TOOLS FOR INSERTIONAL MUTAGENESIS IN THE MOUSE

Release Date:  January 25, 2001

RFA:  RFA-DA-01-011

National Institute on Drug Abuse
 (http://www.nida.nih.gov)
National Institute on Aging
 (http://www.nih.gov/nia/)
National Institute of Mental Health
 (http://www.nimh.nih.gov)
National Institute of Dental and Craniofacial Research
 (http://www.nidcr.nih.gov)
National Eye Institute
 (http://www.nei.nih.gov)
National Institute on Deafness and Other Communication Disorders
 (http://www.nidcd.nih.gov)
National Human Genome Research Institute
 (http://www.nhgri.nih.gov)
National Institute of Diabetes and Digestive and Kidney Diseases
 (http://www.niddk.nih.gov)
National Institute of Arthritis and Musculoskeletal and Skin Diseases
 (http://www.nih.gov/niams)
National Institute of Allergy and Infectious Diseases
 (http://www.niaid.nih.gov)
National Institute of Neurological Disorders and Stroke
 (http://www.ninds.nih.gov)

Letter of Intent Receipt Date:  March 11, 2001
Application Receipt Date:       April 11, 2001

THIS REQUEST FOR APPLICATIONS (RFA) USES THE “MODULAR GRANT” AND “JUST-
IN-TIME” CONCEPTS.  IT INCLUDES DETAILED MODIFICATIONS TO STANDARD 
APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS 
IN RESPONSE TO THIS RFA.

PURPOSE

This RFA solicits proposals for development of tools and techniques for 
the establishment of random and targeted sequence-tagged insertion 
libraries of embryonic stem (ES) cells that can be used to generate 
mutant mice in which the expression of the tagged gene could be 
controlled temporally and spatially.  The development of such a 
resource for wide distribution to the scientific community would make 
it possible to scan the sequence database for any gene of interest and 
order the corresponding targeted ES cell line.  Ideally, the 
insertional mutagenesis system developed would permit a wide range of 
genetic analyses and manipulations, including enhancer-trapping, 
conditional knockouts, conditional expression or overexpression, etc.  
It also would permit the larger community of investigators to utilize 
genomic resources efficiently.

This effort complements ongoing National Institutes of Health (NIH) 
efforts to create and characterize induced point mutations in mice 
using ethylnitrosourea (ENU) and provides a functional genomics tool to 
translate the information from the Mouse Genome Sequencing Project.  
Further information about NIH initiatives on mouse genomics and 
genetics resources is available at http://www.nih.gov/science/mouse.

This initiative will utilize the research project grant (R01) and 
exploratory/development grant (R21) mechanisms.  It will be run in 
parallel with a program of identical scientific scope that uses the 
Small Business Innovation Research/Small Business Technology Transfer 
Research (SBIR/STTR) programs 
(http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf).

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, "Tools 
for Insertional Mutagenesis in the Mouse," 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/.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign, for-profit and 
non-profit organizations, public and private, such as universities, 
colleges, hospitals, laboratories, units of state and local 
governments, and eligible agencies of the federal government.  
Racial/ethnic minority individuals, women, and persons with 
disabilities are encouraged to apply as Principal Investigators.

MECHANISM OF SUPPORT

This RFA will use the NIH research project grant (R01) and 
exploratory/developmental grant (R21).  Applicants are advised to 
contact the appropriate Institute program staff listed under INQUIRIES 
for additional information and specific application procedures.

For research in methods development, the R21 mechanism is particularly 
appropriate. The R21 mechanism is intended to encourage exploratory 
research projects with sound methodology and strong rationales in 
underdeveloped research areas, such as those covered in this RFA.  All 
applicants must use the NIDA R21 Guideline at 
http://grants.nih.gov/grants/guide/pa-files/PA-01-012.html.  The R21 is 
limited to $100,000 maximum direct costs per year for up to three 
years.  Investigators may also choose to include methods development as 
one component within the R01 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 RFA may 
not exceed three years.  This RFA is a one-time solicitation.  Future 
new or competing continuation applications will compete with all 
investigator-initiated applications and be referred and reviewed 
according to the customary peer review procedures.

This RFA is the result of a trans-NIH initiative, and awards will be 
made through the
institute whose mission is most closely related to the proposed work.  
The earliest anticipated award date is September 30, 2001.

