APPLICATION OF EXPLORATORY/DEVELOPMENTAL TECHNOLOGIES TO NIAID-FUNDED
RESEARCH
RELEASE DATE: August 29, 2002
PA NUMBER: PAS-02-160
Application Receipt Dates: Standard new research project grant receipt
dates for AIDS and non-AIDS grants through May 1, 2003 (see
https://grants.nih.gov/grants/funding/submissionschedule.htm).
EXPIRATION DATE: May 1, 2003, unless reissued.
National Institute of Allergy and Infectious Diseases (NIAID)
(http://www.niaid.nih.gov)
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
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 Disease (NIAID)
solicits exploratory/developmental (R21) grant applications that
facilitate the application of innovative/emerging technologies or
established state-of-the-art technologies to augment NIAID funded
research projects related to the study of infectious diseases
(bacterial, viral, fungal and parasitic), HIV/AIDS, basic immunology,
and immune mediated conditions (autoimmunity, asthma, allergy,
organ/tissue transplant rejection). Studies focused on biodefense
research are not eligible for this announcement. Funding opportunities
for biodefense research are identified at
http://www2.niaid.nih.gov/Biodefense/Research/funding.htm#B
R21 grant applications must be scientifically and administratively
linked to ongoing NIAID-funded research project (R01 and R37) grants.
RESEARCH OBJECTIVES
The use of emerging technologies and the application of existing state-
of-the art technologies 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 research questions. Frequently, ongoing research studies
could benefit from expansion of the project scope involving new
collaborators and advanced technologies.
This program will facilitate research to more directly and rapidly
address central questions related to important areas of NIAID"s
research focus including 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 study of
infectious diseases from biology of the microbe to host responses and
pathogenesis, HIV/AIDS, basic immunology and immunity to infectious
agents, 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, PCR technologies, detection
methods for single nucleotide polymorphisms (SNPs) and other genetic
alterations or mutations, 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 studies involving human embryonic stem cells
(http://stemcells.nih.gov/index.asp).
o Application of established technologies such as unique animal models,
flow cytometry, X-ray crystallography, mass spectrometry, 2-dimensional
gel electrophoresis, and differential display to augment existing
research programs.
o Incorporation of imaging technologies such as new and innovative
imaging modalities and/or contrast reagents, with emphasis on their
potential for visualization of cellular trafficking, identification of
specific immune cell populations, and molecular imaging of gene
expression and protein-protein interactions.
o Incorporation of bioinformatics software and computational tools for
emerging DNA sequencing data (e.g. for assembling and finishing genomes
and annotation of genomes), microarray analyses, 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 from the
principal investigator on the R01 or R37 grant award. In this case,
the principal investigator of the R01 or R37 grant should be listed as
a co-investigator on the R21 application and should provide a letter of
support to the R21 applicant.
MECHANISM OF SUPPORT
Support 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.
FUNDS AVAILABLE
NIAID intends to commit approximately $3,000,000 in FY2003 to fund 10-
12 applications in response to this PAS. The usual NIH 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.
ELIGIBILITY REQUIREMENTS
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 NIAID R01 or R37 grant. R21 applicants must have at least 12
months remaining on the R01 or R37 grant at the anticipated time of
award. No-cost extensions do not apply towards the 12 month
requirement. You may submit an application if your institution has any
of the following characteristics:
o For-profit or non-profit organization
o Public or private institutions, such as universities, colleges,
hospitals, and laboratories
o Domestic
o Units of State and local governments
o Eligible agencies of the Federal government
SPECIAL REQUIREMENTS
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:
http://grants2.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.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this PA and welcome the
opportunity to answer questions from potential applicants. Inquiries
may fall into three areas: scientific/research and financial or grants
management issues:
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
Nabila M. Wassef, Ph.D.
PBRB, Division of AIDS, NIAID, NIH
Rockledge Building, Room 4135
6700-B Rockledge Drive, MSC 7626
Bethesda, MD 20892-7626 (overnight mail-20817)
Tel: (301) 435-3751
Fax: (301) 402-3211
Email: nwassef@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
SUBMITTING AN APPLICATION
The PHS 398 research grant application instructions and forms
(rev.5/2001) at
https://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 301-710-0267 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
https://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 NIAID 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 R01 or R37 grant, and how
it is consistent with the exploratory/development nature of the R21
mechanism as described in this notice. The grant assignment number
(e.g. 2 R01 AI123456-07) must be included in the Description section.
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 (just before section a, and separate
from the 10 page limit) should be a section containing the grant
number, abstract and specific aims of the R01 or R37 to which this R21
application is linked.
5. If the principal investigator (PI) of the R21 application is
different from the PI of the R01 or R37 NIAID award, a letter of
support from the PI of the parent award must be included at the end of
Research Plan.
6. 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 two publications, including manuscripts (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 submitted for this PA will be assigned on the basis of
established PHS referral guidelines. An appropriate scientific review
group convened in accordance with the standard NIH peer review
procedures (http://www.csr.nih.gov/refrev.htm) will evaluate
applications 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 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?
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 adequacy of the proposed plan to share data.
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
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
http://stemcells.nih.gov/index.asp 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 RFA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS
This program is described in the 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.