TECHNOLOGIES TO FIND FUNCTIONAL ELEMENTS IN GENOMIC DNA
 
RELEASE DATE:  February 21, 2003 
 
RFA:  HG-03-004
 
National Human Genome Research Institute (NHGRI)
 (http://www.genome.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.172

LETTER OF INTENT RECEIPT DATE: April 13, 2003

APPLICATION RECEIPT DATE: May 13, 2003

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
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

The purpose of this RFA is to solicit applications to develop new and 
improved technologies for the efficient, comprehensive, high-throughput 
identification and verification of all types of sequence-based 
functional elements, particularly those other than coding sequences, 
for which adequate methods do not currently exist.  This effort is part 
of a new public research consortium, the Encylopedia of DNA Elements 
(ENCODE), the intent of which is eventually to identify all functional 
elements in the human genome sequence.  This RFA is being issued in 
conjunction with the RFA HG-03-003, "Determination of All Functional 
Elements in Human DNA", which will support a Research Network that will 
conduct a pilot project to test the ability of current methodologies to 
exhaustively identify functional elements, focused primarily on 
transcriptional units, in a targeted region of the human genome.  

RESEARCH OBJECTIVES

Background

In April 2003, the sequence of the human genome will be essentially 
complete.  For the scientific community to make the best use of that 
fundamental information resource, the identity and precise location of 
all sequence-based functional elements in the genome must be 
determined.  While many of the protein-coding genes are already known, 
many others remain to be identified.  Beyond open reading frames, non-
protein-coding genes, transcriptional regulatory elements and 
determinants of chromosome structure and function remain largely 
unknown.  A comprehensive encyclopedia of all of these features is 
needed to utilize fully the sequence of the human genome to understand 
human biology better, to predict potential disease risks, and to 
stimulate the development of new therapies and other interventions to 
prevent and treat disease.   

One of the primary reasons for the success of the Human Genome Project 
has been the development and use of high-throughput strategies for data 
generation, and the placement of the data immediately in the public 
domain.  Most of the sequence data, the underlying maps and the 
sequence assemblies were generated through the use of large-scale 
automated processes.  Now, methods such as sequence analysis of whole 
genomes, DNA microarray technology and mass spectrometry have been or 
are being developed as high-throughput approaches for additional types 
of genomic analyses, such as determining the parameters of gene 
expression or the location of gene products by the thousands at a time 
instead of individually.  High-throughput methods to determine the 
location of cis-regulatory elements and, to a lesser extent, other 
sequence elements, are also beginning to be developed.  However, at 
present, there is no single approach or compilation of approaches that 
can accurately and efficiently identify every sequence feature in 
genomic DNA. 

To address this need, the NHGRI is initiating the Encyclopedia of DNA 
Elements (ENCODE) project, the goal of which is to comprehensively 
identify functional elements in the human genome sequence.  The ENCODE 
project will begin with two components.  The first is a pilot to test 
and compare existing methods for the exhaustive identification and 
verification of functional sequence elements in a fraction (30 Mb) of 
human genomic DNA.  Because the most well developed current methods 
pertain primarily to coding sequences or transcriptional units, NHGRI 
anticipates that the initial ENCODE pilot will focus primarily on those 
two classes.  A companion RFA HG-03-003, "Determination of All 
Functional Elements in Human DNA", is being issued to solicit proposals 
that address that component of the ENCODE project.  The second 
component of the ENCODE project will address the need for new and 
improved technologies that will enable the ENCODE project to identify 
all sequence-encoded functional elements on a genome-wide scale.  The 
current RFA, HG-03-004, "Technologies to Find Functional Elements in 
Genomic DNA", is intended to solicit proposals to develop novel 
technologies that take systematic and high-throughput approaches to the 
comprehensive identification of functional sequence elements in the 
human genome.  It is envisioned that when such a set of technologies is 
applied in subsequent components of the ENCODE project, it will be 
possible to fully annotate the human genome with biologic information 
that will serve as a platform for more in-depth, detailed studies of 
biological function. 

Research Scope

The purpose of this RFA is to stimulate the development of novel 
technologies to identify functional elements in the human genome.  This 
is a technology development component of the ENCODE project and is 
designed to generate a "tool box" of technologies that can be used to 
comprehensively determine the sequence-encoded functional elements
in human DNA (http://www.genome.gov/pages/research/ENCODE).  To be
successful, the ENCODE project will eventually need to be able to scan the
entire human genome, using high-throughput assays for all types of
sequence-encoded functional elements.  However, many types of functional 
elements cannot currently be studied at such large scale, or even at 
smaller scale, because of the lack of effective, practical high-
throughput methods.  In addition, newer technologies may improve on 
established techniques for the identification of more well–studied 
elements by increasing the accuracy or the efficiency of these methods. 

