SENSOR DEVELOPMENT AND VALIDATION
 
RELEASE DATE:  February 25, 2002
 
RFA:  RFA-EB—02-002

PARTICIPATING INSTITUTES AND CENTERS (ICs):

National Institute of Biomedical Imaging and Bioengineering (NIBIB)
 (http://www.nibib.nih.gov)
National Human Genome Research Institute (NHGRI)
 (http://www.nhgri.nih.gov/)
National Institute on Deafness and Communication Disorders (NIDCD)
 (http://www.nidcd.nih.gov/)
National Institute of Dental and Craniofacial Research (NIDCR)
 (http://www.nidcr.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 (http://www.niddk.nih.gov)

LETTER OF INTENT RECEIPT DATE:  March 29, 2002
APPLICATION RECEIPT DATE:       April 24, 2002
 
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 Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations:

PURPOSE OF THIS RFA

The National Institute of Biomedical Imaging and Bioengineering 
(NIBIB), the National Human Genome Research Institute (NHGRI)the 
National Institute on Deafness and Communication Disorders (NIDCD), the 
National Institute of Dental and Craniofacial Research (NIDCR), and the 
National Institute of Diabetes and Digestive and Kidney Diseases 
(NIDDK) invite applications for NIH Research Project Grants (R01) or 
Phased Innovation Awards (R21/R33) in sensor development and 
validation.  NIBIB is soliciting research that can be applied to 
multiple biological or disease processes.  The NIDCD is interested in 
sensor systems pertaining to the auditory, vestibular, olfactory, taste, 
voice, speech and language neural and sensory systems.  The NIDCR is 
interested in the development of sensor system for simultaneous multi-
analyte detection in saliva and other oral fluids. NIDDK is soliciting 
projects focused on continuous and/or noninvasive glucose measurement, 
as well as research to incorporate glucose sensors into closed-loop 
insulin delivery systems for management of diabetes.  The purpose of 
this Request for Applications (RFA) is to support innovative basic and 
applied research targeted at sensor development including sensor 
arrays, their biointerfaces, quality control issues, validation and 
data interpretation.  Multidisciplinary approaches are encouraged that 
involve disciplines such as materials engineering, biochemistry, 
mathematics, computer science, electrical engineering, physiology, 
medicine, bioengineering and physics.

Biorecognition elements in combination with various transduction 
methods have enabled major advancements in the development of sensors 
and chips. In addition, recent enhancements have enabled the merging of 
functions for computation, communication and power source together with 
sensor and actuator.  To move these technologies into the clinical 
situation, certain impediments must be addressed.  In particular, this 
initiative encourages research to address:
o integration of sensors to obtain multiplexed functionality; 
o sensor interface and related algorithm development to relate sensor 
output to physiologically relevant or clinically relevant parameters;
o biofouling of sensors; and
o sensor system and data validation.
 
RESEARCH OBJECTIVES

Biology and medicine have gained enormous insight into the life process 
by discovery, development and application of sensors.  Such sensors 
have enabled discoveries relating to DNA, RNA and protein synthesis, 
cell organelle function, tissue organization and organ system 
integration in normal and diseased states.  This information has 
enabled researchers to develop new methods for the prevention, 
diagnosis and treatment of diseases.  While these developments have 
been extraordinary, future breakthroughs will depend on improvements in 
sensor technology.  In particular, sensor advancements will be achieved 
with methods to prevent biofouling, to integrate sensors to obtain 
multiplexed functionality, to develop algorithms to relate sensor 
output to physiologically relevant or clinically relevant parameters 
and validation of sensors systems. 

Biological sensor systems have demonstrated the complexity and the 
simplicity of nature.  The olfactory system reveals a strategy that is 
complementary to the conventional chemical sensing approach but 
involves the use of sensor arrays.  Olfactory receptors are not highly 
selective toward specific analytes but rather one receptor responds to 
many analytes and many receptors respond to any given analyte.  Thus, 
sensor arrays do not require the high specificity of an individual 
sensor. Identification of an analyte is determined by a distinct 
pattern of responses over the sensor array (fingerprint) rather then 
the response of a single sensor element.  Sensor arrays would be a 
significant improvement over conventional sensors.

Sensors that are placed in a solution or a human will have a corruption 
of the signal and will eventually fail due to biofouling.  Biofouling 
is the rapid accumulation of adsorbed material on the working surface 
of the sensor.  This problem makes long-term monitoring difficult and 
requires frequent maintenance operations and probe replacement.  
Biofouling is found to occur in every monitoring technique that 
operates in situ (electrochemical, optical electrical, thermal, etc.).  
Techniques to overcome biofouling are urgently needed. 