FUNDS AVAILABLE

The participating institutes intend to commit approximately $2.8 
million in total costs [direct plus Facilities and Administrative (F & 
A) costs] in FY 2001 to fund six to eight new grants in response to 
this RFA.  An applicant may request a project period of up to three 
years.  For R01 grants, an applicant may request a budget for direct 
costs of up to $250,000 per year, including F & A costs on consortium 
arrangements.  For an exploratory/development grant (R21), an applicant 
may request a budget for direct costs of up to $100,000 per year, 
including F & A costs on consortium arrangements.  Because the nature 
and scope of the research proposed may vary, it is anticipated that the 
size of awards also will vary.  Although the financial plans of the 
participating institutes 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

The use of transposon tagging and retroviral insertional mutagenesis in 
model organisms such as Drosophila, C. elegans, and zebrafish has 
greatly facilitated the characterization of gene function and permitted 
rapid cloning of the mutated gene.  This approach has complemented 
analysis of gene function using chemically and X-ray-induced mutations 
where great effort is expended in positional cloning of the mutant 
gene.  Insertional mutagenesis in mice is made practical by the 
availability of efficient methods of transfecting ES cells, the 
production of a 2.5 to 3.5X draft of the mouse genome using C57BL/6 
mouse strain by February 2001, polymerase chain reaction (PCR), and 
automated sequencing methods.

The development of both random and targeted sequence-tagged insertion 
libraries in mouse ES cells would greatly facilitate analysis of gene 
function in mice and permit the rapid development of mouse models for 
human genetic disease.  Not only would such an approach create an 
induced mutation resource, but it would also permit analysis of 
patterns of gene expression.   The value of this resource would be 
greatly enhanced by the use of site-specific gene recombination systems 
or trans-acting factor binding sites that would allow the expression of 
the tagged gene to be controlled temporally and spatially.

There are two recombination systems currently used to create 
conditional mutations or knockouts in mice are the cre-lox and FLP-FRT 
site-specific recombination systems.  The usefulness of these 
recombination systems in vertebrate systems is dependent on the 
activity of the recombinase and the ability to drive the expression of 
the recombinase with non-mammalian promoters, such as ecdysone or 
tetracycline sensitive promoters.  The ability to control the spatial 
expressions of the recombinase is limited by the lack of well-
characterized enhancers that control gene expression.  To overcome 
these obstacles, modifications of these recombinase systems, as well as 
the development of new ones, are needed.  In addition, the flexibility 
of existing systems can be enhanced through the use of inducible 
promoters or fusion protein recombinases that are activated by ligands 
such as steroids.

The creation of appropriate insertional mutagenesis vectors containing 
site-specific recombination targets will also aid in the generation of 
chromosomal deletions, duplications, and inversions when another 
genetic locus is tagged with a vector containing the same target 
sequence.  Chromosomal aberrations are an important tool for selecting 
and mapping mutations in a specific chromosomal region and for 
positional cloning, as well as for the study of position effects and 
contiguous gene syndromes.  In addition, inversions can be combined to 
produce balancer chromosomes.  Balancer chromosomes carrying dominant 
phenotypic markers simplify the maintenance of recessive mutations and 
combinations of alleles from generation to generation because the 
balancer prevents recombination.  Balancer chromosomes also facilitate 
isolation and high-throughput screening for new recessive mutations.
 
Current estimates are that a total of 500,000 ES cell lines may be 
needed to tag every single mouse gene.  Thus high-throughput methods 
are needed to automate the processing of large numbers of clones and to 
identify the site of insertion.

The use of C57BL/6 ES cells will speed the distribution of mice in a 
defined isogenic background by eliminating the need to cross sv129 mice 
over successive generations into C57BL/6.  Many of the current sv129 
cell lines in use are derived from different strains of sv129 mice, 
making comparisons among the various targeted mutations difficult until 
transferred to a defined genetic background.  Moreover, much of the 
public chemical mutagenesis and sequencing effort is being done in 
C57BL/6.  Thus, crosses between mutations created by ENU in C57BL/6 and 
C57BL/6 carrying a targeted deletion can be performed in a single 
generation without concern about the effects of genetic background.  

It is anticipated that the results of funded research projects will 
eventually lead to production of new complete libraries of ES cells 
with random or targeted insertional mutations for wide distribution to 
the research community.