This RFA seeks applications for research projects to develop efficient 
technologies (both experimental and computational) for, but not limited 
to, the following areas:  

o   Transcribed sequences, including protein-coding sequences but with 
an emphasis on non-protein coding transcribed sequences.  A 
description of the gene structure with transcriptional start sites, 
polyadenylation sites, and all alternative transcripts, is an 
example.
o   Conserved non-coding sequences that may represent functional 
elements.
o   Cis-acting elements that regulate gene expression at either the 
transcriptional or post-transcriptional levels.  These elements 
include promoters, enhancers, insulators, and those that regulate 
RNA stability and translation. 
o   Sequence features that affect/control chromosome biology, including 
chromatin structure.   Examples include origins of replication and 
hot spots for recombination. 
o   Epigenetic changes, such as DNA methylation and chromatin 
modifications.

These few examples are illustrative and should not be considered to be 
limiting in any way. Novel and innovative technologies to achieve high-
throughput, large-scale analyses of any type of sequence-encoded 
functional elements are sought. 

The "process" of technology development can be considered to span a 
spectrum of stages. Initially, it involves the development of an 
entirely new methodology (or the significant improvement of an existing 
methodology) to the point of proof of principle. The method must then 
be reduced to practice. For such a new method to have a significant 
impact for genomic studies, it also must be shown that it can be used 
efficiently on a large-scale, or genomic basis, which requires another 
level of technology development. This RFA is intended to solicit 
applications that address any of these phases of technology 
development. 

The NHGRI will give priority to the development of technologies that 
will be used to study the human genome. Technology development projects 
that utilize other eukaryotic organisms will be considered, but direct 
applicability of these technologies to the analysis of the human genome 
must be evident.  An important feature of any newly developed 
technology will be the ease with which it can be exported into other 
laboratories, or in other ways made readily accessible to 
investigators. The development of computational methods for the study 
of genomic function is encouraged under this solicitation. It is 
anticipated that there will be several kinds of large-scale datasets 
relevant to the ENCODE project available for developing new 
computational analyses, including, e.g., genomic sequences of regions 
syntenic to the ENCODE target regions from diverse species and full-
length cDNAs sequences from most human and mouse genes. Since the 
technologies to be developed under this RFA need to be able to be 
applied to the entire genome, applications proposing to analyze a 
particular gene, gene product or non-coding functional element will not 
be considered to be responsive to this RFA. 

To encourage the consideration of novel approaches, applicants 
responding to this RFA are not required to have preliminary data. 
However, the research project must be well designed, must be 
scientifically and technically sound, and should propose alternative 
solutions. In the absence of preliminary data, applicants are 
encouraged to present any other information that can be considered as 
evidence of feasibility.

As the work funded under this RFA progresses, the P.I.s will be 
encouraged to interact with the ENCODE pilot project consortium and its 
members.  If work supported under this RFA, such as a computational 
analysis, results in the generation of data pertaining to the complete 
set of target regions of the ENCODE project, the P.I. may be invited to 
join the consortium (see http://www.genome.gov/pages/research/ENCODE
for a description of the consortium).  Among other requirements, this would 
involve sharing of the data with the members of the consortium, as 
participation involves concurrence with a specific data release policy 
(see RFA HG-03-003 for a detailed description of that policy).  
Applicants to HG-03-004 may wish to address their approach to data 
release in their proposal.

MECHANISM OF SUPPORT

This RFA will use NIH investigator-initiated research project grant 
(R01) 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 in FY2003 (see FUNDS AVAILABLE below).  
Future unsolicited, competing-continuation applications based on this 
project will compete with all investigator-initiated applications and 
will be reviewed according to the customary peer review procedures.  
The anticipated award date is September 2003. Applications that are not 
funded in the competition described in this RFA may be resubmitted as 
NEW investigator-initiated applications using the standard receipt 
dates for NEW applications described in the instructions to the PHS 398 
application
(see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-019.html).  

This RFA 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_2001/part_i_1.htm. 

FUNDS AVAILABLE

The NHGRI intends to commit approximately $2,000,000 in FY 2003 to fund 
4 to 8 grant applications in response to this RFA. An applicant may 
request a project period of up to 3 years and a budget for direct costs 
of up to $350,000 per year.  Awards pursuant of this RFA are contingent 
upon the availability of funds and the receipt of a sufficient number 
of meritorious applications. At this time, it is anticipated that this 
RFA will be reissued in FY 2004 to allow potential applicants to 
consider the development of creative and novel technologies that may 
require additional preparation time prior to submission. 

