ADVANCED RESEARCH COOPERATION FOR ENVIRONMENTAL HEALTH 

RELEASE DATE:  June 19, 2003

RFA:  ES-03-009

National Institute of Environmental Health Sciences (NIEHS)
 (http://www.niehs.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 
93.113, 93.114, 93.115

LETTER OF INTENT RECEIPT DATE: October 21, 2003

APPLICATION RECEIPT DATE: November 21, 2003

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA

The mission of the National Institute of Environmental Health Sciences (NIEHS) 
is to reduce the burden of human illness and dysfunction from environmental 
exposures.  The NIEHS achieves its mission through multidisciplinary 
biomedical research programs, prevention and intervention efforts, and 
communication strategies that encompass training, education, technology 
transfer, and community outreach.  An important element of the NIEHS mission 
is to develop the research capacity of minority-serving institutions that have 
research scientists who are committed to understanding the impact of 
environmental exposures on human health.  To address this need, the NIEHS has 
developed a Thematic Program Project Grant (S11) that focuses on establishing 
research partnerships between investigators at Research Intensive Universities 
(RIUs) with significant biomedical health sciences research and at Minority 
Serving Institutions (MSIs) with graduate and/or professional schools 
conferring doctoral degrees.  MSIs for the purposes of this solicitation are 
academic institutions, either medical or non-medical, that have a minority 
enrollment greater than 50 percent.  This includes Historically Black Colleges 
and Universities (HBCUs), Hispanic Serving Institutions (HSIs), and Tribal 
Colleges and Universities.  The purpose of this grant is to establish a 
research infrastructure and a hypothesis-driven research program at a Minority 
Serving Institute that develops a cadre of investigators that will 
successfully compete for Research Project Grant (RPG) support.

RESEARCH OBJECTIVES

Background

Research programs in environmental health science at MSIs have not been 
extensively pursued or realized.  NIEHS believes there is a critical need for 
a focused program to increase the participation of minority schools and 
investigators in the health research mission of the NIEHS.  To address the 
need for increased minority participation the NIEHS has developed this 
program, which focuses on establishing research partnerships between 
investigators at RIUs with significant environmental health sciences research 
and investigators at MSIs with graduate/professional schools with a strong 
interest in such research.  The low level of involvement of minority serving 
institutions in environmental health science and the lack of sufficient 
training opportunities for minority scientists represent two major obstacles 
to developing an effective cadre of investigators at MSIs engaged in research 
efforts aimed at addressing environmental health issues.  One way of meeting 
these challenges is to increase the pool of well-trained investigators, 
especially in minority groups where the proportion of biomedical investigators 
is strikingly lower than the percentage of minority U.S. citizens.   

Currently, there are four collaborative ARCH programs that are supported by 
the NIEHS.  Awards were made to Southern University Baton Rouge, Xavier 
University, Florida A&M University, and Florida International University.  RIU 
partners are the University of Texas Medical Branch at Galveston (UTMB), 
Tulane University Medical Center, Wayne State University, and the University 
of Miami, respectively.  The Southern-UTMB collaboration scientific thematic 
focus is on the molecular mechanisms of butadiene toxicity.  The Xavier-Tulane 
collaboration focuses on xenobiotic regulation of transcription.  The Florida 
A&M-Wayne State collaboration focuses on signal transduction and Florida 
International-Miami ARCH project addresses marine and freshwater toxics and 
arsenic speciation.  All of these projects feature unique scientific 
partnerships that allow for faculty development at the MSIs while supporting 
sound scientific research at both institutional partners. (See ARCH website: 
http://www.niehs.nih.gov/translat/arch/arch.htm)

The most recent ARCH RFA solicitation, ES-00-006, utilized a two-tiered award 
program for either ARCH I or ARCH II programs.  Key differences between ARCH I 
and ARCH II programs were the number of research projects allowed and 
requirement of a Faculty recruitment component.  The current initiative has 
some significant differences with regards to what an ARCH award will support. 
There will only be one type of ARCH award available, as in the initial ARCH 
RFA (ES-98-005), eliminating opportunities for ARCH I or ARCH II designations. 
Additionally, there will be a greater emphasis placed on the pilot project 
component allowing for collaborative pilot projects at both the MSI and RIU.  
Further, only one research project will be funded at the MSI, however there 
will be an increase in resources allocated for that project to allow more 
opportunities for collaboration.  There will not be a faculty recruitment 
component for ARCH awards made in response to the current RFA.  

