
full RCE application and advance the goals of the NIAID biodefense agenda.  
It is anticipated that the successful developmental projects will become the 
basis for research projects in the RCE application.  Plans for one or more 
developmental projects may be included, with a budget, with the objective of 
testing them as possible research project components for the RCE application.

6. Planning Core Facilities.  Describe as part of the strategic plan, the 
process for identification of core facilities. Then discuss how the cores 
will be developed and maintained and how the Center will assess the success 
or failure of a core.  Acquisition of core facility equipment, and renovation 
of facilities may be supported by the P-RCE award, and implementation may 
begin as soon as an award is made.

7. Biocontainment Assessment.  A necessary component of a Center's success 
will be the availability of adequate access to BSL3/4 biocontainment 
facilities.  Applicants must describe their plans that would require such 
facilities, and provide a description of what facilities are available 
currently, what plans and arrangements have made at the time of application 
for linkages to groups that are applying to build NIAID-funded facilities or 
with other planned or existing containment facilities, and what resources 
they will need to arrange with the help of NIAID staff if an award is made, 
and once the construction awardees have been selected. 

MECHANISM OF SUPPORT

This RFA will use the U56 award mechanism.  The NIH U56 is a cooperative 
agreement planning award mechanism in which the Principal Investigator 
retains the primary responsibility and dominant role for planning, directing, 
and executing the proposed project; however, substantial NIH scientific 
and/or programmatic involvement with the awardee is anticipated during the 
performance of the activities. Under a cooperative agreement, the NIH's 
purpose is to support and stimulate the recipient's activities by involvement 
in and otherwise working jointly with the award recipient in a partner role. 
This interaction is further described under the section "Cooperative 
Agreement Terms and Conditions of Award".  

FUNDS AVAILABLE

The NIAID intends to commit approximately $4-8 million in FY 2003 to fund 
about 4-8 P-RCEs in response to this RFA.  An applicant may request up to $1M 
total direct costs and a project period of up to two years. Current NIAID 
plans do not include support for this program beyond this competition. Since 
this award is not renewable, it is assumed that recipients of awards under 
this RFA will compete for Regional Centers of Excellence awards at the end of 
this planning grant, or acquire other support to continue their activities.   
Awards pursuant to this RFA are contingent upon the availability of funds and 
the receipt of a sufficient number of meritorious applications. 

ELIGIBLE INSTITUTIONS

Any consortium consisting of a group of investigators at more than one 
institution, or a group of collaborating investigators at one institution, 
who are planning to work together to pursue basic and applied research and 
development activities with a common theme that focuses on countering the 
threat of category A-C agents, with emphasis on at least one category A 
agent, may apply.  A consortium may include institutions from other regions.  
Institutions and consortia that are submitting RCE applications may not apply 
to this competition.

Applicant organizations that may respond to this RFA include: 
o For-profit or non-profit organizations 
o Public or private research institutions, such as universities, colleges, 
hospitals, and laboratories 

Foreign organizations are not eligible to serve as grantees and may not be 
part of domestic applications.
 
REGIONAL DEFINITIONS

To achieve nationwide distribution of the RCEs, the NIAID has divided the 
United States into 10 regions based on the HHS system.

REGION I: CT, ME, MA, NH, RI, VT 
REGION II: NJ, NY, PR, VI 
REGION III: DE, D.C., MD, PA, VA, WV 
REGION IV: KY, MS NC, TN, AL, FL, GA, SC 
REGION V: IL, IN, MI, MN, OH, WI 
REGION VI: AR, LA, NM, OK, TX 
REGION VII: IA, KS, MO, NE 
REGION VIII: CO, MT, ND, SD, UT, WY 
REGION IX: AZ, CA, HI, NV, and the six U.S. Associated Pacific jurisdictions 
REGION X: AK, ID, OR, WA 

It is the long-range goal of this program, contingent upon the availability 
of funds, to establish at least one RCE within each region.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS   

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to form a consortium as described above, 
and 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.   

