SBIR INITIATIVE FOR ALCOHOL SENSING AND DATA ANALYSIS SYSTEM

Release Date:  March 4, 2002

RFA NUMBER: AA-02-012

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 (http://www.niaaa.nih.gov)

Letter of Intent Receipt Date: March 26, 2002 

Application Receipt Date: April 26, 2002.

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism of Support
o Mechanism Objectives
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
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

This Request for Applications (RFA) invites grant applications for Small 
Business Innovation Research (SBIR) projects on unobtrusive monitoring and 
continuous quantitation of alcohol (ethanol) content in humans.  

In recognition of the nascence and complexity of this area, the duration and 
amounts of individual grants awarded under this RFA may be greater than those 
routinely allowed under the SBIR program.  Few small businesses possess the 
highly specialized resources needed for development of an alcohol sensor; 
analysis of resulting data using techniques such as spatial/temporal pattern 
analysis and data reduction/compression; and attendant technologies such as 
power supply, to enable calibrated, accurate, high-resolution continuous 
measurements of alcohol content.  Therefore, this RFA encourages team 
approaches to research in the belief that a synergistic blend of expertise 
and resources may be needed to allow for stronger partnerships between the 
small businesses and other entities in Phase I than can be developed with the 
funds usually available through this program.  Applications are encouraged 
from teams of investigators from commercial and other sectors of the research 
community.  Partners to the small businesses may play important roles in 
these projects and may receive appropriate support for their efforts.  In 
addition to requiring collaboration from various sectors, it is expected that 
this initiative will require expertise from a variety of disciplines, 
including alcohol research, engineering, biochemistry, physics, and 
mathematical sciences.

RESEARCH OBJECTIVES

Background

NIAAA understands that achievement of program objectives will require the 
exercise of technologies significantly beyond the current state of the art in 
biomedical research and therefore requires research efforts entailing a 
significant level of technical risk.  It is likely that these efforts will 
require the integration of broad spectrum of technologies and methodologies, 
including some not traditionally associated with biomedical applications.  
Therefore, proposals involving teams of investigators having expertise in key 
areas of sensor system design, data analysis, and/or relevant biomedical 
application areas are appropriate.  Proposals involving individual 
investigators or investigator teams of narrower expertise may also be 
appropriate if they show strong potential applicability to the program goals 
and include a clear mechanism for ultimately integrating successful 
developments into full sensor system development.

Several basic requirements can be identified for the measurement, monitoring, 
recording, and reporting of alcohol data.  Because of the rapid uptake of 
alcohol upon ingestion, a rapid response and good time resolution is 
desirable for a measuring system.  Also, any monitoring system must provide 
measurement data, which is detailed and reliably accurate.  In order to 
obtain data representative of extended natural drinking behavior, a 
monitoring system should provide continuous measurements over extended 
periods (weeks).  To the same end, the measurement process should be 
minimally obtrusive on behavior, and should be immune to accidental or 
intentional disruption or discontinuation of the measurement functions.  
Ideally the individual will act naturally during the data collection period, 
with essentially no awareness of the measurement process.  Additional 
desirable features might include the ability to monitor alcohol levels in 
different body organs and systems simultaneously; a capability to provide 
other physiologic measurements such as blood pressure, temperature, and other 
blood chemistry measurements including glucose, enzyme and hormone levels; 
the ability to sense and record information about the individual's location 
and activity; and the ability to report data telemetrically. 

At a glance, the basic requirement just described seems quite commonplace and 
readily met with modern technology.  However, even this capability is 
surprisingly difficult to obtain in practice. Previous methods of obtaining 
such data have been limited to more or less indirect evaluations of alcohol 
content by a variety of methods including breath tests, self-reporting 
surveys, and wrist-worn alcohol-diffusion measurement devices.  All have 
proven deficient in several key regards.
 
Research Topics

A set of target performance goals and properties for an innovative blood 
alcohol sensor has been identified through consultation with application and 
technology from the alcohol research community as well as experts from other 
application areas in biomedical sensing.  NIAAA is interested in development 
of integrated sensing and processing systems capable of the following:

- Accurate determination of alcohol concentration every 1 to 5 minutes, with 
concentration resolution of (5 mg/dl) within a range of (5 -500 mg/dl), with 
continuous coverage over the period of at least one month.
- Measurement fidelity should be robust to subject's activities up to and 
including active efforts at tampering.
- System should provide for storage and/or telemetric exfiltration of data 
(without removal of the sensor).
- System should provide power and data storage capabilities for at least one 
month of continuous activity.
- Sensor system should have no deleterious effects on subject's comfort, 
health, and safety.

