NATIONAL COOPERATIVE DRUG DISCOVERY GROUPS FOR TUBERCULOSIS (NCDDG-TB)

RELEASE DATE:  November 18, 2002 (see amendment NOT-AI-03-009)

PA NUMBER:  PAR-03-028

RECEIPT DATE:  May 13, 2003, 2004, and 2005 (per amendment NOT-AI-03-009)

EXPIRATION DATE: May 14, 2005 (per amendment NOT-AI-03-009)
 
National Institute of Allergy and Infectious Diseases (NIAID) 
 (http://www.niaid.nih.gov)

APPLICATIONS IN RESPONSE TO THIS PROGRAM ANNOUNCEMENT (PA) MUST BE PREPARED 
USING A MULTI-PROJECT GRANT APPLICATION FORMAT; SPECIFIC INSTRUCTIONS FOR 
COMPLETING THE APPLICATION ARE IN THE NIAID BROCHURE ENTITLED "INSTRUCTIONS 
FOR APPLICATIONS FOR MULTI-PROJECT AWARDS" WHICH IS AVAILABLE AT THE 
FOLLOWING LINK: http://www.niaid.nih.gov/ncn/grants/multibron.htm

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA 

The National Institute of Allergy and Infectious Diseases (NIAID), National 
Institutes of Health (NIH), invites multidisciplinary program project grant 
applications to support projects with adequate preliminary data for serious 
development of new therapies to treat tuberculosis, a prominent AIDS-
associated co-infection.  Studies may include research on identified targets 
for rational design of inhibitors or projects with candidate compounds of 
known chemical identity with suitable efficacy and selectivity for exploration 
as candidate drugs.  It is anticipated that multidisciplinary approaches by 
scientists from a combination of academic, non-profit research, and commercial 
organizations, with the assistance of NIAID, will be necessary to effectively 
accelerate development of new therapeutics.  The focus of this PA is on 
targeted drug discovery research; random or large scale screening as well as 
clinical trials will not be supported under this PA.  Applications that 
include collaborations with the private sector (e.g., pharmaceutical, chemical 
or biotechnological companies) are strongly encouraged.

RESEARCH OBJECTIVES

Although HIV is the primary cause of the progressive immunological 
deterioration seen in AIDS, associated infectious diseases remain the most 
life-threatening complications of HIV infection, resulting in profound 
morbidity and mortality.  Populations without access to potent antiretroviral 
drugs are especially vulnerable to infectious diseases.  The most deadly 
reported co-infection in Africa, Asia, and Eastern Europe is tuberculosis.

The clinical management of co-infections in immunocompromised patients 
remains difficult.  Available drugs to treat opportunistic infections 
(including tuberculosis) do not exhibit adequate potency to completely 
eradicate infecting organisms, and prolonged HIV-mediated immunosuppression 
requires prolonged treatment schedules and prophylaxis regimens against 
recurrence of infections.  Existing anti-tuberculosis drugs administered 
under directly observed therapy are effective in HIV infected patients, but 
the duration and expense of management are considerable obstacles for some 
societies. Toxicity and adverse side effects of therapeutic agents, long-term 
drug use leading to patient intolerance or drug resistance, frequent 
relapses, and drug-drug interactions, complicate the medical management of 
AIDS patients.  The alarming emergence of multiple drug resistant 
Mycobacterium tuberculosis strains is causing many of the current anti-TB 
drugs to become ineffective.  New ideas and novel approaches are urgently 
needed to overcome the lack of therapeutic options available, particularly to 
people with AIDS.

Research Objectives and Scope

The objective of this PA is to encourage biological, chemical/biochemical, or 
pharmacological studies directed toward development of candidate drugs that 
are lethal to the pathogen with minimal toxicity for the host.

The research scope emphasizes studies on drugs to treat pulmonary 
Mycobacterium tuberculosis infection. Example areas of research may include, 
but are not limited to the following suggestions:

o  expression of confirmed drug targets; modeling and synthesis of 
inhibitors; efficacy evaluations in vitro and in vivo; mechanisms of action 
studies.
o evaluation of known gene products expressed during infection for targeted 
drug intervention; comparison of synthesized or known therapeutics on 
organisms growing intracellularly or at the site of infection; selection and 
production of candidate therapeutic agents for animal efficacy and toxicity 
testing.
o development, validation, and implementation of drug evaluation systems 
capable of predicting bactericidal and sterilizing activity of new agents, or 
combinations of agents against M. tuberculosis.
o molecular modeling using available crystalline proteins; selection and 
synthesis of ligands; evaluation of molecular interactions and 
microbiological effects.
o further preclinical development to examine the clinical candidacy of a 
selected compound including synthesis research, biological efficacy testing 
in animal systems, bioavailability estimations, pharmacokinetics and 
preliminary toxicity testing; metabolic effects or modification; interactions 
with anti-retroviral agents.

