INNOVATIVE GRANTS ON IMMUNE TOLERANCE
RELEASE DATE: April 4, 2003
RFA: AI-03-010 (This RFA has been modified, see RFA-AI-05-023)
National Institute of Allergy and Infectious Diseases (NIAID)
(http://www.niaid.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
(http://www.niddk.nih.gov)
National Heart, Lung and Blood Institute (NHLBI)
(http://www.nhlbi.nih.gov)
CATALOGUE OF FEDERAL DOMESTIC ASSISTANCE NUMBERS:
No. 93.855, Immunology, Allergy, and Transplantation Research
No. 93.856, Microbiology and Infectious Diseases Research
No. 93.847, Diabetes, Endocrinology and Metabolism Research
No. 93.837, Heart and Vascular Diseases Research
No. 93.838, Lung Diseases Research
LETTER OF INTENT RECEIPT DATE: June 15, 2003
APPLICATION RECEIPT DATE: July 15, 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 National Institute of Allergy and Infectious Diseases (NIAID), the
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and
the National Heart, Lung and Blood Institute (NHLBI), National Institutes of
Health (NIH), invite applications for exploratory/developmental research
project grants to support novel work on the molecular mechanisms and
applications of antigen-specific immune tolerance, which is the selective and
long-term inactivation of immune responses. The projects should involve a high
degree of innovation, and have a clearly articulated potential to improve
understanding of immune tolerance. Investigators new to immune tolerance are
particularly encouraged to develop projects in this area. Research projects
will be supported by the exploratory/developmental research grant mechanism,
which provides the resources to carry out preliminary tests of feasibility for
new research hypotheses. Clinical trials are excluded from this RFA, as are
studies on HIV/AIDS and behavioral research. However, research involving human
tissues or samples is encouraged.
RESEARCH OBJECTIVES
Background
We are growing closer to the day when allergies, autoimmune diseases, and
transplant rejection will be treated by selective inactivation of harmful
immune responses, without the global impairment of protective immunity that is
currently imposed by immunosuppressive drugs. The past two decades of
immunological research have produced a wealth of information on the cells and
molecules involved in immunoregulation, identifying a variety of approaches to
be tested for selective immune inactivation. Of particular note is the success
achieved in defining certain mechanisms by which antigen-specific immune
tolerance can be induced in animal model systems. Some of these mechanisms are
now being tested in human autoimmune diseases, allergy, and
allotransplantation.
It is likely that a variety of protocols will be needed to control the broad
range of immune-mediated diseases that exist in humans. Such diseases afflict
millions of individuals and often involve serious recurring or long-term
chronic illness. Promising opportunities and important challenges exist to
develop effective protocols for the antigen-specific prevention, or even
reversal, of detrimental immune responses in human allergy, asthma, autoimmune
diseases, and transplantation. The application of new technologies such as
soluble MHC-peptide reagents, the ability to conduct single cell assays and
microarray analyses, and progress in the genetic manipulation of normal cells,
offer opportunities for more definitive analyses of the human immune system
and for the construction of experimental animal systems that more directly
model human diseases, such as autoimmune hepatitis, primary biliary cirrhosis,
sclerosing cholangitis, and inflammatory bowel diseases such as celiac disease.
Research Objectives and Scope
The goal of this initiative is to support truly innovative projects on immune
tolerance and to encourage investigators working in other areas of research to
bring novel perspectives and expertise to this field. For example, concepts
and methodologies from genetics, in vivo imaging, and cell migration and
localization research may provide new insights into controlling immune
tolerance. High risk, high impact projects are sought that have the potential
to significantly increase our understanding of the mechanisms that induce
long-lived, antigen-specific immune tolerance for application to human
disease. This program will not support clinical trials, behavioral studies, or
HIV/AIDS research.
Studies on basic principles of immunological tolerance, and immune tolerance
as a focus for the prevention/treatment of immune-mediated diseases such as
allergy, asthma, transplantation, and autoimmune diseases are of interest to
the NIAID. Studies relevant to the etiology and/or treatment of type 1
diabetes are of particular interest to the NIDDK. In addition, the NIDDK is
interested in applications that study the etiology or potential therapy of
immune-mediated renal diseases, such as renal vasculitis and autoimmune
glomerulonephritis. The NHLBI is interested in studies on the development of
tolerance specific for heart and lung tissues, and heart and lung
transplantation; use of the oral route of antigen administration to induce
lung airway tolerance; and the analysis of tolerance in young animals, before
the immune system matures. The characterization of specific immunoregulatory
cytokines in the setting of chronic inflammation is also of interest to all
ICs.
