TOOLS FOR GENETIC STUDIES IN ZEBRAFISH

RELEASE DATE:  August 2, 2002

PA NUMBER:  PAR-02-142 (This PA has been reissued, see PAR-05-080)

EXPIRATION DATE:  November 20, 2004

LETTER OF INTENT RECEIPT DATES:  October 21, 2002, 2003, 2004

APPLICATION RECEIPT DATES:  November 19, 2002, 2003, 2004

Trans-NIH Zebrafish Coordinating Committee 
 (http://www.nih.gov/science/models/zebrafish/)
National Institute of Child Health and Human Development (NICHD) 
 (http://www.nichd.nih.gov/) 
National Cancer Institute (NCI) 
 (http://www.nci.nih.gov/) 
National Center for Research Resources (NCRR) 
 (http://www.ncrr.nih.gov/) 
National Eye Institute (NEI) 
 (http://www.nei.nih.gov/)
National Heart, Lung, and Blood Institute (NHLBI) 
 (http://www.nhlbi.nih.gov/index.htm) 
National Human Genome Research Institute (NHGRI) 
 (http://www.nhgri.nih.gov/) 
National Institute on Aging (NIA) 
 (http://www.nih.gov/nia/) 
National Institute on Alcohol Abuse and Alcoholism (NIAAA) 
 (http://www.niaaa.nih.gov/) 
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) 
 (http://www.nih.gov/niams/) 
National Institute on Deafness and Other Communication Disorders (NIDCD) 
 (http://www.nidcd.nih.gov/) 
National Institute of Dental and Craniofacial Research (NIDCR) 
 (http://www.nidr.nih.gov/) 
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 
 (http://www.niddk.nih.gov/)
National Institute on Drug Abuse (NIDA) 
 (http://www.nida.nih.gov/) 
National Institute of Environmental Health Sciences (NIEHS) 
 (http://www.niehs.nih.gov/)  
National Institute of General Medical Sciences (NIGMS) 
 (http://www.nigms.nih.gov/) 
National Institute of Mental Health (NIMH)
 (http://www.nimh.nih.gov/) 
National Institute of Neurological Disorders and Stroke (NINDS) 
 (http://www.ninds.nih.gov/) 

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism 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

This Program Announcement (PA) is to encourage investigator-initiated 
applications for research designed to exploit the power of mutagenesis 
screening in zebrafish in order to detect and characterize genes, pathways, 
and phenotypes of interest in development and aging, organ formation, 
behavior, and disease processes.  Applications that propose to advance the 
technologies associated with such phenotyping also are welcome.  A secondary 
goal of this PA is to ensure that tools developed under this initiative are 
widely available to the research community.  This PA is a continuation of the 
program initiated by RFA HD-00-004, "Mutagenesis Screens/Phenotyping Tools for 
Zebrafish" (http://grants.nih.gov/grants/guide/rfa-files/RFA-HD-00-004.html), 
and incorporates an earlier PA, "Development of Zebrafish Mutagenesis and 
Screening Tools" (http://grants.nih.gov/grants/guide/pa-files/PA-01-070.html).  
This effort stems from an NIH initiative with participation of the Institutes 
and Centers listed above, working though the Trans-NIH Zebrafish Coordinating 
Committee (TZCC, http://www.nih.gov/science/models/zebrafish/) 
under the co-chairmanship of NICHD and NIDDK.  Since its formation in 1997, 
the committee has played an active role as an advocate for the zebrafish as an 
important model for development and disease research.

RESEARCH OBJECTIVES

Background

The TZCC continues to play an active role as an advocate for the zebrafish 
model.  On May 10-11, 1999 and on April 1-2, 2002, the TZCC sponsored 
workshops entitled, "Genomic and Genetic Tools for the Zebrafish," at which 
zebrafish researchers were asked to help prioritize the short- and long-term 
needs of the community.  One result of the workshops was the recommendation 
that more genetic screens and more tools for carrying out mutagenesis in the 
zebrafish need to be supported by the NIH.  It also became clear that it is 
critical for non-hypothesis driven, tool development proposals to be reviewed 
as a group, within a single framework.  RFA-HD-00-004, "Mutagenesis 
Screens/Phenotyping Tools for Zebrafish," addressed this need, in part.  The 
current PA continues NIH efforts to support the development of additional 
mutants and additional tools for genetic studies in the zebrafish. 

