NEI CLINICAL VISION RESEARCH DEVELOPMENT AWARD (R21)

Release Date:  January 27, 2000

PA NUMBER:  PAR-00-050

National Eye Institute

THIS PA 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

This Program Announcement (PA) replaces "Clinical Vision Research Development 
Award", which was originally published in the National Institutes of Health 
(NIH) Guide for Grants and Contracts, Vol. 16, No. 23, July 10, 1987, and last 
revised in May, 1998.  The Clinical Vision Research Development Award is an 
NEI support mechanism designed to provide up to $100,000 in annual direct 
costs for up to five years to assist institutions in developing the expertise 
of staff and acquiring resources necessary to enhance their clinical vision 
research programs.

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 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.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic 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.  Foreign institutions are not eligible for NEI 
Clinical Vision Research Development Awards.  Institutions having current or 
past NEI Core Grant for Vision Research (P30) support for a biostatistics 
module are not eligible to apply.  On the application receipt date, the 
prospective Principal Investigators and at least one other participating 
investigator must have a clinical research grant, contract, or cooperative 
agreement award actively funded by the NEI.  Racial/ethnic minority 
individuals, women, and persons with disabilities are encouraged to apply as 
Principal Investigators.

MECHANISM OF SUPPORT

This PA will use the NIH R21 Exploratory/Development Grant award mechanism to 
provide up to $100,000 annual direct costs.  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.  This award cannot be renewed.  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 http://grants.nih.gov/grants/funding/modular/modular.htm .

RESEARCH OBJECTIVES

Background

The NEI supports a large number of clinical research projects, including 
single center and multicenter randomized clinical trials, epidemiologic 
studies, genetic epidemiologic studies, and health services research projects.  
The intent of these projects is to advance the understanding, prevention, or 
clinical management of visual system disorders.  A number of experienced 
investigators and research groups are needed to provide leadership in the 
design and implementation of such clinical vision research projects.  
Therefore, the NEI wishes to help institutions with NEI-funded investigators 
augment staff expertise and acquire the resources necessary to enhance their 
clinical vision research programs.

This award is intended to strengthen interactions among clinicians, 
biostatisticians, epidemiologists, statistical geneticists, and other clinical 
trial specialists to facilitate the design and conduct of clinical research 
projects, such as the development of coordinating center capabilities.  
Prospective applicants should note that institutions holding or planning to 
submit an NEI Core Grant for Vision Research (P30) award application could 
request support for the above-mentioned activities by including a 
biostatistics module.

Applicants should consider the relevance of their proposed research to NEI 
programs and priorities as described in "Vision Research--A National Plan:  
1999-2003", which is available at http://www.nei.nih.gov

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 have been published in the Federal Register of March 28, 1994 
(FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, 
No. 11, March 18, 1994 available on the web at the following URL address:  
http://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 NIH that children (i.e., individuals under the age of 21) 
must be included in all human subjects research, conducted or supported by the 
NIH, unless there are scientific and 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: http://grants.nih.gov/grants/guide/notice-files/not98-024.html .

Investigators also may 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

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.

Applications are to be submitted on the grant application form PHS 398 (rev. 
4/98) and 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 301/435-
0714, email: GrantsInfo@nih.gov .

BUDGET INSTRUCTIONS

Modular Grant applications will request Direct Costs in $25,000 modules, up to 
a Total Direct Cost request of $100,000 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- In item 2 check "Yes" and enter the PA number and "NEI Clinical 
Vision Research Development Award".  Items 7a and 7b should be completed, 
indicating Direct Costs (in $25,000 increments up to a maximum of $100,000) 
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.

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:  
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;
- 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 four 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, one additional copy of the application should be 
sent to:

Andrew P. Mariani, Ph.D.
Chief, Scientific Review Branch
National Eye Institute
Executive Plaza South, Suite 350
6120 Executive Blvd, MSC 7164
Bethesda MD  20892-7164

REVIEW CONSIDERATIONS

Applications will be evaluated for scientific and technical merit by an 
appropriate scientific review group convened by the NEI in accordance with the 
standard NIH peer review procedures.  As part of the initial merit review, all 
applications will receive a written critique and will be discussed and 
assigned a priority score.  All applications also receive a second level 
review by the National Advisory Eye 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.

(1) Significance:  Relationship of the proposed program area in which to 
develop a clinical research capability with the NEI's published priorities as 
set forth in "Vision Research--A National Plan:  1999-2003"

(2) Approach:  Description of the initial problem(s) proposed for study and an 
outline of long-range plans for continuing the studies after termination of 
the requested support;  identification of any potential difficulties that may 
arise in carrying out these plans and proposed strategies for remedial action 

(3) Innovation:  Documentation of the need for, uniqueness of, and probable 
impact of, developing an enhanced clinical vision research capability; 
possible future directions for clinical vision research by the applicant group

(4) Investigator:  Professional background and training of key personnel, with 
special reference to research interests (current and/or planned), experience, 
and administrative capability; identification, even if tentative, of the 
specific person or category of person to be sought and this person's training 
and background; specific, detailed plans for the role this individual will 
play in the development of an enhanced clinical vision research capability; 
evidence of a "critical mass" of potential investigators who can reasonably be 
expected to contribute to the development of a clinical vision research 
capability

(5) Environment:  Opportunities for the proposed individual(s) to formally or 
informally interact with colleagues in Schools of Public Health, Departments 
of Biostatistics, etc.; existence of the requisite research facilities and 
other resources; evidence of institutional personnel, space, and resources for 
developing a clinical vision research program; institutional commitment to the 
continuation of the program beyond the period of NEI support

In addition to the above 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, availability of 
funds, and program priority.

INQUIRIES

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

Direct inquiries regarding programmatic issues to:

Mary Frances Cotch, Ph.D.; Donald F. Everett, M.A.; or Natalie Kurinij, 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) 496-5983
FAX:  (301) 402-0528
Email:  mfcotch@nei.nih.gov, deverett@nei.nih.gov, kurinij@nei.nih.gov

Direct inquiries regarding fiscal matters to:

William W. Darby
Grants Management Officer
Division of Extramural Research
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.  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.


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