MYCOLOGY RESEARCH UNITS

RELEASE DATE:  June 11, 2003

RFA: AI-03-021

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: September 23, 2003
APPLICATION RECEIPT DATE: October 23, 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) invites 
applications for program project (P01) grants to conduct interdisciplinary 
research to increase understanding of the biology and host-pathogen 
interactions of the medically important fungi. This fundamental knowledge will 
be applied to the development of new and improved strategies for the 
prevention, diagnosis, and therapy of the mycoses.  Therefore, the proposed 
research must be focused on the identification and validation of targets for 
the development of diagnostics, vaccines or therapeutics directed against 
systemic mycotic infections, leading to but not including clinical trials.

RESEARCH OBJECTIVES

Nature of the problem

Fungal infections are recognized with increasing frequency as an important 
cause of both morbidity and mortality in immunocompromised and immunocompetent 
hosts.  This increase is in part due to expanded use of immunosuppressive 
therapies in the treatment of patients with malignant disease or organ 
transplants as well as medical intensive care procedures and complicated 
surgeries.  Antifungal therapy remains less than optimal.  Of particular 
concern is evidence that resistance to available drugs is developing.  A lack 
of rapid diagnostic tests for early detection of fungal infection results in 
increased prophylactic antifungal use in high risk populations which in turn 
accelerates development of drug resistance. 

Background

Despite the focus on altered immune status as a risk factor, only 45% of 
invasive fungal infections due to Candida, Aspergillus, Cryptococcus, or 
Histoplasma are associated with HIV/AIDS, neoplasms, or transplants (Wilson, 
et. al., 2002. The direct cost and incidence of systemic fungal infection. 
Value in Health, 5(1):26-33).  While these populations provide a relatively 
well defined group for clinical studies, the other 55% of these fungal 
infections provide additional impetus for expanding efforts to improve 
diagnosis, prevention and therapy.

Invasive candidiasis and aspergillosis are exemplary of some common issues 
surrounding the opportunistic systemic mycoses. The determination of real 
incidence, attributable cost and limitations in treatment are confounded by 
limitations in diagnosis.  Blood cultures are usually negative in disseminated 
aspergillosis and often negative in systemic candidiasis.  Clinical trials 
evaluating new antimicrobials or new regimens of existing antimicrobials in 
high risk groups often must be constructed around empiric treatment before a 
microbiologic diagnosis is proven, and measurement of successful outcome can 
involve interpretation of a complex including signs and symptoms of disease, 
and indirect evidence of infection.
 
Through a series of NIAID-sponsored workshops, participants indicated a need 
for more rapid translation of basic research observations into clinical 
application such as better diagnostic tests for invasive candidiasis and 
aspergillosis; better therapeutic agents; and vaccines against systemic 
mycoses and opportunistic mycoses like cryptococcosis and candidiasis.   The 
program project mechanism provides an opportunity to extend beyond the 
capabilities of single project grants in order to accelerate translational 
research.  

The mycology program in the Division of Microbiology and Infectious Diseases, 
NIAID, focuses on the biology (molecular biology, immunology, biochemistry and 
cell biology) of the medically important fungi.  The Bacteriology and Mycology 
Study Group provides a contract-supported infrastructure dedicated to clinical 
trials of antifungal agents in invasive mycoses.  The Division of AIDS, NIAID, 
also supports pre-clinical and clinical research on AIDS-associated pathogenic 
fungi (Pneumocystis carinii, Candida albicans, Cryptococcus neoformans) with 
an emphasis on drug development.

Research Objectives and Scope

The NIAID wishes to develop multidisciplinary mycology research units to serve 
as foci for innovative new research in fungal diseases.  These units will be 
funded as program project grants.  To achieve medical and public health 
relevance, studies should involve the use of clinical isolates and, where 
appropriate, clinical materials, including human cells.  With the pending 
completion of the whole genome sequence of A. fumigatus, the community is 
poised to apply genomic and proteomic advances in discovery of novel targets 
for diagnosis, prevention and treatment.  Further, it is anticipated that a 
contract will be awarded this year to improve and standardize animal models of 
invasive aspergillosis.  This contract will provide the community access to 
standardized animal models to validate targets.  Accordingly, the NIAID is 
particularly interested in applications focused on Aspergillus fumigatus 
including but not limited to methods applying immunological, nucleic acid, 
physiological, or metabolic methods or markers to target discovery and 
validation.  Studies of diagnostics, prevention and therapy for additional 
fungi of medical importance including, but not limited to, A. flavus, 
Blastomyces dermatitidis, Candida spp., Coccidioides immitis, C. posadasii, 
Cryptococcus neoformans, Histoplasma capsulatum, Pneumocystis carinii, 
Pseudallescheria boydii, Sporothrix schenckii, and Trichosporon beigelii are 
also acceptable.  

Note: Applications focused on Pneumocystis will only be responsive if the 
emphasis is on vaccine development.  