MECHANISM OF SUPPORT 

This PA will use the NIH cooperative agreement grant (U19) award mechanism.  
U19 awards support broadly based, multidisciplinary research programs that 
have a well-defined, central research focus or objective.  An important 
feature is that the interrelationships of the individual scientifically 
meritorious projects will results in a greater contribution to the overall 
program goals than if each project were pursued individually.  The 
cooperative agreement grant consists of a minimum of two interrelated 
individual research projects that contribute to the program objective.  This 
type of award also can provide support for certain common resources termed 
cores.  Such resources should be utilized by two or more projects within the 
award. The total project period for U19 grants may not exceed five years.  In 
addition, U19 grant applications submitted in response to this PA may not 
request in excess of $900,000 first-year total (direct and indirect) costs.

Applicants for U19 grants must follow special application guidelines in the 
NIAID Brochure entitled "Instructions for Applications For Multi-Project 
Awards"; this brochure is available via the World Wide Web at: 
http://www.niaid.nih.gov/ncn/grants/multibron.htm

This PA uses just-in-time concepts.
The NIH U19 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 NIH staff being 
substantially involved as a partner with the Principal Investigator, as 
described under the section "Cooperative Agreement: Terms and Conditions of 
Award".   
ELIGIBLE INSTITUTIONS 

You may submit (an) application(s) if your 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 or foreign institutions

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with 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.  

SPECIAL REQUIREMENTS 

Patent Coverage and Reporting

Because inventions leading to new drugs are the anticipated products of this 
program announcement, it is essential that applicants provide plans to ensure 
such coverage.  Since several institutions may be involved in these 
collaborative projects, complex patent situations may arise.  Where 
applicable, each applicant must provide a detailed description of (1) 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; and (2)the procedures to be followed for the 
resolution of legal issues 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.  Instructions were also published in the NIH Guide to 
Grants and Contracts, Volume 19, Number 23, June 22, 1990.  Note that non-
profit organizations (including universities) and small business firms retain 
the rights to any patents resulting from Government contracts, grants or 
Cooperative Agreements.

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 members can be full partners in the 
research and in any inventions resulting therefrom.  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 their own particular 
circumstances.

The patent agreement among the collaborating institutions, signed and dated 
by the organizational official authorized to enter into patent arrangements 
for each investigator and institution, must be delivered to Dr. Barbara 
Laughon prior to an award at the address listed under INQUIRIES.  A copy of 
the proposed patent agreement should be submitted with the application.  If 
the collaborators wish to place all inventions and discoveries resulting from 
these studies within the public domain, a letter to that effect must be 
submitted to Dr. Laughon in lieu of the patent agreement prior to award.  The 
letter must be co-signed by the Principal Investigator, each investigator, 
and each of the business officials representing the respective institutions.

Federal regulation clause 37 CFR 401 and HHS Inventions regulations at 45 CFR 
Parts 6 and 8 require that NIH be informed of inventions and licensing 
occurring under NIH funded research.  Invention and licensing reports must be 
submitted to the Division of Extramural Invention and Technology Resources, 
Office of Extramural Research, NIH, 6701 Rockledge Drive, Room 3188, 
Bethesda, MD 20892.

Cooperative Agreement Terms 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] 
multiproject cooperative agreement (U19), [an "assistance" mechanism (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.

When clinical studies or trials are a component of the research proposed, 
NIAID policy requires that studies be monitored commensurate with the degree 
of potential risk to study subjects and the complexity of the study. AN 
UPDATED NIAID policy was published in the NIH Guide on July 8, 2002 and is 
available at: 
https://grants.nih.gov/grants/guide/notice-files/NOT-AI-02-032.html. 
The full policy, including terms and conditions of award, is 
available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf. 

Integration into the on-going program of the National Cooperative Drug 
Discovery Groups for the Treatment of Opportunistic Infections (NCDDG) is 
anticipated.  Principal Investigators and project leaders will be expected to 
attend an annual NCDDG meeting to review progress and share information among 
awardees.

Awardee Rights and Responsibilities and Nature of NIAID Participation

It is the primary responsibility of the Principal Investigator to clearly 
define the objectives and approaches of the Group, to plan and conduct the 
research stipulated in the proposal, and to ensure that the results obtained 
are analyzed and published in a timely manner.  The data obtained will be the 
property of the awardee.

