EXFOLIATED CELLS, BIOACTIVE FOOD COMPONENTS, AND CANCER 

RELEASE DATE:  June 18, 2004

PA NUMBER: PA-04-114 (see addendum NOT-CA-04-025)

December 19, 2006 - The R01 portion of this funding opportunity has been 
replaced by PA-07-207, which now uses the electronic SF424 (R&R) 
application for February 5, 2007 submission dates and beyond.

March 2, 2006 (NOT-OD-06-046) – Effective with the June 1, 2006 submission date, 
all R03, R21, R33 and R34 applications must be submitted through Grants.gov using 
the electronic SF424 (R&R) application. This announcement will stay active for 
only the May 1, 2006 AIDS and AIDS-related application submission date for these 
mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms 
expires on the date indicated below. Other mechanisms relating to this announcement 
will continue to be accepted using paper PHS 398 applications until the stated 
expiration date below, or transition to electronic application submission. 
Replacement R03 (PA-06-360) and R21 (PA-06-359) funding opportunity announcements 
have been issued for the submission date of June 1, 2006 and submission dates 
for AIDS and non-AIDS applications thereafter.

EXPIRATION DATE for R03 and R21 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R03 and R21 AIDS and AIDS-Related Applications: May 2, 2006 
Expiration Date for R01 Non-AIDS Applications: November 2, 2006
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007
Department of Health and Human Services (DHHS)

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

COMPONENT OF PARTICIPATING ORGANIZATION:
National Cancer Institute (NCI) 
 (http://www.nci.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.393, 93.399

THIS PA CONTAINS THE FOLLOWING INFORMATION

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

PURPOSE OF THIS PA

The National Cancer Institute (NCI) invites applications for new R01, 
R21, and R03 grants which focus on research to critically evaluate the 
use of exfoliated cells to monitor the physiological effects of dietary 
bioactive food components thought to be involved with cancer 
prevention. The objective is to encourage interdisciplinary 
collaborations between scientists engaged in research using exfoliated 
cells and those conducting nutrition research related to cancer 
prevention. This research will help determine the utility of exfoliated 
cells as a model system to monitor both the absorption and retention of 
bioactive food components and the concomitant  alterations in genomic 
and epigenetic events that occur in intact cells.

RESEARCH OBJECTIVES

Background

A wealth of evidence points to the diet as one of the most important 
modifiable determinants of the risk of developing cancer. A large 
number of bioactive components that are protective at different stages 
of cancer formation have been identified in food.  Although serum and 
blood cells have frequently been used to evaluate exposure and 
physiological response to bioactive food components, their evaluation 
may not always be predictive of the target tissue.  Surrogate samples, 
such as exfoliated cells, may offer a noninvasive opportunity to 
evaluate not only exposures but also physiological responses in the 
target tissue.  Evidence already exists that exfoliated colonocytes may 
provide clinical information for evaluating the physiological effects 
of some food components that may be protective against cancer. However, 
additional research is needed to validate their utility across the 
various classes of bioactive food components. 

Exfoliated colonocytes occurring in stool samples offer a unique 
opportunity to non-invasively evaluate the effects of bioactive food 
components in a target tissue (the colon). 
Exfoliated colonocytes have been used successfully for measurements of 
DNA mutations, changes in gene expression, protein expression, and 
associated activities that are biomarkers of colon cancer. Evidence 
exists that some dietary components can modify molecular markers, such 
as DNA damage and gene expression, in exfoliated colonocytes.  However, 
these studies did not evaluate changes in gene expression in the 
exfoliated colonocytes in relation to the tumor or the normal colonic 
tissue. Thus, the utilization of the exfoliated cells as a surrogate 
for diet-induced changes in colonic cells remains unresolved. 

Exfoliated cells from other sites may also be effective tools for 
monitoring human exposure to bioactive food components. There are many 
other sources of exfoliated epithelial cells that can be obtained 
relatively noninvasively as potential surrogates for target tissues of 
interest.  Examples include bladder urothelial cells present in urine 
samples, and airway epithelial cells present in sputum or from 
bronchoalveolar lavage specimens. Similar to the colon, the level of 
DNA damage in exfoliated lung epithelial cells has been shown to be 
influenced by dietary components. Specifically, consumption of a 
lycopene-rich vegetable juice has been shown to be associated with 
significantly decreased levels of DNA damage in lung epithelial cell 
obtained from healthy volunteers and as measured by the COMET assay.  
In contrast, no changes were observed in DNA damage in leukocytes, 
indicating that they do not reflect the target tissue.

