RELEASE DATE:  August 25, 2003

RFA Number: RFA-AI-03-042 - (Reissued as RFA-AI-08-004)

National Institute of Allergy and Infectious Diseases (NIAID)

No. 93.855, Immunology, Allergy, and Transplantation Research
No. 93.856, Microbiology and Infectious Diseases Research



o Purpose of this RFA
o Research and Development Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Center Directors
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


The Sexually Transmitted Diseases Branch, Division of Microbiology and 
infectious Diseases (DMID), National Institute of Allergy and Infectious 
Diseases (NIAID), National Institutes of Health (NIH), Department of 
Health and Human Services (DHHS) invites applications for the Sexually 
Transmitted Infections and Topical Microbicides Cooperative Research 
Centers (STI TM CRCs). The purpose of this program is to stimulate 
multidisciplinary, collaborative research that is focused on developing 
tools and strategies for prevention and control of STIs and diseases. 
The goal of this initiative is to emphasize research aiding in the 
development of vaccines, therapeutics, diagnostics and behavioral and 
social interventions. Identification and development of topical 
microbicide agents and formulations is a priority. CRCs will conduct 
multiple interrelated research projects organized around a central 
theme, will be supported by administrative and other core resources, and 
will participate in a central Executive Committee of all CRC Directors. 
Together, the CRCs will form a consortium that: 1) conducts 
multi-disciplinary, intervention-oriented research, 2) fosters 
interaction among established STI investigators, and 3) supports 
development of investigators new to the field of STIs. 



STIs are critical global and national health priorities because of the 
devastating impact on women and infants, and the inter-relationships 
with HIV/AIDS. Each year an estimated 15 million Americans suffer the 
effects of STIs at a cost exceeding $16 billion. STIs and HIV are linked 
both by biological interactions and by infections occurring in the same 
populations. Certain STIs can increase the risk of HIV acquisition and 
transmission, as well as alter the course of disease progression.  
Recent studies indicate that the more prevalent STIs (Chlamydia 
trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and organisms 
associated with bacterial vaginosis) that cause non-ulcerative diseases, 
as well as the STIs that cause ulcerative diseases (herpes simplex virus 
type 2, Treponema pallidum and Haemophilus ducreyi) increase the risk of 
HIV transmission by at least two- to five-fold. While all sexually 
active persons are susceptible, women and their children bear a 
disproportionate burden of the harm caused by STIs.

Biologically, STIs are more easily passed from men to women, than from 
women to men. Because some STIs can ascend to the upper female genital 
tract, the long-term consequences of infection are also more severe for 
women. In addition, many infections are less often symptomatic in women, 
resulting in a delay or lack of treatment. Up to 40% of women with 
untreated chlamydia will develop pelvic inflammatory disease (PID); 20% 
of these women will become infertile. A woman with a STI during 
pregnancy may experience ectopic pregnancy, spontaneous abortion, 
chorioamnionitis and premature birth; her baby may be of low birth 
weight, have severe neurologic disease, or die.  Social and economic 
imbalances with men and a lack of female controlled protective devices 
may make it more difficult for women to avoid exposure to STIs.

Adolescents and young adults are particularly vulnerable to STIs and have 
extremely high rates of infection and disease. Most people with herpes 
simplex virus type 2 (HSV-2) and HIV became infected during adolescence. 
This pattern is due, in part, to behavioral factors. Teens are more 
likely to have unprotected intercourse, and to use alcohol and drugs 
during sex than their older counterparts. They may also be more likely to 
choose partners who are infected. Greater numbers of sexual partners and 
closely spaced relationships of shorter duration facilitate spread of 
acute infections. In addition, as a result of hormone-dependent changes, 
young women are at greater risk of acquiring chlamydia and gonorrhea 
during adolescence than at any other time in their lives. 

STIs are an area of significant health disparity. African Americans are 
hardest hit with rates more than thirty times greater than white 
Americans for some STIs. Poverty, inadequate health care and partner 
mixing patterns contribute to the excess disease observed in this and 
other affected communities. In addition, STIs contribute to the spread of 
HIV, which is also increasingly concentrated among women and minorities 
in the US. 