Objectives and Scope

The ARCH grant is a mechanism for the support of a broadly based research 
program involving investigators at an MSI and established investigators at an 
RIU sharing knowledge and common resources.  The goal of the ARCH grant is to 
establish a group of investigators at an MSI that can successfully compete for 
National Institutes of Health (NIH)/NIEHS Research Project Grant (RPG) 
support, typically R01/R15 grants, or awards from other agencies that use the 
peer review mechanism, for example, U.S. Environmental Protection Agency, the 
National Science Foundation, or the American Cancer Society.  To achieve this 
goal an ARCH grant will provide support for a broadly based multidisciplinary 
research program that has a well-defined central research focus or objective. 
The NIEHS envisions the support received from the ARCH grant as the foundation 
necessary for achieving the above stated goal.  It is anticipated that the MSI 
scientists will compete for other types of NIH/NIEHS and peer reviewed grants 
during the period of ARCH funding as part of the overall strategy for this 
effort.  Thus, as the ARCH program develops at the MSI institution, it is 
expected that the MSI investigators will compete for other types of grants in 
areas relevant to the NIEHS mission (K01, R15, R03, R01, P01, F31/32, T32, 
etc.) that will provide research support after the ARCH award support ends.  
Information on the mission and program interests of NIEHS is available on the 
web site: http://www.niehs.nih.gov/dert/programs/special/special.htm.

MECHANISM OF SUPPORT

This RFA will use the NIH S11 award mechanism.  As an applicant you will be 
solely responsible for planning, directing, and executing the proposed 
project.  This RFA is a one-time solicitation.  The anticipated award date is 
July 1, 2004. 

This RFA uses just-in-time concepts.  This RFA uses the non-modular budgeting 
format.  Applicants must use the forms for regular research grants, follow the 
specific instructions in the PHS 398 application kit, and provide a complete 
detailed budget (Forms Pages 4 & 5) with narrative justifications.  This 
program does not require cost sharing as defined in the current NIH Grants 
Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm

FUNDS AVAILABLE

The NIEHS intends to commit approximately $3,000,000 in FY 2004 to fund three 
new and/or competitive continuation grants in response to this RFA.  An 
applicant may request a project period of up to five years and a budget for 
direct costs of up to $750,000 per year.  Because of the nature and scope the 
proposed research will vary from application to application, it is anticipated 
that the size and duration of each award will also vary.  Although the 
financial plans of the NIEHS 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.  

ELIGIBILE INSTITUTIONS

As described below, there are specific eligibility criteria for the partner 
institutions that must be met in order to apply for this RFA.  Potential 
applicants are strongly encouraged to contact the NIEHS program administrator 
listed under WHERE TO SEND INQUIRIES.  

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS 

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with his/her institution to 
develop an application for support.  Individuals from underrepresented racial 
and ethnic groups, women and individuals with disabilities are always 
encouraged to apply for NIH programs.  The Principal Investigator must have 
his or her primary appointment at the applicant MSI institution.   

SPECIAL ELIGIBILITY REQUIREMENTS

Applicant Organization and Investigators

For this RFA, the applicant organization must be a Minority Serving 
Institution (MSI).  The MSI must have a graduate or professional school that 
offers at least one doctoral degree  (Ph.D., M.D., D.V.M., D.D.S., etc.)  The 
Principal Investigator must have his/her primary appointment at the applicant 
MSI, and have a strong interest in environmental health sciences.  The ARCH 
application must also include a Research Intensive University (RIU) with 
significant research support in environmental health sciences, and an RIU 
leader (co-investigator) who has demonstrated interests in environmental 
health sciences. Applications that include RIU investigators who are current 
NIEHS grantees are strongly encouraged, but not required.  Only one 
application will be accepted per eligible minority serving institution and 
each RIU may participate in no more than one application in response to this 
RFA.

