CANCER PREVENTION RESEARCH SMALL GRANT PROGRAM

RELEASE DATE:  August 18, 2004

PA NUMBER:  PAR-04-147 (See amendment, NOT-CA-05-019)

March 2, 2006 (NOT-OD-06-046) – Effective with the June 1, 2006 submission date, 
all R03, R21, R33 and R34 applications must be submitted through Grants.gov 
using the electronic SF424 (R&R) application. Accordingly, this funding 
opportunity expires on the date indicated below. A Replacement R03 (PAR-06-313) 
funding opportunity announcement has been issued for the submission date of June 1, 2006 
and submission dates thereafter.

EXPIRATION DATE FOR R03 Applications:  March 23, 2006

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 

APPLICATION RECEIPT DATES:  December 20, 2004; March 21, 2005; July 21, 
2005; November 21, 2005; March 22, 2006, July 20, 2006, November 20, 
2006; March 20, 2007; July 21, 2007. December 20, 2007 

This Program Announcement (PA) replaces PAR-02-176, which was published 
in the NIH Guide on September 27, 2002.

THIS PA CONTAINS THE FOLLOWING INFORMATION

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

PURPOSE OF THIS PA

The Division of Cancer Prevention of the National Cancer Institute 
(NCI) invites applications that address developmental research in 
chemoprevention agent development, biomarkers, early detection, and 
nutrition science.  The Small Grants Program is designed to aid and 
facilitate the growth of a nationwide cohort of scientists with a high 
level of research expertise in cancer prevention research.  It is 
anticipated that these Small Grant Programs may lead to the submission 
of subsequent individual research project grants (R01).

New, as well as experienced, investigators in relevant fields and 
disciplines (e.g., chemoprevention, nutritional science, genetic and 
infectious agents, and early detection, including biomarker development 
and validation) may apply for small grants to test ideas or do pilot 
studies.

This PA will expire in three years from the first receipt date.  NIH 
Grants policies apply to these awards.

RESEARCH OBJECTIVES

This program is designed to aid and facilitate the growth of a cadre of 
scientists with expertise in cancer prevention research.  Small grants 
are short-term awards that provide support for pilot projects, 
development and testing of new methodologies, or innovative projects 
that provide a basis for more extended research.

The Division of Cancer Prevention invites applications that address 
developmental research in chemoprevention agent development, 
biomarkers, early detection, and nutrition science, in addition to 
clinical studies that focus on specific target organs. The specific 
areas of research may include, but are not limited to:

Early Detection 

o  Identification, development, and evaluation of biological analytic 
techniques, methodologies, and clinical technologies relevant to pre-
clinical cancer detection and prevention

o  Cellular, molecular, and genetic tumor markers
o  Molecular epidemiology and genetic risk factors
o  Imaging technology

o  Identification of molecular signatures of cancer-associated 
infectious agents for earlier cancer detection and risk assessment.

o  Transfer of basic laboratory findings into applications for early 
detection with the goal of extending this research to comparative 
clinical trials.

o  Development and evaluation of new high-throughput genomic- and 
proteomic-based detection techniques as well as of measures of 
sensitivity, specificity, validity, and safety. 

o  Performance of translational research to facilitate the transfer of 
new technologies (to the clinical setting) for earlier detection, 
prevention, and risk assessment.

o  Development and evaluation of computer-based data monitoring systems 
for analysis and interpretation of laboratory data on multiple markers 
of and for the development of modeling systems based on molecular, 
genetic, and other risk factors to be used in the evaluation of cancer 
prevention approaches.

o  Definition and evaluation of prognostic factors of pre-cancerous 
lesions by computer models that include neural networks, artificial 
intelligence, and other techniques.             

o  Development of analytic techniques to identify populations that may 
be at increased risk as indicated by genetic and metabolic phenotypes 
(susceptibility markers).

Chemoprevention

o  Pilot testing and development of new methods of chemoprevention, 
dietary, or nutrition intervention.

o  Development and evaluation of molecular targets to prevent, reverse, 
or retard progression of precancerous lesions (and, hence, the cancer 
process) by natural, synthetic, chemopreventive agents.

o  Feasibility and efficacy testing of rapid screening methods to 
identify and prioritize new chemopreventive agents.

o  Testing of new strategies to prevent cancer or its progression in 
persons at increased genetic risk.

o  Development of innovative animal models to mimic the human cancer 
process in order to expedite research in cancer prevention.