STIs and other reproductive tract infections and syndromes are the focus 
of this RFA. Chlamydia trachomatis is a major cause of PID and is among 
the most prevalent of all STIs.  Asymptomatic infection is common among 
both men and women. Neisseria gonorrhoeae is another major cause of PID. 
An estimated 600,000 new infections occur each year. Treponema pallidum 
is the cause of syphilis, a genital ulcerative disease that may be 
important in contributing to HIV transmission in those parts of the 
country where rates of both infections are high. Trichomonas vaginalis 
causes vaginitis in women and non-gonococcal urethritis in men. An 
estimated 5 million new cases of trichomoniasis occur each year in the 
US, the majority in women. Epidemiologic studies suggest that T. 
vaginalis is associated with a two- to fourfold increased risk of HIV 
transmission. T. vaginalis has also been associated with adverse 
outcomes of pregnancy. 

Bacterial vaginosis (BV) is common in women of reproductive age. In the 
US, as many as 16% of pregnant women have BV. BV is associated with 
adverse outcomes of pregnancy including prematurity and low birth 
weight. BV is also associated with an increased risk of STIs and HIV.

Human papillomavirus (HPV) infections are extremely common. Cervical 
cancer, caused by a subset of HPVs, is the second most common cause of 
cancer death in women worldwide. Genital herpes (HSV-2) is one of the 
most common STIs in the US, with as many as one million people becoming 
infected each year. More than one in five Americans—45 million people—
are infected with HSV-2. Genital herpes can make HIV-infected 
individuals more infectious and is believed to play a role in the 
heterosexual spread of HIV in the US.

The Sexually Transmitted Diseases (STD) CRCs were developed as multi-
disciplinary research programs. Following the original RFA, seven STD 
CRCs were awarded in 1994. An additional RFA was issued and an Adolescent 
CRC was awarded in 1997 to focus on this high risk population. The 
original CRCs were recompeted in 1998 with six awards made. The 
development of topical microbicides as a prevention strategy has emerged 
since the previous competition. This has been integrated into the 
program. In the current RFA, the STD CRCs have been renamed the STI TM 
CRCs to emphasize the need to develop strategies and tools, such as 
topical microbicides, for the prevention and control of STIs and other 
reproductive tract infections.
Research objectives

The objective of the STI TM CRC program is to stimulate research that is 
focused on developing strategies and tools for the prevention and 
control of STIs and other reproductive tract infections, in particular 
BV and Trichomonas vaginalis. This requires multidisciplinary, 
collaborative research using biomedical, clinical, epidemiological, and 
social and behavioral approaches. Research aiding in the development of 
vaccines, therapeutics and behavioral and social interventions is 
needed. Identification and development of topical microbicide agents and 
formulations is a priority. Targeted STIs and syndromes include, but are 
not limited to: Chlamydia trachomatis, Neisseria gonorrhoeae, 
Trichomonas vaginalis, Treponema pallidum, BV, HPV and HSV-2. Centers 
may focus on a single STI or syndrome, or multiple STIs. Projects that 
focus on interactions among STIs, or among STIs and normal vaginal flora 
or HIV are also of interest.

Specific areas of interest include, but are not limited to:

1.   Vaginal ecology and innate defense mechanisms; mechanisms by which 
the normal vaginal flora and epithelial tissues are impacted by STIs, 
and; the impact of hormonal influences on the vaginal ecosystem. 

2.   Mechanisms of pathogenesis of organisms that cause STIs and 
associated syndromes including BV,  PID, infertility, and premature 
delivery; the role of inflammatory and immune defense mechanisms in 
persistence and pathogenesis.

3.   Mucosal immunology in the male and female genital tract including 
mucosal immune responses in normal subjects, those with STIs, and 
after interventions including topical microbicides, therapeutics and 
vaccines; to include development of assays.

4.   Interactions among STIs, and STIs with HIV; the impact of STIs in the 
acquisition and progression of HIV infection and the role of HIV in 
alterations of the natural history, diagnosis, or response to 
treatment of STIs.

