AGING INTERVENTION TESTING PROGRAM

RELEASE DATE:  April 9, 2002

RFA:  AG-02-005 - (Reissued as RFA-AG-09-013)

National Institute on Aging (NIA)
 (http://www.nih.gov/nia/)

LETTER OF INTENT RECEIPT DATE: August 9, 2002

APPLICATION RECEIPT DATE:  September 12, 2002

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o  Purpose of this RFA
o  Research Objectives
o  Mechanism of Support
o  Funds Available
o  Eligible Institutions
o  Individuals Eligible to Become Principal Investigators
o  Special Requirements
o  Where to Send Inquiries
o  Letter of Intent
o  Submitting an Application
o  Peer Review Process
o  Review Criteria
o  Receipt and Review Schedule
o  Award Criteria
o  Required Federal Citations

PURPOSE OF THIS RFA

The National Institute on Aging (NIA) invites applications for cooperative 
agreements (U01s) from groups of investigators capable of, and interested in, 
becoming components of an Aging Intervention Testing Program (also referred 
to below as the Testing Program).  The main purpose of this program is to 
test, under standardized conditions in multiple sites, potential intervention 
strategies which may decelerate the rate of aging in mammals.  Awards will be 
made to groups of investigators whose scientific and technical expertise and 
facilities will enable them to age mice in specific pathogen-free 
environments, and perform pathological, biochemical, physiological, cognitive 
and other behavioral assessments of functional status.  Whereas longitudinal 
assessment is generally preferred, when necessary, invasive assessments will 
have to be done cross-sectionally.  The assessment approaches used will 
reflect the blend of experience and creativity of the component groups, 
although standardized protocols will ultimately be developed by participants 
in the Testing Program.  It is anticipated that positive results could be 
followed up with clinical trials to establish safety and efficacy in an 
appropriate human population, but not as a component of this Testing Program.  
A secondary goal is to identify interventions that are not safe or are not 
effective in delaying at least one significant adverse aspect of aging in 
mice, such knowledge would be highly relevant in assessing appropriate 
candidates for clinical trials.

Potential applicants are directed to the following publication for further 
discussion of this initiative:  Warner HR, et al., 2000.  Meeting report:  
Program for testing biological interventions to promote healthy aging.  Mech. 
Ageing Dev. 115: 199-208.

RESEARCH OBJECTIVES

Objectives

The objectives of this Program are:  1) to choose interventions which have 
either already been shown in peer-reviewed reports to have some potential to 
extend life span in an animal model system and/or postpone age-related 
pathology or disability, or are promising candidates based on well-accepted 
hypotheses about aging mechanisms,  2) to perform phase 1 studies, including 
survival analysis and longitudinal body weight analysis to 50% survivorship, 
plus gross pathology assessment at time of death, and based on these results, 
determine which interventions to elevate to phase 2 studies,  3) to perform 
phase 2 studies for comprehensive evaluation, which may include some invasive 
endpoints, including drawing blood.

Detailed objectives include:

1.  Identifying interventions that increase mean life expectancy by at least 
10% in phase 1 studies which may be terminated at 50% survivorship.  
Applicants should indicate how many mice will be used per group to achieve at 
least 80% power in this analysis.  This survival analysis must be accompanied 
by longitudinal body weight measurements, and gross pathology assessment at 
time of death, following other age-sensitive traits in this phase is 
optional.  These studies should be carried out with both males and females to 
detect whether effects are gender-specific.  Caloric intake must be monitored 
to determine whether the intervention alters food intake.

2.  Carrying out phase 2 studies that must include a complete survival 
analysis, accompanied by assessment of at least 5 age-sensitive endpoints per 
intervention, plus pathology assessment at time of death.  Examples of 
endpoints include, but are not limited to: various measures of behavior, 
cognitive or sensory function, motor activity, T-cell subset analysis and 
other immune responses, indicators of stress, particularly oxidative stress, 
and resistance to stress, protein glycation or other protein modification, 
and changes in gene expression.  The absence of actual validated biomarkers 
of aging requires that the Testing Program must rely on "best judgment" of 
informative age-sensitive traits to use as surrogate biomarkers.  Applicants 
should propose a variety of such endpoints and provide justification for the 
endpoints chosen to evaluate interventions, and details of the methodologies 
to be used, although consensus about the actual protocols to be used across 
sites will be developed by the Steering Committee early in the program.  
Whereas longitudinal studies are preferred, in some cases cross-sectional 
studies may be necessary.  