Nutrition

o  Improvements in methodology development for assessing nutritional 
status, metabolic patterns, and dietary modulation of genetic 
expression.

o  Identification, development, and validation of biochemical or 
biological 
markers for measuring and monitoring dietary compliance and exposure.

o  Development of reliable methods for analysis of nutrients, other 
dietary components, and their metabolites in foods, body fluids, and 
tissues.

o  Development of mechanistic studies of dietary constituent 
interactions, gene-nutrient interactions, and dietary environmental 
factor interactions.  

o  Identification and evaluation of molecular targets to prevent, 
reverse, or retard progression of precancerous lesions (and, hence, the 
cancer process) by dietary/nutritional interventions.

o  Determination of bioavailability and dose-response of foods, 
nutrients, and other naturally-occurring food constituents. 

Although the specific study proposed may attempt only to obtain 
preliminary data and/or conduct pilot studies in support of a future, 
more detailed clinical study, it is important that a long-term human 
cancer prevention hypothesis and supporting scientific justification be 
presented. 

Summary

This program is designed to increase the basic and applied scientific 
knowledge of cancer prevention research, and enhance community-based 
clinical research in cancer prevention.

MECHANISM OF SUPPORT 

This PA will use the NIH Small Grants Program (R03) award mechanism.  
As an applicant, you will be solely responsible for planning, 
directing, and executing the proposed project.  The total budget may 
not exceed $100,000 in direct costs for the entire project. The direct 
costs in any one year must not exceed $50,000.  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.) 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html)

The total project period for an application submitted in response to 
this program announcement may not exceed two years. NIH policy limits 
the number of amendments that may be submitted to one. The small grant 
is not renewable.

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 budget 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 institutions/organizations
o Foreign institutions are not eligible to apply as primary applicants but 
may collaborate with domestic institutions. 
 
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 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 specific scientific/research issues (as 
noted in parenthesis) to:

Padma Maruvada, Ph.D. (Early Detection)
Division of Cancer Prevention
National Cancer Institute
6130 Executive Boulevard, EPN Room 3144, MSC 7362
Bethesda, MD 20892-7362
Rockville, MD 20852 (for express/courier service) 
Telephone: 301-496-3893
E-mail: maruvadp@mail.nih.gov

Harold Seifried, Ph.D. (Nutrition)
Division of Cancer Prevention
National Cancer Institute
6130 Executive Boulevard, EPN Room 3160, MSC 7328
Bethesda, MD 20892-7328
Rockville, MD 20852 (for express/courier service) 
Telephone: 301-496-8573
E-mail: hs41s@nih.gov

Vernon Steele, Ph.D., M.P.H. (Chemoprevention)
Division of Cancer Prevention
National Cancer Institute
6130 Executive Boulevard, EPN Room 2117, MSC 7322
Bethesda, MD 20892-7322
Rockville, MD 20852 (for express/courier service) 
Telephone: 301-594-0420
E-mail: steelev@mail.nih.gov

o Direct your questions about peer review issues to: 

Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Rockville, MD 20852 (for express/courier service) 
Telephone: (301) 496-3428
FAX: (301) 402-0275 
Email:  ncirefof@dea.nci.nih.gov

o Direct your questions about financial or grants management matters 
to:
Shane Woodward
Grants Administration Branch
National Cancer Institute
Fairview Center Building, Suite 300
1003 West 7th St.
Frederick, MD  21701-4106
Telephone: 301-846-1017
Fax: 301-846-5720
E-Mail: woodwars@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 D&B number can be obtained by calling (866) 
705-5711 or through the web site at http://www.dunandbradstreet.com/. 
The D&B 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

Please see the link for the NIH Small Grants Program at 
http://grants1.nih.gov/grants/funding/r03.htm for specific instructions 
on submitting R03 applications.

APPLICATION RECEIPT DATES: Applications submitted in response to this 
program announcement will be accepted by the receipt dates listed on 
the first page of this PA.

