NOVEL APPROACHES TO STUDY POLYMICROBIAL DISEASES

RELEASE DATE:  April 15, 2004  

PA NUMBER:  PA-04-093  

December 14, 2006 - The R01 portion of this funding opportunity has been 
replaced by PA-07-171, which now uses the electronic SF424 (R&R) 
application for February 5, 2007 submission dates and beyond.

March 2, 2006 (NOT-OD-06-046) – Effective with the June 1, 2006 submission date, 
all R03, R21, R33 and R34 applications must be submitted through Grants.gov using 
the electronic SF424 (R&R) application. Accordingly, this funding opportunity 
expires on the date indicated below. A replacement R21 (PA-06-210) funding 
opportunity announcement has been issued for the submission date of June 1, 2006 
and submission dates thereafter.

EXPIRATION DATE: for R21 Applications: March 2, 2006
Expiration Date for R01 Non-AIDS Applications: November 2, 2006
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH) 
 (http://www.nih.gov)

COMPONENTS OF PARTICIPATING ORGANIZATION:
National Institute of Dental and Craniofacial Research (NIDCR)
 (http://www.nidcr.nih.gov/)
National Heart, Lung, and Blood Institute (NHLBI) 
 (http://www.nhlbi.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD)
 (http://www.nidcd.nih.gov/)
National Institute of Biomedical Imaging and Bioengineering (NIBIB) 
 (http://www.nibib.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS:  
93.121 (NIDCR); 93.837 (NHLBI); 93.173 (NIDCD); 93.286 and 
93.287 (NIBIB)

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanisms of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA  

The NIH Institutes listed above invite research grant applications to 
conduct studies designed to develop innovative approaches that would 
contribute to our understanding of the mechanisms that impact on the 
virulence of infections involving two or more microorganisms or strains 
of microorganisms (with the exception of HIV). This announcement 
encourages investigators to think beyond the one organism-one disease 
concept and instead to consider the fact that many diseases are caused 
by the synergistic and inhibitory interactions of bacteria, viruses, 
parasites, and fungi.  Projects should include studies aimed at 
understanding the cellular and molecular interactions of pathogens with 
the normal flora as well as the interactions among pathogens 
themselves, and how commensal organisms can be used to prevent or treat 
infections; however, this PA is limited to those projects that involve 
or are based on intermicrobial interactions that have been well 
documented to occur in clinical settings. In addition, extensive 
research is needed on the host responses to polymicrobial infections in 
order to develop new approaches to treat and prevent these infections. 
The development of co-infection models and the use of genomic and 
proteomic technologies to identify common virulence mechanisms and host 
response patterns as well as the development of diagnostic and 
prognostic microbial/host signature patterns are encouraged. Because of 
the complexity of such projects, the establishment of collaborative 
scientific teams, both domestic and international, with diverse 
scientific disciplines studying polymicrobial diseases, including 
microbiology, immunology, biochemistry, clinical medicine, pathology, 
bioengineering, material science, imaging technology, and mathematical 
modeling are encouraged.

RESEARCH OBJECTIVES

Background

There is increasing evidence in the literature for the importance of 
polymicrobial infections in which microorganisms interact in a 
synergistic or inhibitory fashion, impacting on pathogenesis or the 
maintenance of health. Among these, bacteria-bacteria, virus-virus, 
parasite-parasite or virus-bacteria interactions have been described. 
For example, co-infection of Borrelia and Ehrlichia have been reported 
to enhance the severity and complicate the diagnosis of Lyme 
borreliosis. Also, it is known that the occurrence of multiple 
hepatotropic viruses influence the progression of the disease and that 
individuals infected with parasitic helminthes have increased 
susceptibility to malaria. Further, mixed viral-bacterial infections 
have been associated with excess mortality and meningitis during 
influenza pandemics, increased incidence of otitis media during 
influenza and respiratory syncytial virus epidemics in children, as 
well as antibiotic treatment failures and severe post-transplant 
complications. In addition, epidemiologic shifts in the spectrum of 
bacterial infection have been noted in cancer patients resulting in 
changes in the use of antimicrobial therapy during the management of 
these individuals.

It is conceivable that a viral infection, for instance, may facilitate 
bacterial colonization and enhanced adherence to host cells, paving the 
way for invasive disease. For example, a virus infection may induce 
host cell membrane changes such as the expression of viral 
glycoproteins that may serve as receptors for bacteria, or up-regulate 
platelet activating factor receptor thereby promoting increased 
bacterial adherence. Likewise, it is equally conceivable that a 
bacterial infection may pave the way for increased viral disease. Also, 
the ability of various bacteria in the microbial complex of the oral 
cavity to express surface molecules (e.g., bacteriocins) that 
specifically interact with other bacterial species and host cells has 
been suggested to be a critical determinant in plaque formation and 
structure. Indeed, a number of recent studies have focused on these 
research areas including those using experimental animal models. 
However, in future studies it will be important to develop appropriate 
experimental models to examine the mechanisms associated with the 
actual pathogen-to-pathogen interaction within the same host 
environment that may lead to increased susceptibility or resistance to 
infection. 