3.  Because the purpose of the program is to not only identify effective and 
safe interventions, but also eliminate from further study interventions that 
are not effective and safe, publication of all results by the PI(s) in a 
scientific journal are strongly encouraged.

The research plan

Grants funded under this program must be interdisciplinary efforts.  It is 
expected that applicants will have experience in biogerontology, and either 
have, or have access to, a specific pathogen-free facility.  In their 
research plan, applicants should provide a cross-disciplinary team approach 
to fulfill the objectives of this RFA.  Applicants should detail all the 
unique and specialized facilities, equipment, research expertise and core 
resources and services that are available to evaluate the effect of 
interventions on age-related changes and the development of age-related 
pathology.  An animal pathologist must be included among the personnel.  If 
facilities and expertise other than those at the applicant institution are 
required, applicants should thoroughly describe them and obtain the 
appropriate assurances.

The research plan should also include information about how many animals 
would be used in a survival analysis, and details about what would be 
included in both a gross and comprehensive pathology assessment.  Although 
how the proposed tests will be performed should be briefly described, actual 
details about the interventions to be tested, and the details such as dosage 
to be used, manner of administration, frequency and manner of sampling will 
be determined by the Steering Committee, based on recommendations forwarded 
to it by the Access Panel (see SPECIAL REQUIREMENTS).

Applicants should indicate their willingness to collaborate and share data 
freely, and to participate in the required meetings with members from the 
other sites involved in the Testing Program.

Before preparing their applications, applicants should review the 
SUPPLEMENTAL INSTRUCTIONS under SUBMITTING AN APPLICATION.

MECHANISM OF SUPPORT

This RFA will use the NIH cooperative agreement (U01) award mechanism.  As an 
applicant you are solely responsible for planning, directing, and executing 
the proposed project.  The anticipated award date is April 1, 2003.

The NIH (U01) is a cooperative agreement award mechanism in which the 
Principal Investigator retains the primary responsibility and dominant role 
for planning, directing, and executing the proposed project, with NIH staff 
being substantially involved as a partner with the Principal Investigator, as 
described under the section "Cooperative Agreement Terms and Conditions of 
Award".

If this program is funded and appears to be successful, it is anticipated 
that a follow-up RFA will be issued to facilitate renewal of the Program in 
five years.

FUNDS AVAILABLE

The NIA intends to commit up to $900,000 in FY 2003 to fund up to 3 new 
awards to 3 different sites in response to this RFA.  Budget requests should 
not exceed $200,000 direct costs in the first budget period.  Should an 
applicant plan to include subcontracts to other institutions or 
organizations, only the direct costs associated with the subcontracts will be 
used to tally the direct costs that apply toward the first year cap of 
$200,000.  The annual direct costs will increase each year to a maximum of 
about $500,000 in year 5.  This program will not use modular budgets.  
Applications should provide 5-year budget requests based on the following 
target estimates of annual direct costs per site:

Year 1:  $200,000
Year 2:  $275,000
Year 3:  $375,000
Year 4:  $500,000
Year 5:  $500,000

The budget projections listed above are estimates and should be regarded as 
approximate targets in the application.  The gradual escalation reflects the 
intent to start a limited number (up to 3) of phase 1 studies each year per 
site, with increases beginning in year 4 when phase 2 studies are initiated.  
It is assumed that only one or two out of every three phase 1 studies begun 
each year will eventually lead to phase 2 studies.  Thus, for the first 3 
years only phase 1 studies will be conducted.  From year 4 onward, it is 
expected that both phase 1 and phase 2 studies will be ongoing at every site.

Although the financial plans of the NIA provide support for this program, U01 
awards pursuant to this RFA are contingent upon the availability of funds for 
this purpose in fiscal year 2003, and the receipt of a sufficient number of 
meritorious applications.

ELIGIBLE INSTITUTIONS

You may submit an application if your institution has any of the following 
characteristics:

o  For-profit or non-profit organizations 
o  Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o  Units of State and local governments
o  Eligible agencies of the Federal government
o  Domestic

Applications may represent a single institution, or may involve several 
institutions or organizations.  Applications will not be accepted from 
foreign institutions, however, foreign institutions may establish sub-
contract arrangements with domestic applicant institutions.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support.  Racial/ethnic minority individuals, 
women, and persons with disabilities are encouraged to apply as principal 
investigators.

