PATHOGENESIS OF POLYOMAVIRUS ASSOCIATED NEPHROPATHY

RELEASE DATE:  May 12, 2003

RFA: AI-03-019

National Institute of Allergy and Infectious Diseases (NIAID)
 (http://www.niaid.nih.gov)

CATALOGUE OF FEDERAL DOMESTIC ASSISTANCE NUMBERS:
No. 93.855, Immunology, Allergy, and Transplantation Research
No. 93.856, Microbiology and Infectious Diseases Research

LETTER OF INTENT RECEIPT DATE: August 18, 2003
APPLICATION RECEIPT DATE: September 18, 2003

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism(s) 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 Division of Allergy, Immunology and Transplantation (DAIT) of the National 
Institute of Allergy and Infectious Diseases (NIAID) invites applications for 
basic, pre-clinical, clinical, and epidemiological research projects on 
polyomavirus associated nephropathy (PVAN), which is a serious, emerging 
complication in renal transplant recipients.  Research in this area will 
enhance: understanding of latent polyomavirus reactivation and virulence in 
immunosuppressed individuals; knowledge of immune responses to polyomavirus 
infection associated with nephropathy; risk assessment; and preventive, 
diagnostic and treatment strategies for PVAN.  This request for applications 
(RFA) will not support applications for clinical trials to investigate 
interventional strategies for PVAN.  

RESEARCH OBJECTIVES

Background

The polyomavirus family consists of 13 members of which BK virus (BKV) and JC 
virus (JCV) are most closely associated with human disease.  BKV is linked 
with hemorrhagic cystitis in bone marrow transplant recipients, ureteric 
stenosis in renal transplant recipients, and is thought to be the primary 
etiologic agent of PVAN.  PVAN is an inflammatory disease that occurs after 
renal transplantation and is characterized by viral inclusions, interstitial 
nephritis, and progressive allograft failure.  Over 60% of the population is 
infected with BKV by early childhood; however, primary infection likely occurs 
without clinical symptoms.  The virus remains latent in multiple cells and 
tissues, including peripheral blood lymphocytes, kidney, and brain.  

Improved immunosuppressive regimens have contributed to increases in one-year 
graft survival rates.  However, many serious side effects are associated with 
the use of immunosuppressive drugs.  Kidney transplant recipients are at risk 
for BKV reactivation and development of PVAN.  The incidence of PVAN in kidney 
transplant recipients is reported to be between one and five percent.  
However, due to variability in surveillance and detection methods, the actual 
incidence of PVAN may be higher.  The incidence of PVAN in extra-renal 
transplant recipients is unknown.  Up to 45% of PVAN-diagnosed patients 
develop irreversible graft failure.  Other than immunosuppression, risk 
factors associated with reactivation of latent polyomaviruses are poorly 
understood.  

Current procedures for polyomavirus detection include urine cytology, real-
time polymerase chain reaction (PCR) of viral DNA from peripheral blood 
mononuclear cells, plasma, urine, or renal tissue, and reverse transcriptase 
PCR of viral mRNA from urine.  However, detection of virus does not always 
correlate with disease.  At present, PVAN diagnosis requires allograft biopsy 
and histology.  Therefore, outstanding needs include:  less invasive 
diagnostic methods; more accurate viral detection assays; and better 
correlation of detection results with clinical status.  In addition, 
biomarkers for risk assessment and early indicators of PVAN are needed.  
Development of early, accurate BKV screening and detection methods will enable 
prompt treatment strategies to prevent tissue damage and graft failure.  

Approaches to treatment of PVAN include tapering of immunosuppressive therapy 
and administration of nonspecific antiviral agents.  Unfortunately, these 
treatment strategies increase the risk of graft rejections and nephrotoxicity, 
respectively.  Optimal therapy remains undefined.  There is a need for more 
effective, less toxic inhibitors of viral replication.  Whereas candidate 
antiviral therapies may be tested in vitro, an in vivo model of PVAN is 
necessary for pre-clinical safety and efficacy testing.  Animal studies of 
PVAN are needed for all aspects of the disease, including polyomavirus 
transmission, infection, reactivation, disease progression, and treatment 
strategies.

