TOOLS FOR GENETIC AND GENOMIC STUDIES IN EMERGING MODEL ORGANISMS
RELEASE DATE: July 28, 2004
PA NUMBER: PA-04-135 - September 29, 2007 (Reissued as PA-07-457)
September 17, 2007 - Expiration Date adjusted to accommodate recent changes
to standing submission deadlines, per NOT-OD-07-093.
May 10, 2006 (NOT-GM-06-010) - See this notice for Changes in
Program Announcement PA-04-135: Tools for Genetic and Genomic
Studies in Emerging Model Organisms
EXPIRATION DATE: November 2, 2007, unless reissued (September 28, 2007 per PA-07-457)
(January 8, 2008 per NOT-OD-07-093)
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENT OF PARTICIPATING ORGANIZATION:
National Institute of General Medical Sciences (NIGMS)
(http://www.nigms.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.859
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 Supplementary Instructions
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS PA
This Program Announcement (PA) is to encourage investigator-initiated
applications for research designed to generate genetic tools and genomic
resources that will enable researchers to exploit the full potential of novel
or developing model systems for comparative and functional genomic studies.
The typical model organism to be considered should have a publicly available
draft of the genomic DNA sequence with a minimum of 5X coverage. In addition,
it should have at least one of the following characteristics: (1) shows
promise as, or is, a model for basic biological or behavioral mechanisms; (2)
occupies an important evolutionary niche that may yield novel insights in
comparative studies; or (3) has potential as, or is, a model for
developmental or disease processes. Applicants are expected to ensure that
reagents, technologies, and resources developed under this initiative are
made widely available to the research community.
This PA is not intended to encourage genome sequencing projects or studies of
model organisms for which there are well-established databases and other
genome-related resources e.g. mouse, Drosophila, C. elegans, S. cerevisiae.
In general, resources to study organisms that fit primarily within the
mission of another NIH Institute or Center, such as, pathogenic
microorganisms, are not encouraged through this PA.
RESEARCH OBJECTIVES
The advent of the genomic era has been a boon for the investigation of a
growing number of model organisms. Completion of DNA sequencing of each
genome presents opportunities for novel insights into genomic function, the
regulation of gene expression, and evolutionary processes. Yet, the large
scale of many sequencing projects and the sheer volume of sequence data
create a considerable challenge for the individual investigator as well as
consortia of researchers to obtain the resources and tools required to make
maximal use of genomic information for comparative or functional studies.
The major goal of this PA is to support research that will enhance the
usefulness of DNA sequence information for newly emerging or developing model
organisms for which there are limited genomic resources. Objectives to be
addressed in applications submitted in response to this PA include, but are
not limited to, the following:
o Improvements in tools for mining of data for genomes having unique
composition or structure
o Improved database management and integration with other databases
(Requests for the maintenance of databases alone are not encouraged.)
o Generation of comprehensive cDNA libraries
o Development of microarray reagents and/or services
o Improved methods for linking expression arrays with standard phenotypes or
with specific biological or behavioral outcomes
o Development of novel approaches for mutagenesis and for rapid
identification and characterization of point mutations
o Development of novel transposable element-based techniques for the
generation of knockouts or other mutations
o Improvements in gene transfer technology and in vectors for genomic
manipulation
o Generation of sets of gene knockouts or knock-downs
MECHANISM(S) OF SUPPORT
This PA will use the National Institutes of Health (NIH) research resource
grant (R24) mechanism. Responsibility for the planning, direction, and
execution of the proposed project will be solely that of the applicant. The
total project period for an application submitted in response to this PA may
not exceed four years. A maximum of $250,000 direct costs (exclusive of
subcontractual indirect costs) per year will be provided.
This PA uses just-in-time concepts. It uses the non-modular budgeting format.
Follow the instructions for non-modular budget research grant applications.
This program does not require cost sharing as defined in the current NIH
Grants Policy Statement at
http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm.
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/organizations
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
The NIH is interested in ensuring that the research resources (constructs,
reagents, cell lines, software tools, expression data, methods, etc.)
developed through this PA become readily available to the research community
for further research, development, and application, in the expectation that
this will lead to products and knowledge of benefit to the public. At the
same time, NIH recognizes the rights of grantees to elect and retain title to
subject inventions developed under federal funding under the provision of the
Bayh-Dole Act.
This PA has two special requirements regarding research resources produced in
proposed projects:
(1) Applicants are required to include in their applications a specific plan
by which they will share research resources with the wider scientific
community. A reasonable time frame for periodic deposition of mutants,
reagents, and data should be specified in the application.
(2) Applicants are required to include a plan addressing if, or how, they
will exercise their intellectual property rights while making available to
the broader scientific community patentable research resources. The plan
should address the following questions:
o Will material transfers be made with no more restrictive terms than in the
Simple Letter Material Transfer Agreement or the Uniform Biological
Material Transfer Agreement?
o Will there be reach-through requirements on materials transferred?
o Should any intellectual property arise that requires a patent, will the
technology remain widely available to the research community?
