PREPAREDNESS AGAINST ILLEGITIMATE USE OF BACTERIAL PATHOGENS

Release Date:  October 17, 2000

RFA:  AI-01-002

National Institute of Allergy and Infectious Diseases

Letter of Intent Receipt Date:  December 15, 2000
Application Receipt Date:       January 26, 2001

THIS RFA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  IT 
INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS 
THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA.

PURPOSE

The National Institute of Allergy and Infectious Diseases (NIAID), of 
the National Institutes of Health (NIH) invite investigator-initiated 
research applications to support basic research on molecular and 
genetic aspects of pathogenesis of, and host immune/defense responses 
to, the following bacterial pathogens: Bacillus anthracis, Yersinia 
pestis, Francisella tularensis, Coxiella burnetii, Rickettsia 
rickettsii, Rickettsia prowazeckii, Burkholderia mallei, or Brucella 
species. It is hoped that research from funded projects will be used to 
devise appropriate defense strategies that can be implemented shortly 
before or soon after bioterrorist acts.

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), PREPAREDNESS AGAINST ILLEGITIMATE USE OF BACTERIAL 
PATHOGENS, is related to one or more of the focus 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 institutions, 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.

MECHANISM OF SUPPORT

The mechanisms of support will be the individual research project grant 
(R01) and the Small (Pilot) Research Project Grant (R03). The total 
requested project period for an application submitted in response to 
this RFA should not exceed four years for an R01 or three years for an 
R03.  

Responsibility for the planning, direction, and execution of the 
proposed project will be solely that of the applicant.

NIAID uses R03 grants to support small, highly innovative or pilot 
projects.  Applicants for R03 grants may request up to $50,000 annual 
direct costs for a period not to exceed three (3) years.  Funds and 
time requested should be appropriate for the research proposed.  

Specific application instructions have been modified to reflect 
"MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined 
by the NIH. Complete and detailed instructions and information on 
Modular Grant applications 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 competing renewal 
applications will compete with all investigator-initiated applications 
and will be reviewed according to customary referral and review 
procedures.

FUNDS AVAILABLE

The estimated total funds (direct and facilities and administration 
[F&A] costs) available for the first year of support for all awards 
made under this RFA will be $1.5 million; depending on Fiscal Year 
budget appropriations, this amount may increase. In fiscal year 2001, 
the NIAID plans to fund approximately 3-5 awards.  The usual NIH 
policies governing grants administration and management will apply.  
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

Background

In recent years, there has been a significant change in both the nature 
and degree of the threat posed by the use of weapons of biological 
warfare. The increased risk of misuse of infectious agents as weapons 
of terror, as well as instruments of warfare has prompted the Congress 
of the United States to pass statutes to protect the public from the 
illegitimate use of bacterial pathogens such as Bacillus anthracis, 
Yersinia pestis, Francisella tularensis, Coxiella burnetii, 
Burkholderia mallei, and Brucella species. 

Under normal circumstances, the incidence of naturally occurring 
infections caused by these bacterial pathogens is extremely low in the 
United States.  For this reason, the cadre of investigators conducting 
basic research on these agents is small and of limited scope. 
Substantial gaps in our knowledge concerning mechanisms involved in 
host immune/defense responses and pathogenesis exists. 
Specifically directed research is essential in order to devise 
appropriate protective strategies that could be implemented soon after– 
or shortly before - a bioterrorist incident.    

Research Objectives and Scope

Research proposals submitted in response to this RFA must demonstrate 
that they are relevant to one or more of the following objectives:

o  Identification and characterization of key biochemical, molecular, 
or genetic processes (or factors) that contribute to virulence, 
pathogenesis, and/or host resistance/susceptibility with potential for 
use as candidate targets for new vaccines, drug intervention, or 
immunotherapy to limit in vivo growth or negate the deleterious effects 
of those bacterial pathogens described above.

o  Design of novel therapeutic strategies, that can be implemented soon 
after a bioterrorist event, to prevent the germination of bacterial 
spores in vivo (in the case of anthrax), arrest or interrupt the spread 
of infection in vivo, and/or neutralize -or block-the synthesis of 
toxins (or other microbial products) that damage host tissues early 
during infection.

o  Develop novel or improved candidate vaccines that will generate 
significant protective immunity against aerosol challenge within a 
relatively short period of time after immunization with a minimal 
number of doses, as well as define serologic correlates or measures of 
the degree of protective immunity.

Although appropriate animal models may be used to acquire and evaluate 
the experimental data obtained, the development of a new animal model 
should not be the major focus of a proposal submitted in response to 
this RFA.

Proposals on the development of methods for the rapid detection of 
these bacterial pathogens, as well as for the rapid diagnosis of the 
infections they elicit, would be of value in the development of a 
comprehensive response to bioterrorism. However, such proposals should 
be submitted for consideration and funding as Small Business Innovation 
Research (SBIR) or Small Business Technology Transfer (STTR) grants, 
not in response to this RFA. 
   