SPECIAL REQUIREMENTS

Cooperative Agreement Terms and Conditions of Award

The administrative and funding instrument used for this program is a 
cooperative centers agreement planning award mechanism (U56), an "assistance" 
mechanism (rather than an "acquisition" mechanism) in which substantial NIH 
scientific and programmatic involvement with the awardee is anticipated 
during the grant award.  The NIH purpose is to support and stimulate the 
activity by working jointly with the recipient in a partner role, but it is 
not to assume direction, prime responsibility or a dominant role in the 
activity.  The prime responsibility for the research resides with the 
awardees, although some activities may be carried out as collaborations among 
the awardees with coordination and facilitation by the NIAID Program staff as 
described below. Cooperative agreements are subject to the same 
administrative requirements as grants.  The following Terms and Conditions of 
Award are in addition to, and not in lieu of, otherwise applicable OMB 
administrative guidelines, HHS grant administration regulations in 45 CFR 
Part 74 and 92 and administered under the NIH Grants Policy Statement. 

1.  Awardee Rights and Responsibilities:

a.  Awardees will have primary responsibility for the project as a whole, 
including research design and conduct, data collection, data quality control, 
data analysis and interpretation and preparation of publications, as well as 
collaborations with other awardees.  Awardees will retain primary custody of 
and have primary rights to the data developed under these awards, subject to 
government rights of access consistent with current HHS, PHS, and NIH 
policies.  

b.  The Principal Investigator must attend and participate as a non-voting 
member in regular meetings of the NIAID RCE Management and Oversight 
Committee to discuss progress and directions of research and to ensure that 
overall RCE Program goals are being met. 

c.  The Principal Investigator must coordinate and participate in regular 
meetings of the local Center planning group with the two-year goal of 
developing an application for a Regional Center of Excellence grant. This 
will require discussions about progress and directions of research to ensure 
that the necessary interdisciplinary interactions are forming and that the 
planning processes are on schedule. 

d.  The Principal Investigator and other appropriate investigators will 
attend a RCE Program Annual Meeting to be organized by NIAID staff in the 
Washington, D.C area.  Each P-RCE will submit semi-annual progress reports to 
the NIAID that describe activities and accomplishments during the previous 
funding/reporting period.  

e.   An NIH intramural scientist (IMS) or other federal employee may not 
serve as the Principal Investigator but may participate as part of the 
Center.  The participation of an IMS is independent of and unrelated to the 
role of the NIAID Program Staff as described below.  An IMS who is one of the 
Center's member scientists will have the same programmatic rights and 
responsibilities as other investigators.  These rules apply to scientists 
employed by other parts of the federal government as well.  

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/).

g.  Intellectual Property Plan.  In order to encourage timely presentation 
and publication of results, the P-RCEs are encouraged to file patent 
applications in a timely manner, according to an approved implementation 
plan.   

Awardees shall include the following terms concerning intellectual property 
rights, or provide an alternative plan.  In no event will an award be made 
absent incorporation of either the P-RCEs terms below, or the applicant's own 
plan. 

"Each institution participating in the P-RCE agrees to grant to commercial 
collaborator: (i) a paid-up nonexclusive, nontransferable, royalty-free, 
world-wide license to all P-RCE Inventions for research purposes only; and 
(ii) a time-limited first option to negotiate an exclusive, world-wide 
royalty-bearing license for all commercial purposes, including the right to 
sub-license, to all inventions on terms to be negotiated in good faith by the 
collaborator and Institution. The collaborator shall notify Institution, in 
writing, of its interest in obtaining such an exclusive license to any 
Institution Invention within six (6) months of the collaborator's receipt of 
notice of such Institution Invention(s). In the event that a collaborator 
fails to so notify Institution, or elects not to obtain an exclusive license, 
then the collaborator's option shall expire with respect to that Institution 
Invention, and Institution will be free to dispose of its interests in such 
invention in accordance with participating Institution's policies. If the 
participating institution and collaborator fail to reach agreement within 
ninety (90) days, (or such additional period as collaborator and Institution 
may agree) on the terms for an exclusive license for a particular Institution 
Invention, then for a period of six (6) months thereafter Institution shall 
not offer to license the invention to any third party on materially better 
terms than those last offered to collaborator without first offering such 
terms to collaborator, in which case collaborator shall have a period of 
thirty (30) days in which to accept or reject the offer.

