TECHNOLOGY DEVELOPMENT FOR BIOMEDICAL APPLICATIONS: PHASED INNOVATION AWARD 
(R21/R33)

RELEASE DATE:  March 28, 2002 (see replacement PAR-03-075)

PA NUMBER:  PAR-02-091

EXPIRATION DATE:  February 27, 2003 (per replacement PAR-03-075) 

APPLICATION RECEIPT DATES:  June 1, and October 1 annually  

National Center for Research Resources (NCRR)
 (http://www.ncrr.nih.gov)
National Human Genome Research Institute (NHGRI)
 (http://www.nhgri.nih.gov)
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
 (http://www.nibib.nih.gov)
  
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 Special Requirements
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  

This PA replaces PAR-01-057.

The purpose of this program announcement (PA) is to invite innovative 
applications for (1) the development of new and improved instruments or 
devices, (2) the development of new methodologies using existing instruments, 
or (3) the development of software to be used in biomedical research.  
Current technology development applications from individual investigators 
generally use either the R01 or the R21/R33 mechanisms.  Investigators with 
substantial preliminary data for a technology development application should 
seek an R01 grant by submitting an unsolicited application at the standard 
receipt date or by responding to a particular program announcement.  This 
program announcement uses the R21/R33 phased innovation mechanism.  
Applications using only the R21 mechanism are also welcome.  Applicants who 
are unsure of the appropriate mechanism for their application should contact 
the program staff listed in the "Where to send Inquiries" section.

The proposed research may involve conceptualization, design, fabrication, 
and/or testing of new instruments or devices.  Applications to develop new 
experimental techniques and protocols using existing instrumentation are also 
welcome.  Applications to develop new software are also invited, but this 
does not include most proposals in the area of medical informatics.  It is 
expected that applications in any of these areas will have broad application 
to biomedical research.  The overall objective of these applications for new 
instruments, techniques, or software should be the development of more 
powerful and more precise technology for biomedical research.  

NCRR and NIBIB are especially interested in proposals in the areas of 
biomedical engineering, technologies for the study of structure and function 
of biological systems at all levels of complexity, and biomedical imaging.  
The NHGRI is interested in supporting technological advances in the following 
areas of research: (1) genomic sequencing; (2) human sequence variation 
(e.g., genotyping); (3) functional genomics; (4) comparative genomics; and 
(5) bioinformatics and computational biology related to 1-4, above.  The 
highest priority is for technologies that will support comprehensive analyses 
of entire genomes or their products in cells and tissues.  

RESEARCH OBJECTIVES

The primary intent of this PA is to stimulate the development of new 
techniques for biomedical research that will allow scientists to achieve the 
biomedical breakthroughs of tomorrow.  High risk applications are encouraged, 
and the innovative nature of the application will be part of the review 
criteria.  For some high risk applications, it may be appropriate to use the 
R21 mechanism to generate preliminary data.  

This program announcement is similar in spirit to the "Instrument Development 
for Biological Research" program in the Directorate for Biological Sciences 
at the National Science Foundation (http://www.nsf.gov/cgi-
bin/getpub?nsf98119).  The major difference between the two programs is that 
instrumentation for the conduct of disease-oriented research is specifically 
excluded from the NSF program.  It is clear that some instrument development 
proposals could be considered either under this program announcement or by 
NSF.  Applicants are encouraged to contact program staff at either NSF or NIH 
to discuss which program is more appropriate (see INQUIRIES section).

MECHANISM(S) OF SUPPORT 

This PA will use the NIH R21/R33 award mechanism(s).  As an applicant, you 
will be solely responsible for planning, directing, and executing the 
proposed project. 

Specific features of this mechanism include:
o Single submission and evaluation of both a feasibility/pilot phase (R21) 
and an expanded development phase (R33) as one application.
o Expedited transition of the R21 feasibility phase to a R33 development 
phase for combined applications.
o Flexible budgets.
o Flexible staging of feasibility and development phases.