Validation of sensor measurements is an integral step in the 
application of sensor technology.  The sensor measurements must be 
shown to be consistent even under changing conditions of operation, 
e.g., in vivo, temperature, pH, ion concentration, etc.  While sensor 
redundancy is one method for addressing validation, this method has 
disadvantages.  In general any validation method must address the 
sensor function in real time.  Once the sensor data has been validated, 
it is essential to relate the sensor output to a physiologically 
relevant or clinically meaningful value(s).  The relationship between 
the sensor measurement and the clinical parameter(s) must be clearly 
defined.  Algorithm(s) must be developed to relate sensor measurements 
to these parameters.  For example, the relationship between a sensor 
output and blood glucose must be known in order to regulate insulin 
delivery in response to a glucose measurement made in the interstitium.  
Utilization of sensors without validation and without a clear 
understanding of the relationship of the data to the parameter(s) of 
interest is inappropriate application of sensor technology.

The objectives and scope of this initiative are to support basic and 
applied research for the discovery of novel sensor technology and the 
enhancement of sensor utilization in research, clinical investigations 
and disease management. Irrespective of a sensor's detection system or 
the measured parameter(s), certain basic issues will have to be 
addressed for successful sensor advances.  These issues include 
biofouling, data validation and algorithm determination.  Innovative 
approaches to address any or all of these issues are within the scope 
of this initiative.  In addition, or alternatively, utilization of 
novel sensor array technologies would be appropriate.  Research topics 
might include but are not limited to the following:

o Construction of sensor arrays;
o Development of multi-modality sensor arrays;
o Development of biomimetic materials that will reduce or prevent biofouling;
o Design of a sensor surface that is impregnated with compounds to 
alter the immune response or enhance wound repair;
o Development of robust data validation methods that are applicable to 
a wide range of sensor modalities;
o Development of approaches to relate sensor output to clinical parameters;
o Design of models to relate the sensor's physical response 
characteristics to data integrity;
o Development of sensor quality control systems in real time;
o Utilization of prediction models to measure sensor drift or identify 
incorrect data; 
o Construction of the computer interface, sensor control software, and 
data processing software to link sensor array output to a clinical parameter; 
o Development of biological based high throughput sensor technologies 
using organism specific markers for the detection of middle ear infections; 
o Development of electrostimulatory prostheses capable of sensing head 
acceleration forces to improve the balance of vestibular-deficient individuals; 
o Development and enhancement of sensor technology for the improved 
detection of odor and taste substances;
o Development of sensor arrays for simultaneous analyte detection in 
saliva and other oral fluids;
o Development and evaluation of novel continuous and/or noninvasive 
glucose sensors; and
o Development of approaches to link glucose sensing to insulin systems 
in a closed-loop system for the treatment of diabetes 
o Development of the neural tissue and circuitry hardware interface(s) 
to improve amplification and transmission of sound and speech.

The overall objective of this RFA is to provide flexible funding 
mechanisms to support the research activities required to discover, 
develop and validate innovative sensor approaches.

MECHANISM OF SUPPORT
 
This RFA will use the NIH Research Project Grant (R01) and Phased 
Innovation Award (R21/R33) mechanisms.  As an applicant you will be 
solely responsible for planning, directing, and executing the proposed 
project.  This RFA is a one-time solicitation.  Future unsolicited, 
competing-continuation applications based on this project will compete 
with all investigator-initiated applications and will be reviewed 
according to the customary peer review procedures.  The anticipated 
award date is September 30, 2002. 

This RFA uses just-in-time concepts.  Applications for the R01 
mechanism use the modular as well as the non-modular budgeting formats 
(see http://grants.nih.gov/grants/funding/modular/modular.htm).  
Specifically, if you are submitting a R01 application with direct costs 
in each year of $250,000 or less, the modular format should be used.  
Otherwise follow the instructions for non-modular research grant 
applications.  For this RFA, applications for R21/R33 grants should use 
the detailed budget (non-modular) format only.

The R01 mechanism is recommended for applications that emphasize basic 
research on sensor arrays, glucose sensors, their biointerfaces, 
quality control issues and validation. Research periods associated with 
the R01 proposals are limited to five years.   

The R21/R33 Phased Innovation Award is recommended for system 
engineering approaches such as the development and integration of 
sensors that can be applied to multiple biological or disease 
processes, incorporation of glucose sensors into closed-loop systems, 
or partnerships with industry for technology development and 
dissemination.  The combined R21/R33 application offers two advantages 
over the regular application process – (1) single submission and 
evaluation of both the R21 and R33 phases as one application and (2) 
minimal or no funding gap between the R21 and R33 phases.  A single 
application for the combined R21 and R33 phases with a total period of 
up to five years is required for this initiative.  The R21 phase 
supports exploratory or developmental research aimed at proof-of-
principle for high-risk projects where preliminary data is not 
available.  An R21 application can be for one to two years with a 
maximum budget request of $150,000 direct costs per year.  The R33 
mechanism supports the second phase of the innovative exploratory or 
developmental research initiated under the R21 mechanism.  A R33 
application can be for one to four years with a maximum budget request 
of $500,000 direct costs per year.  Transition from the R21 to the R33 
phase is dependent on successful completion of milestones specified in 
the R21 application as determined by program staff in the context of 
peer review recommendations.