MSI and RIU Collaboration

The MSI/RIU collaboration must be between an MSI with a strong interest in 
environmental health sciences and RIU investigators with a significant 
research base in peer reviewed environmental health sciences-related research 
support such as R01, P20/30, P42, etc.  Environmental health has been defined 
as "those aspects of human health, including quality of life, that are 
determined by physical, chemical, biological, social and psychosocial factors 
in the environment (World Health Organization, 1993)."  Thus, collaborations 
may focus on any component of environmental health science-research as defined 
by the preceding definition of environmental health.  ARCH awards will support 
research that utilizes state of the art methodologies in the conduct of 
environmental health sciences research.

The need for continuous and active communication among sites dictates that 
only MSIs in the United States, its possessions or its territories are 
eligible to apply.  Ideally, the collaborating institutions should be in close 
proximity to one another, less than 100 miles apart.  However, if the distance 
between institutions exceeds 100 miles, applicants should describe procedures 
and/or processes that will be used to overcome any potential problems 
associated with the geographical separation.  Racial/ethnic minority 
individuals, women, and persons with disabilities are encouraged to apply as 
Principal Investigators.

ARCH programs will: (1) help minority institutions develop state-of-the-art 
environmental health science research programs; (2) create more opportunities 
for researchers employed by minority serving institutions to establish 
research collaborations and professional networks with NIH grantees employed 
by research intensive institutions; (3) increase the role of ongoing research 
in maintaining a vigorous, stimulating academic and intellectual milieu that 
will inspire and prepare students and fellows to pursue research careers in 
environmental health sciences; and (4) provide support for pilot research.  
Support of pilot projects is intended to bolster the skills and abilities of 
investigators, to obtain preliminary data, and to publish in peer reviewed 
journals that can help ensure successful competition for traditional research 
grants and awards.

The purpose of this initiative is to form a cooperative program that will 
augment and strengthen the research infrastructure and research capabilities 
of faculty, students, and fellows at minority institutions by supporting the 
development of new, and/or the enhancement of ongoing, basic science and 
translational research that focuses on topics deemed to be of high priority 
and significance because of their critical importance to environmental health. 

ESSENTIAL CHARACTERISTICS OF ARCH GRANTS

Overall Characteristics

The ARCH grant will support a broadly based multidisciplinary research and 
development program that is a collaborative effort between an MSI and an RIU. 
The program focus should be on establishing a group of investigators at the 
MSI that can compete for NIH Research Project Grant (R03, R21, R01 or R15 if 
R15 eligible) support.  Key factors for an ARCH grant are as follows:

o There be should be a unifying, well-defined goal or problem area of research 
to which each project relates and contributes.  This may be a specific disease 
outcome, e.g., asthma, diabetes, cancer, low birth weight or children=s 
health, autoimmune disorders, etc. or a more general area, such as, gene-
environment interactions, xenobiotic gene regulation, molecular mechanisms of 
toxicity.

o There must be the participation of established investigators from the RIU 
and MSI, and all investigators must contribute to, and share the 
responsibilities for, fulfilling the program objectives.  The program should 
include enough participation to make a collaborative effort successful, and 
yet not so diverse in scope as to make program collaboration and communication 
ineffective.

o The RIU investigators included in this project must have significant peer-
reviewed research project grant support that is relevant to the NIEHS mission 
(see NIEHS web site: http://www.niehs.nih.gov/external/intro.htm)

o There must be a demonstrated commitment of the MSI and RIU institutions to 
the support and encourage the ARCH program.  Such support usually involves 
release time of faculty, capital improvements that will facilitate the 
research, and assistance in the acquisition of scientific equipment and 
supplies.  A letter of support from the Chancellor or President of the 
applicant institution will be required to demonstrate support for the ARCH 
program from the highest level of institutional administration.

o All MSI ARCH investigators must spend a sabbatical period in the laboratory 
of their RIU collaborator.  This sabbatical period must consist of a minimum 
of one semester and can include summer research experiences.  It is 
anticipated that during the sabbatical period, the MSI ARCH investigator will 
further hone his/her research skills and write and submit a grant application 
under the tutelage of his/her RIU collaborator.