It is anticipated that the majority of applications under this program 
announcement will use the combined R21/R33 mechanism.  Applications using the 
R21 mechanism alone will be considered, but applications using just the R33 
mechanism will not be considered.  An application using the R21 mechanism 
alone is appropriate when the possible outcomes of the proposed research are 
unclear.  Under these conditions, it would not be possible to propose 
quantitative milestones.  Applicants are strongly encouraged to contact 
program staff with any questions about the appropriate mechanism.  Refer to 
the "Where to send Inquiries" section of this program announcement for 
program staff contacts.
 
ELIGIBLE INSTITUTIONS 

You may submit (an) application(s) if your institution has any of the 
following characteristics: 
	
o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic or foreign

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

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

SPECIAL REQUIREMENTS 
 
Responsibility for the planning, direction, and execution of the proposed 
project will be solely that of the applicant.  The applicant can choose to 
submit an independent R21 application, or a combined R21/R33 application.  
The advantage of the combined R21/R33 mechanism is that it offers a seamless 
transition between the exploratory phase and the development phase of a 
project.  Transition from the R21 to the R33 is dependent on completion of 
negotiated milestones.  Once these milestones have been achieved, the 
investigator will submit a progress report to the program.  Upon 
determination that the milestones have been accomplished, the R33 phase can 
begin.  

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 scientific/research issues to:

Gregory K. Farber, Ph.D.
Biomedical Technology
National Center for Research Resources
One Rockledge Centre, Room 6152
6705 Rockledge Drive MSC 7965
Bethesda, MD 20892-7965
TEL: (301) 435-0755
FAX: (301) 480-3659
Email: farberg@ncrr.nih.gov 

o Direct your questions about peer review issues to:

Mohan Viswanathan, Ph.D.
Office of Review
National Center for Research Resources
One Rockledge Centre, Room 6018
6705 Rockledge Drive MSC 7965
Bethesda, MD  20892-7965
TEL: (301) 435-0829
FAX: (301) 480-3660
Email: viswanathanm@ncrr.nih.gov

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

Mary Niemiec
Team Leader
Office of Grants Management
National Center for Research Resources
One Rockledge Centre, Room 6086
6705 Rockledge Drive MSC 7965
Bethesda, MD 20892-7965
TEL: (301) 435-0842
FAX: (301) 480-3777
Email: mn20z@nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted on June 1 and October 1 annually. 

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. 

SPECIFIC INSTRUCTIONS FOR THE APPENDIX

The only items that may be included in the appendix are original glossy 
photographs or color images of gels, micrographs, etc., provided that a black 
and white photocopy of the same size is included within the research plan.

SPECIFIC INSTRUCTIONS FOR PREPARING A COMBINED R21/R33 PHASED INNOVATION 
AWARD APPLICATION

The combined R21/R33 application must include the specific aims for each 
phase and the feasibility milestones that would justify transition to the R33 
phase.  Applications must include a specific section labeled Milestones 
following the Research Plan of the R21 phase.  Milestones should be well 
described, quantifiable and scientifically justified. A discussion of the 
milestones relative to the progress of the R21 phase, as well as, the 
implications of successful completion of the milestones for the R33 phase 
should be included.  The milestone section should be indicated in the Table 
of Contents.  Applications lacking this information, as determined by the NIH 
program staff, will be returned to the applicant without review.  

Prior to funding an application, the Program Director will contact the 
applicant to discuss the proposed milestones and any changes suggested by the 
review panel as indicated in the Summary Statement.  The Program Director and 
the applicant will negotiate and agree on a final set of milestones.  These 
will be the basis for judging the success of the R21 work.  For funded 
applications, the PI will submit a progress report to the program upon 
completion of the R21 milestones.  Receipt of this progress report will 
trigger a review that will determine whether or not the R33 should be 
awarded.  The release of R33 funds will be based on successful completion of 
negotiated scientific milestones, program priorities, and on the availability 
of funds. The expedited review may result in additional negotiations of 
award.