Additional desirable features may include the following: 

- Capability to monitor alcohol levels in different body organs and systems 
simultaneously, with spatial resolution sufficient to study concentration 
variation between different organ systems and regions of the body.
- Capability to provide and integrate other physiologic measurements, such as 
heart rate, blood pressure, temperature, galvanic skin impedance, and blood 
chemistry measurements, including possibly other metabolites, enzymes, and 
hormone levels.
- Ability to sense and record information about the individual's location and 
activity and ability to report data telemetrically.

Assessment of the current practice in sensing of various analytes present in 
blood has suggested that radical new approaches are required to obtain joint 
measurement and analysis of specific high-resolution vital data through 
tissue.  Challenges include obtaining high-fidelity measured data out of 
tissue, particularly if spatial localization is to be included and multiple 
physiologic effects are to be monitored.  This is difficult because tissue is 
a dispersive and scattering medium, which often foils simple methods of 
moving high-resolution, detailed spatiotemporal information in and out of the 
body.  Another significant challenge will be maintaining calibration over the 
long operating periods and variable operating conditions anticipated for the 
system.

In any system, power requirements for sensing and processing must be 
considered carefully. In each case, system output data must be stored for 
eventual use.  One possibility would employ periodic telemetric data dumps to 
a small base station, possibly installed in the individual's house.  There is 
the possibility of applying miniaturized GPS receivers in association with 
the sensors to provide information on subject location and movement to be 
incorporated into the stored physiological data.

In any sensing approach, there will be a significant need of signal 
processing for elucidating the information contained in the raw sensor 
measurements.  The selection of measurement features and the post-processing 
of these features must be matched to the physical sensor design and the 
ultimate application end use to ensure the production and recording of 
calibrated and robust information suitable to the end use.  In several 
possible approaches, physical fields are used to probe or report the state of 
physical observables.  As these signals pass in or out of tissue, they will 
be significantly modified by the transmitting medium, which must be taken 
into account in the design of these signals and the data processing 
associated with their use.  Modeling of the environment for the purpose of 
matched field processing or physics-based processing will be appropriate to 
several approaches. 

Consideration of the challenges associated with this program indicate that 
advances in signal processing, data analysis, and the creation of valid and 
verifiable models of the basic phenomena under consideration are integral 
parts of any system developed in this program.  Developments in this arena 
should be performed jointly with the development of the sensor hardware, 
rather than as an ancillary activity conditioned on a fixed hardware design.  
In any system, signal processing and physical sensing should be optimized 
jointly rather than independently in order to obtain maximum system 
performance.

The desired end-to-end design and optimization of sensor systems for this 
program will also require an explicit consideration of the various uses for 
the data outputs of the system.  This will include an understanding of the 
experiments which are likely to be conducted using the sensor, possible 
interventions or probing of a person, and attendant requirements of data 
reduction and analysis and pattern discovery.  This is an essential activity, 
too often ignored initially, and ultimately incurring a great downstream cost 
in degraded system performance and resources expended in retrofit activities.  
Program success will require the development of not simply a physical sensor 
device, but rather instantiation of an integrated sensing, processing, and 
analysis system and methodology.  The ultimate goal of such a system is to 
enable the elucidation of useful information patterns, rather than merely 
providing new means for producing enormous stores of unreduced data.

MECHANISM OF SUPPORT   PHASE I

Phase I applications in response to this RFA will be funded as Phase I SBIR 
Grants (R43) with modifications as described below. Responsibility for the 
planning, direction, and execution of the proposed research will be solely 
that of the applicant.  Applications for Phase I grants should be prepared 
using the PHS 398 instructions and forms: 
http://grants.nih.gov/grants/funding/phs398/phs398.html.  Please refer to 
Chapter VI of the PHS 398 instructions prior to preparing an SBIR 
application.  PHS 398 forms specific to SBIR applications are available.  See 
http://grants.nih.gov/grants/funding/phs398/398_SBIRSTTRforms.doc.