SPECIAL REQUIREMENTS

The following terms and conditions will be incorporated into the U01 award 
statement, and will be provided to the PI and the awardee institutional 
official at the time of award.

Cooperative Agreement Terms and Conditions of Award

These special Terms of Award are in addition to, and not in lieu of, 
otherwise applicable OMB administrative guidelines, HHS Grant Administration 
Regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant 
Administration policy statements.

The administrative and funding instrument used for the applicants to this 
program is a cooperative agreement (U01), an "assistance" mechanism (rather 
than an "acquisition" mechanism) in which substantial NIH scientific and/or 
programmatic involvement with the awardee is anticipated during performance 
of the activity.  Under the cooperative agreement, the NIH purpose is to 
support and/or stimulate the recipient"s activity by involvement in and 
otherwise working jointly with the award recipient in a partner role, but it 
is not to assume direction, prime responsibility, or a dominant role in the 
activity.  Consistent with this concept, the prime responsibility for the 
activity resides with the awardee(s) for the project as a whole, although 
specific tasks and activities in carrying out the studies will be shared 
among the awardees and the NIA Program Scientist through the Steering 
Committee.

Awardee Rights and Responsibilities

The PI of a U01 grant will have primary authority and responsibility to 
define objectives and approaches, and to plan, conduct, and analyze results, 
interpretations, and conclusions of studies conducted under the terms and 
conditions of the cooperative agreement award, provided these are not in 
conflict with the goals, priorities, procedures and policies agreed upon by 
the Steering Committee.  The PI will coordinate project activities 
scientifically and administratively at the awardee institution, and at the 
other sites that may be supported by sub-contracts to this award.  The PI 
will assume responsibility and accountability to the applicant organization 
officials and to the NIA for the performance and proper conduct of the 
research supported by the U01 in accordance with the terms and conditions of 
the award.

The PI will attend meetings of, and serve as a voting member of, the Steering 
Committee. The PI will be responsible for accepting and implementing the 
goals, priorities, procedures, and policies agreed upon by the Steering 
Committee, for close coordination and cooperation with the other components 
of the Testing Program, the Steering Committee, and with the NIA staff.  The 
PI will submit periodic progress reports in a standard format to both the 
Steering Committee and the NIA.  The PI will also select an individual to 
serve on the Access Panel.

Effective conduct of the Testing Program goals will require electronic 
communication of data and other information between the PI and the other 
Program components and the NIA..

1.  NIA Extramural Staff Responsibilities

The NIA Program Scientist will exercise substantial scientific and 
programmatic involvement to assist, guide, coordinate and participate in the 
conduct of the Testing Program activities.  The NIA Program Scientist will 
attend and participate in all meetings of the Steering Committee as a voting 
member, and will provide liaison between the Steering Committee and the 
NIA/NIH.  The NIA Program Scientist will assist the Steering Committee in 
developing and drafting operating policies and policies for dealing with 
recurring situations that require a coordinated action.

An NIA Health Scientist Administrator will be the Program Director for this 
award, and will be responsible for normal programmatic and administrative 
stewardship of the award, the NIA Program Director may also serve as this NIA 
Program Scientist.

2.  Collaborative Responsibilities

STEERING COMMITTEE:  This Committee will be the main governing body of the 
Program.  Its voting members will include the PI of each award, at least an 
equivalent number of biogerontologists covering a broad range of 
gerontological expertise who are not affiliated with the Testing Program, and 
the NIA Program Scientist.  These additional members will be chosen by the 
PIs and the NIA Program Scientist.  The primary roles of the Steering 
Committee are to prioritize the interventions recommended by the Access 
Panel, develop consensus on testing protocols to be employed in phase 2 
studies, and decide which phase 1 studies will proceed to phase 2 studies.   
In carrying out these responsibilities, the Steering Committee should seek 
advice from outside experts as needed, and is encouraged to include the 
investigator(s) who either discovered or developed the potential intervention 
in their discussions as appropriate.  These individuals, when present at 
Committee meetings, will be temporary non-voting members of the Committee.  
In addition, the Steering Committee will also review manuscripts to be 
submitted for publication.