5.   Discovery and pre-clinical testing of topical microbicides effective 
against one or more STIs, including methods to measure and assess 
vaginal/cervical inflammation and to compare changes induced by 

6.   Development of prevention and control strategies for STIs including 
identification of vaccine candidates, possible therapeutic agents, 
and other target molecules.

7.   Development and evaluation of new tools for diagnosis of STIs or STI-
related diseases.

8.   Development and use of animal models and infection/acquisition models 
for pathogenesis studies as well as pre-clinical testing of vaccines, 
topical microbicides and therapeutics.

9.   Development and assessment of behavioral or social interventions 
using biomarkers as endpoints; epidemiological, behavioral and social 
factors contributing to introduction, spread and maintenance of STIs 
in communities, especially those populations most affected by STIs.

Applications proposing to develop products may collaborate with an 
industry partner. Applications may also include a foreign research 
component or collaborative site. This application will not fund clinical 

Career Development Objectives

A central Development Awards Program (DAP) will be established by the 
CRCs to support investigators new to the field of STIs by providing them 
with the opportunity to apply for small amounts of funding for 
individual research projects and training activities . The goal of the 
program is to encourage and train young researchers in the field of STI 
research. The DAP will be administered by one CRC. Applicants interested 
in serving as the administrator for the DAP must include a DAP Core with 
proposed administrative structure, review process and criteria for 
selecting Award recipients. Developmental Awards may be used to support 
a specific research project or training activity to take place at one or 
more of the CRCs. 


This RFA will use the NIH multi-project cooperative agreement (U19), an 
"assistance" mechanism, rather than an "acquisition" mechanism. The 
applicant will be solely responsible for planning, directing, and 
executing the proposed project. This RFA is a one-time solicitation. 
Future unsolicited, competing-continuation applications based on this 
project will compete with all investigator-initiated applications and 
will be reviewed according to the customary peer review procedures. 
Individual projects in applications that are not funded in the 
competition described in this RFA may be submitted as new individual RO1 
investigator-initiated applications using the standard receipt dates for 
NEW applications described in the instructions to the PHS 398 

The NIH U19 is a cooperative agreement award mechanism in which the 
Center Director retains the primary responsibility and dominant role for 
planning, directing, and executing the proposed project, with NIH staff 
being substantially involved as a partner with the Center Director, as 
described under the section "Cooperative Agreement Terms and Conditions 
of Award"

The total project period for applications submitted in response to this 
RFA may not exceed five years.

Applicants for U19 grants must follow special application guidelines in 
PROJECT AWARDS; this brochure is available via the WWW at:


NIAID intends to commit approximately $12.5 million in FY 2004 to fund 
up to 8 new and/or competitive continuation grants in response to this 
RFA. An applicant may request a project period of up to 5 years and a 
budget for total costs of up to $1.5 million per year. 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. Although the financial plans of the IC(s) 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. Funds for the DAP Core are in addition to the 
total costs. Details are provided in the Special Requirements section, 
item three, Developmental Awards Program Core.


The applicant may submit (an) application(s) if the institution has any 
of the following characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, 
hospitals, and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic 

Foreign institutions are not eligible to apply.


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. 


CRCs conduct interrelated research projects organized around a central 
theme, are supported by an administrative core and other appropriate 
core scientific resources, and participate in a central Executive 
Committee (EC) of CRC Directors and a program officer in the NIAID STD 
Branch (see NIAID Staff Responsibilities below).  Required aspects of 
CRCs are described below.

1.   CRC Structure

Each CRC must include a minimum of three interrelated research projects 
organized around a central theme. A Project Leader must be named for 
each research project. In addition, CRCs include shared resources, 
called cores, which provide services or resources to at least two 
research projects. These include a required administrative core, headed 
by the Center Director; may include scientific cores, each headed by a 
Core Leader; and may include a DAP core, headed by the Center Director. 
a.   Administrative Core

The Center Director is the Leader of the Administrative Core. The 
institution and the Center Director are responsible for the application 
and for collaborative research activities. Responsibilities of the 
Administrative Core include, but are not limited to: 1) oversight of CRC 
Projects and Scientific Cores; 2) promoting collaboration and 
coordination among Project and Core Leaders; 3) participating in EC 
meetings, conference calls and other activities, and; 4) nominating 
candidates for the Developmental Awards Program.