The R21/R33 Phased Innovation Award application must be submitted as a single 
application, with one face page.  Although it is submitted as a single 
application, it should be clearly organized into two phases.  To accomplish a 
clear distinction between the two phases, applicants are directed to complete 
Sections a-d (Specific Aims, Background and Significance, Preliminary 
Studies, Research Design) for the R21 phase, then the milestones, and then 
sections a and d (Specific Aims, Research Design) for the R33 phase.  The 
Form 398 Table of Contents should be modified to show the sections for each 
phase as well as the milestones.  There is a page limit of 25 pages for the 
composite research plan.  Section a-d of the R21 research plan must not be 
longer than 15 pages.  The milestones, and the a and d sections for the R33 
application can take, at most, an additional 10 pages.  The clarity and 
completeness of the R21/R33 application with regard to specific goals and 
feasibility milestones is critical.  The presentation of milestones that are 
not sufficiently scientifically rigorous to be valid for assessing progress 
in the R21 phase will reflect upon the scientific judgment of the applicant 
in this application.

1.  Face Page of the application:

Item 2.  Check the box marked "YES" and type the number and title of this 
program announcement.  Also indicate that the application is R21/R33 in the 
title.

Items 7 and 8: Costs Requested
For the R21 phase of the application, direct costs are limited to a maximum 
of $100,000 per year for a maximum of three years.  The R33 phase is limited 
to three years.  The combined R21/R33 application is limited to five years.

2.  Page 2 - Description:  As part of the description, identify concisely the 
fundamental research and/or technology or tool to be developed, its 
innovative nature, its relationship to presently available capabilities, and 
its expected impact on biomedical research.

3.  Budget: The application should provide a detailed budget for Initial 
Budget Period (form page 4) for the first year of the R21 phase and a second 
form page 4 for the first year of the R33 phase.  Form page 5 should be used 
to provide a budget for the entire proposed period of support. Form pages 
should indicate which years are R21 and which are R33. All budgets should 
include a written justification.  The modular budget format is not to be 
used.

4.  Research Plan:

Item a: Specific Aims.
Specific aims that the applicant considers to be scientifically appropriate 
for the relevant phases of the project must be presented.  Research that 
develops new technologies or tools is likely to require the application of 
principles of fields such as analytical chemistry, mathematics, physics, and 
engineering.  Clear statements of these underlying principles should be made 
within this section.

Item b: Background and Significance
Elaborate on the innovative nature of the proposed research.  Clarify how the 
fundamental tools or technologies to be developed as proposed in this project 
will result in a significant improvement over existing approaches.  Explain 
the potential of the proposed technology for having an impact on a compelling 
area of biomedical research.  Clearly identify how the project, if 
successful, would result in new capabilities for biomedical research, the 
immediacy of the opportunity, and how any proposed technologies or tools 
would differ from existing technologies or tools.  This item will not be 
present in the R33 portion of the application.

Item c: Preliminary Studies/Progress Report
While preliminary data are not required for submission of the R21 phase, this 
section should provide current thinking or evidence in the field to 
substantiate feasibility of the R21 phase.  If the applicant does have 
preliminary data, it should be presented in this section.  This item will not 
be present in the R33 portion of the application.

Item d: Research Design and Methods
Follow the instructions in the PHS 398 booklet. Applicants should also 
address plans to make the products, tools, or technologies forthcoming from 
this research available to the relevant biomedical research user community.  

5.  Milestones:

For combined R21/R33 applications, a specific section labeled Milestones must 
be included following the Research Design and Methods of the R21 phase.  
Milestones should be well described, quantifiable, and scientifically 
justified.  Milestones should not be simply a restatement of the specific 
aims.  The milestones section should be indicated in the Table of Contents.  
Applications lacking this information, as determined by the program staff, 
will be returned to the applicant without review.

For funded proposals, peer review is not likely between the two phases of the 
proposal.  When the R21 milestones have been achieved, the PI will submit a 
progress report to the program.  Receipt of this progress report will elicit 
a review that will determine whether or not the R33 should be awarded. The 
release of R33 funds will be based on successful completion of milestones, 
program priorities and on the availability of funds. The expedited review may 
result in additional negotiations of award.

SPECIFIC INSTRUCTIONS FOR PREPARATION OF THE R21 APPLICATION WHEN SUBMITTED 
WITHOUT THE R33 PHASE.

1.  Face Page of the application:

Item 2.  Check the box marked "YES" and type the number and title of this 
program announcement and indicate R21 in the title.

