IMPROVING MEASUREMENT TOOLS FOR STERNAL SKIN CONDUCTANCE AND HOT 
FLASHES: PHASE I SBIR 
 
RELEASE DATE:  September 29, 2004 (See NOT-AT-05-001)

RFA Number:  RFA-AT-05-005  

EXPIRATION DATE:  January 21, 2005

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
 (http://www.nih.gov/)
 
COMPONENTS OF PARTICIPATING ORGANIZATION:  
National Center for Complementary and Alternative Medicine (NCCAM)
 (http://nccam.nih.gov/)
National Institute of Aging (NIA)
 (http://www.nia.nih.gov)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
 (http://www.nibib1.nih.gov/)
Office of Research on Women’s Health (ORWH)
 (http://www4.od.nih.gov/orwh/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.213, 93.287, 
93.866
 
LETTER OF INTENT RECEIPT DATE:  December 20, 2004
APPLICATION RECEIPT DATE:  January 25, 2005

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support 
o Project Period and Amount of Award
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

NOTICE:  This Request for Application (RFA) must be read in conjunction 
with the current OMNIBUS SOLICITATION OF THE NATIONAL INSTITUTES OF 
HEALTH, CENTERS FOR DISEASE CONTROL AND PREVENTION, and FOOD AND DRUG 
ADMINISTRATION FOR SMALL BUSINESS INNOVATION RESEARCH (SBIR) AND SMALL 
BUSINESS TECHNOLOGY TRANSFER (STTR) GRANT APPLICATIONS.  The 
solicitation (see 
http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf [PDF] or 
http://grants.nih.gov/grants/funding/sbirsttr1/index.doc [MS Word] 
contains information about the SBIR and STTR programs, regulations 
governing the programs, and instructional information for submission.  
All of the instructions within the SBIR/STTR Omnibus Solicitation apply 
with the following exceptions:

o Special receipt date
o Amount of award 
o Initial review convened by the NCCAM Division of Scientific Review

PURPOSE OF THIS RFA   

The National Center for Complementary and Alternative Medicine (NCCAM), 
the National Institute on Aging (NIA), the National Institute of 
Biomedical Imaging and Bioengineering (NIBIB), and the Office of 
Research on Women’s Health (ORWH) invite Phase 1 small business grant 
applications to conduct research to improve measurement tools or 
devices for sternal skin conductance.  Sternal skin conductance devices 
have been used to monitor hot flashes, but existing tools are limited 
in the amount of data that they can collect and their utility under 
ambulatory conditions.  Improved measurement tools that are reliable, 
user-friendly, reasonably priced, and can collect data for extended 
periods of time are needed to evaluate the efficacy of various 
therapies, including complementary and alternative medicine (CAM) 
modalities, to reduce hot flashes under unsupervised, ambulatory 
conditions in clinical studies.  Such tools and devices could improve 
the efficiency and economy of future clinical trials, but research in 
the area of hot flash measurement has been very limited.  Applicants 
are strongly encouraged to include appropriate bioengineering and 
clinical collaborations to achieve clinically relevant tools or 
devices.  Personnel with appropriate expertise should be involved in 
all phases of the proposed effort, including the development of initial 
concepts and approaches, design of the tool or device, and preliminary 
validation of the clinical measurement tools or devices to monitor 
sternal skin conductance.

RESEARCH OBJECTIVES

Background

Vasomotor symptoms, including hot flashes and night sweats, are 
symptoms frequently reported by menopausal women as well as breast 
cancer survivors and men undergoing androgen deprivation therapy.  
Until recently, estrogen and other forms of hormone therapy were used 
to treat vasomotor symptoms among menopausal women.  However, recent 
findings from the Women’s Health Initiative (WHI) indicate that the 
benefits of hormone-based therapies for hot flashes are outweighed by 
risks, such as coronary heart disease, stroke, and pulmonary embolism.  
Hormone therapy is not an appropriate treatment for hot flashes among 
individuals with a history of hormone-dependent tumors.  

People are now turning to other means to manage hot flashes, including 
complementary and alternative medicine (CAM) therapies.  There is a 
long history of use of CAM therapies for hot flashes, but the empirical 
base to assess safety and efficacy is neither extensive nor very 
strong.  The FDA now recommends that hormones for the treatment of hot 
flashes be used at the lowest dosage and for the shortest period of 
time.  However, little is known about risks and benefits for smaller 
doses, shorter treatment times, and different routes of administration.  
Thus, it is likely that research will be conducted on a range of 
treatments to reduce hot flashes.  

