COOPERATIVE PROGRAM ON RETINAL DEGENERATIVE DISEASE RESEARCH

Release Date:  November 10, 1999

PA NUMBER:  PA-00-009

National Eye Institute

THIS 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 PA.

PURPOSE

The National Eye Institute (NEI) and the Foundation Fighting Blindness (FFB) 
announce a cooperative program of research support on retinal degenerative 
diseases.  This program announcement (PA) signals the interest of NEI and FFB 
in funding grant applications that meet the programmatic interests of the NEI 
and FFB in the area of retinal degenerative diseases.  The PA is intended to 
stimulate basic cellular, molecular, genetic, and clinical research on 
retinal degenerative diseases. Applications in response to this PA will use 
the following grant mechanisms:  research project grant (R01), Small Business 
Technology Transfer Grants (STTR) (R41 and R42), Small Business Innovation 
Research Grants (SBIR) (R43 and R44), Mentored Clinical Scientist Development 
Award (K08), Mentored Patient-Oriented Research Career Development Award 
(K23), and Midcareer Investigator Award in Patient-Oriented Research (K24).

Each of these mechanisms vary in eligibility, applications procedures, review 
criteria, etc.  Pay particular attention to the variances in the mechanisms 
when applying under this PA.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health 
promotion and disease prevention objectives of "Healthy People 2000", a PHS 
led national activity for setting priority areas.  This PA, Cooperative 
Program for Research on Retinal Degenerative Diseases, is related to one or 
more of the priority areas.  Potential applicants may obtain a copy of 
"Healthy People 2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000.

RESEARCH PROJECT GRANTS (R01)

A.  ELIGIBILITY REQUIREMENTS

Applications for R01 grants 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

Responsibility for the planning, direction, and execution of the proposed 
project will be solely that of the applicant.  The total project period for 
an application submitted in response to this PA may not exceed five years.

Specific application instructions have been modified to reflect "MODULAR 
GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH.  
Complete and detailed instructions and information on Modular Grant 
applications can be found at 
https://grants.nih.gov/grants/funding/modular/modular.htm.

B.  SMALL BUSINESS GRANTS (R41, R42, R43, R44)

ELIGIBILITY

Eligibility requirements for applications for Phase I STTR grants (R41) are 
described in the Omnibus Solicitation of the National Institutes of Health 
for STTR Grant Applications (PHS 99-3), which is available at 
https://grants.nih.gov/grants/funding/sttr1/toc.htm .  Eligibility 
requirements for applications for Phase II STTR grants (R42) are described in 
the grant application kit PHS Form 6246-4, which is available at 
https://grants.nih.gov/grants/funding/sttr2/index.html .  All instructions and 
information in these documents also apply to applications submitted in 
response to this PA.

Eligibility requirements for applications for Phase I SBIR grants (R43) are 
described in the Omnibus Solicitation of the National Institutes of Health, 
Centers for Disease Control and Prevention, and Food and Drug Administration 
for SBIR Grant Applications (PHS 99-2).  This Solicitation is available at 
https://grants.nih.gov/grants/funding/sbir1/toc.htm .  Eligibility 
requirements for applications for Phase II SBIR grants (R44) are described in 
the grant application kit PHS Form 6246-2, which is available at 
https://grants.nih.gov/grants/funding/sbir2/index.htm .  All instructions and 
information in these document also apply to applications submitted in 
response to this PA.  Racial/ethnic minority individuals, women, and persons 
with disabilities are encouraged to apply as Principal Investigators.

MECHANISM OF SUPPORT

Responsibility for the planning, direction, and execution of the proposed 
research will be solely that of the applicant.  Phase II SBIR and STTR 
applications in response to this PA will only be accepted as competing 
continuations of previously funded NIH Phase I SBIR or STTR awards.  The 
previously funded Phase I award need not have been awarded under this PA but 
the Phase II proposal must be a logical extension of the Phase I research.

The Fast Track initiative (described in the SBIR and STTR Omnibus 
Solicitations) is designed to expedite the decision and award of SBIR and 
STTR Phase II funding for scientifically meritorious applications for 
projects that have a high potential for commercialization.  Fast Track is a 
parallel review option available to those small business concerns whose 
applications satisfy additional criteria which enhance the probability of the 
project's commercial success.  Those criteria are described in the Omnibus 
Solicitations.  Applications that do not meet these criteria may be 
redirected for review through the standard review procedures described in the 
Omnibus Solicitations.  Fast Track offers two major advantages: 1) concurrent 
submission and peer review of both Phase I and Phase II projects and 2) 
minimal or no funding gap between Phase I and Phase II.