The Administrative Core budget should include funding for overall 
administration (e.g., secretarial and other administrative services), 
expenses for publications for collaborative efforts, and communication 
expenses. In addition, the Administrative Core budget must include funds 
for the Center Director to travel to annual EC meetings as described 
below. Administrative costs (e.g., travel) associated with an individual 
project may be included in the Administrative Core, or the corresponding 

b.   Scientific Cores

Scientific cores are shared resources that provide services or resources 
to at least two research projects. Some examples of services provided by 
scientific cores are monoclonal antibody production, peptide synthesis, 
microbiology laboratory services, and statistical support. Each 
scientific core must have a Core Leader. The application should give a 
clear picture of the facilities, techniques, and skills the core will 
provide and the role of the Core Leader and each key participant. A 
budget must be provided for each core.

c.   Advisory Groups

The application may include funds to support activities of advisory 
groups. It is recommended that advisory groups include community 
representatives as well as scientific experts. The application must 
include plans that indicate how such groups will be included in and 
contribute to the success of Center activities. Funds may be requested 
for reimbursement of reasonable expenses including representation at 
Center meetings. Advisory groups should be constituted after the grant 
award has been made and individual members should not be named in the 
application. Funds to support Advisory Groups may be included in the 
Administrative Core.

2.   CRC Executive Committee (EC)

Center Directors and a program officer from the NIAID STD Branch (see 
NIAID Staff Responsibilities below) will form a central EC. The EC will 
meet at least annually and will hold quarterly conference calls to 
facilitate interaction and collaboration across CRCs and with NIAID 
program staff. The EC will select one member to serve as Chair of the 
Committee. Project and Core Leaders from each CRC may attend annual EC 
meetings to summarize CRC scientific activities. Meetings may also be 
used, for example, to address common training needs, develop cross-
Center initiatives, or host invited speakers. The application must 
include funds for the Center Director (an EC member), Project Leaders 
and Core Leaders to travel to annual EC meetings. 

3.   Developmental Awards Program (DAP) Core

The goal of the DAP program is to encourage and train young researchers 
in the field of STI research. The developmental award will provide 
applicants with small amounts of funding to allow them to formulate 
projects and collect data to support an application for an independent 
grant or to receive relevant training in the field of STIs.

A Center Director or their designee interested in serving as the 
administrator for the DAP must propose a DAP Core with administrative 
structure, review process and criteria for selecting award recipients. 
One CRC will be selected to serve as the coordinator of the DAP. The DAP 
Core budget may include administrative personnel and typical office costs 
(e.g., photocopying, supplies) in addition to the $300,000 maximum in 
award funds, as described below. The budget for the DAP may be in 
addition to the total costs for the CRC. The DAP Core will be evaluated 
by the IRG, but will not influence the overall score.  

Potential Elements of the DAP:

a.   Candidates for a developmental award must be nominated by a CRC 
Director and can be internal or external to the CRC.

b.   The EC will review applications for developmental awards and will 
select awardees without regard to institutional association.

c.   At any time, there may be none, one, or multiple awardees at one or 
more of the CRCs.

d.   Developmental awards may be requested for a specific research project 
to take place at one or more of the CRCs or for a training activity 
(e.g. a course or workshop). The annual amount available for all 
developmental awards is $300,000 in direct costs.  Individual awards 
may not exceed $75,000  

e.   The duration of support for each developmental award can be for up to 
three years. The EC will review progress on a regular basis.

f.   Recipients of a developmental award may not receive subsequent awards 
from this pool. If the investigator achieves independent funding 
through a traditional research grant (for example: R01, R21, R03) 
prior to the end of the developmental award, the award must be 
terminated, and unexpended funds must be returned to the central DAP 

g.   A progress report on the DAP should be included in the annual report 
of the CRC.


The following terms and conditions will be incorporated into the award 
statement and provided to the Center Director as well as the 
institutional official at the time of award.