It is anticipated that a better understanding of the mechanisms 
involved in the observed clinical phenomena may provide opportunities 
to more critically evaluate the role of suspected virulence 
determinants involved in these mixed infections and the innate or 
specific host immune response patterns involved; these projects should 
also provide useful information for investigators in the development of 
more effective diagnostic, prevention and treatment strategies. For 
example, there is good clinical evidence that eradication of 
predisposing viral infections reduce the onset of otitis media. Thus, 
therapeutic approaches can be strengthened by taking into account the 
polymicrobial nature of the disease.

Research Objectives and Scope

A major focus of this PA is to encourage investigators to develop novel 
approaches for examining polymicrobial interactions and to think beyond 
the one organism-one disease concept. Projects will be considered 
responsive to this PA if the studies involve intermicrobial 
interactions that have been well-documented to occur in clinical 
settings or are based on clinically significant studies and are 
designed on the basis of sound scientific arguments with clearly 
defined endpoints such as profiles of immunological responses, 
synergizing metabolic activities or the inhibition/promotion of 
adherence to host cells.  The NIBIB has specific interest on the 
development of new imaging and bioengineering technologies. Proposals 
submitted to the NIBIB should have a primary emphasis on the 
development of new technologies useful for studying polymicrobial 
interactions. 

Research studies to be investigated under this PA are expected to 
develop novel, mechanistic ideas for polymicrobial interactions. 
Projects to be examined include, but are not limited to the following:

o   Elucidation of the mechanisms by which viral or parasitic 
infections increase the risk for bacterial infection or vice 
versa;
o   Determination of how surface adhesions are altered during 
microbial interactions;
o   Identify the mechanisms by which polymicrobial infections lead 
to enhanced resistance of microbes to acquired or innate 
immunity;  
o   Development of co-infection animal models or cell culture 
systems for multiple pathogens; 
o   Development of vaccines against polymicrobial infections;
o   Use of genomics and proteomics to identify microbial virulence 
genes and/or proteins that may be uniquely expressed during 
co-infection;
o   Evaluation of host response patterns, in response to single 
vs. multiple infections (simultaneous or sequential 
activation), required to elicit synergy or inhibition;
o   Ability of bacteria to colonize or invade host tissues 
following recent viral infection;
o   Development of biotherapeutics such as phage therapy and the 
ability of bacteria to block the pathogenicity of other 
bacteria (i.e. probiotic organisms); 
o   Characterization of lung host responses to polymicrobial 
infections and lung host response patterns;
o   Polymicrobial interactions as determinants of lung disease;
o   Development of new imaging techniques for probing 
polymicrobial interactions; and, 
o   Development of mathematical models and analysis tools for the 
study of polymicrobial interactions.

MECHANISMS OF SUPPORT 

This PA will use the NIH R01 and R21 award mechanisms.  As an 
applicant, you will be solely responsible for planning, directing, and 
executing the proposed project.  The R21 proposals should have the 
potential for truly groundbreaking impact.  Use of this mechanism to 
explore new biomedical approaches to address basic and applied research 
questions is encouraged. Applicants are encouraged to contact program 
staff for advice about choosing the appropriate grant mechanism. R21 
applications may request up to a total of two years of support, and 
total direct costs for the two years cannot exceed $275,000.      

The objective of the R21 mechanism is to support innovative, high 
risk/high impact research requiring preliminary testing or development; 
exploration of the use of approaches and concepts new to polymicrobial 
research; research and development of new technologies, techniques or 
methods; or initial research and development of data upon which 
significant future research may be built.  Applications will be 
considered as high impact if they demonstrate the potential for ground-
breaking, precedent-setting significance, and high risk because they 
either lack sufficient preliminary data to ensure their feasibility, or 
involve using a new model system or technique. While this PA is 
intended to encourage innovation and high impact research, and while 
 minimal preliminary data are expected to be described in the 
application, applications should clearly indicate that the proposed 
research and/or development is scientifically sound, that the 
qualifications of the investigators are appropriate, and that resources 
available to the investigators are adequate.  

This PA uses just-in-time concepts.  It also uses the modular as well 
as the non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  
Specifically, if you are submitting an application with direct costs in 
each year of $250,000 or less, use the modular format.  Otherwise 
follow the instructions for non-modular research grant applications.  
This program does not require cost sharing as defined in the current 
NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm.  

