COMPREHENSIVE CENTERS ON HEALTH DISPARITIES (CCHD) AT RCMI-ELIGIBLE 
INSTITUTIONS 
 
RELEASE DATE:  February 3, 2003 

RFA: RR-03-004
   
National Center for Research Resources (NCRR)
 (http://www.ncrr.nih.gov) 
National Institute of Mental Health (NIMH)
 (http://www.nimh.nih.gov)
 
LETTER OF INTENT RECEIPT DATE: March 17, 2003

APPLICATION RECEIPT DATE:  April 16, 2003
 
THIS RFA CONTAINS THE FOLLOWING INFORMATION:

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

PURPOSE OF THIS RFA 

The National Center for Research Resources (NCRR) and the National 
Institute of Mental Health (NIMH) invite applications for the 
establishment of Comprehensive Centers on Health Disparities (CCHD) at 
NCRR-supported Research Centers in Minority Institutions (RCMI) with 
affiliated medical schools. 

The purpose of this Request for Applications (RFA) is to augment and 
strengthen the institutional clinical research capabilities that are 
needed to address the cause(s) of health disparities in the racial and 
ethnic minority populations served by these institutions.  Equally 
important will be the development of sustainable, replicable and 
culturally appropriate prevention and/or intervention research programs 
targeted to minority populations, designed to decrease the burden of 
disease in these populations.  This is consistent with the health 
disparities agenda set forth by the National Institutes of Health (NIH) 
and the Department of Health and Human Services (DHHS).  

These CCHD will provide support to augment and strengthen the research 
capabilities of faculties at the grantee institutions to encourage 
innovative and effective research strategies to reduce the burden of 
diseases that disproportionately affect minority populations.  Support 
will be provided to recruit established clinical researchers with an 
active research laboratory and independent research support.  They will 
serve as mentors to junior researchers in basic or clinical research.  
These new faculty will receive support to establish their research 
laboratories, acquire specialized equipment, and hire postdoctoral 
fellows and technical assistants.  It is anticipated that they will 
serve as magnet investigators for the recruitment of other research 
faculty who will complement the thematic focus of the application.  
Support will also be provided to facilitate collaboration with other 
NIH-supported disease-specific centers and community health centers.  
Therefore, the research focus of the application must be one or more of 
the diseases that disproportionately affect the indigenous populations 
served by the RCMI institution.  In the long range, it is anticipated 
that this program will facilitate the development of the institution's 
clinical research capacity.  It is also anticipated that the CCHD will 
complement existing support provided to the applicant institution via 
the NCRR RCMI Program and other Public Health Service (PHS) funding.  
 
RESEARCH OBJECTIVES

This program seeks to foster improved health status and reduce the 
health disparity experienced by racial and ethnic minority Americans. 
The NIH recognizes that minority institutions are important and 
essential in fulfilling the promise of the NIH biomedical research 
agenda.  Therefore, the NCRR and NIMH are offering programmatic 
assistance for the development of the technology and resources that are 
necessary to conduct state-of-the-art biomedical and behavioral 
research at these institutions.  Over the long range, it is anticipated 
that this will facilitate the participation of these institutions in 
preparing the next generation of biomedical investigators, especially 
from those populations that are under-represented in the biomedical 
sciences.  This RFA is one way that the NIH identifies and supports 
biomedical and clinical researchers at eligible institutions to conduct 
and report the meritorious research that will foster successful 
competition for traditional research project grants (e.g., R-series and 
P-series).  The long-range objectives of this initiative are to:(1) 
assist the participating institutions to conduct clinical research that 
will improve the health of the nation's citizens, especially racial and 
ethnic minorities; (2) enhance the clinical research capacity of the 
eligible institutions; and (3) position the grantee institutions to 
compete successfully for PHS-supported research.

The primary goals of CCHD are to:  (1) develop sustainable, replicable 
and culturally appropriate prevention and/or intervention research 
programs targeted to minority populations designed to decrease the 
incidence and prevalence of disease; (2) strengthen clinical and 
translational research capacity at minority medical schools committed 
to addressing health disparities; (3) enhance opportunities for multi- 
disciplinary research collaborations between minority institutions and 
institutions with more established research programs in the identified 
areas; and (4) increase the role of research in maintaining a vigorous 
and stimulating academic environment that will inspire students and 
fellows to pursue careers that focus on health disparities.

RESEARCH AREAS:  In FY 1985, the legislation that authorized the RCMI 
Program called attention to the disparity in the health status of 
minorities as compared to Caucasian Americans.  Research areas for the 
CCHD initiative include such disparities, as have now been identified 
for a variety of cancers (breast, prostate and colon/rectal), diabetes, 
infant mortality, cerebrovascular and cardiovascular disease, and 
Acquired Immunodeficiency Syndrome (AIDS).  NIMH support will be 
limited to Centers focusing on HIV/AIDS research, funded through the 
Center for Mental Health Research on AIDS (CMHRA).  