Administrative and Planning Core

There must be strong leaders at both the MSI and RIU who are substantially 
committed to the project, are capable of scientific leadership and are willing 
to accept responsibility for the administration and integration of the 
program.  Assessment of the ability of the program Principal Investigator 
(ARCH Director) and RIU leader to develop a tightly integrated program of 
collaborative research will be a significant consideration in evaluation of 
the application.

The administrative/planning core must provide the support of administrative 
and research development infrastructure for the entire program and should not 
be duplicated within any other components or within support normally provided 
by the MSI or RIU institutions.  The responsibilities and activities for the 
administrative and planning core include:

o Appropriate and adequate organization and facilities for conduct of the 
research and development activities such as seminars, workshops, reference 
collection, computer support, etc.  Specifically the administration and 
planning core must develop and support a grants writing course (not a seminar) 
that is available to all MSI ARCH grant investigators and other MSI faculty.  
Additionally this core must also subscribe and provide access to electronic 
library services that allow MSI ARCH grant investigators to remain current 
with scientific literature relevant to their research pursuits.

o An Internal Steering Committee formed of the individual project leaders (RIU 
and MSI investigators) that will assist the Principal Investigator in making 
scientific and administrative decisions in the operation of the program.

o An External Advisory Committee, comprised of at least three members who are 
outside both the MIU and RIU and are recognized leaders in the biomedical 
sciences related to the scientific theme of the program, that will provide 
overall guidance and advice to the Principal Investigator and program 
investigators on program direction.

o A Senior Scientific Advisor (SSA) who is on the faculty of the MSI and has 
been successful in attracting RPGs (R01, P01, etc.) from the NIH.  This 
individual will assist the ARCH Director in the overall development of the MSI 
research infrastructure and advise the MSI investigators on the preparation of 
research grant applications.  The SSA must have affiliation with the MSI and 
serve as a liaison between ARCH grant investigators and administration. 

Research Program Development Core

The function of the core is to strengthen, stabilize and consolidate 
interaction and cooperation between the Minority Serving Institution and the 
collaborating RIU=s environmental health science program.  All research 
projects will be part of the Research Development Core.  Two types of projects 
(Pilot and Research) will be supported as part of the ARCH program and both 
types must be present.  It is of paramount importance that each project (Pilot 
and Research) be of sufficient scientific merit to warrant independent support 
and that each project is an integral part of the ARCH program.  To be funded, 
an ARCH program must have at least three Pilot projects and one Research 
project that are judged to have significant and substantial scientific merit 
on their own.

Research projects are R01-type projects that have as the project leader either 
RIU or MSI faculty who have been Principal Investigators on R01 grants from 
the NIH in the past three years.  A faculty member from the other 
collaborating institution is required to be included in the project.  The 
maximum project period for a Research project is five years.  One research 
project will be funded by an ARCH award.  The roles of both the MSI and RIU 
collaborators must be clearly described in the ARCH grant application.

Pilot projects are intended to provide an MSI investigator an opportunity to 
develop his/her research skills and/or for the MSI investigator to obtain the 
preliminary research data needed for the submission of a peer reviewed 
research grant application.  Additionally pilot projects may provide RIU 
collaborators/mentors an opportunity to develop/pursue new research activities 
that generate preliminary data to be used in subsequent traditional grant 
submissions.  Pilot projects can also be developed in the RIU investigators 
established area of research.  

Pilot projects are established between an MSI investigator and an RIU 
mentor/collaborator.  The maximum project period for a Pilot project is 36 
months.  Pilot project leaders may be either MSI or RIU investigators. 

