MOUSE PHENOTYPING: DEVELOPMENTAL AND FERTILITY DEFECTS
Release Date: October 9, 2001
RFA: RFA-HD-01-020
National Institute of Child Health and Human Development
(http://www.nichd.nih.gov)
Letter of Intent Receipt Date: February 11, 2002
Application Receipt Date: March 13, 2002
PURPOSE
This Request for Applications (RFA) solicits applications to phenotype mutant
mouse strains with developmental and fertility defects and to characterize
the mutations responsible for their defects. These projects should be
designed to characterize mouse strains with defects in development and
reproduction so as to isolate new alleles of known genes and identify new
genes that are involved in the processes of development and fertility. The
mouse strains to be characterized should be obtained from existing mouse
mutagenesis projects. Appropriate sources of mutant strains include both
small-scale mutagenesis projects and large-scale mutagenesis facilities, such
as the NIH-funded mouse mutagenesis and phenotyping facilities at Baylor
College of Medicine, Northwestern University, Jackson Laboratory, and the
University of Tennessee. Characterizing these mouse strains, and their
mutations, is expected to help elucidate the basic cellular, molecular, and
genetic mechanisms that direct embryonic and post-embryonic development, as
well as yield insights into the mechanisms that control fertility.
These projects should identify and obtain mutant mouse strains with disrupted
development and fertility, phenotype the strains to provide a detailed
characterization of the defects, and characterize the mutations and the genes
responsible for the defects. The phenotypic characterization may also
include high-throughput screens to identify a broad range of general features
of these strains, where appropriate. The detailed characterization should
describe the specific cellular, molecular, and genetic features of the
defects, whereas high-throughput screens, if included, should provide a
general overview of the biological features of the animals with these
defects. Characterization of the mutations and genes should include analyses
to increase the value of the mutants to the scientific community, such as
genetic mapping to localize the mutations within the genome.
These projects will be part of NIH’s initiative to determine the function of
mammalian genes. Accordingly, their activities will be coordinated with
related facilities, including the NIH-funded Mouse Mutagenesis and
Phenotyping: Developmental Defects Facility at Baylor College of Medicine
(http://www.mouse-genome.bcm.tmc.edu/ENU/MutagenesisProj.asp). Additionally,
the mutant strains, phenotypic and genetic information, protocols, assays,
assessment criteria, and other materials and information generated by
projects funded under this RFA will be made available to the wider biomedical
community. Further information about NIH initiatives on mouse genomics and
genetics resources is available at http://www.nih.gov/science/mouse.
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 priority areas. Potential applicants may obtain "Healthy People
2010" at http://www.health.gov/healthypeople/.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic, for-profit and non-profit
organizations, public and private, such as universities, colleges, hospitals,
and laboratories, units of State and local governments, and eligible agencies
of the Federal government. Applications will not be accepted from foreign
institutions. Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as Principal Investigators (PIs).
MECHANISM OF SUPPORT
This RFA will use the National Institutes of Health (NIH) Cooperative
Research Project Grant (U01) award mechanism, an assistance mechanism
(rather than an acquisition mechanism) in which substantial NIH scientific
and/or programmatic involvement with the awardee is anticipated during
performance of the activity. Under the cooperative agreement, the NIH
purpose is to support and stimulate the recipients activity by involvement
in the activity and otherwise working jointly with the award recipients in a
partner role, but it is not to assume direction, prime responsibility, or a
dominant role in the activity. Details of the responsibilities,
relationships, and governance of the studies to be funded under cooperative
agreements are discussed below under Terms and Conditions of Award.
This RFA is a one-time solicitation. The earliest anticipated award date is
September 30, 2002.
FUNDS AVAILABLE
The NICHD intends to commit approximately $3 million in total costs [direct
plus Facilities and Administrative (F&A) costs] in FY 2002 to fund about four
new grants in response to this RFA. An applicant may request a project
period of up to five years. Because the nature and scope of the research
proposed may vary, it is anticipated that the size of each award also will
vary, with an average total cost of approximately $750,000 per year.