The Steering Committee will meet twice a year, or as needed.  The initial 
meeting will take place at the NIA in Bethesda, MD, with subsequent meetings 
at a location the Committee selects, and with which the NIA concurs.  The 
Steering Committee may, when it is deemed necessary, invite additional non-
voting scientific advisors to the meetings.  

ACCESS PANEL:  The function of the Access Panel is to nominate and review 
promising interventions to be tested in Phase 1 trials, these nominations may 
be made by anyone either within or outside of the Testing Program.  
Nominations should be accompanied by sufficient information, either published 
or unpublished, to permit the Access Panel to evaluate the potential efficacy 
of the intervention in mice.    

The Access Panel shall consist of one representative (not the PI) from each 
testing site, and at least three other scientists chosen by NIA staff from 
the biogerontology research community.  The Panel will include one non-voting 
NIA representative.  An intervention to be recommended for testing would 
require a majority vote of this panel.  

In evaluating the merit of a proposed intervention,  the Access Panel should 
solicit relevant information from a wide range of experts, and use both 
published and unpublished data. Where appropriate, the Panel is encouraged to 
include the investigator(s) who discovered or developed a potential 
intervention in their discussions as temporary non-voting members of the 
Panel.  Recommendations from this panel will be prioritized by the Steering 
Committee.

The Panel will meet twice a year, although some meetings may be conducted by 
telephone conference calls and/or by email.  Proceedings of the Access 
Panel"s meetings will be forwarded to the Steering Committee in writing, 
accompanied by appropriate supporting materials, and a priority rating, i.e. 
low, medium, high.  The NIA may provide limited funds to permit the Access 
Panel to widely publicize the Testing Program, and solicit nominations on an 
annual basis.

3.  Arbitration Panel

The function of this ad hoc Panel is to review any scientific or programmatic 
disagreement (within the scope of the U01 award) between U01 awardees and the 
NIA.  The panel will be composed of three members:  one selected by the 
Steering Committee (without NIA staff voting), or by an individual U01 
awardee in the event of an individual disagreement, a second member selected 
by the NIA, and, the third member selected by the two prior selected members.  
This special arbitration procedure in no way affects the awardee"s right to 
appeal an adverse action that is otherwise appealable in accordance with the 
PHS regulations at 42 CPR Part 50, subpart D and HHS regulation at 45 CPR 
Part 16.

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into three 
areas:  scientific/research, peer review, and financial or grants management 
issues.

o  Direct your questions about scientific/research issues to:

Huber R. Warner, Ph.D., Associate Director
Biology of Aging Program
National Institute on Aging
7201 Wisconsin Avenue
Gateway Building, Suite 2C231
Bethesda, MD 20892
TEL:  301/496-4996
FAX:  301/402-0010
Email:  warnerh@nia.nih.gov

o  Direct your questions about peer review issues to:

Mary Nekola, Ph.D., Chief
Scientific Review Office
National Institute on Aging
7201 Wisconsin Avenue, Room 2C212
Bethesda, MD 20892-9205
TEL:  301/496-9666
Email:  nekolam@nia.nih.gov

o  Direct your questions about financial or grants management issues to:

Ms. Linda Whipp, Grants Management Officer
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Avenue
Gateway Building, Suite 2N212
Bethesda, MD 20892
TEL:  301/496-1472
FAX:  301/402-3672
Email:  whippl@nia.nih.gov

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes 
the following information:

o  Descriptive title of the proposed research
o  Name, address, and telephone number of the Principal Investigator
o  Names of other key personnel and participating institutions
o  Number and title of this RFA

Although a letter of intent is not required, is not binding, and does not 
enter into the review of a subsequent application, the information that it 
contains allows NIA staff to estimate the potential review workload and plan 
the review.

The letter of intent is to be sent by the date listed at the beginning of 
this document.  The letter of intent should be sent to:

Huber R. Warner, Ph.D., Associate Director
Biology of Aging Program
National Institute on Aging
7201 Wisconsin Avenue
Gateway Building, Suite 2C231
Bethesda, MD 20892
TEL:  301/496-4996
FAX:  301/402-0010
Email:  warnerh@nia.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001) available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact Grants Info, Telephone: 301/710-0267, 
Email: grantsinfo@nih.gov.