In January 2004, NCCAM and several other NIH Institutes and Centers 
convened a meeting to assess current measurements for hot flashes.  A 
summary of that meeting is available online.  (See 
http://nccam.nih.gov/health/hotflashes/hotflash_summ.htm) Sternal skin 
conductance monitors have been used in a limited number of studies 
conducted in research laboratories and ambulatory settings. While the 
correlation between sternal skin conductance measures and self-reported 
hot flashes is high under laboratory conditions, the correlation 
between these measures is lower in ambulatory studies due to 
underreporting of subjective hot flashes.  Unfortunately, current 
monitors have limitations that prohibit long-term use in ambulatory 
settings. Some are too bulky or weigh too much and thus interfere with 
daily activities and sleep. Electrodes placed on the sternum can be 
problematic for a number of reasons.  They can become unattached with 
excessive sweating and bathing.  Placement and attachment of electrodes 
requires training, requiring the subject to return to the study site 
for reattachment. And some units cannot collect and store data for 
sufficiently long periods of time.  

It is likely that further clinical trials of interventions for hot 
flashes will be conducted. Some treatments are likely to be relatively 
weak when compared with estrogen, but some women may find incomplete 
relief to be adequate if the benefits of treatment outweigh risks. 
Given large placebo effects, which have been reported in many studies, 
unstable self-reported measures of hot flashes, and modest treatment 
effects, important choices in the conduct of future trials must be 
made.  Investigators can either conduct very large studies to 
accommodate the limitations of subjective self-reported measures, or 
they can develop more sensitive and reliable objective measures for use 
in smaller studies, which would afford important economies in terms of 
time and resources.  

Thus, the scientists assessing existing measures of hot flashes at the 
January meeting called for improved sternal skin conductance monitors 
to capture data on the frequency of hot flashes.  This initiative 
addresses the need for improved tools and devices for clinicians and 
researchers to collect meaningful measures of hot flashes under 
ambulatory conditions.

Scope and Objectives

SBIR applications responsive to this initiative may include, but are 
not limited to, research projects to improve the performance 
characteristics of existing sternal skin conductance devices or 
research projects to develop new sternal skin conductance monitoring 
tools or devices.  Potential products should be capable of reliable and 
accurate detection, measurement, and data collection of sternal skin 
conductance under ambulatory conditions.  These tools are needed to 
evaluate treatments seeking to manage vasomotor symptoms, including hot 
flashes and night sweats.  An important objective is for the proposed 
device to be affordable, user friendly, and designed for use in an 
unsupervised environment.  It should be able to collect data under 
conditions of daily life, during waking and sleeping hours, without 
interfering with daily activities.  The proposed tool may be developed 
to interface with an existing piece of equipment or may be 
modifications of an existing system, but it should be designed 
specifically to collect data on hot flashes and night sweats.  The 
applicant’s proposed objectives must be feasible within the time frame 
and amount of award stated in this RFA. 

Applications with multidisciplinary projects should demonstrate the 
potential for integrative collaboration/consultation among a team of 
investigators such as bioengineer(s) and clinician(s) with an 
understanding of the complex systems related to vasomotor symptoms.  An 
informed justification of why and how the proposed tool or device could 
be beneficial for assessing hot flashes is expected.  Essential to 
Phase I feasibility applications are adequate descriptions and 
rationale for the objectives of the proposal and clearly defined Phase 
I milestones, noting how they would lead to prospective Phase II goals, 
which would not be supported through this initiative.  Responsive 
applications will include thorough and detailed descriptions and 
justifications for the chosen approaches, assessment criteria, 
evaluation procedures, and outcome measures for the tool or device. 
When human subjects research is proposed, the application must 
thoroughly and completely address all of the pertinent issues described 
in Part I of the SBIR/STTR Omnibus Solicitation  instructions.  An 
adequately focused project will have an expected scope and completion 
time that will be compatible with the time frame and amount of award 
stated in this RFA.  

Specifically, the objectives of this RFA are to: 

o Identify characteristics of existing sternal skin conductance 
monitors that hinder use under ambulatory conditions and for long term 
data collection;
o Identify and develop modifications or new systems that would improve 
characteristics that currently limit data collection of hot flashes 
under ambulatory conditions;
o Develop a prototype device;
o Conduct pilot tests of that device in the laboratory in individuals 
experiencing hot flashes, noting correlation between self reported hot 
flashes and those identified by the tool or device;
o Conduct a pilot test of that device under ambulatory conditions, 
noting correlation between self reported data on hot flashes and those 
identified by the tool or device.
o Determine subsequent steps needed to refine or improve this device 
for use in larger scale studies;
o Estimate cost of producing larger numbers of devices (e.g., 50 to 100 
units).