Examples of research that may be considered responsive to this RFA 
include, but are not limited to, those listed below.

o  Feasibility studies for the establishment of sequence-tagged 
insertional libraries of C57BL/6 ES cells in which the expression of 
the tagged gene can be controlled temporally and spatially.

o  The development of new or modified site-specific recombination 
systems for efficient random and targeted insertional mutagenesis and 
enhanced control of conditional expression.

o  The development of novel vectors that allow imaging of specific cell 
types or tissues, metabolic activity, or other cellular or 
physiological functions.

o  The invention of efficient systems for transposon tagging in 
mammalian systems for the wide use of the scientific community.

o  The development of vectors for identification ("trapping") of 
promoters and enhancers that could be used for tissue-specific and 
temporal expression of recombinases and for the study of gene 
expression patterns.

o  Methods to automate the processing of large numbers of clones and to 
identify the sites of insertion.

SPECIAL REQUIREMENTS

Restricted availability of unique research resources upon which further 
studies are dependent can impede the advancement of research and 
delivery of medical care.  The sharing of biomaterials, data, and 
software in a timely manner, on the other hand, has been an essential 
element in the rapid progress that has been made in the genetic 
analysis of mammalian genomes.  NIH policy requires investigators to 
make unique research resources readily available for research purposes 
to qualified individuals within the scientific community when they have 
been published [NIH Grants Policy Statement 
(http://grants.nih.gov/grants/policy/nihgps); Principles and Guidelines 
for Recipients of NIH Research Grants and Contracts on Obtaining and 
Disseminating Biomedical Research Resources:  Final Notice, December 
1999 (http://www.nih.gov/od/ott/RTguide_final.htm)].  Biomaterials and 
other patentable research resources (e.g., mutagenesis protocols, 
vectors, embryonic cell lines, etc.) produced in projects funded by 
this RFA are expected to be made available and distributed to the 
broader scientific community.

The NIH is interested in ensuring that the research resources developed 
through this RFA 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.  For 
this reason, NIH is concerned that patents on the vectors, mutagenesis 
methods, cell lines, and other research resources might have a chilling 
effect on the future development of products and information that may 
improve the public health.  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.

There are two special requirements for this RFA regarding research 
resources produced in proposed projects: 

(1)  Applicants are required to include in their application a specific 
plan by which they will share research resources with the wider 
scientific community. 

(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.  These plans should be consistent with the policies of their 
institutional offices of technology transfer.

Applicants are encouraged to discuss their proposed plans for 
addressing these requirements with their institutional offices of 
technology transfer.  Each of the two requirements is discussed in 
detail below. 

Plan to Share Research Resources 

To address the joint interests of the government in the availability 
of, and access to, the results of publicly funded research, NIH 
requires applicants who respond to this RFA to propose detailed plans 
for sharing the research resources generated through the grant.  It is 
expected that the resources to be shared include all materials 
developed in projects funded under the RFA, including but not limited 
to, the following:  vectors, high-throughput methods for identifying 
insertion sites, mutagenesis protocols, and cell lines.  A reasonable 
time frame for release of materials should be specified in the 
application and will be considered during the review of the plan for 
sharing.

It is expected that the investigator's data and biomaterials sharing 
plan will include the access to biomaterials and methods not currently 
available to the wider scientific community. 

The scientific review group will evaluate the adequacy of the proposed 
plan for sharing and data access. Comments on the plan and any concerns 
will be presented in an administrative note in the Summary Statement.  
The adequacy of the plan will be considered by NIH program staff and 
will be important in determining whether the grant shall be awarded. 
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.

Intellectual Property Rights 

NIH is interested in ensuring that the research resources developed 
through this RFA become readily available to the research community. 
 
With regard to patentable research results, such as mutagenesis 
protocols, methodologies, cell lines, and vectors, the NIH requires 
applicants who respond to this RFA to develop a plan addressing if, or 
how, they will exercise their intellectual property rights while making 
available to the broader scientific community research resources 
produced in projects funded under this RFA.  This is expected to 
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 should be consistent with 
the applicant's institution's policies on intellectual property rights.  
This plan is also expected to include disclosure of any pre-existing 
agreements involving intellectual property rights, including options to 
for-profit research sponsors that are associated with biomaterials and 
data that may be generated.  The requirement for this plan is in 
addition to the requirement for the plan for sharing and disseminating 
research resources described in the previous section.  