SUPPLEMENTAL INSTRUCTIONS:  For standardization of research protocols, 
applicants should prepare a research plan consistent with the following 
conditions:

1.  Four-way cross, genetically heterogeneous mice generated by the NIA under 
contract to a commercial supplier are recommended for use in this Testing 
Program to ensure consistency and that results obtained will not be strain-
specific.  Such mice are produced by mating two F1 hybrid populations with 
each other so that each mouse will share a random 50% of its genes with its 
siblings.  Currently the NIA is generating two F1 hybrid populations by 
crossing BALB/cJNia mice with C57BL/6JNia mice, and C3H/HeJNia mice with 
DBA/2JNia mice and then crossing these hybrids to obtain a genetically 
heterogeneous population of mice.  These mice will be provided at 4 months of 
age through the NIA Office of Biological Resources and Resource Development 
(TEL: 301/496-0181) at the usual NIA-subsidized price.  

With scientific justification, other genotypes may be used with concurrence 
of the Steering Committee.  However, budget limitations may preclude 
performing many tests on multiple strains.

2.  The mice will have ad libitum access to sterilized NIH31 food and 
sterilized water, and will be maintained in a specific pathogen-free barrier 
facility on a 12/12 hr light-dark cycle.  For these studies the mice must be 
maintained free of Helicobacter, Mycoplasma, Salmonella, Pasteurella, 
Bordetella, Pseudomonas, Citrobacter and Corynebacter.  Mice must also be 
maintained virus-antibody free for MHV, Sendai, PVM, Reo3, TMEV GDVII, MVM, 
parvovirus, ectromelia, MAD, polyoma, rotavirus, LCM, Hantaan, K-virus, MCMV 
and E. Cunicuii.  Mice must also be free of external parasites and 
pathological internal parasites.  Sentinel mice housed in the same room(s) as 
the test mice must be submitted for health evaluation quarterly.  Health 
assessments should include all of the above   mentioned organisms as well as 
Staphybococcus, Streptococcus and Klebsiella.  Mice should be group housed, 
maximum of 4 per cage, with their original cage mates as shipped from the 
supplier.  Cage sizes and all other husbandry issues not specifically 
addressed must conform to DHHS standards as published by ILAR in Guide for 
the Care and Use of Laboratory Animals, 1996, available online at 
http://www.nap.edu/catalog/5140.html.

3.  Applicants are requested to propose age-sensitive endpoints to be 
measured, although the actual endpoints to be measured for each intervention, 
and standardized assay procedures for use in phase 2 studies, will eventually 
be established by the Steering Committee (see SPECIAL REQUIREMENTS) to 
facilitate reliable comparison of results among sites.

4.  To reduce the possibility for bias, the animal handlers and researchers 
should be blinded with regard to treatment status of each animal.

Applicants should construct a tentative budget that clearly outlines the 
costs of what they propose to do in each phase 1 and phase 2 trial.  However, 
budgets will be adjusted by NIA staff, on an annual basis, to reflect 1) the 
resources available for this program, and 2) the composition of the studies 
anticipated each year at each funded site.  Estimates should be provided for 
the anticipated average cost per given assay per animal to facilitate these 
adjustments of budgets each year, as required to reflect the number of 
interventions actually under study each year in both phase 1 and phase 2 
studies.  The PI must budget for travel and per diem expenses for a total of 
4 Access Panel and Steering Committee meetings per year, at the rate of 1
person per meeting.

USING THE RFA LABEL:  The RFA label available in the PHS 398 (rev. 5/2001) 
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 RFA title, 
"Aging Intervention Testing Program", and number, RFA AG-02-005, must be 
typed on line 2 of the face page of the application form and the YES box must 
be marked.  The sample RFA label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.

SENDING AN APPLICATION TO THE NIH:  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)

At the time of submission, two additional signed photocopies of the 
application must also be sent to:

Chief of Review
Scientific Review Office
National Institute on Aging
7201 Wisconsin Avenue, Room 2C212
Bethesda, MD 20892-9205

APPLICATION PROCESSING:  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 Review (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 a substantial 
revision of an application already reviewed, but such an application must 
include an Introduction addressing the previous critique.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR, and 
for responsiveness by the NIA.  Incomplete and/or non-responsive applications 
will be returned to the applicant without further consideration.