However, in no case should total costs requested exceed $1.5 million per
year. Although the financial plans of the NICHD provide support for this
program, awards pursuant to this RFA are contingent upon the availability of
funds and the receipt of a sufficient number of meritorious applications.
RESEARCH OBJECTIVES
Background
In 1998, the NIH convened a large group of distinguished scientists to
recommend priorities for generating mouse genetic and genomic resources to
help elucidate the genetic basis of human health and disease. The
recommendations included functional analyses of the mouse genome (see
http://www.nih.gov/welcome/director/reports/mgenome.htm). In response to
this recommendation, 13 of the NIH institutes issued a pair of RFAs to
support facilities to perform genome-wide mutagenesis and large-scale
phenotyping of the resulting mutants. Those RFAs led to the establishment of
four mutagenesis and phenotyping facilities in 2000 and early 2001. One is
focused on developmental defects (Baylor College of Medicine) and three are
focused on the nervous system and behavior (Northwestern University,
University of Tennessee, and Jackson Laboratory). Several other similar
facilities are currently in operation and others will begin soon. These
facilities are producing a large number of mutant mouse strains that are
providing new and critical insights into the mechanisms that govern normal
and disrupted biological processes. The projects to be funded by the current
RFA will aid in characterizing the strains that display defects in
development and in fertility regulation, and in identifying the mutations and
the genes that control these processes.
Scope and Objectives
This RFA will support projects to phenotype mouse strains of utility for
understanding embryonic development, post-embryonic development, and
reproduction, and to characterize the mutations and the genes involved in
these processes. The scope of the proposed research may range from small
projects that focus on the specific details of a few phenotypes to larger
projects that examine many phenotypes and that characterize a broad range of
features of those phenotypes. Funded projects will make available obtained
phenotypic and genetic data for wide distribution. Additionally, they will
make available mutant strains that are generated by the projects. In
particular, these projects will be required to:
o Identify and obtain mutant mouse strains that are appropriate for studying
embryonic and post-embryonic development and fertility regulation. Include
strains with mutations that are recessive and dominant, and viable and
embryonic lethal, as appropriate. These strains may be obtained from any
appropriate source, including small-scale mutagenesis projects and large-
scale mutagenesis facilities, such as the four NIH-funded mouse mutagenesis
and phenotyping facilities mentioned above. Describe the source(s) of the
mutant mouse strains to be used, justify their appropriateness for the
proposed studies, and provide evidence of their availability.
o Perform phenotypic analyses to identify and characterize developmental
and/or fertility defects (see examples, below). The goal of the
characterization should be to elucidate the defect’s biological and genetic
features. The scope of projects may range from those designed to identify
and examine a few categories of defects to those designed to identify and
examine many categories of defects. Additionally, projects may include high-
throughput phenotypic screens to identify and summarize a broad range of
features of the mutant strains with developmental and/or fertility defects.
If included, these screens should be designed to identify and characterize
the developmental, reproductive, anatomical, cellular, physiological,
molecular, genetic, metabolic, and/or pathological features of the mutants
with the defects.
o Characterize the mutations by performing analyses that will make the
mutants maximally useful to the scientific community. Analyses should
include rapid genetic mapping of the mutations to identify the region of the
genome that contains the mutated genes, and other appropriate analyses of the
mutations, genes, and gene products.
o Develop and maintain a database including all of the phenotypic and
mapping data on these mutant mice.
o Propose a sharing plan to ensure that animals, preserved embryos/sperm,
phenotyping assays, and phenotypic and genetic data for the mutant strains
are widely available to the scientific community. This plan should also
address if, or how, the PI and grantee institution will exercise their
intellectual property rights regarding patentable research resources. These
issues are addressed below under SPECIAL REQUIREMENTS.
o The distribution plan must ensure that the mice, and their embryos and/or
sperm, will be free from pathogens.