Research Goals and Scope

In August 2002, the NIAID and the NIH Office of Rare Diseases convened a 
workshop entitled "Polyomavirus Nephropathy in Immunosuppressed Kidney and 
Other Solid Organ Transplant Recipients."  At the workshop, virologists, 
nephrologists, and transplant surgeons discussed new research and clinical 
findings, gaps in knowledge, impediments, and future research directions.  The 
goal of this RFA, which is based in part on recommendations from workshop 
participants, is to stimulate research in PVAN, with particular emphasis on 
BKV.  It is anticipated that expertise in multiple disciplines may be required 
to address the effects of immunosuppression on BKV virulence and the 
development of PVAN.  The research scope of applications may include, but is 
not limited to, the following areas:  (1) risk factors for reactivation and 
pathogenesis of BKV, and epidemiology of PVAN, as related to transplantation; 
(2) immune reactivity to BKV infection;  (3) immune responses to BKV in PVAN-
diagnosed patients; (4) innovative PVAN diagnostic methods; and (5) 
development of rodent adapted BKV strains for evaluation of new strategies in 
PVAN prevention and treatment in the immunosuppressed host.  Thus, the general 
aims and scope of research projects proposed under this RFA may vary 
significantly.  This RFA will not support clinical trials.  Below are examples 
of research topics of major interest.  However, the list is not all-inclusive.

o  Determine the relative contribution of BKV infection/PVAN to allograft loss
o  Identify polyomavirus biomarkers for early diagnosis of PVAN and/or for use 
as therapeutic targets 
o  Identify T cell and/or antibody epitopes of BKV
o  Develop clinically applicable detection/diagnostic assays for BKV 
infection/PVAN
o  Identify viral/host factors and mechanisms critical to polyomavirus 
infection, persistence, and reactivation in immunosuppressed hosts
o  Characterize polyomavirus-specific and other immune responses during active 
infection, latency, reactivation, disease, and clearance 
o  Determine PVAN frequency and/or incidence of co-infection with different 
polyomavirus strains 
o  Determine modes of polyomavirus transmission 

MECHANISM OF SUPPORT

This RFA will use the NIH Individual Research Project Grant (R01) and 
Exploratory/Developmental Research Project Grant (R21) awards. The total 
requested project period for an application submitted in response to this RFA 
may not exceed five years for an R01 or two years for an R21. Applicants will 
be solely responsible for planning, directing, and executing the proposed 
project. This RFA is a one-time solicitation. Future unsolicited, competing-
continuation applications based on this project will compete with all 
investigator-initiated applications and will be reviewed according to the 
customary peer review procedures.

Applications that are not funded in the competition described in this RFA may 
be resubmitted as NEW investigator-initiated applications using the standard 
receipt dates for NEW applications described in the instructions to the PHS 
398 application.

This RFA uses just-in-time concepts. It also uses the modular budgeting 
format. (see http://grants.nih.gov/grants/funding/modular/modular.htm). 
Specifically, if the investigator is submitting an application with direct 
costs in each year of $250,000 or less, use the modular format. This program 
does not require cost sharing as defined in the current NIH Grants Policy 
Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. 

FUNDS AVAILABLE

The NIAID intends to commit approximately $1.2 million in FY2004 to fund two 
to six new R01 and/or R21 grants in response to this RFA. An applicant may 
request a project period of up to five years for an R01 or up to two years for 
an R21 application. The annual direct costs are capped at $500,000 for R01s 
and $100,000 for the R21 mechanism. Because the nature and scope of the 
proposed research will vary from application to application, it is anticipated 
that the size and duration of each award will also vary. Although the 
financial plans of the NIAID provide support for this program, awards pursuant 
to this RFA are contingent upon the availability of funds and the receipt of a 
sufficient number of meritorious applications. 

ELIGIBLE INSTITUTIONS

The applicant may submit (an) application(s) if the 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 or foreign

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. Individuals from underrepresented racial and 
ethnic groups as well as individuals with disabilities are always encouraged 
to apply for NIH programs.

