NHLBI SHARED MICROARRAY FACILITIES

Release Date:  October 9, 2001

RFA:  RFA-HL-02-007

National Heart, Lung, and Blood Institute
 (http://www.nhlbi.nih.gov/index.htm)

Letter of Intent Receipt Date:  January 29, 2002
Application Receipt Date:       February 26, 2002

PURPOSE

This RFA seeks to facilitate the application of microarray technology to 
fundamental, hypothesis-driven research in the areas of cardiovascular, 
pulmonary, hematological, and sleep disorders.  The National Heart, Lung, and 
Blood Institute (NHLBI) will meet this goal by establishing (or expanding) 
Shared Microarray Facilities with the appropriate infrastructure, including 
equipment and expertise in relevant disciplines (molecular biology, robotics, 
bioinformatics, genomics, statistics, etc.), to facilitate the application of 
microarray technology and analysis to ongoing NHLBI supported research.  Each 
Shared Microarray Facility must serve a minimum of five ongoing NHLBI-funded 
research projects, encompassing two of the four program areas (cardiovascular, 
pulmonary, hematology, and sleep), at their local institution.  The Shared 
Microarray Facilities will provide study design guidance, microarray services, 
analytical tools and guidance in the interpretation of gene expression 
profiling results, and applicable knowledge/skills development and education 
to the NHLBI-supported researchers in all relevant aspects regarding 
microarray technology and its application.  

As there are different needs and circumstances of NHLBI-supported 
investigators, a companion Notice (HL-02-003) will be issued for 
administrative supplements for microarray applications and analysis to ongoing 
NHLBI-supported studies.

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), 
"NHLBI Shared Microarray Facilities," is related to several 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, 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.  Foreign institutions are not eligible to apply.   
Racial/ethnic minority individuals, women, and persons with disabilities are 
encouraged to apply as Principal Investigators.

To be eligible, institutions must have substantial ongoing NHLBI-supported 
research activity; give firm assurance concerning the availability of strong 
institutional commitment and support; assure continued maintenance and 
operation, including professional direction and technical support; and 
demonstrate that the Shared Microarray Facility will increase the effective 
application of microarray technology for the research community supported by 
NHLBI.
MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) Research Project 
Grant (R01) award mechanism.  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 four years.  This RFA is a one-time solicitation.  Future 
unsolicited competing continuation applications will compete with all 
investigator-initiated applications and be reviewed according to the customary 
peer review procedures.  The anticipated award date is September 30, 2002.

FUNDS AVAILABLE 

The NHLBI intends to commit approximately $4,500,000 in FY 2002 to fund six 
new grants in response to this RFA.  An applicant may request a project period 
of up to four years and a budget for direct costs of up to $500,000 per year. 
 The grantee must provide a description of institutional support, such as 
equipment, supplies, laboratory space and other funding sources . No award 
will be issued unless the availability of strong institutional support has 
been certified by an appropriate institutional business official.  No 
escalation of costs will be allowed beyond this maximum amount. Because the 
nature and scope of the research proposed may vary, it is anticipated that the 
size of each award will also vary.  Although the financial plans of the NHLBI 
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 
meritorious applications.  At this time, it is not known if this RFA will be 
reissued.

RESEARCH OBJECTIVES

A.  Background
Heart, lung, blood, and sleep disorders are complex conditions that are 
currently investigated from the perspective of the impact of only one or a few 
genes operating at a time.  With the progress of the Human Genome Project, the 
ability to examine all human genes and their products simultaneously and 
attempt to relate them to research questions relevant to heart, lung, blood, 
and sleep disorders is approaching.  One key tool in this endeavor is 
microarray technology.  Through the use of this technology to study the 
differing patterns of gene expression of normal and pathological cells and 
tissues, investigators may be able to dissect important molecular pathways, 
delineate pathogenic mechanisms, and identify novel therapeutic targets.  The 
knowledge gained through this application may have tremendous potential for 
the development of new and more effective diagnostic, preventive, and 
therapeutic approaches.

B.  Objectives and Scope
Many heart, lung, and blood investigators are eager to apply microarray 
technologies to further their research questions.  The major barriers to 
applying this technology are (1) the lack of funds to purchase or fabricate 
the microarrays, (2) access to bioinformatic resources and analytical tools to 
store, edit, share and analyze data derived from microarrays, and (3) access 
to a critical mass of investigators with the essential capabilities and 
sophistication for appropriate design and interpretation of experiments.  The 
NHLBI Shared Microarray Facilities are designed to overcome these barriers and 
enable multiple NHLBI-supported research groups to employ this contemporary 
technology in their approach to research problems in one centralized facility. 
 This Shared Microarray Facility will require the collaboration of 
investigators with expertise in many fields, such as molecular biology, 
bioengineering, robotics, bioinformatics, genomics, and statistics.  This RFA 
will support the establishment (or expansion) of a Shared Microarray Facility 
that will provide study design guidance, microarray services, analytical tools 
and guidance in the interpretation of gene expression profiling results, and 
applicable knowledge/skills development and education to the NHLBI-supported 
researchers in all relevant aspects regarding microarray technology and its 
application.