Item 7a: DIRECT COSTS REQUESTED FOR INITIAL PERIOD OF SUPPORT
For the R21 application, direct costs are limited to a maximum of $100,000 
per year for a maximum of three years.  R21 applications alone use 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 $100,000 
or less, use the modular format.  R21 budgets can exceed this cap, up to 
$125,000 to accommodate F&A costs of subcontracts to the project. 

2.  Page 2 - Description:  As part of the description, identify concisely the 
fundamental research and/or technology or tool to be developed, its 
innovative nature, its relationship to presently available capabilities, and 
its expected impact on biomedical research.

3.  Budget: The application should provide a detailed budget for Initial 
Budget Period (form page 4), as well as a budget for the entire proposed 
period of support (form page 5).  All budgets should include a written 
justification.  The modular budget format is not to be used.

4.  Research Plan:

The research plan for an R21 application is limited to 15 pages.

Item a: Specific Aims.
Specific aims that the applicant considers to be scientifically appropriate 
for the relevant phases of the project must be presented.  Research that 
develops new technologies or tools is likely to require the application of 
principles of fields such as analytical chemistry, mathematics, physics, and 
engineering.  Clear statements of these underlying principles should be made 
within this section.

Item b: Background and Significance
Elaborate on the innovative nature of the proposed research.  Clarify how the 
fundamental tools or technologies to be developed as proposed in this project 
will result in a significant improvement over existing approaches.  Explain 
the potential of the proposed technology for having an impact on a compelling 
area of biomedical research.  Clearly identify how the project, if 
successful, would result in new capabilities for biomedical research, the 
immediacy of the opportunity, and how any proposed technologies or tools 
would differ from existing technologies or tools.  

Item c: Preliminary Studies/Progress Report
While preliminary data are not required for submission of the R21 phase, this 
section should provide current thinking or evidence in the field to 
substantiate feasibility of the R21 phase.  If the applicant does have 
preliminary data, it should be presented in this section.  

Item d: Research Design and Methods
Follow the instructions in the PHS 398 booklet.  

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 five 
copies of the Appendix, are to be sent to: 

Office of Review 
National Center For Research Resources
6705 Rockledge Drive, Suite 6018, MSC 7965
Bethesda, MD 20892-7965
Bethesda, MD 20817 (for express/courier service) 

APPLICATION PROCESSING: Applications must be sent on or before June 1 or 
October 1 annually.  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.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review group 
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 Receive a written critique
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 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 discuss the following 
aspects of your application in order to judge the likelihood that the 
proposed research will have a substantial impact on the pursuit of these 
goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The scientific review group will address and consider each of these criteria 
in assigning your application's overall score, weighting them as appropriate 
for each application.  Your application does not need to be strong in all 
categories to be judged likely to have major scientific impact and thus 
deserve a high priority score.  

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

(2) APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project?  Do you acknowledge potential problem areas and consider alternative 
tactics?

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

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

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

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

PROTECTIONS:  The adequacy of the proposed protection for humans, animals, or 
the environment, to the extent they may be adversely affected by the project 
proposed in the application.

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

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

OTHER REVIEW CRITERIA:  
o  How appropriate are the proposed milestones for judging the success of the 
proposed R21 work?
o  How appropriate are the proposed milestones in determining whether the R33 
phase should be awarded?
o  Are the milestones quantitative?
o  To what degree does the research or development of technologies or tools 
support the needs of the targeted biomedical research community?  
o  What is the time frame for developing the proposed approaches, tools, or 
technologies?  Is this time frame suitable for meeting the relevant 
biomedical research community's needs?  
o  How easy will it be to use the proposed approach, tool, or technology? 
o  Are the plans for dissemination of the proposed endpoints, tools or 
technologies of the project adequate?


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 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

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

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

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them. This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

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

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

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

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

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

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 in the following citations:  No. 93.371, 93.286 
and 93.287.  The program is not subject to the intergovernmental review 
requirements of Executive Order 12372 or Health Systems Agency review.  
Awards are made under authorization of Sections 301 and 405 of the Public 
Health Service Act as amended (42 USC 241 and 284) and administered under NIH 
grants policies described at http://grants.nih.gov/grants/policy/policy.htm 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 

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.
http://grants.nih.gov/grants/guide/pa-files/PA-02-015.html.


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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