NOVEL APPROACHES TO ENHANCE ANIMAL STEM CELL RESEARCH

RELEASE DATE:  July 8, 2004

PA NUMBER:  PA-04-125  

January 18, 2007 - The R01 portion of this funding opportunity has been 
replaced by PA-07-303, R21 is replaced by PA-07-304,which now uses the 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. Parent 
R03 (PA-06-180) and R21 (PA-06-181) funding opportunity announcements have been 
issued for the submission date of June 1, 2006 and submission dates for AIDS and 
non-AIDS applications thereafter. Applications relating to R33 and R34 activities 
must be in response to NIH Institute/Center (IC)-specific announcements.

EXPIRATION DATE for R21 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for 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)

COMPONENTS OF PARTICIPATING ORGANIZATION:
National Center for Research Resources (NCRR)
 (http://www.ncrr.nih.gov/)
National Cancer Institute (NCI)
 (http://www.nci.nih.gov/)
National Eye Institute (NEI)
 (http://www.nei.nih.gov/)
National Heart, Lung and Blood Institute (NHLBI) 
 (http://www.nhlbi.nih.gov/)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
 (http://www.niams.nih.gov/)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
 (http://www.nibib.nih.gov/)
National Institute of Child Health and Human Development (NICHD) 
 (http://www.nichd.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 (http://www.niddk.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS)
 (http://www.niehs.nih.gov/)
National Institute of Mental Health (NIMH)
 (http://www.nimh.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS) 
 (http://www.ninds.nih.gov/)
National Institute on Aging (NIA)
 (http://www.nia.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD) 
 (http://www.nidcd.nih.gov/)
National Institute on Drug Abuse (NIDA) 
 (http://www.nida.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS:  93.389, 93.396, 93.867, 
93.839, 93.846, 93.286, 93.865, 93.849, 93.113, 93.242, 93.853, 93.866, 
93.173, 93.279.

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
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 purpose of this program announcement (PA) is to encourage the submission 
of applications for research to enhance animal stem cells as model biological 
systems.  Innovative approaches to isolate, characterize and identify 
totipotent and multipotent stem cells from nonhuman biomedical research 
animal models, as well as to generate reagents and techniques to characterize 
and separate those stem cells from other cell types is encouraged.  Studies 
involving human subjects are not allowed under this PA.  This PA supersedes 
PA-02-147 issued earlier by the NCRR.

RESEARCH OBJECTIVES

Embryonic stem cells and other stem cells are valuable biomedical research 
models for the study of biological and disease processes, and for creation of 
disease models.  In addition, these cells hold promise as model systems for 
development of therapeutics and for development of replacement tissues through 
understanding of control of cellular differentiation.

Thus far, embryonic stem cells have been isolated from some biomedically 
important nonhuman research models.  In addition, stem cells with a more 
restricted potential have been characterized from post-embryonic tissue types.  
However, research is needed to provide for a full array of totipotent and 
multipotent stem cells from nonhuman biomedical research animal models, as 
well as to provide the research tools to identify, characterize, and purify 
those cells.

This initiative will support the isolation and characterization of embryonic 
and other multipotent stem cells in a variety of nonhuman animal species.  
Examples of research areas appropriate to this announcement include, but are 
not limited to:

o  Projects to expand the number of nonhuman animal model systems in which 
embryonic stem cells are available.

o  Projects to identify, isolate, culture and characterize multipotent stem 
cell populations derived from nonhuman embryonic stem cells.

o  Projects to identify, isolate, culture and characterize multipotent stem 
cells from post-fetal tissue types.

o  Projects to generate and use panels of markers for stem cell attributes 
common across species for use in characterization and isolation of stem cells 
in a range of animal species or tissues.

o  Projects to create universal methods of culture to maintain the 
undifferentiated state of embryonic or other characterized, multipotential 
stem cells across nonhuman animal species.

Projects supported by the National Center for Research Resources under this PA 
are intended to generate research tools, reagents or stem cells of utility to 
research on a broad range of tissue or cell types and of interest to more than 
one categorical or disease-oriented Institute or Center of the National 
Institutes of Health.  Projects that will focus on research on tissues or 
disease processes specific to the mission of an Institute or Center should be 
directed to the respective Institute or Center.

The research supported under this PA should clearly expand the usefulness of 
nonhuman animal model systems by generating multipotential stem cells 
appropriate to those systems and tools that will allow for further research on 
those stem cells.  

MECHANISMS OF SUPPORT 

This PA will use the NIH R01 and R21 award mechanisms.  As an applicant, you 
will be solely responsible for planning, directing, and executing the 
proposed project.  

