HYPERACCELERATED AWARD/MECHANISMS IN IMMUNOMODULATION TRIALS

Release Date:  October 24, 2000

RFA:  AI-01-001

National Institute of Allergy and Infectious Diseases
National Institute on Aging
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
National Institute of Neurological Disorders and Stroke

Letter of Intent Receipt Date:  One month prior to application receipt date.
Application Receipt Date:  Applications will be accepted MONTHLY on the 9th of 
each month.

THIS RFA USES "MODULAR GRANT" CONCEPTS AND JUST IN TIME. THIS RFA 
INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS 
THAT MUST BE USED WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS 
RFA. 

PURPOSE

The National Institute of Allergy and Infectious Diseases (NIAID), the 
National Institute on Aging (NIA), the National Institute of Arthritis 
and Musculoskeletal and Skin Diseases (NIAMS), the National Institute 
of Diabetes and Digestive and Kidney Diseases (NIDDK), and the National 
Institute of Neurological Disorders and Stroke (NINDS) of the National 
Institutes of Health (NIH) invite investigator-initiated research 
applications for mechanistic studies in clinical trials of 
immunomodulatory interventions for immune system mediated diseases, 
including, but not limited to, asthma and allergy, graft failure in 
solid organ, tissue, cell and stem cell transplantation, and autoimmune 
diseases.  Specifically, this Request for Applications (RFA) is a 
continuation and modification of RFA AI-00-005.  It focuses on the 
inclusion of patients and utilization of patient samples for the 
evaluation of immunologic and other relevant parameters to facilitate 
the study and definition of immunological mechanisms underlying the 
intervention, the mechanisms of disease pathogenesis, 
surrogate/biomarkers markers of disease activity and therapeutic 
effect, and mechanisms of human immunologic function. The parent or 
core clinical trial must have independent financial support and will 
NOT receive support under this RFA.  Proposed mechanistic studies 
associated with clinical trials supported by industry are particularly 
encouraged but clinical trials supported by any source, public or 
private, are eligible.

In order to review and confer awards to applications received in 
response to this RFA in a timely fashion without delay of the parent or 
core clinical trial, NIAID has developed a pilot project in 
collaboration with the Center for Scientific Review (CSR): NIAID/CSR 
PILOT OF HYPERACCELERATED REVIEW/AWARD.  All applications responding to 
this RFA will be subject to this hyperaccelerated review/award process.  
Highly meritorious applications selected for funding under this RFA 
will receive their awards thirteen weeks after the application receipt 
date.  Holidays and other circumstances may alter this schedule 
slightly.

HEALTHY PEOPLE 2010

The Public Health Service (PHS) is committed to achieving the health 
promotion and disease prevention objectives of "Healthy People 2010," a 
PHS led national activity for setting priority areas. This Request for 
Applications (RFA), Title of RFA, is related to one or more of the 
focus areas. Potential applicants may obtain a copy of "Healthy People 
2010" at http://www.health.gov/healthypeople.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign for-profit and 
non-profit organizations; public and private institutions, 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

The mechanism of support will be the individual research project grant 
(R01).  The total requested project period for an application submitted 
in response to this RFA may not exceed four years.  Some sponsoring 
Institutes may administratively limit the duration of award.  
Applicants for the R01 mechanism must not exceed a first-year limit of 
$250,000 direct costs.  Modular grant procedures should be used.

Responsibility for the planning, direction, and execution of the 
proposed project will be solely that of the applicant.

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.

A notice of modification and update (OD-00-046) regarding modular 
grants was released on 7/24/00 and can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-046.html.

FUNDS AVAILABLE

The estimated total funds, direct and facilities and administrative 
(F&A), available for the first year of support for all awards made 
under this RFA in FY 2001 will be $1,850,000.  The usual NIH policies 
governing grants administration and management will apply.  
Although this program is provided for in the financial plans of the 
participating institutes, awards pursuant to this RFA are contingent 
upon the availability of funds for this purpose and the receipt of a 
sufficient number of applications of high scientific merit.  Funding 
beyond the first and subsequent years of the grant will be contingent 
upon satisfactory progress during the preceding years and availability 
of funds.