These special Terms of Award are in addition to, and not in lieu of, 
otherwise applicable OMB administrative guidelines, HHS Grant 
Administration Regulations at 45 CFR part 74 and 92, and other HHS, PHS, 
and NIH Grant Administration policy statements.

The administrative and funding instrument used for this program is the 
multiproject cooperative agreement (U19), which is an "assistance" 
rather than an "acquisition", mechanism in which substantial NIH 
scientific and/or programmatic involvement with the awardee is 
anticipated during the performance of the activity. Under the 
cooperative agreement, the NIH purpose is to support and/or stimulate 
the recipient's activity by involvement 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 awardees for the project as a whole, 
although specific tasks and activities in carrying out the research will 
be shared among the awardees and the NIAID Scientific Coordinator.

2. Awardee Rights and Responsibilities

Awardees will have primary responsibility for defining the research 
objectives, approaches and details of the projects within the guidelines 
of the RFA and for performing the scientific activity. Specifically, 
awardees have primary responsibility as described below. 

Awardees agree to accept close coordination, cooperation, and 
participation of NIAID staff in all aspects of scientific and technical 
management of the project as stated below under NIAID Staff 
Responsibilities. Awardees will retain custody of and have primary 
rights to the data developed under these awards, subject to Government 
rights to access consistent with current HHS, PHS and NIH policies.

Under the Cooperative Agreement, a partnership relationship exists 
between the recipient of the award and NIAID in which successful 
applicants are responsive to the guidelines and conditions set forth in 
the RFA.  At the same time, Center Directors are expected to define 
research objectives and approaches in accord with their own interests 
and perceptions of novel and exploitable approaches to the research 
which ultimately is likely to result in improved prevention and control 
of STIs and diseases.

The Center Director will have ultimate responsibility for the 
coordination of efforts within the CRC and ensuring that results 
obtained are analyzed and published in a timely manner. It will be the 
responsibility of the Project and Core Leaders to plan and conduct the 
activities stipulated in the project proposal. Timely publication of 
major findings is encouraged.  Publications and oral presentations of 
work performed under this agreement will require appropriate 
acknowledgment of the STI TM CRCs and NIAID support. NIAID may 
periodically review and generate internal reports from data and progress 
reports developed under this cooperative agreement.  The data obtained 
will, however, be the property of the awardee.

The multi-disciplinary and collaborative nature of the STI TM CRCs 
creates an extraordinary opportunity for information exchange and 
scientific advancement in STI research.  CRC investigators are expected 
to take advantage of this opportunity by participation in both formal 
events established expressly for this purpose and informal investigator-
initiated dialogues.

3. NIAID Staff Responsibilities

NIAID staff assistance will be provided by a program officer in the STD 
Branch who will serve as NIAID's Scientific Coordinator. The NIAID 
Scientific Coordinator will have substantial scientific/programmatic 
involvement during the conduct of this activity through technical 
assistance, advice and coordination above and beyond normal program 
stewardship for grants, as described below.

During performance of the award, the NIAID Scientific Coordinator, with 
assistance from other scientific program staff who are designated based 
on the research topic and their relevant expertise, may provide 
appropriate assistance, advice, and guidance by: participating in the 
design of the activities; advising in the selection of sources or 
resources (e.g., determining where a particular reagent can be found and 
facilitating reagent exchange among CRCs); coordinating or participating 
in the collection and/or analysis of data; advising in management and 
technical performance; or participating in the preparation of 
publications. The NIAID Scientific Coordinator will serve as a 
liaison/facilitator between the awardee, pharmaceutical and biotech 
industries, and other government agencies (e.g., FDA, USDA, CDC) and 
will serve as a resource of scientific and policy information related to 
the goals of the awardee's research. However, the role of NIAID will be 
to facilitate and not to direct the activities. It is anticipated that 
decisions in all activities will be reached by consensus and the NIAID 
staff will be given the opportunity to offer input into this process. 
The manner of reaching this consensus and the final decision-making 
authority will rest with the Center Director.

The NIAID Scientific Coordinator will be a voting member of the CRC EC, 
will provide support for EC meetings and conference calls, and will 
respond to requests for EC meeting content.