Participating institution agrees that notwithstanding anything contained 
herein to the contrary, any inventions, discoveries or innovations, whether 
patentable or not, which are not Subject inventions as defined in 35 USC 
201(e), arising out of any unauthorized use of the collaborator's agent 
and/or any modifications to the agent, shall be the property of the 
collaborator (hereinafter "Collaborator Inventions").  Institution will 
promptly notify the collaborator in writing of any such Collaborator 
Inventions and, at collaborator's request and expense, participating 
institution will cause to be assigned to collaborator all right, title and 
interest in and to any such collaborator inventions and provide collaborator 
with assignment or other documents).  Participating institution may also be 
conducting other research using the agent under the authority of a separate 
Material transfer Agreement (MTA) with the collaborator.  Inventions arising 
there under shall be subject to the terms of the MTA, and not to this 
clause." 

h.  Protection of Proprietary Data

Raw and primary data may be provided exclusively to the NIAID, industrial 
collaborators, and the FDA, as appropriate.  This provision shall not affect 
the investigators' right to disseminate their research findings through 
publications or presentations.

2. NIAID Program Staff responsibilities:

a.  The RCE Program Director from the Division of Microbiology and Infectious 
Diseases and NIAID Program Staff Scientists assigned to each P-RCE awardee 
will work closely with the PI and other member scientists to aid the efforts 
to develop toward an RCE application, to facilitate collaborations and to 
leverage the resources available to the Program.  Other NIAID staff will be 
responsible for normal program stewardship and monitoring of award.

b. NIAID Program Staff Scientists will coordinate activities that involve all 
the awardees and will work with Center leadership to help focus research 
efforts. The NIAID Program Staff Scientist, through the Management and 
Oversight Committee, may work to establish new research and development 
objectives within and among the P-RCEs based upon new scientific opportunity 
and national need. The NIAID Program Staff Scientist will assist and 
facilitate this process and not direct it.  When necessary issues may be 
brought to the Management and Oversight Committee for advice.

c. NIAID RCE Program Staff Scientists will help organize an annual meeting of 
investigators from all funded RCEs and P-RCEs to share progress and research 
insights that may benefit all of the projects and to accomplish the RCE 
Program's overall goals. 

3. Collaborative responsibilities:

a.  The NIAID RCE Management and Oversight Committee will provide overall 
scientific coordination of the RCE Program; RCE Principal Investigators, 
Directors of the BSL3/4 cores, and the NIAID RCE Program Director will be 
voting members with the NIAID Program Director as Chairperson.  Additional 
NIAID Program Staff, P-RCE Principal Investigators, and scientists other than 
PIs may attend as non-voting members of the committee, where additional 
expertise may be required.  The P-RCE component of the Program will be guided 
by a sub-committee of the MOC that includes NIAID staff, RCE PIs and P-RCE 
PIs.   The NIAID RCE Program Director will serve as chairperson.  

b.  The Management and Oversight Committee will meet twice yearly or as 
needed in the event of a bioterrorism emergency. 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 and/or NIH 
intramural scientists and other federal government agencies; to establish 
priorities that will accelerate the translation of preclinical findings into 
clinical applications; to consider reallocating resources; and to conduct 
other business of the RCE Program.  

4.  Arbitration: 

When agreement between an awardee and NIAID staff about scientific, 
programmatic issues that may arise after the award cannot be reached, an 
arbitration panel will be formed. The panel will consist of one person 
selected by the awardee, one person selected by NIAID staff, and a third 
person selected by the two.  The decision of the arbitration panel, by 
majority vote, will be binding. This special arbitration procedure in no way 
affects the right of an awardee to appeal an adverse action in accordance 
with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 
CFR Part 16.

WHERE TO SEND INQUIRIES 

Written and telephone inquiries from potential applicants to clarify any 
issues or questions about the P-RCE Program and responding to this RFA are 
welcome.  Direct inquiries regarding programmatic issues to: 

Dr. Rona Hirschberg
RCE Program Director
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infections Diseases  
6700B Rockledge Drive, Room 3129, MSC 7630 
Bethesda, MD  20892-7630
Zip code for express couriers: 20817 
Telephone  (301) 496-1884
Fax:  (301) 480-4528
Email:  rhirschberg@niaid.nih.gov 

Direct inquiries regarding review issues to:

Edward W. Schroder, Ph.D.
Chief, Microbiology and Immunology Review Branch
NIAID Scientific Review Program
6700-B Rockledge Drive MSC 7616
Bethesda, MD 20892-7616
Zip code for express couriers: 20817 
Phone:  301-435-8537
FAX: 301-402-2638
e-mail: es170m@nih.gov 

Direct inquiries regarding fiscal matters to: 