Projects should examine mutant mouse strains with defects in development
and/or fertility. Phenotypes of interest include, but are not limited to:
Developmental Defects:
o Defects leading to embryonic lethality,
o Patterning defects, such as alterations in the basic body plan, or absence
or duplication of structures,
o Alterations in organogenesis,
o Alterations in growth rate,
Fertility Defects Resulting from Alterations in:
o sex differentiation,
o gametogenesis and gamete function,
o development and function of the reproductive tract and gonads,
o neuroendocrine control of reproduction,
o neural mechanisms involved in mating behavior.
Guidance and Management Structure
The overall guidance and management of the program will be provided by a
Steering Committee (SC). The SC is the projects main governing committee
and the committee through which the NIH interacts and collaborates with the
projects. It will consist of the PIs of each of the projects to be funded by
this RFA, one or two NICHD Project Scientists, and a nonvoting, independent
chairperson.
Additional advice will be provided by the Mouse Genomics and Genetics
Scientific Panel (MSP), which will help integrate and coordinate the
projects funded under this RFA with other related facilities. It consists of
about 10 scientists who are not affiliated with any of the projects.
SPECIAL REQUIREMENTS
Meetings
PIs are expected to participate in two SC meetings annually, of two days
duration each. Budget requests should include travel funds for the PI and
critical staff to attend those meetings in the Bethesda, MD area.
Milestones and Evaluations
Applications should define yearly milestones, which may be modified at the
time of the award. The awardee"s milestones will be provided to the SC. It
is expected that the milestones should be adjusted annually at the award
anniversary date, both to incorporate the group"s scientific accomplishments
and progress in the field in general, as well as to reflect the
recommendations of the SC and the MSP. In accordance with the procedure
described under Terms and Conditions of Award, below, NICHD program staff may
recommend augmenting any project, as discussed with the SC, or reducing or
withholding funds if a project substantially fails to meet its milestones or
to remain state-of-the-art.
Research Resources
Restricted availability of unique research resources, upon which further
studies are dependent, can impede the advancement of research. The timely
sharing of biomaterials, data, and software is an essential element of the
rapid progress that has been made in the genetic analysis of mammalian
genomes. Accordingly, the NIH is interested in ensuring that the research
resources developed by these projects become readily available to the broader
research community in a timely manner for further research, development and
application, in the expectation that this will lead to products and knowledge
that benefit public health. Resources to be shared will include biomaterials
(pathogen-free mutant animals, preserved embryos and sperm), other patentable
research resources (e.g., phenotyping assays, protocols, and
instrumentation), and phenotypic and genetic data produced in projects funded
by this RFA. Additionally, NIH policy requires that investigators make
unique research resources readily available for research purposes to
qualified individuals within the scientific community when they have been
published.
To address the joint interests of the government in the availability of, and
access to, the results of publicly funded research, there are two special
requirements regarding research resources produced in the applications
submitted in response to this RFA: (1) applicants are required to include a
specific plan by which they will share research resources with the wider
scientific community. This plan must address if, and how, applicants will
exercise their intellectual property rights while making available to the
broader scientific community patentable research resources (e.g., mutant
mice, phenotypic and genetic information, phenotyping assays, protocols,
instrumentation, and methodologies), (2) NIH has made a Determination of
Exceptional Circumstances (DEC) to eliminate the potential for patents on new
mutant strains that are generated by this project and on newly identified
uses of existing mutant strains. These requirements are discussed below.
(1) Plan to Share Research Resources
The plan to share research resources must make unique research resources
readily available and accessible for research purposes to qualified
individuals within the scientific community in accordance with the NIH Grants
Policy Statement (see NIH Grants Policy Statement at
http://grants.nih.gov/grants/policy/nihgps_2001/index.htm and Principles and
Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining
and Disseminating Biomedical Research Resources at
http://www.ott.nih.gov/policy/rt_guide_final.html). These documents also
define terms, parties, responsibilities, prescribe the order of disposition
of rights, prescribe a chronology of reporting requirements, and delineate
the basis for and extent of government actions to retain rights. This plan
should include an elaboration of the applicant"s anticipated plans to
generate, or not generate, patents and/or exclusive or non-exclusive
licensing of biomaterials and other patentable subject matter created in
projects funded under this RFA. This plan is also expected to include
disclosure of any pre-existing intellectual property rights, including
options to for-profit research sponsors, that are associated with
biomaterials and data that may be generated. Standard patent rights clauses
may be found at 37 CFR Part 401.14 and are accessible from the Interagency
Edison web page, http://www.iedison.gov. Applicants are encouraged to
discuss their plans for addressing this requirement with their institutional
offices of technology transfer.
