RFA-RR-04-007: CENTERS OF BIOMEDICAL RESEARCH EXCELLENCE (COBRE)

CENTERS OF BIOMEDICAL RESEARCH EXCELLENCE (COBRE)

RELEASE DATE: June 24, 2004

RFA Number: RFA-RR-04-007

EXPIRATION DATE: October 21, 2004 (This RFA has been reissued, see RFA-RR-06-002)

Department of Health and Human Services (DHHS)

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

COMPONENT OF PARTICIPATING ORGANIZATION:
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: September 22, 2004
APPLICATION RECEIPT DATE: October 20, 2004

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 biomedical research
institutions that award doctoral degrees in the health sciences or sciences
related to health or at independent biomedical research institutes 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 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 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 of the 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 ensuring 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
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 an 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
an 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 and previous history of peer-reviewed research support.

A junior investigator must hold a faculty appointment (or equivalent at a
research institute) at the time that the award is made. Moreover, a clear
commitment to support this 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 an RPG or PPG
and who are not changing 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 two 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 from mentored support to independent investigator. 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
is stressed that the goal of the COBRE program is to promote the development
of an independent and sustainable center. Investigators who have acquired
independent status or completed a research project should not be excluded
from center activities. These investigators should be allowed access to core
facilities and should be encouraged to participate in collaborative research
efforts. If appropriate, an investigator who has acquired independent status
may direct a core facility or serve as a mentor.

It is 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. 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.

A junior investigator who has achieved independent status and no longer
supervises a research project may be replaced by a new investigator.
Replacement investigators and new research projects may be substituted
following review by the PI and the EAC. The PI must communicate the EAC's
recommendation to the NCRR for Programmatic review.

In some instances, a junior investigator may be placed on probation or
considered for removal from the COBRE program if a review by the EAC
indicates a failure by the 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 two years of COBRE
support.

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. Junior investigators should indicate in the Biographical Sketch
their current and previous history of peer-reviewed research support.

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 only in year one 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 only in year one, 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 $300,000 is
restricted until project documentation/architectural drawings have been
reviewed and approved by NIH staff. A&R projects of less than $300,000 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 July 2005.

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
https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

FUNDS AVAILABLE

The NCRR intends to commit approximately $15 million in FY05 to fund 6 to 8
new grants in response to this RFA contingent upon the availability of funds.
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 year one 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 $200,000 for the first year and $100,000 per
year thereafter for each position. These funds may be used for salary,
supplies, and/or equipment costs. The PI must communicate plans for the
expenditure of funds for recruitment purposes to the NCRR for Programmatic
review.

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.

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
as indicated in the policy statement at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html.
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 available at
https://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/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 1999-2003. Also included are those states
that had higher success rates, but received less than $100 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 from eligible institutions that hold two or
less 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.

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 planning 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 fields;
their expertise must be directly relevant to the scientific theme of the
respective 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 of each proposed member. The PI may recruit additional
members to the EAC after an award is made. The PI must communicate the
selection of additional EAC members to the NCRR for Programmatic review.

The EAC critiques the scientific progress of the COBRE and also offers advice
on scientific matters to the COBRE PI. The EAC activities include developing
and planning concepts and programs, encouraging and assisting faculty
development and mentoring, identifying resources, evaluating the development
of the center, evaluating 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 COBRE investigators at the center. The EAC also will
review and recommend candidate investigators for replacement/substitute
projects, as required, before such requests are forwarded to the NCRR for
Programmatic review. The EAC must meet at least twice per year. Video-,
teleconferencing or other means may be used in situations where it would be
difficult to hold an in person meeting. 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. Sheryl K. Brining
Office of Review
National Center for Research Resources
National Institutes of Health
6701 Democracy Boulevard, Room 1072
Bethesda, MD 20892-4874
Telephone: (301) 435-0811
FAX: (301) 480-3660
E-mail: sb44k@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. Sheryl K. Brining
Office of Review
National Center for Research Resources
National Institutes of Health
6701 Democracy Boulevard, Room 1072
Bethesda, MD 20892-4874
Bethesda, MD 20817-4874 (for express/courier service)
Telephone: (301) 435-0811
FAX: (301) 480-3660
E-mail: sb44k@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
https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
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 Alteration and Renovation section does not
have a page limit, nor does this section count against the 25-page limit. 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. Each Biographical Sketch is limited to no more
than four pages. If not specifically cited in the PHS 398 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
may 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:
https://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:

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

Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and funding
assignments 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.
However, when a previously unfunded application, originally submitted as an
investigator-initiated application, is to be submitted in response to an RFA,
it is to be prepared as a NEW application. That is, the application for the
RFA must not include an Introduction describing the changes and improvements
made, and the text must not be marked to indicate the changes from the
previous unfunded version of the 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 understanding of
biological systems, improve the control of disease, and enhance health. In
the written comments, reviewers are asked to evaluate the application 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 criteria listed below in assigning the
application's overall score, weighting them as appropriate for each
application.

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

Additionally, the review of the COBRE application is not only based on the
traditional review criteria (Significance, Approach, Innovation,
Investigator, Environment), 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.

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

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 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. Each application must describe how the
institutional biomedical research capacity will be augmented and
strengthened, how basic and/or clinical research will be encouraged, how a
scientific thematic focus will be established and maintained, and how
appropriate and suitable evaluation strategies and specific milestones to
measure progress toward attaining long-range goals will be selected and
employed.

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 ability to provide support for the development of a thematic
multidisciplinary center, including the level of institutional commitment.
Each application must demonstrate 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 suitability of the External Advisory Committee.

EFFECTIVENESS IN TRAINING AND PROMOTING JUNIOR INVESTIGATORS: The Scientific
Review Group will be asked to use the following 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.

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?

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
https://grants.nih.gov/grants/policy/data_sharing.

SHARING OF MODEL ORGANISMS FOR BIOMEDICAL RESEARCH: All applicants must
include a description of a specific plan for sharing and distributing unique
model organism research resources generated using NIH funding so that other
researchers can benefit from these resources, or state appropriate reasons
for why such sharing is restricted or not possible. Unlike the NIH Data
Sharing Policy, the submission of a model organism sharing plan is not
subject to the cost threshold of $500,000 or more in direct costs in any one
year, and is expected to be included in all applications where the
development of model organisms is anticipated. The adequacy of plans for
sharing model organisms or the rationale for not sharing model organisms will
be assessed by the reviewers. However, reviewers will not factor the proposed
model organism sharing plan into the determination of scientific merit or
priority score. The NIH policy on sharing of model organisms, as well as
guidance on this subject, can be found at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html.

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: September 22, 2004
Application Receipt Date: October 20, 2004
Peer Review Date: March 15, 2005 (subject to change)
Council Review: May 19, 2005
Earliest Anticipated Start Date: July 1, 2005

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

ANIMAL WELFARE PROTECTION: Recipients of PHS support for activities
involving live, vertebrate animals must comply with PHS Policy on Humane Care
and Use of Laboratory Animals
(https://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as
mandated by the Health Research Extension Act of 1985
(https://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA
Animal Welfare Regulations
(http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable.

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:
https://grants.nih.gov/grants/guide/notice-files/not98-084.html).

SHARING RESEARCH DATA: Investigators submitting an NIH application seeking
$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.
https://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
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
https://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.

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
https://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
https://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
https://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
https://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).

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
https://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 https://grants.nih.gov/grants/policy/policy.htm

The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

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