RESEARCH PLAN:  The research plan of a CCHD application should have a 
single-disease focus, and must contain a description of three to five 
multi-disciplinary, collaborative, developmental research projects that 
will be mutually beneficial to participating investigators through 
coordinated, cooperative interactions.  The research excellence of 
these projects will be enhanced by effectively using the scientific and 
technical strengths of collaborating investigators.  These projects 
must add to the body of knowledge that will address the 
disproportionate effect of various diseases in minority populations.  
The proposed application must be presented in two phases.  Phase I may 
last for up to two years.  During Phase I, a PI and/or other essential 
scientific personnel will be hired and collaborative research links and 
partnerships will be developed. Phase II, lasting up to four years, 
will be a research development phase whereby CCHD research faculty and 
their collaborators will conduct exploratory studies.  For a detailed 
description of the structure of the CCHD application, refer to the 
Supplemental Instructions in this RFA.  

Program Characteristics:  The Principal Investigator (PI) of the CCHD 
application must be an established clinical investigator with relevant 
expertise and a documented record of research accomplishments and 
administrative skills to direct a prevention-intervention research 
program and train junior faculty. The PI must have an active research 
program receiving NIH 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 CCHD.  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 CCHD PI.
 
A Program Advisory Committee (PAC) that advises the PI must be 
established.  For a detailed description of the PAC, refer to the Terms 
and Conditions of Award in this RFA.

MECHANISM OF SUPPORT

The NIH U54 is a cooperative agreement award mechanism in which the 
Principal Investigator retains the primary responsibility and dominant 
role for planning, directing, and executing the proposed project, with 
the NIH Program Official being substantially involved as a partner with 
the Principal Investigator, as described in the section "Cooperative 
Agreement Terms and Conditions of Award".  

FUNDS AVAILABLE 
 
The NCRR intends to commit up to $1,500,000 in FY03 to fund one to two 
new grants in response to this RFA.  NIMH intends to commit up to 
$350,000 in FY03.  NIMH support will be limited to Centers focusing on 
HIV/AIDS research.  In Phase I, an applicant may request up to $500,000 
direct costs per year for two years.  In Phase II, the applicant may 
request up to $2,000,000 direct costs per year for up to four years.  
Phase II funds will not be released until Phase I objectives have been 
successfully achieved, a qualified Principal Investigator has been 
hired, and Phase II exploratory prevention-intervention research 
studies have been reviewed by the PAC and approved by the participating 
funding components of the NIH.  Because the nature and scope of the 
proposed research will vary from application to application, it is 
anticipated that the size and duration of each award will also vary.  
At least 75% of the direct costs in any given year should be used to 
support CCHD activities at the applicant institution. Costs are 
expected to decrease in the final years of Phase II, which should be 
devoted to data analysis and the reporting of results.  Although the 
financial plans of the NCRR and the NIMH 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.  

ELIGIBLE INSTITUTIONS

Applications will be accepted only from RCMI-supported institutions 
with affiliated medical schools that have not previously received NCRR 
support for the establishment of a CCHD.  Each applicant institution 
must identify one or more collaborating disease-specific centers 
supported by the NIH and a network of community health centers.  All 
collaborating institutions must be domestic Federal or non-Federal, 
public or private, non-profit organizations. 

Ideally, participating applicant investigators who are already resident 
at the applicant institution must have completed two or more years of 
postdoctoral clinical research and must be full-time employees of the 
applicant institution.  All collaborating investigators must be NIH 
grantees currently supported by R-series, P-series, and/or U-series 
grants.

INDIVIDUALS ELIGIBLE TO BECOME THE PRINCIPAL INVESTIGATOR 

Any individual with the skills, knowledge, and resources necessary to 
carry out the proposed research is invited to work with their 
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 CCHD application must be an established clinical investigator who 
has demonstrated the administrative abilities to effectively carry out 
the objectives of the CCHD program and meet its goals. The 
qualifications of the PI have been previously described.

COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD:  The following 
Terms of Award are in addition to, and not instead of, otherwise 
applicable OMB administrative guidelines, DHHS Grant Administration 
Regulations at 45 CFR Part 74 and 92, and other DHHS, PHS, and NIH 
grant administration policies.  Cooperative Agreements are subject to 
the administrative requirements outlined in pertinent OMB, DHHS, PHS, 
and NIH guidelines, with particular emphasis on DHHS regulations at 42 
CFR Part 52 and 45 CFR Part 74.  F&A costs are calculated and awarded 
for cooperative agreement awards the same as for grants.  The 
administrative and funding instrument used for this program is a 
cooperative agreement (U54), an "assistance" mechanism (rather than an 
"acquisition" mechanism) in which substantial NIH scientific and/or 
programmatic involvement with the grantee is anticipated during 
performance of the activity.  Under the cooperative agreement, the NIH 
supports and/or stimulates the recipient's activity by being involved 
in and otherwise working jointly with the award recipient in a partner 
role, but it is not to assume direction, prime responsibility, or a 
dominant role in the activity.  Consistent with this concept, the 
dominant role and prime responsibility for the activity resides with 
the awardee(s) for the project as a whole, although specific tasks and 
activities in carrying out the studies will be shared among the 
awardees and the NCRR and NIMH Program Coordinators.  These are 
summarized below:

1. Awardee Rights and Responsibilities 

a. Awardees will work to establish research priorities within the 
approved research scope of each CCHD award through discussions with the 
Division of Research Infrastructure (DRI), NCRR.  The Center for Mental 
Health Research on AIDS (CMHRA), NIMH will provide advice as needed.  
The NCRR and NIMH reserve the right to include outside 
consultants/experts in these discussions.  Awardees will have primary 
responsibility for the project as a whole, including research design 
and conduct, data collection, data quality control, data analysis and 
interpretation, and preparation of publications, and collaborations 
with other awardees.  Awardees will retain primary rights to the data 
developed under these awards, subject to government rights of access 
consistent with current DHHS, PHS, and NIH policies.  However, awardees 
must be committed to making available to the research community the 
research tools and research materials they develop. 

b. Awardees agree to follow the advice and recommendations of the 
Program Advisory Committee, whenever possible, in meeting the intent of 
this initiative.

c. Awardees and each partner in the CCHD should plan regular meetings 
(no less frequently than monthly) to discuss the progress and 
directions of its activities and to ensure that the necessary 
interactions are taking place via teleconferencing, videoconferencing 
or web conferencing, as well as face-to-face meetings (semi-annually or 
quarterly).

d. The Co-Investigators and other designated investigators from 
partnering institutions will attend the annual meetings of the CCHD-
funded investigators. 

e. Awardees will submit annual progress reports on behalf of all 
collaborating entities (including the PAC annual meeting evaluation and 
recommendations) to the appropriate NCRR Program Official.  The 
progress report describes activities and accomplishments during the 
previous funding period as part of the non-competing continuation 
application.  The awardee and the NCRR will interact in a cooperative 
manner throughout the duration of the award to facilitate progress and 
resolve any problems that may arise.  The NIMH will provide advice as 
needed.  Other NIH program staff may participate in establishing 
research priorities throughout the performance period of the CCHD 
award.

f. Intellectual Property.  All Awardees must adhere to the policy for 
distribution of unique research resources produced with PHS funding, 
published in the NIH Guide for Grants and Contracts (NIH Guide, Vol. 
25, No. 23, July 12, 1996). The Guide can be accessed electronically 
at: http://grants.nih.gov/grants/guide/index.html.  

All awardees must also adhere to the Principles and Guidelines for 
Recipients of NIH Research Grants and Contracts on Obtaining and 
Disseminating Biomedical Research Resources (64 Federal Register 
72090).  The Principles and Guidelines can be accessed electronically 
at: http://www.nih.gov/od/ott/RTguide_final.html.

"Institution agrees to grant to commercial collaborator: (i) a paid-up 
nonexclusive, nontransferable, royalty-free, world-wide license to all 
Institution Inventions for research purposes only; and (ii) a time-
limited first option to negotiate an exclusive, world-wide royalty-
bearing license for all commercial purposes, including the right to 
sub-license, to all Institution Inventions on terms to be negotiated in 
good faith by the collaborator and Institution. The collaborator shall 
notify Institution, in writing, of its interest in obtaining such an 
exclusive license to any Institution Invention within six (6) months of 
the collaborator's receipt of notice of such Institution Invention(s).  
In the event that a collaborator fails to so notify Institution, or 
elects not to obtain an exclusive license, then the collaborator's 
option shall expire with respect to that Institution Invention, and 
Institution will be free to dispose of its interests in such 
Institution Invention in accordance with Institution's policies.  If 
Institution and collaborator fail to reach agreement within ninety (90) 
days, (or such additional period as collaborator and Institution may 
agree) on the terms for an exclusive license for a particular 
Institution Invention, then for a period of six (6) months thereafter 
Institution shall not offer to license the Institution Invention to any 
third party on materially better terms than those last offered to 
collaborator without first offering such terms to collaborator, in 
which case collaborator shall have a period of thirty (30) days in 
which to accept or reject the offer."