The majority of transfers to not-for-profit entities should be 
implemented under terms no more restrictive than the Uniform Biological 
Materials Transfer Agreement (UBMTA). In particular, recipients are 
expected to use the Simple Letter Agreement provided at 
http://www.nih.gov/od/ott/RTguide_final.htm, or another document with 
no more restrictive terms, to readily transfer unpatented tools 
developed with NIH funds to other recipients for use in NIH-funded 
projects.  If the materials are patented or licensed to an exclusive 
provider, other arrangements may be used, but commercialization option 
rights, royalty reach-through, or product reach-through rights back to 
the provider are inappropriate. 

Similarly, when for-profit entities are seeking access to NIH-funded 
tools for internal use purposes, recipients should ensure that the 
tools are transferred with the fewest encumbrances possible.  The 
Simple Letter Agreement may be expanded for use in transferring tools 
to for-profit entities, or simple internal use license agreements with 
execution or annual use fees may be appropriate.

The scientific review group will evaluate the adequacy of the proposed 
plan for handling intellectual property rights.  Comments on the plan 
and any concerns will be presented in an administrative note in the 
Summary Statement.  The adequacy of the proposed plan will be 
considered by NIH program staff in determining whether the grant shall 
be awarded.  The 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 
awardee’s adherence to the proposed plan.

Applicants also 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 mutagenesis protocols, cell lines, vectors, 
or other patentable subject matter are adversely affecting the goals of 
this RFA.

Principles and guidelines for recipients of NIH research grants on 
obtaining and disseminating biomedical research resources can be found 
at http://www.nih.gov/od/ott/RTguide_final.htm.

Post-Award Management

During the course of the award period, the Principal Investigator may 
be invited to meet with NIH staff to review and share scientific 
progress.  Other scientists external to and knowledgeable about these 
studies also may be invited to participate.  Application budget 
requests should include travel funds for the Principal Investigator to 
attend annual meetings in the metropolitan Washington, D.C., area.

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.  Reviewers are cautioned that 
their anonymity may be compromised when they directly access an 
Internet site.

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that 
includes a descriptive title of the overall proposed research; the 
name, address and phone number of the Principal Investigator; and the 
number and title of this RFA.  In addition, the letter of intent should 
identify all other personnel who will be involved in the research and 
their institutions. Although the letter of intent is not required, is 
not binding, does not commit the sender to submit an application, and 
does not enter into the review of subsequent applications, the 
information that it contains allows NIH staff to estimate the potential 
review workload and to plan for the review.  

The letter of intent is to be sent to:

Jonathan D. Pollock, Ph.D.
Division of Neuroscience and Behavioral Research
National Institute on Drug Abuse/NIH
6001 Executive Boulevard, Room 4284, MSC 9555
Bethesda, MD  20892-9555
Phone: (301) 443-6300
Fax: (301) 594-6043

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used 
in applying for these grants.  Application kits are available at most 
institutional offices of sponsored research and may be obtained from 
the Division of Extramural Outreach and Information Resources, National 
Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 
20892-7910, Phone (301) 435-0714, E-mail:  GrantsInfo@nih.gov.  

SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS

The modular grant concept establishes specific modules in which direct 
costs may be requested, as well as a maximum level for requested 
budgets.  Only limited budgetary information is required under this 
approach.  The just-in-time concept allows applicants to submit certain 
information only when there is a possibility for an award.  It is 
anticipated that these changes will reduce the administrative burden 
for the applicants, reviewers, and institute staff.  The research grant 
application form PHS 398 (rev. 4/98) is to be used in applying for 
these grants, with the modifications noted below.

BUDGET INSTRUCTIONS

Modular Grant applications will request direct costs in $25,000 
modules, up to a total direct cost request of $250,000 per year.  The 
total direct costs must be requested in accordance with the program 
guidelines and the modifications made to the standard PHS 398 
application instructions described below:

PHS 398

o  FACE PAGE - Items 7a and 7b should be completed, indicating Direct 
Costs (in $25,000 increments up to a maximum of $250,000) and Total 
Costs [Modular Total Direct plus Facilities and Administrative  (F&A) 
costs] for the initial budget period. Items 8a and 8b should be 
completed indicating the Direct and Total Costs for the entire proposed 
period of support.

o  DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form 
Page 4 of the PHS 398.  It is not required and will not be accepted 
with the application.

o  BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete 
the categorical budget table on Form Page 5 of the PHS 398.  It is not 
required and will not be accepted with the application.

o  NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget 
Narrative page.  (See 
http://grants.nih.gov/grants/funding/modular/modular.htm for sample 
pages.)  At the top of the page, enter the total Direct Costs requested 
for each year.  This is not a Form page.

