PARTNERSHIPS FOR NOVEL THERAPEUTIC, DIAGNOSTIC AND VECTOR CONTROL STRATEGIES IN 
INFECTIOUS DISEASES

Release Date:  December 4, 2001

PA NUMBER:  PAR-02-026 (also see addenda NOT-AI-02-022, NOT-AI-02-013, NOT-AI-02-007)

National Institute of Allergy and Infectious Diseases
 (http://www.niaid.nih.gov/)

Letter of Intent Receipt Date:  February 20, 2002
Application Receipt Date:       March 20, 2002

PURPOSE

The objective of this program is to support the development of drugs and 
diagnostics for human infectious diseases of public health importance and 
products for controlling arthropod vectors that transmit infectious agents. 
This PAR emphasizes areas that could have a high impact on public health, but 
currently appear not to be a high priority or that may be considered too 
financially risky for industry. In addition, research on agents of 
bioterrorism concern are of high priority. Projects supported under this PAR 
should have the ultimate goal of producing a novel therapeutic, diagnostic 
tool, or vector control agent or strategy that adds substantively to the 
current armamentarium for control of an infectious disease that causes a 
significant public health burden but is not a current priority for industry 
Research and Development (see under Research Objectives and Scope for areas 
deemed responsive to this PAR). Research conducted through this program may 
fall anywhere along a broad spectrum of activities, from target 
identification and validation through preclinical development and initial 
clinical/field evaluation (phase I and II or limited field trials). A key 
component of this initiative is the development of appropriate partnerships 
among government, academia, and the biotechnology, chemical and 
pharmaceutical industries. This initiative is meant to stimulate industry 
participation in these research areas. For the purpose of this PAR, 
"industry" is defined as large and small pharmaceutical, biotechnology, and 
chemical companies, and Public Private Partnerships that include such 
entities as partners.  All projects must demonstrate substantive involvement 
by a private sector (industry) component. "Substantive involvement" is 
defined, for the purpose of this PAR, as the commitment of any one or more of 
the following resources: funds, personnel, in kind contributions of materials 
and reagents, including but not limited to chemical libraries, innovative 
biotechnology platforms for screening drugs and inhibitors, scale up GMP 
chemical synthesis, access to preclinical development methods for 
toxicological and pharmacological testing, clinical testing and data 
management resources. The Principal Investigator may be affiliated with 
either a private- or public-sector institution.  

The National Institute of Biomedical Imaging and Bioengineering (NIBIB) has 
an interest in this research area.  Support for applications within the 
mission of the NIBIB and of high scientific merit may be considered by NIBIB.

HEALTHY PEOPLE 2010

The Public Health Service (PHS) is committed to achieving the health 
promotion and disease prevention objectives of "Healthy People 2010," a PHS 
led national activity for setting priority areas. This Request for 
Applications (PAR), PARTNERSHIPS FOR NOVEL THERAPEUTIC AND VECTOR CONTROL 
STRATEGIES IN INFECTIOUS DISEASES, is related to one or more of the priority 
areas. Potential applicants may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople/.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic or foreign for-profit and non-
profit organizations, public and private institutions, such as universities, 
colleges, hospitals, laboratories, units of State and local governments, and 
eligible agencies of the Federal government. All applications must include 
substantive involvement by industry (as defined above). Racial or ethnic 
minority individuals, women, and persons with disabilities are encouraged to 
apply as Principal Investigators.

MECHANISM OF SUPPORT

The administrative and funding mechanism to be used to undertake this program 
will be the Cooperative Agreement (U01), an "assistance" mechanism, rather 
than an "acquisition" mechanism, in which substantial NIH scientific 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 otherwise stimulate the recipient"s activity by involvement 
in and 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. Details of the responsibilities, relationships, and governance of a 
study funded under cooperative agreements are discussed later in this 
document under the section Terms and Conditions of Award.

The total project period for applications submitted in response to this PAR 
may not exceed five years. At this time, the NIAID has not determined whether 
and how this solicitation will be continued beyond the present PAR.  The 
anticipated award date is September 3, 2002.   