Although there are technological challenges, mammary epithelial cells 
have been obtained by ductal lavage, from nipple aspirate fluid and 
from fine needle aspiration of the breast parenchyma. Prolonged 
consumption of soy protein isolate has been shown to increase the 
appearance of hyperplastic epithelial cells obtained by nipple 
aspiration.  Human breast milk has also been shown to be an excellent 
source of luminal epithelial cells from a cohort of lactating women.  
Epithelial cells present in milk have been analyzed for carcinogen-DNA 
adducts in order to assess exposure to dietary and environmental 
carcinogens. Therefore, exfoliated mammary epithelial cells may also be 
useful samples for monitoring exposure to bioactive food components. 

Buccal mucosal cells can be obtained very easily by scraping the cheeks 
with a tooth brush or wooden spatula and also may be useful samples in 
nutrition studies. Specifically, green tea was protective against 
micronuclei formation in exfoliated oral cells of individuals with oral 
leukoplakia.   It has been suggested that global DNA methylation status 
in buccal mucosal cells may reflect global methylation status in lung 
tissues because there is a significant association between global DNA 
methylation in buccal mucosal cells and malignant tissues of the lung, 
but not between methylation in peripheral leukocytes and lung tissues. 
Therefore, buccal cells hold promise because of their easy 
accessibility; however, their response to bioactive food components 
needs to be compared with the responses of cells in target tissues.

Objectives and Scope

This initiative is designed to promote innovative preclinical and 
clinical research to critically evaluate the utility of using 
exfoliated cells to monitor variation in dietary intakes of bioactive 
food components thought to be involved with cancer prevention. 
Collaborations with the mouse models consortium may allow opportunities 
to simultaneously examine altered genomics on the response to bioactive 
food components.  The emphasis should be on a comparison of the 
activity of bioactive food components in exfoliated cells, normal cells 
(such as the target tissue and blood cells), and, when available, tumor 
cells. Potential areas of investigation include studying the effect of 
individual dietary components on molecular or biochemical processes 
(e.g., gene expression, DNA methylation, protein expression, and 
accumulation of bioactive food components) and predicting the 
anticancer response in surrogate samples, blood and its constituents 
and target tissues.

Examples of  the types of research topics and approaches that would be 
relevant areas of investigation for the development of R01, R21 and R03 
grant applications under this PA include (but are not limited to):

o Comparison of global and gene-specific DNA methylation in lung 
epithelial cells obtained from sputum samples, leukocytes, normal lung 
cells, and lung tumor cells of humans following consumption of dietary 
folate.

o Examination of relative gene changes in exfoliated colonic epithelial 
cells, normal colonic mucosal cells, colonic tumor cells, and 
leukocytes of rats following consumption of omega-3 fatty acids;

o Comparison of micronuclei formation in buccal cells, cells in sputum, 
leukocytes, and cells in the lung as influenced by green tea 
consumption;

o Modulation of carcinogen-DNA adduct formation in rat exfoliated 
colonic epithelial cells and normal colonic mucosal cells by dietary 
sulforaphane; and 

o Comparison of genistein concentrations in cells of the blood, mammary 
epithelial cells, and mammary biopsy samples after soy supplementation.

MECHANISM OF SUPPORT

This PA will use the NIH Investigator-initiated Research Project Grant 
(R01),  the NIH Exploratory/Developmental grant (R21), and the NIH 
Small Grants  Program (R03) as award mechanisms.  As an applicant, you 
will be solely responsible for planning, directing, and executing the 
proposed project. 

An R21 applicant may request a project period of up to 2-years with a 
combined budget for direct costs of up $275,000 for the 2-year period.  
For example, the applicant may request $100,000 in the first year and 
$175,000 in the second year. The request should be tailored to the 
needs of the project.  Normally, no more than $200,000 may be requested 
in any single year.  For R03 applications, the total budget may not 
exceed $100,000 in direct costs for the entire project and the direct 
costs in any one-year for R03 grant applications must not exceed 
$50,000.  The total project period for R03 applications submitted in 
response to this announcement may not exceed 2 years.  The R21 and R03 
grants are not renewable. Investigators are encouraged to seek 
continued support after completing an Exploratory/Developmental Grant 
project or a Small Grant project through a Research Project Grant 
(R01).  (Please note that facilities and administrative (F&A) costs 
requested by any consortium participants are excluded from the direct 
cost limit per NIH Guide Notice NOT-OD-04-040.)