"Institution agrees that notwithstanding anything contained herein to 
the contrary, any inventions, discoveries or innovations, whether 
patentable or not, which are not Subject Inventions as defined in 35 
USC 201(e), arising out of any unauthorized use of the collaborator's 
agent and/or any modifications to the agent, shall be the property of 
the collaborator (hereinafter "Collaborator Inventions"). Institution 
will promptly notify the collaborator in writing of any such 
Collaborator Inventions and, at collaborator's request and expense, 
Institution will cause to be assigned to collaborator all right, title 
and interest in and to any such collaborator inventions and provide 
collaborator with assignment or other documents. Institution may also 
be conducting other research using the agent under the authority of a 
separate Material transfer Agreement (MTA) with the collaborator. 
Inventions arising there under shall be subject to the terms of the 
MTA, and not to this clause."

g. Protection of Proprietary Data. The ability to publish new results 
in a timely and intellectually unconstrained manner is fundamental to 
the academic enterprise.  This need must be balanced with the 
legitimate requirements of commercial collaborators to protect the 
proprietary or confidential information that they provide concerning 
their proprietary agents.  Commercial collaborators also may require 
exclusive access to the raw and primary data generated in studies of 
their agents. Therefore, The NCRR urges that the following statement 
also be incorporated in Partner applications:

"Raw and primary data may be provided exclusively to the NCRR, 
industrial collaborators, and the FDA, as appropriate. This provision 
shall not affect the investigators' right to disseminate their research 
findings through publications or presentations."

2. NCRR Staff Responsibilities 

The NCRR Program Official will be responsible for normal stewardship of 
the award and may recommend the termination or curtailment of an 
investigator or project/program (or an individual award) in the event 
the partnerships fail to evolve within the intent and purpose of this 
initiative.  In addition, the NCRR Program Official, and the NIMH 
Program Official as needed, will have substantial scientific-
programmatic involvement during the conduct of this activity through 
technical assistance, advice, and coordination as follows:  

a. Receive information from the PAC and provide advice as necessary.

b. Work closely with individual investigators and partners to 
facilitate collaborations.

c. Assist the partnership efforts by facilitating access to fiscal and 
intellectual resources provided by the NIH, industry, private 
foundations, and other federal funding agencies.

d. Ensure that activities proposed for development or implementation do 
not overlap or duplicate activities supported by other peer-reviewed 
funding mechanisms.

e. Interact with each partner, coordinate approaches between partners, 
and contribute to the adjustment of projects/programs or approaches as 
warranted.  

f. Provide assistance in reviewing and commenting on all major 
transitional changes of an individual partner's activities prior to 
implementation to assure consistency with the goals of this RFA.

g. Coordinate activities with other ongoing studies supported by the 
NIH to avoid duplication of effort and encourage sharing and 
collaboration in the development of new, clinically useful agents and 
methodologies.

h. Coordinate access to other resources provided by the NIH for pre-
clinical and clinical testing.

i. Link the approaches developed from these partnerships to each other 
and to other NIH-supported Centers to ensure that information is shared 
and utilized on the widest basis possible. 

j. Help re-program efforts within the peer-reviewed scope of work, 
including options to modify projects/programs when projects/programs 
are not making headway relative to the time-line for achieving the 
objectives of the RFA.

k. Assist the Program Advisory Committee in the evaluation of new pilot 
and full projects/ programs when requested as replacements for ongoing 
activities.

l. Monitor institutional commitments and resources to ensure that the 
partnership receives the maximum chance of stabilization and success.

m. Assist in the organization of an annual meeting that engages all of 
the partnerships and other participants as needed. This meeting will be 
held for all CCHD-funded investigators to share progress and research 
insights that may benefit all of the projects. 

3. Collaborative Responsibilities of the Program Advisory Committee    

A Program Advisory Committee (PAC) must include representation from 
each partnering institution, and external advisors with the scientific 
expertise necessary to provide objective advice relative to the CCHD. 
The committee must be composed of two subcommittees: a) an external 
committee, and b) an internal committee.  Depending on the scope and 
complexity of the CCHD Program, each of these subcommittees may consist 
of eight to twelve members.  Ideally, the members should be appointed 
on a rotating basis.  The efforts and recommendations of these 
subcommittees must be coordinated.  Meetings of the external 
subcommittee must be held at least annually; the internal subcommittee 
must meet at least quarterly. The PAC may establish subcommittees with 
additional ad hoc advisors in order to meet its planning, priority 
setting, and evaluation responsibilities.  The PAC will serve as the 
primary advisory board of the CCHD Program and will have the 
responsibility of developing criteria to be used in establishing 
priorities, changing directions, approving new faculty recruits within 
the prioritized areas, and identifying areas of new opportunity based 
on continuing evaluation. The PI may not be a voting member of the PAC.  
The PI and NCRR Program Official receive recommendations from the PAC, 
and provide advice as necessary.  The PAC must submit at least one 
written annual report to the PI and to the NCRR Program Official.  
These recommendations are to be used by the Principal Investigator to 
guide and direct the development of the CCHD program.  Awardees 
generally will be expected to accept and implement the recommendations 
of the PAC; in those situations where the recommendations are not 
feasible to implement, the Principal Investigator must provide a 
thorough explanation and rationale to the NCRR Program Official.