FUNDS AVAILABLE

The estimated total funds [direct and facilities and administrative (F&A) 
costs] available for the first year of support for all awards made under this 
PAR will be $6 million.  In Fiscal Year 2002, the NIAID plans to fund 
approximately 3-10 awards with a mixture of both large and small grants. 
Although this program is provided for in the financial plans of the NIAID, 
awards pursuant to this PAR are contingent upon the availability of funds for 
this purpose and the receipt of a sufficient number of applications of high 
scientific merit. Funding beyond the first and subsequent years of the grant 
will be contingent upon satisfactory progress during the preceding years and 
availability of funds.

RESEARCH OBJECTIVES

Background

In late 2000, the NIAID led a Summit on Drug Development for Infectious 
Diseases.  The purpose of this meeting was to discuss the role and nature of 
NIAID/industry collaborations in antimicrobial drug development for public 
health needs and to learn how NIAID could better assist industry and academia 
in these endeavors. A report of this meeting is available at 
http://www.niaid.nih.gov/dmid/drug/#7. Many recommendations from this 
workshop have been incorporated into this initiative.

Investment by industry in the commercialization of products for the control 
of a number of infectious diseases of public health importance remains 
limited. This initiative is meant to help stimulate industry participation in 
decreasing the impact of these important diseases for which effective 
vaccines or therapies are lacking or for which existing therapies are 
incompletely effective and/or toxic to humans.  In addition, this initiative 
is focused on infectious diseases caused by agents of bioterrorism concern.  
The evolution of drug resistance has diminished the effectiveness of even 
some of the most safe and efficacious agents, creating a need for the 
discovery and development of therapeutic agents directed at novel targets.

There is also an urgent need for sensitive, specific, rapid, cost-effective, 
point-of-care diagnostics to guide therapy and stimulate therapeutic 
development for many of these high public health impact infections, including 
agents of bioterrorism concern. The wealth of newly available genomic 
sequence information provides a superb source for the identification of novel 
targets to use as the basis of design of new specific and selective 
therapeutic agents and diagnostics. In addition, in some cases, already 
identified targets have not been used as the basis of drug or diagnostic 
development.  

The control of vector-borne diseases is imperiled by the emergence of vector 
control product resistance and growing concerns regarding safety and 
environmental impact of existing agents. The development of vector control 
products has the benefit of a long history of agricultural development and 
consequently, there exist a large number of validated targets and available 
chemical entities registered for related arthropods or partially developed 
for medically relevant vectors. This research will fill critical gaps and 
will not duplicate activities of industry or other public agencies. 

The need to support the research specified by this PAR has been emphasized by 
a number of advisory groups, Task Forces and Program reviews. In addition to 
the Summit on Drug Development for Infectious Diseases described above, these 
include NIAID-convened reviews of its TB (1996) and Clinical Antiviral 
Programs (1995), a review of NIAID"s vector biology research agenda (2000), a 
Rockefeller Foundation-sponsored meeting on TB Drug Development (2000), the 
IOM report on TB Elimination: "Ending Neglect" (2000), and the NIAID Blue 
Ribbon Panel on Genomics (1999). In releasing its final report, the 
Interagency Task Force on Antimicrobial Resistance stated that the discovery 
and development of therapeutic agents that address new genetic targets is 
essential to combat antimicrobial resistance (2001).

Research Objectives and Scope 

Responsive research proposals will address treatment or diagnostic strategies 
for human infections caused by bacteria, parasites, fungi or viruses other 
than HIV. In addition, projects may target the invertebrate vectors of human 
disease. Specifically, each proposal should be focused on development of a 
single ultimate product and address one of the following three high public 
health impact scientific areas:

1. Development of therapeutic agents for infections that cause significant 
public health burden for which there is currently felt to be insufficient 
return on investment to engage private sector investment. To be considered 
responsive within scientific area "1.", an application must address one of the 
following problems:

a.  Infectious diseases whose current treatments are too toxic for one or more 
medically important patient populations (e.g., cytomegalovirus, 
trypanosomiasis),
b.  Infections causing diseases for which there are no available effective 
drugs (e.g., hemolytic uremic syndrome, pathogenic fungi, Dengue virus, viral 
encephalitides),
c.  Infections for which drug resistance is making current therapies 
ineffective (e.g., bacterial nosocomial infections, tuberculosis, hepatitis 
B, viral infections, malaria).
d.	Infectious diseases that are relatively rare except for their emergence 
as a result of a bioterrorist incident (e.g. anthrax, plague, tularemia, 
botulism, smallpox, or viral hemorrhagic fevers).