Under Personnel, list all project personnel, including their names, 
percent of effort, and roles on the project.  No individual salary 
information should be provided.  However, the applicant should use the 
NIH appropriation language salary cap and the NIH policy for graduate 
student compensation in developing the budget request.

For Consortium/Contractual costs, provide an estimate of total costs 
(Direct plus F&A) for each year, each rounded to the nearest $1,000.  
List the individuals/organizations with whom consortium or contractual 
arrangements have been made, the percent effort of all personnel, and 
the role on the project.  Indicate whether the collaborating 
institution is foreign or domestic.  The total cost for a 
consortium/contractual arrangement is included in the overall requested 
Modular Direct Cost amount.  Include the letter of intent to establish 
a consortium.

Provide an additional narrative budget justification for any variation 
in the number of modules requested.

o  BIOGRAPHICAL SKETCH - The Biographical Sketch provides information 
used by reviewers in the assessment of each individual's qualifications 
for a specific role in the proposed project, as well as to evaluate the 
overall qualifications of the research team.  A biographical sketch is 
required for all all personnel, following the instructions below.  No 
more than three pages may be used for each person.  A sample 
biographical sketch may be viewed at:  
http://grants.nih.gov/grants/funding/modular/modular.htm

- Complete the educational block at the top of the Form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on 
research projects ongoing or completed during the last three years; and
- List selected peer-reviewed publications with full citations.

o  CHECKLIST - This page should be completed and submitted with the 
application.  If the F&A rate agreement has been established, indicate 
the type of agreement and the date.  All appropriate exclusions must be 
applied in the calculation of the F&A costs for the initial budget 
period and all future budget years.

The applicant should provide the name and phone number of the 
individual to contact concerning fiscal and administrative issues if 
additional information is necessary following the initial review. 

The RFA label available in the PHS 398 (rev. 4/98) application form 
must be affixed to the bottom of the face page of the application.  
Type the RFA number on the label.  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 title 
and number of this RFA must be typed in Item 2 on the face page of the 
application form, and the YES box must be marked.  The sample RFA label 
available at:  
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been 
modified to allow for this change.  Please note this is in pdf format.

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)

Applications must be received by the application receipt date listed in 
the heading of this RFA.  If an application is received after that 
date, it will be returned to the applicant without review.

The Center for Scientific Research (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.  The 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

Applications that are complete and responsive to the RFA will be 
evaluated for scientific and technical merit by a peer review group 
convened by CSR in accordance with the standard NIH peer review 
procedures.  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, 
generally the top half of the applications under review, will be 
discussed, assigned a priority score, and receive a second level review 
by the appropriate national advisory council or board.

REVIEW CRITERIA

The goals of NIH-supported research are to advance the 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 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.

(1)  Significance: Does this study address an important problem?  If 
the aims of the application are achieved, how will scientific knowledge 
be advanced?  What will be the effect of these studies on the concepts 
or methods that drive this field?  

(2)  Approach:  Are the conceptual framework, design, methods, and 
analyses adequately developed, well-integrated, and appropriate to the 
aims of the project?  Does the applicant acknowledge potential problem 
areas and consider alternative tactics?  

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

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

(5)  Environment:  Does the scientific environment in which the work 
will be done contribute to the probability of success?  Do the proposed 
experiments take advantage of unique features of the scientific 
environment or employ useful collaborative arrangements?  Is there 
evidence of institutional support?

Additional Review Criteria

Since the objective of this proposal is to invite research applications 
that may in whole or part consist of exploratory research rather than 
proof of a well-established idea, innovation will be given high 
priority in the review.  Furthermore, there will be less emphasis on 
preliminary data with respect to highly innovative proposals.  Although 
preliminary data should provide evidence that the applicant has the 
means and understanding to carry out the proposed studies, preliminary 
data does not necessarily have to provide a specific demonstration of 
the hypotheses to be tested.