Linda Shaw
Grants Management Branch
Division of Extramural Activities
National Institute of Allergy and Infectious Disease, NIH
6700-B Rockledge Drive, MSC 7614
Room 2125
Bethesda, MD  20892-7614 (Express Zip 20817)
Email:  ls15k@nih.gov     
Tel:  (301) 402-6611
Fax:  (301) 480-3780

or

Lesia A. Norwood
Grants Management Branch
Division of Extramural Activities
National Institute of Allergy and Infectious Disease, NIH
6700-B Rockledge Drive, MSC 7614
Room 2117
Bethesda, MD  20892-7614 (Express Zip 20817)
Email:  ln5t@nih.gov     
Tel:  (301) 402-7146
Fax:  (301) 480-3780

LETTER OF INTENT   

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

o Number and title of this RFA
o Descriptive title of the proposed application
o Region (see list above)
o Names of Institution(s) participating in the P-RCE application
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 

Although a letter of intent is not required, is not binding, and does not 
enter into the review of subsequent applications, 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:

Edward W. Schroder, Ph.D.
Chief, Microbiology and Immunology Review Branch
NIAID Scientific Review Program
6700-B Rockledge Drive MSC 7616
Bethesda, MD 20892-7616
Zip code for express couriers: 20817 
Phone:  301-435-8537
FAX: 301-402-2638
e-mail: es170m@nih.gov

SUBMITTING AN APPLICATION  

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html  in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email:  GrantsInfo@nih.gov.  

SUPPLEMENTAL  INSTRUCTIONS.

Sections A-F of the Research Plan (see below) may not exceed 100 pages if one 
research project is proposed or 125 pages if two research projects are 
proposed, and no more than 50 pages of appendix material may be included.  
Applications exceeding these limits will be returned without review. 

See "RESEARCH OBJECTIVES – Objectives and Scope" above for information 
important to application preparation. 

In addition, applicants must consult and use "Instructions for Applications 
for Multi-Project Awards"  at 
http://www.niaid.nih.gov/ncn/grants/multibron.htm  with the following 
additional instructions specific to this RFA:

Table of Contents: Organize the application and table of contents as 
described below:

Face Page
Description, performance sites and key personnel
Table of contents
Detailed Budget for Initial Budget Period:
Administrative core
	Research Project - budget for each project
	Developmental projects - one budget for all planned activities
	Training projects
	Facilities cores – one budget for all planned activities
Budget for entire project period
Budgets pertaining to consortium/contractual arrangements
Biographical sketch of the Principal Investigator (not to exceed two pages)
Biographical sketch of other researchers associated with the P-RCE effort 
(not to exceed two pages each)
Biographical sketch of other Key Personnel including anticipated Core 
Directors (not to exceed two pages each)
List of all participating members of the Center

A.  Introduction (10 pages total)
        Background and objectives
	Letter of commitment from Institution(s)
	Chronological review of planning and priority setting processes
B.  Strategic Plan Status Report (15 pages total)
	Strengths
	Opportunities
	Action plan
	Outcome measures
	Emergency Response Plans
C. Research Project(s) (25 pages or less for sections A-D for up to two 
projects)
	Use standard R01 format and budget pages
	Planning process to initiate other projects
D. Identification and implementation of training activities (10 pages)
E.  Establishment of developmental projects (10 pages total)
	Process for review and award
Assessment process, including termination or promotion to full research 
project status
	Project descriptions for immediate implementation, if any
	Budget 
F. Cores and Facilities (30 pages total)
	Administrative Core
	Other Cores
Discussion/documentation of need for BSL3/4 facilities, including 
renovations, if planned
Budget for all planned cores

A collaborating NIH Intramural Scientist, or employee of another Federal 
Institution may not receive salary from this RFA. These scientists must 
obtain approval of his/her Scientific Director to receive additional funds 
for this the project.  This letter must specify that no more than $600,000 
direct costs of intramural resources will be allocated to the project and 
provide assurance that the conduct of the project will comply with the DHHS 
regulations for research involving human subjects (if applicable) and with 
the PHS policy of vertebrate animal research.).

Each applicant P-RCE must provide in the application a detailed description 
of the approach to be used for obtaining patent coverage and for licensing 
where appropriate, in particular where the invention may involve 
investigators from more than one institution.  Procedures must be described 
for resolution of legal problems should they arise. Your attention is drawn 
to P.L. 96-517 as amended by P.L. 98-620 and 37 CFR Part 401.  Instructions 
were also published in the NIH Guide for Grants and Contracts (NIH Guide, 
Vol. 19, No. 23, June 22, 1990).)

