INFECTIOUS ETIOLOGY OF CHRONIC DISEASES:  NOVEL APPROACHES TO PATHOGEN DETECTION

Release Date:  February 14, 2001

RFA:  RFA-AI-01-004

National Institute of Allergy and Infectious Diseases
National Cancer Institute
National Institute of Diabetes and Digestive and Kidney Diseases
Office of Research on Women’s Health

Letter of Intent Receipt Date:  April 16, 2001
Application Receipt Date:       May 15, 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 purpose of this Request for Applications (RFA) is to solicit 
applications for research projects that propose developing novel 
technologies or improving established technologies to enhance the 
ability to identify and validate the role of microbial pathogens in 
chronic diseases and cancer for which an infectious etiology is 
suspected. Areas of particular interest are studies using recent 
technological approaches in genomics, molecular biology, proteomics and 
computational biology.  The creation of interdisciplinary collaborative 
research teams is encouraged.  It is anticipated that the availability 
of innovative methods for detecting and identifying the infectious agent 
will stimulate avenues of research for studying the pathogenesis and 
etiology of chronic diseases and cancer.

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),  Infectious Etiology of Chronic Diseases: Novel 
Approaches to Pathogen Detection  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.  
Foreign institutions are not eligible for R21 grants.  Racial/ethnic 
minority individuals, women, and persons with disabilities are 
encouraged to apply as Principal Investigators.

MECHANISM OF SUPPORT

The mechanism of support will be the NIH individual research project 
grant (R01) and Exploratory/Developmental Research Project Grant (R21).  
The total requested project period for an application submitted in 
response to this RFA may not exceed four years for an R01 and two years 
for an R21. 

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

The R21 mechanism is particularly appropriate and encouraged for 
research technology development. R21 grants will be used 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.

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.

For administrative reasons all applications received in response to this 
RFA will be assigned initially to NIAID.  After discussions among the 
participating Institutes, applications will be reassigned to the 
Institute(s) that is programmatically most appropriate.  Because the 
scope of some of the research projects proposed in response to this RFA 
encompasses the interests of several NIH institutes, applications may 
receive dual assignments based on established PHS guidelines.  Awards 
will be made and managed by NIAID and/or the other participating 
institutes.

FUNDS AVAILABLE

The estimated total funds, (direct and Facility & Administrative (F&A) 
costs), available for the first year of support for all awards made 
under this RFA will be $3,000,000. In fiscal year 2002, the NIH plans to 
fund approximately 5-10 awards.  Although this program is provided for 
in the financial plans of the sponsoring institutes, 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

Chronic diseases contribute significantly to worldwide morbidity and 
mortality. In the United States chronic diseases account for 70% of all 
deaths and 61% of all health care costs.  Recent evidence indicates that 
microbial organisms play a role in the pathogenesis of a number of 
chronic diseases, including some cancers and a variety of 
cardiovascular, respiratory, gastrointestinal, and neurological 
diseases. Examples include peptic ulcers and gastric cancer(Helicobacter 
pylori), as well as Lyme arthritis and neuroborreliosis (Borrelia 
burgdorferi). In addition, there are a number of chronic diseases in 
which an infectious etiology is likely, but not proven. Recently, an 
association between Chlamydia pneumonia infection and the development of 
atherosclerosis in human and animal models has been noted.  

In a number of chronic diseases an infectious etiology has been 
suggested. Crohn’s Disease and Mycobacterium paratuberculosis or 
adherent E. coli have been suggested as potential etiologic agents. In 
colon rectal cancer Streptococcus bovis and schistosomes have been 
implicated as possible etiologic agents. Infectious agents may be 
involved in the pathogenesis of urologic and renal diseases such as 
nephrolithiasis, chronic prostatitis, and interstitial cystitis, and 
interstitial nephritis and immune complex renal diseases, such as 
various forms of glomerulonephritis.   Infectious organisms have been 
implicated in the pathogenesis of a number of gastrointestinal and 
hepatic chronic diseases including ulcerative colitis, tropical sprue, 
necrotizing enterocolitis, celiac diseases, sclerosing cholangitis, 
biliary atresia, achalasia, autoimmune and cryptogenic hepatitis, acute 
liver failure and possibly obesity.  In addition, viral agents have been 
suggested as possible triggers for an autoimmune process, which 
culminates in development of Type 1 Diabetes or immune complex renal 
disease in genetically susceptible individuals.
  
The detection of the pathogen and validation of its role in chronic 
diseases is critical to establishing an infectious etiology and 
development of effective treatment and prevention strategies.  

Research Objectives and Scope

The purpose of this initiative is to stimulate research on the 
infectious etiology of chronic diseases and cancer and in particular, to 
focus on developing novel or improved technologies for the detection and 
identification of microbial pathogens in tissue samples from patients 
with chronic diseases and cancer.  This research is critical for 
establishing an infectious etiology for chronic diseases and cancer, 
especially for those diseases for which an association with a specific 
pathogen is minimal, weak, or absent.  This RFA encourages the use of 
recent technological advances in genomics, molecular biology, proteomics 
and computational biology to develop innovative approaches for pathogen 
detection and identification.  Collaborative arrangements are also 
encouraged, in which scientists with expertise in epidemiology, 
pathology, clinical aspects of chronic diseases, molecular biology, and 
computational biology, and genomic technology work together to apply 
innovative approaches for identifying the infectious agents in chronic 
diseases.    

