INNOVATIONS IN BIOMEDICAL COMPUTATIONAL SCIENCE AND TECHNOLOGY: SBIR/STTR 
INITIATIVE

RELEASE DATE:  May 12, 2003

PA NUMBER: PAR-03-119 (This PAR has been reissued, see PAR-06-088 and PAR-06-089)
                      (Scientific program contact change, see NOT-LM-05-006)
                      (Contact change for programmatic issues, see NOT-GM-05-103)
                      (see addendum NOT-RR-04-007)

EXPIRATION DATE: December 19, 2005

National Institute of General Medical Sciences (NIGMS)
 (http://www.nigms.nih.gov/)
National Cancer Institute (NCI)
 (http://www.nci.nih.gov/)
National Center for Research Resources (NCRR) 
 (http://www.ncrr.nih.gov/)
National Eye Institute (NEI)
 (http://www.nei.nih.gov/)
National Human Genome Research Institute (NHGRI) 
 (http://www.genome.gov/)
National Heart, Lung, and Blood Institute (NHLBI)
 (http://www.nhlbi.nih.gov/index.htm)
National Institute on Aging (NIA) 
 (http://www.nia.nih.gov/)
National Institute of Alcohol Abuse and Alcoholism (NIAAA)
 (http://www.niaaa.nih.gov/)
National Institute of Allergy and Infectious Diseases (NIAID)
 (http://www.niaid.nih.gov/default.htm)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
 (http://www.nibib.nih.gov/)
National Institute of Child Health and Human Development (NICHD)
 (http://www.nichd.nih.gov/)
National Institute on Drug Abuse (NIDA) 
 (http://www.nida.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD)
 (http://www.nidcd.nih.gov/)
National Institute of Dental and Craniofacial Research (NIDCR)
 (http://www.nidr.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS)
 (http://www.niehs.nih.gov/)
National Institute of Mental Health (NIMH) 
 (http://www.nimh.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS)
 (http://www.ninds.nih.gov/)
National Library of Medicine (NLM)
 (http://www.nlm.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS:  93.396, 93.371, 93.867, 
93.172, 93.839, 93.866, 93.273, 93.855, 93.287, 93.209, 93.279, 93.173, 
93.121, 93.114, 93.821, 93.242, 93.853, 93.879.

APPLICATION RECEIPT DATES: (See revised dates in NOT-OD-03-044)
 October 24, 2003
February 24, 2004; June 24, 2004; October 24, 2004
February 24, 2005; June 24, 2005; October 24, 2005
February 26, 2006

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA 
o Research Objectives 
o Mechanism(s) of Support
o Project Period and Amount of Award
o Eligible Institutions 
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
o Where to Send Inquiries 
o Submitting an Application
o Peer Review Process
o Review Criteria 
o Award Criteria
o Receipt and Review Schedule
o Required Federal Citations 

PURPOSE OF THE PA

Participating Institutes and Centers of the National Institutes of Health 
(NIH) invite applications for innovative research in biomedical computational 
science and technology to promote the progress of biomedical research. 

There exists an expanding need to speed the progress of biomedical research 
through the power of computing to manage and analyze data and to model 
biological processes.  The NIH is interested in promoting research and 
developments in biomedical computational science and technology that will 
support rapid progress in areas of scientific opportunity in biomedical 
research.  As defined here biomedical computing or biomedical information 
science and technology includes, database design, graphical interfaces, 
querying approaches, data retrieval, data visualization and manipulation, 
data integration through the development of integrated analytical tools, and 
tools for electronic collaboration, as well as computational research 
including the development of structural, functional, integrative, and 
analytical models and simulations. 

This PA will utilize the Small Business Innovation Research (SBIR) and Small 
Business Technology Transfer (STTR) mechanisms, but will be run in parallel 
with a program announcement of identical scientific scope (PAR-03-106) that 
will utilize the traditional research project grant (R01) or the phased 
innovation award (R21/R33).

RESEARCH OBJECTIVES

Computational and informatics tools have become increasingly important in 
enabling progress in biomedical research.  In recognition of the critical 
role of computer science in biomedical research, the NIH Director 
commissioned a Working Group on Biomedical Computing in June 1999.