As a vertebrate, the zebrafish, Danio rerio, is more closely related to humans 
than are yeast, worms, or flies.  It has a number of advantageous features as 
a model organism for the study of vertebrate development, disease, and 
biological pathways, which have been validated further by the demonstration 
that many zebrafish genes show a high degree of structural and functional 
similarity to their human homologues.  The most powerful and unique feature of 
the zebrafish is that it is a vertebrate model organism with a proven track 
record of easily executed, large-scale forward mutagenesis screens.  
Nevertheless, there is a need for more mutants as, for example, few screens 
have been carried out to identify mutations affecting adult behavior, 
physiology, or morphology.  In addition, there are few tools for targeted gene 
knockout, conditional gene expression, enhancer trapping, or rapid insertional 
mutagenesis.  The two goals of the PA, identifying additional mutants and 
developing new genetic tools, are synergistic, as the availability of more 
efficient tools will make screens easier and the discovery of mutants 
affecting important processes will stimulate additional research on methods to 
study those mutants.

Research Scope 

The objective of this PA is to continue to broaden the range, power, and 
utility of screens for new mutants of zebrafish.  It will, therefore, support 
proposals for development of improved or novel methods for mutagenesis 
screens, as well as proposals for the actual execution of such screens.  
Methodology developed and data and mutants generated as a result of this PA 
are expected to be made widely available to the research community.  
Applicants must include as part of their applications a plan for disseminating 
these resources (see SPECIAL REQUIREMENTS, below), adequacy of this plan will 
be considered in making funding decisions for applications responding to this 
PA (see AWARD CRITERIA, below).  Objectives to be addressed in applications 
submitted in response to this PA include, but are not limited to, the 
following:

o Development and/or application of novel methods of mutagenesis (e.g., 
insertional, site-specific, conditional knockout vectors or systems).

o Development and/or application of novel screens for mutants.  These may be: 

Phenotypic screens based on observation of alterations in morphology, 
physiology, or behavior,

Genetic screens focusing on identifying mutations that affect the structure 
and function of specific tissue/organ systems,

Screens focusing on identifying novel developmental genes and pathways, 
including those mediating sensitivity or resistance to environmental 
teratogens,

Screens to analyze the genetic basis of adult phenotypes including behavior, 
aging, organ disease, cancer, and responses to environmental toxins, alcohol, 
and drugs of abuse,

Sensitized screens, using strains carrying a known mutation, in order to 
identify extragenic suppressors or enhancers of that mutation. 

o Development of systems for rapid mapping or identification of point 
mutations.   

o Development of technology for gene inactivation and for gene expression 
manipulation including, but not limited to, morpholino oligonucleotides, new 
types of antisense technology, techniques for homologous recombination, 
techniques for gene trapping, and strategies for directing gene misexpression, 
or other transgenic methodologies.

Interests of Participating Institutes and Centers 

The participating NIH Institutes and Centers have provided a brief outline of 
their interests as they relate to the goals of this PA.  These brief mission 
statements are intended to indicate the breadth of the biomedical areas of 
interest in which zebrafish are likely to be a useful model. 

NCI:  Generation and study of zebrafish models to identify and place genes in 
functional pathways that affect growth and development, in particular, 
genes/pathways that, when altered, result in uncontrolled or cancerous growth.  

NCRR:  The NCRR supports research projects that broaden the utility of the 
zebrafish model for cross-cutting biomedical research that is not encompassed 
within a single NIH Institute or Center.  Interests include, but are not 
limited to, development of new methods for mutagenesis and/or phenotypic 
characterization that would be of use in research on a wide range of diseases 
or organs, particularly if these methods could be applied to other animal 
models as well as the zebrafish. 

NEI:  Fundamental mechanisms underlying all aspects of eye development, 
function, and disease, including development of the retina and lens, optic 
nerve axon guidance, and the neural circuitry producing eye movements and 
oculomotor behaviors.

NHLBI:  Cellular and molecular functions of the mutant genes in development as 
models for human cardiovascular, blood, and pulmonary disorders, and circadian 
mechanisms regulating rest/activity cycles.  Genetic basis of disorders of 
cardiovascular development and function, developmental aspects of endothelial 
dysfunction as the basis for systemic and pulmonary vascular disorders, 
developmental defects in hematopoiesis and relationship to disorders of the 
hematopoietic system, genetic basis of angiogenesis and vasculogenesis, effect 
of mutations on subsequent organ development leading to such disorders as 
arrhythmia, cardiac hypertrophy, dilated cardiomyopathy, heart failure, lung 
hypoplasia and bronchopulmonary dysplasia, the genetic basis, regulation, and 
role of biological clock mechanisms in development and circadian behavior.  