Incomplete and/or non-responsive applications will be returned to the 
applicant without further consideration.

Applications that are complete and responsive to the RFA will be evaluated 
for scientific and technical merit by an appropriate peer review group 
convened by the NIA in accordance with the review criteria stated below.  
There will be no site visits.  Applications must be complete at the time of 
submission.  The Scientific Review Office of the NIA will determine whether 
late materials will be accepted.  If so, they will be limited to three typed 
pages, and the Scientific Review Administrator in charge of the review must 
authorize their submission.  As part of the initial merit review, all 
applications will:  

o  Receive a written critique
o  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, and assigned a priority score.
o  Receive a second level review by the National Advisory Council on Aging 
(NACA).

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.  

o  Significance
o  Approach
o  Innovation
o  Investigator
o  Environment

The scientific review group will address and consider each of these criteria 
in assigning the overall score, weighting them as appropriate for each 
application.  Your 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.  Applicants are encouraged to submit and describe their own 
ideas about how best to meet the goals of the Testing Program, and are 
expected to address issues identified under "SPECIAL REQUIREMENTS".  The peer 
review group will assess the merit of the applications and related factors, 
including:

1.  SIGNIFICANCE:  Are the age-sensitive endpoints proposed for evaluating 
interventions appropriate?

2.  APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed and appropriate to the aims of the Testing Program?  
Does the applicant acknowledge potential problem areas and consider 
alternative tactics?  Are the parameters chosen to characterize interventions 
sufficient and appropriate?  Would they be relevant to evaluating 
effectiveness in human clinical trials?

3.  INNOVATION:  Does the project employ novel concepts, approaches or 
methods? Is the project original and innovative?  Does the project challenge 
existing paradigms or develop new methodologies or technologies?   

4.  INVESTIGATORS:  Are the principal investigator and his/her collaborators 
appropriately trained and well suited to carry out this work?  To what extent 
do these investigators have the necessary complementary skills?  Have 
collaborations been established or consultants identified to provide the 
appropriate depth and breadth of scientific expertise required for the 
project?  Will this team of investigators contribute unique skills to the 
Testing Program?  Factors considered to be important for review include a 
multi-disciplinary team of collaborators, substantial interactions among 
collaborating researchers, demonstration of appropriate facilities and 
resources, willingness to share data and reagents freely. 

5.  ENVIRONMENT:  Are the facilities for mouse maintenance and 
experimentation appropriate to support the endeavor?  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 and incorporate the best use of collaborative 
arrangements?  Is there evidence of institutional support?

6.  INTERACTION AND DATA SHARING:  Are there adequate plans for effective 
interaction and coordination among Testing Program components and the NIA?  
Do the investigators state their willingness to collaborate extensively and 
share information fully?  Do the investigators state their willingness to 
abide by the priorities and policies agreed upon by the Steering Committee? 

ADDITIONAL REVIEW CRITERIA:  In addition to the above criteria, your 
application will also be reviewed with respect to the following:

ANIMAL WELFARE:  Are there adequate plans for protection of animals during 
the testing protocol?

BUDGET:  Does the apportionment of the budget among fundamental 
infrastructure, and intervention testing indicate that the applicants 
understand the requirements of managing this sort of enterprise?  Is the 
budget reasonable?

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  August 9, 2002
Application Receipt Date:  September 12, 2002
Council Review:  January 2003
Earliest Anticipated Award Date:  April 1, 2003

AWARD CRITERIA

Award criteria that will be used to make award decisions include: 

o  Scientific and technical merit (as determined by peer review)
o  Availability of funds
o  Programmatic priorities

REQUIRED FEDERAL CITATIONS

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT:  The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds, and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at:  
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this RFA in a public 
archive, which can provide protection for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application.

URLS IN NIH GRANT APPLICATIONS OR APPENDICES:  All applications and proposals 
for NIH funding must be self-contained within the usual page limitations.  
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.

HEALTHY PEOPLE 2010:  The Public Health Services (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 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.

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of 
Federal Domestic Assistance No. 93.866.   Awards are made under authorization 
of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 
241 and 284), and administered under NIH grants policies and Federal 
Regulations 42 CFR 52 and 45 CFR Part 74 and Part 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, 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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

			Department of Health and Human Services (HHS)
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