In order to assess the success of the Pilot projects and to provide for new 
Pilot projects, the application must include a provision for:

o The scientific merit review of new Pilot projects that may be submitted by 
MSI or RIU investigators.  Copies of all proposals, with documentation of 
their reviews, relative ranking, and final action must be retained by the ARCH 
Director.

o The tracking of the results of each Pilot project (abstract, peer reviewed 
grant applications, publications, presentations, etc.).  These records must be 
available to NIEHS program staff.

A. Facilities Core may be proposed provided it meets the criteria listed 
below:

o The Core must provide service, on a continuing basis to two or more Research 
or Pilot projects.  This support may be directed to different projects as the 
scientific program advances.

o The Facility Core should utilize state-of-the-art techniques and equipment 
in order to maximize the efficiency of the entire ARCH program.

o Core support funded by this grant should provide service for only Research 
and Pilot projects.  Service provided to other projects may be done on a fee-
for-service basis or there must be some reciprocal service provided to the 
program that is substantially of the same value.

o The Facilities Core(s) must be located on the MSI campus.

ALLOWABLE COSTS

The ARCH award will provide multiple components of support that in total will 
provide funds for the establishment of research and development collaboration 
between groups of investigators at an MSI and an RIU.  The general budget 
categories and dollar levels that can be supported by this award are listed 
below.  However, the specifics for each budget category are the responsibility 
of the Principal Investigator.  The total direct cost that may be requested 
for an ARCH program is limited to $750,000 per year.  Indirect costs for the 
subcontract to the RIU that are included as a part of the MSI direct costs are 
not included in the $750,000 per year budget limit.

A. Administrative/Planning Core  

1. The ARCH grant will provide up to $150,000 (direct cost) per year for 
administrative/planning support.  These funds are intended to support the 
research infrastructure necessary to provide MSI investigators an adequate 
opportunity to develop competitive research applications.  Funds for the 
conduct of Pilot and Research projects including salary are to be included in 
the Research Program Development Core budget.  The MSI Principal Investigator 
and the RIU leader are responsible for development of the 
Administrative/Planning Core budget.  A listing of some of the items that may 
be included in this core is provided below.

Budget Item and Maximum Allowable Support:
o Principal Investigator -  25 percent effort
o RIU Leader - 15 percent effort
o MSI or RIU Senior Scientific Advisor - 10 percent effort
o Administrative Assistant at MSI -  50 percent effort
o Administrative Assistant at RIU -  25 percent effort
o Computer network support/Office supplies -  as justified
o Seminars/Program enhancement/courses -  as justified
o Travel for ARCH investigators -  as justified
o Travel for external advisory committee -  as justified

2. An additional request of up to $100,000 for major equipment items for MSI 
investigators may be included in the Administrative/Planning Core budget in 
the first two years.  This equipment may be in addition to equipment that is 
requested for the Research/Pilot projects or the Core facility.  These 
equipment items must be well justified and be an integral part of the research 
program the MSI investigator(s) plan to develop.  These funds are in addition 
to the $150,000 for the administrative/planning core budget items identified 
above. 

B. Research Program Development Core

The ARCH grant will provide up to $550,000 in direct costs per year for the 
research program development core at the ARCH to include: 1) At least three 
collaborative pilot projects between ARCH (MSI and RIU) investigators; and 2) 
one collaborative Research project between MSI and RIU investigators  [most 
likely will be at RIU] [Describe Facility Cores separately from the Research 
Program Development Core].

1. Pilot Projects

Items that may be included are MSI and RIU investigator salaries, technical 
support, supplies, small equipment items, travel and other items that are 
necessary for the conduct of the Pilot Project.  The maximum direct cost for 
each Pilot Project is $100,000 per 12-month period, and the maximum length of 
a Pilot Project is 36 months.  At least three Pilot Projects must be 
recommended by the Special Emphasis Panel (SEP) in order to be eligible for an 
ARCH award.  Pilot Projects may be located on either the MSI or RIU campus and 
each Pilot Project will be a collaborative effort between MSI and RIU 
investigators.