The result of the deliberations of the Working Group on Biomedical Computing 
was a report entitled "The Biomedical Information Science and Technology 
Initiative" (BISTI) which can be accessed at the following site: 
http://www.nih.gov/welcome/director/060399.htm.  A major recommendation of 
the BISTI is that the NIH should provide additional resources and incentives 
for basic research to provide adequate support for those who are inventing, 
refining, and applying the tools of biomedical computing.  The promotion of 
the interface of biomedical information science and technology with 
biomedical research should result in new digital and electronic tools that 
will have substantial impact on broad areas of biomedical research.

The Institutes and Centers of the NIH acknowledge the wisdom of this 
recommendation and are offering support to small business through the current 
solicitation for fundamental research in biomedical information science and 
technology, as well as for the development of new informatics and 
computational tools and technologies. 
 
This solicitation targets support for fundamental research in biomedical 
computing science and technology as well as the development and application 
of new biocomputing tools or technologies for a particular area(s) of 
scientific opportunity in biomedical research.  Programs may target one or 
multiple areas of biomedical computing that will enable progress in 
biomedical research.  Examples of data types that could be considered include 
but are not limited to genomic sequences, biomedical images, qualitative 
descriptors for health and social science, remote sensing and geospatial 
images, and chemical formulae.  Specific research areas solicited in 
informatics or computational science include but are not limited to research, 
development, and application of:
o  Tools for data acquisition, archiving, querying, retrieval, visualization, 
integration, and management
o  Platform-independent translational tools for data exchange and for  
promoting interoperability 
o  Web-based linkage tools for data sharing and tools for electronic 
communication
o  New analytical and statistical tools for interpretation of large and 
complex data sets
o  New models or simulations of complex biological processes and systems 

Areas of biomedical research likely to be critically dependent on 
biocomputing advances include but are not limited to:
o  Behavioral science
o  Biological rhythms
o  Biomedical imaging 
o  Cell biology
o  Clinical research 
o  Developmental biology
o  Drug design at the molecular and cellular levels
o  Dynamic modeling of health, chronic disease, and disablement
o  Environmental science
o  Epidemiology
o  Genetics and genomics
o  Immunology/inflammation
o  Morphology
o  Neurobiology and cognitive science
o  Pharmacology
o  Physiology
o  Population biology
o  Structural biology
o  Substance abuse research
o  Surgery and virtual tools

Projects must span the interface of biomedical research and biomedical 
computational science and technology.  Applicants will be expected to 
demonstrate fundamental understanding and adequate expertise in both the 
relevant areas of computational science and technology and biomedical 
research.  Cross-disciplinary collaborations are strongly encouraged. 

Given the expanding needs in biomedical research for advances in a variety of 
areas of information science and technology, the approaches and technologies 
proposed under this announcement should ultimately be generalizable, 
scalable, extensible, interoperable and use sophisticated computational 
resources.  The projects should take into account the needs of the biomedical 
research community that will be the ultimate end users of the products of the 
research.  The projects should also address plans for ensuring the 
dissemination of useful products of the research, including approaches, 
technologies, and tools, to the relevant research and user communities.  The 
informatics and computational research proposed should be future-oriented, 
fill an area of need or projected need, and seek to exceed the current state-
of-the-art. 

MECHANISMS OF SUPPORT 

This PA uses the SBIR and STTR mechanisms, which are set-aside programs. 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/STTR 
applications and will be reviewed according to the customary peer review 
procedures.

This PA uses just-in-time concepts. It also uses the modular budgeting 
format.  Specifically, if you are submitting an application budget of 
$100,000 total costs (direct, F&A and fee) or less, use the modular format 
and instructions as 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/archive/grants/policy/nihgps_2001/part_i_1.htm.

Except as otherwise stated in this PA, awards will be administered under NIH 
grants policy as stated in the NIH Grants Policy Statement, March 2001, 
available at http://grants.nih.gov/grants/policy/nihgps_2001.  

Applications may be submitted for support as Phase I STTR (R41) or Phase I 
SBIR (R43) grants; Phase II STTR (R42) or Phase II SBIR (R44) grants; or the 
SBIR/STTR FAST-TRACK option as described in the SBIR/STTR Omnibus 
Solicitation.  Phase II applications in response to this PA will only be 
accepted as competing continuations of previously funded NIH Phase I 
SBIR/STTR awards.  The Phase II application must be a logical extension of 
the Phase I research but not necessarily a Phase I project supported in 
response to this PA.  