4. Arbitration 

Any disagreement that may arise on scientific/programmatic matters 
(within the scope of the award), between award recipients and the NIH 
IC may be brought to arbitration.  An arbitration panel will be 
composed of three members -- one selected by the Program Advisory 
Committee (with the NIH Program Official not voting), a second member 
selected by the NIH IC, and a third member selected by the other two 
selected members. This special arbitration procedure is not intended to 
affect the awardee's right to appeal an adverse action that is 
otherwise appealable in accordance with the PHS regulations at 42 CFR 
Part 50, Subpart D and DHHS regulation at 45 CFR Part 16.

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. Shelia McClure
Division of Research Infrastructure
National Center for Research Resources
6705 Rockledge Drive, Suite 6030, MSC 7965
Bethesda, MD  20892-7965
Telephone:  (301) 451-6536
FAX:  (301) 480-3770
E-mail:  mcclures@ncrr.nih.gov

Dr. David M. Stoff
Center for Mental Health Research on AIDS
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6210, MSC 9619
Bethesda MD 20892-9619
Telephone:  (301) 443-4625
FAX:  (301) 443-9719
E-mail:  dstoff@nih.gov
  
o Direct your questions about peer review issues to:

Dr. Eric Brown
Scientific Review Administrator
National Center for Research Resources
6701 Rockledge Drive, Room 6018
Bethesda, MD  20892-7965
Telephone:  301-435-0815
Fax:  301-480-3660
E-mail:  browne@ncrr.nih.gov

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

Ms. Irene Grissom
Office of Grants Management
National Center for Research Resources
6701 Rockledge Drive, Room 6086
Bethesda, MD  20892-7965
Telephone:  301-435-0844
Fax:  301-480-3777
E-mail:  grissomi@ncrr.nih.gov 

Mr. Brian Albertini
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda MD 20892-9605
Telephone:  (301) 443-0004
FAX:  (301) 443-0219
E-mail:  albertinib2@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
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 IC 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. Eric Brown
Scientific Review Administrator
National Center for Research Resources
6701 Rockledge Drive, Room 6018
Bethesda, MD  20892-7965
Telephone:  301-435-0815
Fax:  301-480-3660
E-mail:  browne@ncrr.nih.gov

SUBMITTING AN APPLICATION

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

SUPPLEMENTAL INSTRUCTIONS: The proposed application must be presented in 
two parts, Phase I and Phase II.   Phase I, consisting of up to two 
years, will be a recruitment phase, whereby staff at the applicant 
institution will develop and implement plans to recruit the PI and/or 
other essential scientific personnel; establish institutional and 
collaborative research links and partnerships; and develop the overall 
administrative structure of the proposed CCHD Program.  Phase I may 
also include the initiation of developmental clinical research projects 
by participating investigators.  By the end of Phase I, a PI should 
have been hired and the NCRR, NIMH, or other collaborating Institutes 
and Centers at NIH, and the PAC should have approved the research plans 
and budgets for the exploratory prevention/intervention research 
studies to be conducted during Phase II.

Phase II, lasting up to four years, will be a research development 
phase whereby CCHD research faculty and their collaborators will 
conduct exploratory studies.  These exploratory studies will allow 
investigators to develop preliminary data necessary to compete for 
research funding through conventional granting mechanisms (e.g., R-
series or P-series).  The PI and CCHD research faculty will select, and 
the PAC will review the Phase II exploratory prevention/intervention 
research studies prior to implementation.
 
The CCHD application must address the following key elements:

1.  Administration

o Define the chain of responsibility for decision-making and 
administration, beginning at the level of the institution's President 
and including all key staff (e.g., Sponsored Programs Administrator, 
Department Chair, and Dean).  Describe the plans for day-to-day 
administration of the CCHD, including program coordination, planning, 
and evaluation.  Describe the proposed relationship of the CCHD to the 
RCMI Clinical Research Infrastructure Initiative (RCRII), Centers of 
Clinical Research Excellence (CCRE) and other clinical research 
activities, and explain, in detail, how the CCHD initiative will 
augment and strengthen the existing research infrastructure.

o Identify all support staff (e.g., grants management, administrative, 
and technical) and outline plans to ensure the timely ordering of 
research supplies, equipment, and other resources essential to the 
scientific productivity of the research award.  If these resources are 
provided via an existing RCMI or other awards, they may not be 
requested in this application.

2.  Program Direction/Advisory Committee

o Describe a process for the selection and appointment of a CCHD 
Principal Investigator who has active clinical research funding and 
research training experience.  

o Appoint a Program Advisory Committee whose composition consists of 
clinical investigators whose research experience and expertise 
complement the research focus of the CCHD. 

o Develop a plan for up to six years (two years planning; four years 
research) that includes the proposed organization and component 
functions of the CCHD. The plan should demonstrate the applicant's 
knowledge regarding minority health or health disparities, and 
ingenuity and commitment to developing a productive, competitive 
clinical research program.  The plan should include a timeline that 
details the specific activities of the CCHD for each year and should 
describe how the proposed activities enhance the scientific 
capabilities of faculty and fellows involved in clinical research.

o Propose three to five meritorious developmental clinical research 
projects that are relevant to the focus of the Center.  Competitive 
applications will develop new and/or strengthen existing collaborative 
projects with NIH/PHS grantees from research-intensive institutions.  
Applicants must clearly define the nature and extent of the research 
collaboration, such that the necessary fiscal and scientific aspects 
are fully explained in the application.

o Describe the research and research training goals and capabilities of 
the proposed CCHD.  The Principal Investigator and the PAC must 
establish a timeline for developmental project investigators to prepare 
and submit proposals for traditional research grant review during the 
performance period of the CCHD award. The timeline must require each 
subproject investigator to submit R-series or P-series type 
applications by the end of the third year of funding to the 
investigator.