2. Research Projects

Research Projects are to be conducted by RIU and MSI investigators.  The 
maximum direct cost for a Research Project is $150,000 per year, and funding 
may be requested for up to five years.  One Research Project will be supported 
per ARCH award.

C. Facility Core

The Principal Investigator may request up to $100,000 per year (direct cost) 
for the Facility Core.

The Facility Core unit is a resource for the Research/Pilot projects that 
provides centralized services or equipment to several projects.  At a minimum, 
a Facility Core must provide service or equipment for at least one Pilot 
Project and one Research Project.  The Facility Core must be located at the 
MSI and the support may be directed to different component research projects 
as the scientific program advances.  

The ARCH program is not intended to provide support for graduate students.  
Such support should be obtained through competitive training programs of the 
NIH/NIEHS such as the Individual (F31), Institutional (T32) National Research 
Service Awards or through supplements to ongoing RPGs.

D. Supplemental Funds for Additional MSI Investigators or Postdoctoral 
Trainees

As the program develops, supplemental funds may be requested for support of 
additional MSI/RIU faculty and postdoctoral trainees on RIU Research projects. 
This includes Research Supplements for Underrepresented Minorities   
(http://grants.nih.gov/grants/guide/pa-files/PA-01-079.html) and is restricted 
to the RIU Research Projects.  Other types of administrative supplement 
requests will require approval of NIEHS staff prior to submission, and is 
contingent upon availability of funds. 

ADDITIONAL CRITERIA

A. Mid-Program Evaluation Criteria for ARCH Awardees.

In addition to the usual review of the non-competing application each year, 
there will be an in-depth review of the progress of each ARCH award toward 
meeting the program goal at the end of the third year of the grant period.  
The criteria to be used for the evaluation are the following:

o Number of peer reviewed publications with an MSI author/co-author.
o Number and type of peer reviewed grants submitted and awarded.
o Quality and efficacy of mentoring activities provided by the RIU.
o Status of the MSI research infrastructure, and plans for sustaining and 
nurturing it after the ARCH grant funding ends.

The in-depth mid-program evaluation will be used as a basis for awarding the 
fourth and fifth year of funds.

B. Pre-application Phase.  

Communications between a potential Principal Investigator and program staff of 
the NIEHS at the pre-application planning phase will serve to (1) advise the 
applicant concerning the areas of program interests of the NIEHS; (2) 
facilitate the receipt of a well-organized, tightly-focused application; and 
(3) ensure that the application conforms to established guidelines and 
criteria for an S11 application.  The initial contact with NIEHS program staff 
is the responsibility of the potential applicant and should be made as early 
as possible.  This interaction may take the form of correspondence, such as a 
letter of intent, telephone conversations, etc.  The program staff are 
particularly cognizant of the scope of their programs and the S11 guidelines 
and are especially qualified to advise applicants concerning the preparation 
of a complete and well-developed application.  This communication will enable 
the program staff to discuss issues such as the need for integration of all 
projects into the theme of the overall program, the established review 
guidelines, the proper format of the applications, and the necessary relevancy 
of the proposal to the programs supported by the NIEHS.

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into three 
areas: scientific/research, peer review, and financial or grants management 
issues:

o Direct your questions about scientific/research issues to:

Frederick L. Tyson, Ph.D.
Program Administrator
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
111 T.W. Alexander Drive, MD EC-21
P.O. Box 12233 
Research Triangle Park, NC 27709
Tel:  (919) 541-0176
Fax: (919) 316-4606
Email: tyson2@niehs.nih.gov

Direct your questions about peer review issues to:

Leroy Worth, Jr., Ph.D.
Scientific Review Administrator
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-30
111 T.W. Alexander Drive
Research Triangle Park, NC  27709
Telephone:  (919) 541-0670
Fax:  (919) 541-2503
Email: worth@niehs.nih.gov

Direct your questions about financial or grants management matters to:

Ms. Lerlita Dingle Garcia
Grants Management Specialist
Grants Management Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-22
Telephone:  (919) 316-4638
Fax:  (919) 541-2860
Email: garcia1@niehs.nih.gov

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes 
the following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating Institutions
o Number and title of this RFA

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 NIEHS staff to estimate the potential review workload and plan 
the review.