RESEARCH OBJECTIVES

Background

In December 1996, NIAID convened a workshop at which leading basic and 
clinical immunologists discussed the role the NIH should play in 
current and projected clinical trials for various immune mediated 
diseases.  It was considered likely that clinical trials of many new 
immunologic interventions would be supported by the 
pharmaceutical/biotechnology industry.  However, gaps in both knowledge 
and in research effort were identified which represent opportunities 
for the NIH to contribute to progress in this area.

There was agreement that the mechanisms underlying immunologic 
interventions are poorly understood even in cases where efficacy has 
been shown (e.g., allergen immunotherapy and IFN Beta treatment for 
multiple sclerosis.)  In addition, clinical trials supported by 
industry and other sources including NIH often do not include studies 
of underlying mechanisms.  There was consensus that high priority 
should be given to the utilization of patient samples from clinical 
trials in immunologic diseases for studies of the basic underlying 
mechanisms of therapeutic effect, immunologic function, and disease 
pathogenesis.

There was also agreement that the usual time required for grant review 
and funding is often incompatible with the time line of a clinical 
trial.  Specifically, when a clinical protocol is finalized (which is 
required for applications submitted under this RFA), investigators are 
often ready to begin as soon as Institutional Review Board approval is 
obtained.  NIAID was encouraged to develop a means of responding 
rapidly to opportunities to study underlying mechanisms in order to 
facilitate collaborations with industry-supported clinical trials.

These recommendations were strongly supported by a large number of 
investigators who participated in NIAID focus groups in the 
winter/spring of 1997.  The RFA AI-98-006 and the NIAID/CSR PILOT OF 
HYPERACCELERATED REVIEW/AWARD were developed in order to implement 
these recommendations and exploit the research opportunities 
identified.  Based on the successful implementation of RFA AI-98-006, 
the follow-up RFA AI-00-005 and the Pilot, the current RFA is being 
issued to continue this effort.

Research Objectives and Scope

The objective of this RFA is to support mechanistic research studies in 
clinical trials of immuno-modulatory interventions for immune system 
mediated diseases, including asthma and allergy, graft failure in solid 
organ and stem cell transplantation, and autoimmune diseases.  
Specifically, the goal is to utilize patients and patient materials 
from such trials for the evaluation of immunologic and other relevant 
parameters in order to study the underlying mechanisms of the 
intervention, the mechanisms of disease pathogenesis, surrogate markers 
of disease activity and therapeutic effect, and mechanisms of human 
immunologic function.  Such studies are not part of the parent or core 
clinical trial, and are commonly referred to as substudies or ancillary 
studies.  The parent or core clinical trial must have independent 
financial support and will NOT receive support under this RFA. Clinical 
trials supported by any source, public or private, are eligible.  
Clinical trials of any phase (i.e. I-IV) are eligible.  Examples of 
relevant research include, but are not limited to, the following:

o  Quantitation of disease-related, autoreactive or alloreactive 
lymphocytes using methods such as MHC/peptide tetramers, chimeric 
antibodies, or very early activation antigens.

o  Analysis of autoreactive or alloreactive cells by PCR for expression 
of genes implicated in immunity or inflammation, or by FACS for cell 
surface markers that identify functions (e.g., cytokine receptors that 
distinguish TH1 from TH2 or chemokine receptors or integrins that 
indicate preferential 
patterns of homing).

o  Assessment of reagents that can identify newly recognized 
populations of regulatory T cells (e.g., Valpha24JalphaQ bearing 
invariant T cells) which appear to be altered in autoimmune disease.

o  Identification and evaluation of cytokine and cytokine receptor 
polymorphisms and analysis for genetic linkage to disease. 

o  Use of high throughput technologies (e.g. chip technology using 
expressed sequence tags) to identify and evaluate genes activated in 
disease sites.

o  Identification of useful surrogate markers by correlation of the 
above parameters with disease activity and/or response to intervention.

o  Comparison of samples from peripheral blood with those from sites of 
disease, i.e., do peripheral blood samples provide useful information?

o  Assessment for the presence of molecular evidence (e.g. using PCR 
probes) of potential causative environmental agents.

The areas outlined above are not intended to be all-inclusive.

NOTE: Clinical trials in infectious diseases, which involve the immune 
system (e.g. AIDS and Lyme Disease), are NOT eligible for this RFA. 

