CENTERS OF BIOMEDICAL RESEARCH EXCELLENCE (COBRE)

RELEASE DATE:  August 19, 2003

RFA Number:  RFA-RR-03-014

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATIONS:

National Institutes of Health (NIH) 
 (http://www.nih.gov/)

COMPONENTS OF PARTICIPATING ORGANIZATIONS:

National Center for Research Resources (NCRR) 
 (http://www.ncrr.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.389

LETTER OF INTENT RECEIPT DATE:  October 17, 2003

APPLICATION RECEIPT DATE:  November 18, 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 Supplementary Instructions
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 purpose of the Institutional Development Award (IDeA) Program is to 
foster health-related research and increase the competitiveness of 
investigators at institutions located in states with historically low 
aggregate success rates for grant awards from the National Institutes of 
Health (NIH). The National Center for Research Resources (NCRR) of the 
National Institutes of Health invites applications for Centers of Biomedical 
Research Excellence (COBRE) from investigators at independent biomedical 
research institutes or biomedical research institutions that award doctoral 
degrees in the health sciences or sciences related to health within IDeA-
eligible states. Collaboration with other non-doctoral degree-granting and 
research-performing institutes or institutions is encouraged. However, funds 
for research activities cannot be used at collaborative institutions in non-
IDeA states.

The purpose of this Request for Applications (RFA) is to augment and 
strengthen institutional biomedical research capacity through flexible 
support to expand and develop biomedical faculty research capability and to 
enhance research infrastructure through support of a thematic multi-
disciplinary center, led by a peer-reviewed, funded investigator with 
expertise central to the research theme of the proposal. The application must 
have a thematic scientific focus in a specific research area, such as 
neuroscience, cancer, structural biology, immunology, or bioengineering, and 
may use basic, clinical or both research approaches to attain the goals of 
the proposed center. The scientific leadership provided by one or more 
established biomedical research faculty is critical to the success of this 
initiative, especially for the mentoring of promising junior investigators. 
The center is intended to support investigators from several complementary 
disciplines. It will enable the institution to develop a critical mass of 
investigators and enhance their competitiveness in a specific research area 
that accelerates the rate at which those investigators compete for other 
complementary NIH, Federal or non-Federal external peer-reviewed research 
grant support. It is also anticipated that, in some instances, the support 
through this initiative will facilitate the development of new disease-
specific research centers or augment the capability of existing centers.

RESEARCH OBJECTIVES

This program seeks to promote the initiation and development or expansion of 
unique, innovative state-of-the-art biomedical and behavioral research at 
institutions in IDeA-eligible states. The research focus of this program 
encompasses the full spectrum of the basic and clinical sciences and also 
includes cellular and molecular biology, biophysics and biotechnology, 
genetics and developmental biology, pharmacology and other biomedical 
research areas. The NIH recognizes that the contributions from the 
institutions in IDeA-eligible states are important and essential in 
fulfilling the promise of the NIH research agenda. The intent of this RFA is 
to assist these institutions to implement and use the technologies and other 
resources needed to conduct state-of-the-art biomedical research.

The objectives of this program are (1) to strengthen an institution's 
biomedical research infrastructure through the establishment of a thematic 
multi-disciplinary center and (2) to enhance the ability of investigators to 
compete independently for complementary NIH individual research grant or 
other external peer-reviewed support. Although the individual career 
development of the junior investigators is an important and significant part 
of this program, the primary objective of the COBRE initiative is to build 
and develop thematic multi-disciplinary research centers. These centers are 
expected to engage in future growth through the promotion of collaborative 
interactive efforts among researchers with complementary backgrounds, skills 
and expertise and to compete independently for external peer-reviewed center 
or program project grant support. This goal is accomplished through the 
direction provided by a Principal Investigator (PI), who provides leadership 
to junior investigators (defined below) and has the primary responsibility 
for administering the program and for overseeing the development of the 
center and its associated core facilities. The PI of the COBRE application 
must be an established biomedical or behavioral research scientist who will 
ensure that high-quality research be performed and who has the experience to 
effectively administer and integrate all components of the program. The PI 
must have an active biomedical or behavioral research program that receives 
NIH, NSF or other peer-reviewed support in the scientific area of the center 
and have the requisite administrative experience to direct the program. A 
minimum time commitment of 25-percent is required for this individual; 
however, up to 50-percent effort will be supported for mentoring and 
administrative oversight of the COBRE. If the PI is not in place at the 
institution at the time of review or award, a plan to recruit such an 
individual must be included in the application. An award pursuant to this RFA 
will not be made until and unless the institution has appointed a permanent 
COBRE PI.

OVERALL RESEARCH PLAN: Each application must describe an overall research 
plan to justify support of a thematic multi-disciplinary COBRE program for 
five years. Ideally, it is recommended that the research plan contain the 
descriptions of at least three and up to five individual research projects. 
In addition, the establishment of core facilities necessary to carry out the 
objectives of a multi-disciplinary, collaborative program may be proposed.

With respect to the overall COBRE program, the PI should describe the unique 
research opportunities that will be provided to the junior investigators and 
to the institution. If the proposed COBRE research is closely related to 
ongoing research or an existing center, an explanation how the research 
activities of the COBRE will complement but not overlap with existing 
research should be described. In addition, the PI should describe how the 
efforts of each junior investigator will assist in the establishment of a 
multi-disciplinary research center.