NHGRI:  Proposals for the development of high throughput, widely applicable 
technologies or methodologies to examine gene function on a genomic scale.  
This could include initial development of high throughput or large-scale 
methods for examining gene expression, development of tools for comprehensive 
mutational analysis or genome-scale identification of regulatory regions. 

NIA:  Basic research on the genetic and molecular basis of aging and 
longevity.  Generation and analysis of late-age onset or long-lived mutants 
that can be used to identify, clone, and characterize genes involved in normal 
and pathological aging.  Cellular and molecular function of genes expressed, 
for example, in the aging nervous system, cardiovascular, immune, and 
musculoskeletal systems.  Such genes include, but are not limited to, those 
involved in neurodegenerative disorders, neuroplasticity, cell death, damage 
and repair of DNA and proteins, and oxidative metabolism, and maintenance of 
differentiated cell function. 

NIAAA:  Mechanistic studies of ethanol-induced teratogenesis, behavioral 
impairments, and organ damage.  These studies may include screening methods 
for alcohol-related phenotypes, gene identification, and functional analyses 
of these genes.

NIAMS:  Mutations that have the potential to illuminate the development and 
function of the vertebrate musculoskeletal system and skin.  The 
musculoskeletal system includes muscle, bone, articulated joints, cartilage, 
tendon, and ligament.  Priority will be given to the establishment of 
collaborations between investigators with expertise in the zebrafish and 
investigators with expertise in the musculoskeletal systems and skin of 
mammals and humans. 

NICHD:  Identification, cloning, and characterization of the genes important 
in normal development as well as those mutant genes that cause developmental 
defects.  Elucidation of the cellular, biochemical, molecular, and genetic 
mechanisms underlying normal and defective development.  This includes, but is 
not limited to, the study of general mechanisms of pattern formation and cell 
lineage, neural crest development, cell specification, differentiation, 
migration, and fate in early development of many organs/systems such as limb, 
nervous system, immune system, and heart. 

NIDCD:  Identification and cloning of genes/proteins involved in the normal 
and disordered development in the areas of hearing, balance, smell, taste, 
voice, speech, and language.  Elucidation of the cellular, molecular, and 
biochemical mechanisms governing the proliferative, regenerative, lineage 
determination, and developmental capacities of these sensory cells and 
tissues. 

NIDCR:  All aspects of normal and abnormal craniofacial development, including 
genetics, complex origins of craniofacial disorders, cell lineages and 
differentiation, cell signaling and gene regulation, embryonic patterning, 
imaging, biomimetics, and new technologies for high-throughput genetic and 
protein screens. 

NIDDK:  Research on diabetes, particularly studies on pancreatic beta cell 
function and development, obesity and mechanisms underlying satiety, other 
endocrine and metabolic diseases, hematologic disorders, and diseases of the 
digestive system, liver, kidney, and urinary tract.  Studies aiming to clarify 
the cellular and molecular events that dictate tissue and organ formation in 
all these systems are considered of relevance.  These studies could include, 
but need not be limited to, studies to develop cell lines from any of the 
tissues or organs of interest, studies to characterize normal or abnormal 
function of tissues or organs of interest, methods to screen and identify 
additional mutations in these systems, and studies to define the molecular 
mechanisms that dictate cell-specific gene expression in relevant cell types. 

NIDA:  Identification of mechanisms underlying tolerance, sensitization, and 
addiction to drugs of abuse such as nicotine, amphetamine, cocaine, opiates, 
barbiturates, and hallucinogens.  Identification of genetic suppressors and 
enhancers of the teratological effects of drugs of abuse on behavior and the 
nervous system.  Processes involved in the development of brain regions and 
neurotransmitter systems  mediating the hedonic and addictive properties of 
drugs of abuse. 

NIEHS:  Studies to examine the mechanism whereby environmental factors/agents 
alter any aspect of development.  This includes the screening for mutants that 
ameliorate the toxicity of environmental agents, and the subsequent 
identification and characterization of the genes and pathways involved in 
their action.  Characterization of the interactions among genetics, 
environmental agents, and time during development that lead to structural or 
functional abnormalities.  Studies to examine the mechanistic pathways 
involved in developmental exposure to environmental agents and subsequent 
increased susceptibility to adult onset disease (developmental imprinting).  
Development of a mechanistically based model for testing environmental agents 
for developmental toxicity.

NIGMS:  Development of novel methods for mutagenesis and manipulation of gene 
expression.  Mutagenesis screens to identify and characterize genes that 
control fundamental biological mechanisms such as those that underlie gene 
regulation, chromosome organization and mechanics, cell growth and 
differentiation, pattern formation, sex determination, morphogenesis, cell 
cycle control, and behavior.