R21 applications should meet the requirements for this mechanism as recently 
redefined in PA-03-107, “NIH Exploratory/Developmental Research Grant Award 
(R21);” http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html.  In 
brief, by using the R21 mechanism, the NIH seeks to foster the introduction of 
novel scientific ideas, model systems, tools, agents, targets, and 
technologies that have the potential to substantially advance biomedical 
research.  The R21 mechanism is intended to encourage new exploratory and 
developmental research projects.  For example, such projects could assess the 
feasibility of a novel area of investigation or a new experimental system that 
has the potential to enhance health-related research.  Another example could 
include the unique and innovative use of an existing methodology to explore a 
new scientific area.  These studies may involve considerable risk but may lead 
to a breakthrough in a particular area, or to the development of novel 
techniques, agents, methodologies, models or applications that could have 
major impact on a field of biomedical, behavioral, or clinical research.

Applications for R21 awards should describe projects distinct from those 
supported through the traditional R01 mechanism.  For example, long-term 
projects, or projects designed to increase knowledge in a well-established 
area will not be considered for R21 awards.  Applications submitted under 
this mechanism should be exploratory and novel.  These studies should break 
new ground or extend previous discoveries toward new directions or 
applications. 

Applications for R21 awards may request a project period of up to two years 
with a combined budget for direct costs of up $275,000 for the two 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.  

This PA uses just-in-time concepts.  It also uses the modular budgeting as 
well as the non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  Specifically, if 
you are submitting an application with direct costs in each year of $250,000 
or less, use the modular budget format.  Otherwise follow the instructions 
for non-modular budget research grant applications.  This program does not 
require cost sharing as defined in the current NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm.  

ELIGIBLE INSTITUTIONS 

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

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic or foreign 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.   

SPECIAL REQUIREMENTS 

An application with direct costs greater than $500,000 in any single year 
will be expected to address data sharing, as described in NOT-OD-03-032, 
“Final NIH Statement on Sharing Research Data;” 
http://www.grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.    

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:

John D. Harding, Ph.D.
Division of Comparative Medicine
National Center for Research Resources
6701 Democracy Boulevard, Room 950, MSC 4874
Bethesda, MD  20892-4874
Telephone: (301) 435-0744
FAX:  (301) 480-3819
Email:  hardingj@mail.nih.gov

Donald Blair, Ph.D.
Cancer Cell Biology Branch
Division of Cancer Biology
National Cancer Institute
6130 Executive Boulevard, Suite 5000
Bethesda, MD 20892-7396
Telephone:  (301) 496-7028
FAX:  (301) 402-1037
Email:  blaird@mail.nih.gov

Richard S. Fisher, Ph.D.
Corneal Diseases Program
Division of Extramural Activities
National Eye Institute
5635 Fishers Lane, Suite 1300, MSC 9300
Bethesda, MD 20892-7164
Telephone:  (301) 451-2020
FAX:  (301) 402-0528
Email:  cornea@nih.gov

John W. Thomas, Ph.D.
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 10154
Bethesda, MD  20892-7950
Telephone:  (301) 435-0050
FAX:  (301) 451-5453
Email:  thomasj@nhlbi.nih.gov

Bernadette Tyree, Ph.D.
Rheumatic Diseases Branch, Extramural Program
National Institute of Arthritis and Musculoskeletal and Skin Diseases
6701 Democracy Boulevard, Suite 800
Bethesda, MD 20892
Telephone:  (301) 594-5032
FAX :  (301) 480-4543
Email:  bt16w@nih.gov

Christine A. Kelley, Ph.D.
Division of Discovery Science and Technology
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Boulevard, Suite 200
Bethesda MD 20892-5469
Telephone:  (301) 451-4778
FAX:  (301) 480-4973
Email:  kelleyc@mail.nih.gov

Richard J. Tasca, Ph.D.
Center for Population Research
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room B01-MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6973
FAX: (301) 496-0962
Email:  rt34g@nih.gov

Sheryl M. Sato, Ph.D.
Cellular Basis of Metabolic Diseases Program 
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 6103
Bethesda, MD  20892-5460
Telephone:  (301) 594-8811
FAX:  (301) 480-3503
Email:  satos@extra.niddk.nih.gov

Jerrold Heindel, Ph.D.
Division of Extramural Research and Training
Cellular, Organ and Systems Pathobiology Branch
National Institute of Environmental Health Sciences
79 T.W. Alexander Drive
4401 Building, 3rd Floor
Research Triangle, Park, NC 27709
Telephone:  (919) 541-0781
FAX:  (919) 541-5064
Email:  heindelj@niehs.nih.gov

Beth-Anne Sieber, Ph.D.
Developmental Neurobiology Program 
National Institute of Mental Health
6001 Executive Boulevard, Room 7186, MSC 9641
Bethesda, MD  20892-9641
Telephone:  (301) 443-5288
FAX:  (301) 402-4720
Email:  bsieber@mail.nih.gov

Arlene Y. Chiu, Ph.D.
Repair and Plasticity Program
National Institute of Neurological Disorders and Stroke
Neuroscience Center, Room 2207
6001 Executive Boulevard
Bethesda, MD 20892
Telephone:  (301) 496-1447
FAX:  (301) 480-1080
Email:  chiua@ninds.nih.gov