The qualifications of the COBRE PI selected for this effort must be clearly 
described. The PI must demonstrate that he/she is an established biomedical 
or behavioral research scientist, that the he/she has an active research 
laboratory, that he/she has relevant peer-reviewed funding (either NIH, NSF 
or other Federal or non-Federal investigator-initiated support), and that 
he/she has demonstrated administrative leadership and mentoring experience. 
If that individual is not a member of the faculty at the time of review of 
the application, include a detailed plan that will result in having that 
individual on the full-time faculty within one year from the date of peer-
review of the institution's application.

Although no non-Federal matching funds are required for these applications, 
clear evidence of institutional commitment must be included with the 
application. The level of institutional commitment will differ among 
applicant institutions because of the variability of resources available 
among institutions. At a minimum, a letter of support from a senior 
institutional official (e.g., President or Dean) should outline the 
commitment of resources and facilities to sustain and support the COBRE 
throughout the period of funding and to maintain these resources beyond the 
period of grant support.

The institutional environment and resources that are available to 
investigators must be briefly described. Available resources (e.g., 
laboratory facilities, patient populations, geographic distributions of space 
and personnel) and collaborative resources should be described. If core 
facilities are included for support, the relationship of each component 
research project to the core(s) should be described.

INDIVIDUAL RESEARCH PROJECTS: Each COBRE program should ideally include three 
to five individual research projects that stand alone, but share a common 
thematic scientific focus. Each research project should be supervised by a 
single junior investigator who is responsible for insuring that the Specific 
Aims of that project are met. An initial minimum commitment of 50-percent 
effort is required for this individual. It is recognized that during the 
development of a junior investigator's career (for example, the acquisition 
of other research support) it may be necessary to reduce this effort. 
Investigators should consult with NCRR Program staff regarding appropriate 
reductions. Each individual research project should describe the Specific 
Aims in the selected area of research and the goals for the first year and 
for the long term. The design principles supporting the research or the 
hypotheses to be tested should be delineated. Preliminary studies are not 
required for COBRE applications, but applicants with preliminary results 
should describe them. In the absence of preliminary results, applicants 
should describe the rationale and scientific basis for the proposed research. 
Furthermore, each research project should describe the area of multi-
disciplinary research that is the focus of the COBRE and critically assess 
the existing knowledge and approaches that have been or are being directed in 
the area with an emphasis on specifically how the multi-disciplinary COBRE 
approach will advance the field. Moreover, the importance and health 
relevance of the proposed research to the Specific Aims should be concisely 
stated.

CRITERIA FOR ELIGIBILITY OF JUNIOR INVESTIGATORS: For the purpose of 
eligibility a junior investigator is defined either as (1) an individual who 
does not have or has not previously had an external, peer-reviewed Research 
Project Grant (RPG) or Program Project Grant (PPG) from either a Federal or 
non-Federal source that names that investigator as the PI or (2) an 
established investigator who is making a significant change to his/her 
career.

With respect to item (1), grants that name an individual as a co-
investigator, collaborator, consultant, or to a position other than Principal 
Investigator do not disqualify that investigator. Starter grants (such as 
NIH's FIRST award mechanism, R29), Academic Research Enhancement Award grants 
(AREA, R15), exploratory/pilot project grants (such as NIH R03 and R21 
awards), career development awards (such as NIH K01 and K08 awards), or other 
Federal or non-Federal funding whose purpose is to provide preliminary 
support in anticipation of a RPG or PPG also do not disqualify the 
investigator. The intent of this initiative is not to disallow promising 
investigators whose early career support consists of awards geared toward 
initiating their intended area of research. However, investigators who have 
managed to obtain significant support in the form of a RPG or PPG (e.g., NIH 
R01 or P01, NSF, or other Federal or non-Federal agency awards) are not 
eligible. Investigators who propose to develop a new or alternate line of 
research, but whose intention is to maintain support through an active RPG or 
PPG in a different area of research are also not eligible. Investigators 
should indicate in the Biographical Sketch their current or previous history 
of peer-reviewed research support.

A junior investigator must hold a faculty appointment at the time that the 
award is made. Moreover, a clear commitment to support this faculty 
appointment independent of the outcome of this application must be 
demonstrated from the institution by a letter(s) from the appropriate senior 
institutional official(s). Postdoctoral fellows or other positions that do 
not carry independent faculty status will disqualify that individual and 
his/her research project from further consideration.

With respect to item (2), support may be provided to an established 
investigator who is making a significant change to his/her career goals by 
initiating a new line of research that is distinctly and significantly 
different than his/her current investigative program. The current or previous 
history of independent peer-reviewed research support, which may be indicated 
in the Biographical Sketch, in a different investigative area than that 
proposed in this application does not disqualify the investigator. 
Furthermore, this individual can be of any faculty rank. Please note that the 
intent of this initiative is to allow established investigators the 
opportunity to initiate and develop a new line or research. However, 
investigators whose current research is already supported by a RPG or PPG and 
who do not intend to change their current research program are not eligible.

This initiative is not intended to replace support for ongoing investigator-
initiated research programs of established investigators. Instead, 
established investigators should serve as mentors to advance the junior 
investigators' careers.