SPECIAL REQUIREMENTS

To assist in the overall evaluation of this Pilot RFA, the Principal 
Investigators of grants funded under this RFA will be asked to provide 
brief (1-2 pages) summary report one year following the end of the 
funding period.  The reports will summarize the major scientific 
knowledge gained and identify other substantive outcomes such as 
publications, patents, and new grants, contracts, or research studies 
based on this mechanistic research.

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 are provided 
indicating 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 UPDATED "NIH Guidelines for Inclusion of Women and Minorities 
as Subjects in Clinical Research," published in the NIH Guide for 
Grants and Contracts on August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a 
complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: 
The revisions relate to NIH defined Phase III clinical trials and 
require: a) all applications or proposals and/or protocols to provide a 
description of plans to conduct analyses, as appropriate, to address 
differences by sex/gender and/or racial/ethnic groups, including 
subgroups if applicable; and b) all investigators to report accrual, 
and to conduct and report analyses, as appropriate, by sex/gender 
and/or racial/ethnic group differences.

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 may obtain copies of these policies from these sources or 
from the program staff (listed in INQUIRIES below) who may also provide 
additional relevant information concerning the policy.

URLS IN NIH GRANT APPLICATIONS OR APPENDICES
All applications and proposals for NIH funding must be self-contained 
within specified page limitations. Unless otherwise specified in an NIH 
solicitation, internet addresses (URLs) should not be used to provide 
information necessary to the review because reviewers are under no 
obligation to view the Internet sites. Reviewers are cautioned that 
their anonymity may be compromised when they directly access an 
Internet site.

LETTER OF INTENT

Prospective applicants are asked to submit, one month prior to the 
application receipt date, a letter of intent that includes: a 
descriptive title of the overall proposed research; the name, address 
and telephone number of the Principal Investigator, the identities of 
other key personnel and participating institutions and the number and 
title of this RFA.  Although the letter of intent is not binding and 
does not enter into the review of a subsequent application, the 
information that it contains allows NIH staff review to estimate the 
potential review workload and to plan the review. The Letter of Intent 
is to be sent to Dr. Politis at the address listed under INQUIRIES.

APPLICATION PROCEDURES

Applicants are strongly encouraged to contact program staff listed 
under INQUIRES with any questions regarding the responsiveness of their 
proposed project to the goals of this RFA.  

Applications are to be submitted on the grant application for PHS 398 
(rev. 4/98).  These forms are available at most institutional offices 
of sponsored research; 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; and on the Internet at 
http://grants.nih.gov/grants/funding/phs398/phs398.html

For purposes of identification and processing, item 2a on the face page 
of the application must be marked "YES" and the RFA number “AI-01-001” 
and the words "HYPERACCELERATED AWARD/MECHANISMS IN IMMUNOMODULATORY 
TRIALS" must be entered on the face page.

Applications must be received by the 9th of each month.  Applications, 
which are received after the 9th, will automatically be processed the 
following month.  Applications not received as a single package (See 
Special Instructions Section below) on the receipt date or not 
conforming to the instructions contained in PHS 398 (rev. 4/98) 
Application Kit (as modified in, and superseded by, the special 
instructions below, for the purposes of this RFA), will be judged non-
responsive and will be returned to the applicant.  

The RFA label available in the application form PHS 398 must be affixed 
to the bottom of the face page.  The RFA label and line 2 of the 
application must indicate the RFA number.  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. The sample RFA label 
available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been 
modified to allow for this change.  Please note this is in pdf format.

If the application submitted in response to this RFA is substantially 
similar to a grant application already submitted to the NIH for review, 
but that has not yet been reviewed, the applicant will be asked to 
withdraw either the pending application or the new one.  Simultaneous 
submission of identical applications will not be allowed, nor will 
essentially identical applications be reviewed by different review 
committees.  Therefore, an application that is essentially identical to 
one that has already been reviewed cannot be submitted in response to 
this RFA.  This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must 
include an introduction addressing the previous critique.

Submit a signed, typewritten original of the application, including the 
checklist; five signed, exact, single-sided photocopies; and five sets 
of appendix material in one package to:

PLEASE NOTE THAT THIS ADDRESSES IS DIFFERENT FROM THE INSTRUCTIONS IN 
THE PHS 398 APPLICATION KIT AND FAILURE TO COMPLY WILL RESULT IN 
DEFERRAL OF REVIEW. 

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 2030, MSC 7720
BETHESDA, MD 20892-7720
BETHESDA, MD 20817 (for express/courier service)

Applicants from 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.