Project Period and Amount of Award

Because the duration and cost of research to develop an alcohol sensor and/or 
associated data analyses are likely to exceed that routinely awarded for SBIR 
grants, well-justified Phase I applications under this RFA will be considered 
with a project period up to two years and a budget not to exceed a total cost 
of $400,000 (i.e., an average of $200,000 per year).

Consultant and Contractual Costs

The total amount of all consultant costs and contractual costs normally 
may not exceed 33% of the total costs requested for Phase I SBIR 
applications. Phase I grant applications submitted under this PA may exceed 
this limit if the resources required for developing an alcohol sensor and 
data analysis system are relatively scarce, highly specialized, and 
multidisciplinary. Deviations must be appropriate and fully justified. 

Page Limitations

The 25-page limitation for Phase I applications applies (see Omnibus 
Solicitation).

MECHANISM OF SUPPORT - PHASE II

Phase II applications in response to this RFA will be awarded as Phase II 
SBIR grants (R44) with modifications as described below.  Phase II 
applications in response to this RFA will only be accepted as competing 
continuations of previously funded NIH Phase I SBIR awards.  The previously 
funded Phase I award need not have been awarded under this RFA but the Phase 
II proposal must be a logical extension of the Phase I research.

Applications for Phase II awards should be prepared using the PHS 398 
instructions and forms:
http://grants.nih.gov/grants/funding/phs398/phs398.html.  Please refer to 
Chapter VI of the PHS 398 instructions prior to preparing an SBIR 
application.  PHS 398 forms specific to SBIR applications are available.  See 
http://grants.nih.gov/grants/funding/phs398/398_SBIRSTTRforms.doc.

Project Period and Amount of Award

Because the duration and cost of research to develop an alcohol sensor and/or 
data analysis system is likely to exceed that routinely awarded for SBIR 
grants, well-justified Phase II applications under this PA will be considered 
with a project period up to three years and a budget not to exceed a total 
cost of $1,200,000 (i.e., an average of $400,000 for each of three years).

Consultant and Contractual Costs

The total amount of all consultant costs and contractual costs normally 
may not exceed 50% of the total costs requested for Phase II SBIR 
applications. Phase I grant applications submitted under this PA may exceed 
this limit if the resources required for developing an alcohol sensor and/or 
data analysis system are relatively scarce, highly specialized, and 
multidisciplinary. Deviations must be appropriate and fully justified.

The Fast-Track initiative can be utilized under this RFA.

This RFA uses just-in-time concepts.  It also uses the modular budgeting 
format. (see 
http://grants.nih.gov/grants/funding/phs398/instructions2/p1_SBIRSTTR
_general_instructions.htm. Specifically, if you are submitting an 
application budget of $100,000 total costs or less, use the modular format.

PROGRAM OBJECTIVES

The SBIR program consists of the following three phases:

Phase I

The objective of Phase I is to establish the technical merit and feasibility 
of the proposed research, or research and development efforts, and to 
determine the quality of performance of the small business grantee 
organization prior to providing further federal support in Phase II.

Phase II

The objective of this phase is to continue the research or research and 
development efforts initiated in Phase I.

Phase III

The objective of this phase, where appropriate, is for the small business 
concern to pursue the commercialization of the results of the research or 
research and development funded in Phases I and II.  Phase III occurs without 
SBIR funding.

FUNDS AVAILABLE 
 
The participating IC(s) intends to commit approximately $2,500,000 in FY 2002 
to fund 12 to 15 new Phase I SBIR grants (R43) in response to this RFA. An 
applicant may request a project period of up to 2 years and a budget for 
total costs of up to $200,000 per year. 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 financial plans of NIAAA 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. At this time, it 
is not known if this RFA will be reissued.

ELIGIBLE INSTITUTIONS

- Independently owned and operated, is not dominant in the field of operation 
in which it is proposing, has its principal place of business located in the 
United States, and is organized for profit.

- At least 51% owned, or in the case of a publicly owned business, at least 
51% of its voting stock is owned by United States citizens or lawfully 
admitted permanent resident aliens.

- Must not have, including its affiliates, more than 500 employees and meets 
the other regulatory requirements found in 13 CFR Part 121.