DEVELOPMENT AND MENTORING PLAN FOR JUNIOR INVESTIGATORS: A clear plan for the 
development of junior investigators and for their transition to and 
attainment of independent status must be included. This plan should detail 
the long-term goals as to how the institution intends to make the transition 
from the research support of multi-disciplinary COBRE projects to competitive 
grant support through applications submitted by its faculty members to 
relevant NIH Institutes and Centers or to other appropriate Federal or non-
Federal agencies or organizations. Each junior investigator must submit an 
investigator-initiated RPG application by the end of three years of support 
to maintain continued funding through the COBRE award.

The development plan must include both formative and summative evaluation 
strategies with specific milestones. Faculty development should include a 
mentoring plan that involves oversight by established senior faculty members 
assigned as mentors, constructive evaluations by members of the External 
Advisory Committee (EAC) (see below under Special Requirements), and 
coordinated management of all of these individuals by the PI of the COBRE 
program. Additional oversight may be augmented through the use of an internal 
advisory committee, but this committee should not act as a substitute for the 
EAC.

Each junior investigator should have at least one mentor. The mentor must be 
an established investigator who has demonstrated the ability to advise others 
through the acquisition of external support and the maintenance of an 
independent research laboratory. In some instances a suitable mentor may not 
be available within the applicant's institution and it is therefore 
acceptable to enlist appropriate mentors from outside institutions. Mentors 
may be provided 10 to 15-percent effort and should be listed in the 
Administrative Core's budget section of the application and not in the 
individual projects' budget sections. The junior investigators should clearly 
designate in the text the identity of their mentors and describe their 
qualifications, both scientific and advisory, that make them appropriate to 
assist in the oversight of the project.

The award of a Research Project Grant (RPG) to a junior investigator should 
be viewed as a milestone and a criterion for changing the status of an 
investigator either from mentored to transitional support within the COBRE 
program (described below) or from mentored support to independent status 
where continued COBRE support would no longer be necessary. A junior 
investigator may also be considered for a status change if independence is 
indicated by the acquisition of sufficient skills and knowledge. However, it 
must be stressed that the intent of the COBRE program is to foster the 
development of a center and to encourage the continued participation of 
junior investigators in center activities. For example, investigators who 
have acquired independence can mentor newly appointed junior investigators or 
can direct one of the COBRE's core facilities. In any case, newly independent 
investigators should continue to contribute to COBRE activities and be 
allowed to use the center's facilities.

It must be emphasized that COBRE support cannot be provided in instances 
where a junior investigator's new award overlaps or is significantly similar 
to that described in the COBRE program. In such cases a status change for the 
junior investigator must be invoked (see CHANGE IN STATUS OF JUNIOR 
INVESTIGATORS FROM MENTORED TO TRANSITIONAL SUPPORT). However, if the 
specific aims of the junior investigator's RPG are significantly different 
from the project described in the COBRE, then the junior investigator has an 
obligation to remain in the program to complete his/her COBRE project. In 
this latter case, continued support for personnel (e.g., postdoctoral 
associates, graduate students, technicians, etc.) associated with the COBRE 
project but also listed on the other award can be provided. However, the 
percent efforts of these individuals must be appropriately adjusted.

Following the status change of a junior investigator, another junior 
investigator may be added following review of the replacement project by the 
PI and the EAC. The PI must communicate the EAC's recommendation to NCRR 
Program staff for review and approval of the appointment of the replacement 
investigator (and possibly new mentors) to the program.

In some instances a junior investigator may be removed from the COBRE program 
if a review by the EAC indicates a failure by the junior investigator to make 
significant progress toward achieving the specific aims of his/her project 
or, as noted above, to submit an investigator-initiated RPG application by 
the end of three years of COBRE support. In these instances another junior 
investigator may replace the removed investigator after review of the 
replacement project by the PI and the EAC. The PI must communicate the EAC's 
recommendation to NCRR Program staff for review and approval of the 
appointment of the replacement investigator (and possibly new mentors) to the 
program.

CHANGE IN STATUS OF JUNIOR INVESTIGATORS FROM MENTORED TO TRANSITIONAL 
SUPPORT: The PI and EAC can determine that a junior investigator has achieved 
independent status either by receipt of an RPG or PPG and/or through an 
indication that independence has been achieved through the acquisition of 
sufficient skills and knowledge. The PI and EAC have the discretion of either 
withdrawing additional COBRE support or supplying the junior investigator 
with transitional support. When considering a change in status, every effort 
should be made to continue to include investigators who have achieved 
independence in the activities of the center. The PI must notify NCRR Program 
staff of any change in junior investigator status and may be asked to provide 
a revised budget and other support information for those junior 
investigators, as appropriate.

The purpose of transitional support is to provide protected time for the 
investigator to further develop his/her research program. During the 
transitional support period, salary for the investigator can be requested for 
levels of effort between 25 and 50-percent. The actual salary provided by the 
NIH is based on the investigator's full-time, 12-month institutional salary. 
The salary requested must be consistent both with the established salary 
structure at the institution and with salaries actually provided by the 
institution from its own funds to other staff members of equivalent 
qualifications, rank, and responsibilities in the department concerned. If 
full-time, 12-month salaries are not currently paid to comparable staff 
members, the salary proposed must be appropriately related to the existing 
salary structure. The award will also provide fringe benefits on the 
calculated base salary at the established institutional rate.

