TECHNOLOGY DEVELOPMENT FOR BIOMEDICAL APPLICATIONS

RELEASE DATE:  January 20, 2004
 
RFA Number:  RFA-RR-04-005  (This RFA has been reissued as RFA-RR-06-004)
(This RFA has been reissued, see RFA-RR-05-001)

Department of Health and Human Services (DHHS)
 
PARTICIPATING ORGANIZATION:  
National Institutes of Health (NIH)
 (http://www.nih.gov)

COMPONENT OF PARTICIPATING ORGANIZATION: 
National Center for Research Resources (NCRR)
 (http://www.ncrr.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER:  93.389

APPLICATION RECEIPT DATE:  June 18, 2004 and October 15, 2004
 
THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA 

This RFA replaces PAR-03-075.

The purpose of this request for applications (RFA) 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 related to 
instrumentation.  Any of these projects should propose tools, 
methodologies, or software that can be used by a wide range of 
biomedical or clinical researchers.  Projects that are focused on a 
specific organ or disease will be returned without review; however, 
proposals may use a specific organ or disease as a model system.  Awards 
made for applications received in response to this announcement will 
employ the R21 and the R21/R33 mechanisms that are designed to support 
high-risk applications for which few if any preliminary findings are 
available.  Investigators with substantial preliminary data should seek 
an R01 grant by submitting an unsolicited application at the standard 
receipt date or by responding to a particular program announcement.

Questions about the suitability of proposals should be addressed to 
program staff listed in the "Where to Send Inquiries" section well 
before submission.  Proposals in the areas of biomedical imaging, 
sensors, biomaterials, microelectromechanical systems (MEMS), tissue 
engineering, and nanotechnology will be considered nonresponsive and 
returned without review.  Investigators considering research in these 
areas may want to look at the NIBIB 
(http://www.nibib1.nih.gov/research/investigators.htm) and BECON 
(http://www.becon.nih.gov/becon_funding.htm) web pages for funding 
opportunities in bioengineering research or biomedical imaging research.  
In addition, proposals that are focused on a specific organ or disease 
will be considered nonresponsive and also returned without review; 
however, proposals may use a specific organ or disease as a model 
system.  

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 
related to instrumentation are encouraged, with the exception of 
proposals with a primary focus in the area of medical informatics. The 
overall objective of applications for new instruments, techniques, or 
software should be the development of more powerful and more precise 
technology with broad applicability to biomedical research.
 
RESEARCH OBJECTIVES
 
The primary intent of this RFA is to stimulate the development of new 
techniques for biomedical research that will allow scientists to achieve 
biomedical breakthroughs.  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 alone to generate preliminary data.  For applications with two 
distinct phases where the high-risk portion of the research occurs 
early, the R21/R33 mechanism is appropriate.  As a simple example, 
consider an applicant who had developed a new material that might be 
used to fabricate a lens.  The R21 portion of such a research plan would 
be the fabrication and testing of the lens.  In the R21 portion of the 
application, the Principal Investigator would propose a set of 
quantitative milestones that the new lens would have to achieve.  Such 
quantitative milestones might deal with the focal length, field of view, 
and aberrations of the lens.  Once the lens had been made, the R33 phase 
of the research could be to incorporate this lens into a working 
microscope.  At the end of a successful R21/R33 award, it is expected 
that there be a working instrument or new technique.  Since the R21/R33 
award cannot be renewed, it is not suitable for establishing a long-term 
research project in a particular area.  Investigators should not propose 
to test a biological hypothesis as the R33 phase of an application.

Examples of new tools and techniques that are responsive to this RFA 
include optical spectroscopy, mass spectrometry, electrophoresis and 
other separation techniques, microscopy, lasers and optics, X-ray tools 
and techniques, nuclear magnetic resonance spectroscopy, bioreactors and 
other forms of cell culture, centrifugation, proteomics, genomic 
sequencing, functional genomics, comparative genomics, microarrays, and 
human sequence variation (e.g., genotyping).  This list is not 
exhaustive, but investigators outside of these areas are encouraged to 
contact program staff to ensure that their applications are responsive.

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.  
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 identify the best program 
for the application.

MECHANISM OF SUPPORT
 
This RFA will use NIH R21 and 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.

Applications under this program announcement will use either the 
combined R21/R33 mechanism or the R21 mechanism alone.  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 or describe the R33 
phase of the research.  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.

This RFA uses just-in-time concepts.  It also uses only the non-modular 
budgeting format.  This program does not require cost sharing as defined 
in the current NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.  

FUNDS AVAILABLE
 
NCRR intends to commit approximately $1 million in FY 2005 to fund five 
to eight new grants in response to this RFA.  Because the nature and 
scope of the proposed research will vary from application to 
application, it is anticipated that the size and duration of each award 
will vary. Although the financial plans at NCRR provide support for this 
program, awards pursuant to this RFA are contingent upon the 
availability of funds and the receipt of a sufficient number of 
meritorious applications.  
 
ELIGIBLE INSTITUTIONS
 
You may submit (an) application(s) if your institution has any of the 
following characteristics:
   
o For-profit or non-profit organizations, however applicants from for-
profit organizations should contact program staff prior to submitting an 
application 
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
 
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 program staff.  Upon determination that the milestones have 
been accomplished, the R33 phase can begin.  
 
