EXPLORATORY/DEVELOPMENTAL GRANTS:  TECHNOLOGY APPLICATIONS TO 
NIAID-FUNDED RESEARCH

Release Date:  December 5, 2001

PA NUMBER:  PAS-02-031

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

Application Receipt Date:  February 26, 2002

THIS PAS USES THE "MODULAR GRANT" AND JUST-IN-TIME CONCEPTS.  MODULAR 
INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS REQUESTING LESS THAN 
$250,000 PER YEAR IN ALL YEARS.  MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN 
SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT 
http://grants.nih.gov/grants/funding/phs398/phs398.html.

PURPOSE

The National Institute of Allergy and Infectious Disease (NIAID) solicits 
exploratory/developmental (R21) grant applications that facilitate the 
application of innovative/emerging technologies to currently funded research 
projects related to the study of infectious diseases (bacterial, viral, fungal 
and Parasitic), diseases caused by category A agents of bioterrorism, 
HIV/AIDS, basic immunology, and immune mediated conditions.  This R21 
mechanism is designed to capitalize on scientific opportunities that would 
augment the value of the project and may not have been available at the time 
of submission of the Parent grant. Therefore, R21 grant applications should be 
coupled to ongoing NIAID-funded research projects.  

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 PAS 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 and foreign, for-profit and not-for-
profit organizations, public and private, such as universities, colleges, 
hospitals, laboratories, units of State and local governments, eligible 
agencies of Federal government, and small businesses. Investigators currently 
supported by the following NIAID funding mechanisms are eligible to apply: 
Research Project Grant (R01) and MERIT awards (R37). Grantees are eligible for 
funding of one R21 award for each Parent NIAID grant. 

MECHANISM OF SUPPORT

Support of this PAS will be through the National Institutes of Health 
exploratory/developmental grant (R21) award mechanism. R21 grants are non-
renewable and limited to 2 years for up to $150,000 in direct costs per year.

Responsibility for the planning, direction, and execution of the proposed 
project will be solely that of the applicant.

This PAS is a one-time solicitation and R21 grant applications are not 
renewable. NIAID may repeat the announcement in future years, depending on the 
needs of the scientific community and the availability of funds. 

FUNDS AVAILABLE

NIAID intends to commit approximately $3,000,000 in FY2002 to fund 10-12 
applications in response to this PAS.  The usual PHS policies governing 
grants administration and management will apply.  Although this program is 
provided for in the financial plans of the NIAID, awards pursuant to this PAS 
are contingent upon the availability of funds for this purpose and the 
receipt of a sufficient number of applications of high scientific merit.  

RESEARCH OBJECTIVES

New and emerging technological advances have great potential to expand the 
analytical power and scope of research studies that may lead to new approaches 
for the diagnosis, treatment, and prevention of infectious diseases and to 
manipulate immune responses by vaccination and immunotherapeutic strategies.  
Recent advances in genomics, gene expression and function analyses, 
proteomics, new imaging technology, and bioinformatics have proven the 
applicability of these technologies to many different types of biological 
problems.  Ongoing research studies frequently need to expand the project 
scope and involve new collaborators and facilities to take advantage of 
emerging technologies.  This PAS supports the application of new technology to 
existing projects as exploratory/developmental projects that will increase the 
capability of the research to more directly and rapidly address central 
questions related to important areas of NIAID's research focus.  This focus 
includes diseases that are a current or emerging threat to public health as 
well as investigations into normal and Pathogenic immune responses. Specific 
areas of research interest include infectious diseases, diseases caused by 
category A bioterrorism agents (http://www.bt.cdc.gov/agent/Agentlist.asp); 
HIV/AIDS; basic immunology; and immune-mediated conditions such as asthma, 
allergy, autoimmune diseases and transplant rejection. Research technologies 
to be supported by the R21 mechanism include, but are not limited to:

o Application of novel or established genomic and/or molecular genetic 
approaches such as comparative genomics studies to facilitate gene 
identification and/or function, microarray technology, and in vitro/in vivo 
systems for genetic manipulations that may include more facile transfection 
technologies, novel gene knockout technologies, inducible gene expression 
systems, RNA interference, and genome-wide mutagenesis. 