The institution may supplement the NIH contribution to the salary up to a 
level that is consistent with the institution's salary scale. Institutional 
supplementation of salary must not require extra duties or responsibilities 
that would interfere with the purpose of the transitional support phase of 
the investigator's career.

In addition, recipients of transitional support may derive additional 
compensation for effort associated with other Federal sources or awards 
provided the total salary derived from all Federal sources does not exceed 
the maximum legislated salary rate and the total percent effort does not 
exceed 100-percent.

No additional funds above those described in the FUNDS AVAILABLE section of 
this RFA will be provided for transitional support of junior investigators.

No support will be provided to the mentor during the transitional support 
period.

The progress of the transitioned investigator should be monitored by the PI 
and the EAC yearly to determine whether transitional support should be 
continued.

BIOGRAPHICAL SKETCHES: The Principal Investigator, co-investigator(s), junior 
investigators, and mentors must provide biographical sketches as indicated in 
the PHS 398 document instructions. This section must not exceed four pages 
per person.

RESOURCES: The application must describe the equipment and facilities 
available to the proposed COBRE.

CORE FACILITIES: Funds may be requested to establish core facilities. The 
applicant must demonstrate that each proposed core will serve the scientific 
needs of the individual research projects and must show how each core will 
impact the development of the center. Although the COBRE award is not 
intended to replace support for ongoing investigator-initiated research 
projects of established investigators, both the mentors, as well as other 
investigators at the institution, may use these facilities. Additional 
justification may be offered by showing how a core facility will benefit 
these individuals and improve the research infrastructure of the institution. 
Each core description should indicate the qualifications of personnel 
selected to manage the facility and/or plans to recruit personnel to operate 
the core, if needed. Furthermore, the PI should indicate any institutional 
commitment to support and maintain the proposed facilities.

ALTERATION AND RENOVATION: Alteration and Renovation (A&R) costs to improve 
existing research laboratories or animal facilities are allowed. This RFA 
will provide up to $500,000 in direct costs in year one only of the award as 
a one-time cost expenditure. Direct costs requested for A&R are not subject 
to facilities and administrative costs (F&A). Although this amount will be 
provided in year one only, the proposed A&R work does not have to be 
completed in year one. However, PIs are strongly encouraged to complete all 
A&R work in an expeditious manner and all A&R work must be completed before 
expiration of the award. Alteration and Renovation projects must be relevant 
to the scope of the proposed research. Sufficient detail must be provided to 
estimate the cost and suitability of the project. Failure to adequately 
justify an A&R request will likely result in its deletion from the requested 
budget. This RFA will not provide support for new construction, including the 
completion of shell space, or for movable research equipment/instrumentation 
or for equipment intended for teaching or other non-research related 
purposes. Please note that Alteration and Renovation costs will be approved 
only for facilities improvements at the applicant's organization. Proposed 
improvements at consortia sites are disallowed.

The expenditure of funds for all A&R projects in excess of $500,000 is 
restricted until project documentation/architectural drawings have been 
reviewed and approved by NIH staff. A&R projects of less than $500,000 that 
support the installation of fixed equipment or other structural alterations 
should not be initiated until the project documentation/architectural 
drawings have been reviewed and approved by NIH staff.

For any proposed A&R, a narrative summary (as outlined below), line drawings, 
and cost estimates must be provided. The following sample format is 
suggested:

o NARRATIVE SUMMARY

(1) Relate the proposed renovations to the research projects that will use 
the facility. If renovations to animal facilities are proposed, relate the 
proposed renovations to the projected animal populations (by species). If 
renovations to animal facilities are proposed, include the lines of authority 
and responsibility for administering the institution's animal care and use 
program. The role and composition of the Institutional Animal Care and Use 
Committee (IACUC) and how compliance with relevant laws, policies, and 
guidelines are achieved should also be included.

(2) List the functional components, including the size (dimensions) and 
square footage of each component (room, alcove, cubicle) that will be 
directly affected by the renovation project.

(3) List engineering criteria applicable to each component (mechanical, 
electrical, and utilities). Include information such as the number of air 
changes per hour, electrical power, light levels, hot and cold water, and 
steam.

(4) List appropriate architectural criteria (such as width of corridors and 
doors, surface finishes).

(5) List and justify all fixed equipment items requested for the renovated 
area.

o LINE DRAWINGS

(1) Submit line drawings on 8-1/2" x 11" paper only. (DO NOT SUBMIT 
BLUEPRINTS.) These drawings will not be counted against the 25-page limit. 
All floor plans must be legible, with the scale clearly indicated.

(2) The line drawings of the proposed renovation must be at a scale adequate 
to explain the project. The drawings should indicate size (dimensions), 
function, and net and gross square feet of space for each room. The total net 
and gross square feet of space to be renovated should also be given.

(3) The plan should indicate the location of the proposed renovation area in 
the building.

(4) Include the as-built drawings of the proposed renovation area and 
indicate any areas that will be demolished.

(5) Changes or additions to existing mechanical and electrical systems should 
be clearly described in notes made directly on the plan or attached to the 
plan.

(6) Indicate the type(s) of new finishes to be applied to room surfaces.

o COST ESTIMATES

Detailed cost estimates must be included. Provide vendor quotes when 
available.

Those individuals interested in seeking additional funds for facilities 
improvements are referred to the NCRR Research Facilities Improvement and 
Animal Facilities Improvement Programs, which accept applications for 
construction and for extensive renovation. Please refer to the NCRR Website: 
http://www.ncrr.nih.gov/.