- Business concerns include, but are not limited to, any individual (sole 
proprietorship), partnership, corporation, joint venture, association, or 
cooperative.

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 organization 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.  The primary employment of the PI must 
be with the small business concern at the time of award and during the 
conduct of the proposed project.  Primary employment means that more than one 
half of the PI's time is spent in the employ of the small business concern.  
Primary employment with a small business concern precludes full-time 
employment at another organization.

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:

Direct your questions about scientific/research issues to:

Michael J. Eckardt, Ph.D.
Office of Scientific Affairs
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 409
Bethesda, MD  20892-7003
Telephone: (301) 443-6107
Fax: (301) 443-6077 
Email: [email protected]

Direct your questions about peer review issues to:

Extramural Project Review Branch
Office of Scientific Affairs
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 409
Bethesda, MD 20892-7003
Telephone: (301) 443-4375
Fax: (301) 443-6077

Direct your questions about financial or grants management matters to:

Ms. Judy Simons
Grants Management Officer
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 504
Bethesda, MD 20892-7003
Telephone: (301) 443-2434
Fax: (301) 443-3891
Email: [email protected]

LETTER OF INTENT
 
Prospective applicants are asked to submit a letter of intent by March 26, 
2002 that includes the following information:

Descriptive title of the proposed research
Name, address, and telephone number of the Principal Investigator
Names of other key personnel 
Participating institutions
Number and title of this RFA (AA-02-012)

Although a letter of intent is not required, is not binding, and does not 
affect the review of a subsequent application, the information that it 
contains allows NIAAA 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.  The letter of intent should be sent to:

Michael J. Eckardt, Ph.D.
Office of Scientific Affairs
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Blvd., Suite 409
Bethesda, MD 20892-7003
Telephone: (301) 443-6107
Fax: (301) 443-6077
Email: [email protected]

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.  Please refer to Chapter VI of the PHS 398 instructions prior to 
preparing a SBIR application.  PHS 398 forms specific to SBIR applications 
are available: 
http://grants.nih.gov/grants/funding/phs398/398_SBIRSTTRforms.doc.  For 
further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: 
[email protected].
  
Specific Instructions for Modular Grant Applications 

SBIR applications requesting up to $100,000 per year in total costs (direct 
costs, indirect costs and fee) 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.  Section VI 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 SBIR 
modular grants is available at 
http://grants.nih.gov/grants/funding/phs398/instructions2/p1_SBIRSTTR
_general_instructions.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 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 must be 
sent to:

Extramural Project Review Branch
Office of Scientific Affairs
Attn: RFA-02-012
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Blvd., Suite 409
Bethesda, 20892-7003
Telephone: (301) 443-4375
Fax: (301) 443-6077

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 NIAAA.  Incomplete and/or non-responsive applications 
will be returned to the applicant without further consideration.

An appropriate peer review group convened by NIAAA in accordance with the 
review criteria stated below will evaluate applications that are complete and 
responsive to the RFA for scientific and technical merit.  As part of the 
initial merit review, all applications will:

- Receive a written critique
- 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
- Receive a second level review by the NIAAA National 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: 

Significance 
Approach 
Innovation
Investigator
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? Does the 
proposed project have commercial potential to lead to a marketable product or 
process?  What may be the anticipated commercial and societal benefits of the 
proposed activity?  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?  Is the proposed plan a sound approach to establishing technical and 
commercial feasibility?  Are the milestones and evaluation procedures 
appropriate?

(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)?  Is the 
investigator capable of coordinating and managing the proposed SBIR?

(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:

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.

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)

The adequacy of the proposed plan to share data.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date: March 26, 2002 
Application Receipt Date: April 26, 2002
Peer Review Date: May-June 2002
Council Review: September 18, 2002
Earliest Anticipated Start Date: September 28, 2002

AWARD CRITERIA

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

Scientific merit (as determined by peer review)
Availability of funds
Programmatic priorities
Commercialization potential

Applications will compete for available funds with all other favorably 
recommended SBIR applications.  Note that applicants may achieve all Phase I 
goals and milestones and still not receive Phase II funding.

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 a 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. 
93.273 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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

			Department of Health and Human Services (HHS)
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