For projects to be deemed responsive, a biological process or entity must be 
identified as a potential target for prevention, diagnosis, or treatment.  
Processes or entities that could yield potential targets may include but are 
not limited to: cellular and molecular biology (cell biology, genetics, genome 
structure, gene expression, gene manipulation; genomics); virulence factors 
and mechanisms of pathogenesis; host-pathogen interactions (including the role 
of the immune system in resistance, pathogenesis, and recovery); and fungal 
physiology, biochemistry and metabolism.  While drawing on the preceding 
disciplines the central focus of proposed research must be on the 
identification and validation of targets for the development of diagnostics, 
vaccines or therapeutics for systemic mycotic infections.  Evaluations must 
utilize appropriate in vitro assays or in vivo model systems that demonstrate 
clinical relevance.

o  Diagnostics.  Targets could include fungal antigens or metabolites for a 
systemic fungal pathogen or related group of pathogens.  Specific research 
aims should include methods for qualitative and quantitative analysis of the 
target in an in vitro system. Clinical relevance should be demonstrated by an 
appropriate preclinical model or by application to patient samples.  Ideally, 
the target would serve not only to identify a specific infection at an early 
stage, but also to track the course of infection in response to treatment.  
Multiple foci of basic research could be integrated and applied to culminate 
in a specific aim that validates the entity or target as a legitimate 
diagnostic candidate.

o  Prevention. Research to identify antigens that are immunoprotective or 
immunotherapeutic for the systemic mycoses is appropriate.  Multiple 
approaches are encouraged, but the one(s) selected for study must contain a 
validation step whereby acquisition of infection or modification of the course 
of disease is demonstrated in an appropriate preclinical model for assessment.  
Studies to address new methods or new models of evaluating vaccine efficacy 
for the systemic mycoses are also acceptable.

o  Therapeutics.  Areas of interest include, but are not restricted to: immune 
based therapy, including antibody; novel approaches to enhancing antifungal 
efficacy; and novel approaches to enhancing antifungal delivery. Novel 
antimicrobial compounds may be a component of study if emphasis is to validate 
new chemical entities or therapeutic approaches; drug development and drug 
screening are not areas of interest for the purposes of this RFA.  Project 
directors are encouraged to address or document how the research approaches 
are unique or underexploited and are not duplicative of approaches under 
extensive industrial development.

A given program project could be of either organism-specific, multi-
disciplinary focus on a single fungus of medical importance; or theme 
specific, with different medically important fungi serving as models to 
address closely related areas of research emphasis.  For example, a program 
project focused on development of approaches to fungal vaccines would have a 
common goal, would allow for interdisciplinary projects to draw upon 
discipline-specific strengths, requires key components from the above research 
areas, and has the potential to demonstrate true synergy where the project sum 
is greater than the addition of individual project components.  Program 
projects may involve collaboration among investigators at several 
institutions. Information on the NIH policy regarding consortium agreements is 
available at 
http://grants.nih.gov/grants/policy/nihgps/part_iii_5.htm#Consortium.

MECHANISM OF SUPPORT

This RFA will use the NIH program project (P01) award mechanism. The applicant 
will be solely responsible for planning, directing, and executing the proposed 
project. This type of award supports broadly based multidisciplinary research 
programs that have a well-defined central research focus or objective. An 
important feature is that the interrelationships among the individual 
scientifically meritorious projects will result in a greater contribution to 
the overall program goals than if each project was pursued individually. The 
program project grant consists of a minimum of three interrelated individual 
research projects that contribute to the program objective. The award also can 
provide support for certain common resources termed cores. Such resources 
should be utilized by two or more projects within the award.

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.

FUNDS AVAILABLE 

The NIAID intends to commit approximately $2.5 million in FY 2004 to fund 3 to 
4 new and/or competitive continuation grants in response to this RFA. An 
applicant may request a project period of up to five (5) years and a budget 
for direct costs of up to $600,000 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 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

Foreign Institutions are not eligible to apply

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 

A budget for travel should be included for the purpose of attending an annual 
one day progress review meeting of the Project Directors at a site to be 
designated (either in Bethesda or in association with a relevant national 
meeting).

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

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA and welcome the opportunity to 
answer questions from potential applicants. Inquiries may fall into three 
areas: scientific/research, peer review, and financial or grants management 
issues:

o Direct questions about scientific/research issues to:

Rory A. Duncan, MS
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room Number 4109, MSC-6603
6610 Rockledge Drive
Bethesda, MD 20892-6603
Telephone: (301) 402-8613
FAX: (301) 402-2508
Email: [email protected]

o Direct questions about peer review issues to:

Edward W. Schroder, Ph.D.
Chief, Microbiology and Immunology Review Branch
Scientific Review Program, DEA, NIAID, NIH, DHHS
6700-B Rockledge Drive MSC 7616, Room 2217
Bethesda, MD 20892-7616
Zip code for express couriers: 20817 
Phone:  301-496-2550
FAX: 301-402-2638
e-mail: [email protected]

o Direct questions about financial or grants management matters to:

Maryellen M. Connell
Grants Management Specialist
NIH/NIAID/DEA/GMB
6700B Rockledge Drive
Room 2123, MSC 7614
Bethesda, Maryland  20892-7614

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:

Edward W. Schroder, Ph.D.
Chief, Microbiology and Immunology Review Branch
Scientific Review Program, DEA, NIAID, NIH, DHHS
6700-B Rockledge Drive MSC 7616, Room 2217
Bethesda, MD 20892-7616
Zip code for express couriers: 20817 
Phone:  301-496-2550
FAX: 301-402-2638
e-mail: [email protected] 

SUBMITTING AN APPLICATION

Applicants for P01 grants must follow special application guidelines in the 
NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT 
AWARDS; this brochure is available via the WWW at:  
http://www.niaid.nih.gov/ncn/grants/multibron.htm.