A number of scientific opportunities, including the newly available enabling 
technologies, exist for the development of new drugs to treat these high 
public health impact diseases. Responsive applications addressing scientific 
area "1." should propose research along the critical path for development of 
new therapeutic agents and may encompass one or more steps along this path, 
including but not limited to: the development and/or use of 
genomic/proteomic-based technologies to identify and validate novel targets 
for therapeutic intervention (targets may be either in the pathogen or the 
host), the utilization of structural and computer-assisted drug design 
strategies for the discovery of candidate compounds, the development of rapid 
and high throughput methods for producing and screening libraries of diverse 
chemical entities, the development of lead compounds through medicinal 
chemistry, iterative synthesis and evaluation, and preclinical toxicity and 
pharmacology testing, and early (phase I and II) clinical evaluation.

2.  Development of vector control products.

Vector-borne infectious diseases present an increasing threat to human health 
at the same time the tools used to control them are being lost.To be 
considered responsive within scientific area "2.", an application must 
address one of the following diseases:
a. Malaria, vectored by anopheline mosquitoes,
b. Dengue fever, vectored by Aedes mosquitoes, 
c. West Nile fever, vectored by Culex mosquitoes,
d. Lyme disease, vectored by ticks,
e. Leishmaniasis, vectored by phlebotomine sand flies, 
f. Chagas" disease, vectored by triatomine bugs, and
g. African trypanosomiasis, vectored by tsetse flies  

Vector control products include, but are not limited to, adulticides, 
larvacides, synergists that alter the insects" susceptibility to an 
insecticide, and semiochemicals that alter insect behavior. Development of 
chemical entities as vector control products involves a series of steps, 
including: initial screening of candidates for activity against vector 
arthropods, dose finding studies, toxicology, formulation, environmental fate 
and effects studies, and field studies of efficacy in control of disease 
transmission.

Since this vector control strategy development path presents significant 
hurdles for candidates, there may by candidate chemical entities developed 
for potential use against other targets that can be screened against 
medically important arthropods.  Similarly, developing data about dipteran 
insect genomes may allow identification of novel targets for insecticidal or 
semiochemical activity. Research at any point along this development path is 
appropriate for this solicitation.

Because this PAR is intended to support the development of environmentally 
sound vector control agents, particular attention should be paid to the 
development of data about the environmental fate and effects on non-target 
organisms. 

3.  Development of rapid, inexpensive, point-of-care diagnostic methods to 
guide therapy and stimulate therapeutic development.

Responsive applications within scientific area "3." include but are not 
limited to those that propose to utilize genomics and related technologies to 
identify and validate targets for development of these diagnostic tools. Such 
tools should ideally be sensitive, specific, rapid, affordable, and easily 
implemented in routine clinical settings (i.e., at the point-of-care). 
Responsive applications in scientific area "3." must include projects focused 
on developing methods for detecting and diagnosing one of the following:

a. drug resistance among (culturable or nonculturable) parasites, fungi, 
viruses and bacteria (including for example but not limited to: nosocomial 
infections and mycobacteria), 
b. viral respiratory infections and clinical syndromes such as otitis media, 
sinusitis, and pneumonia,
c. enteric infections and clinical syndromes such as diarrhea and bloody 
diarrhea,
d. neonatal and congenital infections, and 
e.	infection with opportunistic fungi, especially Aspergillus and Candida, 
in immunocompromised hosts where diagnosis is rate-limiting to therapeutic 
development and testing.
f.	diseases caused by agents of bioterrorism concern.

SPECIAL REQUIREMENTS

Each application must propose a research and development project whose 
ultimate goal is to produce a novel therapeutic, diagnostic tool, or vector 
control agent or strategy that adds substantively to the current 
armamentarium for control of an infectious disease (other than HIV/AIDS) that 
causes a significant public health burden and is not a current priority for 
industry activity (as defined in the lists provided above, under Research 
Objectives and Scope), or is focused on an infectious disease caused by an 
agent of bioterrorism concern.  

Each applicant must define the proposed project goal, interim objectives 
(development milestones) and potential ultimate product, and provide a 
schedule or timeline for milestone and goal attainment.

Any applicant proposing a clinical trial or field study as part of the 
project must submit a study protocol as part of the application. For guidance 
on protocol format and/or other clinical issues contact Dr. Ann Ginsberg 
(contact information is provided below).