An NIAID Program Official will be assigned to perform normal program 
stewardship responsibilities for this award. The Program Official may 
serve as the Scientific Coordinator. 

4. Collaborative Responsibilities

Center Directors and the NIAID Scientific Coordinator will participate 
in a central Executive Committee (EC). The EC will meet at least 
annually and will hold quarterly conference calls to facilitate 
interaction and collaboration across CRCs and with NIAID program staff. 
Project and Core Leaders from each CRC may attend annual EC meetings to 
summarize CRC scientific activities. Meetings may also be used, for 
example, to address common training needs, develop cross-Center 
initiatives, or host invited speakers.

A major activity of the EC will be administration of the EC Development 
Awards Program for investigators new to the field of STIs. Only 
applicants interested in serving as the DAP administrator should include 
a plan for this activity. 


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 questions about scientific/research issues to:

Dr. Heidi Friedman
Sexually Transmitted Diseases Branch
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room 5022, MSC-6604
6610 Rockledge Drive MSC 6604
Bethesda, MD 20892-6604
Telephone: (301) 402-0443
FAX: (301) 480-3617

o Direct questions about peer review issues to: 

Dr. Madelon Halula
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2180, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Telephone: (301) 402-2636
FAX: (301) 402-2638

o Direct questions about financial or grants management matters to:

Sharie Bernard
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3219, MSC-7614
6700-B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: (301) 402-5540
FAX: (301) 480-3780


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

o Descriptive title of the proposed CRC
o Name, address, and telephone number of the Center Director
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. Madelon Halula
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2180, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Telephone: (301) 402-2636
FAX: (301) 402-2638


Applicants for U19 grants must follow the forms and standard guidelines 
in the NIH public Health Service grant application (PHS 398, rev. 
5/2001, Sections I-III) available at and the special 
application guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR 
APPLICATIONS FOR MULTI-PROJECT AWARDS; this brochure is available via 
the Internet at: 
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 The DUNS number should be entered on 
line 11 of the face page of the PHS 398 form. For further assistance 
contact GrantsInfo, Telephone (301) 710-0267, Email:

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:

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)
The Center for Scientific Review now accepts delivery of applications 
only by mail or courier service. Personal deliveries of applications 
will not be accepted 
At the time of submission, two additional exact copies of the 
grant application and all five sets of any appendix material must be 
sent to:

Dr. Madelon Halula
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2180, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Telephone: (301) 402-2636
FAX: (301) 402-2638

Applications that are not received as a single package on the receipt 
date or that do not conform to the instructions contained in PHS 398 
(rev. 5/01) Application Kit (including areas modified and superseded by 
PROJECT AWARDS"), will be judged non-responsive and will be returned to 
the applicant. 


Applicants for U19 cooperative agreements must follow special 
application guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR 
APPLICATIONS FOR MULTI-PROJECT AWARDS; this brochure is available from 
NIAID listed under INQUIRIES via the WWW at: This brochure 
presents specific instructions for sections of the PHS 398 (rev. 5/01) 
application form that should be completed differently than usual.  For 
all other items in the application, follow the usual instructions in the 
PHS 398, Sections I-III.

APPLICATION PROCESSING: All applications, whether new or recompeting, 
must be received by the application receipt date listed in the heading 
of this RFA (not merely postmarked on that date).  If an application is 
received after that date, it will be returned to the applicant without 
Concurrent submission of an R01 and a Component Project of a Multi-
project Application:  Current NIH policy permits a component research 
project of a multi-project grant application (P01 or U19) to be 
concurrently submitted as a traditional individual research project 
(R01) or SBIR application.  If, following review, both the multi-project 
application and the R01 or SBIR application are found to be in the 
fundable range, the investigator (Project Leader) must relinquish the 
R01 or SBIR and will not have the option to withdraw from the multi-
project grant.  This is an NIH policy intended to preserve the 
scientific integrity of a multi-project grant, which may be seriously 
compromised if a strong component project(s) is removed from the 
program.  Investigators wishing to participate in a multi-project grant 
must be aware of this policy before making a commitment to the Center 
Director and awarding institution.  Applicants to this RFA may not 
submit a U01 proposal containing a project identical to a project in a 
U19 proposal. 


Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by NIAID.

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 NIAID 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 
o Receive a written critique
o Receive a second level review by the National Institute of Allergy and 
Infectious Diseases Council


The general review criteria for U19 multi-project cooperative agreement 
applications are presented in the NIAID brochure entitled "INSTRUCTIONS 

The criteria to be used in the evaluation of grant applications are 
listed below. To put those criteria in context, the following 
information is contained in instructions to the peer reviewers.  The 
reviewers will comment on the following aspects of the application in 
their written critiques in order to judge the likelihood that the 
proposed research will have a substantial impact on the pursuit of the 
RFA goals.  Each of these criteria will be addressed and considered by 
the reviewers in assigning the overall score, weighting them as 
appropriate for each application. Note that the application does not 
need to be strong in all categories to be judged likely to have a major 
scientific impact and thus deserve a high priority score.  For example, 
an investigator may propose to carry out important work that by its 
nature is not innovative but is essential to transition toward 
applications development. 

The following review criteria will be used to evaluate the overall 

o Cohesiveness of Effort:  Are the component research projects clearly 
focused on achieving a common goal?  Projects with no direct relevance 
to the common goal will be designated as non-responsive and not 
contributing to requirements for multi-project grants.

o Intra- and Inter-Center Collaborative Activities:  Is there an 
effective network of collaborative activities within each Center 
(component projects and cores)?  Applications must describe how they 
will establish successful collaborative efforts within their Center and 
with investigators from the other STI TM CRCs.  Competitive renewals 
from existing STD CRCs must include a comprehensive progress report 
which must include evidence of successful collaborative activities 
supported through their CRC.

The five criteria described below will be used to evaluate each 
component project.

(1) Significance: Is this project likely to significantly advance the 
research area that is the specific focus of the application and 
facilitate applications development.

(2) Approach: Are the conceptual framework, design, methods, and 
analyses adequately developed, well integrated, and appropriate to the 
aims of the project? Does the applicant acknowledge potential problem 
areas and consider alternative tactics? Is the likelihood of successful 
project completion high given the current state of research and 
development and the technical approach? Are the proposed timeline and 
interim milestones appropriate, feasible and technically sound? 

(3) Innovation: Does the proposed project leverage multi-disciplinary 
involvement to accelerate applications development. Does the approach 
represent the best use of current or emerging technologies and 
appropriate collaborations to achieve the research objectives.

(4) Center Director and Project Leaders: Is the research and development 
team appropriately trained and experienced and well suited to carry out 
this work? Is the work proposed appropriate to the experience level of 
the Center Director and Project Leaders? 

(5) Environment: Does the 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 environments 
including partnerships with industry or employ useful collaborative 
arrangements? Is there adequate evidence of institutional support?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, 
applications will also be reviewed with respect to the following:

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

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


Letter of Intent Receipt Date:     November 17, 2003
Application Receipt Date:          December  16, 2003
Scientific Peer Review Date:       March, 2004
Advisory Council Review:           June, 2004
Earliest Anticipated Start Date:   August, 2004


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

o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.


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 
a complete copy of the updated Guidelines are available at 
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.

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 

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

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of 
research on hESCs can be found at and at  
Only research using hESC lines that are registered in the NIH Human 
Embryonic Stem Cell Registry will be eligible for Federal funding (see   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. 

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

Applicants may wish to place data collected under this PA 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.

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


This program is described in the Catalogue of Federal Domestic 
Assistance in the following citations: No. 93.855, Immunology, Allergy, 
and Transplantation Research and No. 93.856, Microbiology and Infectious 
Diseases Research. Awards are made under authorization of Sections 301 
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 
and administered under NIH grants policies and Federal Regulations 42 
CFR 52 and 45 CFR Parts 74 and 92.  This program is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.

The NIH Grants Policy Statement is available at  This document includes 
general information about the grant application and review process; 
information on the terms and conditions that apply to NIH Grants and 
cooperative agreements; and a listing of pertinent offices and officials 
at the NIH.

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

  N I H National Institutes of Health (NIH)
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