ADVANCED RESEARCH COOPERATION IN ENVIRONMENTAL HEALTH SCIENCES

Release Date:  June 1, 2000

RFA:  ES-00-006

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

Letter of Intent Receipt Date:  August 1, 2000
Application Receipt Date:       October 19, 2000

PURPOSE

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 multi-disciplinary 
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 Research Program Project Grant that focuses on 
establishing research partnerships between investigators at Research Intensive 
Universities (RIUs) with significant environmental health sciences research 
and at Minority Serving Institutes (MSIs).  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 
Institutes (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.

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), 
"Advanced Research Cooperation in Environmental Health Sciences," (ARCH) 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/

ELIGIBILITY REQUIREMENTS

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 Program Administrator listed 
under INQUIRIES.



Applicant Organization and Investigators

For this RFA, the applicant organization must be an MSI.  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.

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 Athose 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 training that utilizes state of the art methodologies that can be 
used to conduct environmental health sciences research. 

MSI/RIU partners should be within a reasonable working distance (100 miles or 
less).  If there is a significant distance between the collaborating 
institutions (greater than 100 miles,) the Principal Investigator should 
provide information on how the collaboration will work and a description of 
past successful collaborations with the partner RIU, if applicable. 

MECHANISM OF SUPPORT

The NIEHS ARCH Program will use the NIH Minority Biomedical Research Support 
Thematic Project Award (S11). The NIEHS ARCH Program will be a two-tiered 
program and feature two levels of support.  The maximum requested direct costs 
and project period will be $1 million per year for a maximum of five years for 
ARCH-I.  The maximum requested direct costs and project period will be 
$500,000 per year for a maximum of five years for ARCH-II.  The fundamental 
differences between ARCH- I and ARCH-II awards include maximum direct costs; 
the numbers of allowable research and pilot projects; and support for faculty 
recruitment.  ARCH-I awards will have a minimum of two Research Projects and 
two Pilot Projects.  ARCH-II awards will support a minimum of one Research 
Project and two Pilot Projects.  ARCH-I awards will provide support for 
faculty recruitment, while ARCH-II awards will not support faculty 
recruitment.  More detailed distinctions between ARCH-I and ARCH-II awards can 
be found under the "Research Program Development Core" section.

FUNDS AVAILABLE


It is anticipated that approximately one to two ARCH-I and one to two ARCH-II 
grants will be awarded depending upon the availability of funds and the 
quality of the applications received.  Awards are not renewable, and 
supplements, except as described under the section, "Other ARCH Program 
Requirements, Budget Limits and Evaluation," are not allowed.  The NIEHS will 
make a commitment for funding an institution for the full term of the award.  
However, the fourth and fifth years of ARCH funding will be restricted pending 
the results of an in-depth review of the grantee's progress toward meeting the 
goals of the grant.  The criteria for this review are described in the 
Mid-Program Evaluation Criteria for ARCH Awardee section of this RFA.

RESEARCH OBJECTIVES

Background

The National Institutes of Health (NIH) has initiated many programs over the 
past twenty years to assist minority-serving institutions to develop the 
scientific resources necessary to participate in the NIH research mission.  
Although there have been successes, investigators at minority institutions 
have not generally been competitive for the mainstream NIH research programs. 
 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 Institute.  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 a strong interest in such research.  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.  While 12 percent of the 
population is Black, less than 0.25 percent of persons holding a Ph.D. in 
science are Black.  The figures are even lower for Black Ph.D.s in the 
biomedical sciences.  Furthermore, the number of doctorates, both M.D.s and 
Ph.D.s, in other ethnic minority groups (such as American Indians or 
Hispanics) is proportionally lower than for Blacks.  

Two ARCH awards were made as a result of the first ARCH RFA solicitation.  
These awards were made to Southern University of Baton Rouge, Louisiana and 
Xavier University of New Orleans University.  Their RIU partners are The 
University of Texas Medical Branch at Galveston (UTMB) and Tulane University 
Medical Center, 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. 
 Both of these projects feature unique scientific partnerships that allow for 
faculty development at the MSIs while supporting sound scientific research at 
both institutional partners.

