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 https://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 https://grants.nih.gov/archive/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: https://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: pk5s@nih.gov
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: mh30x@nih.gov
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: ad22x@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
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: mh30x@nih.gov
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
https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
Email: GrantsInfo@nih.gov.
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
https://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
https://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:
https://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 (https://grants.nih.gov/grants/guide/notice-
files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are
available at https://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
https://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
https://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
https://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
https://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
https://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.