1.  Meetings

a.  One mandatory intra-Group meeting is required per year.  The Principal 
Investigator and Project and Core Leaders will meet to review progress, plan 
and design research activities, and establish priorities within the Group.  
The Principal Investigator will be responsible for scheduling the time and 
place (generally at one of the performance sites), for notifying the 
Scientific Coordinator at least thirty days prior to the meeting date, and for 
preparing concise (2-3 pages) minutes or summaries of the Group meetings which 
will be delivered to the members of the Group including the Scientific 
Coordinator within thirty days following the meeting.  NIAID Scientific 
Coordinator will participate but not chair Group meetings.

b.  One mandatory meeting of the entire NCDDG program will be held each year 
at a site designated by NIAID (Bethesda, Maryland is anticipated) during which 
all Principal Investigators and Project Leaders will present significant 
findings in symposium format.  Data presented at this meeting are selected by 
the individual presenters in consultation with their Principal Investigator 
thus affording appropriate protection of proprietary or commercially sensitive 
information.

c.  Group communications.  A critical determinant of Group success will be the 
degree of communication among members.  Therefore, in addition to the three 
meetings listed above, additional meetings for coordination of Group 
activities may be necessary.  Regular telephone and written communication will 
be important and are encouraged.

2.  Publications

The Principal Investigator will be responsible for the timely submission to 
the Scientific Coordinator of all abstracts, manuscripts, and reviews 
(co)authored by members of the Group and supported in part or in total under 
this Agreement.  The Principal Investigator and Project Leader are requested 
to submit manuscripts to the Scientific Coordinator within three weeks of 
acceptance for publication so that an up-to-date summary of program 
accomplishments can be maintained.

Publications or oral presentations of work done under this Agreement are the 
responsibility of the Principal Investigator and appropriate Project Leader.

All publications (abstracts, peer reviewed manuscripts, reviews) and oral 
presentations of work supported in part or in total by the NCDDG cooperative 
agreement must be acknowledged as part of the presentation and will include 
the mechanism, cooperative agreement number and Institute; for example, "This 
work was supported in whole (or in part) by the NCDDG program, cooperative 
agreement number U01-AI-12345, NIAID."

3.  Progress Reports

An annual Progress Report will be submitted with the Non-Competing Grant 
Progress Report" which must include significant experimental data obtained and 
a complete and cumulative list of all publications (abstracts, manuscripts, 
reviews) (co)authored by Group members and supported in part or in total under 
this Agreement.

Each Progress Report should also include a brief section outlining intra-Group 
interactions that have augmented activities, citing specific occurrences 
(e.g., compound X was synthesized under Project 1 and transferred to Project 2 
for bioassays).  Inter-Group collaboration with other NCDDGs should be 
specified, where applicable. Interaction with the Scientific Coordinator and 
the NIAID during the reporting period should be described.

The Progress Report must also include basic information as instructed with PHS 
2590 "Non-Competing Grant Progress Report"

4.  Rights to Data

Although the NIAID Scientific Coordinator has a right of access to the data 
(see NIAID staff responsibilities below), the awardee will retain custody of 
and rights to the data.  Information obtained from the data may be used by the 
Scientific Coordinator for the preparation of internal reports on the Group's 
activities.  Timely publication of major findings is strongly encouraged.

The NIAID Scientific Coordinator may assist the Groups by providing them with 
compounds for voluntary initial and confirmatory testing.  In testing 
compounds supplied by the NIAID, the Groups agree to abide by any 
confidentiality agreement between the NIAID and a third party who may have 
supplied the compounds for testing through NIAID.

The awardee institution and the Principal Investigator will be responsible for 
the Group's application.  The award will be made to the applicant institution 
on behalf of the Group as a whole and not to individual research projects 
within the Group.  The awardee institution will provide a Central Operations 
Office for the Group, will be responsible for the performance of the entire 
Group, and will be accountable for the funds awarded.

NIAID Staff Responsibilities:  Nature of NIAID Participation

Assistance via a Cooperative Agreement differs from the traditional research 
grant in that, in addition to the normal programmatic and administrative 
stewardship responsibilities, the awarding component (NIAID) anticipates 
substantial programmatic involvement during performance of the research 
program.  NIAID shall participate as a member of the Group and shall be 
represented by a Scientific Coordinator.  The Coordinator shall be selected 
from the Division of Acquired Immunodeficiency Syndrome, or from the Division 
of Microbiology and Infectious Diseases, which are extramural programs of the 
NIAID.