3.  Institutional Commitment/Supporting Infrastructure

o Provide evidence that the senior leadership at the applicant 
institution has addressed issues such as tenure, promotion, release-
time, and other personnel matters pertaining to the scientific success 
of the CCHD.

o Include a research plan for up to four years in Phase II that 
includes the proposed organization and component functions of the CCHD, 
and demonstrates the institution's commitment to developing a 
significant and productive research program.

o Document evidence of institutional commitment and the availability of 
technical resources and facilities for the long-term support of the 
CCHD.  Describe features of the institutional environment that are 
relevant to effective accomplishment of the CCHD overall goals.

o Provide a letter of support from a senior institution official (e.g., 
President or Dean) outlining the commitment of resources and facilities 
to sustain and support the CCHD throughout the period of funding and 
beyond the performance period of this award.

o Provide a description of the current research infrastructure 
(laboratory space, clinical facilities, major equipment, research 
support services, computer resources, patient populations, geographic 
distributions of space and personnel) and collaborative resources for 
conducting studies aimed at developing a competitive CCHD.

o Delineate needed enhancements to the existing research 
infrastructure. 

o Describe previous (past five years) and current research support used 
for clinical research.  

4.  Developmental Projects and Research Collaborations

o The CCHD must include three to five developmental clinical research 
projects.  These projects should focus on one of the diseases that 
disproportionately affect the health status of minority populations and 
addresses the impact of sex and gender differences within these 
populations.

o Projects should be led by a junior investigator who is responsible 
for insuring that the specific aims of that project are met.  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 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.  Investigators are required to devote a minimum of 50-percent 
research effort to their respective projects.

With respect to the item (1), grants that name an individual as a co-
investigator, collaborator or consultant do not disqualify that 
investigator.  Starter grants (such as NIH's FIRST award mechanism, 
R29), Academic Research Enhancement Award grants (AREA, R15), or 
exploratory/pilot project grants (such as NIH R03 or R21 awards) also 
do not disqualify the investigator.  The investigator must hold either 
a tenure track or non-tenure track faculty appointment of any rank at 
the time that the award is made.  Furthermore, a clear commitment to 
support this faculty appointment 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 the item (2), support may be provided to an individual 
who is making a significant change to his/her career goals by 
initiating a new line of research that is distinctly and significantly 
different from his/her current investigative program.  In this case a 
current or previous history of independent peer-reviewed research 
support in a different investigative area from that proposed in this 
application does not disqualify the investigator.  Moreover, this 
individual can be of any faculty rank.

This initiative is not intended to replace support for ongoing 
investigator-initiated research programs of established investigators, 
nor are established investigators eligible for support.  Instead, 
established investigators should serve as mentors to advance the junior 
investigators' careers.

o Each project must involve collaboration with an investigator at a  
research-intensive institution who has an R01 or other similar PHS 
support.  Investigators must clearly define the nature and extent of 
the research collaboration, by fully explaining the necessary 
administrative, fiscal, and scientific aspects in the application.

o Collaborating investigators must devote a minimum of 15-20 percent 
research effort to the respective projects.  These costs may be paid 
via a subcontract.

o Each project must be presented in the format of an R01 application.  
The research plan should be limited to 15 pages (a-d in the PHS 398).  
The maximum allowable direct cost is $200,000 per year/project.  These 
projects must involve clinical investigators at nearby institutions as 
collaborators.

o The application should show clear collaborations between key 
components within the institution, especially those activities 
supported via the NCRR Research Centers in Minority Institutions 
Program, and other NIH- supported programs that may complement the 
proposed program. If in place, programs such as the RCMI Centers of 
Clinical Research Excellence (CCRE) grants may complement this CCHD 
initiative.

o The applicant organization should also identify collaborating 
research institutions and community health centers as partners that may 
be non-profit organizations, Federal or non-Federal, public or private.  
Because the applicant institution may need continuous and substantial 
research collaboration to achieve the objectives of this initiative, 
the collaborating organizations should be in the U.S., its possessions, 
or its territories.

o Each applicant must provide a detailed description of the approach to 
be used for obtaining patent coverage and for licensing where 
appropriate, in particular where the invention may involve 
investigators from more than one institution.  