MECHANISM OF SUPPORT
 
This RFA uses the SBIR mechanism, which is a set-aside program. As an 
applicant, you will be solely responsible for planning, directing, and 
executing the proposed project.  Future unsolicited, competing 
continuation applications based on this project will compete with all 
SBIR applications and will be reviewed according to the customary peer 
review procedures.  The anticipated award date is September 1, 2005.  
Applications that are not funded in the competition described in this 
RFA may be resubmitted as NEW applications using the standard receipt 
dates for NEW applications described in the current SBIR/STTR Omnibus 
Solicitation. 

This RFA uses just-in-time concepts.  It also uses the modular 
budgeting as well as the non-modular budgeting formats.  Specifically, 
if you are submitting an application budget of $100,000 total costs 
(direct, F&A and fee) or less, use the modular budget format.  For 
applications requesting more than $100,000, use the non-modular budget 
format.  Instructions for both are described in the current SBIR/STTR 
Omnibus Solicitation.  This program does not require cost sharing as 
defined in the current NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm.  
Except as otherwise stated in this RFA, awards will be administered 
under NIH grants policy as stated in the NIH Grants Policy Statement, 
December 2003, available at 
http://grants.nih.gov/grants/policy/nihgps_2003/index.htm.

Applications may be submitted for support only as Phase I SBIR (R43) 
grants.  This RFA does NOT support STTR nor SBIR or STTR Phase II 
applications.  It also does NOT include the SBIR/STTR Fast-Track option 
as described in the SBIR/STTR Omnibus Solicitation.  Upon successful 
completion of Phase I research funded by this RFA, the Phase II 
application must be a logical extension of the Phase I research and 
will be submitted using the standard receipt dates for new and 
competing continuation applications described in the current SBIR/STTR 
Omnibus Solicitation 
http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf [PDF] or 
http://grants.nih.gov/grants/funding/sbirsttr1/index.doc [MS Word.

PROJECT PERIOD AND AMOUNT OF AWARD

The SBIR/STTR Omnibus Solicitation indicates the statutory guidelines 
of funding support and project duration periods for SBIR and STTR Phase 
I awards.  For this RFA, Phase I budgets up to $250,000 total costs per 
year and time periods up to one year for Phase I may be requested. 
Total costs include direct costs, F & A, and fee/profit. 

FUNDS AVAILABLE 
 
NCCAM, NIBIB, and NIA intend to commit approximately $ 1,500,000 in FY 
2005 to support four to six new Phase I applications under the SBIR 
set-aside funding mechanism.  Because the nature and scope of the 
proposed research will vary from application to application, it is 
anticipated that the size of each award will also vary.  Although the 
financial plans of the ICs 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 competing renewal applications will be 
accepted and/or if this RFA will be reissued.
 
ELIGIBLE INSTITUTIONS

Eligibility requirements are described in the SBIR/STTR Omnibus 
Solicitation.  Only small business concerns are eligible to submit 
SBIR/STTR applications.  A small business concern is one that, on the 
date of award for both Phase I and Phase II agreements, meets ALL of 
the criteria as described in the current SBIR/STTR Omnibus 
Solicitation.  
 
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.  On an 
SBIR application, the principal investigator must have his/her primary 
employment (more than 50 percent) with the small business at the time 
of award and for the duration of the project.  

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:

Heather Miller, Ph.D., M.F.S. 
Senior Advisor for Women’s Health
National Center for Complementary and Alternative Medicine
31 Center Drive, Room 2B11, MSC 2182
Bethesda, MD  20892-2182
Telephone:  (301) 451-3453
FAX:  (301) 480-2762
Email:  hmiller@mail.nih.gov

Sherry Sherman, Ph.D.
Director, Clinical Aging and Reproductive Hormone Research
National Institute on Aging, NIH
Gateway Building
Suite 3C-307
7201 Wisconsin Ave.
Bethesda, MD 10892-9205
(Courier/Express Mail ZIP is 20814)
Telephone: (301) 435-3048
FAX: (301) 402-1784
Email: shermans@mail.nih.gov

Peter Moy, Ph.D.
Program Director
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Boulevard
Suite 200 MSC 5469
Bethesda, MD 20892-5469
Telephone: (301) 451-4778
FAX:  (301) 480-4973
moype@mail.nih.gov

o Direct your questions about peer review issues to:

Dr. Martin Goldrosen
Director, Office of Scientific Review
National Center for Complementary and Alternative Medicine
Democracy 2, Suite 401
6707 Democracy Blvd.
Bethesda, MD  20892-5475
Telephone:  (301) 594-2014
FAX:  (301) 480-2419
Email: goldrosm@mail.nih.gov

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

George Tucker
Grants Management Officer
National Center for Complementary and Alternative Medicine
Democracy 2, Suite 401
6707 Democracy Blvd.
Bethesda, MD  20892-5475
Telephone:  (301) 594-9102
FAX:  (301) 480-1552
Email: gt35v@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 IC 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:

Heather Miller, Ph.D., M.F.S.
Senior Advisor for Women’s Health
Division Extramural Research and Training
National Center for Complementary and Alternative Medicine
31 Center Drive, Room 2B11, MSC 2182
Bethesda, MD  20892-2182
Telephone:  (301) 451-3453
FAX:  (301) 480-2762
Email:  hmiller@mail.nih.gov

SUBMITTING AN APPLICATION

The PHS 398 research grant application must be used for all SBIR/STTR 
Phase I, Phase II and Fast-Track applications (new and revised.)  
Effective October 1, 2003, 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 on the face page of the PHS 398 form.  The 
PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html.  Prepare you 
application in accordance with the SBIR/STTR Omnibus Solicitation and 
the PHS 398.  Helpful information for advice and preparation of the 
application can be obtained at: 
http://grants.nih.gov/grants/funding/sbirgrantsmanship.pdf.  The NIH 
will return applications that are not submitted on the 5/2001 version 
of the PHS 398.  For further assistance, contact GrantsInfo, Telephone: 
(301) 435-0714, Email: GrantsInfo@nih.gov.

USING THE RFA LABEL:  The RFA label available in the PHS 398 
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.doc or
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 appendices, 
and three signed, photocopies (including appendices), 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)
 
To expedite the review process, at the time of submission, send two 
additional copies of the application to:
 
Dr. Martin Goldrosen
Director, Office of Scientific Review
National Center for Complementary and Alternative Medicine
Democracy 2, Suite 401
6707 Democracy Blvd. 
Bethesda, MD  20892-5475
Telephone:  (301) 594-2014
FAX:  (301) 480-2419
Email: goldrosm@mail.nih.gov
 
RECEIPT OF APPLICATIONS: 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 eight 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.  However, when a 
previously unfunded application, originally submitted as an 
investigator-initiated application, is to be submitted in response to an 
RFA, it is to be prepared as a NEW application.  That is, the 
application for the RFA must not include an Introduction describing the 
changes and improvements made, and the text must not be marked to 
indicate the changes from the previous unfounded version of the 
application.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by NCCAM.  Incomplete and/or nonresponsive 
applications will be returned to the applicant without further 
consideration.  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 NCCAM 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 NCCAM or NIA or NIBIB 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 evaluate the 
application in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals within the 
context of the SBIR/STTR Program.  The scientific review group will 
address and consider each of the following criteria in assigning the 
application’s overall score: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment

(1)Significance:  Does the proposed project have commercial potential 
to lead to a marketable product or process?  Does this study address an 
important problem?  What may be the anticipated commercial and research 
benefits of the proposed activity?  If the aims of the application are 
achieved, how will scientific knowledge be advanced?  Does the proposal 
lead to enabling technologies (e.g., instrumentation, software) for 
further discoveries?  Will the technology have a competitive advantage 
over existing/alternative technologies that can meet the market needs?

(2)Approach: Are the conceptual framework, design, methods, and 
analyses adequately developed, well-integrated, and appropriate to the 
aims of the project?  Is the proposed plan a sound approach for 
establishing technical and commercial feasibility?  Does the applicant 
acknowledge potential problem areas and consider alternative 
strategies?  Are the milestones and evaluation procedures appropriate? 
  
(3)Innovation: Does the project challenge existing paradigms or employ 
novel technologies, approaches, or methodologies?  Are the aims 
original and innovative?

(4)Investigators: Is the Principal Investigator capable of coordinating 
and managing the proposed SBIT/STTR? Is the work proposed appropriate 
to the experience level of the Principal Investigator and other 
researchers, including consultants and subcontractors (if any)?  Are 
the relationships of the key personnel to the small business and to 
other institutions appropriate for the work proposed?

(5)Environment: Is there sufficient access to resources (e.g., 
equipment, facilities)?  Does the scientific and technological 
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?