SPECIAL REQUIREMENTS

o The primary intent of this RFA is to enhance the capability of NHLBI-
funded investigators to work at the cutting edge of contemporary biomedical 
science through the establishment or expansion of shared microarray 
facilities.  Each Shared Microarray Facility will provide study design 
guidance, microarray services, analytical tools and guidance in the 
interpretation of gene expression profiling results, and applicable education 
and knowledge/skills development to the NHLBI-supported researchers in all 
relevant aspects regarding microarray technology and its application.  
Applicants must carefully describe the services, technology, and education 
plans that the Shared Microarray Facility will provide to the supported 
studies.  Discussion and justification of methodologies, technologies, 
bioinformatics, statistical analytical tools, knowledge/skills development and 
education plans, and the limitations of the approaches should be included.  A 
specific discussion of quality control/quality assurance must be included.  
Time lines for each phase of the service should be provided.  As the Shared 
Microarray Facility may be working with both animal model and human subject 
samples, care should be given to the issues regarding the use of these 
samples. 

o Each Shared Microarray Facility supported under this program must be 
initiated by providing service to a minimum of five ongoing NHLBI-supported 
research projects, where at least two of the four major scientific areas 
(cardiovascular, pulmonary, hematology, and sleep) are the focus of the 
research.  Each of these initial microarray studies must be summarized in the 
application.  The applicant should address the goals of the NHLBI-supported 
research and how the new microarray study will enhance those goals, the 
microarray study design (including quality control), the microarray analysis 
plan, and the time line associated with achieving the microarray study aims.  
In addition, the studies that have access to the Shared Microarray Facility 
must be committed to putting the data into the public domain through 
publication and public databases.

o The Shared Microarray Facility must also describe future plans, 
including an access and prioritization process and a time line, for supporting 
new NHLBI-supported projects once the initial microarray studies are 
completed.  A description or list of available NHLBI-supported studies at the 
grantee institution will be useful to determine the ultimate capacity of the 
Shared Microarray Facility.  A description of how the Shared Microarray 
Facility will attract new studies should be discussed.  The Shared Microarray 
Facility must have a process to document which studies gain access and are 
completed. 

o The Shared Microarray Facility must have an Internal Operations 
Committee.  This group will be involved in the oversight of the Shared 
Microarray Facility, the progress of the microarray studies, monitoring the 
timely dissemination of the microarray data to the scientific community, the 
access to the Shared Microarray Facility, the quality of the data, and the 
adaptation to changing technologies.  The applicant should describe the 
composition, function, process, and procedures of the Internal Operations 
Committee.

o Genome-wide expression analysis is a rapidly evolving field.  Hence, 
applicants will need to discuss how they will be poised to take advantage of 
technical and methodological advances and their impact on the throughput and 
costs proposed.

o This RFA is intended to support the cost-effective introduction of 
techniques to measure patterns of gene expression in specific tissues or cells 
of interest to NHLBI-supported investigators.  The Principal Investigator must 
detail a complete description of his or her Institutional resources and 
existing microarray facilities and describe how the application does not 
duplicate existing resources.  Assurance of the appropriate institutional 
commitment for the establishment, maintenance, staffing, and operation of a 
facility must be provided.

o To encourage exchange of information among investigators who participate 
in this RFA program, yearly meetings will be held.  A major goal of these 
meetings is to facilitate interaction by providing a forum that will lead to 
sharing technology, informatic, and analytical ideas.  In addition, discussion 
can include issues of quality assurance, bioinformatics, coordination, and 
knowledge/skills development and education.  Applicants must include travel 
funds that will allow the Principal Investigator and at least two other key 
scientists to participate each year at a two-day meeting in Bethesda, MD.  At 
least one of the key scientists should be at the doctoral, post-doctoral or 
junior faculty level.  Applications should include a statement indicating the 
willingness to participate in these meetings.

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.

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.  This policy announcement is found 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 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 NHLBI staff 
to estimate the potential review workload and plan the review.

The letter of intent is to be sent Dr. Deborah P. Beebe (see INQUIRIES) by the 
letter of intent receipt date listed.

APPLICATION PROCEDURES

The PHS 398 research grant application instructions and forms (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html must be used in 
applying for these grants. This version of the PHS 398 is available in an 
interactive, searchable PDF format. For further assistance contact GrantsInfo, 
Telephone 301/435-0714, Email: GrantsInfo@nih.gov.

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, including the 
Checklist, and three signed, photocopies, in one package to:

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

At the time of submission, two additional copies of the application as well as 
all five collated sets of Appendix material must be sent to Dr. Deborah Beebe 
at the address listed under Inquiries.  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.

