SUPPLEMENTS TO SUPPORT CANDIDA DNA MICROARRAY FACILITIES

Release Date:  March 27, 2000

RFA:  DE-00-004

National Institute of Dental and Craniofacial Research
http://www.nidcr.nih.gov/

Letter of Intent Receipt Date:  April 15, 2000
Application Receipt Date:       May 15, 2000

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 Dental and Craniofacial Research (NIDCR) 
announces the availability of competitive supplements to assist 
institutions with establishing DNA microarray facilities. The DNA 
microarray facilities must be designed to support research on Candida 
species or Saccharomyces cerevisiae that will lead to advancements in 
diagnosis, prevention or treatment of candidiasis.  The DNA microarray 
facility must be located at a site receiving an NIDCR grant to study 
Candida species or candidiasis.  A minimum of five additional NIH-
funded research projects conducting research on Candida or 
Saccharomyces must be served by the activities of the DNA microarray 
facility.  For the purpose of this initiative, each project within a 
multi-project grant can be considered as a qualifying research project.

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), SUPPLEMENTS TO SUPPORT CANDIDA DNA MICROARRAY 
FACILITIES, is related to the focus area, Oral Health. Potential 
applicants may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople/.

ELIGIBILITY REQUIREMENTS

Institutions having a NIDCR-funded research project (R01), MERIT award 
(R37), program project (P01), Center Core (P30), Comprehensive Center 
(P60), conducting research on Candida species or candidiasis, and 
having at least two years remaining on the grant, are eligible to 
receive a supplement for a DNA microarray facility.  The collaborating 
sites that would use the array facility must have an NIH-funded grant, 
be conducting research on Candida species or Saccharomyces cerevisiae, 
and have at least two years remaining on the grant.  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.  

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) competitive 
supplement award to a peer-reviewed, funded project.  Responsibility 
for the planning, direction, and execution of the proposed project will 
be solely that of the applicant.  The total project period for an 
application submitted in response to this RFA may not exceed 2 years.  
This RFA is a one-time solicitation.  The anticipated award date is 
September 29, 2000.

FUNDS AVAILABLE

The NIDCR intends to commit approximately $2.0 million in FY 2000 to 
fund 8 DNA microarray facilities in response to this RFA.  Applicants 
may request up to two years of support; the requested budget may not 
exceed $250,000 total costs in year 1 and $100,000 total costs in year 
2.  Although the financial plans of the NIDCR provide support for this 
program, awards pursuant to this RFA are contingent upon the 
availability of funds and the receipt of a sufficient number of 
applications of outstanding scientific and technical merit. 

RESEARCH OBJECTIVES

Background

This competitive supplement program is issued in response to 
recommendations developed at several recent NIDCR Workshops and the 
NIDCR Advisory Council.  The workshop participants and Council members 
expressed a growing need in the research community for access to high 
quality and affordable microarray technology.  The need for such 
technology is also based in part on the soon-to-be-completed sequences 
of the NIDCR-supported Candida albicans genome project 
(http://www-sequence.stanford.edu/group/candida/).  

Scope

The DNA microarray facilities must be designed to support research on 
Candida species or Saccharomyces cerevisiae that will lead to 
advancements in diagnosis, prevention or treatment of candidiasis.  The 
DNA microarray facility must be located at a site receiving an NIDCR 
grant to study Candida species or candidiasis.  A minimum of five NIH-
funded research projects studying Candida or Saccharomyces must be 
served by the activities of the array facility.  For the purpose of 
this initiative, each distinct project within a multi-project grant 
(e.g., Program Project or Center) can be considered as a qualifying 
research project.

Requests for supplements are limited to one per institution.  Requests 
must be limited to the purchase of equipment, supplies, and technical 
personnel critical to the DNA microarray facility.  There is no 
restriction to the type of array technology that the applicants may 
select.  Appropriate use of the support includes, but is not limited 
to, purchase of DNA arrayers and readers, as well as robotic equipment 
for automation; and, with strong justification, computers and software 
for informatics.  Since these supplements are intended to assist 
institutions, it is expected that the applicant institutions will 
support personnel, equipment, and supplies associated with the 
establishment and operation of the facility.  

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women, 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 is 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 "NIH Guidelines for Inclusion of Women and Minorities as 
Subjects in Clinical Research", published in the Federal Register of 
March 28, 1994 (FR 59 14508-14513), and in the NIH Guide for Grants and 
Contracts, Vol. 23, No. 11, March 18, 1994, available on the web at: 
http://grants.nih.gov/grants/guide/notice-files/not94-100.html. 

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.

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 a letter of intent that 
includes a descriptive title of the 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 the RFA in response to which the application 
may be submitted. Although a letter of intent is not required, is not 
binding, and does not enter into the review of a subsequent 
application, the information that it contains allows NIDCR staff 
to estimate the potential review workload and avoid conflict of 
interest in the review process.