This PA 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 budgeting 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_2003/NIHGPS_Part2.htm.

ELIGIBLE INSTITUTIONS 

You may submit (an) application(s) if your institution has any of the 
following characteristics:

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, 
hospitals, and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government 
o Domestic or foreign institutions/organizations
o Faith-based or community-based organizations
 
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to 
carry out the proposed research is invited to work with their 
institution to develop an application for support.  Individuals from 
underrepresented racial and ethnic groups as well as individuals with 
disabilities are always encouraged to apply for NIH programs.

WHERE TO SEND INQUIRIES

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

o Direct your questions about scientific/research issues to:

Cindy D. Davis, Ph.D.
Nutritional Science Research Group
Division of Cancer Prevention
National Cancer Institute
6130 Executive Blvd., EPN Room 3159, MSC 7328
Bethesda, MD  20892-7328
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 594-9692
FAX: (301) 480-3925
Email: davisci@mail.nih.gov

Virginia W. Hartmuller, Ph.D., R.D.
Epidemiology and Genetics Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Blvd., EPN Room 5102, MSC 7324
Bethesda, MD 20892-7324
Rockville, MD 20852 (for express/courier service) 
Telephone:  (301) 594-3402
FAX:  (301) 402-4279
E-mail: hartmulv@mail.nih.gov

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

Crystal Wolfrey
Grants Administration Branch
National Cancer Institute
6120 Executive Blvd., EPS Room 234, MSC 7150
Bethesda, MD 20892-7150
Telephone: (301) 496-8634
FAX: (301) 496-8601
Email: wolfreyc@mail.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001).  Applications must 
have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) 
number as the Universal Identifier when applying for Federal grants or 
cooperative agreements. The DUNS number can be obtained by calling 
(866) 705-5711 or through the web site at 
http://www.dunandbradstreet.com/. The DUNS number should be entered on 
line 11 of the face page of the PHS 398 form.  The PHS 398 document is 
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in 
an interactive format.  For further assistance, contact GrantsInfo; 
Telephone (301) 435-0714; Email: GrantsInfo@nih.gov.

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

SUPPLEMENTARY INSTRUCTIONS:  All instructions for the PHS 398 (rev. 
5/2001) must be followed, with these exceptions for R21 applications:

o  Research Plan

Items a - d of the Research Plan (Specific Aims, Background and 
Significance, Preliminary Studies, and Research Design and Methods) may 
not exceed a total  of 15 pages.  No preliminary data is required but 
may be included if it is available.  Please note that a Progress Report 
is not needed; competing continuation applications for an 
exploratory/developmental grant will not be accepted.

o Appendix.  Use the instructions for the appendix detailed in the PHS 
398 except that no more than 5 manuscripts, previously accepted for 
publication, may be included. 

All instructions for the PHS 398 (rev. 5/2001) must be followed, with 
these exceptions for R03 applications:

o Research Plan

Items a - d of the Research Plan (Specific Aims, Background and 
Significance, Preliminary Studies, and Research Design and Methods) may 
not exceed a total  of 10 pages. Please note that a Progress Report is 
not needed; competing continuation applications for a small grant will 
not be accepted.

o Appendix.  The appendix may include original, glossy photographs or 
color images of gels, micrographs, etc., provided that a photocopy (may 
be reduced in size) is also included within the page limits of the 
research plan. No publications or other printed material, with the 
exception of pre-printed questionnaires or surveys, may be included in 
the appendix.

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

SPECIFIC INSTRUCTIONS FOR MODULAR 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.

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

Applicants requesting more than $500,000 must carry out the following 
steps:

1. Contact the IC program staff at least 6 weeks before submitting the 
application, i.e., as you are developing plans for the study; 

2. Obtain agreement from the IC staff that the IC will accept your 
application for consideration for award; and,

3. Include a cover letter sent with the application that identifies the 
staff member and IC who agreed to accept assignment of the application.  

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

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten 
original of the application, including the checklist, and five signed 
photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

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

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and 
funding assignment within 8 weeks.

