MOLECULAR STRUCTURE/FUNCTION OF ORGANISMS DEGRADING CONTAMINANTS
 
RELEASE DATE:  February 3, 2003
 
RFA: ES–03-005
 
National Institute of Environmental Health Sciences (NIEHS)
 (http://www.niehs.nih.gov)
 
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS
93.113; 93.115; 95.143

Letter of Intent Receipt Date:  March 16, 2003

Application Receipt Date:  April 16, 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

This RFA is fully titled MOLECULAR ASSESSMENT OF THE STRUCTURE AND FUNCTION 
OF ECOLOGICAL POPULATIONS IN THE SEQUESTRATION/DEGRADATION OF ENVIRONMENTAL 
CONTAMINANTS and is within the mission of the National Institute of 
Environmental Health Sciences (NIEHS) to promote research that will 
ultimately reduce the burden of human illness and dysfunction from 
environmental causes. Complementary to this mission are the goals of the 
national Superfund Program, established by Congress in 1980 to: identify 
uncontrolled hazardous wastes; characterize the impacts of hazardous waste 
sites and emergency releases on the surrounding environment (i.e. 
communities, ecological systems, and ambient air, soil, water); and, 
institute control or remediation approaches to minimize risk from exposure to 
these contaminants.  

In 1986, six years after the Comprehensive Environmental Response, 
Compensation, and Liability Act (CERCLA) was enacted, Congress authorized 
NIEHS to implement a university-based program of basic research and training 
grants. The intent was to improve the ability to identify, assess, and 
evaluate the potential health effects of exposure to hazardous waste and to 
develop innovative chemical, physical and biological technologies for 
remediating sites contaminated by hazardous substances. The assignment of 
this Program, the Hazardous Substances Research and Training program 
[Superfund Basic Research Program (SBRP)], to the NIEHS underscored an 
emphasis on human health effects assessment, evaluation and prevention. 
However, NIEHS was provided latitude to support non-traditional NIH research 
areas such as fate and transport and remediation strategies for environmental 
contaminants. NIEHS has implemented this program by supporting coordinated 
multiproject, multidisciplinary university-based programs that link 
biomedical research with related engineering, hydrogeologic and ecologic 
research. A component of this multidisciplinary approach has been basic 
research focused on the mechanistic basis for chemical degradation and 
sequestration by microbial as well as other biological systems and exploiting 
this knowledge to develop improved bioremediation strategies for hazardous 
substances that limit and/or prevent exposure. 

The research supported by the SBRP has been successful in applying cutting 
edge molecular research tools to advance our understanding of biological 
processes involved in the degradation and sequestration of hazardous 
chemicals (http://www-apps.niehs.nih.gov/sbrp/index.cfm). For example 
innovative approaches applying microarray technology have been used to begin 
to understand how microbial populations respond to chemicals in environmental 
media.

This initiative is designed to encourage the research community to apply 
molecular approaches to assess the structure and function of ecological 
populations involved in the sequestration and degradation of environmental 
contaminants. These populations could include microorganisms such as bacteria 
and fungi, nematodes, aquatic organisms, plants, or any other ecological 
population that could be used for bioremediation purposes. There have been 
remarkable advancements in the development of molecular tools over the past 
few years, and there is an ever-growing use of these molecular approaches to 
advance bioremediation strategies. However, this is a rapidly evolving area 
of research. Therefore, it is the intent of this solicitation to support 
exploratory or developmental research grants in this area. This RFA will make 
use of the NIH R21 Exploratory/Developmental Research Grant mechanism which 
is ideally suited to foster the introduction of novel scientific ideas, 
methods, model systems, tools or technologies that have the potential to 
substantially advance bioremediation practices.
 
RESEARCH OBJECTIVES
 
Background

Contamination of soils, sediments and groundwaters by hazardous substances 
represents a significant potential threat to human and ecological health.  
Bioremediation, whether it be in situ, using naturally occurring 
microorganisms, or attenuated by adding genetically modified organisms such 
as plants or microbes, holds great promise as a mechanism to convert toxic 
chemicals to harmless forms. Therefore, bioremediation can be viewed as a 
preventive medicine of the future, and it will be essential to know the 
natural habitat of the degradative or sequestrative microbial populations as 
well as the structure and function of these populations in order to embark on 
cost effective, ecologically safe and environmentally sound bioremediation 
plans. 