SPECIAL INSTRUCTIONS FOR COMPLETION OF APPLICATIONS IN RESPONSE TO THIS RFA

The research plan in the application should be limited to 15 pages.  
The research plan includes specific aims, background and significance, 
preliminary studies, and research design and methods (Sections A to D).  
In the research plan, include a justification for why the proposed 
studies require the use of patients in this clinical trial as opposed 
to using patients with the same disease state but not in a trial. 

Methods of data analysis and power calculations must be included.  
Include a justification for the required sample size.  A restatement of 
the sample size calculations from the parent clinical trial is 
insufficient.  If appropriate to your application, discuss whether it 
is necessary to perform the mechanistic studies on all patients 
enrolled in the parent trial or whether a sub-sample would be 
sufficient.  There must be a discussion of the statistical procedures 
that will be used to analyze the data.  The manner in which 
immunological parameters will be related to the clinical outcomes in 
the main study should also be discussed. 

The protocol and the investigators’ brochure for the parent or core 
clinical trial should be included with the application as part of the 
human subjects’ section. Inclusion of the complete clinical protocol 
within the PHS 398 grant application is intended to simplify the 
application process by eliminating the need to duplicate protocol 
details in the Research Plan section. Informed Consent form(s) must 
also be included as part of this section.  While drafts of the consent 
forms at participating sites are not required, it would be useful to 
include them if they are available.  NIH will treat as confidential any 
scientific, preclinical, clinical, or formulation data and information 
that the sponsor deems to be proprietary and confidential.

Amended applications will be accepted for Hyperaccelerated Review/Award 
ONLY if invited by NIH.  Applicants with minor or easily corrected 
problems will be invited to submit an abbreviated amendment (5 page 
limit and one time only), which directly addresses the questions and 
concerns raised in the initial review.

In order to ensure coordination between the mechanistic studies and the 
parent or core clinical trial, the principal investigator and the 
sponsor of the parent or core clinical trial must provide written 
agreement for the conduct of the mechanistic studies as presented in 
the application.

Prior to award, the applicant must provide to the funding institute a 
memorandum of understanding signed by the applicant, an appropriate 
representative of the applicant institution, the principal investigator 
of the parent or core clinical trial, and an appropriate representative 
of the sponsor of the parent or core clinical trial.  This memorandum 
will indicate agreement and will outline the specifics of the agreement 
for the following areas: 1) data from the mechanistic studies 
(including ownership, analysis, access, and release), 2) access to the 
data from the parent or core clinical trial (how/when) which is needed 
to analyze the mechanistic studies, including procedures for prevention 
of unblinding of the parent trial, 3) documentation of quality 
assurance procedures for both the parent trial and the mechanistic 
studies, and documentation of Data Safety Monitoring procedures for the 
parent trial, especially for efficacy trials, 4) ownership of 
intellectual property developed during the mechanistic studies, and 5) 
publication of the results of the mechanistic studies.

MODULAR APPLICATION DETAILS:

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

BUDGET INSTRUCTIONS

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

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

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

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

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

o Under Personnel, list all project personnel, including their names, 
percent of effort, and roles on the project. No individual salary 
information should be provided. However, the applicant should use the 
NIH appropriation language salary cap and the NIH policy for graduate 
student compensation in developing the budget request.
For Consortium/Contractual costs, provide an estimate of total costs 
(direct plus 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: 
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. 

REVIEW CONSIDERATIONS  

Applications that are complete and responsive to the RFA will be 
evaluated for scientific and technical merit by a Scientific Review 
Group (SRG) established for the NIAID/CSR PILOT OF HYPERACCELERATED 
REVIEW/AWARD and convened in accordance with NIH peer review 
procedures.  As part of the initial merit review, all applications will 
receive a written critique, will be discussed by the SRG, assigned a 
priority score, and receive a second level review by the National 
Advisory Council of the assigned Institutes.  

Review Criteria

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 
analyses adequately developed, well integrated, and appropriate to the 
aims of the project?  Does the applicant acknowledge potential problem 
areas and consider alternative tactics?
 
3.  Innovation.  Does the project employ novel concepts, approaches or 
method?  Are the aims original and innovative? Does the project 
challenge existing paradigms or develop new methodologies or 
technologies? 