The letter of intent is to be sent by the date listed at the beginning of this 
document.  The letter of intent should be sent to:

Leroy Worth, Jr., Ph.D.
Scientific Review Administrator
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-30
111 T.W. Alexander Drive
Research Triangle Park, NC  27709
Telephone:  (919) 541-0670
Fax:  (919) 541-2503
Email: worth@niehs.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov

USING THE RFA LABEL:  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

SENDING AN APPLICATION TO THE NIH: 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 must be 
sent to:

Leroy Worth, Jr., Ph.D.
Scientific Review Administrator
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-30
111 T.W. Alexander Drive
(79 T.W. Alexander Drive, 4401 Building, 3rd Floor)(Express/Courier Service)
Research Triangle Park, NC  27709
Telephone:  (919) 541-0670
Fax:  (919) 541-2503
Email: worth@niehs.nih.gov

APPLICATION PROCESSING: Applications must be received on or before 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.
  
Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.

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.  
However, when a previously unfunded application, originally submitted as an 
investigator-initiated application, is to be submitted in response to an RFA, 
it is to be prepared as a NEW application.  That is the application for the 
RFA must not include an Introduction describing the changes and improvements 
made, and the text must not be marked to indicate the changes.  While the 
investigator may still benefit from the previous review, the RFA application 
is not to state explicitly how.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NIEHS.  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 NIEHS in accordance with the review criteria stated below.  As part of the 
initial merit review, all applications will:
 
o Receive a written critique
o 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 and assigned a priority score
o Receive a second level review by the National Advisory Environmental Health 
Sciences 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:

o Significance
o Approach
o Innovation
o Investigator
o Environment

The scientific review group will address and consider each of these criteria 
in assigning the application's overall score, weighting them as appropriate 
for each application.  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.

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?

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?

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?

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)?

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?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following 
items will be considered in the determination of scientific merit and the 
priority score:

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 following is a listing of items considered by the review committee.

A.  Overall Program

1. A program cohesiveness that clearly indicates that the presence of the 
ARCH program will make a difference in the research infrastructure and 
capacity of the MSI.

2. The likelihood that the collaboration between the RIU and MSI will be 
successful.

B. Administrative and Planning Core

1. Scientific and administrative leadership ability and experience of the MSI 
Principal Investigator and the RIU leader, and their commitment and ability to 
devote adequate time to the effective management of the ARCH program.

2. Appropriateness and adequacy of multidisciplinary teams constituting the 
program's members.

3. Academic environment and resources in which the research will be conducted, 
including availability of space, equipment, human subjects, animals, or other 
resources as required, and the potential for interaction with scientists from 
other departments.

4. Administrative organization to foster the scientific development of the 
investigators and institution.

5. Institutional commitments to the program including provision of space, 
technical resources, personnel, equipment, release time and salary for 
faculty.  In addition, fiscal responsibility and management capability of the 
institutions to assist the MSI Principal Investigator and the RIU leader in 
following DHHS, PHS, and NIH policies.

6. Appropriateness of the budget in relation to the proposed program.

7. Human subjects protection, animal welfare, and biohazard issues.

8. Appropriateness of first year equipment requested, if any, for the program.

9. External advisory committee composition and arrangements to provide ongoing 
direction and guidance.

10. Demonstration of effective collaboration between MSI scientists and RIU 
scientists to achieve programmatic goals, such as to help minority 
institutions develop state-of-the-art biomedical research programs; create 
more opportunities to establish research collaborations and professional 
networks with NIH grantees employed by RIUs; to provide support for the pilot 
research needed to show the skills and abilities of investigators by obtaining 
the preliminary data and publications that can help ensure successful 
competition for traditional research project grants during the performance 
period of the grant.