MECHANISM OF SUPPORT

This RFA will use the NIH exploratory grant award mechanism (P20). The 
applicant is solely responsible for planning, directing, and executing the 
proposed project. This RFA is a one-time solicitation. The anticipated award 
date is June 2004.

This RFA uses just-in-time concepts. It also uses the non-modular budget 
format. Please follow the instructions for non-modular budget research grant 
applications. Individual project and core facility budgets should be grouped 
together with justifications and prefaced by a summary or composite budget 
for the entire center. 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 NCRR intends to commit approximately $20 million in FY04 to fund 10 to 12 
new grants in response to this RFA. An applicant must request a project 
period of five years and may request a budget for direct costs of up to and 
no more than $1.5 million per year, excluding facilities and administrative 
(F&A) costs on consortium arrangements. The applicant may also request 
additional direct costs in year one only of up to $500,000 as a one-time 
expenditure for Alteration and Renovation of laboratory or animal facilities. 
If Alteration and Renovation costs are requested, then the total budget 
request for year one must not exceed $2 million in direct costs, excluding 
F&A costs on consortium arrangements. Regardless whether Alteration and 
Renovation costs are requested, budget requests for years two through five 
cannot exceed $1.5 million per year, excluding F&A costs on consortium 
arrangements.

Individual research projects and core facilities that are proposed to begin 
in the first year should have corresponding individual budgets. Although the 
applicant can propose research projects and/or core facilities to begin in 
later years, each year's budget should include costs for those projects or 
cores that will be active in that year only.

Funds may be used to develop Offices of Sponsored Programs or to recruit 
additional faculty who complement the scope of the proposed program. 
Recruitment funds are limited to $100,000 per year for each position. These 
funds may be used for salary, supplies, and/or equipment costs. The 
expenditure of funds for recruitment purposes must be approved by NCRR 
Program staff.

Because the nature and scope of the proposed research will vary from 
application to application, it is anticipated that the size of each award 
will also vary. Although the financial plans of the NCRR 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.

CONSORTIUM ARRANGEMENTS: When a grant application includes research 
activities that involve institutions other than the grantee institution, it 
is considered a consortium effort. Such activities may be included in the 
COBRE grant application, but it is imperative that a consortium application 
be prepared so that the programmatic, fiscal, and administrative 
considerations are explained fully. In addition, the thematic scientific 
focus of the COBRE must be evident in applications that include consortia 
arrangements. Applicants for COBRE grants should exercise great diligence in 
preserving the interactions of the participants and the integration of the 
consortium project(s) with those of the parent institution because synergism 
and cohesiveness can be diminished when projects are located outside of the 
group at the parent institution.

For the purposes of this RFA, F&A costs for the consortium organization(s) 
are excluded from the limit on the amount of direct costs that can be 
requested for the entire application. Applicants are encouraged to review the 
NIH policy and procedures applicable to consortium agreements, which are 
published as part of the NIH Grants Policy Statement, Part III, available on 
the NIH homepage at 
http://grants.nih.gov/grants/policy/nihgps_2001/index.htm. Questions may be 
directed to the fiscal contact identified below under Inquiries.

ELIGIBLE INSTITUTIONS

o CRITERIA FOR ELIGIBILITY OF AN IDeA STATE

In making its assessment for eligibility, NCRR included all 
states/commonwealths with a success rate for obtaining NIH grant awards 
(number of applications awarded vs. number of applications approved) of less 
than 20 percent over the period of 1997-2001. Also included are those states 
that had higher success rates, but received less than $75 million average NIH 
funding over the five-year period. Under these criteria, the following 
states/commonwealth are eligible IDeA states:

Alaska            Arkansas          Delaware          Hawaii
Idaho             Kansas            Kentucky          Louisiana
Maine             Mississippi       Montana           Nebraska
Nevada            New Hampshire     New Mexico        North Dakota
Oklahoma          Puerto Rico       Rhode Island      South Carolina
South Dakota      Vermont           West Virginia     Wyoming

o CRITERIA FOR INSTITUTIONAL ELIGIBILITY

An eligible institution must be within an IDeA state. An eligible institution 
must either be (1) a domestic, public or private, or non-profit research 
institution that awards doctoral degrees in health sciences or sciences 
related to health, or (2) an independent biomedical research institute. 

Applications will be accepted only from eligible institutions that hold fewer 
than three active COBRE awards. Eligible institutions that do not hold a 
current COBRE award are encouraged to apply. Please note that applications 
will NOT be accepted from institutions that hold three or more active COBRE 
awards; these institutions cannot submit applications.

Applications are encouraged from veterinary and dental schools in IDeA 
states. For purposes of this RFA, veterinary and dental school components of 
institutions will be treated as separate eligible entities and will be 
allowed to submit applications in addition to the parent institution.

Applications are also encouraged from eligible institutions in IDeA states 
that propose research that relates to the scope and mission of the National 
Institute on Deafness and Other Communication Disorders (NIDCD).

o RESTRICTIONS FOR SUBMITTING AN APPLICATION

No eligible institution, including veterinary and dental schools, can submit 
more than one application in response to this RFA. Multiple applications 
received from these institutions or applications received from ineligible 
institutions (those that hold three or more active COBRE awards) will not be 
reviewed. If an institution is writing more than one application, it is the 
responsibility of that institution to appoint a steering or selection 
committee to decide which single application to submit in response to this 
RFA.