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 
NIH/NIEHS Research Project Grant (RPG) support, typically R01/R15 grants, or 
awards from other agencies that use the peer review mechanism to generate 
competitive programs for support of scientific research proposals by funding 
agencies, for example, U.S. Environmental Protection Agency or the National 
Science Foundation.  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 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, R01, P01, 
F31/32, T32  etc.) that will provide research support after the ARCH 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.

In addition, it is anticipated that as a result of the research collaboration 
between an MSI and RIU, talented minority undergraduates will be attracted to 
the graduate training program(s) of the RIU.  As the program project develops, 
the RIU and MSI may wish to develop a collaborative training program that 
takes advantage of the unique strengths of each institution.

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 Program Grant (R01 or R15 if R15 
eligible) support.  Key factors for an ARCH program project are as follows:

o  There must be a unifying, well-defined goal or problem area of research to 
which each project relates and contributes.

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 encouragement of 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.

o  For ARCH-I awards there must be a commitment of the MSI to the recruitment 
of new faculty that have successfully competed for NIH R01/R15 grants in areas 
of science relevant to the mission of the NIEHS or have successfully competed 
for peer reviewed awards from other funding sources.

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 program director) and RIU leader to develop a tightly integrated program 
of collaborative research will be a significant consideration in the 
evaluation of the application.

The administrative/planning core must provide the support of the 
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 the conduct of the 
research and development activities such as seminars, workshops, reference 
collection, computer support, etc.

o  An Internal Advisory 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 
recognized leaders in biomedical sciences, that will provide overall guidance 
and advice to the Principal Investigator and program investigators on program 
direction.

o  A Senior Scientific Advisor (SSA)who has been successful in attracting RPGs 
(R01, P01, etc.) from the NIH.  This individual will assist the Principal 
Investigator in the overall development of the MSI research infrastructure and 
advise the MSI investigators on the preparation of research grant 
applications.  The SSA can have affiliation with either the MSI or the RIU.

Research Program Development Core

Two types of  projects (Pilot and Research) will be supported as part of the 
ARCH programs 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 two 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.  The number of 
Research projects supported by the ARCH grant cannot exceed the number of 
Pilot projects.

Pilot projects are intended to provide an MSI investigator an opportunity to 
develop his/her research skills and/or to obtain the preliminary research data 
needed for the submission of a NIH Research Project Grant (R01/R15) 
application. 

Distinctions between ARCH-I awards and ARCH-II awards include:

o  the minimum number of Research and Pilot projects;
o  total direct cost; and
o  faculty recruitment.

The minimum number of Research/Pilot projects funded in an ARCH-I award will 
be two Research projects and two Pilot projects.  The minimum number of 
Research projects and Pilot projects funded in an ARCH-II award will be one 
and two respectively.  ARCH-I awards can be funded maximally at $1 million in 
direct costs for up to five years.  Maximum ARCH-II awards will be $500,000 in 
direct costs for up to five years.  Applicants are strongly encouraged to 
contact Program staff (see below) in order to determine whether the proposed 
MSI-RIU collaboration is best suited for an ARCH-I or ARCH-II application.

Pilot projects are established between an MSI investigator and an RIU 
mentor/collaborator.  The maximum project period for a Pilot project is 30 
months.  However, the project leader for a Pilot project may delay the start 
of the Pilot project for up to six months after the award of an ARCH grant to 
begin the project.  This will provide the MSI investigator a period of time to 
establish his/her research laboratory.

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 investigators. Copies of all proposals, with documentation of their 
reviews, relative ranking, and final action must be retained by the ARCH 
Program Project Principal Investigator.

o  the tracking of the results of each Pilot project (abstract, R01/R15 
application, 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 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 a 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 $1 million (ARCH-I) and 
$500,000(ARCH-II).  Indirect costs for the subcontract to the RIU that are 
included as a part of the MSI direct costs are not included in the $1 
million/$500,000 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% effort
o  RIU Leader - 15% effort
o  MSI or RIU Senior Scientific Advisor - 10% effort
o  Administrative Assistant at MSI -  50% effort
o  Administrative Assistant at RIU -  25% 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 year.  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 (1).