The letter of intent receipt date is listed in the heading of this RFA 
and is to be sent to the program staff listed under INQUIRIES.

APPLICATION PROCEDURES

Requests must meet the criteria required for all supplements: the 
project period of the grant to be supplemented must have at least two 
years remaining at the time of award.  The other participating sites 
must have a NIH-funded project with at least two years remaining at the 
time of award.  Applicants may request up to two years of support; the 
requested budget may not exceed $250,000 total costs in year 1 and 
$100,000 total costs in year 2.  

The applicant should provide the following:

1. A description of five or more NIH-funded research projects that will 
benefit from the presence of a microarray facility, including how the 
array technology will enhance ongoing research projects.  A signed 
letter of collaboration from each participating site should be 
submitted with the application.  Collaborations with less research 
intense institutions is encouraged. 

2. . A detailed description of the administration and management of the 
DNA microarray facility.  Important consideration should be given to 
setting priorities for the facility workload, cost-sharing 
considerations, and ensuring broad access by five or more projects 
listed in Item 1 as well as others in the Candida and Saccharomyces 
research communities.

3. Documentation of strong institutional commitment to support the 
microarray facility, including continued support for the facility and 
the technology after the time period of the supplement.  Applicants 
must document the resources and environment available at the 
institution to effectively operate the facility, including support for 
personnel, equipment, supplies, and availability of laboratory space.

4.  Under the standard Modular Grant Application instructions, only a 
justification for key personnel has been required.  However, due to the 
nature of this RFA, a narrative justification should be provided for 
all personnel, equipment or supplies.  A detailed budget for these 
requests, however, is not needed.  

The application should be developed using the PHS Form 398 (revised 
4/98) Face Page, Biosketch of the Principal Investigator, and Resources 
Form Page 8.  The Research Plan should address points 1 through 4 above 
and must not exceed FIVE pages.

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 (revised 4/98) is to be used in applying for 
these grants, with the modifications noted below.

BUDGET INSTRUCTIONS

Modular Grant applications must request direct costs in $25,000 
modules, up to a total direct cost request of $250,000 per year.  In 
this RFA, the modular grant application format has been applied to 
additional grant activities (R37, P01, P30, and P60) that are not part 
of the standard NIH model. The modular budget request must be in 
accordance with 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 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.  For this RFA, Total Costs may 
not exceed $250,000 in year 1 and $100,000 in year 2.

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 key 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 a 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. 

The RFA label available in the PHS 398 (rev. 4/98) application form 
must be affixed to the bottom of the face page of the application. 
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 title and number of this RFA must be typed in 
Item 2 on the face page of the application form, and the YES box must 
be marked.  The RFA number must be typed on the label as well.  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 the pdf 
format.

Submit a signed, typewritten original of the application, including the 
Checklist, and three (3) signed photocopies, in one package to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH 
SUITE 1040
6701 ROCKLEDGE DRIVE, MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)

At the time of submission, two (2) additional copies of the application 
must be sent to:

Dr. H. George Hausch
Scientific Review Branch 
Division of Extramural Research
National Institute for Dental and Craniofacial Research 
45 Center Drive, Room 4AN-38D- MSC 6402
Bethesda, MD 20892-6402

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

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness and 
responsiveness by the CSR and NIDCR.  Incomplete and/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 NIDCR in accordance with the review 
criteria stated below.  A process will be used by the initial review 
group in which all applications receive a written critique but 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 review 
by the National Advisory Dental and Craniofacial Research Council.

Review Criteria

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.

(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 study 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:     April 15, 2000
Application Receipt Date:          May 15, 2000
Peer Review Date:                  July 2000
Council Review:                    September 2000
Anticipated Start Date:            September 29, 2000

AWARD CRITERIA

Award criteria that will be used to make award decisions include:
o-scientific merit (as determined by peer review) 
o-availability of funds
o-programmatic priorities


INQUIRIES

Inquiries concerning this RFA are strongly encouraged.  The opportunity 
to clarify any issue or questions from potential applicant is welcome.

Direct inquiries regarding programmatic issues to:

Denise A. Russo, Ph.D.
Infectious Diseases and Immunity Branch
Division of Extramural Research
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AN-32F
Bethesda, MD 20892-6402
Telephone: (301) 594-2617
FAX: (301) 480-8318
Email: Denise.Russo@nih.gov


Direct fiscal inquiries to:

Martin Rubinstein
Grants Management Branch
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AN-44
Bethesda, MD 20892-6402
Telephone: (301) 594-4800
FAX: (301) 480-8301
Email: Martin.Rubinstein@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance 
No. 93.121, Oral Diseases and Disorders Research Awards.  Awards are 
made under authorization of the Public Health Service Act, Title IV, 
Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 
and 285) 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 PHS strongly encourages all grant 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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