11. The nature, scope, and effectiveness of the plans for coordination and 
cooperation among research project investigators.

C. Research Program Development Core: Facility Core

1. Utility/benefit of the Facility Core to the program.

2. Qualifications, experience, commitment of the personnel involved in the 
core.

3. Appropriateness of the budget.

D. Research Program Development Core: Scientific Projects

The review of the individual Research Projects is similar to the review of 
individual project grant applications (R01/R15) for the Research and Pilot 
Projects.  These projects must have substantial scientific merit and, in 
essence, be of sufficient quality to be supported if they were submitted as 
individual projects.  Research Project proposals that are not at this level of 
quality will not be funded.  The review criteria are intended to focus more on 
the global picture of each project and the program overall rather than 
concentrating on the details of each experiment in their critiques.  

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human 
subjects and protections from research risk relating to their participation in 
the proposed research will be assessed.  (See criteria included in the section 
on Federal Citations, below.)

INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans 
to include subjects from both genders, all racial and ethnic groups (and 
subgroups), and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects will also be 
evaluated. (See Inclusion Criteria in the sections on Federal Citations, 
below.)

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to 
be used in the project, the five items described under Section f of the PHS 
398 research grant application instructions (rev. 5/2001) will be assessed.

ADDITIONAL CONSIDERATIONS

BUDGET:  The reasonableness of the proposed budget and the requested period of 
support in relation to the proposed research.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date: October 21, 2003
Application Receipt Date: November 21, 2003
Peer Review Date: February 2004
Council Review: May 2004
Earliest Anticipated Start Date: July 1, 2004

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.

REQUIRED FEDERAL CITATIONS

HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and 
others, and the importance of the knowledge gained or to be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. 

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects involving 
human subjects unless a clear and compelling justification is provided 
indicating that inclusion is inappropriate with respect to the health of the 
subjects or the purpose of the research.  This policy results from the NIH 
Revitalization Act of 1993 (Section 492B of Public Law 103-43).

All investigators proposing clinical research read the AMENDMENT "NIH 
Guidelines For Inclusion of Women and Minorities as Subjects in Clinical 
Research B Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001, http://grants.nih.gov/grants/guide/notice-
files/NOT-OD-02-001.html; a complete copy of the updated Guidelines are 
available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm 
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable; and 
b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy 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 is available at 
http://grants.nih.gov/grants/funding/children/children.htm. 

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy 
requires education on the protection of human subject participants for all 
investigators submitting NIH proposals for research involving human subjects. 
 You will find this policy announcement in the NIH Guide for Grants and 
Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

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.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  The 
Department of Health and Human Services (DHHS) issued final modification to 
the "Standards for Privacy of Individually Identifiable Health Information", 
the "Privacy Rule," on August 14, 2002.  The Privacy Rule is a federal 
regulation under the Health Insurance Portability and Accountability Act 
(HIPAA) of 1996 that governs the protection of individually identifiable 
health information, and is administered and enforced by the DHHS Office for 
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified 
under the Rule as "covered entities") must do so by April 14, 2003  (with the 
exception of small health plans which have an extra year to comply).  

Decisions about applicability and implementation of the Privacy Rule reside 
with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including 
a complete Regulation Text and a set of decision tools on "Am I a covered 
entity?"  Information on the impact of the HIPAA Privacy Rule on NIH processes 
involving the review, funding, and progress monitoring of grants, cooperative 
agreements, and research contracts can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.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.  Furthermore, we 
caution reviewers that their anonymity may be compromised when they directly 
access an Internet site.

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 RFA is 
related to one or more of the priority areas.  Potential applicants may obtain 
a copy of "Healthy People 2010" at: http://www.health.gov/healthypeople/

AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal 
Domestic Assistance at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under authorization of Sections 301 
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and 
under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  All awards 
are subject to the terms and conditions, cost principles, and other 
considerations described in the NIH Grants Policy Statement.  The NIH Grants 
Policy Statement can be found at 
http://grants.nih.gov/grants/policy/policy.htm.

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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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