NIMH:  Investigations that examine molecular, cellular, and biochemical bases 
of genetic mutations affecting neurogenesis, biological rhythms, learning, 
memory, and other cognitive functions and behaviors of the nervous system.  
These studies include, but are not limited to, development of screening 
methods for such mutations, identification, isolation, mapping, and functional 
analyses of the genes underlying mutations. 

NINDS:  Research on the development, normal function, and diseases of the 
nervous system.  This research might include the use of mutants to understand 
the mechanisms controlling the following processes:  neurogenesis, nervous 
system patterning, cell lineage, cell migration, programmed cell death, axon 
pathfinding and regeneration, myelination, and motor and sensory function.  In 
addition, the utility of mutants as models for neurodegenerative diseases for 
use in translational research including therapeutic drug screens, functional 
neuroanatomy of the developing and adult nervous system, and use of optical 
imaging techniques to visualize neural activity is of particular interest.

The areas of interest listed above are not presented in any order of priority, 
they are only examples of areas of research to consider.  Applications 
representing areas of interest to more than one Institute or Center will be 
assigned to multiple Institutes or Centers for funding consideration.  
Applicants are encouraged to propose work in other areas that are related to 
the objectives and scope of this PA.
   
MECHANISM OF SUPPORT

This PA will use the NIH individual research project grant (R01) award 
mechanism.  Because the nature and scope of the research proposed in response 
to this PA may vary, it is anticipated that the size of awards will also vary.  
Responsibility for the planning, direction, and execution of the proposed 
project will be solely that of the applicant.

Although this PA is the result of a trans-NIH initiative, awards will be made 
through the IC whose mission is most closely related to the proposed work.  
Through the TZCC, each funding component will share with the other committee 
members findings of any research supported as a result of this PA.  All 
investigators funded under this initiative will be expected to work together 
cooperatively so that the information learned and the mutants and tools 
developed will be of maximum usefulness to the community.

This PA uses just-in-time concepts.  It also uses the modular as well as the 
non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  Specifically, if 
you are submitting an application with direct costs in each year of $250,000 
or less, use the modular format.  Otherwise follow the instructions for non-
modular research grant applications.  

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

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 

Restricted availability of unique research resources, upon which further 
studies are dependent, can impede the advancement of research.  Conversely, 
sharing biomaterials, reagents, data, and software in a timely manner has been 
an essential element in the rapid progress that has been made in research on 
zebrafish and other non-mammalian model organisms.  NIH policy requires that 
investigators make unique research resources readily available for research 
purposes to qualified individuals within the scientific community after 
publication [NIH Grants Policy Statement 
(http://grants.nih.gov/grants/policy/nihgps_2001/index.htm, Principles and 
Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining 
and Disseminating Biomedical Research Resources:  Final Notice, December 1999 
(http://www.ott.nih.gov/policy/rt_guide_final.html)].  

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, including but not limited to:  mutant fish, embryos, and sperm, 
genetic and phenotypic screens, mutagenesis protocols, and genetic and 
phenotypic data for all mutant strains.  The National Resource for Zebrafish 
at the University of Oregon (http://zfin.org/zf_info/stckctr/stckctr.html), 
with its associated Zebrafish Information Network database (ZFIN, 
http://zfin.org/cgi-bin/webdriver?MIval=aa-ZDB_home.apg), is the focal point 
for sharing of resources among investigators using zebrafish.  Plans to share 
materials generated by projects under this PA through the National Resource 
for Zebrafish should include evidence/documentation of coordination with 
investigators at the Resource.  A reasonable time frame for periodic 
deposition of mutants, sperm, reagents, and data should be specified in the 
application and will be considered during the review of the plan for sharing. 

(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 MTA or the UBMTA?

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 on 
zebrafish identified through phenotypic screens, and phenotypic and genotypic 
data for all zebrafish strains or other patentable subject matter 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.  For general inquiries contact: 

Dr. Lorette Javois
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B01, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-5541
FAX: (301) 480-0303
Email:  lj89j@nih.gov

Inquiries may fall into three areas:  scientific/research, peer review, and 
financial or grants management issues.  A complete listing of contacts for 
programmatic, review, and fiscal/administrative inquiries may be found at: 
http://www.nichd.nih.gov/PA/Zebrafish_GeneticStudies.htm.

LETTER OF INTENT
 
Prospective applicants are asked to submit a letter of intent that includes 
the following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this PA 

Although a letter of intent is not required, is not binding, and does not 
enter into the review of a subsequent application, the information that it 
contains allows NIH staff to estimate the potential review workload and plan 
the review.
 