It is also expected that this plan will include all elements of the
guidelines developed by the NIH and the Department of Energy (DOE) to address
the special needs of genome research
http://www.nhgri.nih.gov/Grant_info/Funding/Statements/data_release.html.
Where appropriate, the awardee may work with the private sector to make
unique resources available to the wider biomedical research community at a
reasonable cost. Applicants may request funds to defray the costs of sharing
resources, with adequate justification.
The Scientific Review Group will evaluate the adequacy of the proposed plan
for sharing and data access. NICHD program staff also will consider the
adequacy of the plan when determining whether a grant shall be awarded. The
approved plan will become a condition of the award. Progress Reports must
contain information on activities for the sharing of research resources and
intellectual property, if any. Evaluation of any future renewal applications
will include an assessment of the effectiveness of research resource release.
(2) Determination of Exceptional Circumstances
NIH is interested in ensuring that the research resources developed through
this RFA become readily available to the research community in accordance
with the NIH Mouse Mutagenesis and Phenotyping Initiative. To ensure
unrestricted availability of mutant mice developed under this RFA, NIH has
made a Determination of Exceptional Circumstances (DEC) pursuant to 37 C.F.R.
401.3(a)(2) that covers mutant animals, embryos and sperm generated by the
project, and newly identified uses of existing mutant strains. The purpose
of the DEC is to eliminate the potential for patents on mutant mice, embryos,
sperm, and newly identified uses of existing mutant strains that could
undermine the development of a widely available national resource that is the
fundamental purpose of the NIH initiative to determine the function of
mammalian genes.
Terms and Conditions of Award
The following Terms and Conditions will be incorporated into the award
statement. They are to be followed in addition to, and not in lieu of,
otherwise applicable OMB administrative guidelines, HHS grant administration
regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when state and
local governments are eligible to apply), and other HHS, PHS, and NIH grant
administration policies.
The administrative and funding instrument used for this program will be the
U01, an "assistance" mechanism (rather than an "acquisition" mechanism), in
which substantial NIH scientific and/or programmatic involvement with the PI
is anticipated during performance of the activities. Under the cooperative
agreement, the NIH purpose is to support and/or stimulate the PI"s activities
by involvement in and otherwise working jointly with the PI in a partnership
role, it is not to assume direction, prime responsibility, or a dominant role
in the activities. Consistent with this concept, the dominant role and prime
responsibility resides with the PI for the project as a whole, although
specific tasks and activities may be shared between the awardee and NIH
program staff. Facilities and administrative cost (indirect cost) award
procedures apply to cooperative agreements in the same manner as for grants.
Business management aspects of these awards will be administered by the NICHD
Grants Management Branch in accordance with HHS, PHS, and NIH grant
administrative requirements.
1. Awardee Rights and Responsibilities
The PI will coordinate project activities scientifically and administratively
at the awardee institution and at other sites that may be supported by
subawards to this award. The PI will have the primary responsibility for
defining the details for the project within the guidelines of this RFA, and
for performing the scientific activities. The PI will agree to accept close
coordination, cooperation, and participation of the NICHD Project Scientist,
the Steering Committee (SC) and the Mouse Genomics and Genetics Scientific
Panel (MSP) in those aspects of scientific and technical management of the
project described under "Project Scientist Responsibilities," "Steering
Committee Functions," and " Mouse Genomics and Genetics Scientific Panel
Functions" (below). Specifically, the PI will:
o Determine experimental approaches, design protocols, direct experiments,
and set project milestones, in consultation with NICHD program staff and the
SC,
o Implement approved plans for sharing research resources,
o Submit periodic progress reports in a standard format, as agreed upon by
the SC,
o Present results and plans at SC meetings,
o Accept and implement the common guidelines and procedures approved by the
SC and the MSP,
o Solicit the views of the broad biomedical research community for the
phenotypes and/or genotypes of interest,
o Release data and publish results, as agreed upon by NICHD program staff
and the SC.