PROJECT PERIOD AND AMOUNT OF AWARD  

Because the length of time and cost of research involving advanced 
information science and technology projects often exceed those normally 
awarded for SBIR/STTR grants, NIH will entertain well-justified Phase I 
applications with a project period up to two years and a budget not to exceed 
$100,000 per year direct cost (maximum of $200,000 direct costs for two years 
excluding subcontractor indirect costs).

Because the length of time and cost of research in this area often exceed 
those normally awarded for SBIR applications, NIH will entertain well-
justified Phase II applications submitted under this announcement with a 
project period of up to three years with no budget limitation.

Applications submitted through the FAST-TRACK option are subject to the same 
direct costs limits per year as when submitted outside of the FAST-TRACK 
option: Phase I (R41/43), not to exceed $100,000 per year total direct costs 
excluding subcontractor indirect costs; Phase II (R42/44), no dollar limit.  
However, for this solicitation the total duration (Phase I plus Phase II 
applications) cannot exceed five years.

ELIGIBLE INSTITUTIONS

Eligibility requirements are described in the SBIR/STTR Omnibus Solicitation.  
Only small business concerns are eligible to submit 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 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%) with the 
small business at the time of award and for the duration of the project.  The 
PI on an STTR application may be employed with the small business concern or 
the participating non-profit research institution as long as s/he has a 
formal appointment with or commitment to the applicant small business 
concern, which is characterized by an official relationship between the small 
business concern and that individual. 

SPECIAL REQUIREMENTS

An annual meeting of all investigators funded through this program may be 
held to share progress and research insights that may further progress in the 
program.  Applicants should request travel funds in their budgets for the 
principal investigator and one additional senior investigator to attend this 
annual meeting.

FAST-TRACK APPLICATIONS.  Applications may be submitted for the FAST-TRACK 
review option.  Information on the FAST-TRACK process may be found at:  
http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf.

To be eligible for the FAST-TRACK option, the Phase I (R41/43) application 
must include well defined quantifiable milestones that will be used to judge 
the success of the proposed research, as well as a credible development plan 
for the Phase II (R42/44) application.  The FAST-TRACK must have a section 
labeled "Milestones" at the end of the Research Plan for Phase I R41/43.  

An additional requirement of the FAST-TRACK mechanism is the 
Commercialization Plan (formerly, Product Development Plan).  The small 
business must submit a concise Commercialization Plan (limited to five pages) 
as an Appendix to the Phase II application addressing the four areas 
described in the instructions for FAST-TRACK applications in the OMNIBUS 
SOLICITATIONS.  In the event that an applicant feels that technology is too 
proprietary to disclose, applicants at a minimum should provide a 
demonstration (e.g., results) of the capabilities of the proposed technology.  

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity to 
answer questions from potential applicants.  

Inquiries or contacts concerning Institute-specific scientific, technical, or 
financial issues should be directed to the NIH BISTI technical or financial 
contacts listed at the following Web site: 
http://www.bisti.nih.gov/SBIR-contacts.cfm.

Direct more general questions regarding programmatic issues to:

Peter Lyster, Ph.D.
NIGMS 45 Center Drive, Room 2AS.55k, MSC 
6200 Bethesda, MD 20892-6200 
TEL: 301-451-6446 
Email: lysterp@mail.nih.gov

Direct your questions about peer review issues to: 

Donald Schneider, Ph.D.
Center for Scientific Review
6701 Rockledge Drive, Room 4172
Bethesda, MD  20892-7806
TEL:  (301) 435-1727
FAX:  (301) 480-2327
Email:  schneidd@csr.nih.gov

SUBMITTING AN APPLICATION

The PHS 398 (rev 5/01) research grant application must be used for all 
SBIR/STTR Phase I, Phase II and Fast-Track applications (new and revised.)  
The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html.  Prepare your 
application in accordance with the SBIR/STTR Omnibus Solicitation and the PHS 
398. Helpful information on the 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 using the PHS 398 grant 
application.  For further assistance contact GrantsInfo, Telephone: (301) 435-
0714, Email: GrantsInfo@nih.gov. 

The title and number of this PA must be typed on line 2 of the face page of 
the application.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS:  This PA uses the 
modular budgeting format.  Specifically, if you are submitting an application 
budget of $100,000 total (direct, F&A and fee) or less, use the modular format 
and instructions as described in the SBIR/STTR Omnibus Solicitation. 