WHERE TO SEND INQUIRIES

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

o Direct your questions about scientific/research issues to:

Gregory K. Farber, Ph.D.
Division of Biomedical Technology
National Center for Research Resources
6701 Democracy Boulevard, MSC 4874
Bethesda, MD 20892-4874
TEL: (301) 435-0755
FAX: (301) 480-3659
Email: gf48a@nih.gov

o Direct your questions about peer review issues to:

Bo Hong, Ph.D.
Office of Review
National Center for Research Resources
6701 Democracy Boulevard, MSC 4874
Bethesda, MD 20892-4874
TEL: (301) 435-0813
FAX: (301) 480-3660
Email: bh219i@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
6701 Democracy Boulevard, MSC 4874
Bethesda, MD 20892-4874
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). Applications must have 
a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number 
as the Universal Identifier when applying for Federal grants or 
cooperative agreements. The DUNS number can be obtained by calling (866) 
705-5711 or through the web site at http://www.dunandbradstreet.com/. 
The DUNS number should be entered on line 11 of the face page of the PHS 
398 form. The PHS 398 document is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an 
interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.
 
APPLICATION RECEIPT DATES: Applications submitted in response to this 
program announcement will be accepted on June 18 and October 15. Both 
new applications and revisions to previously reviewed applications are 
due on the same date.

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:
   
Contact the IC program staff at least six 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.  

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 
and 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 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 Principal Investigator 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 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 should 
submit 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 are 
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 approach as proposed by the investigator and 
may affect the priority score. 

1.  Face Page of the application:

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

Items 7 and 8: Costs Requested
For the R21 phase of the application, direct costs are limited to a 
maximum of $125,000 per year for no more than three years.  R21 budgets 
can only exceed this cap to accommodate F&A costs of subcontracts to the 
project.  The combined R21/R33 application is limited to five years in 
duration, and the R33 phase may not exceed three years in duration.

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 detailed budget (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 should not be used.

4.  Research Plan:

Item a: Specific Aims.
Specific aims must be presented which the applicant considers to be 
scientifically appropriate for the relevant phases of the project.  
Research that develops new technologies or tools is likely to require 
application of principles from fields such as analytical chemistry, 
mathematics, physics, and engineering.  Clear statements of the 
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 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, will result in new capabilities for biomedical 
research, the immediacy of the opportunity, and how any proposed 
technologies or tools differ from existing technologies or tools.  This 
item should not be included in the R33 portion of the application.

Item c: Preliminary Studies
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 
should not be included in the R33 portion of the application.

Item d: Research Design and Methods
Follow the instructions in the PHS 398 form. 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.  Applicants should write the milestones 
assuming that a scientifically literate non-expert will use them to 
evaluate the progress that has been achieved.  Milestones should not be 
simply a restatement of the specific aims or a timeline.  The milestones 
section should be indicated in the Table of Contents.  Applications 
lacking this information will be returned to the applicant without 
review.

For funded proposals, peer review is not likely between the two phases 
of the project.  When the R21 milestones have been achieved, the 
Principal Investigator must submit a progress report to program staff.  
Receipt of this progress report will elicit a review to 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. 

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.

Item 7a: DIRECT COSTS REQUESTED FOR INITIAL PERIOD OF SUPPORT
For the R21 application, direct costs are limited to a maximum of 
$125,000 per year for a maximum of three years.  R21 budgets can only 
exceed this cap 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 from fields such as analytical chemistry, 
mathematics, physics, and engineering.  Clear statements of the 
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 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
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 form.  

5.  Milestones:

Applications using the R21 mechanism without the R33 phase do not need 
to include milestones.
 
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 
5/2001) application form must be affixed to the bottom of the face page 
of the application.  Type the RFA number on the label.  Failure to use 
this label could result in delayed processing of the application such 
that it may not reach the review committee in time for review.  In 
addition, the RFA title and number must be typed on line 2 of the face 
page of the application form and the YES box must be marked. The RFA 
label is also available at: 
http://grants.nih.gov/grants/funding/phs398/labels.pdf.
 
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 material must be sent to:

Office of Review 
National Center for Research Resources
6701 Democracy Boulevard, MSC 4874
Bethesda, MD 20892-4874
Bethesda, MD 20817 (for express/courier service) 
 
APPLICATION PROCESSING: Applications must be received on or before the 
application receipt date listed in the heading of this RFA.  If an 
application is received after that date, it will be returned to the 
applicant without review. 

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.
 
The Center for Scientific Review (CSR) will not accept any application 
in response to this RFA that is essentially the same as one currently 
pending initial review, unless the applicant withdraws the pending 
application. 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.    

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by NCRR. Incomplete applications will not be 
reviewed.  Applications that are complete and responsive to the RFA will 
be evaluated for scientific and technical merit by an appropriate peer 
review group convened by NCRR in accordance with the review criteria 
stated below.  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 Advisory Research 
Resources Council.
 
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 the 
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:

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  For R21/R33 proposals, are the proposed milestones appropriate for 
judging the success of the R21 work?

o  For R21/R33 proposals, are the proposed milestones appropriate in 
determining whether the R33 phase should be awarded?

o  For R21/R33 proposals, are the milestones quantitative?  Will a 
scientifically literate non-expert be able to determine whether the 
milestones have been achieved?

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

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

ADDITIONAL REVIEW CONSIDERATIONS

SHARING RESEARCH DATA:  Applicants requesting more than $500,000 in 
direct costs in any year of the proposed research must 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. http://grants.nih.gov/grants/policy/data_sharing  

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

RECEIPT AND REVIEW SCHEDULE

Application Receipt Date: June 18, 2004 and October 15, 2004
Peer Review Date: October 2004 and February 2005
Council Review: January 2005 and May 2005
Earliest Anticipated Start Date: April 1, 2005 and July 1, 2005

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
 
REQUIRED FEDERAL CITATIONS 

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

SHARING RESEARCH DATA:  Starting with the October 1, 2003 receipt date, 
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.

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

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

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

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

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of 
"Healthy People 2010," a PHS-led national activity for setting priority 
areas. This RFA is related to one or more of the priority areas. 
Potential applicants may obtain a copy of "Healthy People 2010" at 
http://www.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


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