ELIGIBLE INSTITUTIONS 

You may submit (an) application(s) if your 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 institutions/organizations
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.   

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the 
opportunity to answer questions from potential applicants. Inquiries 
may fall into two areas: scientific/research and financial or grants 
management issues:

o Direct your questions about scientific/research issues to:

Dennis F. Mangan, Ph.D.
Division Basic and Translational Sciences, NIDCR
Building 45, Room 4AN-12J
Bethesda, MD  20892-6402
Telephone:  (301) 594-2421
FAX:  (301) 402-8319
Email:  Dennis.Mangan@nih.gov

Susan Banks-Schlegel, Ph.D.
Division of Lung Diseases, NHLBI
Two Rockledge Center, Suite 10018
6701 Rockledge Drive
Bethesda, MD 20892-7952
Telephone:  (301) 435-0202
FAX:  (301) 480-3557
Email:  Schleges@nih.gov

Bracie Watson, Jr., Ph.D.
Hearing Program
Division of Scientific Programs, NIDCD
6120 Executive Blvd., 400-C, MSC-7180
Bethesda, MD 20892-7180
Telephone:  (301) 402-3458
FAX:  (301) 402-6251
E-mail: watsonb@nidcd.nih.gov 

Peter Moy, Ph.D.
Division of Discovery Science and Technology, NIBIB
6707 Democracy Boulevard, Suite 200
Bethesda, MD 20892
Telephone: (301) 496-9270
FAX: (301) 480-4973
Email: moype@mail.nih.gov

o Direct your questions about financial or grants management matters 
to:

Mary Daley
Chief Grants Management Officer, NIDCR
45 Center Drive MSC 6402
Building 45, Room 4AN-44B
Bethesda, MD  20892-6402
Telephone: (301) 594-4808
FAX: (301) 480-8303
Email: md74u@nih.gov

Robert A. Pike
Lung Team Section Chief
Grants Operations Branch, NHLBI
Two Rockledge Center, Room 7154
6701 Rockledge Drive 
Bethesda, MD  20892-7926
Telephone:  (301) 435-0182
FAX: (301) 480-3310
Email:  Piker@mail.nhlbi.nih.gov

Sara Stone
Chief, Grants Management Branch, NIDCD
Executive Plaza South, Room 400B
6120 Executive Boulevard, MSC-7180
Bethesda, MD 20892
Rockville, MD 20852 (express mail)
Telephone:  (301) 402-0909
Email:  stones@nidcd.nih.gov

Karen Shields
Grants Management Specialist, NIBIB
6707 Democracy Boulevard, Suite 900
Bethesda, MD 20892
Telephone: (301) 451-4971
FAX: (301) 480-4974
Email: shieldsk@mail.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001). Applications must 
have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) 
number as the Universal Identifier when applying for Federal grants or 
cooperative agreements. The DUNS number can be obtained by calling 
(866) 705-5711 or through the web site at 
http://www.dunandbradstreet.com/.  The DUNS number should be entered on 
line 11 of the face page of the PHS 398 form. 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.

The title and number of this program announcement must be typed on line 
2 of the face page of the application form and the YES box must be 
checked.

APPLICATION RECEIPT DATES: Applications submitted in response to this 
program announcement will be accepted at the standard application 
deadlines, which are available at 
http://grants.nih.gov/grants/dates.htm.  Application deadlines are also 
indicated in the PHS 398 application kit.

SUPPLEMENTARY INSTRUCTIONS: 

R21 Applications:  All application instructions outlined in the PHS 398 
application kit are to be followed with the following modifications for 
R21 applications:

1. FACE PAGE, Item 6:  Up to a total of two years of support may be 
requested.  Total direct costs for the two years cannot exceed 
$275,000.  

2. Items a-d of the Research Plan for the R21 application may not 
exceed fifteen (15) pages, including tables and figures.  The following 
information should be taken into account for items a, b and c:  

o  Item a, SPECIFIC AIMS--The instructions for this section suggest 
that the applicant state "the hypotheses to be tested".  Since some 
applications submitted in response to this PA may also be design- or 
problem-driven (e.g., development of novel technologies), or need-
driven (initial research to develop a body of data upon which future 
research will build), hypothesis testing per se may not be the driving 
force in developing such a proposal and, therefore, may not be 
applicable.  The application should state the hypotheses, design, 
problem and/or need which will drive the proposed research.

o  Item b, BACKGROUND AND SIGNIFICANCE--In this section, it is 
important to identify clearly how the application addresses the 
specific objectives of this PA and the purpose of the R21 mechanism.

o  Item c, PRELIMINARY STUDIES/PROGRESS REPORT—No preliminary data are 
required for an R21 application.  