The requirement of living systems to both acquire and reject toxic chemicals 
has led to the selection of a whole repertoire of mechanisms of interactions 
that ensure the adaptation of microorganisms to a changing and frequently 
hostile environment. Although microbes that have the capacity to grow on 
unusual carbon sources or thrive under extreme conditions have been known for 
several decades, it has only been recently that it has been possible to 
understand the molecular basis of these specific properties. Genetic analysis 
of these microbes can suggest new ways to handle toxic pollutants. Although 
genetic changes develop through natural selection, it takes a long time for 
an organism to adapt and be capable of cleaning up modern-day pollution. A 
challenge is to recreate and accelerate these natural processes by using 
genetic engineering for improving biodegradation of recalcitrant pollutants. 
The anticipation that genetically engineered organisms would greatly enhance 
remediation options has not been realized, partly, because the results 
obtained under controlled laboratory conditions do not readily translate to 
real world situations. A genetically engineered organism released into a 
community faces many unknown factors. It must establish itself, interact with 
other members of the community in unknown ways and face a multitude of poorly 
controlled external factors. Our ability to understand, monitor and 
manipulate the complex microbial communities performing bioremediation has 
been hampered in the past by reliance upon traditional culture-based 
techniques. One of the existing challenges has been to link changes in 
population structure with system-level processes where the composition of the 
community is not known a priori and the function of the individual 
populations cannot be studied in defined cultures. Our understanding of how 
microbial or other ecological populations develop an ability to adapt to and 
transform contaminants is limited because of an inability to predict when 
adaptive events will occur. Many of these issues of microbial ecology and 
biodiversity and adaptation now have the potential to be addressed through 
the use of molecular techniques. For example, DNA chips or gene expression 
arrays could be used to create a "metagenomic" library that captures the 
genetic diversity of an entire microbial ecosystem. By applying molecular 
tools to these various communities not only will it be possible to begin to 
ascertain the relationship between structure/function and ultimately outcome, 
but this knowledge can also be used to develop biomarkers of contaminant 
stress. 

Many Superfund hazardous waste sites contain a large number of diverse toxic 
chemicals such as polycyclic aromatic hydrocarbons (PAHs), other chlorinated 
organics and metals. In addition, many contain synthetic chemicals having 
novel structures that are rarely found in nature; hence they are degraded 
slowly by naturally occurring organisms. Through the multidisciplinary nature 
of the SBRP, both basic and applied research has been supported that has led 
to the development of innovative bioremediation strategies that are tackling 
these difficult contamination scenarios. For example, bioremediation 
strategies have included the use of microbes and engineered microbes, to 
reduce or eliminate the toxicity of hazardous substances. Phytoremediation 
strategies are being developed to remove volatile organics and metals from 
aquifers and sediments. Although progress is being made, our inability to 
understand at a mechanistic level the relationships between the number and 
type of species found at a site, the environmental contaminants, the nutrient 
requirements and other factors that need to be considered in developing 
efficient bioremediation strategies has hampered the application of 
innovative bioremediation strategies at complex waste sites. The potential to 
greatly enhance the effectiveness of bioremediation strategies by applying 
molecular tools to understand these interactions shows great promise. For 
example, 16S rRNA-targeted technologies have been used as important tools in 
molecular microbial ecology to identify, and quantitate microbial populations 
directly from environmental samples without the need to culture. This 
methodology has yielded significant information regarding the structure of 
degradative microbial communities. However, it has not been effective in 
providing functional information of these target communities. Developing 
molecular tools that can address both these issues would be a major advance.

Objectives and Scope

A goal of this proposed research initiative is to stimulate the use of modern 
molecular biology tools as well as biochemical, cellular or engineering 
approaches to enhance our understanding of the basic structural and 
functional properties of ecological populations that are involved in the 
bioremediation of hazardous substances. The SBRP has provided long-term 
investments in basic research, with the appreciation that this investment 
could result in useful applications directed toward attenuation and 
prevention of exposure. It is expected that the projects supported under this 
solicitation will enhance the overall goals of the SBRP. The overarching goal 
of the SBRP is that support of basic research builds the foundation of 
knowledge necessary to realize practical benefits for the environment and 
public health, by lowering cleanup costs and improving human and ecological 
risk assessments. For more information about the SBRP refer to the SBRP 
website that describes all projects supported by the program:
http://www-apps.niehs.nih.gov/sbrp/program2000/programs00.cfm.   

