MOLECULAR ANATOMY OF HEAD & NECK CANCER: A GENOMIC/PROTEOMIC APPROACH
 
RELEASE DATE:  May 6, 2003
 
RFA: DE-04-003
 
National Institute of Dental and Craniofacial Research (NIDCR)
 (http://www.nidcr.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER:  93.121  
 
LETTER OF INTENT RECEIPT DATE:  7/26/2003 

APPLICATION RECEIPT DATE:  8/26/2003
 
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 Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA

The National Institute of Dental and Craniofacial Research (NIDCR) 
invites applications that foster basic and translational research aimed 
at deciphering the complex molecular networks involved in the 
development of squamous cell carcinomas of the head and neck (HNSCCs). 
This Request for Applications (RFA) encourages research projects that 
focus on: 1) Correlation of the genomic state, gene transcription 
profiles, and repertoire of proteins expressed and their activities 
with the functional status of both normal and aberrant cells; 2) New 
and existing discoveries in genomics/proteomics to develop novel 
biomarkers for early detection of pre-neoplastic and neoplastic lesions 
which might also serve as candidate targets for therapy. Collaborative 
projects involving interdisciplinary teams of investigators are 
strongly encouraged.

RESEARCH OBJECTIVES

BACKGROUND

Cancers of the oral cavity, larynx and pharynx, collectively referred 
to as squamous cell carcinomas of the head and neck (HNSCCs), represent 
the 6th most common cancer in the developed world, and are often 
associated with low survival and high morbidity rates. Surgery, 
radiation and/or chemotherapy have not improved the 50% overall 5-year 
survival of this devastating disease over the past thirty years. 
Moreover, because of their location, treatment can lead to long-term 
functional and cosmetic defects in survivors, which can have a 
significant impact on the quality of life. The high mortality rate may 
be, in part, due to the fact that head and neck cancers are being 
diagnosed at predominantly later stages of the disease. Thus, early 
diagnosis plays a key role in disease progression, treatment response, 
and ultimately the quality of life and patient survival. Elucidation of 
the molecular mechanisms leading to head and neck cancer may result in 
the identification of new biomarkers of diagnostic/prognostic value and 
aid in the clinical management of these patients. The discovery of 
these biomarkers can also be useful for identification of pre-
neoplastic lesions, which are difficult to distinguish from other 
lesions that are not pre-neoplastic in nature. Such knowledge will be 
of great value in the prevention and prognosis of HNSCCs.

Like other malignancies, alterations of genes that control cell growth, 
differentiation and motility play an important role in the development 
and progression of head and neck cancers. HNSCCs arise in a multi-step 
process resulting from sequential accumulation of genetic changes. 
These changes involve a combination of both inherited and acquired 
alterations in the DNA sequence, ranging from point mutations to 
deletions, amplifications, and translocations. Invariably, changes in 
the genetic information result in alterations in expression patterns, 
both at the transcriptional and post-transcriptional levels. 

A number of genetic alterations in HNSCCs have been identified, thus 
providing a preliminary molecular progression model in squamous cell 
carcinogenesis. One of the most common genetic changes that occurs 
early in the progression of these tumors is loss of chromosomal region 
9p21, whose main effect is inactivation of the p16 tumor suppressor 
gene, an inhibitor of cyclin-dependent kinase. Other changes include a 
mutation in the p53 gene in half the cases, resulting in the 
progression from pre-invasive to invasive lesions and amplification of 
the cyclin D1 oncogene observed in about a third of primarily invasive 
tumors. Since early genetic changes do not always correlate with 
changes in morphology and clinical diagnoses, testing for genetic 
alterations in early lesions may be of significant diagnostic value.

The completion of the human genome project and the recent development 
of novel, highly sensitive high-throughput techniques have now afforded 
the unique opportunity to perform a comprehensive molecular 
characterization of normal, pre-cancerous, and malignant cells. Novel 
and emerging proteomic approaches will build on and complement the 
information obtained from these genomic studies. Proteomics describes 
the level of expression and activity of each protein, as well as the 
complexity of protein-protein interactions within the cell. Proteins 
can undergo a number of post-translational modifications and are 
dynamic molecules, with their composition constantly changing, making 
the study of the proteome even more complex. Nonetheless, the 
importance of these revolutionary approaches lies in unraveling the 
nature of the molecular alterations responsible for HNSCC development, 
including those affecting intricate molecular networks coupling protein 
expression profiles with signaling, and regulatory networks controlling 
cell cycle progression and cell survival or death. These efforts will 
constitute the foundation for the complete understanding of the 
molecular pathogenesis of HNSCCs, thus facilitating the identification 
of new markers for the early detection of pre-neoplastic lesions and 
novel targets for pharmacological intervention of this devastating 
disease.