If appropriate to the proposed project (e.g., for Phase II clinical trials 
and some field studies), NIAID will require the establishment of an 
independent DSMB to oversee relevant studies.  Applicants proposing clinical 
trials or field studies should discuss this possibility with NIAID Program 
Staff before submission of the application.  If a DSMB is required, funds to 
support and convene the DSMB must be included within the proposed budget.

Proposed budgets must include funds to travel at least the Principal 
Investigator to an annual two-day investigators" meeting in Bethesda, MD. In 
addition, progress will be reviewed annually by NIAID with the help of 
external advisors, to be named after award by NIAID in consultation with the 
Principal Investigator.  Names of suggested advisors should not be included 
in the application. Proposed budgets must include funds to help support 
travel of two external advisors to an annual progress review meeting. 
  
TERMS AND CONDITIONS OF AWARD

The following terms and conditions will be incorporated into the award 
statement and provided to the Principal Investigator 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 
cooperative agreement (U01), an "assistance" mechanism, rather than an 
"acquisition" mechanism, in which substantial NIH scientific and programmatic 
involvement with the awardee is anticipated during the performance of the 
activity. Under the cooperative agreement, the NIH purpose is to support and 
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.

Cooperative agreements are subject to the administrative requirements 
outlined in OMB circulars A-102 and A-110.  All pertinent HHS, PHS, and NIH 
grant regulations, policies and procedures, with particular emphasis on PHS 
regulations at 42 CFR Part 52 and HHS regulations at 45 CFR Part 74, are 
applicable. These special terms and conditions pertaining to the scope and 
nature of the interaction between the NIAID and the investigators will be 
incorporated in the Notice of Grant Award.  However, these terms will be in 
addition to, not in lieu of, the customary programmatic and financial 
negotiations that occur in the administration of cooperative agreements.

1. 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 PAR and for performing the scientific activity. Specifically, awardees 
have primary responsibility as described below.

The awardee performing clinical studies sponsored by the NIAID must comply 
with all Federal regulations for investigational agents.

Federally Mandated Regulatory Requirements.  The awardee shall be in 
compliance with all Federal regulations, and NIH policies applying to the 
conduct of research involving human subjects.  These include but are not 
limited to: Title 21 CFR 50, 56, 312, and Title 45 CFR 46.

Awardees will comply with the approved intellectual property disposition plan 
that details (1) the approach agreed to by all parties for disposition of 
intellectual property, including but not limited to obtaining patent coverage 
and licensing, where appropriate, and (2) procedures to be followed for the 
resolution of legal problems that potentially may develop.

For research conducted in foreign countries, the awardee must assure 
compliance with the host country regulations for human subjects, and must 
assure that the trials are conducted according to one of the following:  the 
US Federal Policy (Common Rule) for the Protection of Human Subjects and/or 
the US Department of Health and Human Services (HHS) regulations at 45 CFR 
46, the May 1, 1996 International Conference on Harmonization E-6 Guidelines 
for Good Clinical Practice (ICH-GCP-E6) Sections 1 through 4, The 1993 
Council for International Organizations of Medical Sciences (CIOMS) 
International Ethical Guidelines for Biomedical Research Involving Human 
Subjects,
the 1998 Medical Research Council of Canada Tri-Council Policy Statement on 
Ethical Conduct for Research Involving Humans, 
the 2000 Indian Council of Medical Research Ethical Guidelines for Biomedical 
Research on Human Subjects, or other internationally recognized standards for 
the protection of human subjects.

When experimental field applications of chemical pesticides are included in 
the scope of work the awardee is responsible for abiding by all of the 
pertinent regulations and laws that exist in the jurisdiction where the work 
will take place.

2. NIAID Staff Responsibilities

NIAID staff assistance will be provided by an NIAID Scientific Coordinator. 
The NIAID Scientific Coordinator will be the NIAID Program staff member with 
the most appropriate expertise for assisting the awardee. Therefore, the 
NIAID Program Officer and Scientific Coordinator may be the same individual. 
The Scientific Coordinator will have substantial scientific and 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.

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. The 
NIAID Scientific Coordinator will facilitate coordination of project 
activities during the course of the project.