The letter of intent is to be sent by the date listed at the beginning of this 
document.  The letter of intent should be sent to:

Dr. Lorette Javois
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B01, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-5541
FAX: (301) 480-0303
Email:  lj89j@nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  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) 435-0714, 
Email: GrantsInfo@nih.gov.

APPLICATION RECEIPT DATES:  Applications submitted in response to this program 
announcement will be accepted on November 19, 2002, 2003, and 2004.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS:  Applications requesting 
up to $250,000 per year in direct costs must be submitted in a modular grant 
format.  The modular grant format simplifies the preparation of the budget in 
these applications by limiting the level of budgetary detail.  Applicants 
request direct costs in $25,000 modules.  Section C of the research grant 
application instructions for the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step 
guidance for preparing modular grants.  Additional information on modular 
grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING MORE THAN $250,000 BUT LESS 
THAN $500,000:  Applicants planning on requesting more than $250,000 but less 
that $500,000 in direct costs for any year are urged to contact program staff 
at the IC whose mission is most closely related to the proposed work before 
submitting the application to discuss the budget.  

SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: 
Applications requesting $500,000 or more in direct costs for any year must 
include a cover letter identifying the NIH staff member within one of NIH 
institutes or centers who has agreed to accept assignment of the application.   

Applicants requesting more than $500,000 must carry out the following steps:
	
1) Contact the IC program staff at least six weeks before submitting the 
application, i.e., as you are developing plans for the study, 

2) Obtain agreement from the IC staff that the IC will accept your application 
for consideration for award, and,
  
3) Identify, in a cover letter sent with the application, the staff member and 
IC who agreed to accept assignment of the application.  

This policy applies to all investigator-initiated new (type 1), competing 
continuation (type 2), or any amended or revised version of these application 
types.  Additional information on this policy is available in the NIH Guide 
for Grants and Contracts, October 19, 2001 at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.

ADDITIONAL INSTRUCTIONS:  Please describe your plans to share research 
resources and to exercise your intellectual property rights in a brief section 
immediately following the Research Plan (see SPECIAL REQUIREMENTS).  The 
section addressing these plans is limited to three pages in length. 

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 received by or mailed on or 
before the receipt dates listed above.  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.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  A special emphasis panel 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 appropriate national advisory council 
or 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.  In 
the written comments, reviewers will be asked to discuss the following aspects 
of your application in order to judge the likelihood that the proposed 
research will have a substantial impact on the pursuit of these goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The scientific review group will address and consider each of these criteria 
in assigning your application"s overall score, weighting them as appropriate 
for each application.  Your 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, you 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 your study address an important problem? If the aims 
of your application are achieved, how do they advance scientific knowledge?  
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?  Do you acknowledge potential problem areas and consider alternative 
tactics?

(3) INNOVATION:  Does your project employ novel concepts, approaches or 
methods? Are the aims original and innovative?  Does your project challenge 
existing paradigms or develop new methodologies or technologies?

(4) INVESTIGATOR: Are you appropriately trained and well suited to carry out 
this work?  Is the work proposed appropriate to your experience level as the 
principal investigator and to that of other researchers (if any)?

(5) ENVIRONMENT:  Does the scientific environment in which your 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.

DATA SHARING: The scientific review group will evaluate the adequacy of the 
proposed plans for sharing and data access.  Comments on the plan and any 
concerns will be presented in an administrative note in the Summary Statement.  
 
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 and technical merit of the proposed project as determined by peer    
review,

o Cost effectiveness of the proposed strategy,
 
o Adequacy of plans to make widely available to the research community in a 
timely manner all research resources developed during the project, the sharing 
plan as approved, after negotiation with the applicant when necessary, will be 
a condition of the award, evaluation of non-competing continuation 
applications will include assessment of the effectiveness of research resource 
release,

o Adequacy of plans to exercise (or not exercise) intellectual property rights 
while permitting wide availability to the research community of patentable 
research resources developed during the project,

o Program priorities and program balance,

o Availability of funds.

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

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 Catalog of 
Federal Domestic Assistance Nos. 93.865, 93.396, 93.306, 93.867, 93.837, 
93.839, 93.172, 93.866, 93.273, 93.846, 93.173, 93.121, 93.849, 93.279, 
93.113, 93.862, 93.242, 93.853 and is not subject to the intergovernmental 
review requirements of Executive Order 12372 or Health Systems Agency review.  
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 described at http://grants.nih.gov/grants/policy/policy.htm 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.

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


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Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
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Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
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