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 
biomedical and behavioral research projects involving human subjects, 
unless a clear and compelling rationale and justification are 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 research involving human subjects should 
read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities 
as Subjects in Clinical Research," published in the NIH Guide for 
Grants and Contracts on August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a 
complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: 
The revisions relate to NIH defined Phase III clinical trials and 
require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, 
and to conduct and report analyses, as appropriate, by sex/gender 
and/or racial/ethnic group differences.

NIH POLICY AND GUIDELINES ON THE 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 which is 
available at the following URL address: 
http://grants.nih.gov/grants/guide/notice-files/not98-024.html

Investigators may obtain copies from these sources or from 
Phillip J. Baker, Ph.D. (listed in INQUIRIES below) who may also 
provide additional relevant information concerning the policy.

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.

LETTER OF INTENT

Prospective applicants are asked to submit, by December 15, 2000, a 
letter of intent that includes a descriptive title of the overall 
proposed research; the name, address and telephone number of the 
Principal Investigator; 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 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 to Dr. Madelon Halula at 
the address listed under INQUIRIES.

APPLICATION PROCEDURES

Applicants are strongly encouraged to call NIAID program staff with any 
questions regarding the responsiveness of their proposed project to the 
goals of this RFA.  

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 Institute staff.  The research grant 
application form PHS 398 (rev. 4/98) is to be used in applying for 
these grants, with the modifications noted below.

BUDGET INSTRUCTIONS

MODULAR APPLICATION DETAILS:

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 Institute staff.  The research grant 
application form PHS 398 (rev. 4/98) is to be used in applying for 
these grants, with the modifications noted below.

BUDGET INSTRUCTIONS

Modular Grant applications will request direct costs in $25,000 
modules, up to a total direct cost request of $250,000 per year. 
(Applications that request more than $250,000 direct costs in any year 
must follow the traditional PHS 398 application instructions.) The 
total direct costs must be requested in accordance with the program 
guidelines and the modifications made to the standard PHS 398 
application instructions described below:

PHS 398

o FACE PAGE: Items 7a and 7b should be completed, indicating Direct 
Costs (in $25,000 increments up to a maximum of $250,000) and Total 
Costs [Modular Total Direct plus Facilities and Administrative (F&A) 
costs] for the initial budget period Items 8a and 8b should be 
completed indicating the Direct and Total Costs for the entire proposed 
period of support.

o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form 
Page 4 of the PHS 398. It is not required and will not be accepted with 
the application.

o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete 
the categorical budget table on Form Page 5 of the PHS 398. It is not 
required and will not be accepted with the application.

o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget 
Narrative page. (See 
http://grants.nih.gov/grants/funding/modular/modular.htm for sample 
pages.) At the top of the page, enter the total direct costs requested 
for each year. This is not a Form page.

o Under Personnel, list all project personnel, including their names, 
percent of effort, and roles on the project. No individual salary 
information should be provided. However, the applicant should use the 
NIH appropriation language salary cap and the NIH policy for graduate 
student compensation in developing the budget request.

For Consortium/Contractual costs, provide an estimate of total costs 
(direct plus facilities and administrative) for each year, each rounded 
to the nearest $1,000. List the individuals/organizations with whom 
consortium or contractual arrangements have been made, the percent 
effort of key personnel, and the role on the project. Indicate whether 
the collaborating institution is foreign or domestic. The total cost 
for a consortium/contractual arrangement is included in the overall 
requested modular direct cost amount. Include the Letter of Intent to 
establish a consortium.

Provide an additional narrative budget justification for any variation 
in the number of modules requested.

o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information 
used by reviewers in the assessment of each individual's qualifications 
for a specific role in the proposed project, as well as to evaluate the 
overall qualifications of the research team. A biographical sketch is 
required for all key personnel, following the instructions below. No 
more than three pages may be used for each person. A sample 
biographical sketch may be viewed at: 
http://grants.nih.gov/grants/funding/modular/modular.htm

- Complete the educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on 
research projects ongoing or completed during the last three years.
- List selected peer-reviewed publications, with full citations;

o CHECKLIST - This page should be completed and submitted with the 
application. If the F&A rate agreement has been established, indicate 
the type of agreement and the date. All appropriate exclusions must be 
applied in the calculation of the F&A costs for the initial budget 
period and all future budget years.

o The applicant should provide the name and phone number of the 
individual to contact concerning fiscal and administrative issues if 
additional information is necessary following the initial review. 

Applications are to be submitted on the grant application for PHS 398 
(rev. 4/98).  These forms are available at most institutional offices 
of sponsored research; from the Division of Extramural Outreach and 
Information Resources, National Institutes of Health, 6701 Rockledge 
Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, 
email: grantsinfo@nih.gov; and on the internet at 
http://grants.nih.gov/grants/funding/phs398/phs398.html

For purposes of identification and processing, item 2a on the face page 
of the application must be marked "YES" and the RFA number "AI-01-002" 
and the words "PREPAREDNESS AGAINST ILLEGITIMATE USE OF BACTERIAL 
PATHOGENS" must be entered on the face page.