Jill L. Carrington, Ph.D.
Biology of Aging Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 2C231
Bethesda, MD 20892-9205
Telephone:  (301) 496-6402
FAX:  (301) 402-0010
Email:  carringtonj@nia.nih.gov

Barry J. Davis, Ph.D.
Taste and Smell Program
National Institute on Deafness and Other Communication Disorders
Executive Plaza South-400C
6120 Executive Boulevard, MSC 7180
Rockville, MD 20852
Telephone:  (301) 402-3464
FAX:  (301) 402-6251
Email:  davisbl@nidcd.nih.gov

Geraline C. Lin, Ph.D.
Division of Neuroscience and Behavioral Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4282, MSC 9555
Bethesda, MD 20892-9555
Telephone:  (301) 435-1305
FAX:  (301) 594-6043
Email:  glin@nida.nih.gov

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

Ms. Irene Grissom
Office of Grants Management
National Center for Research Resources
6701 Democracy Boulevard, Room 1036
Bethesda, MD  20892
Telephone:  (301) 435-0844
FAX:  (301) 480-3777
Email:  grissomi@mail.nih.gov

Ms. Joy Kearse
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Room 243
Bethesda, MD  20892
Telephone:  (301) 846-1010
FAX:  (301) 846-5720
Email:  kearsej@mail.nih.gov

Mr. William W. Darby
Division of Extramural Research
National Eye Institute
5635 Fishers Lane, Suite 1300, MSC 9300
Bethesda, MD 20892-7164 
Telephone:  (301) 451-2020
FAX:  (301) 496-9997
Email:  wwd@nei.nih.gov

Mr. Robert Vinson
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, MSC 7926
Bethesda, MD  20892-7926
Telephone: (301) 435-0166
FAX:  (301) 480-3310
Email:  vinsonr@nhlbi.nih.gov

Ms. Melinda Nelson
Grants Management Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
6701 Democracy Boulevard, Suite 800, MSC 4872
Bethesda, MD 20892-4872
Telephone:  (301) 594-3535
Email:  nelsonm@mail.nih.gov

Ms. Florence Turska
Grants Management Office
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Blvd, Suite 900
Bethesda, MD  20892-5469
Telephone: (301) 496-9314
FAX:  (301) 451-5735
Email:  turskaf@mail.nih.gov

Ms. Annette Hanopole
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A02
Bethesda, MD  20892-7510
Telephone:  (301) 496-5001
FAX:  (301) 402-0915
Email:  ah23k@nih.gov

Ms. Mary K. Rosenberg
Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 722
Bethesda, MD  20892-5460
Telephone:  (301) 594-8891
FAX:  (301) 480-3504
Email:  rosenbergm@extra.niddk.nih.gov

Ms. Susan Ricci
Grants Management Branch
National Institute of Environmental Health Sciences
79 T.W. Alexander Drive
4401 Building, 3rd Floor
Research Triangle, NC 27709
Telephone: (919) 316-4666
FAX:  (919) 541-2860
Email:  ricci@niehs.nih.gov 

Ms. Rebecca Claycamp
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6122, MSC 9605
Bethesda, MD  20892-9605
Telephone:  (301) 443-2811
FAX:  (301) 443-6885
Email:  rc253d@nih.gov

Mr. Gavin Wilkom
Grants Management Branch, DER
National Institute of Neurological Disorders and Stroke
Neuroscience Center, Room 3250, MSC 9537
6001 Executive Boulevard
Bethesda, MD 20892
Telephone:  (301) 496-7480
FAX:  (301) 402-0219
Email:  gw62m@nih.gov

Ms. Linda Whipp
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2N212
Bethesda, MD 20892-9205
Telephone:  (301) 496-1472
FAX:  (301) 402-3672
Email:  whippl@nih.gov

Ms. Sara Stone
Grants Management Office
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400-B, MSC 7180
Bethesda, MD 20892-7180
Telephone:  (301) 402-0909
FAX:  (301) 402-1758
Email:  stones@nidcd.nih.gov

Ms. Edith Davis
Grants Management Branch
National Institute on Drug Abuse
6101 Executive Boulevard, Room 270, MSC 8403
Bethesda, MD 20892-8403
Telephone:  (301) 443-6710
FAX:  (301) 594-6849
Email:  edavis1@nida.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 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.

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 BUDGET GRANT APPLICATIONS:  Applications 
requesting up to $250,000 per year in direct costs must be submitted in a 
modular budget grant format.  The modular budget 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 NIH 
institutes or centers who has 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) Identify, in a cover letter sent with the application, 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 the 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 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, 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:

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. Please refer to 
NOT-OD-03-032, 
http://www.grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.  
 
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.

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 or state why this is not possible. 
http://grants.nih.gov/grants/policy/data_sharing 
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.

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.

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.healthypeople.gov/.

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


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