RAPID RESPONSE GRANT PROGRAM ON BIOTERRORISM-RELATED RESEARCH (RRGP-BTRR)

Release Date:  December 5, 2001

RFA:  RFA-AI-02-002

National Institute of Allergy and Infectious Diseases
 (http://www.niaid.nih.gov)
National Institute of Biomedical Imaging and Bioengineering
 (http://www.nibib.nih.gov/)

Letter of Intent Receipt Date:  January 15, 2002
Application Receipt Date:       February 15, 2002

THE APPLICATIONS IN RESPONSE TO THIS RFA SHOULD USE "MODULAR GRANT" AND 
"JUST-IN-TIME" CONCEPTS.  MODULAR INSTRUCTIONS MUST BE USED FOR RESEARCH 
GRANT APPLICATIONS UP TO $250,000 PER YEAR. MODULAR BUDGET INSTRUCTIONS ARE 
PROVIDED IN SECTION C OF THE PHS 398 (VER 5/2001) AVAILABLE AT 
http://grants.nih.gov/grants/funding/phs398/phs398.html.

PURPOSE

The Division of Microbiology and Infectious Diseases (DMID), National 
Institute of Allergy and Infectious Diseases (NIAID), National Institute of 
Biomedical Imaging and Bioengineering, National Institutes of Health (NIH), 
announces a new Rapid Response Grant Program on Bioterrorism-Related Research 
(RRGP-BTRR).  

The RRGP-BTRR will support innovative research targeted at the design and 
development of specific diagnostics, therapies, and prevention strategies for 
Category A biological diseases as defined by the CDC 
(http://www.bt.cdc.gov/Agent/Agentlist.asp), which includes:  Bacillus 
anthracis (anthrax), Clostridium botulinum (botulism), Yersinia pestis 
(plague), pox viruses, Francisella tularensis (tularemia), and viral 
hemorrhagic fevers.

Specifically, this initiative encourages research to develop:  
o  new prevention strategies for those at risk of exposure,
o  novel targets and therapeutics for effective treatments for those 
infected, 
o  rapid, accurate diagnostics for natural and bioengineered microbes and/or 
toxins, and
o  more complete understanding of the pathogenesis, physiology, and host 
immune interactions with these organisms.  

Research that builds on recent advances in genomics and proteomics of these 
organisms is especially encouraged.  Applications are especially welcome from 
young investigators and those not currently active in the field of 
bioterrorism research.  

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 Request for 
Applications (RFA), Title of 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.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign, for-profit and non-
profit organizations, public and private, such as universities, colleges, 
hospitals, laboratories, units of State and local governments, and eligible 
agencies of the Federal government.  Racial/ethnic minority individuals, 
women, and persons with disabilities are encouraged to apply as principal 
investigators.  Please note that special terms of award will be added to any 
awards made to foreign institutions.  In addition, all work must be performed 
in compliance with Federal regulations regarding biohazards.

MECHANISM OF SUPPORT

The mechanism of support will be Exploratory/Developmental Research Project 
Grant, R21 award.  The total requested project period for an application 
submitted in response to this RFA may not exceed two years for an R21.

NIAID uses R21 grants to provide short-duration support for preliminary 
studies of a highly speculative nature, which are expected to yield, within 
this time frame, sufficient information upon which to base a well-planned and 
rigorous series of further investigations.

Responsibility for the planning, direction, and execution of the proposed 
project will be solely that of the applicant. It is hoped that successful 
grantees funded through this program will seek continuing support for 
research further through the R01 grant mechanism.

Applications will request direct costs in $25,000 modules.  A typical modular 
grant application requests the same number of modules in each year.  
Applicants may request up to two years of support and up to $150,000 per 
annum in direct costs, although with compelling justification exceptions can 
be made if specific costly reagents, animals, specimens or laboratory 
modifications are needed to perform these studies.  Contact the program staff 
listed under INQUIRIES for further information.  