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 as well as individuals with disabilities are always 
encouraged to apply for NIH programs. The PI of the COBRE application must be 
an established biomedical or behavioral research scientist who has 
demonstrated the administrative abilities to effectively carry out the 
objectives of the COBRE program and meet its goals. The qualifications of the 
PI have been previously described.

SPECIAL REQUIREMENTS

The COBRE PI should budget for an annual two-day meeting in Bethesda, 
Maryland with NCRR staff.

Each COBRE application must include an External Advisory Committee (EAC) 
comprised of scientists with national scientific reputations in their field; 
their expertise must be directly relevant to the scientific theme of the 
COBRE. The PI must select and name in the application at least three, but no 
more that five scientists who will serve as EAC members. Furthermore, the 
participation of each member in the EAC must be confirmed by inclusion in the 
application of a letter of acceptance and a current biographical sketch. The 
PI may recruit additional members to the EAC after an award is made. However, 
the selection of additional EAC members must be approved by NCRR staff.

The EAC critiques the scientific progress of the COBRE and also offers advice 
on scientific matters to the COBRE PI. The EAC activities include concept 
development, program planning, encouraging and assisting faculty development 
and mentoring, identifying resources, evaluating the development of the 
center, critiquing the progress of the individual research projects, and 
evaluating the junior investigators' progress toward acquiring independent 
status. The PI will share the advice and critiques provided by the EAC with 
other investigators at the center. The EAC also will review and approve 
candidates for replacement/substitute projects and investigators, as 
required, before such requests are forwarded to NCRR for confirmation and 
approval. The EAC must meet at least twice per year on average. Minutes are 
to be recorded and made available for review by NCRR Program staff 
responsible for the COBRE. A summary of the issues discussed at each EAC 
meeting, recommendations made, and actions taken must be included in the 
yearly progress reports submitted to the NCRR.

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:

Dr. Lawrence N. Yager
Division of Research Infrastructure
National Center for Research Resources
National Institutes of Health
6701 Democracy Boulevard, Room 930
Bethesda, MD  20892-4874
Telephone: (301) 435-0760
FAX: (301) 480-3770
E-mail: yagerL@mail.nih.gov

o Direct your questions about peer-review issues to:

Dr. Bo Hong
Office of Review
National Center for Research Resources
National Institutes of Health
6701 Democracy Boulevard, Room 1078
Bethesda, MD  20892-4874
Telephone: (301) 435-0811
FAX: (301) 480-3660
E-mail: hongb@mail.nih.gov

o Direct your questions about financial or grants management matters to:

Ms. Alice Chi
Office of Grants Management
National Center for Research Resources
National Institutes of Health
6701 Democracy Boulevard, Room 1056
Bethesda, MD  20892-4874
Telephone: (301) 435-0844
FAX: (301) 480-3777
E-mail: chia@mail.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; and
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 NCRR 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:

Dr. Bo Hong
Office of Review
National Center for Research Resources
National Institutes of Health
6701 Democracy Boulevard, Room 1078
Bethesda, MD  20892-4874
Bethesda, MD  20817-4874 (for express/courier service) 
Telephone: (301) 435-0811
FAX: (301) 480-3660
E-mail: hongb@mail.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001). Applications must have a DUN and 
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the 
Universal Identifier when applying for Federal grants or cooperative 
agreements. The DUNS number can be obtained by calling (866) 705-5711 or 
through the web site at http://www.dunandbradstreet.com. The DUNS number 
should be entered on line 11 of the face page of the PHS 398 form. The PHS 
398 document 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, 
E-mail: GrantsInfo@nih.gov.

SUPPLEMENTARY INSTRUCTIONS

An application for a COBRE award must include the following:

o  A clear definition of the nature and extent of research collaboration, 
including a full explanation of the necessary administrative, fiscal, and 
scientific aspects of the proposed COBRE.

o  A research plan for five years that includes the proposed organization and 
component functions of the COBRE. The plan should demonstrate the applicant's 
knowledge, ingenuity, practicality, and commitment to developing a 
significant and productive research program.

o  A description of and justification for the proposed individual research 
projects and core service facilities that collectively will contribute to the 
center. Applicants should ideally propose at least three and up to five 
meritorious individual research projects and must describe the nature and 
scope of any scientific research collaborations.

o  A description of the research and research training or career development 
goals and capabilities of the proposed COBRE. The PI must establish a time 
line indicating the plans for each COBRE supported junior investigator to 
prepare and submit proposals for traditional research grant review during the 
performance period of the COBRE award.

o  A description of the infrastructure for conducting studies aimed at 
developing a nationally competitive biomedical research program.

o  A narrative summary, line drawings and cost estimates must be provided for 
any proposed Alteration and Renovation project. An itemized budget and 
justification of the impact that this Alteration and Renovation would have on 
the COBRE activities must also be provided.