The following evaluation will be presented in an administrative note in 
the Summary Statement, and will not factor into the numerical score:

- The adequacy of plans to make data available to other investigators 
in a timely fashion.  What is the likelihood that the methods and 
materials generated in the project will be made widely available in a 
timely fashion to the scientific community, given the proposed plan to 
exercise (or not to exercise) intellectual property rights?

- The plan to share research resources and the plan to exercise (or not 
exercise) intellectual property rights regarding patentable research 
resources will be judged for appropriateness.  

- The reasonableness of the proposed budget and duration in relation to 
the proposed research.

- The adequacy of the proposed protection for animals and the 
environment, to the extent they may be adversely affected by the 
project proposed in the application.

Schedule:

Letter of Intent Receipt Date:    March 11, 2001		
Application Receipt Date:         April 11, 2001
Peer Review Date:                 June/July 2001  
Council Review:                   September 2001	
Earliest Anticipated Award Date:  September 30, 2001

AWARD CRITERIA

Award criteria that will be used to make award decisions include:  
scientific merit as determined by peer review, adequacy of plans to 
make widely available to the research community all research resources 
developed during this project, 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 this project, availability of funds, and programmatic 
priorities.

INQUIRIES

Inquiries concerning this RFA are strongly encouraged.  The opportunity 
to clarify issues or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Jonathan D. Pollock, Ph.D.
Division of Neuroscience and Behavioral Research
National Institute on Drug Abuse/NIH
6001 Executive Boulevard, Room 4284, MSC 9555
Bethesda, MD  20892-9555
Phone: (301) 443-6300
Fax: (301) 594-6043
Email: jp183r@nih.gov

Anna M. McCormick, Ph.D.
Chief, Genetics and Cell Biology Branch
Genetics Program Director
Biology of Aging Program
National Institute on Aging/NIH
Gateway Building, Suite 2C231
Bethesda, MD  20892 (20814 for express deliveries)
Phone: (301) 496-6402
Fax: (301) 402-0010
Email: mccormia@exmur.nia.nih.gov

Dr. Thomas M. Johnson
Program Director
Scientific Programs Branch
National Institute on Deafness and Other Communication Disorders/NIH
Executive Plaza South-400C
6120 Executive Boulevard
Bethesda, MD 20892-7180
Phone: (301) 402-3461
Fax: (301) 402-6251
Email: tj65y@nih.gov

Rochelle K. Small, Ph.D.
Craniofacial Anomalies and Injuries Branch
National Institute of Dental and Craniofacial Research/NIH
Natcher Building, Room 4AN-24K
Bethesda, MD 20892
Phone: (301) 594-9898
Fax: (301) 480-8318
Email: rochelle.small@nih.gov

Peter A. Dudley, Ph.D.
Division of Extramural Research
National Eye Institute/NIH
Executive Plaza South, Suite 350
Bethesda, MD  20892-7164
Phone: (301) 496-0484
Fax: (301) 402-0528
Email: pad@nei.nih.gov

Bettie J. Graham, Ph.D.
Division of Extramural Research
National Human Genome Research Institute/NIH
Building 31, Room B2B07
Bethesda, MD 20892-2033
Phone: (301) 496-7531
Fax: (301) 480-2770
Email: bettie_graham@nih.gov

Dr. Sheryl Sato
Division of Diabetes, Endocrinology, and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases/NIH
6707 Democracy Plaza, Room 6105
Bethesda, MD  20892-5460
Phone: (301) 594-8811
Fax: (301) 480-3503
Email: satos@extra.nddk.nih.gov

Hemin R. Chin, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health/NIH
6001 Executive Boulevard, Room 7190, MSC 9643
Bethesda, MD 20892-9643
Phone: (301) 443-1706
Fax: (301) 443-9890
Email: hemin@nih.gov

William J. Sharrock, Ph.D.
Musculoskeletal Diseases Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
45 Center Drive, Natcher Building, Room 5AS-37A, MSC 6500
Bethesda, MD  20892-6500
Phone: (301) 594-5055
Fax: (301) 480-4543
Email: ws19h@nih.gov

Dr. Alison Deckhut
Basic Immunology Branch
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases/NIH 
6700-B Rockledge Drive, Room 5138, MSC 7640 
Bethesda, MD 20892-7640 
Phone: (301) 496-7551
Fax:  (301) 402-2571
Email: adeckhut@niaid.nih.gov