C.  RESEARCH CAREER DEVELOPMENT AWARDS  (K08, K23, K24)

ELIGIBILITY

Eligibility requirements for applications for Mentored Clinical Scientist 
Development Awards (K08) are described at 
https://grants.nih.gov/grants/guide/pa-files/PA-00-003.html .  Eligibility 
requirements for applications for Mentored Patient-Oriented Research Career 
Development Awards (K23) are described at 
https://grants.nih.gov/grants/guide/pa-files/PA-00-004.html .  And eligibility 
requirements for Midcareer Investigator Awards in Patient-Oriented Research 
(K24) are described at https://grants.nih.gov/grants/guide/pa-files/PA-00-005.html.  
NEI-specific supplemental information regarding these awards is 
available at http://www.nei.nih.gov/funding/NEIFM.htm .

MECHANISM OF SUPPORT

Responsibility for the planning, direction, and execution of the proposed 
research will be solely that of the candidate on behalf of the applicant 
organization.  The total project period for an application submitted in 
response to this PA may be three, four, or five years.  K08 and K23 career 
development awards are not renewable; the K24 award may be renewable for one 
additional five-year period if the candidate still meets the stated 
requirements.

Candidates for career development awards should consult the NIH website for 
details:  https://grants.nih.gov/training/careerdevelopmentawards.htm.

RESEARCH OBJECTIVES

Background

Retinal degenerative diseases including retinitis pigmentosa (RP), Usher's 
syndrome, macular degeneration, and other rare disease forms affect over six 
million Americans.  These blinding diseases affect persons of all ages and 
races.  During the past decade, dramatic progress had been made in 
understanding many aspects of retinal degenerative diseases through studies 
of the structure, function, and metabolism of the normal retina and retinal 
pigment epithelium (RPE).  In particular, the application of molecular 
techniques has allowed the identification of many genes responsible for a 
number of retinal degenerative diseases.  The identified human gene mutation 
has allowed scientists to identify or create animal models with retinal 
degeneration.  In addition, genes responsible for retinal degeneration in 
naturally-arising RD and RDS mouse strains are now known to be homologous to 
genes associated with retinal degenerative diseases in humans.  All these 
animal models are the subject of intensive study to determine the 
pathophysiological mechanisms by which gene defects lead to photoreceptor 
degeneration.

New knowledge about molecular defects underlying inherited blindness in 
animals and humans has shown that retinal degenerations are a highly 
heterogeneous group of diseases.  Yet, studies from many laboratories have 
defined several promising new therapeutic approaches.  Progress has been made 
in gene targeting approaches with the development of a new generation of 
vectors, which may be more effective and safe.  In addition, several 
laboratories have shown slowing of photoreceptor degeneration in several 
animal models following therapy with neuronal survival factors or growth 
factors.  Retinal transplantation has seen some advances, but there is a need 
for better understanding of the immunological issues related to 
transplantation into the subretinal space.  Scientists are also exploring 
other approaches that may be potentially useful in treatment of retinal 
degenerative diseases.  These include studies of anti-apoptotic proteins as 
potential therapeutic agents as well as ribozymes, antisense nucleic acids, 
and triplex-forming oligonucleotides.  Identifying the underlying molecular 
and cellular defects in retinal degenerative diseases will be critical to the 
development of effective therapies to slow or halt the degenerative process.

Research Topics

It is the intent of this solicitation to invite applications from 
investigators with diverse scientific interests to enhance our understanding 
of the etiology and pathogenesis of retinal degenerative diseases, and to 
develop innovative strategies to prevent, treat, or cure these blinding 
diseases.  It is hoped that applicants will capitalize on recent and emerging 
research progress and research tools.  Broad areas of interest related to the 
goals of this PA include, but are not limited to:

o  Identify novel causes of retinal degenerative diseases; examine the 
cellular and molecular mechanisms whereby gene defects cause retinal 
degenerations.

o  Further delineate the pathophysiology of human retinal degenerative 
disease

o  Identify additional genes and modifiers involved in retinal degenerative 
diseases.

