PLANNING GRANTS FOR BIOMEDICAL EPIDEMIOLOGIC AND INTERVENTION STUDIES

Release Date:  August 18, 1999

PA NUMBER:  PA-99-145

National Institute on Aging
National Institute of Environmental Health Sciences

THIS PA USED THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  IT INCLUDES
DETAILED MODIFICATIONS TO THE STANDARD APPLICATION INSTRUCTIONS THAT MUST BE
USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA.

PURPOSE

This program announcement (PA) is a reissuance of PAR-97-011, which was
published in the NIH Guide, Vol. 25, No. 39, November 15, 1996.

The National Institute on Aging (NIA) and National Institute of Environmental
Health Sciences (NIEHS) will provide grant support for planning and protocol
development of biomedical epidemiologic and intervention studies in research
areas supported by the Geriatrics Program (see RESEARCH OBJECTIVES section of
this program announcement).

The planning grant application and review process is intended to provide a
mechanism for peer review of the rationale and basic design of an
epidemiologic or intervention study which would require extensive detailed
protocols and/or complex organization for proper implementation.  The planning
grant itself is intended to provide support for the development of a refined
study design, organizational plan, detailed protocol, collection and analysis
of biological and/or environmental samples to generate preliminary data,
manual of Procedures, and budget, for implementation of studies whose
rationale and basic design are considered sufficiently meritorious.  After
these are completed, planning grant awardees may submit applications to
conduct the full-scale study.  These applications will also be peer-reviewed.

Thus, the planning grant mechanism is intended to facilitate careful and
detailed protocol development and peer review of proposed complex intervention
and epidemiologic studies through a two-stage process (rationale and basic
design first, detailed protocol and organization second), in order to minimize
unnecessary effort by applicants and reviewers, and allow careful scrutiny of
the methods proposed for projects whose basic rationale and design have been
judged to be of high quality.

HEALTHY PEOPLE 2000

Each NIH PA addresses one or more of 22 Health Promotion and Disease
Prevention priority areas identified. These areas can be found via the WWW at
http://odphp.osophs.dhhs.gov/pubs/hp2000

ELIGIBILITY REQUIREMENTS

Applications may be submitted by foreign and 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. Racial/ethnic minority individuals, women,
and persons with disabilities are encouraged to apply as principal
investigators.

Applicant institutions that have a General Clinical Research Center (GCRC)
funded by the NIH National Center for Research Resources may wish to identify
the GCRC as a resource for conducting the proposed research.  If so, a letter
of agreement from either the GCRC Program Director or Principal Investigator
should be included with the application.

MECHANISM OF SUPPORT

The mechanism of support will be the NIA Planning Grant (R21), which will
provide up to $150,000 in direct costs for one year. The award cannot be
renewed. Applicants should note that NIA or NIEHS funding of a planning grant
does not imply a commitment by NIA or NIEHS to fund the proposed full-scale
study, nor even to accept a subsequent application for such a study.

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

RESEARCH OBJECTIVES

The NIA Geriatrics Program supports biomedical research on clinically-oriented
aging topics. More detailed information on the range of research topics for
which the Geriatrics Program provides support is available on the Geriatrics
Program's section of the NIA Home Page http://www.nih.gov/nia/research/extramural/geriatrics/.
Additional information regarding specific topics may be obtained from the
staff contacts listed for specific research areas on the Home Page.

The NIEHS Division of Extramural Research and Training supports population-
based and laboratory research on the role of environment exposures in the
development conditions or diseases which affect human health.  Areas of
special emphasis can be reviewed at the NIEHS homepage
http://www.niehs.nih.gov/dert.  NIEHS is particularly interested in the
interaction between exposure to environmental toxicants, genetic
susceptibility, and timing of exposures throughout the lifespan.  Applicants
are encouraged to contact program staff to discuss specific research ideas.

Applicants for planning grants may request funds for activities such as:

o  Preparation of detailed protocols and a Manual of Procedures. These
protocols and the Manual must be included in the Final Report for this award.

o  Analyses of existing data needed for refinement of study design and
protocols (e.g., power calculations, dosage or intensity of intervention,
budget estimates).

o  Preliminary studies to guide selection of,  and/or refine, study procedures
and instruments, and estimate recruitment and retention potential, and
collection and analysis of biological and environmental specimens to
characterize exposure levels in the study groups.

o  Travel expenses of individuals from multiple sites to planning meetings for
the project.