o  The Research Plan section of the application describing the proposed 
center, but not including the individual junior investigators' research 
projects, core facilities, and Alteration and Renovation descriptions, is 
limited to no more than 25-pages, including all text, tables, graphs, 
figures, diagrams and charts. The Research Plans for the junior 
investigators' research projects and core descriptions are limited to no more 
than 10-pages each. These limitations do not include the sections describing 
Human Subject Research, Vertebrate Animals, Literature Cited, 
Consortium/Contractual Arrangements, Consultants, and/or supporting letters. 
The Alteration and Renovation section does not have a page limit, nor does 
this section count against the 25-page limit. Each Biographical Sketch is 
limited to no more than four pages. If not specifically cited in the PHS 398 
document instructions, no page limit is in place for any other section. 
However, applicants are strongly urged to be succinct.

o  Applicants should follow the order of content described in the PHS 398 
document instructions and indicated on the Table of Contents page. With 
respect to specific sections, the Budget section should begin with the 
summary or composite budget for the center, followed by the individual 
budgets for all projects, cores, consortia and contractual arrangements. Do 
not separate the individual project budgets into each project section. All 
Biographical Sketches should be grouped together with the PI's biographical 
sketch presented first followed by all other sketches in alphabetical order. 
Do not separate the biographical sketches into each project section. The 
Research Plan for the center should be followed with letters indicating 
institutional commitment, any letters of support for the proposed center (if 
applicable), and letters of acceptance from EAC members. Do not place these 
letters in the Appendix. The Research Plan for the center (including letters) 
should be followed with the Alteration and Renovation section. Core 
descriptions and individual junior investigator Research Plans should follow 
next. Although a PHS 398 face page for each individual research project is 
not required, a cover page should be included that indicates the project 
title, the name of the junior investigator supervising the project, the name 
of the mentor(s), whether human subject/human subject materials will be used 
in the project, and whether vertebrate animals will be used in the project. A 
Description page that provides an Abstract of the proposed project is 
required and should immediately precede each project's Research Plan. As 
necessary, each project section can be concluded with letters of commitment 
from mentors and, as needed, letters of commitment from collaborators and/or 
consultants. Do not place these letters in the Appendix. Consecutively number 
the pages throughout the application. Do not include unnumbered pages and do 
not use suffixes, such as 5a, 5b, etc.

o  The main body of the application should be self contained and the Appendix 
must not be used to circumvent page limitations. Applicants must adhere to 
the guidelines described in the PHS 398 document instructions regarding the 
preparation and presentation of materials that can be included in the 
Appendix.

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  20817-7710 (for express/courier service)

At the time of submission, two additional copies of the application and all 
copies of the appendix material must be sent to:

Dr. Bo Hong
Office of Review
National Center for Research Resources
National Institutes of Health
6701 Democracy Boulevard, Room 1078
Bethesda, MD  20892-4874
Bethesda, MD  20817-4874 (for express/courier service)
Telephone: (301) 435-0811
FAX: (301) 480-3660
E-mail: hongb@mail.nih.gov

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

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within eight 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. 

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NCRR. Incomplete applications will not be reviewed. 
Applications that are not responsive to this RFA or that exceed the maximum 
allowable first-year direct cost limit of $1.5 million (or $2 million, if 
requesting first year Alteration and Renovation costs), excluding F&A costs 
for consortium budgets, will not be reviewed.

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 Office of Review, NCRR in accordance with the review criteria 
stated below. As part of the initial merit review, all applications will:

o undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score;

o receive a written critique; and

o receive a second-level review by the National Advisory Research Resources 
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 are asked to evaluate the application in 
order to judge the likelihood that the proposed research will have a 
substantial impact on the pursuit of these goals. The scientific review group 
will address and consider each of the following criteria in assigning the 
application's overall score, weighting them as appropriate for each 
application.

o Significance
o Approach
o Innovation
o Investigator
o Environment

The application does not need to be strong in all categories to be judged 
likely to have major scientific impact. For example, important work may be 
proposed that by its nature is not innovative but is essential to move a 
field forward.

The review of the COBRE application is additionally based not only on these 
traditional review criteria, but also on the qualification and stature of the 
PI to provide both scientific and administrative leadership and on the 
feasibility and potential for investigators to become competitive for 
independent funding. Senior, funded investigators must not be proposed as 
leaders for individual research projects.

The following criteria will be used to evaluate the 1) administrative 
leadership and overall potential for enriching the intellectual milieu for 
doing research, 2) scientific merit of the individual biomedical research 
projects, and 3) effectiveness in training and promoting junior 
investigators:

ADMINISTRATIVE LEADERSHIP AND OVERALL POTENTIAL FOR ENRICHING THE 
INTELLECTUAL MILIEU FOR DOING RESEARCH: The scientific review group will be 
asked to consider the following criteria:

o The qualifications of the Principal Investigator to provide scientific and 
administrative leadership in developing and directing the COBRE, and 
establishing thematic collaborative research efforts. The PI must demonstrate 
that he/she is an established biomedical or behavioral research scientist, 
that the he/she has an active research laboratory, that he/she has relevant 
peer-reviewed funding (either NIH, NSF or other Federal or non-Federal 
investigator-initiated support), and that he/she has demonstrated 
administrative leadership and mentoring experience.

o The significance, approach, and innovation of the proposed research 
projects and of the COBRE as a whole.