ALLOWABLE COSTS:  Phase I costs may include the planning and 
recruitment of essential personnel (e.g., PI) for the administrative 
activities.  The costs for these activities should not exceed 20 
percent of the direct costs of $500,000 per year.  Other allowable 
costs include salaries for key research support personnel; equipment 
and supplies to support the administrative structure; planning and 
coordination activities for travel of advisory committees; workshops 
and seminars; consortium interactions; and if appropriate, 
developmental research projects by participating CCHD faculty.  Phase 
II costs may include funds for the newly hired PI; funds to recruit and 
support magnet clinical investigators; support for research staff; 
support for research resources and infrastructure to enhance scientific 
collaborations; and support for developmental clinical research 
projects, that should lead to independent research funding for the CCHD 
investigator.  Training and career development activities may also be 
considered for funding.

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 CCHD 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 CCHD thematic focus must be evident in the application.  Applicants 
for CCHD 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, 
Facilities and Administrative (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.

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 
5/2001) application form must be affixed to the bottom of the face page 
of the application.  Type the RFA number on the label.  Failure to use 
this label could result in delayed processing of the application such 
that it may not reach the review committee in time for review.  In 
addition, the RFA title and number must be typed on line 2 of the face 
page of the application form and the YES box must be marked. The RFA 
label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
 
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten 
original of the application, including the Checklist, and three signed, 
photocopies, in one package to:
 
Center For Scientific Review
National Institutes Of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)
 
At the time of submission, two additional copies of the application 
must be sent to:

Dr. Eric Brown
Scientific Review Administrator
National Center for Research Resources
6701 Rockledge Drive, Room 6018
Bethesda, MD  20892-7965
Telephone:  301-435-0815
Fax:  301-480-3660
E-mail:  browne@ncrr.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.

The Center for Scientific Review (CSR) will not accept any application 
in response to this RFA that is essentially the same as one currently 
pending initial review, unless the applicant withdraws the pending 
application.  The CSR will not accept any application that is 
essentially the same as one already reviewed.  This does not preclude 
the submission of substantial revisions of applications already 
reviewed, but such applications must include an Introduction addressing 
the previous critique.
 
PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the 
Center for Scientific Review and responsiveness by the NCRR.  
Incomplete and/or non-responsive applications will be returned to the 
applicant without further consideration.

Applications that are complete and responsive to the RFA will be 
evaluated for scientific and technical merit by an appropriate peer- 
review group convened by the NCRR in accordance with the review 
criteria stated below.  As part of the initial merit review, all 
applications will:

o Receive a written critique
o Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications 
under review, will be discussed and assigned a priority score
o Receive a second-level review by an appropriate National Advisory 
Council or Board
 
REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  
In the written comments, reviewers will be asked to discuss the 
following aspects of your application in order to judge the likelihood 
that the proposed research will have a substantial impact on the 
pursuit of these goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The scientific review group will address and consider each of these 
criteria in assigning your application's overall score, weighting them 
as appropriate for each application.  

(1) SIGNIFICANCE:  Does your study address an important problem? If the 
aims of your 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?

(2) APPROACH:  Are the conceptual framework, design, methods, and 
analyses adequately developed, well integrated, and appropriate to the 
aims of the project?  Do you acknowledge potential problem areas and 
consider alternative tactics?

(3) INNOVATION:  Does your project employ novel concepts, approaches or 
methods? Are the aims original and innovative?  Does your project 
challenge existing paradigms or develop new methodologies or 
technologies?

(4) INVESTIGATOR:  Are you appropriately trained and well suited to 
carry out this work?  Is the work proposed appropriate to your 
experience level as the principal investigator and to that of other 
researchers (if any)?

(5) ENVIRONMENT:  Does the scientific environment in which your 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, your 
application will also be reviewed with respect to the following:

o PROTECTIONS:  The adequacy of the proposed protection for humans, 
animals, or the environment, to the extent they may be adversely 
affected by the project proposed in the application.

o INCLUSION:  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 included in the section on Federal Citations, below)

o DATA SHARING:  The adequacy of the proposed plan to share data. 

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

o OTHER REVIEW CRITERIA:  

The review of the CCHD application is based not only on the traditional 
review criteria for research projects, but also considerers the plans 
for the recruitment of a Principal Investigator to provide leadership, 
both scientific and administrative; the plans for establishing thematic 
collaborative clinical research programs; as well as the feasibility 
and potential for investigators to become competitive for independent 
funding. Phase I will be evaluated for appropriate measurable goals and 
objectives that should be achieved prior to initiating Phase II. 