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

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:

Edward W. Schroder, Ph.D.
Chief, Microbiology and Immunology Review Branch
Scientific Review Program, DEA, NIAID, NIH, DHHS
6700-B Rockledge Drive MSC 7616, Room 2217
Bethesda, MD 20892-7616
Zip code for express couriers: 20817 
Phone:  301-496-2550
FAX: 301-402-2638
e-mail: [email protected]

Applications must be received on or before October 23, 2003. Applications that 
are not received as a single package on the receipt date or that do not 
conform to the instructions contained in PHS 398 (rev. 5/01) Application Kit 
will be judged non-responsive and will be returned to the applicant. 

Investigators wishing to participate in a multi-project grant must be aware of 
this policy before making a commitment to the Principal Investigator and 
awarding institution.

It is highly recommended that the appropriate NIAID program contact be 
consulted before submitting the letter of intent and during the early stages 
of preparation of the application. (See program contact under INQUIRIES).

SPECIAL INSTRUCTIONS FOR COMPLETION OF APPLICATIONS IN RESPONSE TO THIS RFA: 

Applicants for P01 grants must follow special application guidelines in the 
NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT 
AWARDS; this brochure is available via the WWW at: 
http://www.niaid.nih.gov/ncn/grants/multibron.htm.

The brochure presents specific instructions for sections of the PHS 398 (rev. 
5/01) application form that should be completed differently than usual. For 
all other items in the application, follow the usual instructions in the PHS 
398.

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.

Concurrent submission of an R01 and a Component Project of a Multi-project 
Application: Current NIH policy permits a component research project of a 
multi-project grant application to be concurrently submitted as a traditional 
individual research project (R01) application. If, following review, both the 
multi-project application and the R01 application are found to be in the 
fundable range, the investigator must relinquish the R01 and will not have the 
option to withdraw from the multi-project grant. This is an NIH policy 
intended to preserve the scientific integrity of a multi-project grant, which 
may be seriously compromised if a strong component project(s) is removed from 
the program. Investigators wishing to participate in a multi-project grant 
must be aware of this policy before making a commitment to the Principal 
Investigator and awarding institution.

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 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 
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 National Institute of Allergy and 
Infectious Diseases Council

REVIEW CRITERIA

The general review criteria for P01 grant applications are presented in the 
NIAID brochure entitled "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT 
AWARDS" at http://www.niaid.nih.gov/ncn/grants/multibron.htm.

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

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:       September 23, 2003
Application Receipt Date:            October 23, 2003
Scientific Peer Review Date:         February, 2004
Advisory Council Review:             March, 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://ohrp.osophs.dhhy.gov/humansubjects/guidance/45cfr46.htm.

MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures. In addition, it is NIH policy that 
all clinical trials require data and safety monitoring, with the method and 
degree of monitoring being commensurate with the risks (NIH Policy for Data 
Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of the 
research. This policy results from the NIH Revitalization Act of 1993 (Section 
492B of Public Law 103-43).

All investigators proposing clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-
files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are 
available at http://grants.nih.gov/grants/funding/women_min/guidelines_
amended_10_2001.htm.

The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community. The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable; and 
b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported by 
the NIH, unless there are scientific and ethical reasons not to include them. 
This policy applies to all initial (Type 1) applications submitted for receipt 
dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm.

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

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances. Data that are (1) first produced in a project 
that is supported in whole or in part with Federal funds and (2) cited 
publicly and officially by a Federal agency in support of an action that has 
the force and effect of law (i.e., a regulation) may be accessed through FOIA. 
It is important for applicants to understand the basic scope of this 
amendment. NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this RFA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time. If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the application. 
In addition, applicants should think about how to structure informed consent 
statements and other human subjects procedures given the potential for wider 
use of data collected under this award.

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

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

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

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

AUTHORITY AND REGULATIONS

This program is described in the Catalogue of Federal Domestic Assistance at 
http://www.cfda.gov/ in the following citations: No. 93.855, Immunology, 
Allergy, and Transplantation Research and No. 93.856, Microbiology and 
Infectious Diseases Research. Awards are made under authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 
and administered under NIH grants policies and Federal Regulations 42 CFR 52 
and 45 CFR Parts 74 and 92. This program is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.

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

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the use of all tobacco products. In addition, Public 
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain 
facilities (or in some cases, any portion of a facility) in which regular or 
routine education, library, day care, health care, or early childhood 
development services are provided to children. This is consistent with the PHS 
mission to protect and advance the physical and mental health of the American 
people.

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