SPECIAL REQUIREMENTS

When clinical studies or trials are a component of the research proposed, 
NIAID policy requires that studies be monitored commensurate with the degree 
of potential risk to study subjects and the complexity of the study. An updated 
NIAID policy was published in the NIH Guide on July 8, 2002 and is available 
at: http://grants.nih.gov/grants/guide/notice-files/NOT-AI-02-032.html. 
The full policy, including terms and conditions of award, is available at: 
http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf.

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 questions about scientific/research issues to:

Patricia Kehn, M.S.
Division of Allergy, Immunology, and Transplantation
National Institute of Allergy and Infectious Diseases
Room 5249, MSC-7640
6700-B Rockledge Drive
Bethesda, MD 20892-7640
Telephone:  (301) 496-5598
FAX:  (301) 480-0693
Email:  [email protected]

o Direct questions about peer review issues to:

Madelon Halula, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2150, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Telephone:  (301) 402-2636
FAX:  (301) 402-2638
Email:  [email protected]

o Direct questions about financial or grants management matters to:

Ann Devine
Division Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2118, MSC-7614
6700-B Rockledge Drive
Bethesda, MD 20892-7614
Telephone:  (301) 402-5601
FAX:  (301) 402-5601
Email:  [email protected] 

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
o 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 IC 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:

Madelon Halula, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2150, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Telephone:  (301) 402-2636
FAX:  (301) 402-2638
Email:  [email protected] 

SUBMITTING AN APPLICATION

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

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting 
up to $250,000 per year in direct costs must be submitted in a modular grant 
format. The modular grant format simplifies the preparation of the budget in 
these applications by limiting the level of budgetary detail. Applicants 
request direct costs in $25,000 modules. Section C of the research grant 
application instructions for the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step 
guidance for preparing modular grants. Additional information on modular 
grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

SUPPLEMENTAL INSTRUCTIONS FOR R21 APPLICATIONS: To apply, please follow NIH 
guidelines for submission of an R21 application as listed below: 

1) The description (abstract) must include a brief explanation of the proposed 
activity, and how it is consistent with the exploratory/development nature of 
the R21 mechanism as described in this notice. 

2) Although preliminary data are neither expected nor required for an R21 
application, they may be included. 

3) Sections a-d of the Research Plan may not exceed 10 pages, including tables 
and figures. 

4) Appendix materials should be limited, as is consistent with the exploratory 
nature of the R21 mechanism, and should not be used to circumvent the page 
limit for the research plan. Copies of appendix material will only be provided 
to the primary reviewers of the application and will not be reproduced for 
wider distribution. The following materials may be included in the appendix: 

o Up to five publications, including manuscripts (submitted or accepted for 
publication), abstracts, patents, or other printed materials directly relevant 
to the project. These may be stapled as sets. 

o Surveys, questionnaires, data collection instruments, and clinical 
protocols. These may be stapled as sets. 

o Original glossy photographs or color images of gels, micrographs, etc., 
provided that a photocopy (may be reduced in size) is also included within the 
10-page limit of items a-d of the research plan. 

Include five collated sets of all appendix material, in the same package with 
the application, following all copies of the application. Identify each item 
with the name of the principal investigator.

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 and number 
must be typed on line 2 of the face page of the application form and the YES 
box must be marked. The 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 exact copies of the grant 
application and all five sets of any appendix material must be sent to:

Madelon Halula, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2150, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Bethesda, MD 20817 (for express mail or courier service)

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. 
However, when a previously unfunded application, originally submitted as an 
investigator-initiated application, is to be submitted in response to an RFA, 
it is to be prepared as a NEW application. That is the application for the RFA 
must not include an Introduction describing the changes and improvements made, 
and the text must not be marked to indicate the changes. While the 
investigator may still benefit from the previous review, the RFA application 
is not to state explicitly how.

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the (IC). Incomplete applications will be returned to the 
applicant without further consideration. And, if the application is not 
responsive to the RFA, NIH staff may contact the applicant to determine 
whether to return the application to the applicant or submit it for review in 
competition with unsolicited applications at the next appropriate NIH review 
cycle.

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 (IC) in accordance with the review criteria stated below. As part of the 
initial merit review, all applications will:

o Receive a written critique
o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a second level review by the National Advisory Allergy and 
Infectious Diseases 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: 

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 application's overall score, weighting them as appropriate 
for each application. 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.