PEER REVIEW PROCESS

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

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

o Undergo a selection process in which only those applications deemed 
to have the highest scientific merit, generally the top half of 
applications under review, will be discussed and assigned a priority 
score
o Receive a written critique
o Receive a second level review by an appropriate national advisory 
council or board.
 
REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  
In the written comments, reviewers will be asked to evaluate 
applications in order to judge the likelihood that the proposed 
research will have a substantial impact on the pursuit of these goals.  
The scientific review group will address and consider each of the 
following criteria in assigning the application’s overall score, 
weighting them as appropriate for each application.

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The application does not need to be strong in all categories to be 
judged likely to have major scientific impact and thus deserve a high 
priority score.  For example, an investigator may propose to carry out 
important work that by its nature is not innovative but is essential to 
move a field forward.

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

APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of 
the project?  Does the applicant acknowledge potential problem areas 
and consider alternative tactics?

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

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

ENVIRONMENT:  Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed 
experiments take advantage of unique features of the scientific 
environment or employ useful collaborative arrangements?  Is there 
evidence of institutional support?  

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 below on Federal Citations.)  

INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH:  The adequacy 
of plans to include subjects from both genders, all racial and ethnic 
groups (and subgroups), and children as appropriate for the scientific 
goals of the research will be assessed.  Plans for the recruitment and 
retention of subjects will also be evaluated.  (See Inclusion Criteria 
in the sections below on Federal Citations.)

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

ADDITIONAL REVIEW CONSIDERATIONS 

SHARING RESEARCH DATA:  Applicants requesting more than $500,000 in 
direct costs in any year of the proposed research are expected to 
include a data sharing plan in their application. The reasonableness of 
the data sharing plan or the rationale for not sharing research data 
will be assessed by the reviewers. However, reviewers will not factor 
the proposed data sharing plan into the determination of scientific 
merit or priority score.  Details are available at 
http://grants.nih.gov/grants/policy/data_sharing.
 
BUDGET:   The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research.

AWARD CRITERIA

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

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

REQUIRED FEDERAL CITATIONS 

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.  See 
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.

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

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

All investigators proposing clinical research should read the "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research - Amended, October, 2001," published in the NIH Guide 
for Grants and Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a 
complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition 
of clinical research; updated racial and ethnic categories in 
compliance with the new OMB standards; clarification of language 
governing NIH-defined Phase III clinical trials consistent with the new 
PHS Form 398; and updated roles and responsibilities of NIH staff and 
the extramural community.  The policy continues to require for all NIH-
defined Phase III clinical trials that: (a) all applications or 
proposals and/or protocols must provide a description of plans to 
conduct analyses, as appropriate, to address differences by sex/gender 
and/or racial/ethnic groups, including subgroups if applicable; and (b) 
investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

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

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

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

HUMAN EMBRYONIC STEM CELLS (hESC):  Criteria for federal funding of 
research on hESCs can be found at http://stemcells.nih.gov/index.asp 
and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the 
NIH Human Embryonic Stem Cell Registry will be eligible for Federal 
funding (see http://escr.nih.gov).  It is the responsibility of the 
applicant to provide, in the project description and elsewhere in the 
application as appropriate, the official NIH identifier(s) for the hESC 
line(s) to be used in the proposed research.  Applications that do not 
provide this information will be returned without review. 

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

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

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  
The Department of Health and Human Services (DHHS) issued final 
modification to the “Standards for Privacy of Individually Identifiable 
Health Information,” the “Privacy Rule,” on August 14, 2002.  The 
Privacy Rule is a federal regulation under the Health Insurance 
Portability and Accountability Act (HIPAA) of 1996 that governs the 
protection of individually identifiable health information, and is 
administered and enforced by the DHHS Office for Civil Rights (OCR).  

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

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

HEALTHY PEOPLE 2010:  The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of 
"Healthy People 2010," a PHS-led national activity for setting priority 
areas.  This PA is related to one or more of the priority areas. 
Potential applicants may obtain a copy of "Healthy People 2010" at 
http://www.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 the 
authorization of Sections 301 and 405 of the Public Health Service Act 
as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 
and 45 CFR Parts 74 and 92.  All awards are subject to the terms and 
conditions, cost principles, and other considerations described in the 
NIH Grants Policy Statement.  The NIH Grants Policy Statement can be 
found at http://grants.nih.gov/grants/policy/policy.htm.

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.