Specific application instructions have been modified to reflect "MODULAR 
GRANT" and "JUST-IN-TIME" streamlining efforts that have been adopted by the 
NIH. Complete and detailed instructions and information on Modular Grant 
applications have been incorporated into the PHS 398 (rev. 5/01). Additional 
information on Modular Grants can be found at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

A notice of modification and update (OD-00-046) regarding modular grants was 
released on 7/24/00 and can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-046.html.

This RFA is a one-time solicitation.  Future unsolicited competing renewal 
applications will compete with all investigator-initiated applications and 
will be reviewed according to customary referral and peer review procedures.

The anticipated award date is July, 2002.

FUNDS AVAILABLE

The estimated total funds [direct and facilities and administrative (F&A) 
costs] available for the first year of support for all awards made under this 
RFA will be $3 million.  In Fiscal Year 2002 the NIAID plans to fund 
approximately 8-12 awards.  Although this program is provided for in the 
financial plans of the NIAID, awards pursuant to this RFA are contingent upon 
the availability of funds for this purpose and the receipt of a sufficient 
number of applications of high scientific merit.  Funding beyond the first 
and subsequent years of the grant will be contingent upon satisfactory 
progress during the preceding years and availability of funds.

RESEARCH OBJECTIVES

The RRGP-BTRR will support all pertinent areas of investigation that will 
contribute toward development of specific diagnostics, therapies, and 
prevention strategies for Category A biological diseases 
(http://www.bt.cdc.gov/Agent/Agentlist.asp), as well as studies leading to a 
more complete understanding of the pathogenesis, physiology, and host immune 
interactions with these organisms.  Research topics might include but are not 
limited to the following:

Therapeutics

1.  Design, synthesis and evaluation of therapeutic strategies for diseases 
caused by poxviruses and hemorrhagic fever viruses.
2.  Novel therapeutic approaches for anthrax, botulism, plague, and tularemia 
to:  
o  Prevent the germination of anthrax spores in vivo,
o  Inhibit the synthesis or neutralize the lethal effects of toxins generated 
in vivo during the course of infection, and
o  Inactivate or block the attachment and entry of toxins to host target 
cells during the course of infection or after the deliberate release of 
bacterial exotoxins (e.g. botulinum toxin) into the environment (air, food, 
or water).

Vaccines and other Prevention Strategies

1.  Design and development of a replacement for Variella Immune Globulin 
(VIG).
2.  Design, development, and evaluation (preclinically and clinically) of the 
next generation vaccines for smallpox that can be safely administered to the 
entire population.
3.  Perform basic, preclinical and clinical research on vaccines for 
hemorrhagic fever viruses.
4.  Application of new approaches for the expression and delivery of 
protective antigens as new, more effective vaccines against anthrax, 
botulism, plague and tularemia.

Diagnostics

1.  Application of genomics/proteomics data to identify targets suitable for 
use as rapid diagnostics.
2.  Design and development rapid diagnostics applicable in a variety of 
environments.

Basic Research

1.  Evaluate immune-evasive responses associated with spore formation and/or 
latency.
2.  Evaluate the role of general antimicrobial peptides (e.g. defensins) in 
activating innate immune response.
3.  Identify mechanisms of pathogenesis, virulence, resistance, and host 
responses.

Approaches involving the use of antibiotics to limit or inhibit bacterial 
growth in vivo will not be considered responsive to this announcement since 
such approaches are supported by other mechanisms.  In addition, applications 
that propose research on organisms other than those associated with the 
diseases listed in CDC Category A will not be considered responsive.   

TERMS AND CONDITIONS OF AWARD  

When clinical studies or trials are a component of the research proposed, 
NIAID policy requires that studies be monitored commensurate with the degree 
of potential risk to study subjects and the complexity of the study.  Terms 
and Conditions of Award will be included with awards.  NIAID policy was 
announced in the NIH Guide on February 24, 2000 and is available at: 
http://grants.nih.gov/grants/guide/notice-files/NOT-AI-00-003.html.  The full 
policy including terms and conditions of award is available at:
http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf.