The RFA label and line 2 of the application should both indicate the 
RFA number.  The RFA label must be affixed to the bottom of the face 
page.  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.

The sample RFA label available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been 
modified to allow for this change.  Please note this is in pdf format.

Applications must be received by January 26, 2001.  Applications not 
received as a single package on the receipt date or not conforming to 
the instructions contained in PHS 398 (rev. 4/98) Application Kit (as 
modified in, and superseded by, the special instructions below, for the 
purposes of this RFA), will be judged non-responsive and will be 
returned to the applicant. 

If the application submitted in response to this RFA is substantially 
similar to a grant application already submitted to the NIH for review, 
but that has not yet been reviewed, the applicant will be asked to 
withdraw either the pending application or the new one.  Simultaneous 
submission of identical applications will not be allowed, nor will 
essentially identical applications be reviewed by different review 
committees.  Therefore, an application that is essentially identical to 
one that has already been reviewed cannot be submitted in response to 
this RFA.  This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must 
include an introduction addressing the previous critique.

Submit a signed, typewritten original of the application, including the 
checklist, and three signed, exact, single-sided 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 mail or 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 
Dr. Madelon Halula at the address listed under INQUIRIES.

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 
application.

REVIEW CONSIDERATIONS  

Upon receipt, applications will be reviewed for completeness and 
adherence to the Special Instructions above by the NIH Center for 
Scientific Review and for responsiveness by NIAID staff; those judged 
to be incomplete or not in the format specified in this RFA will be 
returned to the applicant without review. Those considered to be non-
responsive will be returned without 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 NIAID in accordance with the review criteria 
stated below.  As part of the initial merit review, a process will be 
used by the initial review group in which all applications will receive 
a written critique but only those applications deemed to have the 
highest scientific merit will be discussed, assigned a priority score, 
and receive a second level review by the National Advisory Allergy and 
Infectious Diseases Council.

Schedule

Letter of intent receipt date:  December 15, 2000
Application receipt date:       January 26, 2001
Scientific review date:         May, 2001
Advisory Council date:          June, 2001
Earliest award date:            September, 2001

Review Criteria

The five criteria to be used in the evaluation of grant applications 
are listed below.  To put those criteria in context, the following 
information is contained in instructions to the peer reviewers.

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  
The reviewers will comment on the following aspects of the application 
in their written critiques 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 
by the reviewers 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 a 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.

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 
method?  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.

The personnel category will be reviewed for appropriate staffing based 
on the requested percent effort. The direct costs budget request will 
be reviewed for consistency with the proposed methods and specific 
aims. For modular grant applications, any budgetary adjustments 
recommended by the reviewers will be in $25,000 modules. The duration 
of support will be reviewed to determine if it is appropriate to ensure 
successful completion of the requested scope of the project.

AWARD CRITERIA
  
Funding decisions will be made on the basis of scientific and technical 
merit as determined by peer review, program balance, and the 
availability of funds.  The earliest anticipated date of award is 
September 15, 2001.

INQUIRIES  
  
Written and telephone inquiries concerning this RFA are encouraged.  
The opportunity to clarify any issues or questions from potential 
applicants is welcome.
 
Direct inquiries regarding programmatic (research scope and     
eligibility) issues to:  

Phillip J. Baker, Ph.D.
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases  
6700-B Rockledge Dr., MSC 7630, Room 3114
Bethesda, MD  20892-7630
Telephone:  (301) 435-2855
FAX:  (301) 402-2508
E-Mail:  pb26o@nih.gov
  
Direct inquiries regarding review issues and special instructions for 
application preparation; address the letter of intent to; and mail two 
copies of the application and all five sets of appendices to:
  
Madelon Halula, Ph.D.  
Division of Extramural Activities  
National Institute of Allergy and Infectious Diseases  
6700-B Rockledge Dr., MSC 7616, Room 2150
Bethesda, MD  20892-7616
Telephone:  (301) 402-2636
FAX:  (301) 402-2638
E-Mail: mh30x@nih.gov

Direct inquiries regarding fiscal matters to:  

Annette Hanopole
Division of Extramural Activities  
National Institute of Allergy and Infectious Diseases  
6700-B Rockledge Dr., MSC 7614, Room 2122
Bethesda, MD  20892-7614
Telephone:  (301) 496-7075
Fax: (301) 480-3780
E-mail:  ahanopole@niaid.nih.gov

AUTHORITY AND REGULATIONS

This program is supported under authorization of the Public Health 
Service Act, Sec. 301 (c), Public Law 78-410, as amended.  The 
Catalogue of Federal Domestic Assistance Citations are Sec. 93.856, 
Microbiology and Infectious Diseases Research, and No. 93.855 - 
Immunology, Allergy, and Transplantation Research.  Awards will be 
administered under PHS grants policies and Federal Regulations 42 CFR 
Part 52 and 45 CFR Part 74.  This program is not subject to the 
intergovernmental review requirements of Executive Order 12372 or 
Health Systems review.

The Public Health Service 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, 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.


Return to Volume Index

Return to NIH Guide Main Index


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


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.