B.  Research Program Development Core

The ARCH grant will provide up to $400,000 (ARCH-I)/$200,000 (ARCH-II) in 
direct costs per year for research program development at the MSI to include: 
1) Pilot projects between ARCH (MSI and RIU) investigators, 2) MSI faculty 
recruitment of NIH R01-level scientists, (only for ARCH-I applications), and 
3) Facility Core at the MSI.  

In addition, the ARCH grant will provide the RIU up to $125,000 per year for 
each Research project.

1) Pilot Projects.
Items that may be included are MSI and RIU investigator salaries, technical 
support, supplies, small equipment items, travel and other items which are 
necessary for the conduct of the pilot project.  The maximum direct cost for 
each Pilot project is $75,000 per 12 month period, and the maximum length of a 
Pilot project is 30 months.  At least two Pilot projects must be recommended 
by the Special Emphasis Panel (SEP) in order to be eligible for an ARCH-I 
award and at least two Pilot projects must be recommended by the SEP for an 
ARCH-II award.

2) MSI Faculty Recruitment for ARCH-I.
Funds may be requested to help recruit up to two talented investigators to the 
MSI who have been successful in obtaining NIH RPG support, typically R01 
grants.  The ARCH-I award will provide up to $125,000 per year (direct cost) 
for three years for the establishment of a research laboratory at the MSI.  
These funds may be used to provide partial salary support (up to 50 percent) 
and laboratory set-up costs for investigators newly recruited to the MSI.  The 
institution must provide a commitment of 50 percent salary support for the 
recruited investigator that is derived from non-Federal funds.  Because it is 
unlikely that a specific individual to be recruited can be identified, a 
well-described plan for recruiting these individuals should be included in the 
application.  MSI faculty recruitment will not be a feature of the ARCH-II 
awards.

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

4)  Research Projects.
Research projects are conducted by the RIU in conjunction with MSI 
investigators. The maximum direct cost for a Research project is $125,000 per 
year, and funding may be requested for up to five years.  At least two 
Research projects must be recommended by the SEP in order to be eligible for 
the ARCH-I award and one Research project must be recommended by the SEP to be 
eligible for an ARCH-II award.

OTHER ARCH PROGRAM REQUIREMENTS, BUDGET LIMITS AND EVALUATION

A.  Submission of Research Project Grants (RPG) applications to the NIH.

Administrative and Research Program Development support is intended to provide 
the MSI investigators the time, information and skills required to prepare NIH 
RPG applications, typically R01s/R15s.  Since the ARCH grant is not intended 
to provide long term research support, MSI investigators are required to apply 
for other NIH/NIEHS grants that will provide the long-term support required 
for environmental health sciences research projects.

B.  Graduate Student Support.

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.

C.  Supplemental Funds for Additional MSI Investigators or Postdoctoral 
Trainees.

As the program develops, supplemental funds may be requested with the approval 
of the NIEHS staff, for the support of additional MSI faculty and postdoctoral 
trainees on RIU Research projects.

D.  Mid-Program Evaluation Criteria for ARCH Awardee.

In addition to the usual review of the noncompeting 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 NIH RPG applications submitted by and awarded to MSI 
investigators(R01, R03, R15, P01, K01).
o  Success in attracting MSI faculty who have successfully competed for NIH 
RPGs.
o  Status of the MSI research infrastructure, and plans for sustaining and 
nurturing it after the ARCH funding ends.

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

E. 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; (3) 
ensure that the application conforms to established guidelines and criteria 
for an S11 application; and (4) determine the intention to apply for ARCH-I or 
ARCH-II.  Applications submitted as ARCH-I will be reviewed only as ARCH-I 
applications.  This means that if not enough projects are recommended for 
funding at the ARCH-I level, the application will not be considered by default 
for ARCH-II funding.  The initial contact with NIEHS program staff is the 
responsibility of the potential applicants 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.  Program staff are 
particularly cognizant of the scope of their programs and of 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 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.