This award provides support for one or more NIH-defined Phase III clinical 
trials.  The NIH Policy for research supported as an NIH Phase III Clinical 
Trial has been updated in Section III.B. of the "NIH Guidelines on the 
Inclusion of Women and Minorities as Subjects in Clinical Research", updated 
August 1, 2000 (URL listed below under STUDY POPULATIONS).  A description of 
plans to conduct analyses, as appropriate, by sex/gender and/or racial/ethnic 
groups must be included in clinical trial protocols and the results of the 
subset analyses must be reported to NIH in Progress Reports, Competitive 
Renewal Applications, and in the required Final Progress Report, as stated in 
Section III.B. of the Guidelines.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

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

It is the policy of NIH 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 was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address:  http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators also may obtain copies of these policies from the program staff 
listed under INQUIRIES. Program staff may also provide additional relevant 
information concerning the policy.

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 the following website: 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

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.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

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.

LETTER OF INTENT   

Prospective applicants are asked to submit, by January 15, 2002, a letter of 
intent that includes a descriptive title of the overall proposed research, 
the name, address and telephone number of the Principal Investigator, the 
identities of other key personnel and participating institutions, and the 
number and title of this RFA.  Although the letter of intent is not required, 
is not binding, does not commit the sender to submit an application, 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 to Dr. Edward Schroder 
at the address(s) listed under INQUIRIES.

APPLICATION PROCEDURES

The PHS 398 research grant application instructions and forms (rev. 5/01) at 
http://grants.nih.gov/grants/forms.htm must be used in applying for these 
grants and will be accepted at the receipt date stated at the top of this 
RFA. This version of the PHS 398 is available in an interactive, searchable  
format. For further assistance contact GrantsInfo, Telephone 301/710-0267, 
Email:  [email protected].

For purposes of identification and processing the application, mark "YES" in 
item 2 on the face page and enter:  "RFA AI-02-002 Rapid Response Grant 
Program for Bioterrorism-Related Research".

The research plan will be strictly limited to 10 pages total.  Applications 
that exceed the page limit will be returned without review.  An appendix may 
be included in the application, however, the appendix is not to be used to 
circumvent the page limit of the research plan.  Explicit instructions 
concerning what may be included in an appendix can be found in Section 1B 
"General Instructions" for the PHS 398 Grant Application.  Late or incomplete 
applications will not be accepted.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS

The modular grant concept establishes specific modules in which direct costs 
may be requested as well as a maximum level for requested budgets. Only 
limited budgetary information is required under this approach.  The 
just-in-time concept allows applicants to submit certain information only 
when there is a possibility for an award. It is anticipated that these 
changes will reduce the administrative burden for the applicants, reviewers 
and NIH staff.  The research grant application form PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in 
applying for these grants, with modular budget instructions provided in 
Section C of the application instructions.  

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.

Submit a signed, typewritten original of the application 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 appendix material must be sent to:

Dr. Edward W. Schroder
Scientific Review Administrator
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Room 2151, MSC 7616
6700-B Rockledge Drive
Bethesda, MD  20892-7616
(for FedEx use zip code 20817)

The Center for Scientific Review (CSR) will not accept any application in 
response to this announcement 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.

Applicants from institutions that have a General Clinical
Research Center (GCRC) funded by the NIH National Center for Research 
Resources may wish to identify the GCRC as a resource for conducting the 
proposed research.  If so, a letter of agreement from either the GCRC Program 
Director or Principal Investigator should be included with the

REVIEW CONSIDERATIONS

Applications will be evaluated for scientific and technical merit by an 
appropriate scientific review group convened by NIAID in accordance with the 
standard NIH peer review procedures.  As part of the initial merit review, 
all applications will receive a written critique. Only those applications 
deemed to have the highest scientific merit, generally the top half of 
applications under review, will be discussed, assigned a priority score, and 
receive a second level review by the appropriate national advisory council or 
board.