o  Develop and critically evaluate potential therapeutic strategies, such as 
gene transfer, tissue and cell transplantation, growth factor therapy, and 
pharmacological intervention.  Identify innovative therapeutic interventions 
and gene-targeted approaches to slow or prevent the progression of retinal 
degeneration.

o  Identify retinal genes and expressed sequence tags (ESTs) that are unique 
to the visual system or that have hall marks of candidates for retinal 
degenerative diseases.

o  Understand the normal function of the retina and RPE and apply this 
knowledge to the treatment, prevention, and diagnosis of retinal degenerative 
diseases.

o  Identify genes, pathways, and factors important for retina development, 
especially those that may be involved in controlling cell fate determination 
and differentiation.

o  Investigate the regenerative capacity of the retina.

o  Improve neuroprotective strategies that could prevent retinal cell death, 
promote survival, or stimulate regeneration.

o  Develop improved methods for clinical diagnosis of retinal degenerative 
diseases and for monitoring progression of the disease and treatment 
effectiveness.

Information regarding NEI programmatic interest in retinal degenerative 
diseases is available in NEI's publication, Vision Research--A National Plan:  
1999-2003, which is located at
http://www.nei.nih.gov/resources/strategicplans/plan.htm.

FFB Mission Statement:  The mission of the FFB is to discover the causes, 
treatments, preventions, and cures for retinitis pigmentosa, macular 
degeneration, Usher's syndrome, and other related retinal degenerative 
diseases.  More information regarding the Foundation and its programmatic 
interests can be found at http://www.blindness.org.

SPECIAL REQUIREMENTS

The NEI and FFB plan to sponsor periodic meetings to facilitate exchange of 
information among investigators funded as a result of this initiative and to 
foster cooperation and collaborative efforts among investigators.  For this 
purpose, requests for travel funds for a one-day meeting each year in 
Bethesda, Maryland, should be included in the budget.

In order for an application to be considered for funding by the FFB, the 
applicant must submit a brief letter of authorization, co-signed by the 
Principal Investigator and the official signing for the applicant 
institution, authorizing the NEI to release the application, the summary 
statement and all related materials to the FFB.  These materials will be 
shared with the FFB when available.  Applications without such authorization 
will not be considered for funding by the FFB.

Dissemination of Research Resources

It is anticipated that research developed under this PA will generate 
reagents such as cDNA libraries, ESTs, clones, and sequences.  The sharing of 
such materials, data, and software in a timely manner has been an essential 
element in the rapid progress that has been made in biomedical research.  
Research materials and results produced in projects funded by this PA will be 
distributed to scientific investigators in the wider research community, and 
will augment existing resources.  PHS policy requires that investigators make 
unique research resources readily available for research purposes to 
qualified individuals within the scientific community, see 
https://grants.nih.gov/grants/guide/notice-files/not96-184.html 
.

The NIH is interested in ensuring that the research resources 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.  For this 
reason, NIH is concerned that patent applications for a large number of ESTs, 
cDNAs, 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.  Indeed for inventions developed in its 
intramural program, NIH does file patent applications, in accord with a set 
of policies described at http://ott.od.nih.gov/phspat_policy.html.

To address the joint interests of the government in the availability of, and 
access to, the results of publicly-funded research and in the opportunity for 
economic development based on these results, NIH requires applicants who 
respond to this PA to propose detailed plans for sharing the research 
resources and data generated through the grant, if applicable.  For this 
purpose, it is the opinion of the NIH that dissemination of such developments 
via individual laboratory web sites is not sufficient, as it would force 
interested investigators to have to search several different data collections 
to make use of the results of this initiative.  Specifically, applicants 
should (1) propose a plan for placing clones, ESTs, and other research 
resources in common, public databases and repositories, and (2) address if or 
how they plan to exercise their intellectual property rights, including 
options to for-profit research sponsors, that might be associated with 
clones, ESTs, and cDNA libraries that may be generated.

It is expected that the investigator's data sharing plan include all elements 
of the guidelines developed by the NIH and the Department of Energy to 
address the special needs of human genome research.  These guidelines call 
for material and information to be made available within six months of the 
time the data or materials are collected, and are available at
http://www.nhgri.nih.gov/Grant_info/Funding/Statements/data_release.html   
Adherence with this time frame is highly desirable.  More rapid sharing is 
encouraged.  Requests for exemptions or extensions will require compelling 
justification and will be fully evaluated by program staff.