The search for an infectious cause of chronic diseases is particularly 
difficult when the organisms replicate slowly or not at all in culture, 
are present in low numbers or are present early or transiently in the 
disease process.  Advances in DNA sequencing technology have allowed 
scientists to rapidly and efficiently sequence DNA of microbial genomes.  
Having access to the DNA sequence of entire microbial genomes has, and 
will continue to, provide an enormous amount of information about the 
microbe and facilitate the development of more sensitive and specific 
methods for universal analysis of microorganisms in biological samples. 
It is anticipated that genomic targets of microbial nucleic acid 
sequences or gene families can be used for pathogen detection in 
biological tissues. Host global gene or protein expression profiles, 
reflecting responses in the host to a particular infectious agent, also 
have the potential to provide novel approaches to microbial pathogen 
identification. The identification of a particular microbial pathogen as 
the etiologic agent responsible for a chronic disease will allow 
research to progress on studying the mechanism of microbial 
pathogenesis, as well as design of new treatment and prevention 
strategies for that disease.  

This RFA is intended to support research that will develop novel 
technologies or improved ones for the detection and identification of 
microbial pathogens in tissue samples. The sharing of biomaterials, 
data, software and research technologies in a timely manner has been an 
essential element in the rapid process that has been made in the genetic 
analysis of mammalian and microbial genomes.  NIH policy requires that 
investigators make unique research resources readily available for 
research purposes to qualified individuals within the scientific 
community when they have been published [NIH Grants Policy Statement 
(http://grants.nih.gov/grants/policy/nihgps), Principles and Guidelines 
for Recipients of NIH Research Grants and Contracts on Obtaining and 
Disseminating Biomedical Research Resources: Final Notice, December 1999 
http://www.nih.gov/od/ott/RTguide_final.htm)].  NIH is interested in 
ensuring that research resources developed through this RFA become 
readily available to the research community for further research, 
development and application. Research technologies and resources 
produced in projects funded by this RFA are expected to be made 
available and disseminated to the scientific community.  Applicants are 
therefore expected to address in the application the timely and broad 
dissemination of these research resources to scientific community, 
essential in studying the infectious etiology of chronic diseases and 
cancer.

Research topics of interest include, but are not limited to, the 
following:

o Development of novel or established approaches for wide screening 
methods for universal pathogen detection in biological specimens using, 
for example, sequence-based methods such as PCR technology and DNA 
microarrays, or emerging technologies that are designed for 
identification, quantitation and analysis of gene products and their 
interactions including mass spectrophotometry, protein arrays and 
biosensors. 

o Validation of new and novel technologies for the identification 
and investigation of pathogens involved in chronic diseases and cancer.  
Representative studies for technology validation should include initial 
infection, and/or determination of etiologic role for new agents, and/or 
progression to chronic diseases and cancer.

o Development of innovative approaches to identify infectious agents 
in chronic diseases and cancer for which there may be a long interval 
between initial exposure to a pathogen and the subsequent development of 
clinically manifest disease. 

o Development of improved techniques for subtractive hybridization 
methods such as representational difference analysis for identifying 
unique nucleic acids of microbial origin, including oncogenic viruses in 
biological specimens.

o Development of methods for studying the host response to infection 
from the microbial pathogen using state-of-the-art technologies for 
examining global gene or protein expression in the host cell, 
identifying possible diagnostic signatures that may distinguish 
infection by a particular pathogen and may include using genetically 
manipulated animals such as transgenic or gene knockout animals. 

o Development of methods to isolate and express microbial and viral 
sequences that encode clinically relevant antigens leading to 
serological test for microbial detection, as well as tissue 
immunochemical staining procedures.

o Development of bioinformatics tools to assist in facilitating 
pathogen identification in chronic diseases such as development of 
databases and software algorithms for processing and analyzing 
microarray data, genomic comparisons and DNA sequence or protein 
analysis for identifying gene families and protein structures such as 
antigenic sites and membrane proteins. 

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

STUDY POPULATIONS

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, compelling rationale, and justification are provided 
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 Maria Y. 
Giovanni, 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 April 16, 2001, 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, 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 to plan 
the review.  The letter of intent is to be sent to Dr. Eleazar Cohen at 
the address listed under INQUIRIES.

APPLICATION PROCEDURES

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

Applications are to be submitted on the grant application form PHS 398 
(rev. 4/98) and will be accepted at the standard application deadlines 
as indicated in the application kit. Application kits are available at 
most institutional offices of sponsored research and may be obtained 
from the Division of Extramural Outreach and Information Resources, 
National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, 
MD 20892-7910, telephone 301/710-0267, email: [email protected]. In 
addition, the application kits can be found on the following URL: 
http://grants.nih.gov/grants/forms.htm.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS

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 BUDGET NARRATIVE 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.