Gabrielle Leblanc, Ph.D.
Neurogenetics
National Institute of Neurological Disorders and Stoke/NIH
6001 Executive Boulevard, Room 2133
Bethesda, MD 20892
Phone: (301) 496-5745
Fax: (301) 402-1501
Email: gl54h@nih.gov

Direct inquiries regarding fiscal matters to:

Gary Fleming, J.D., M.A.
Grants Management Branch
Office of Planning and Resource Management
National Institute on Drug Abuse/NIH
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD 20892-9541
Phone: (301) 443-6710
Fax: (301) 594-6847
Email: gf6s@nih.gov

Ms. Linda Whipp
Grants and Contracts Management Office
National Institute on Aging/NIH
Gateway Building, Suite 2N212, MSC 9205
7201 Wisconsin Avenue
Bethesda, MD 20892-9205
Phone: (301) 496-1472
Fax:  (301) 402-3672
Email: whippl@nia.nih.gov

Ms. Sara Stone
Chief, Grants Management Office
Division of Extramural Research
National Institute on Deafness and Other Communication Disorders/NIH
Executive Plaza South-400B
6120 Executive Boulevard
Bethesda, MD 20892-7180
Phone: (301) 402-0909
Fax: (301) 402-1758
Email: stones@nidcd.nih.gov

Mr. Martin Rubinstein
Grants Management Branch
National Institute of Dental and Craniofacial Research/NIH
45 Center Drive, Room 4AN-44
Bethesda, MD 20892-6402 
Phone: (301) 594-4800
Fax: (301) 480-8301 
Email: Martin.Rubinstein@nih.gov

Mr. William Darby
Grants Management Officer
National Eye Institute/NIH
Executive Plaza South, Suite 350
Bethesda, MD  20892-7164
Phone: (301) 496-5884
Fax: (301) 496-9997
Email: wwd@nei.nih.gov

Ms. Jean Cahill 
Grants Administration Branch 
National Human Genome Research Institute/NIH 
Building 31, Room B2-B34
Bethesda, MD 20892-2031 
Phone: (301) 402-0733 
Fax: (301) 402-1951
Email: jc166o@nih.gov

Mr. George Tucker
Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases/NIH
6707 Democracy Boulevard, Rm. 654, MSC 5456
Bethesda, MD 20892-5456
Phone: (301) 594-8853
Fax: (301) 480-3504
Email: gt35v@nih.gov

Mr. Bruce L. Ringler
Grants Management Branch
National Institute of Mental Health/NIH
6001 Executive Boulevard, Room 6122, MSC 9605
Bethesda, MD  20892-9605
Phone: (301) 443-2811
Fax: (301) 443-6885
Email: bringler@mail.nih.gov

Ms. Melinda Nelson
Grants Management Officer
National Institute of Arthritis and Musculoskeletal and Skin 
Diseases/NIH
45 Center Drive, Natcher Building, Room 5A49, MSC 6500
Bethesda MD 20892-6500
Phone: (301) 594-3535
Fax: (301) 480-5450
Email: mn23z@nih.gov

Ms. Pamela Fleming
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases/NIH
6700-B Rockledge Drive, Room 2119, MSC 7614 
Bethesda, MD  20892-7614 (Regular Mail) 
Bethesda, MD  20817 (Express Mail) 
Phone:  301-402-6580 
Fax:  301-493-0597 
Email:  pf49e@nih.gov

Ms. Tina Carlisle
Grants Management Branch
National Institute of Neurological Disorders and Stoke/NIH
6001 Executive Boulevard, Room 3290
Bethesda, MD 20892
Phone: (301) 496-9231
Fax: (301) 402-0219
Email: tc48k@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance 
No. 93.279 (NIDA), 93.173 (NIDCD), 93.867 (NEI), 93.242 (NIMH), 93.866 
(NIA), 93.121 (NIDCR), 93.172 (NHGRI), 93.846 (NIAMS), 93.855  (NIAID), 
93.853 (NINDS), and 93.847 (NIDDK).  Awards are made under 
authorization of Sections 301 and 405 of the Public Health Service Act 
as amended (42 USC 241 and 284) and are administered under NIH grants 
policies and Federal Regulations 42 CFR 52 and 45 CFR Part 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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Research (OER)
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Bethesda, Maryland 20892
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and Human Services (HHS)
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