During performance of the award, the NIAID Scientific Coordinator, may provide 
appropriate assistance, advice, and guidance by:  participating in the design 
of Group activities; advising in the selection of sources or resources; 
coordinating or participating in collection and/or analysis of data; advising 
in management and technical performance; or participating in the preparation 
of publications.  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 of the Group and that NIAID staff will be given 
the opportunity to offer input to this process.  The manner of reaching this 
consensus and the final decision-making authority will rest with the Principal 
Investigator.

NIAID Participation in Design of Group Activities, Development of Research 
Protocols and Evaluation of Results

a.  The NIAID Scientific Coordinator, like other Group members, may suggest 
studies within the scope of the Group's objectives and research activities; 
may present to the Group experimental findings from published sources or from 
contract projects in support of these suggestions; may participate in the 
design, but not in the execution, of experiments agreed to by the Group; and 
may participate in the analysis of results.

b.  The NIAID Scientific Coordinator may assist the Group or other individual 
members in research planning, particularly by:
o  providing needed resources and information that may not be otherwise be 
available to the Group;
o  providing data from testing conducted in resource contract laboratories;
o  providing information concerning work being conducted in other NIAID-
supported extramural projects, in order to reduce or prevent duplication of 
efforts.

c.  The Scientific Coordinator may serve as a resource for information, 
laboratory testing, and biological supplies, when such resources are not a 
normal requirement of the Group's day-to-day research activities but may be 
required on an occasional basis.  The NIAID has a contract program for the 
preclinical development of compounds for the treatment of AIDS-associated 
opportunistic infections, including animal models. These resources are 
intended for initial studies and may not be available on a continual basis.  
Examples of potential assistance include:  reference compounds for 
standardization of test systems, facilitation of confirmatory testing at 
research sites including other NCDDG Groups, limited testing in appropriate 
animal model(s), focused searches of NIAID's computer files of chemical 
structures and biological activity, chemical re-synthesis, analysis, 
formulation, and toxicology testing through existing pre-clinical development 
contracts (contingent upon NIAID's recommendation and prioritization), and 
networking with other NIH staff, NCDDGs, other collaborators and other 
Government and non-Government researchers who may provide guidance, expertise 
or resources to facilitate development of therapies identified by the Group.

In addition, the NIAID supports Phase I, Phase II and Phase III clinical 
trials through a variety of mechanisms.  These clinical development resources 
are available to study promising therapies brought forward from sources such 
as the NCDDG program.  It is understood that the Government provides its 
consulting and testing services in the interest of promoting experimental 
anti-infective agents through preclinical and clinical testing and development 
in the most expeditious fashion, and that newly marketed agents that have 
utilized this service will be offered to the public at a reasonable cost.

NIAID Participation in Collection and Analysis of Data, Procedures for 
Submission of Results to NIAID, and Preparation of Group Findings for 
Presentation and Publication.  

In addition to the special reports and stipulations described below, reporting 
requirements will be identical to those currently in existence for awardees of 
traditional NIH research project grants.

a.  The principal end product of NCDDG activities will be the development of 
new entities and strategies for treatment of AIDS-associated tuberculosis.  
Subsequent developmental work through private resources is encouraged. 
Alternatively, the Group may recommend that development be sponsored by NIAID 
(see below).  In the latter case, it will be necessary for the Principal 
Investigator, appropriate Project Leaders and NIAID Scientific Coordinator to 
collaborate in the analysis, summarization, preparation, and presentation of 
data to the appropriate NIAID staff and its advisory committees.

b.  NIAID will retain the option to cross-file or independently file an 
application for investigational clinical trial; e.g., an Investigational New 
Drug (IND) application to the United States Food and Drug Administration of 
any invention resulting from these NIAID supported Cooperative Agreements.  
Reports of data generated by the Group or any of its members required for 
inclusion in INDs and Clinical Brochures and for cross-filing purposes will be 
submitted by the Principal Investigator to the Scientific Coordinator upon 
request. Such reports will be in final draft form and include background 
information, methods, results, and conclusions.  They will be subject to 
approval and revision by NIAID and may be augmented with test results from 
other Government sponsored projects prior to submission to the appropriate 
regulatory agency.

Arbitration Process

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 formed to review any scientific 
or programmatic issue that is significantly restricting progress. This panel 
will be composed of three members -- one selected by the Steering Committee or 
by the individual awardee in the event of an individual disagreement, a second 
member selected by the NIAID, and a third member with expertise in the 
relevant area and selected by the two prior members.  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.