The NIAID Scientific Coordinator will assist the awardee with access to other 
NIAID-supported resources and services, including resources for preclinical 
and clinical development, such as animal models, screening facilities, 
standardized research reagents, a genomics resource center and clinical 
trials networks, where available.	
The NIAID Scientific Coordinator will assist the awardee with advice about: 
(i) other NIAID/NIH clinical studies, (ii) subject safety, (iii) compliance 
with Federal regulations, (iv) study oversight and monitoring, (v) 
feasibility of timely completion, and (vi) when appropriate, plans for 
interim monitoring and analysis. 

3.  Collaborative Responsibilities

The specific timelines, interim objectives and funding levels agreed to by 
the awardee and the NIAID shall be included in the terms and conditions of 
award.  Given the nature of product development, it is recognized that 
timelines and interim objectives may require revision and renegotiation 
during the course of the project period.  All such revisions must be agreed 
to by the awardee and NIAID. Release of each funding increment by NIAID will 
be based on a NIAID review of progress towards achieving the previously 
agreed upon interim objective.

4.  Arbitration

Any disagreement that may arise on scientific or programmatic matters within 
the scope of the award between award recipients and the NIAID may be brought 
to arbitration. An arbitration panel will be composed of three members -- one 
selected by the individual awardee in the event of an individual 
disagreement, a second member selected by the NIAID, and the third member 
with expertise in the relevant area and selected by the two prior members 
will be formed to review any scientific or programmatic issue that is 
significantly restricting progress.  While the decisions of the Arbitration 
Panel are binding, these special arbitration procedures will in no way affect 
the awardee"s right to appeal an adverse action in accordance with PHS 
regulations at 42 CFR Part 50, subpart D, and HHS regulations at 45 CFR Part 16.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and 
their 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 are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.   
The amended policy incorporates: the use of an NIH definition of 
clinical research, updated racial and ethnic categories in compliance with 
the new OMB standards, clarification of language governing NIH-defined Phase 
III clinical trials consistent with the new PHS Form 398, and updated roles 
and responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable, 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children, i.e., individuals under the age of 21, 
must be included in all human subjects research, conducted or supported by 
the NIH, unless there are scientific and ethical reasons not to include them. 
This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines on the Inclusion of Children as Participants in 
Research Involving Human Subjects" that was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and which is available at the following 
URL address:  http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators may also obtain copies from Ann M. Ginsberg (contact 
information under INQUIRIES, below), who may also provide additional relevant 
information concerning the policy.

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.  This policy announcement is found in the NIH Guide for Grants and 
Contracts Announcement dated June 5, 2000, at the following website: 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

URLS IN NIH GRANT APPLICATIONS OR APPENDICES

All applications for NIH funding must be self-contained within specified page 
limitations. Unless otherwise specified in an NIH solicitation, internet 
addresses (URLs) should not be used to provide information necessary to the 
review because reviewers are under no obligation to view the Internet sites. 
Reviewers are cautioned that their anonymity may be compromised when they 
directly access an Internet site.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT

The Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at: 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PAR 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.

LETTER OF INTENT

Prospective applicants are asked to submit, by February 20, 2002, a letter of 
intent that includes a descriptive title of the overall proposed research, 
the name, address and telephone number of the Principal Investigator, the 
identities of other key personnel and participating institutions, and the 
number and title of this PAR.  Although the letter of intent is not required, 
is not binding, does not commit the sender to submit an application, and does 
not enter into the review of subsequent applications, the information that it 
contains allows NIAID staff to estimate the potential review workload and to 
avoid conflict of interest in the review.  

The letter of intent is to be sent to Dr. Madelon Halula at the address 
listed under INQUIRIES by the letter of intent receipt date listed.

APPLICATION PROCEDURES

All potential applicants are strongly encouraged to call NIAID program staff 
before beginning to prepare an application to discuss the responsiveness of 
their proposed project to the goals of this PAR.  

The PHS 398 research grant application instructions and forms (rev. 5/2001) 
at http://grants.nih.gov/grants/funding/phs398/phs398.html must be used in 
applying for these grants and will be accepted at the standard application 
deadlines (http://grants.nih.gov/grants/dates.htm) as indicated in the 
application kit.  This version of the PHS 398 is available in an interactive, 
searchable format.  For further assistance contact GrantsInfo, Telephone 
301/710-0267, Email:  [email protected].

