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 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 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: 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:

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 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
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 
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:

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 (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.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on 
hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at  
http://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 
http://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 
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 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 
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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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