NIAID acknowledges that some commercial collaborators that are members of 
applicant P-RCEs, or who provide material to applicant P-RCEs, may require 
that Institution agree to grant to them certain intellectual property rights, 
as described by the terms above.  If Institution voluntarily agrees to the 
described terms, then they should appear in the P-RCE application.  NIAID 
recognizes that Institutions' and consortia of Institutions' ability to 
access agents from commercial collaborators for this effort may be limited 
absent such a voluntary agreement, or a substantially similar independent 
agreement between Institution and commercial collaborators providing agents.  
However, in no event will the award of cooperative agreement be dependent 
upon the described terms' being part of a P-RCE application.  Rather, the 
consortia and the Institution's application may provide Institution's own 
plan for accessing agents from commercial collaborators. 

USING THE RFA LABEL:  The RFA label available in the PHS 398 (rev. 5/01) 
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
(20817 FOR EXPRESS SERVICE)
 
At the time of submission, two additional copies and all copies of appendix 
material for  the application must also be sent to:

Edward W. Schroder, Ph.D.
Chief, Microbiology and Immunology Review Branch
NIAID Scientific Review Program
6700-B Rockledge Drive MSC 7616
Bethesda, MD 20892-7616
Zip code for express couriers: 20817 
Phone:  301-435-8537
FAX: 301-402-2638
e-mail: es170m@nih.gov 

APPLICATION PROCESSING:  Applications must be received by Jan. 15, 2002.  If 
an application is received after that date, it will be returned to the 
applicant without review.   

The Center for Scientific Review (CSR) 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 
CSR will not accept any application that is essentially the same as one 
already reviewed. This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must 
include an Introduction addressing the previous critique.  Applications must 
meet all eligibility requirements as described above and must address all 
programmatic requirements (see SPECIAL REQUIREMENTS above) in the RFA. 

PEER REVIEW PROCESS  

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NIAID.  Incomplete or non-responsive applications will 
be returned to the applicant without further consideration.  

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 Division of Extramural Affairs (DEA) at NIAID, in accordance 
with the review criteria stated below.  As part of the initial merit review, 
all applications will:

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

Review Criteria for Planning Grants for Regional Centers of Excellence for 
Biodefense and Emerging Infectious Diseases Research (P-RCE)

The application as a whole will be evaluated using the following criteria:

Significance – The effect that a planning grant award would have on an 
institution, or consortium's biodefense and emerging infectious disease 
research efforts:  

1.  Evidence that the proposal will lead to development of a RCE application 
that would be competitive. 
2.  Documented focus on research projects and topics that includes NIAID 
category A-C agents and that may lead to new drugs, vaccines, and diagnostics 
for them.
3.  Evidence of institutional commitment to the formation of an RCE.
4.  Evidence that the strategic plan which is being developed will lead to a 
dynamic action plan that will result in strong linkages to the appropriate 
regional partners, outstanding research in biodefense and emerging infectious 
diseases, a quality training plan, and an energetic vision of what the P-RCE 
can become.

Approach – The likelihood that a planning grant will achieve its objectives, 
including the quality of the planning and management process, and the quality 
of the research proposed.

1. Clarity and feasibility of the strategic planning processes and 
strategies.
2. The ability of the proposed research projects to accomplish the stated 
goals and contribute to the biodefense effort, and the suitability of plans 
to select additional research projects.
3. The ability of the proposed cores to support the planned research efforts, 
foster drug, vaccine, and diagnostics development, and enhance the overall 
research environment, and produce an economy of scale.
4.  Suitability of the plan to identify highest priority training needs to be 
addressed by Career Development Projects.
5.  Appropriateness of the plans for selecting Developmental Projects and the 
scientific quality of the Developmental Projects included in the application.

Innovation – The utilization of planning grant resources in unique ways to 
achieve the long-term scientific goals of the RCE Program. 
1.  The creativity and quality of biodefense and emerging infectious diseases 
research that are proposed.
2.  Creative acquisition and use of resources other than P-RCE funds, and 
establishment of innovative linkages to federal state, and local agencies and 
other regional partners. 
3.  Evidence that a P-RCE award would support novel and creative activities 
that cannot be supported other ways.
4.  Evaluation of the process for establishment of an emergency response 
plan.