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?

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?

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

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)?

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?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following 
items will be considered in the determination of scientific merit and the 
priority score:

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human 
subjects and protections from research risk relating to their participation in 
the proposed research will be assessed. (See criteria included in the section 
on Federal Citations, below).

INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans 
to include subjects from both genders, all racial and ethnic groups (and 
subgroups), and children as appropriate for the scientific goals of the 
research. Plans for the recruitment and retention of subjects will also be 
evaluated. (See Inclusion Criteria in the sections on Federal Citations, 
below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to 
be used in the project, the five items described under Section f of the PHS 
398 research grant application instructions (rev. 5/2001) will be assessed.

ADDITIONAL CONSIDERATIONS

DATA SHARING: The adequacy of the proposed plan to share data.

BUDGET: The reasonableness of the proposed budget and the requested period of 
support in relation to the proposed research.

MULTI-CENTER STUDIES: Since the PVAN incidence at a single center may preclude 
appropriate statistical analysis, multi-center epidemiology studies are 
encouraged.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:   August 18, 2003
Application Receipt Date:        September 18, 2003
Peer Review Date:                January, 2003
Council Review:                  January 26, 2004
Earliest Anticipated Start Date: April 1, 2004

AWARD CRITERIA

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

o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Programmatic priorities.

REQUIRED FEDERAL CITATIONS

HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and 
others, and the importance of the knowledge gained or to be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: 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 clinical research projects unless a 
clear and compelling justification is 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 clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-
files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are 
available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended
_10_2001.htm.  The amended policy incorporates: the use of an NIH 
definition of clinical research; updated racial and ethnic categories in 
compliance with the new OMB standards; clarification of language governing 
NIH-defined Phase III clinical trials consistent with the new PHS Form 398; 
and updated roles and responsibilities of NIH staff and the extramural 
community. The policy continues to require for all NIH-defined Phase III 
clinical trials that: a) all applications or proposals and/or protocols must 
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) investigators must report annual accrual and progress in 
conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy 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 is available at 
http://grants.nih.gov/grants/funding/children/children.htm.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy 
requires education on the protection of human subject participants for all 
investigators submitting NIH proposals for research involving human subjects. 
This policy announcement is in the NIH Guide for Grants and Contracts 
Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

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 protections 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. 
In addition, applicants should think about how to structure informed consent 
statements and other human subjects procedures given the potential for wider 
use of data collected under this award.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  The 
Department of Health and Human Services (DHHS) issued final modification to 
the "Standards for Privacy of Individually Identifiable Health Information", 
the "Privacy Rule," on August 14, 2002.  The Privacy Rule is a federal 
regulation under the Health Insurance Portability and Accountability Act 
(HIPAA) of 1996 that governs the protection of individually identifiable 
health information, and is administered and enforced by the DHHS Office for 
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified 
under the Rule as "covered entities") must do so by April 14, 2003  (with the 
exception of small health plans which have an extra year to comply).  

Decisions about applicability and implementation of the Privacy Rule reside 
with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including 
a complete Regulation Text and a set of decision tools on "Am I a covered 
entity?"  Information on the impact of the HIPAA Privacy Rule on NIH processes 
involving the review, funding, and progress monitoring of grants, cooperative 
agreements, and research contracts can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

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. Furthermore, we 
caution reviewers that their anonymity may be compromised when they directly 
access an Internet site.

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 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 Catalogue of Federal Domestic Assistance at 
http://www.cfda.gov/ in the following citations: No. 93.855, Immunology, 
Allergy, and Transplantation Research and No. 93.856, Microbiology and 
Infectious Diseases Research. 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 Parts 74 and 92. This program is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.

The NIH Grants Policy Statement is available at 
http://grants.nih.gov/grants/policy/policy.htm. This document includes general 
information about the grant application and review process; information on the 
terms and conditions that apply to NIH Grants and cooperative agreements; and 
a listing of pertinent offices and officials at the NIH. All awards are 
subject to the terms and conditions, cost principles, and other considerations 
described in the NIH Grants Policy Statement.

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the 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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