2. NICHD Responsibilities
NICHD Project Scientist:
The NICHD Project Scientist(s) will be staff member(s) of the Developmental
Biology, Genetics and Teratology Branch and/or the Reproductive Sciences
Branch. They will have substantial scientific/programming involvement that
includes facilitating the partnership between NIH and the phenotyping
projects, helping to balance the projects activities with new and emerging
research opportunities, and ensuring that the projects activities are
consistent with the mission of NICHD. They will help to maintain scientific
balance between accomplishing goals and addressing emerging research
opportunities. The role of the NICHD Project Scientist will be to
facilitate, but not to direct activities. It is anticipated that decisions
will be reached by consensus with the PI through the SC. One or two Project
Scientists will participate as members of the SC. NICHD staff will have a
total of one vote. The NICHD Project Scientist(s) will:
o Provide relevant expertise and overall knowledge,
o Provide information about ongoing NIH-supported research and resource
collections,
o Attend SC meetings as one voting member and participate with other SC
members in the group process of setting research priorities, deciding optimal
research approaches and protocol designs, and contributing to the adjustment
of research protocols or approaches as warranted. The Project Scientist(s)
will assist and facilitate the group process and not direct it. They will
help develop operating guidelines, quality control procedures, and consistent
policies for dealing with situations that require coordinated action. The
Project Scientist(s) must be informed of all major interactions of SC
members,
o Serve as liaison to the MSP, attend MSP meetings as a non-voting member to
help coordinate the activities of the projects with those of other NIH
mutagenesis and phenotyping projects, and with other NIH mouse genomics and
genetics initiatives. The Project Scientist will also coordinate the
activities of projects funded under this RFA with other US and international
efforts,
o Serve as liaison between the grantees and the other NIH program staff,
o Coordinate the projects activities with NIH-funded repositories and
databases, to ensure the rapid and efficient distribution and long-term
storage of biomaterials and data,
o Assist in developing timetables for, and facilitating, the timely and wide
distribution of biomaterials and data to the biomedical community,
o Participate in data analysis, interpretations and, where warranted, co-
author publications that report results of studies performed under this RFA.
NICHD Project Officer:
The NICHD will appoint a Project Officer, apart from the Project Scientist,
who will:
o carry out continuous review of all activities to ensure that the objective
are being met and that all regulatory, fiscal, and administrative matters are
handled according to NIH guidelines.
o have the option to withhold support to a participating institution if
technical performance requirements are not met.
o Perform other duties normally required for program stewardship of grants.
3. Collaborative Responsibilities
Steering Committee Functions:
The Steering Committee (SC) will be the main governing body of the projects
to be funded by this RFA. It will oversee and coordinate interactions among
the projects, and will mediate interactions between the projects and the NIH.
The SC will discuss scientific goals and progress, and recommend how mutant
strains should be obtained, analyzed, and shared in order to be maximally
valuable to all interested investigators. It will help to monitor the plans
for sharing research resources. It will also address the recommendations
made by the MSP. The SC will consist of the PIs of each of the projects, one
or two NICHD Project Scientists, and a nonvoting independent chairperson.
Each PI will have one vote and the NIH Project Scientist(s) will have a total
of one vote.
Mouse Genomics and Genetics Scientific Panel (MSP) Functions:
The MSP coordinates activities among the projects, facilities and resources
participating in NIH"s mouse mutagenesis and phenotyping initiative,
including those to be funded in response to this RFA. The MSP uses its
knowledge of the activities of all of the participating projects to ensure
adequate investigation, communication and sharing, and to avoid redundant
activities. It helps to coordinate activities that involve the mutagenesis,
phenotyping, mapping, maintenance, and distribution and sharing of mutant
mouse strains. The MSP evaluates and makes recommendations regarding the
coordination of the activities of the projects that are funded by the
mutagenesis and phenotyping initiatives, and other related activities that
may be developed in the future.