Although the basic research supported by the SBRP has been through large 
multi-project grants, this solicitation provides an opportunity to address an 
emerging need by supporting individual research grants that focus on 
integrating molecular, cellular, biochemical and engineering approaches for 
structural and functional studies of populations involved in the remediation 
of hazardous substances. The NIH R21 Exploratory/Developmental Research Grant 
mechanism will be used. This mechanism is intended to encourage research 
projects that are distinct from those supported through the traditional R01 
mechanism. For example, long-term projects, or projects designed to increase 
knowledge in a well-established area will not be considered. Applications 
submitted under this mechanism should be innovative and novel, whether 
breaking new ground or extending previous discoveries or adapting scientific 
tools towards new directions or applications.

This solicitation is in support of basic developmental/exploratory research 
that will enhance our ability to understand at a mechanistic level the 
relationships between the number and type of species found at a site, the 
environmental contaminants, the nutrient requirements and other factors that 
need to be considered in developing efficient bioremediation strategies.  
Genetic engineering of novel organisms to degrade or sequester hazardous 
chemicals as a project in itself will be considered non-responsive to the 
RFA. However, genetically engineered organisms being developed and studied 
within a framework that considers its role within a population of organisms 
is acceptable within the context of this RFA.

Suggested research topics appropriate for this initiative include but are not 
limited to the following: 

o Developing novel methods for molecular ecology
o Monitoring bioremediation effectiveness by applying molecular tools
o Conducting studies designed to understand the impact of chemical 
contaminants on population diversity at sites
o Conducting studies designed to understand the impact of chemical 
contaminants on the function of populations degrading and or sequestering 
hazardous substances 
o Conducting studies to link changes in population structure with system-
level effects and the function of the individual populations  
o Developing and monitoring innovative bioremediation strategies with mixed 
populations 

Approaches should take advantage of state-of-the-art molecular, engineering 
or bioengineering methods that can be applied to better understand the 
structure and function of ecological populations such as microbes, nematodes, 
aquatic organisms, plants, etc., that are involved in the degradation or 
sequestration of hazardous substances found in environmental media such as 
soil, sediments and aquifers. Appropriate chemicals for bioremediation 
approaches are: 

o Hazardous substances found with some frequency at Superfund sites.
o Hazardous breakdown products of such substances formed in environmental 
media.
o Mixtures of substances or breakdown products of such substances found with 
some frequency at Superfund sites.

Note also that the applicant may refer to the Web site:
http://www-apps.niehs.nih.gov/sbrp/descrip/respri.cfm to obtain information
on hazardous substances that are relevant to Superfund and to the Environmental
Protection Agency (EPA) and the Agency for Toxic Substances and Disease
Registry (ATSDR). Substances that have been of particular interest to the SBRP
include PAHs, polychlorinated hydrocarbons (PCBs), other chlorinated organics
and metals. 

Examples of tools that could be applied in structure/function analysis 
include but are not limited to the following:

o gene expression microarrays
o proteomic methodologies
o 16-S rRNA-targeted technologies
o real-time quantitative polymerase chain reaction (RT-qPCR)
o bio-analytical sensors
o cell-based bioassays
o clone library construction/sequencing
o terminal restriction fragment length polymorphisms (T-RFLP)
o fluorescent in situ hybridization 

Note: Studies proposed under this RFA will not support vertebrate animals or 
human subjects research.

MECHANISM OF SUPPORT
 
This RFA will use the NIH R21 Exploratory/Developmental Research grant award 
mechanism. As an applicant you will be solely responsible for planning, 
directing, and executing the proposed project. This RFA is a one-time 
solicitation. The anticipated award date is September 30, 2003.

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 you are 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 NIEHS intends to commit approximately $1.5 million of SBRP appropriated 
funds in FY 2003 to support six to eight new grants in response to this RFA. 
An applicant may request a project period of up to two years. The direct 
costs for the two-year project period may not exceed $275,000. For example, 
if you request $150,000 direct costs in year one, the maximum available for 
direct costs in year two is $125,000. 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 NIEHS 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
 
You may submit an application 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
 
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

Annual Meetings: The SBRP holds annual meetings that are hosted by one of the 
grantee institutions receiving P42 funds. These meetings are 
multidisciplinary in nature and it is expected that R21 grantees plan to 
attend the annual SBRP meeting. The annual meeting allows for the exchange of 
information among investigators. Applicants must budget travel costs for the 
Principal Investigator to attend. 

