Two overheads were presented to illustrate some of the major goals
and the coordination of the Mutagenesis and Phenotyping Facilities
Attendees were reminded of up-coming dates.
Attendees asked, and received, answers to questions.
- Given that the facilities funded under MH-99-007 probably
will find several mutants with developmental defects, and that
the facility funded under HD-99-007 will probably find mutants
with nervous system and behavioral phenotypes, how will the different
facilities interact so that each can analyze mutants developed
by the others?
We appreciate that a facility may produce phenotypes in which
they are not interested, and that some of these phenotypes may
be of interest to another facility. Sharing mutants between facilities
is a major feature of these RFAs. This is an important reason
why facilities will be funded under the cooperative agreement
mechanism (U01), rather than the standard R01 mechanism. We hope
that cooperation among the facilities and between the facilities
and the NIH through the oversight committees will
foster the exchange of mice among the facilities and distribution
of mice to the scientific community.
- By what mechanisms will the mice be shared, or distributed,
between the facilities? Where will we get the funds to enable
Each facility will meet regularly with its Oversight Committee,
and describe the types of mutants being produced. The committee
will recommend that particular mice be sent to another facility
to be examined further. Additionally, each facility must be aware
of the mutants that are produced by the other facilities, and
they must make information about their own mutants available to
the other facilities. A portion of the budget may be allotted
to these activities.
- How flexible is the number of Facilities to be established?
Could there be more than 1 facility established under HD-99-007?
A. There may be some flexibility. But, we wont know whether
we need to be flexible until we see the applications. The outcome
of the peer review will help to determine what, if any, flexibility
would be beneficial.
- The RFA states that NIH will eliminate the potential for
patenting mutant mice, sperm, and embryos. Likewise, will NIH
prevent the patenting of genes?
The Bayh-Dole Act stipulates that the U.S. Government will
not interfere with a grantees right to derive economic
benefit from their intellectual property, except under extenuating
circumstances. NIH believes that the ready distribution of the
mice developed by these facilities constitutes such an exceptional
situation. This is because creation and distribution of new
mouse models to the scientific community is one of the main
purposes of these facilities, and because we are establishing
these facilities in response to the communitys needs.
NIHs policy is that exceptions to the Bayh-Dole Act be
defined in a fashion that is as least restrictive as possible.
Thus, the decision was made to not extend the patent prohibition
to also include genes and gene products.
- Who will be the members of the steering committees for projects
funded under the two RFAs?
The External Steering Committee (ESC) and the Neuroscience Steering
Committee (NSC) will be composed of the PI(s) of the facility(ies),
NIH program staff, and three other scientists with appropriate
expertise who are not affiliated with any facility.
- Who selects the steering committee members?
NIH program staff.
- Who is on the committee that provides oversight for the steering
A. The Mouse Genomics and Genetics Scientific Panel (MSP) will
be made up of about 10 scientists who are not affiliated with
any of the facilities. They will have broad expertise covering
all aspects of the facilities, such as animal husbandry, databases,
phenotyping, etc. The members will be selected by NIH program
- Are the PIs members of the steering committees for the facilities
established under the two RFAs?
PIs will serve on the Neuroscience Steering Committee (which
will oversee facilities funded under MH-99-007) or the External
Steering Committee (which will oversee the facility funded under
HD-99-007). Oversight of these two steering committees will be
provided by the Mouse Genomics and Genetics Scientific Panel,
which will not include any researchers affiliated with any of
- Do you see these RFAs as a way of establishing infrastructure?
Do you consider this to be a pilot? Is there a static amount of
money for these efforts, or do you plan to expand in the future?
These initiatives are building blocks for a broad and comprehensive
course of NIH-funded research to enhance mouse genetics and genomics
resources. Future initiatives to exploit these resources and encourage
further research on mouse biology are important components of
NIHs long-term plans.
- Establishing and maintaining a database can be very expensive.
How do we apportion the funds between the database and the other
components of the project?
The RFA states that one of the objectives of primary importance
is to develop and maintain a database of all phenotypic data generated
from mutants. This is not meant to be a comprehensive database
from which generated data will be downloaded by scientists in
the wider community. Such databases and repositories will be made
available to accomplish these purposes. It is expected that databases
developed by the facilities funded under the RFAs will minimally
contain the data generated, and will be sufficiently flexible
to permit downloading of data to common, public repositories currently
established or to be established.
- The Neuroscience RFA states that a website at each individual
facility is not sufficient to disseminate data to the wider scientific
community. Which databases will be used to accomplish this?
Several such databases are being developed, and further information
will be available at the time of award. The important point for
applicants to bear in mind is that it is preferable for applicants
to propose a plan by which data, protocols, technologies, and
biomaterials generated in grants funded under the RFA will be
placed in common, public repositories that are widely accessible
to the scientific community.
- Will the NIH support the renovation of our facilities to
enable them to be use by guest investigators? Can some of the
funds from the RFAs be used for that purpose?
Technically, some of the funds can be budgeted for facilities
renovations. However, we view the NIH funds as providing partial
support for the project of guest investigators. We would like
to see evidence of institutional commitment to provide additional
support, for example, to do necessary facility renovation.
- What is the proper balance of depth verses breadth?
An important goal of these RFAs is to establish facilities for
generating mutants that ultimately will be studied by a wide range
of scientists in the broader community. It is highly likely that
more mutants may be generated that can be intensively studied
by any one facility. One of the award criteria is that each facility
will serve as a resource for the broader scientific community;
consequently, breadth is of paramount importance.
- Will all of the applications for the Neuroscience RFA be
reviewed by the same review group?
Yes. In fact, all of the application for both of the RFAs will
be reviewed by the same group of reviewers during the same review
- So, is there going to be only one Study Section?
Yes. There will be only one Review Group for all of the applications.
- After awards are made, how long does NIH expect it to take
for facilities to begin functioning?
We expect the facilities to be functioning within several
months to a year of the award date.
- How "large-scale" is large-scale mutagenesis?
Researchers should propose what they feel is both scientifically
justified and feasible. Ultimately, this question is one to be
addressed by the scientific review panel.
- Given that NIH has issued these two RFAs, will similar investigator-initiated
projects submitted in the future be considered for funding?
Yes. The NIH will continue to consider submission of investigator-initiated
applications for mutagenesis and phenotyping. In fact, we expect
the facilities that are being established through these RFAs to
serve as focal points for other investigators. Thus, we hope that
these facilities will enable many investigators to examine mutants
for phenotypes in which they are interested. We expect applications
from other investigators to take advantage of the mutants produced
by these facilities.
- Projects that are funded by these RFA will be subjected to
restrictions for the good of the community (e.g., the prohibition
against patenting mutant mice). This prohibition will only be
beneficial if all similar projects not only those funded
with the RFAs are subjected to the same restrictions. Are
there plans to impose similar restrictions on other existing projects
and on projects that may be funded in the future?
We would like to convert existing, and future, large-scale NIH-funded
mutagenesis and phenotyping projects to cooperative agreements
so that they can be monitored and coordinated along with the facilities
funded by these RFAs. We think that this action may also enable
us to prevent those projects from imposing proprietary restrictions
on their mutant mice, hence limiting their wide availability to
the scientific community.
- Can we study mutants paid for by non-NIH sources (e.g., a
Yes, but the expectation is that such animals will not be patented
and will be made available to the wider scientific community.
Contractual arrangements with third parties who provide funding
for the creation of animals used by the facility will be expected
to acknowledge this, and NIH will review such contracts prior
to any award being made.