The MSP’s responsibilities include making recommendations that lead to
exchanging mutants among the projects, sharing assay strategies, adopting
common policies on data sharing, creating compatible databases, and other
activities that will make these facilities of maximal utility to the
scientific community. The MSP also sets standards for data format and
nomenclature, as well as developing common guidelines and procedures for
deposition of the primary phenotypic data, and for the preservation of mutant
mouse strains.
The committee consists of about 10 scientists who are not affiliated with any
of the mutagenesis and phenotyping projects, and are not members of the
advisory committees of those projects. Collectively, they have broad
expertise in relevant topics such as developmental biology, reproduction,
neurobiology, behavior, mutagenesis, phenotyping, mouse genetics, husbandry,
genomics, and databases issues. The NIH Project Scientist(s) attend the MSP
as non-voting members and act as a representative of the SC. The MSP meets
at least once each year.
4. Arbitration Process
Any disagreements that may arise in scientific or programmatic matters within
the scope of the award between grantees and the NIH may be brought to
arbitration. This special arbitration procedure in no way affects the
awardee"s right to appeal an adverse action that is otherwise appealable in
accordance with PHS regulations 42 CFR Part 50, Subpart D, and HHS regulation
at 45 CFR Part 16. An Arbitration Panel will help resolve both scientific
and programmatic issues that develop during the course of work that restrict
progress. The Arbitration Panel will be composed of three members: a
designee of the SC chosen without the NIH staff voting, one NIH designee, and
a third designee with expertise in the relevant area who is chosen by the
other two members.
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 review the Internet sites. Reviewers are cautioned that their anonymity
may be compromised when they directly access an Internet site.
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 RFA 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.
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes a
descriptive title of the proposed research, the name, address, telephone
number, and e-mail address of the Principal Investigator, the identities of
other key personnel and participating institutions, and the number and title
of this RFA. 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 NICHD staff to estimate the potential
review workload and plan the review.
The letter of intent is to be sent to Dr. Steven Klein, at the address listed
under INQUIRIES, below, by February 11, 2002.
APPLICATION PROCEDURES
The PHS 398 research grant application instructions and forms (rev. 5/2001)
at http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in
applying for these grants. This version of the PHS 398 is available in an
interactive, searchable PDF format. Beginning January 10, 2002, the NIH will
return applications that are not submitted on the 5/2001 version. For
further assistance contact GrantsInfo, Telephone 301-710-0267, Email:
GrantsInfo@nih.gov.
Application Instructions
Applicants must describe the project in the Research Plan section of the
application within the normal page limitation (25 pages). The application’s
Research Plan must include sections on: (1) overall purpose, strategy and
plans, (2) phenotyping, (3) characterizing the mutations and the genes, (4)
database/ bioinformatics, and (5) procedures for sharing research resources,
including plans to exercise, or not to exercise, intellectual property rights
(see SPECIAL REQUIREMENTS, above). However, if necessary, you may use up to
five additional pages to describe the procedures for sharing mice, and
phenotypic and genetic data (sections 4 and 5). This exception is made to
enable a more complete description of these components, which are critical to
the goals of this RFA.
For the purpose of accomplishing the goals of this RFA, the project may
include investigators at more than one site, and subcontracts may be included
in the budget to support investigators at sites other than the awardee
institution. Applications should define yearly milestones, which may be
modified at the time of award. Budget requests should include travel funds
for the PI and other critical staff to attend the SC meetings in the
Bethesda, MD area twice per year.
Submission Instructions
The RFA label available in the PHS 398 (rev. 5/01) application form must be
stapled to the bottom of the face page of the application and must display
the RFA number, HD-01-020. A sample RFA label is available at
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Please note this
is the pdf format. Failure to use this label could result in delayed
processing of the application such that it may not reach the review
committee in time for review. In addition, the RFA title and number must be
typed on line 2 of the face page of the application form and the YES box must
be marked.