The following are some examples of research topics relevant to this 
initiative:

o Identification and characterization of the relationship between gene 
expression profiling and protein networks to identify key cellular 
processes involved in normal and cancerous growth;

o Identification and characterization of the relationship between gene 
and protein expression profiles and/or the presence of virally encoded 
molecules during tumor progression; 

o Characterization of the molecular changes during tumor progression in 
squamous epithelial cells and the stroma as well as exploration of the 
molecular interplay between squamous epithelial cells and the cellular 
components of the stroma;

o Use of genomic, expressional and proteomic technologies to identify 
the molecular determinants responsible for malignant progression of 
oral pre-malignancies;

o Elucidation of the molecular events leading to the acquisition of an 
invasive and metastatic phenotype;

o Examination of specific signal transduction networks functionally 
altered during tumorigenesis;

o Use of protein microarrays (e.g., arrayed antibodies and MALDI mass 
spectrometry) to study changes in protein abundance, phosphorylation 
states, protein-protein interactions, protein expression patterns etc. 
in squamous epithelium;

o Establishment and characterization of cell cultures, organotypic 
cultures, and animal model systems to decipher the mechanisms of HNSCC 
initiation and progression;

o Epigenetic characterization of head and neck tumors i.e., use of CGH 
arrays, promoter methylation arrays, and transcription factor analysis 
during tumor progression;

o Use of gene and protein expression profiling for staging as well as 
predicting prognosis of HNSCCs;

o Use of high-throughput genomic and proteomic analyses to study 
squamous carcinoma cell growth, differentiation, apoptosis, and 
senescence;

o Use of bioinformatics tools to analyze data related to gene and 
protein expression, interaction, and modification, and their 
relationship to genetic alterations in HNSCCs.

The collaboration between individuals with diverse backgrounds in 
molecular biology, genetics, bioinformatics, genomics, proteomics etc. 
is strongly encouraged. 

MECHANISM OF SUPPORT

This RFA will use NIH R01 (Investigator-Initiated Research Project 
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.  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 earliest award date is April 2004. 
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. 

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 NIDCR intends to commit approximately $3.0 million total costs 
(direct plus indirect costs) in FY 04 or FY 05 to fund 8 to 9 R01s in 
response to this RFA. An applicant may request a project period of up 
to five years and a budget for direct costs of up to $250,000 per year. 
Because the nature and scope of the proposed research will vary from 
application to application, it is anticipated that the size and 
duration of each award will also vary. Although the financial plans of 
the NIDCR 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(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:

Yasaman Shirazi, Ph.D.
Director, Epithelial Cell Regulation and Transformation Program
Division of Basic and Translational Sciences
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AN-18C
Bethesda, MD  20892-6402
Telephone:  (301) 594-4812
FAX: (301) 480-8318
Email: Yasaman.Shirazi@nih.gov

o Direct your questions about peer review issues to:

H. George Hausch, Ph.D. 
Acting Director, Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health 
45 Center Drive, Room 4AN-44F 
Bethesda, MD 20892-6402 
Telephone: (301) 594-2904 
FAX: (301) 480-8303 
Email: George.Hausch@nih.gov

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

Mary Daley
Chief Grants Management Officer
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AN-44B
Bethesda, MD  20892-6402
Telephone:  (301) 594-4808
FAX: (301) 480-3562
Email: md74u@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:

Yasaman Shirazi, Ph.D.
Director, Epithelial Cell Regulation and Transformation Program
Division of Basic and Translational Sciences
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AN-18C
Bethesda, MD  20892
Telephone:  (301) 594-4812
FAX: (301) 480-8318
Email: Yasaman.Shirazi@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 
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 
package must be sent to:

H. George Hausch, Ph.D. 
Acting Director, Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health 
45 Center Drive, Room 4AN-44F 
Bethesda, MD 20892-6402 
Telephone: (301) 594-2904 
FAX: (301) 480-8303 
Email: George.Hausch@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 NIDCR. 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 (IC) 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 NIDCR 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 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?

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:

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of 
human subjects and protections from research risk relating to their 
participation in the proposed research will be assessed. (See criteria 
included in the section on Federal Citations, below).
 
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy 
of plans to include subjects from both genders, all racial and ethnic 
groups (and subgroups), and children as appropriate for the scientific 
goals of the research.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria in the 
sections on Federal Citations, below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals 
are to be used in the project, the five items described under Section f 
of the PHS 398 research grant application instructions (rev. 5/2001) 
will be assessed.  

ADDITIONAL CONSIDERATIONS 

DATA SHARING:  The adequacy of the proposed plan to share data.
 
BUDGET:  The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  July 26, 2003
Application Receipt Date:  August 26, 2003
Peer Review Date:  November 2003
Council Review:  January 2004
Earliest Anticipated Start Date:  April 2004

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 

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 

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

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

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

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

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of 
"Healthy People 2010," a PHS-led national activity for setting priority 
areas. This 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.

Return to Volume Index

Return to NIH Guide Main Index

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, RealPlayer, Video or Flash files, see Help Downloading Files.