Applicants are also reminded that the grantee institution is required to 
disclose each subject invention to the Federal agency providing research 
funds within two months after the inventor discloses it in writing to grantee 
institution personnel responsible for patent matters.  The NEI reserves the 
right to monitor grantee activity in this area to ascertain if patents on 
large numbers of research resources related to this PA are being filed.

Where appropriate, grantees may work with the private sector to make unique 
resources available to the wider biomedical research community at a 
reasonable costs.  Applicants may request funds to defray the costs of 
sharing resources, with adequate justification.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and 
their subpopulations must be included in all NIH supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification is provided that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of 
the research.  This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43).

All investigators proposing research involving human subjects should read the 
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research," which has been published in the Federal Register of March 28, 1994 
(FR 59 14508-14513) and in the NIH Guide to Grants and Contracts, March 18, 
1994, available on the web at the following URL address:
https://grants.nih.gov/grants/guide/notice-files/not94-100.html.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that children (individuals under the age of 21) 
must be included in all research involving human subjects conducted or 
supported by the NIH, unless there are scientific or ethical reasons not to 
include them.  This policy applies to all initial (Type 1) applications 
submitted for receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines on the Inclusion of Children as Participants in 
Research Involving Human Subjects" that was published in the NIH Guide for 
Grants and contracts, March 6, 1998, and is available at the following URL 
address:  https://grants.nih.gov/grants/guide/notice-files/not98-024.html .

Investigators may also obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.

APPLICATION PROCEDURES


A.  RESEARCH PROJECT GRANTS (R01)

Applications for R01 grants are to be submitted on the grant application form 
PHS 398 (rev. 4/98).  All submissions will be accepted at the standard 
application deadlines as indicated in the application kit.  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, telephone 301/710-0267, email:  GrantsInfo@nih.gov.

Applicants planning to submit a grant application requesting $500,000 or more 
in direct costs for any year are required to discuss their eligibility with 
the NEI program staff contact listed at the end of this program announcement 
before submitting the application.  Furthermore, the applicant must obtain 
agreement from NEI program staff that the NEI will accept the application for 
consideration of award.  Finally, the applicant must identify, in a cover 
letter sent with the application, the program staff member who agreed to 
accept assignment of the application.  This policy requires an applicant to 
obtain agreement for acceptance of both any such application and any 
subsequent amendment.  Refer to the NIH Guide for Grants and Contracts, March 
20, 1998, which is available at
https://grants.nih.gov/grants/guide/notice-files/not98-030.html 

The title and number of this Program Announcement must be typed on line 2 of 
the face page of the application form and the YES box must be marked.

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.  (Applications that 
request more than $250,000 Direct Costs in any year must follow the 
traditional PHS 398 application instructions.)  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 https://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.

o PERSONNEL - List key 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.

o CONSORTIUM/CONTRACTUAL COSTS - Provide an estimate of Total Costs (Direct 
plus F&A Costs) 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 key personnel, and their 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.

o 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 key personnel, following the instructions below.  No more than three 
pages may be used for each person.  A sample biographical sketch may be 
viewed at:  https://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;
- 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.

o 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.

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)

B.  SMALL BUSINESS GRANTS (R41, R42, R43, R44)

Applications for SBIR or STTR Phase I, Phase II, or Fast Track grants are to 
be submitted on the grant application forms in the Omnibus Solicitations 
described above.  Applications will be accepted on or before the receipt 
dates indicated in the application kits.  The Omnibus Solicitations are 
available on the Internet at https://grants.nih.gov/grants/funding/sbir.htm .
A limited number of hard copies of the Omnibus Solicitation are available 
from:  PHS SBIR/STTR Solicitation Office, 13685 Baltimore Avenue, Laurel, MD  
20707-5096, telephone 301/206-9385, FAX 301/206-9722, Email a2y@cu.nih.gov .

Submit a signed, typewritten original of the application, including the 
checklist, and two  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)

C.  RESEARCH CAREER DEVELOPMENT AWARDS (K08, K23, K24)

Potential candidates are strongly encouraged to contact an NEI staff person 
listed under INQUIRIES.  Such contact should occur early in the planning 
phase of application preparation.  Such contact will help ensure that 
applications are responsive to the goals and policies of the NEI.