For purposes of identification and processing, item 2a on the face page of 
the application must be marked "YES," the PAR number and the words 
"PARTNERSHIPS FOR NOVEL THERAPEUTIC AND VECTOR CONTROL STRATEGIES IN 
INFECTIOUS DISEASES" must be entered on the face page.

Disposition of Intellectual Property.  Since an application may include 
several institutions, including the private sector, complex intellectual 
property-related situations may arise.  To avoid delays related to 
intellectual property issues, each multi-project group is required to 
provide, as part of the application, a plan detailing (1) the approach agreed 
to by all parties for disposition of intellectual property, including but not 
limited to obtaining patent coverage and licensing, where appropriate, and 
(2) procedures to be followed for the resolution of legal problems that 
potentially may develop.  Attention is drawn to the reporting requirements of 
35 U.S.C. Parts 200-212 and 37 CFR Part 401 or FAR 55.227-11 for intellectual 
property issues. Instructions were also published in the NIH GUIDE FOR GRANTS 
AND CONTRACTS, Vol. 19, No. 23, June 22, 1990. Note that all NIH grantees may 
elect title to any new invention made by their employee(s) under the grant or 
cooperative agreement.

It is also noted that a Presidential memorandum of February 18, 1983 extended 
to all business concerns, regardless of size, the first option to the 
ownership of rights to inventions as provided in P.L. 96-517. As a result of 
this memorandum, the relationships among industrial organizations and other 
participants are simplified, since all group members can now be full partners 
in the research and in any inventions resulting there from.  The specific 
patenting arrangements among the institutions may vary and could include 
joint patent ownership, exclusive licensing arrangements, etc.  Applicants 
are encouraged to develop an arrangement that is most suitable for the 
group"s particular circumstances.

The disposition of intellectual property agreement among the institutions 
comprising the group, signed and dated by the organizational officials 
authorized to enter into intellectual property rights arrangements for each 
group member and member institution, should be submitted to Dr. Ginsberg 
(listed under INQUIRIES) prior to award. Details of financial arrangements 
may be redacted before submission.  The agreement should not be submitted 
with the application. If the group wishes to place all inventions and 
discoveries resulting from these studies within the public domain, a letter 
to that effect must be submitted to Dr. Ginsberg in lieu of the intellectual 
property rights agreement.  The letter must be co-signed by the Principal 
Investigators, the lead investigators for each institution, and each of the 
business officials representing the respective institutions.

Applications must be received by March 20, 2002.  Applications not received 
as a single package by this receipt date or not conforming to the 
instructions contained in PHS 398 (rev. 5/01) Application Kit, as modified in 
and superseded by the special instructions below for the purposes of this 
PAR, will be judged non-responsive and will be returned to the applicant. 

If the application submitted in response to this PAR is substantially similar 
to a grant application already submitted to the NIH for review, but that has 
not yet been reviewed, the applicant will be asked to withdraw either the 
pending application or the new one. Simultaneous submission of identical 
applications will not be allowed, nor will essentially identical applications 
be reviewed by different review committees.  Therefore, an application that 
is essentially identical to one that has already been reviewed cannot be 
submitted in response to this PAR. This does not preclude the submission of 
substantial revisions of applications already reviewed, but such applications 
must include an introduction addressing the previous critique.

Submit a signed, typewritten original of the application, including the 
checklist, and three signed, exact, single-sided 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 mail or courier service)

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:

Madelon Halula, Ph.D.  
Division of Extramural Activities  
National Institute of Allergy and Infectious Diseases  
Room 2150, MSC-7614
6700-B Rockledge Drive  
Bethesda, MD  20892-7614
BETHESDA, MD  20817 (for express mail or courier service)

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

Applicants from institutions that have a General Clinical
Research Center (GCRC) funded by the NIH National Center for Research 
Resources may wish to identify the GCRC as a resource for conducting the 
proposed research.  If so, a letter of agreement from either the GCRC Program 
Director or Principal Investigator should be included with the application.

When clinical studies or trials are a component of the research proposed, 
NIAID Clinical Terms and Conditions of Award will be included with awards.  
NIAID policy includes the requirement that studies be monitored commensurate 
with the degree of potential risk to study subjects and the complexity of the 
study.  NIAID policy was announced in the NIH Guide on February 24, 2000 and 
is available at 
http://grants.nih.gov/grants/guide/notice-files/NOT-AI-00-003.html.  The full 
policy including terms and conditions of award is available at 
http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf.