Highly innovative, short-term pilot projects to evaluate new, but as yet
untested, concepts in immune tolerance may include, but are not limited to,
research in the following areas:
o the mechanistic basis for differences in tolerance induced by systemic
versus mucosal routes;
o the identification and characterization of promising new T, B, or antigen-
presenting cell molecular targets for tolerance induction, including antigen
identification;
o the parameters of tolerance induction to non-peptide self antigens,
alloantigens, or allergens;
o the molecular events responsible for the loss of tolerance to self antigens;
o methods to extend the duration of antigen-specific tolerance;
o novel technologies to identify and quantitate tolerant T or B cells;
o the development or application of cell and tissue engineering methods to
predictably induce tolerance rather than immunity;
o the characterization of novel, antigen-specific immunosuppressive cell types;
o the identification of mechanisms by which currently known tolerogenic
biological or pharmaceutical agents induce and/or maintain immune tolerance;
o the development of simple and reliable assays for the identification of
tolerant states in humans; and
o the development of vaccine strategies to induce antigen-specific tolerance
to disease-related autoantigens or allergens.
MECHANISM OF SUPPORT
This RFA will use the NIH Exploratory/Developmental Research Project Grant
(R21) award. The total requested project period for an application submitted
in response to this RFA may not exceed two years. The applicant 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.
The anticipated award date is February, 2004.
NIH uses R21 grants to provide short-duration support for preliminary studies
of a highly speculative nature, which are expected to yield, within this time
frame, sufficient information upon which to base a well-planned and rigorous
series of further investigations.
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 participating IC(s) intends to commit approximately $5,400,000 in FY 2004
to fund 22 to 28 new grants in response to this RFA. An applicant may request
a project period of up to two years and a budget for direct costs of up to
$150,000 per year. 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
IC(s) 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
o Faith-based or community-based organizations
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 are a component of the research proposed, studies must
be monitored commensurate with the degree of potential risk to study subjects
and the complexity of the study. AN UPDATED NIAID policy on the requirements
for such monitoring 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:
Helen Quill, Ph.D.
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases
Room 1128, MSC-7640
6700-B Rockledge Drive
Bethesda, MD 20892-7640
Telephone: (301) 496-7551
FAX: (301) 480-2381
Email: hquill@niaid.nih.gov
Beena Akolkar, Ph.D.
Division of Diabetes, Endocrinology and Metabolism
National Institute of Diabetes and Digestive and Kidney Diseases
Room 681, MSC-5460
2 Democracy Plaza
Bethesda, MD 20892-5460
Telephone: (301) 594-8812
FAX: (301) 480-3503
Email: ba92i@nih.gov
Judith Massicot-Fisher, Ph.D.
Division of Heart and Vascular Diseases
National Heart, Lung and Blood Institute
Room 9184, MSC-7940
6701 Rockledge Drive
Bethesda, MD 20892-7940
Telephone: (301) 435-0528
FAX: (301) 480-1454
Email: jm294z@nih.gov
o Direct questions about peer review issues to:
Dr. Priti Mehrotra
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2100, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Telephone: (301) 435-9369
FAX: 301-403-2638
Email: pm158b@nih.gov
o Direct questions about financial or grants management matters to:
Maryellen M. Connell
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2123, MSC-7614
6700-B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: (301) 402-5576
FAX: (301) 480-3780
Email: mc40u@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:
Dr. Priti Mehrotra
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2100, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Telephone: (301) 435-9369
FAX: 301-403-2638
Email: pm158b@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.
SUPPLEMENTAL INSTRUCTIONS
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:
Dr. Priti Mehrotra
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2100, 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 NIAID.
Incomplete and/or non-responsive applications will be returned to the
applicant without further consideration.
Applications that are complete and responsive to the RFA will be evaluated for
scientific and technical merit by an appropriate peer review group convened by
the NIAID 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 appropriate council or board.
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In the
written comments, reviewers will be asked to discuss the following aspects of
the application in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals:
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?
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.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: June 15, 2003
Application Receipt Date: July 15, 2003
Peer Review Date: November, 2003
Council Review: January, 2004
Earliest Anticipated Start Date: February, 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.
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.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on
hESCs can be found at https://grants.nih.gov/grants/stem_cells.htm and at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only
research using hESC lines that are registered in the NIH Human Embryonic Stem
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).
It is the responsibility of the applicant to provide the official NIH
identifier(s)for the hESC line(s)to be used in the proposed research.
Applications that do not provide this information will be returned without
review.
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 PA 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 PA 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; No. 93.856, Microbiology and Infectious
Diseases Research; No. 93.847, Diabetes, Endocrinology and Metabolism
Research; No. 93.837, Heart and Vascular Diseases Research; and No. 93.838,
Lung 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.