SPECIAL REQUIREMENTS
 
Annual meetings, to be held in Research Triangle Park, NC, are planned for the 
exchange of information among investigators.  Applicants must budget travel 
costs for all key personnel at both the MSI and RIU to attend these meetings 
in their applications.

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 subpopulations 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 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," which was 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, and is 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 NIEHS staff 
to estimate the potential review workload and plan the review.

The letter of intent is to be sent to:

Ethel Jackson, D.V.M.
Chief,  Scientific Review Branch
Office of Program Operations
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-24
111 T.W. Alexander Drive
Research Triangle Park, NC  27709
Telephone:  (919) 541-7846
Fax:  (919) 541-2503
Email: jackson4@niehs.nih.gov

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used in 
applying for these grants.  These forms are available at most institutional 
offices of sponsored research and may be obtained from the Division of 
Extramural Outreach and Information Resources, National Institutes of Health, 
6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 
301/435-0714, Email: GrantsInfo@nih.gov


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

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:

Ethel Jackson, D.V.M.
Chief, Scientific Review Branch
Office of Program Operations
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-24
111 T.W. Alexander Drive
Research Triangle Park, NC  27709
Telephone:  (919) 541-7846
Fax:  (919) 541-2503
Email: jackson4@niehs.nih.gov

Applications must be received by October 19, 2000.  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 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 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 
NIEHS National Advisory Council.

Review Criteria

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.  

The review criteria are as follows:

1.  Significance: Does the study address an important environmental health 
sciences problem?  If the aims of the application are achieved, then how will 
scientific knowledge be advanced?  What will be the effect of these studies on 
the concepts or methods that drive the 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 methods? 
 Are the aims original and innovative?  Does the project challenge existing 
paradigms or develop new methodologies or technologies?


4.  Investigators:  Address the adequacy of their time commitment.  Assess 
measures that will strengthen and enhance collaboration between MSI and RIU 
investigators.

5.  Environment: Does the environment in which the work will be performed 
contribute to the probability of success?  Do the proposed experiments take 
advantage of the unique features of the scientific environment or employ 
useful collaborative arrangements?

6.  When human subjects are involved, the adequacy of plans to include women 
and minorities in the study design and the potential of that design to address 
the scientific question(s) proposed must be addressed.

7.  When vertebrate animals are used, ensure that appropriate animal welfare 
and IRB concerns have been addressed.

E.  Research Program Development Core: Faculty Recruitment for ARCH-I.

1.  For ARCH-I proposals, plans to recruit new faculty that have successfully 
competed for NIH RPG grants.

2.  The commitment of the MSI to recruit investigators with respect to money, 
laboratory and office space, and other support.

In addition to the above criteria all applications will also be reviewed with 
respect to the following:

o  Evaluate the facilities, resources, and environment of the applicant 
institution (including existing relevant equipment, animal, and/or computer 
resources, and departmental or interdepartmental cooperation);

o  Appropriateness of proposed budget and duration in relation to the 
project's objectives.

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 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.

AWARD CRITERIA

The anticipated date of award is July 1, 2001. 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;
  
o  commitment of the university to establish a research infrastructure that is 
sustainable after ARCH support ends;

o  potential of the MSI investigators to obtain NIH research project grants 
(R01s/R15s) or support from other funding agencies that use the peer review 
process, relevant to the mission of the NIEHS;

o  potential of the ARCH program to make a significant contribution to the 
NIEHS mission;

o  quality of the Research and Pilot projects scientific merit as determined 
by peer review; and

o  availability of funds.

Schedule

Letter of Intent Receipt Date:    August 1, 2000
Application Receipt Date:         October 19, 2000
Peer Review Date:                 February 2001
Council Review:                   May 2001
Earliest Anticipated Start Date:  July 1, 2001

INQUIRIES

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

Direct inquiries regarding programmatic issues to:

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

Direct inquiries regarding fiscal matters to:

Ms. Jacqueline M. Russell
Grants Management Specialist
Grants Management Branch
Office of Program Operations
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
Telephone:  (919) 541-0751
Fax:  (919) 541-2860
Email: russell@niehs.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.113, 93.114, 93.115 and 93.866.  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.


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