When experimental field applications of chemical pesticides are included in 
the scope of work the applicant must abide by all of the pertinent 
regulations and laws that exist in the jurisdiction where the work will take 
place. In the United States, that usually involves application for and 
receipt of an Experimental Use Permit from the Environmental Protection 
Agency (EPA). When such work would take place outside the Untied States, 
NIAID may also solicit the advice of appropriate experts, and awardees will 
be expected to provide the same level of protection for the environment as 
would be afforded if the work were being done in the United States.

REVIEW CONSIDERATIONS  

Upon receipt, applications will be reviewed for completeness by the NIH 
Center for Scientific Review (CSR) and for responsiveness by NIAID staff, 
those judged to be incomplete or non-responsive will be returned to the 
applicant without review.

Applications that are complete and responsive to the PAR will be evaluated 
for scientific and technical merit by an appropriate peer review committee 
convened by the Division of Extramural Activities, NIAID. As part of the 
initial merit review, all applications receive a written critique and undergo 
a process in which only those applications deemed to have the highest 
scientific merit, generally the top half of the applications under review, 
will be discussed, assigned a priority score, and receive a second level 
review by the National Advisory Allergy and Infectious Diseases Council. The 
NIAID will withdraw from competition those applications judged to be non-
competitive for award and will notify the applicant and institutional 
business officials.

Review Criteria

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 PAR 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 move a field forward.

1. Significance.  Is this project likely to result in or significantly 
advance development of a novel therapeutic or vector control agent/strategy 
or diagnostic technique that will add substantively to our ability to 
diagnose or treat or control an infectious disease of public health 
importance? Is the industry commitment adequate to have an impact on the 
success of the proposed research objectives? If the aims of the application 
are achieved, are important biomedical agents or diagnostic technologies 
likely to result?  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?  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.  Many aspects of drug, diagnostic and vector control method 
development are not inherently innovative.  However, each project will be 
judged on whether, if successful in completing its aims, the project will add 
substantially to our ability to diagnose, treat or control an infectious 
disease that currently causes a public health burden and is not currently 
considered an attractive investment by the private sector (i.e., 
biotechnology, chemical or pharmaceutical industry).

4. Investigator.  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 principal investigator and other 
researchers (if any)? Is there strong evidence of substantive industrial 
commitment?

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?

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

O  The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects will also be 
evaluated.

o  The reasonableness of the proposed budget and duration in relation to the 
proposed research.

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 the proposed plan to share data, if appropriate.

Schedule

Letter of Intent Receipt Date:    February 20, 2002
Application Receipt Date:         March 20, 2002
Scientific Peer Review Date:      July 8, 2002
Advisory Council Date:            August, 2002
Earliest Anticipated Award Date:  September 3, 2002

AWARD CRITERIA

The following will be considered in making funding decisions: 

o scientific merit (as determined by peer review)
o availability of funds
o programmatic priorities
  
The earliest anticipated date of award is September 3, 2002.

INQUIRIES  

Written and telephone inquiries concerning this PAR are encouraged.  The 
opportunity to clarify any issues or questions from potential applicants is 
welcome.

Direct inquiries regarding programmatic, research scope, and eligibility 
issues to:  

Ann M. Ginsberg, M.D., Ph.D.  
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases  
Room 3133, MSC-7630
6700-B Rockledge Drive
Bethesda, MD  20892-7630
Telephone:  (301) 496-5305
FAX:  (301) 496-8030
E-Mail:  [email protected]
  
Direct inquiries regarding review issues, address the letter of intent, and 
mail two copies of the application and all five sets of appendices to:
  
Madelon Halula, Ph.D.  
Division of Extramural Activities  
National Institute of Allergy and Infectious Diseases  
Room 2150, MSC-7614
6700-B Rockledge Drive  
Bethesda, MD  20892-7614
Telephone:  (301) 402-2636
FAX:  (301) 402-2638
E-Mail:  [email protected]

Direct inquiries regarding fiscal matters to:  

Ms. Jeanette Gorden                
Division of Extramural Activities  
National Institute of Allergy and Infectious Diseases  
Room 3222, MSC-7614
6700-B Rockledge Drive  
Bethesda, MD  20892-7614
Telephone:  (301) 402-5065
Fax:  (301) 480-3780
E-mail:  [email protected]

AUTHORITY AND REGULATIONS

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

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