The R21 application must include milestones that will be used to judge 
the success of the proposed exploratory research.  The Phased 
Innovation Award application must have a section titled "Milestones" at 
the end of the Research Plan for the R21 application.  This section 
must propose well-defined, quantifiable milestones for the completion 
of the R21 phase, a discussion of the suitability of the proposed 
milestones for assessing the success of the R21 research, and a 
discussion of the implications of successful completion of these 
milestones for the R33 phase.

FUNDS AVAILABLE 

The NIBIB, NHGRI, NIDCD, NIDCR and NIDDK intend to commit approximately 
$6.9 million in FY 2002 to fund 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 also vary.  Although the FY 2002 financial 
plans of the NIBIB, the NIDCD and the NIDDK provide support for this 
program, awards pursuant to the RFA are contingent upon the 
availability of funds and the receipt of a sufficient number of 
meritorious applications.  At this time, it is not known if this RFA 
will be reissued. 

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

o For-profit or non-profit organization
o Public or private institutions such as universities, colleges, 
hospitals, and laboratories
o National 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.   

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:

Joan T. Harmon, Ph.D.
Acting Director
Division of Bioengineering
National Institute of Biomedical Imaging and Bioengineering
Building 31, Room 1B37
Bethesda, MD  20892
Telephone:  (301) 451-6772
FAX:  (301) 480-4515
Email:  joan_harmon@nih.gov

Jeffery A. Schloss, Ph.D.
Division of Extramural Research 
National Human Genome Research Institute
Building 31, Room B2.B07
Bethesda, MD  20892-2033
Telephone:  (301)496-7531
FAX:  (301)480-2770
Email:  jeff_schloss@nih.gov

Nancy L. Freeman, Ph.D.
Scientific Program Director
National Institutes of Health
National Institute on Deafness and Other Communication Disorders
Executive Plaza South-400C
6120 Executive Blvd.  MSC-7180
Bethesda, MD  20892-7180
Telephone:  (301) 402-3458
Fax:  (301) 402-6251 
Email:  nancy_freeman@NIH.gov

Maren R. Laughlin, Ph.D.
Director, Metabolism Program
National Institute of Diabetes and Digestive and Kidney Diseases
2 Democracy Plaza, 6707 Democracy Blvd., Room 6101, MSC 5460
Bethesda, MD  20892-5460
Telephone:  (301)594-8802
FAX:  (301) 480-3503
Email:  Maren.Laughlin@nih.gov

Eleni Kousvelari, DDS, D.Sc.
Biotechnology and Biomaterials Program
Cellular & Molecular Biology, Physiology 
& Biotechnology Branch
Division of Basic and Translational Sciences
National Institute of Dental and Craniofacial Research
Building 45 Room 4AN-18A
Bethesda, MD  20892
Telephone:  (301) 594-2427
FAX:  (301) 480-8318
Email:  eleni.kousvelari@nih.gov

o Direct your questions about peer review issues to:

Calbert Laing, Ph.D.
Chief
Immunological Sciences Integrated Review Group
Center for Scientific Review
Building RKL2, Room 4210
Bethesda, MD  20892
Telephone:  (301) 435-1221
FAX:  (301) 480-4045
Email:  laingc@csr.nih.gov

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

Ms. Annette Hanopole
Grants Management Officer
National Institute of Biomedical Imaging and Bioengineering
Building 31, Room 1B37
Bethesda, MD  20892-2077
Telephone:  301-451-6768
Fax:  301-480-4515
Email:  hanopola@nibib.nih.gov

Jean Cahill 
Grants Administration Branch 
National Human Genome Research Institute
Building 31, Room B2.B34
Bethesda, MD  20892-2031
Telephone:  (301) 402-0733
FAX:  (301) 402-1951
Email:  jc166o@nih.gov

Sara Stone
Chief, Grants Management Branch
NIH/NIDCD
Executive Plaza South, Room 400B
6120 Executive Boulevard, MSC-7180
Bethesda, MD  20892 
Telephone:  (301) 402-0909 
Fax:  (301) 402-1758 
Email:  sara_stone@nih.gov

Ms. Denise Payne
Grants Management Specialist
National Institute of Diabetes and Digestive and Kidney Diseases
2 Democracy Plaza, 6707 Democracy Blvd., Room 733, MSC 5456
Bethesda, MD  20892-5456
Telephone:  (301)594-8845
FAX:  (301) 480-3504
Email:  payned@extra.niddk.nih.gov

H. George Hausch, Ph.D.
Acting Director,
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health
45 Center Drive, Room 4AN-44F
Bethesda, MD  20892-6402
Telephone:  (301) 594-2904
FAX:  (301) 480-8303
Email:  George.Hausch@nih.gov

LETTER OF INTENT
 
Prospective applicants are asked to submit a letter of intent that 
includes the following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this RFA 

Although a letter of intent is not required, is not binding, and does 
not enter into the review of a subsequent application, the information 
that it contains allows NIBIB and CSR staff to estimate the potential 
review workload and plan the review.
 