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

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 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:

Elise Feingold, PhD or Peter Good, PhD
Program Directors
Division of Extramural Research
NHGRI
Building 31, Room B2B07
Bethesda, MD  20892-2033
Telephone:  (301) 496-7531
FAX:  (301) 480-2770
Email:  Elise_Feingold@nih.gov or Peter_Good@nih.gov

o Direct your questions about peer review issues to:

Rudy Pozzatti, PhD
Scientific Review Administrator
Division of Extramural Research
NHGRI
Building 31, Room B2B37
Bethesda, MD  20892-2032
Telephone:  (301) 402-0838 
FAX:  (301) 435-1580
Email:  pozzattr@mail.nih.gov

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

Jean Cahill
Chief, Grants Administration Branch
Division of Extramural Research
NHGRI 
Building 31, Room B2B34 
Bethesda, MD  20892-2031
Telephone:  (301) 301-435-7858
FAX: (301) 402-1951
Email:  cahillj@mail.nih.gov

Prospective Applicant Meeting.  There will be a combined meeting at the 
Natcher Conference Center on the NIH campus from 9:00 a.m. to 
approximately 2:00 p.m. on March 7, 2003 to launch the ENCODE project 
and to answer questions about the RFA from prospective applicants.  
Attendance at this meeting is not a prerequisite for responding to the 
RFA or for participation in the ENCODE consortium.  For more 
information about this meeting, see 
http://www.genome.gov/Pages/Research/ENCODE/ or send an email request 
for information to encode@mail.nih.gov. 

LETTER OF INTENT
 
Prospective applicants are asked to submit a letter of intent that 
includes the following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this RFA 

Although a letter of intent is not required, is not binding, and does 
not enter into the review of a subsequent application, the information 
that it contains allows IC staff to estimate the potential review 
workload and plan the review.
 
The letter of intent is to be sent by the date listed at the beginning 
of this document.  The letter of intent should be sent to:

Peter Good, PhD
Program Director
Division of Extramural Research
NHGRI
Building 31, Room B2B07
Bethesda, MD  20892-2033
Telephone:  (301) 496-7531
FAX:  (301) 480-2770
Email:  Peter_Good@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.
  
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications 
requesting up to $250,000 per year in direct costs must be submitted in 
a modular grant format.  The modular grant format simplifies the 
preparation of the budget in these applications by limiting the level 
of budgetary detail.  Applicants request direct costs in $25,000 
modules.  Section C of the research grant application instructions for 
the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-
by-step guidance for preparing modular grants.  Additional information 
on modular grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm. 

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 copies of the application 
must be sent to:

Rudy Pozzatti, PhD
Scientific Review Administrator
Division of Extramural Research
NHGRI
Building 31, Room B2B37
Bethesda, MD  20892-2033
Telephone:  (301) 402-0838 
FAX:  (301) 435-1580
Email:  pozzattr@mail.nih.gov
 
APPLICATION PROCESSING: Applications must be received on or before 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.

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.

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.
 
PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the NHGRI.  

Incomplete applications will be returned to the applicant without 
further consideration.  And, if the application is not responsive to 
the RFA, NIH staff may contact the applicant to determine whether to 
return the application to the applicant or submit it for review in 
competition with unsolicited applications at the next appropriate NIH 
review cycle.

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 NHGRI 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 Council for 
Human Genome Research.

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.

The application must be directed toward attaining the programmatic 
goals as stated under RESEARCH OBJECTIVES.  The following criteria will 
be used by peer review groups to evaluate these applications: 

(1) SIGNIFICANCE:  Does the application address the problem outlined in 
this RFA?  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 as outlined in this RFA?  Are potential problem 
areas acknowledged and alternative tactics considered?  Does the 
technical approach have the potential to be applied efficiently and 
cost-effectively at large scale?  

(3) INNOVATION:  Does the project employ novel concepts, approaches, or 
methods for identifying and verifying sequenced-based functional 
elements?  Does your project challenge existing paradigms or develop 
new methodologies or technologies?  Does the project develop new 
methods or technologies to reduce costs or increase quality or 
throughput? 

(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?

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 INCLUSION:  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. 

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:  April 13, 2003
Application Receipt Date:  May 13, 2003
Peer Review Date:  July 2003
Council Review:  September 2003
Earliest Anticipated Start Date:  September 30, 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, including both the likelihood that the 
proposed technology could be applied to the ENCODE project in a timely 
manner and the range of technologies that could be developed under this 
component of the ENCODE project. 

REQUIRED FEDERAL CITATIONS 

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.  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://grants.nih.gov/grants/stem_cells.htm and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  
Only research using hESC lines that are registered in the NIH Human 
Embryonic Stem Cell Registry will be eligible for Federal funding (see 
http://escr.nih.gov).   It is the responsibility of the applicant to 
provide the official NIH identifier(s)for the hESC line(s)to be used in 
the proposed research.  Applications that do not provide this 
information will be returned without review. 

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

Applicants may wish to place data collected under this 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 administered under NIH grants policies described 
at http://grants.nih.gov/grants/policy/policy.htm 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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