Phase I will be evaluated based on the following:

o adequacy of the plans to develop the overall administrative structure 
of the proposed CCHD Program;

o the nature, scope, and effectiveness of plans to recruit the 
Principal Investigator and/or other essential scientific staff;

o the nature and effectiveness of plans to establish institutional and 
collaborative research links and partnerships necessary to achieve 
program goals;

o the need for proposed core facilities or other infrastructure 
improvements and the effectiveness of these improvements in enhancing 
the proposed research efforts;

Phase II will be evaluated based on the following:

o significance, approach, and innovation of the proposed clinical 
research projects and of the CCHD as a whole;

o quality of the career development and mentoring plan for the junior 
investigators in the center;
 
o the ability to augment and strengthen the institutional clinical 
research capacity;  

o evidence of collaborations with other NIH -supported disease specific 
research centers and with community health centers;

o adequacy of the plans for the dissemination of research results;

o the evaluation strategies, with specific milestones, to measure 
progress in attaining long-range goals;

The following criteria will be used to evaluate the 1) administration 
and overall potential for strengthening the institutional clinical 
research capabilities; 2) program direction and advisory committee 
structure; 3) institutional commitment and supporting infrastructure; 
and 4) scientific merit of collaborative clinical research projects.

1.  Administration 

o The chain of command in the administration of the grant and the Center;
 
o The day-to-day administration of the Center, coordination of research 
activities and planning;

o The plans for the establishment and utilization of the support 
structures (grants management, administrative, technical) to provide 
resources essential to carry out the scientific projects;

o The relationship of the proposed program to the already existing 
RCMI, RCRII, and CCRE, as applicable;

o The evaluation strategies, with specific milestones, to measure 
progress in attaining long-range goals. 

2.  Program Direction/Advisory Committee

o The qualifications and track record of the proposed CCHD Principal 
Investigator; his/her experience and publication record in clinical 
research as a funded clinical investigator; previous experience as 
mentor of junior investigators; and the administrative qualifications 
to direct the Center; 

o Institutional plans for the recruitment of a Principal Investigator 
for the  CCHD during Phase I, including a description of the 
qualifications, roles and responsibilities of the CCHD Principal 
Investigator; a timeline for the recruitment efforts; and criteria used 
in the selection process. 

o Selection and appointment of members of the PAC; the proposed 
oversight role of the PAC in the functioning of the Center 

3.  Institutional Commitment/Supporting Infrastructure

o Documentation of institutional endorsement of the proposed plan, 
including a letter of support from a senior institutional official; 
features of the institutional environment that are relevant or unique 
in assuring the success of the program;

o Existing research infrastructure (e.g. laboratory space, equipment, 
clinical facilities, computer resources) and its commitment to the 
proposed CCHD program that would facilitate and support the proposed 
clinical research;

o Justification for any proposed infrastructure enhancement;

o Availability of patient population and plans for patient recruitment.

4.  Overall Program Quality  

o Past and current clinical research support, including institutional 
grant support for clinical research;

o Recruitment of senior clinical investigators who would facilitate the 
development of clinical research on diseases that have a 
disproportionate effect on minority populations;

o Research training or career development goals and capabilities of the 
CCHD.  The potential for enriching the academic and intellectual milieu 
for doing clinical research and the feasibility and potential for 
junior investigators to gain scientific independence under the 
mentorship of senior clinical investigators; 

o The proposed research plan and plans to prepare junior investigators 
to write their own grant proposals and become independent 
investigators.

5.  Collaboration

o Evidence of existing collaborative research links and partnerships or 
plans to establish such links and partnerships during Phase I; 

o The strength of the relationship between the applicant investigators 
and collaborating researchers, particularly the academic 
qualifications, research experience, expertise, and research 
productivity of the collaborators; 

o The administrative and fiscal relationships between the applicant 
investigators and collaborating researchers;

o The importance and relevance of each collaborative project to the 
achievement of CCHD program objectives.  

6.  Developmental Projects

Bearing in mind that the proposed research projects are exploratory 
studies for which significant amounts of preliminary data may not be 
available, the reviewers will evaluate these projects using the 
standard NIH review criteria (described under the review criteria 
section of this RFA).  

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  March 17, 2003
Application Receipt Date:  April 16, 2003
Peer Review Date:  June 25, 2003 (subject to change) 
Council Review:  September 11, 2003
Earliest Anticipated Start Date:  September 30, 2003

AWARD CRITERIA

Award criteria that will be used to make award decisions include the 
following:

o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities
 
REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research 
components involving Phase I and Phase II clinical trials must include 
provisions for assessment of patient eligibility and status, rigorous 
data management, quality assurance, and auditing procedures.  In 
addition, it is NIH policy that all clinical trials require data and 
safety monitoring, with the method and degree of monitoring being 
commensurate with the risks (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).  

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 AMENDMENT 
"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 is 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://grants.nih.gov/grants/stem_cells.htm 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 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.  The 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.

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 No. 93.389, Research Infrastructure and is 
not subject to the intergovernmental review requirements of Executive 
Order 12372 or Health Systems Agency review.  Awards are made under 
authorization of Sections 301 and 405 of the Public Health Service Act 
as amended (42 USC 241 and 284)and administered under NIH grants 
policies described at http://grants.nih.gov/grants/policy/policy.htm  
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 

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


H H S Department of Health
and Human Services

 
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