The letter of intent is to be sent by the date listed at the beginning 
of this document.  It is preferred that the letter of intent be sent 
electronically to noi@nibib.nih.gov.   If necessary, the letter of 
intent can be sent by regular mail to Dr. Joan T. Harmon, listed in the 
WHERE TO SEND INQUIREIES section of this announcement.

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.
  
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications 
requesting up to $250,000 per year in direct costs must be submitted in 
a modular grant format.  The modular grant format simplifies the 
preparation of the budget in these applications by limiting the level 
of budgetary detail.  Applicants request direct costs in $25,000 
modules.  Section C of the research grant application instructions for 
the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-
by-step guidance for preparing modular grants.  Additional information 
on modular grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

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/label-bk.pdf.
 
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 received by 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.
 
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 substantial revisions of applications already 
reviewed, but such applications 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 the NIBIB.  Incomplete applications will be 
returned to the applicant without further consideration.  And, if the 
application is not responsive to the RFA, CSR staff may contact the 
applicant to determine whether to return the application to the 
applicant or submit it for review in competition with unsolicited 
applications at the next appropriate NIH review cycle.

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 the CSR in accordance with the review criteria 
stated below.  As part of the initial merit review, all applications will:

o Receive a written critique
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 second level review by the appropriate Institute 
Advisory 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 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.  For example, 
you may propose to carry out important work that by its nature is not 
innovative but is essential to move a field forward.

(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?  To what degree does the technology 
support the needs for research on biological or disease processes?

(2) APPROACH:  Are the conceptual framework, design, and methods 
adequately developed, well integrated, and appropriate for (l) cross-
cutting fundamental discovery (R01) or (2) technology and tool 
development (R21/R33)?  Does the applicant acknowledge potential 
problem areas and consider alternative tactics?  If appropriate, what 
is the time frame for developing the proposed technologies or tools, 
and what is the suitability of this time frame for meeting the 
community's needs?  How easy will it be to use the proposed technology 
or tools?  Are the plans adequate for integrating the proposed 
technology as an effective solution for implementation and 
dissemination?  If industrial partnerships are proposed, how will they 
facilitate and complement the technology and tool development?

(3) INNOVATION:  Does the project address discovery or technology/tool 
development that represents innovation for the field?  Does the project 
challenge existing paradigms or employ novel concepts, approaches, or 
methods?  What are the innovative applications of the proposed 
fundamental discovery, technology, or tools?

(4) INVESTIGATOR:  Does the principal investigator possess appropriate 
experience and capabilities to direct and carry out this work?  Is the 
experience level of the principal investigator, other researchers, or 
collaborators appropriate for the proposed effort?

(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 or collaborative agreements?

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

o 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.

o 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)

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

o MILESTONES FOR COMBINED R21/R33 APPLICATIONS:  For the R21/R33 
applications, how appropriate are the proposed milestones for 
evaluating the demonstration of feasibility for the R21 effort and 
transition to the R33 development phase?  

For R21/R33 Phased Innovation Award applications, the scientific review 
group will evaluate the specific goals of each phase and the 
feasibility milestones that would justify progression to the R33 phase.  
A single priority score will be assigned to each scored application.  
As with any grant application, the scientific review group has the 
option of recommending support for a shorter duration than that 
requested by the applicant, and basing the final merit rating on the 
recommended portion of the application.  This may result in a 
recommendation that only the R21 phase of the combined R21/R33 
application be supported based on the relative merit of the two 
research plans, adequacy of the milestones for determining success of 
the R21 feasibility studies, and capacity to provide easily assessed 
justification for progression to the R33 phase without further review.  
The scientific review group may recommend modifications to or the 
addition of milestones.  Deletion of the R33 phase by the review panel 
or inadequate milestones may affect the rating of the application.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:    March 29, 2002
Application Receipt Date:         April 24, 2002
Peer Review Date:                 June/July 2002
Council Review:                   September 2002
Earliest Anticipated Start Date:  September 30, 2002

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 

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 initiative 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 RFA 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 No. 93.287 (NIBIB), No. 93.172 (NHGRI), No. 
93.173 (NIDCD), No. 93.173 (NIDCR) and No. 93.847  (NIDDK) and 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.

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