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)

Applications must be received by the receipt dates described on the first page 
of this program announcement.  The Center for Scientific Research (CSR) will 
not accept any application in response to this PA that is essentially the same 
as one currently pending initial review unless the applicant withdraws the 
pending application.  The CSR will not accept any application that is 
essentially the same as one already reviewed.  This does not preclude the 
submission of a substantial revision of an application already reviewed, but 
such an application must include an Introduction addressing the previous 
critique.

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review group 
convened in accordance with the standard NIH peer review procedures 
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific 
and technical merit.  

As part of the initial merit review, all applications will:

o Receive a written critique
o Undergo a 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 national advisory council 
or board  

REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to discuss the following 
aspects of the 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

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 societal 
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/alternate 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 SBIR/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 applied to ALL applications in the determination of scientific 
merit and the priority score:

MILESTONES:  The appropriateness and suitability of the proposed milestones 
to evaluate transition to the R42/R44 development phase.

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.  
Animal Welfare:  If vertebrate animals are involved, are adequate plans 
proposed for their care and use?  Are the applicant's responses to the five 
required points appropriate?  Will the procedures be limited to those that 
are unavoidable in the conduct of scientifically sound research? 
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? 

DATA SHARING:  The adequacy of the proposed plan to share data. 

ADDITIONAL CONSIDERATIONS:  The following items may be 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?  On applications requesting up to $100,000 total costs, is the 
overall budget realistic and justified in terms of the aims and methods 
proposed?  On applications requesting over $100,000 in total costs, is each 
budget category realistic and justified in terms of the aims and methods? 

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

PHASE II APPLICATION REVIEW CRITERIA:  In addition to the above criteria:
1.  How well did the applicant demonstrate progress toward meeting the 
Phase I objectives, demonstrating feasibility, and providing a solid 
foundation for the proposed Phase II activity? 
2.  Did the applicant submit a concise Commercialization Plan [formerly 
Product Development Plan] that adequately addresses the seven areas 
described in the Research Plan item J? 
3.  Does the project carry a high degree of commercial potential, as 
described in the Commercialization Plan? 

AMENDED APPLICATIONS:  In addition to the above criteria, the following 
criteria will be applied to revised applications.
1.  Are the responses to comments from the previous SRG review adequate? 
2.  Are the improvements in the revised application appropriate? 

PHASE I/PHASE II FAST-TRACK APPLICATION REVIEW CRITERIA:  For Phase I/Phase 
II Fast Track applications, the following criteria also will be applied:

1.  Does the Phase I application specify clear, appropriate, measurable 
goals (milestones) that should be achieved prior to initiating Phase II? 

2.  Did the applicant submit a concise Commercialization Plan [formerly 
Product Development Plan] that adequately addresses the seven areas 
described in the Research Plan, item J? 

3.  To what extent was the applicant able to obtain letters of interest, 
additional funding commitments, and/or resources from the private 
sector or non-SBIR/ STTR funding sources that would enhance the 
likelihood for commercialization? 

4.  Does the project carry a high degree of commercial potential, as 
described in the Commercialization Plan? 
Phase I and Phase II FAST-TRACK applications that satisfy all of the review 
criteria will receive a single rating. Failure to provide clear, measurable 
goals may be sufficient reason for the scientific review group to exclude the 
Phase II application from FAST-TRACK review.

AWARD CRITERIA

Applications submitted in response to a PA will compete for available funds 
with all other recommended SBIR and STTR applications.  The following will be 
considered in making funding decisions:  

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

For FAST-TRACK applications, the Phase II portion may not be funded until a 
Phase I final report and other documents necessary for continuation have been 
received and assessed by program staff that the Phase I milestones have been 
successfully achieved.

RECEIPT AND REVIEW SCHEDULE  

See dates at beginning of this announcement. 

REQUIRED FEDERAL CITATIONS 

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

MONITORING PLAN AND DATA AND SAFETY 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 "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.

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

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

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

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

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under the authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92). All 
awards are subject to the terms and conditions, cost principles, and other 
considerations described in the NIH Grants Policy Statement.  The NIH Grants 
Policy Statement can be found at 
http://grants.nih.gov/grants/policy/policy.htm 

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the use of all tobacco products.  In addition, 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities (or in some cases, any portion of a facility) in which 
regular or routine education, library, day care, health care, or early 
childhood development services are provided to children.  This is consistent 
with the PHS mission to protect and advance the physical and mental health of 
the American people.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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