Under Personnel, provide budget narrative for ALL personnel by position, 
role and level of effort.  This includes consultants and any  to be 
appointed  positions.  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 all 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 a Letter of Commitment or 
Intent if there is or is to be a subcontract/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, including consultants, 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. Applicant institutions should calculate the Facilities and 
Administration (F&A) costs using the current negotiated F&A rate, less 
exclusions, for the initial budget period and all future budget periods.  
It is not necessary to list the exclusions on the Checklist nor anywhere 
in 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. 
For purposes of identification and processing, item 2a on the face page 
of the application must be marked "YES" and the RFA number "AI-01-004" 
and the words "Infectious Etiology of Chronic Diseases: Novel Approaches 
to Pathogen Detection" must be entered on the face page.

Applications must be received by May 15, 2001.  Applications not 
received as a single package on the receipt date or not conforming to 
the instructions, including page limitations and font size, contained in 
PHS 398 Application Kit (rev. 4/98) (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. 

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.

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. Eleazar Cohen
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3239, MSC-7616
6700-B Rockledge Drive
Bethesda, MD  20892-7616

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

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  

Review Considerations

Upon receipt, applications will be reviewed for completeness by the NIH
Center for Scientific Review and for responsiveness by NIAID staff, 
those judged to be incomplete 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 the Division of Extramural Activities, NIAID in 
accordance with the review criteria stated below. As part of the initial 
merit review, all applications will receive a written critique and 
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, assigned a priority score, and receive 
a second level of review provided by the appropriate NIH National 
Advisory Council.  

Review Criteria

The 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?

The Scientific Review Group will also comment in an administrative note 
on the sharing and dissemination of research resources including, but 
not limited to, methods, protocols, and software to the scientific 
research community that may be developed in the research supported 
through this RFA.

The initial review group will also examine: the appropriateness of 
proposed project budget and duration, the adequacy of plans to include 
children and both genders and minorities and their subgroups as 
appropriate for the scientific goals of the research and plans for the 
recruitment and retention of subjects, the provisions for the protection 
of human and animal subjects, and the safety of the research 
environment.  

Schedule

Letter of Intent Receipt Date:    April 16, 2001	 
Application Receipt Date:         May 15, 2001
Scientific Peer Review Date:      September/October 2001
Advisory Council Date:            January 2002
Earliest Anticipated Award Date:  April 2002

AWARD CRITERIA
  
Funding decisions will be made on the basis of scientific
and technical merit as determined by peer review, programmatic 
priorities, and the availability of funds.  The earliest anticipated 
date of award is April 1, 2002.

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:  

Dr. Maria Y. Giovanni
Division of Microbiology and Infectious Disease
National Institute of Allergy and Infectious Diseases  
Room 3146, MSC-7630
6700-B Rockledge Drive
Bethesda, MD  20892-7630
Telephone:  (301) 496-1884
FAX:        (301) 480-4528
E-Mail:     [email protected]

Dr. Jack Gruber
Division of Cancer Biology
National Cancer Institute
Room 5012, MSC-7398
Executive Plaza North
Bethesda, MD 20892-7398
Telephone: (301) 496-9740
Fax:       (301) 496-2025
E-mail:  [email protected]

Dr. Jose Serrano 
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
Room 671, MSC 5450
2 Democracy Plaza
Bethesda, MD 20892-5450
Telephone: (301) 594-8871 
FAX    	 (301) 480-8300
Email: [email protected]

Dr. Lisa Beggs
Research Programs
Office of Research on Woman’s Health
Room 201 MSC 0161
Building 1 9600 Rockville Pike
Bethesda, MD 20892-0161
Telephone: (301) 402-1770
FAX:       (301) 402-1798
Email: [email protected]

Direct inquiries regarding review issues, address the letter of intent 
to, and mail two copies of the application and all five sets of 
appendices to:
  
Dr. Eleazar Cohen  
Division of Extramural Activities  
National Institute of Allergy and Infectious Diseases  
Room 3239, MSC-7616
6700-B Rockledge Drive  
Bethesda, MD  20892-7616
Telephone:  (301) 496-2550
FAX:        (301) 402-2638
E-Mail:     [email protected]

Direct inquiries regarding fiscal matters to:  

Annette Hanapole
Grants Management Specialist  
Division of Extramural Activities  
National Institute of Allergy and Infectious Diseases  
Room (insert), MSC-7614
6700-B Rockledge Drive  
Bethesda, MD  20892-7614  
Telephone:  (301) 402-5937
Fax:        (301) 480-3780
E-mail:     [email protected]

AUTHORITY AND REGULATIONS

This program is described in the Catalogue of Federal Domestic 
Assistance No. 93.8__(Use appropriate program number.  NIAID citations 
are Sec. 93.856, Microbiology and Infectious Diseases Research, and No. 
93.855 - Immunology, Allergy, and Transplantation 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 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.

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