o Application of innovative proteomics approaches such as techniques that 
increase the sensitivity or capacity of existing approaches with regard to 
throughput, quantitation, temporal resolution, reliability; new methods for 
defining protein properties related to their cellular functions; novel 
approaches for characterization of protein-protein, protein-DNA, or other 
protein-molecule interactions; novel applications of proteomic methodologies 
to the study of specific cellular processes; and use of proteomic approaches 
in the development and proof-of-concept testing of therapeutics. 

o Incorporation of imaging technology such as new and innovative imaging 
modalities and/or contrast reagent, with emphasis on their potential for 
cellular trafficking, identification of specific immune cell populations, and 
molecular imaging of gene expression and protein-protein interactions.

o Incorporation of bioinformatics approaches/tools such as analysis software 
for microarray analyses, new informatics methods appropriate for specific 
proteomics applications (e.g. for management of time-series proteomics data 
obtained in basic research and clinical trials, and collation and 
dissemination of biological information to the scientific community (e.g., 
database development).

Requests may include purchase of equipment needed for the specific technology 
application or enhancement.  They may also include support for personnel who 
may collaborate with the principal investigator on experimental design, 
technology implementation, or data analysis.  The principal investigator of 
the R21 application may be different than the principal investigator on the 
Parent NIAID grant award.  In this case, the principal investigator of the 
Parent grant should be listed as a co-investigator on the R21 application.

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 clear and compelling 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 is available at the following URL 
address:  http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators also may obtain copies of the policy from the program staff 
listed under INQUIRIES.  Program staff 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.

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 PAS 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.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

APPLICATION PROCEDURES

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.  This version of the PHS 398 is available in an 
interactive, searchable format.  For further assistance contact GrantsInfo by 
telephone 301-435-0714 or email:  GrantsInfo@nih.gov.

The title and number of the program announcement must be typed on line 2 of 
the face page of the application form and the YES box must be marked.


SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS

R21 applications will use the "MODULAR GRANT" and "JUST-IN-TIME" concepts, 
with direct costs requested in $25,000 modules, up to $150,000 total direct 
costs per year. 

The modular grant concept establishes specific modules in which direct costs 
may be requested as well as a maximum level for requested budgets. Only 
limited budgetary information is required under this approach.  The 
just-in-time concept allows applicants to submit certain information only when 
there is a possibility for an award. It is anticipated that these changes will 
reduce the administrative burden for the applicants, reviewers and NIH staff.  
The research grant application form PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in 
applying for these grants, with modular budget instructions provided in 
Section C of the application instructions. 

Submit a signed, typewritten original of the application, including the 
Checklist, and five 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)

SPECIFIC INSTRUCTIONS FOR R21 APPLICATIONS

To apply, please follow NIH guidelines for submission of an R21 application as 
listed below:

1.  The description (abstract) must include a brief explanation of the 
proposed activity, how it is related to the parent grant, and how it is 
consistent with the exploratory/development nature of the R21 mechanism as 
described in this notice. 

2.  Although preliminary data are neither expected nor required for an R21 
application, they may be included.

3.  Sections a-d of the Research Plan may not exceed 10 pages, including 
tables and figures.

4.  Included in the application (but separate from the 10 page limit) should 
be a section containing the parent grant's grant number, abstract and specific 
aims.  

5.  Appendix materials should be limited, as is consistent with the 
exploratory nature of the R21 mechanism, and should not be used to circumvent 
the page limit for the research plan.  Copies of appendix material will only 
be provided to the primary reviewers of the application and will not be 
reproduced for wider distribution. The following materials may be included in 
the appendix:
o Up to five publications, including manuscripts (submitted or accepted for 
publication), abstracts, patents, or other printed materials directly 
relevant to the project.  These may be stapled as sets.
o Surveys, questionnaires, data collection instruments, and clinical 
protocols.  These may be stapled as sets.
o Original glossy photographs or color images of gels, micrographs, etc., 
provided that a photocopy (may be reduced in size) is also included within 
the 10-page limit of items a-d of the research plan.  