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 If the application includes a multidisciplinary team of 
investigators, does it demonstrate the potential for integrative 
collaboration/consultation among these investigators and an 
understanding of vasomotor symptoms?  

o Is there appropriate and informed justification of why and how the 
proposed tool or device could be beneficial for assessing frequency of 
hot flashes?  

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 
additional information and 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 additional information and 
Inclusion Criteria in the sections on Federal Citations, below).

Human Subjects:

1. Protection of Human Subjects from Research Risks – for all studies 
involving human subjects.  See instructions and “Guidance for Preparing 
the Human Subjects Research Section.”  If an exemption is claimed, is 
it appropriate for the work proposed?  If no exemption is claimed, are 
the applicant’s responses to the six required points appropriate?  Are 
human subjects placed at risk by the proposed study?  If so, are the 
risks reasonable in relation to the anticipated benefits to the 
subjects and others?  Are the risks reasonable in relation to the 
importance of the knowledge that reasonably may be expected to be 
gained?  Are the plans proposed for the protection of human subjects 
adequate? 

2. Inclusion of Women Plan – for clinical research only.  Does the 
applicant propose a plan for the inclusion of both genders that will 
provide their appropriate representation?  Does the applicant provide 
appropriate justification when representation is limited or absent?  
Does the applicant propose appropriate and acceptable plans for 
recruitment/outreach and retention of study participants?

3. Inclusion of Minorities Plan – for clinical research only.  Does the 
applicant propose a plan for the inclusion of minorities that will 
provide their appropriate representation?  Does the applicant provide 
appropriate justification when representation is limited or absent?  
Does the applicant propose appropriate and acceptable plans for 
recruitment/outreach and retention of study participants?

4. Inclusion of Children Plan – for all studies involving human 
subjects.  Does the applicant describe an acceptable plan in which the 
representation of children of all ages (under the age of 21) is 
scientifically appropriate and recruitment/retention is addressed 
realistically?  If not, does the applicant provide an appropriate 
justification for their exclusion?

5. Data and Safety Monitoring Plan – for clinical trials only.  Does 
the applicant describe a Data and Safety Monitoring Plan that defines 
the general structure of the monitoring entity and mechanisms for 
reporting Adverse Events to the NIH and the IRB?

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals 
are to be used in the project, the required five items described under 
Vertebrate Animals (section f of the Research Plan instructions) will 
be assessed.  

BIOHAZARDS:  Is the use of materials or procedures that are potentially 
hazardous to research personnel and/or the environment proposed?  Is 
the proposed protection adequate?

ADDITIONAL REVIEW CONSIDERATIONS:  The following items may also be 
considered by reviewers but will not be included in the determination 
of scientific merit.

BUDGET:  The reasonableness of the proposed budget may be considered.  
For all applications, is the percent effort listed for the PI 
appropriate for the work proposed?  Is the overall budget realistic and 
justified in terms of the aims and methods proposed? 

PERIOD OF SUPPORT:  The appropriateness of the requested period of 
support in relation to the proposed research.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  December 20, 2004
Application Receipt Date:  January 25, 2005  
Peer Review Date:  June, 2005
Council Review:  September, 2005
Earliest Anticipated Start Date:  September 1, 2005

AWARD CRITERIA

The following will be considered in making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities
 
REQUIRED FEDERAL CITATIONS 

ANIMAL WELFARE PROTECTION: Recipients of PHS support for activities 
involving live, vertebrate animals must comply with PHS Policy on 
Humane Care and Use of Laboratory Animals
(http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), 
as mandated by the Health Research Extension Act of 1985
(http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the 
USDA Animal Welfare Regulations
(http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.

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

DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required 
for all types of clinical trials, including physiologic, toxicity, and 
dose-finding studies (phase I); efficacy studies (phase II); efficacy, 
effectiveness and comparative trials (phase III).  The establishment of 
data and safety monitoring boards (DSMBs) is required for multi-site 
clinical trials involving interventions that entail potential risk to 
the participants.  (NIH Policy for Data and Safety 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 "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_20
01.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. 
 
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).

Decisions about applicability and implementation of the Privacy Rule 
reside with the research 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.health.gov/healthypeople.

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 ODS was mandated by Congress in 1994 and established with the 
Office of the Director, NIH.  The Dietary Supplement Health and 
Education Act (SHEA) [Public Law 103-417, Section 3.a] amended the 
Federal Food, Drug, and Cosmetic Act “to establish standards with 
respect to dietary supplements.”  This law authorized the establishment 
of the ODS.

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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