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

o The strengths of the applicant investigators and the collaborating 
researchers, if involved, particularly their academic qualifications, 
biomedical expertise and research productivity.

o The level of institutional commitment with regard to assuring that the 
resources and facilities to sustain the COBRE program are present, including, 
but not restricted to, existing relevant equipment, animal, and/or computer 
resources, and departmental or interdepartmental cooperation.

o The need for the proposed core facilities and the effectiveness of these 
facilities to enhance the research effort. The applicant must demonstrate 
that each proposed core will serve the scientific needs of the individual 
research projects and must show how each core will impact the development of 
the center.

o The ability to augment and strengthen the institutional biomedical research 
capability.

o The ability to provide support for the development of a thematic 
multidisciplinary center.

o The means by which basic or clinical research is encouraged.

o The establishment and maintenance of a scientific thematic focus.

o The suitability of the External Advisory Committee.

o The appropriateness and suitability of evaluation strategies and specific 
milestones necessary to measure progress toward attaining long-range goals.

SCIENTIFIC MERIT OF THE INDIVIDUAL BIOMEDICAL RESEARCH PROJECTS: 
Although the scientific review group should evaluate the qualifications of 
each junior investigator using the traditional criteria and considerations 
indicated in this RFA, reviewers should also evaluate each junior 
investigator's qualifications in terms of his/her career development 
potential and ability to achieve independent status.

o SIGNIFICANCE: Does the study address an important problem? If the aims of 
the application are achieved, how do they advance scientific knowledge? What 
will be the effect of these studies on the concepts or methods that drive 
this field?

o APPROACH: Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project? Are potential problem areas acknowledged and alternative tactics 
considered?

o 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?

o 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 investigator and to that of other researchers (if any)?

o 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?

EFFECTIVENESS IN TRAINING AND PROMOTING JUNIOR INVESTIGATORS: The scientific 
review group will be asked to use the following criteria in evaluating this 
criterion:

o The quality of the research training, career development and mentoring plan 
for junior investigators of the center.

o The plan for development of junior investigators and for their transition 
to and attainment of independent status.

o The suitability of the plan for recruiting new faculty.

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:

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 REVIEW CONSIDERATIONS:

SHARING RESEARCH DATA: Applicants requesting more than $500,000 in direct 
costs in any year of the proposed research must include a data sharing plan 
in their application. The reasonableness of the data sharing plan or the 
rationale for not sharing research data will be assessed by the reviewers. 
However, reviewers will not factor the proposed data sharing plan into the 
determination of scientific merit or priority score. The NIH policy on data 
sharing, as well as guidance on this subject, can be found at 
http://grants.nih.gov/grants/policy/data_sharing. 

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 17, 2003
Application Receipt Date: November 18, 2003
Peer Review Date: March 15, 2004 (subject to change)
Council Review: May 20, 2004
Earliest Anticipated Start Date: June 1, 2004

AWARD CRITERIA

Award decisions will be based on scientific and technical merit as determined 
by peer-review, the National Advisory Research Resources Council, geographic 
distribution, program balance, the enhancement of the research 
competitiveness of the institution, and the availability of funds.

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

DATA SAFETY AND MONITORING PLAN: Data and safety monitoring is required for 
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II); efficacy, 
effectiveness and comparative trials (phase III). The establishment of data 
and safety monitoring boards (DSMBs) is required for multi-site clinical 
trials involving interventions that entail potential risk to the 
participants. (NIH Policy for Data Safety and Monitoring, NIH Guide for 
Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, 
investigators submitting an NIH application seeking more than $500,000 or 
more in direct costs in any single year are expected to include a plan for 
data sharing or state why this is not possible. 
http://grants.nih.gov/grants/policy/data_sharing. Investigators should seek 
guidance from their institutions, on issues related to institutional 
policies, local IRB rules, as well as local, state and Federal laws and 
regulations, including the Privacy Rule. Reviewers will consider the data 
sharing plan but will not factor the plan into the determination of the 
scientific merit or the priority score.

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 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 should read the "NIH Guidelines 
for Inclusion of Women and Minorities as Subjects in Clinical Research - 
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.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research 
on hESCs can be found at http://stemcells.nih.gov/index.asp and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see 
http://escr.nih.gov/). It is the responsibility of the applicant to provide, 
in the project description and elsewhere in the application as appropriate, 
the official NIH identifier(s)for the hESC line(s)to be used in the proposed 
research. Applications that do not provide this information will be returned 
without review.

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 the authorization of Sections 
301 and 405 of the Public Health Service Act as amended (Public Law 78-410, 
as amended by Public Law 99-158, 42 USC 241 and 285) 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 and contract recipients to provide a 
smoke-free workplace and promote the non-use of all tobacco products.  In 
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking 
in certain facilities (or in some cases, any portion of a facility) in which 
regular or routing 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.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 should read the "NIH Guidelines 
for Inclusion of Women and Minorities as Subjects in Clinical Research - 
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.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research 
on hESCs can be found at http://stemcells.nih.gov/index.asp and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see 
http://escr.nih.gov/). It is the responsibility of the applicant to provide, 
in the project description and elsewhere in the application as appropriate, 
the official NIH identifier(s)for the hESC line(s)to be used in the proposed 
research. Applications that do not provide this information will be returned 
without review.

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 the authorization of Sections 
301 and 405 of the Public Health Service Act as amended (Public Law 78-410, 
as amended by Public Law 99-158, 42 USC 241 and 285) 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 and contract recipients to provide a 
smoke-free workplace and promote the non-use of all tobacco products.  In 
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking 
in certain facilities (or in some cases, any portion of a facility) in which 
regular or routing 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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