Applicants who will be using a General Clinical Research Center (GCRC) are 
requested to include a letter from either the GCRC Program Director or the 
Principal Investigator with the application.

Applications are to be submitted on the grant application form PHS 398 (rev. 
4/98) using the instructions in Section IV and the NEI-specific instructions 
at http://www.nei.nih.gov/funding/NEIFM.htm as appropriate.  Applications 
will be accepted on or before the receipt dates indicated in the application 
kit.  Forms are available at most institutional offices of sponsored research 
and from the Division of Extramural Outreach and Information Resources, 
National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 
20892-7910, Phone (301) 435-480-0525, Email:  grantsinfo@nih.gov.  Forms are 
also available on the NIH website at https://grants.nih.gov/grants/forms.htm.

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)


REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established PHS referral 
guidelines.  Applications will be evaluated for scientific and technical 
merit by an appropriate scientific review group convened in accordance with 
the standard NIH peer review procedures.  As part of the initial merit 
review, all applications will receive a written critique and undergo a 
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.  All applications will receive a 
second level review by the appropriate National Advisory  Council.

Review Criteria

A.  RESEARCH PROJECT GRANTS (R01)

The goals of NIH-supported research are to advance our understanding of  
biological systems, improve the control of disease, and enhance health.  The 
reviewers will comment on the following aspects of the application in their 
written critiques 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 by the reviewers 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 a 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.

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 analyzes 
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?


B.  SMALL BUSINESS GRANTS (R41, R42, R43, R44)

SBIR and STTR application review criteria are described in the Omnibus 
Solicitations.  Phase I applications should specify clear, measurable goals 
(milestones) that should be achieved prior to initiating Phase II.  Failure 
to provide clear, measurable goals may be sufficient reason for the study 
section to judge the application non-competitive.

C.  RESEARCH CAREER DEVELOPMENT AWARDS (K08, K23, K24)

Mentored Clinical Scientist Development Award (K08) applications will be 
reviewed according to the criteria described in 
https://grants.nih.gov/grants/guide/pa-files/PA-00-003.html.  Mentored 
Patient-Oriented Research Career Development Award (K23) applications will be 
reviewed according to criteria described in 
https://grants.nih.gov/grants/guide/pa-files/PA-00-004.html.  Midcareer 
Investigator Award in Patient-Oriented Research (K24) applications will be 
reviewed according to criteria described in 
https://grants.nih.gov/grants/guide/pa-files/PA-00-005.html.

In addition to the above review criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

o  The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects will also be 
evaluated.

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.

AWARD CRITERIA

Applications will compete for available funds with all other recommended 
applications.  The following will be considered in making funding decisions:  
Quality of the proposed project as determined by peer review, adequacy of 
plans to make research resources developed during this project publicly 
available in a timely manner, cost effectiveness of the proposed strategy, 
promise of the proposed program to accomplish the goals of this PA, and 
availability of funds.

INQUIRIES

Inquiries are encouraged.  The opportunity to clarify any issues or questions 
from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Peter A. Dudley, Ph.D. or Maria Y. Giovanni, Ph.D.
Division of Extramural Research
National Eye Institute
Executive Plaza South, Suite 350
6120 Executive Blvd, MSC 7164
Bethesda, MD  20892-7164
Telephone:  (301) 496-0484
FAX:  (301) 402-0528
Email:  pad@nei.nih.gov or giovanni@nei.nih.gov

Santa J. Tumminia, Ph.D.
Science Programs Manager
The Foundation Fighting Blindness
Executive Plaza I, Suite 800
11350 McCormick Rd.
Hunt Valley, MD  21031-1014
Telephone:  (410) 785-1414
FAX:  (410) 771-9470
Email:  stumminia@blindness.org

Direct inquiries regarding fiscal matters to:

William W. Darby
Grants Management Officer
Grants Management Branch
National Eye Institute
Executive Plaza South, Suite 350
6120 Executive Blvd, MSC 7164
Bethesda, MD  20892-7164
Telephone:  (301) 496-5884
FAX:  (301) 496-9997
Email:  wwd@nei.nih.gov

AUTHORITY AND REGULATIONS 

This program is described in the Catalog of Federal Domestic Assistance No. 
93.867, Vision Research.   Awards are made under authorization of the Public 
Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public 
Law 99-158, 42 USC 241 and 285) 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 and contract 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, a 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

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.