The planning grant proposal should describe:

o  The principal hypotheses to be tested, and the rationale for doing so.

o  Basic study design, estimated sample size, and time course.

o  The intervention(s) (if any), populations (including general eligibility
and exclusion criteria), and outcomes to be studied, and the rationale for
their selection.

o  Outline of strategies for recruitment, retention, and maintenance of
subjects' adherence to study protocols.

o  Outline of methods for outcome measures and other measurements.

o  Outline of methods for data management and analysis.

o  The study elements to be planned or refined if the planning grant is
awarded. These must be included in the protocol and draft Manual of Procedures
to be produced by the awardees upon or before the end of the planning grant
award period: e.g., number and identity of sites; power and sample size
calculations; protocol elements; external data and safety monitoring
procedures; quality assurance of data and study protocols; external data and
safety monitoring; liaisons with industry (if any); data coordination and
standardization; and planned staffing, organization, and budget.

Applicants for planning grants for human intervention studies should review
the NIA document "Implementation of Policies for Human Intervention Studies"
(NIH Guide for Grants and Contracts: Vol. 25, No. 33; October 4, 1996).  This
is available in the "Grants and Contracts" section of the NIH Home Page
(http://www.nih.gov). Persons without access to the NIH Home Page may obtain
copies of the policy from: Office of Extramural Affairs, National Institute on
Aging; Gateway Building, Suite 2C218; Bethesda, MD 20892-9205. Phone (301)
496-9322)

o  Proposed preliminary analyses of existing data needed for refinement of
study design and protocols (e.g., power calculations, dosage or intensity of
intervention, budget estimates).

o  Proposed preliminary studies to guide selection of,  and/or refine, study
procedures and instruments, and estimate recruitment and retention potential.

o  The participants in the planning process, their roles in the development of
the plan, and their experience in related studies.

o  The organizational approach and timetable to be followed in developing the
protocol and draft Manual of Procedures over the course of the planning grant
award.

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 sub-populations 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,
https://grants.nih.gov/grants/guide/notice-files/not94-100.html

APPLICATION PROCEDURES

Applications are to be submitted on grant application form PHS 398 (rev.
4/98).  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) 710-0267,
Email:  GRANTSINFO@NIH.GOV. Applications are also available on the internet at 
https://grants.nih.gov/grants/funding/phs398/phs398.html .

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)

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 $150,000 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 $150,000) 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  Under 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.

For Consortium/Contractual costs, provide an estimate of total costs (direct
plus facilities and administrative) 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 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 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.

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established Public Health
Service referral guidelines.  Applications that are complete will be evaluated
for scientific and technical merit by an appropriate peer review group
convened in accordance with 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,
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 our understanding of
biological systems, improve the control of disease, and enhance health.  In
the written comments, reviewers will be asked to discuss the following aspects
of the application in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals.  Each of these
criteria will be addressed and considered in assigning the overall score,
weighting them as appropriate for each application.  Note that the application
does not need to be strong in all categories to be judged likely to have major
scientific impact and thus deserve a high priority score.  For example, an
investigator may propose to carry out important work that by its nature is not
innovative but is essential to move a field forward.

o  Significance:  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?

o  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?

o  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?

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

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

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 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:

o  Quality of the proposed project as determined by peer review
o  Availability of funds
o  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:

Evan C. Hadley, M.D.
Associate Director (Geriatrics)
National Institute on Aging
7201 Wisconsin Avenue, Suite 3E327, MSC 9205
Bethesda, MD  20892-9205
FAX:  (301) 402-1784
Email:  HadleyE@exmur.nia.nih.gov

Gwen W. Collman, Ph.D.
Program Administrator, Environmental and Molecular Epidemiology
National Institute of Environmental Health Sciences
P.O. Box 12233
Research Triangle Park, NC  27514
Telephone: (301) 541-4980
FAX:  (919) 541-4937
Email: Collman@niehs.nih.gov

Direct inquiries regarding fiscal matters to:

Mr. Joseph Ellis
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2N212, MSC 9205
Bethesda, MD  20892-9205
Telephone:  (301) 496-1472
FAX:  (301) 402-3672
Email: EllisJ@exmur.nia.nih.gov

Mr. David L. Mineo
Grants Management Officer
National Institute of Environmental Health Sciences
P.O. Box 12233
Research Triangle Park, NC  27514
Telephone: (301) 541-1373
FAX:  (919) 541- 2860
Email: Mineo@niehs.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.866.  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 PHS grants policies and Federal
Regulations 42 CFR 52 and 45 CFR Part 74.  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, 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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