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity 
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:

Barbara E. Laughon, Ph.D. 
Division of AIDS 
National Institute of Allergy and Infectious Diseases 
Room 5108, MSC-7624
6700-B Rockledge Drive
Bethesda, MD 20892-7624 
Telephone: (301) 402-2304 
FAX: (301) 402-3171 
Email: Blaughon@niaid.nih.gov

Direct inquiries regarding review issues to:

Edward W. Schroder, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2151, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Zip code for express couriers: 20817 
Phone:  301-435-8537
FAX: 301-402-2638
Email: es170m@nih.gov

Direct inquiries regarding fiscal matters to:

Jeannette Gordon
Division of Extramural Activities
National Institute of Allergy and Infectious Disease, NIH
Room 2125, MSC-7614
6700-B Rockledge Drive
Bethesda, MD  20892-7614
Zip code for express couriers: 20817 
Tel:  (301) 402-5065
Fax:  (301) 480-3780
Email:    jg82s@nih.gov

SUBMITTING AN APPLICATION

Applicants for U19 grants must follow special application guidelines in the 
NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT 
AWARDS; this brochure is available via the WWW at: 
http://www.niaid.nih.gov/ncn/grants/multibron.htm

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 710-0267, 
Email: GrantsInfo@nih.gov.

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 exact copies of the grant 
application and all five sets of any appendix material must be sent to:

Edward W. Schroder, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2151, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Zip code for express couriers: 20817 

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 (as modified in, and superseded by, the NIAID BROCHURE 
ENTITLED "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS"), will be 
judged non-responsive and will be returned to the applicant. 

SPECIAL INSTRUCTIONS FOR COMPLETION OF APPLICATIONS IN RESPONSE TO THIS RFA:

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: http://www.niaid.nih.gov/ncn/grants/multibron.htm.

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.

APPLICATION PROCESSING: Applications must be received by the receipt date 
shown on the first page.  

The CSR will not accept any application in response to this PA 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 a substantial revision of an application 
already reviewed, but such application must include an Introduction 
addressing the previous critique.

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 to be concurrently submitted as a traditional 
individual research project (R01) application. If, following review, both the 
multi-project application and the R01 application are found to be in the 
fundable range, the investigator must relinquish the R01 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 Principal 
Investigator and awarding institution.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NIAID.  Incomplete or non-responsive applications will 
be returned to the applicant without further consideration.  

An appropriate peer review group convened by the Division of Extramural 
Affairs (DEA) at NIAID, in accordance with the review criteria stated below, 
will evaluate applications that are complete and responsive to this PA for 
scientific and technical merit.  As part of the initial merit review, all 
applications will:

o Receive a written critique
o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a second level review by the National Institute of Allergy and 
Infectious Diseases Council

REVIEW CRITERIA

The general review criteria for U19 multi-project cooperative agreement 
applications are presented in the NIAID brochure entitled "INSTRUCTIONS FOR 
APPLICATIONS FOR MULTI-PROJECT AWARDS" at 
http://www.niaid.nih.gov/ncn/grants/multibron.htm

o Overall evaluation and scoring

The overall application score will be based on review and merit of the 
individual components as well as the merit of the application taken as a 
whole.  A single numerical priority score will be assigned to the whole 
application after consideration of all of the review elements listed below.  
The overall research plan and the individual Research Projects will be 
assigned numerical priority scores, while the Administrative and Facilities 
Cores will be rated acceptable or unacceptable without numeric scores. The 
overall score will be based on the scientific merit of the individual 
components as well as the overall synergy, the effectiveness and adequacy of 
plans for sharing resources, the overall program organization and capability 
of the associated personnel and the likelihood that new, effective 
antimicrobial agents will be identified during the course of the proposed 
research.

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

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.

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)

DATA SHARING:  The NIH encourages the timely dissemination of research tools 
and results, in support of further research and development.  The NIH has 
issued a document that addresses these concerns:  
http://www.ott.nih.gov/policy/rt_guide_final.html

COMPLIANCE WITH THE NIH GUIDELINES FOR RESEARCH INVOLVING RECOMBINANT DNA 
MOLECULES:  Applications proposing to use recombinant DNA molecules and 
techniques must adhere to the NIH Guidelines for Research Involving 
Recombinant DNA Molecules, 
http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html, which outline 
practices to ensure the safety and containment of this research.

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

AWARD CRITERIA

Applications submitted in response to a PA will compete for available funds 
with all other recommended applications.  The following will be considered in 
making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities and programmatic balance

REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components 
involving Phase I and 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: https://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 
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); 
a complete copy of the updated Guidelines are available at 
https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community. The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable; 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them. 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 
https://grants.nih.gov/grants/funding/children/children.htm. 

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects. You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

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

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

Applicants may wish to place data collected under this 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.

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

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.