Include five collated sets of all appendix material, in the same package with 
the application, following all copies of the application.  Identify each item 
with the name of the principal investigator.

INSTRUCTIONS SPECIFIC TO APPLICATIONS FOR SUPPORT OF TECHNOLOGY RESEARCH, 
DEVELOPMENT OR ENHANCEMENT

Applications submitted in response to this program announcement may be design-
driven or hypothesis-driven. Thus, the application should state the hypotheses 
and/or designs that will drive the proposed research.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the CSR. 
Incomplete applications will be returned to the applicant without further 
consideration.

Applications that are complete and responsive to the PAS will be evaluated 
for scientific and technical merit by an appropriate peer review groups 
convened by the CSR in accordance with the review criteria stated below.  As 
part of the initial merit review, all applications will 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 Institute of Allergy and Infectious 
Disease Advisory Board.

REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  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 these 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: Does this study address an important problem? If the aims of 
the application are achieved, how will scientific knowledge be advanced?  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? Will the application of the technology enhance research 
conducted under the parent grant award? 

3.  Innovation: Does the project employ novel concepts, approaches or method? 
Are the aims innovative?  Will the proposed project have a significant impact 
on the field? 

4. Investigator: Is the investigator appropriately trained and well suited to 
carry out this work?  Is the work proposed appropriate to the experience level 
of the principal investigator and other researchers (if any)?

5.  Environment: Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements?  Is there evidence of institutional 
support?

The initial review group will also examine: the appropriateness of proposed 
project budget and duration; the adequacy of plans to include both genders and 
minorities and their subgroups, and children as appropriate for the scientific 
goals of the research and plans for the recruitment and retention of subjects; 
the provisions for the protection of human and animal subjects; and the safety 
of the research environment.

AWARD CRITERIA

Funding decisions will be made on the basis of scientific and technical merit 
as determined by peer review, programmatic priorities, and the availability of 
funds.  

INQUIRIES

Direct inquiries regarding programmatic issues to:

Alison Deckhut, Ph.D.
Program Officer
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases
National Institutes of Health
6700-B Rockledge Drive MSC 7640
Bethesda, MD  20892-7640
Phone:  (301) 496-7551
FAX:  (301) 402-2571
Email:  adeckhut@niaid.nih.gov

Maria Giovanni, Ph.D.
Assistant Director for Microbial Genomics
Division of Microbiology and Infectious Disease
National Institute of Allergy and Infectious Diseases
National Institutes of Health
6700-B Rockledge Drive MSC 7630
Bethesda, MD  20892-7630
Phone:  (301) 496-1884
FAX:  (301) 480-4528
Email:  mgiovanni@niaid.nih.gov

Irene Glowinski, Ph.D.
Associate Director for Operations, Communication and Policy
Division of Microbiology and Infectious Disease
National Institute of Allergy and Infectious Diseases
National Institutes of Health
6700-B Rockledge Drive MSC 7630
Bethesda, MD  20892-7630
Phone:  (301) 496-1884
FAX:  (301) 480-4528
Email:  iglowinski@niaid.nih.gov

Polly Sager, Ph.D.
Director, Office of Scientific Coordination
Division of AIDS
National Institute of Allergy and Infectious Diseases
National Institutes of Health
6700-B Rockledge Drive MSC 7620
Bethesda, MD  20892-7620
Phone:  (301) 402-0755
FAX:  (301)480-0753
Email:  psager@niaid.nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Linda Shaw
Grants Managements Specialist
Grants Management Branch
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6700-B Rockledge Drive, MSC 7614
Bethesda, MD  20892-7614
Telephone:  301-402-6611
FAX:  301-480-3780
Email:  lshaw@niaid.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance 
93.855, Allergy, Immunology and Transplantation and No. 93.856 Microbiology 
and Infectious Diseases.  Awards are made under the authorization of the 
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 PHS 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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