Both the sharing and intellectual property plans should, at a minimum,
address these elements in a clear and concise manner. Applicants are
encouraged to inform and/or confer with their institutional offices of
technology transfer to develop plans for addressing these requirements.
Applicants are reminded that the grantee institution is required to disclose
each subject invention to NIH within two months after the inventor discloses
it in writing to grantee institutional personnel responsible for patent
matters. The awarding Institute reserves the right to monitor awardee
activity in this area to ascertain if patents or patent applications are
adversely affecting the goals of this PA.
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 two
areas: scientific/research and financial or grants management issues:
o Direct your questions about scientific/research issues to:
Anthony Carter, Ph.D.
Division of Genetics and Developmental Biology
National Institute of General Medical Sciences
Building 45, Room 2AS-25R, MSC 6200
Bethesda, MD 20892-6200
Telephone: 301-594-0943
FAX: 301-480-2228
Email: CarterA@nigms.nih.gov
o Direct inquiries about financial or grants management matters to:
Ms. Marcia Cohn
Grants Administration Branch
National Institute of General Medical Sciences
Building 45, Room 2AN50E, MSC 6200
Bethesda, MD 20892-6200
Telephone: 301-594-3918
FAX: 301-480-2554
Email: cohnm@nigms.nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). Applications must have a Dun and
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the
Universal Identifier when applying for Federal grants or cooperative
agreements. The DUNS number can be obtained by calling (866) 705-5711 or
through the web site at http://www.dunandbradstreet.com/. The DUNS number
should be entered on line 11 of the face page of the PHS 398 form. The PHS
398 is available at http://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.
The title and number of this program announcement must be typed on line 2 of
the face page of the application form and the YES box must be checked.
SUPPLEMENTARY INSTRUCTIONS
APPLICATION CONTENTS: In the Background section, the applicant should include
a description of existing publicly available resources for the model organism
being studied. The applicant should define how the proposal will enhance
available resources and provide evidence of research community consultation
and consensus regarding the potential value of the resource.
In a brief section following the research plan, the applicant must describe
plans to share research resources and to exercise intellectual property
rights (see SPECIAL REQUIREMENTS).
APPLICATION RECEIPT DATES: Applications submitted in response to this program
announcement will be accepted at the standard application deadlines, which
are available at http://grants.nih.gov/grants/dates.htm. Application
deadlines are also indicated in the PHS 398 application kit.
SENDING AN APPLICATION TO THE NIH: 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)
APPLICATION PROCESSING: Applications must be mailed on or before the receipt
dates described at
http://grants.nih.gov/grants/funding/submissionschedule.htm. 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 unfunded version of an application
already reviewed, but such application must include an Introduction
addressing the previous critique.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and funding
assignment within 8 weeks.
PEER REVIEW PROCESS
Applications submitted for this PA will be assigned on the basis of
established PHS referral guidelines. Appropriate scientific review groups
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 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 written critique
o Receive a second level review by the National Advisory General Medical
Sciences 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. In
the written comments, reviewers will be asked to evaluate application in
order to judge the likelihood that the proposed research will have a
substantial impact on the pursuit of these goals. The scientific review
group will address and consider each of the following criteria in assigning
the application’s overall score, weighting them as appropriate for each
application.
o Significance
o Approach
o Innovation
o Investigator
o Environment
The application does not need to be strong in all categories to be judged
likely to have 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.
SIGNIFICANCE: Does the proposed resource or technology development address an
important problem or need? If the aims of the application are achieved, how
will scientific knowledge be advanced? What will be the effect of this
project on the concepts or methods that drive the field? Will this project
enhance the usefulness of the model organism being studied?
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?
INNOVATION: Does the project employ novel concepts, approaches or methods?
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)?
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 CRITERION: In addition to the above criteria, the following
item will be considered in the determination of scientific merit and the
priority score:
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to
be used in the project, the five items described under Section f of the PHS
398 research grant application instructions (rev. 5/2001) will be assessed.
ADDITIONAL REVIEW CONSIDERATIONS
DATA SHARING: Reviewers will evaluate the reasonableness of the data sharing
plan. However, reviewers will not factor the proposed data sharing plan into
the determination of scientific merit or priority score.
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
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 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.healthypeople.gov/.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject
to the intergovernmental review requirements of Executive Order 12372
or Health Systems Agency review. Awards are made under the
authorization of Sections 301 and 405 of the Public Health Service Act
as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52
and 45 CFR Parts 74 and 92. All awards are subject to the terms and
conditions, cost principles, and other considerations described in the
NIH Grants Policy Statement. The NIH Grants Policy Statement can be
found at http://grants.nih.gov/grants/policy/policy.htm.
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.
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