3. APPENDIX -  Use the instructions for the appendix detailed in the 
PHS 398 except that no more than 5 manuscripts, previously accepted for 
publication, may be included. 
  
APPLICATION RECEIPT DATES: Applications submitted in response to this 
program announcement will be accepted at the standard application 
deadlines, which are available at 
http://grants.nih.gov/grants/dates.htm.  Application deadlines are also 
indicated in the PHS 398 application kit.

SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS: 
Applications requesting up to $250,000 per year in direct costs must be 
submitted in a modular budget grant format.  The modular budget 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.

SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER 
YEAR:  Applications requesting $500,000 or more in direct costs for any 
year must include a cover letter identifying the NIH staff member 
within one of NIH institutes or centers (IC) who has agreed to accept 
assignment of the application.   

Applicants requesting more than $500,000 must carry out the following 
steps:
   
1) Contact the IC program staff at least 6 weeks before submitting the 
application, i.e., as you are developing plans for the study; 

2) Obtain agreement from the IC staff that the IC will accept your 
application for consideration for award; and,
  
3) Identify, in a cover letter sent with the application, the staff 
member and IC who agreed to accept assignment of the application.  

This policy applies to all investigator-initiated new (type 1), 
competing continuation (type 2), competing supplement, or any amended 
or revised version of these grant application types. Additional 
information on this policy is available in the NIH Guide for Grants and 
Contracts, October 19, 2001 at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. 

SENDING AN APPLICATION TO THE NIH: Submit a signed original copy of the 
application, including the checklist, and five 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)

APPLICATION PROCESSING: Applications must be received by or mailed on 
or before the receipt dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm.  The CSR 
will not accept any application in response to this PA that is 
essentially the same as one currently pending initial review unless the 
applicant withdraws the pending application.  The CSR will not accept 
any application that is essentially the same as one already reviewed.  
This does not preclude the submission of a substantial revision of an 
application already reviewed, but such application must include an 
Introduction addressing the previous critique.

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

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review 
group convened in accordance with the standard NIH peer review 
procedures (http://www.csr.nih.gov/refrev.htm) will evaluate 
applications for scientific and technical merit.  

As part of the initial merit review, all applications will:

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 written critique
o Receive a second level review by the appropriate national advisory 
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 evaluate 
application in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals.  The 
scientific review group will address and consider each of the following 
criteria in assigning the application’s overall score, weighting them 
as appropriate for each application.

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
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).
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

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 will be assessed.  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 REVIEW CONSIDERATIONS 

Sharing Research Data

Applicants requesting more than $500,000 in direct costs in any year of 
the proposed research are expected to include a data sharing plan in 
their application. The reasonableness of the data sharing plan or the 
rationale for not sharing research data will be assessed by the 
reviewers.  However, reviewers will not factor the proposed data 
sharing plan into the determination of scientific merit or priority 
score. (See:  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html)
 
BUDGET:  The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research.

AWARD CRITERIA

Applications submitted in response to a PA will compete for available 
funds with all other recommended applications.  The following will be 
considered in making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities

REQUIRED FEDERAL CITATIONS 

ANIMAL WELFARE PROTECTION:  Recipients of PHS support for activities 
involving live, vertebrate animals must comply with PHS Policy on 
Humane Care and Use of Laboratory Animals 
(http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), 
as mandated by the Health Research Extension Act of 1985 
(http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the 
USDA Animal Welfare Regulations 
(http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable.

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

SHARING RESEARCH DATA:  Investigators submitting an NIH application 
seeking $500,000 or more in direct costs in any single year are 
expected to include a plan for data sharing or state why this is not 
possible. http://grants.nih.gov/grants/policy/data_sharing .  
Investigators should seek guidance from their institutions, on issues 
related to institutional policies, local IRB rules, as well as local, 
state and Federal laws and regulations, including the Privacy Rule. 
Reviewers will consider the data sharing plan but will not factor the 
plan into the determination of the scientific merit or the priority 
score.

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 "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. 

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.  You will find this policy 
announcement 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://stemcells.nih.gov/index.asp 
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, in the project description and elsewhere in the 
application as appropriate, 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).  

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.healthypeople.gov/.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject 
to the intergovernmental review requirements of Executive Order 12372 
or Health Systems Agency review.  Awards are made under the 
authorization of Sections 301 and 405 of the Public Health Service Act 
as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 
and 45 CFR Parts 74 and 92. All awards are subject to the terms and 
conditions, cost principles, and other considerations described in the 
NIH Grants Policy Statement.  The NIH Grants Policy Statement can be 
found at http://grants.nih.gov/grants/policy/policy.htm .

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


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Research (OER)
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and Human Services (HHS)
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