Submit a signed, typewritten original of the application, including the
Checklist, and three signed photocopies, in one package to:
CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application should be
sent to:
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E03F, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Applications must be received by March 13, 2002. If an application is
received after that date, it will be returned to the applicant without
review.
The Center for Scientific Review (CSR) will not accept any application in
response to this RFA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application. CSR
will not accept any application that is essentially the same as one already
reviewed. This does not preclude the submission of substantial revisions of
applications already reviewed, but such applications must include an
introduction addressing the previous critique.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed for completeness by CSR, and for
responsiveness to this RFA by NICHD. Incomplete and/or nonresponsive
applications will be returned to the applicant without further consideration.
Applications that are complete and responsive will be evaluated for
scientific and technical merit by an appropriate peer review group convened
by NICHD, in accordance with the review criteria stated below. These reviews
will not include site visits. As part of the initial merit review, all
applications will receive a written critique and may undergo a process in
which only those applications deemed to have the highest scientific merit
will be discussed, assigned a priority score, and receive a second level
review by the National Advisory Child Health and Human Development 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 discuss the following
aspects of the application 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 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 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.
o Significance: What will be the expected impact of the phenotypic and
mapping information produced by the project on our understanding of the
genetic bases of development and reproduction?
o Approach: Does this study specify methodologies for phenotyping the
mutants and for characterizing the mutations responsible for their defects?
Is the conceptual framework for conducting phenotyping and mapping adequately
developed, well integrated, and appropriate to the aims of the project? Will
the proposed strategies enable identification of both dominant and recessive
mutations that alter the processes of development and/or fertility? Does the
applicant acknowledge potential problem areas and consider alternative
tactics?
o Innovation: Does the project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does the project challenge
existing paradigms or develop new methodologies or technologies?
o 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)?
o 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?
Reviewers will also evaluate:
o the response to the Research Objectives described above,
o Integration with other resources: Are the plans adequate to ensure that
the project will be able to obtain appropriate mutant strains? Are the plans
adequate to integrate the mutants and the phenotypic data with those
collected in other comparable projects?
o Exportability and Accessibility: What is the likelihood that the mutant
mouse strains developed and/or used in the project will be made widely
available in a timely fashion to the scientific community? What is the
likelihood that patentable research results, such as phenotypic and mapping
information and methodologies, will be widely available for the scientific
community, given the proposed plan to exercise, or not to exercise,
intellectual property rights on those products? Does the project specify
plans for creation of a highly efficient and organized bioinformatics
database? Do the investigator"s quality control plans assure that databases
provided to the wider scientific community will be accurate and highly
efficient?
In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:
o The reasonableness of the proposed budget and duration in relation to the
proposed research.
o 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.
SCHEDULE
Letter of Intent Receipt Date: February 11, 2002
Application Receipt Date: March 13, 2002
Peer Review Date: June 2002
Advisory Council Date: September 2002
Earliest Award Date: September 30, 2002
AWARD CRITERIA
Factors that will be used to make award decisions are as follows:
o Scientific and technical merit of the proposed project as determined by
peer review,
o Cost effectiveness of the proposed strategy,
o Promise of the proposed project to accomplish the goals of this RFA,
o Geographical distribution of projects,
o Availability of funds.
INQUIRIES
Inquiries concerning this RFA are strongly encouraged. NICHD staff welcomes
the opportunity to clarify issues or questions from potential applicants.
Direct inquiries regarding programmatic issues to:
Dr. Steven Klein
Developmental Biology, Genetics and Teratology Branch
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
E-mail: kleins@exchange.nih.gov
Dr. Tracy L. Rankin
Reproductive Sciences Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B01, MSC 7510
Bethesda, MD 20892-7510
Telephone: 301-435-6979
Fax: 301-480-2389
E-mail: tr44x@nih.gov
Direct inquiries regarding fiscal matters to:
Mr. Chris Myers
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17, MSC 7510
Bethesda, MD 20892-37510
Telephone: 301-435-6996
E-mail: myersc@exchange.nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance Nos.
93.864 and 93.865. 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 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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