Investigator – The choice of appropriate leaders to carry out the Planning 
Grant and develop a RCE.
1.  Designation of a P-RCE PI with appropriate managerial experience, 
commitment, leadership in biodefense or emerging infectious disease research; 
inclusion ofother appropriate leadership at the applicant institution and 
within the consortium (if applicable).
2.  Qualifications of core directors and other key personnel, e.g., 
experience, competence and commitment.

Environment – the availability of resources and clear evidence of 
institutional commitment.
1.  Existing resources available to the P-RCE. Included in this assessment is 
an evaluation of the prioritization process. 
2.  Commitment of consortium partners, including space, institutional 
financial support and other resources and oversight provided for P-RCE 
activities.
3.  Appropriateness of the individual cores and the value of their 
contribution to the research environment.
4.  Plans for prioritization of use of resources and making resources 
available to partners and others in the region.

The Research Project(s) will be evaluated using the standard NIH criteria 
applied in the context of the RCE Program's goals.

Significance: Does this study address an important problem?  If the aims of 
the application are achieved, how will scientific knowledge be advanced?  
What will be the effect of these studies on the concepts or methods that 
drive this field?  

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

Innovation: Does the project employ novel concepts, approaches or method?  
Are the aims original and innovative?  Does the project challenge existing 
paradigms or develop new methodologies or technologies?  

Investigator: is the investigator appropriately trained and well suited to 
carry out this work?  Is the work proposed appropriate to the experience 
level of the principal investigator and other researchers (if any)?  

Environment: Does the scientific environment in which the work will be done 
contribute to the probability of success?  Do the proposed experiments take 
advantage of unique features of the scientific environment or employ useful 
collaborative arrangements?  Is there evidence of institutional support?  

ADDITIONAL REVIEW CRITERIA: In addition each of the research projects, as 
well as planned developmental projects, and the project as a whole will be 
evaluated with respect to the following:

o PROTECTIONS:  The adequacy of the proposed protection for humans, animals, 
or the environment, to the extent they may be adversely affected by the 
project proposed in the application.

o INCLUSION:  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 
included in the section on Federal Citations, below)

o DATA SHARING:  The adequacy of the proposed plan to share data. 

o BUDGET: The initial review group will also examine the reasonableness of 
the proposed budget and the requested period of support in relation to the 
proposed research.  The support for attendance at Management and Oversight 
Committee meetings can be provided through the Team's award as part of the 
travel budget.

AWARD CRITERIA

If an RCE or P-RCE has already been awarded within a region, the NIAID 
reserves the right to fund additional centers and planning grants within that 
region. 

Additional award criteria that may be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities
o Coverage of the desired research scope
o Regional distribution of meritorious applications

REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: 

Research components involving Phase I and II clinical trials must include 
provisions for assessment of patient eligibility and status, rigorous data 
management, quality assurance, and auditing procedures.  In addition, it is 
NIH policy that all clinical trials require data and safety monitoring, with 
the method and degree of monitoring being commensurate with the risks (NIH 
Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, 
June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Clinical trials supported or performed by NIAID require special 
considerations.  It is anticipated that the P-RCEs will run very limited 
proof of concept trials, and limited safety studies of new agents.  
Activities beyond this will require approval by the full Management and 
operations committee.

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH:  

It is the policy of the NIH that women and members of minority groups and 
their sub-populations must be included in all NIH-supported clinical research 
projects unless a clear and compelling justification is provided indicating 
that inclusion is inappropriate with respect to the health of the subjects or 
the purpose of the research. This policy results from the NIH Revitalization 
Act of 1993 (Section 492B of Public Law 103-43).

All investigators proposing clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a 
complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.  
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable; 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:  

The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them. This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: 

NIH policy requires education on the protection of human subject participants 
for all investigators submitting NIH proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.  

HUMAN EMBRYONIC STEM CELLS (hESC): 
Criteria for federal funding of research on hESCs can be found at 
http://grants.nih.gov/grants/stem_cells.htm and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see 
http://escr.nih.gov/).  It is the responsibility of the applicant to provide 
the official NIH identifier(s)for the hESC line(s)to be used in the proposed 
research.  Applications that do not provide this information will be returned 
without review.

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 Catalog of Federal Domestic Assistance No. 
93.3393 and is not subject to the intergovernmental review requirements of 
Executive Order 12372 or Health Systems Agency review. 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 
described at http://grants.nih.gov/grants/policy/policy.htm and under Federal 
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.

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)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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