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 your questions about scientific/research issues to:

Claudia Thompson, Ph.D.
Scientific Program Administrator
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, EC-27
79 T.W. Alexander Drive
Research Triangle Park, NC 27709
Telephone: 919-541-4638
Fax: 919-541-4937
E-mail: thompso1@niehs.nih.gov

o Direct your questions about peer review issues to:

Sally Eckert-Tilotta, Ph.D.
Scientific Review Administrator
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, EC-30
79 T.W. Alexander Drive
Research Triangle Park, North Carolina 27709
Telephone: 919-541-1446
Fax: 919-541-2503
E-mail: eckertt1@niehs.nih.gov 

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

Ms. Jacqueline Russell 
Grants Management Officer
Grants Management Branch
Division of Extramural Research and Training
National Institute of Environmental Health Science
P.O. Box 12233, EC-22
79 T.W. Alexander Drive
Research Triangle Park, NC 27709
Telephone: 919-541-0751
Fax: 919-541-2860
E-mail: russell@niehs.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 NIEHS staff to estimate the potential review workload and 
plan the review.
 
The letter of intent is to be sent by March 16, 2003. The letter of intent 
should be sent to:

Sally Eckert-Tilotta, Ph.D.
Scientific Review Administrator
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, EC-30
79 T. W. Alexander Drive
Research Triangle Park, North Carolina 27709
Telephone: 919-541-1446
Fax: 919-541-2503
E-mail: eckertt1@niehs.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

o The description (abstract), must include a brief explanation of how the 
intent of the application is consistent with the exploratory/development 
nature of the R21 mechanism as described in this notice. 

o Although preliminary data are neither expected or required for an R21 
application, they may be included.

o Sections a-d of the Research Plan may not exceed 15 pages, including tables 
and figures. 

o 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: (1) 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. (2) Surveys, questionnaires, data 
collection instruments, and clinical protocols. These may be stapled as sets. 
(3) Original glossy photographs or color images of gels, micrographs, etc., 
provided that a photocopy (may be reduced in size) is also included within 
the 15-page limit of items a-d of the research plan. 

Identify each item with the name of the Principal Investigator.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications 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.

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, send two additional copies of the application and 
include five collated sets of all appendix material to:

Sally Eckert-Tilotta, Ph.D.
Scientific Review Administrator
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, EC-30
79 T. W. Alexander Drive
Research Triangle Park, North Carolina 27709
Telephone: 919-541-1446
Fax: 919-541-2503
E-mail: eckertt1@niehs.nih.gov 
 
APPLICATION PROCESSING: Applications must be received on or before the 
application receipt date of April 16, 2003 as listed in the heading of this 
RFA. If an application is received after that date, it will be returned to 
the applicant without review.

Although there is no immediate acknowledgment of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.
 
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. The 
CSR will not accept any application that is essentially the same as one 
already reviewed. This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must 
include an Introduction addressing the previous critique.

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NIEHS. 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 NIEHS 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 process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications under 
review, will be discussed and assigned a priority score.
o Receive a second level review by the National Advisory Environmental Health 
Sciences Council.

REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health. In 
the written comments, reviewers will be asked to discuss the following 
aspects of your 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 your application's overall score, weighting them as appropriate 
for each application. Your 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, you may propose to carry out 
important work that by its nature is not innovative but is essential to move 
a field forward.

(1) SIGNIFICANCE: Does your study address an important problem? If the aims 
of your application are achieved, how do they advance scientific knowledge?  
What will be the effect of these studies on the concepts or methods that 
drive this field?

(2) APPROACH: Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project? Do you acknowledge potential problem areas and consider alternative 
tactics?

(3) INNOVATION: Does your project employ novel concepts, approaches or 
methods? Are the aims original and innovative? Does your project challenge 
existing paradigms or develop new methodologies or technologies?

(4) INVESTIGATOR: Are you appropriately trained and well suited to carry out 
this work? Is the work proposed appropriate to your experience level as the 
principal investigator and to that of other researchers (if any)?

(5) ENVIRONMENT: Does the scientific environment in which your 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?

For R21 applications, the above stated criteria will be reviewed but it will 
be noted that the R21 is a developmental/exploratory grant mechanism that is 
used for projects to generate preliminary data to develop novel hypotheses. 
Therefore, review standards for preliminary data and past performance are not 
applicable for this mechanism.

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following 
items will be considered in the determination of scientific merit and the 
priority score:

o PROTECTIONS: The adequacy of the proposed protection for humans, animals, 
or the environment, to the extent they may be adversely affected by the 
project proposed in the application.

o DATA SHARING: The adequacy of the proposed plan to share data. 

o 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: March 16, 2003
Application Receipt Date: April 16, 2003
Peer Review Date: July, 2003
Council Review: September 15-16, 2003
Earliest Anticipated Start Date:  September 22, 2003

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o Scientific merit (as determined by peer review).
o Availability of funds.
o Programmatic priorities.
 
REQUIRED FEDERAL CITATIONS 

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.

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 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 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.

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