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

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

The initial review group will also examine: the appropriateness of 
proposed project budget and duration; the adequacy of plans to include 
both genders, minorities and their subgroups, and children as 
appropriate for the scientific goals of the research and plans for the 
recruitment and retention of subjects; adequacy of plans for including 
children as appropriate for the scientific goals of the research; the 
provisions for the protection of human and animal subjects; and the 
safety of the research environment.

AWARD CRITERIA
  
Funding decisions will be made on the basis of scientific and technical 
merit as determined by peer review, program balance, and the 
availability of funds.
 
INQUIRIES  
  
Written and telephone inquiries concerning this RFA are encouraged.  
The opportunity to clarify any issues or questions from potential 
applicants is welcome.

Direct inquiries regarding programmatic (research scope and 
eligibility) issues to:  

Stephen M. Rose, Ph.D.
Chief, Genetics and Transplantation Branch
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases
NIH
6700-B Rockledge Drive, Room 5130
Bethesda, MD 20892-7640
301.496.5598 voice
301.402.2571 fax
SRose@niaid.nih.gov

Anna M. McCormick, Ph.D.
Chief, Genetics and Cell Biology Branch
Genetics Program Director
Biology of Aging Program
National Institute on Aging
Gateway Building, Suite 2C231
Bethesda, Maryland  20892 (20814 for express deliveries)
Phone:  301-496-6402
FAX:	301-402-0010
mccormia@exmur.nia.nih.gov (or am38k@nih.gov)

Susana A. Serrate-Sztein, M.D.
Rheumatic Diseases Program
National Institute of Arthritis and Musculoskeletal and Skin Diseases
45 Center Drive, Room 5AS-25E, MSC 6500
Bethesda, MD  20892-6500
Telephone:  (301) 594-5032
FAX:  (301) 480-4543
Email: szteins@exchange.nih.gov

Joan T. Harmon, Ph.D.
Diabetes Research Section
National Institute of Diabetes and Digestive and Kidney Disease
45 Center Drive, Room 5AN-18G, MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-8808
FAX: (301) 480-3503
Email: jh90u@nih.gov 

A. P. Kerza-Kwiatecki, Ph.D.
Program Officer, DCIID
National Institute of Neurological Disorders and Stroke
Federal Building, Room 504
7550 Wisconsin Avenue
Bethesda, MD 20892
Telephone: 301-496-1431
FAX: 301-402-2060
E-Mail: ak45w@nih.gov

Direct inquiries regarding review issues and special instructions for 
application preparation to:

Alexander D. Politis, Ph.D.
Scientific Review Administrator
Special Study Section SSS-J
Center for Scientific Review, NIH
Room 4204, RKLII Building, MSC 7812
6701 Rockledge Drive
Bethesda, MD  20892-7812 (20817 for couriers)
Telephone:  301-435-1225
FAX:        301-480-4042
E-Mail:     politisa@csr.nih.gov

Direct inquiries regarding fiscal matters to:  

Sharie Bernard
Division of Extramural Activities  
National Institute of Allergy and Infectious Diseases  
Solar Building, Room 4B21 
6003 Executive Boulevard  
Bethesda, MD 20892-7610  
Telephone: 301-402-5540
FAX: 301-480-3780
E-mail: sb34k@nih.gov

Schedule

Letter of Intent Receipt Date:  One month prior to application receipt date.
Application Receipt Date:       9th of each month.
Earliest Award Date:            13 weeks after receipt of application.

AUTHORITY AND REGULATIONS

This program is supported under authorization of the Public Health 
Service Act, Sec. 301 (c), Public Law 78-410, as amended.  The 
Catalogue of Federal Domestic Assistance Citations are No. 93.855 - 
Immunology, Allergy, and Transplantation Research, No. 93.853, No. 
93.838, No. 93.846 –Aging, No.93.866 - Arthritis, Musculoskeletal and 
Skin Diseases Research, and No. 93.847 - Diabetes, Endocrinology and 
Metabolism Research. Awards will be administered under PHS grants 
policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74.  
This program is not subject to the intergovernmental review 
requirements of Executive Order 12372 or Health Systems review.

The Public Health Service strongly encourages all grant recipients to 
provide a smoke-free workplace and promote the non-use of all tobacco 
products.  In addition, Public Law 103-227, the Pro-Children Act of 
1994, prohibits smoking in certain facilities (or in some cases, and 
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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	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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