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.

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 and 
all five copies of the appendix must be sent to:

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD  20892-8329
Rockville, MD  20852 (for express/courier service)
Telephone: (301) 496-3428 (for express/courier service)

Appendices should be comprised of unbound materials with separators 
between documents.

APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER 
INSTITUTE WILL NO LONGER BE ACCEPTED.  This policy does not apply to 
courier deliveries (i.e., FEDEX, UPS, DHL, etc.) 
(http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html)  
This policy is similar to and consistent with the policy for 
applications addressed to Centers for Scientific Review as published in 
the NIH Guide Notice at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.

APPLICATION PROCESSING: Applications must be received on or before the 
receipt dates listed on the first page of this PA.  The CSR will not 
accept any application in response to this PA that is essentially the 
same as one currently pending initial review unless the applicant 
withdraws the pending application.  The CSR will not accept any 
application that is essentially the same as one already reviewed.  This 
does not preclude the submission of a substantial revision of an 
application already reviewed, but such application must include an 
Introduction addressing the previous critique.

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

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the NCI.   Incomplete and/or non-responsive 
applications will not be reviewed.

Applications that are complete and responsive to the program 
announcement will be evaluated for scientific and technical merit by an 
appropriate peer review group convened by the Division of Extramural 
Activities of the NCI, in accordance with the standard NIH peer review 
procedures. 

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

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 written critique 
o  Receive a second level review by the National Cancer Advisory Board.

REVIEW CRITERIA

The NIH R03 small grant is a mechanism for supporting discrete, well-
defined projects that realistically can be expected to be completed in 
two years and that require limited levels of funding.  Because the 
research plan is restricted to 10 pages, a small grant application will 
not have the same level of detail or extensive discussion found in an 
R01 application.  Accordingly, reviewers should evaluate the conceptual 
framework and general approach to the problem, placing less emphasis on 
methodological details and certain indicators traditionally used in 
evaluating the scientific merit of R01 applications including 
supportive preliminary data. Appropriate justification for the proposed 
work can be provided through literature citations, data from other 
sources, or from investigator-generated data.  Preliminary data are not 
required, particularly in applications proposing pilot or feasibility 
studies.  

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.  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, you may propose to carry out important 
work that by its nature is not innovative but is essential to move a 
field forward.

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

INVESTIGATOR: Are the investigators 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, your 
application will also be reviewed with respect to the following:

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 will be assessed.  Plans for the recruitment and 
retention of subjects will also be evaluated. (See Inclusion Criteria 
in the sections on Federal Citations, below.)

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

ADDITIONAL REVIEW CONSIDERATIONS 

BUDGET:  The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research.

AWARD CRITERIA

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

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

REQUIRED FEDERAL CITATIONS

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

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

DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required 
for all types of clinical trials, including physiologic, toxicity, and 
dose-finding studies (phase I); efficacy studies (phase II), and 
efficacy, effectiveness and comparative trials (phase III). The 
establishment of data and safety monitoring boards (DSMBs) is required 
for multi-site clinical trials involving interventions that entail 
potential risk to the participants.  (See NIH Policy for Data and 
Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998; 
at http://grants.nih.gov/grants/guide/notice-files/not98-084.html.) 

Clinical trials supported or performed by NCI require special 
considerations.  The method and degree of monitoring should be 
commensurate with the degree of risk involved in participation and the 
size and complexity of the clinical trial.  Monitoring exists on a 
continuum from monitoring by the principal investigator/project manager 
or NCI program staff or a Data and Safety Monitoring Board (DSMB).  
These monitoring activities are distinct from the requirement for study 
review and approval by an Institutional review Board (IRB).  For 
details about the Policy for the NCI for Data and Safety Monitoring of 
Clinical trials, see 
http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm.  For Phase I 
and II clinical trials, investigators must submit a general description 
of the data and safety monitoring plan as part of the research 
application.  For additional information see NIH Guide Notice on 
“Further Guidance on a Data and Safety Monitoring for Phase I and II 
Trials” at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html.
Information concerning essential elements of data safety 
monitoring plans for clinical trials funded by the NCI is available at 
http://www.cancer.gov/clinical_trials/.

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.


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