Principal investigators should not send supplementary material without first 
contacting the Scientific Review Administrator (SRA).  The SRA will be 
identified in the letter sent to you indicating that your application has been 
received.  If you have not yet received such a letter within 10 business days 
of your submission, contact Dr. Deborah Beebe at the address listed under 
Inquiries.

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 by the CSR and 
responsiveness by the NHLBI.  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 NHLBI 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 
review by the NHLBI National Advisory 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 aspects of the 
application listed below, 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.

o Significance:  Does the proposed Shared Microarray Facility address 
important problems?  If the aims of the application are achieved, how will 
scientific knowledge be advanced?  What will be the impact of the Shared 
Microarray Facility on the productivity of multiple NHLBI-supported 
investigators and advancement of NHLBI program areas?  Are there sufficient 
numbers of NHLBI-supported research projects to establish a Shared Microarray 
Facility?

o Approach:  How well did the applicant address the special requirements 
listed in this RFA?  Does the applicant adequately describe the services and 
technology that the Shared Microarray Facility will provide to the NHLBI-
supported studies?  Are the methodologies, technologies, bioinformatics, 
statistical analytical tools, knowledge/skills development and education 
plans, and the limitations of the approaches discussed and justified?  Is a 
plan for quality control/quality assurance included?  Are the proposed time 
lines for each phase of the service appropriate? Are the descriptions of the 
initial microarray studies well thought out and appropriate?  Will the Shared 
Microarray Facility significantly improve progress made by the initial studies 
selected?  Are the conceptual framework, design, methods, and analysis 
adequately developed, well-integrated, and appropriate to the aims of the 
microarray studies?  Are there appropriate controls considered in each study 
that allows for meaningful results and data interpretation?  Does the 
applicant acknowledge potential problem areas and consider alternative 
tactics?  Is the bioinformatics support adequate?  Are the plans for providing 
future access to the Shared Microarray Facility adequately described?   Is the 
applicant willing and able to participate actively in a collaborative program?

o Innovation: Are the services and resources provided by the Shared Microarray 
Facility innovative?   Will this proposed Facility achieve the goals of the RFA?

o Scientific and Technical Competence of Investigators:  Are the investigators 
appropriately trained and well suited to carry out this work?  Is the work 
proposed appropriate to the experience level of the investigators?

o Environment: Do the scientific and administrative environments in which the 
work will be done contribute to the probability of success?  Do the proposed 
technologies take advantage of unique features of the scientific environment 
or employ useful collaborative arrangements?  Is there evidence of strong 
institutional support?  Is there evidence of adequate infrastructure (e.g., 
technologies, equipment, analytical tools and bioinformatic expertise)?

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 29, 2002
Application Receipt Date:         February 26, 2002
Peer Review Date:                 June/July, 2002
Council Review:                   September 5-6, 2002
Earliest Anticipated Start Date:  September 30, 2002

AWARD CRITERIA

The anticipated award date is September 30, 2002.  Criteria that will be used 
to make award decisions include:

o Scientific merit as determined by peer review;

o Availability of funds;

o Geographic balance;

o Quality of meeting the special requirements stated in this RFA;

o Programmatic balance; 

o Total cost of the project.

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to clarify any 
issues or answer questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Martha S. Lundberg, Ph.D.
Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Rm 9146, MSC 7940
Bethesda, MD  20892-7940
Telephone:  (301) 435-0513
Fax:  (301) 480-1335
Email:  lundberm@nhlbi.nih.gov 

Sandra Colombini Hatch, M.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Suite 10124, MSC 7952
Bethesda, MD  20892-7952
Phone:  (301) 435-0222
FAX:  (301) 480-3557
Email:  hatchs@nhlbi.nih.gov 

Greg Evans, Ph.D. 
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 10152, MSC 7950
Bethesda, Maryland  20892-7950
Telephone:  (301) 435-0055
FAX:  (301) 480-0868
E-Mail:  evansg@nih.gov 

Heidi Krause-Steinrauf, M.S.
Division of Epidemiology and Clinical Applications
National Heart, Lung and Blood Institute
6701 Rockledge Drive, Rm 8151
Rockledge II, Rm , MSC 7936
Bethesda, MD  20892-7936
Telephone:  (301) 435-0399
FAX:  (301) 480-3667
Email:  krauseh@nhlbi.nih.gov 

Direct inquiries regarding review issues to:

Deborah P. Beebe, Ph.D.
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7178, MSC 7924
Bethesda, MD  20892-7924 (20817 for Courier)
Telephone:  (301) 435-0270
FAX: (301) 480-3541
Email:  BeebeD@nhlbi.nih.gov 

Direct inquiries regarding fiscal matters to:

Raymond L. Zimmerman
Grants Operations Branch
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7156, MSC 7926
Bethesda, MD  20892-7926
Telephone:  (301) 435-0171
FAX:  (301) 480-3310
Email:  ZimmmermR@nhlbi.nih.gov  

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.837, 93.838, and 93.839.  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 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.


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.