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments reviewers will be asked to discuss the following aspects 
of the application in order to judge the likelihood that the proposed 
research will have a substantial impact on the pursuit of these goals.  Each 
of these criteria will be addressed and considered in assigning the overall 
score, weighting them as appropriate for each application.  Note that the 
application does not need to be strong in all categories to be judged likely 
to have major scientific impact and thus deserve a high priority score.  For 
example, an investigator may propose to carry out important work that by its 
nature is not innovative but is essential to move a field forward.

Review Criteria

(1) 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?

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

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

(4) 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)?

(5) 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?

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:
  
o  The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research. Plans for the recruitment and retention of subjects will also be 
evaluated.

o  The reasonableness of the proposed budget and duration in relation to the 
proposed research

o  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.

Schedule

Letter of Intent Receipt Date:    January 15, 2002
Application Receipt Date:         February 15, 2002
Scientific Peer Review Date:      May, 2002
National Advisory Council Date:   June, 2002
Earliest Anticipated Award Date:  July, 2002

AWARD CRITERIA 

The following will be considered in making funding decisions:  the scientific 
and technical merit of the proposed project as determined by peer review, and 
the availability of funds.  In the final selection of applications to be 
funded, consideration will be given to developing a portfolio that most 
directly addresses issues of public health and bioterrorism. 

INQUIRIES

Inquiries are strongly encouraged.  The opportunity to clarify any issues or 
questions from potential applicants is welcome.

The Division of Microbiology and Infectious Diseases has a website for 
bioterrorism-related research: 
http://www.niaid.nih.gov/publications/bioterrorism.htm.  The website has 
information describing the various programs targeting bioterrorism-related 
research and listings of currently active bioterrorism-related program 
announcements and contracts and their associated deadlines.  

Direct inquiries regarding programmatic issues to:

Dr. Barbara Mulach 
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room 3266, MSC-7630
6700-B Rockledge Drive
Bethesda, MD  20892-7630
Telephone:  (301) 496-1884
FAX:  (301) 480-4528
Email:  [email protected]

Joan T. Harmon, Ph.D.
Division of Bioengineering
National Institute of Biomedical Imaging and Bioengineering
Room 1B37, MSC 2077
31 Center Drive
Bethesda, MD  20892-2077
Telephone:  (301) 451-6772
FAX:  (301) 480-4515
Email:  [email protected]

Direct inquiries regarding review issues to:

Dr. Edward W. Schroder
Scientific Review Administrator
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Room 2151, MSC 7616
6700-B Rockledge Drive
Bethesda, MD  20892-7616
(for FedEx use zip code 20817)
Telephone:  (301) 435-8537
FAX:  (301) 402-2638
Email:  [email protected]

Direct inquiries regarding fiscal matters to:

Theresa Mercogliano
Grants Management Specialist
Grants Management Branch
National Institute of Allergy and Infectious Diseases
National Institutes of Health
6700-B Rockledge Drive, MSC 7610
Bethesda, MD  20892-7610
Phone:  (301) 402-5512
Fax:  (301) 480-3780
Email:  [email protected]

Annette Hanopole, CRA
Grants Management Officer
National Institute of Biomedical Imaging and Bioengineering
Room 1B37, MSC 2077
31 Center Drive
Bethesda, MD  20892-2077
Telephone:  (301) 451-6768
FAX:  (301) 480-4515
Email:  [email protected]

AUTHORITY AND REGULATIONS

This program is described in the Catalogue of Federal Domestic Assistance in 
the following citations: No. 93.855, Immunology, Allergy, and Transplantation 
Research and No. 93.856, Microbiology and Infectious Diseases Research and 
No. 93.020, Bio-engineering Research. 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.  This program is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.

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.

The PHS strongly encourages all grant and contract recipients to provide a 
smoke-free workplace and promote the non-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, and 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.

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