TECHNOLOGY AND AGING:  NIA SBIR/STTR PROGRAM INITIATIVE

RELEASE DATE: February 20, 2004  

PA NUMBER: PA-04-064 (This PA has been reissued, see PA-06-048 and PA-06-049)

EXPIRATION DATE: November 3, 2005
  
Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION:  
National Institutes of Health (NIH) 
 (http://www.nih.gov)

COMPONENT OF PARTICIPATING ORGANIZATION: 
National Institute on Aging (NIA) 
 (http://www.nia.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE: NUMBER: 93.866

APPLICATION RECEIPT DATE(S):  Applications submitted in response to this 
program announcement will be accepted at the standard application deadlines 
[April 1, August 1, December 1]

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  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

NOTICE: This program announcement (PA) 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 current SBIR/STTR Omnibus Solicitation apply.

PURPOSE OF THE PA

The National Institute on Aging (NIA) seeks small business applications in 
specific areas to enhance the coordination and optimization of the SBIR and 
STTR grant programs across and within NIA's four programs of research: 
Behavioral and Social Research, Biology of Aging, Geriatrics and Clinical 
Gerontology, and Neuroscience and Neuropsychology of Aging.  All four of 
NIA’s programs are participating in this initiative.  This program 
announcement is NIA's first systematic effort to solicit SBIR and STTR 
research proposals within a strategic perspective that emphasizes the 
importance and viability of public and private-sector research collaboration 
as part of NIA's overall mission to improve the health and well-being of 
older Americans through translational research.  Specific areas of research 
interest are described below.

RESEARCH OBJECTIVES

The topics in this announcement are grouped according to their program area 
and reflect the priorities outlined in NIA's five-year strategic research 
plan: http://www.nia.nih.gov/AboutNIA/StrategicPlan/.  Applications are 
encouraged on these and other topics relevant to the health and well-being of 
older adults.  

Behavioral and Social Research  

1.  Applications on Technology for Adaptive Aging: NIA recently commissioned 
a report from the National Academy of Sciences (NAS), “Technology for 
Adaptive Aging,” to identify opportunities in translational research and 
technological development that could be pursued via the SBIR mechanism.  The 
report is available on the NAS website 
(http://books.nap.edu/catalog/10857.html) and contains recommendations and 
directions in the areas of: communication, employment, health, learning, 
living environments, and transportation.  This report identified the 
following issues that investigators might consider when designing SBIR 
proposals: access, cohorts, control/autonomy/agency/dignity, culture and 
language, customization, expectations, legal constraints, privacy, safety, 
stereotyping, training, trust, and usability. 

2. Products and technologies that translate social and behavioral research on 
aging processes.  These include interventions and products that take into 
account the adaptations that individuals and society need to make to address 
population aging, such as visual, cognitive, familial, communication and 
other adaptations. Examples of products include technologies that allow older 
drivers to better adapt to sensory declines or media programs designed for 
older adults to increase compliance with complex healthcare regimens. 

3. Research innovations and new products that improve data collection, data 
analysis, and data dissemination of gerontological research. Innovative 
methods for improving the measurement of well-being in older populations are 
particularly encouraged.

4. Data Dissemination: The development of electronic data repositories that 
facilitate rapid dissemination and analysis of complex longitudinal and 
epidemiological data.  Such electronic database resources should be highly 
accessible to researchers while ensuring respondent confidentiality; they 
should include user-friendly interface modules and utilities, and should 
enable cross-platform exchange of data with minimal additional programming 
and manipulation.  

5. Methodological Innovation: This includes new products and techniques that 
facilitate the forecasting of domestic and international demographic trends 
in aging segments of these populations and their healthcare needs; the 
development of high quality micro- or macro-simulation models that measure 
the impact of targeted interventions on health expenditures, well-being, and 
other outcomes; the development and evaluation of strategies to improve 
healthcare organization and delivery, including attention to assisted living 
and new forms of in-home care.  

6. Healthcare Interventions: Social, behavioral, environmental, and/or 
technical interventions on the individual for health maintenance, improved 
well-being, and disease/disability prevention. Such interventions comprehend 
the development of strategies and technologies to enhance long-term adherence 
to medical regimens for chronic conditions and behavioral-change 
interventions for health promotion in older adults.  These interventions 
might include self-management technologies that enhance compliance.  
Interventions of particular interest are those that target less educated 
patients with chronic diseases or new programs, products and services to 
improve the health, functioning, and well-being of older persons.  Potential 
settings of these interventions would include home or the community and 
potential users would include the patient, the individual, formal and/or 
formal caregivers, and even larger social networks. 

Biology of Aging Program

7.  Vaccine Development:   Development of novel vaccine protocols that 
enhance innate and adaptive immune responses for use in elderly populations.  
These may include development and testing of adjuvants, immunotherapeutic 
agents, novel recombinant or subunit vaccine formulations, and optimization 
of delivery protocols.  Research approaches may include evaluation in 
appropriate laboratory animals, including aged rodents or non-human primate 
models.  
 
8.  Tissue Bioengineering:   Development of cells and biomaterials for 
augmentation of tissue regeneration, including strategies to achieve 
functional repair of tissue defects with integrated graft materials and 
cells.

Geriatrics and Clinical Gerontology

9. Exercise Technology: Development of a compact, sturdy treadmill for use by 
ambulatory elderly persons for exercise during inclement weather to maintain 
their normal walking speed.

10. Sensor technology: Development of new and/or validation of existing but 
unproven technologies for detection/surveillance and/or communication of 
problems to allow older persons to live independently.

Neuroscience and Neuropsychology of Aging

11. Pre-clinical discovery and development of drugs or natural products to 
treat, delay the progression of, or prevent age-related cognitive decline, 
Alzheimer's disease, and other dementias of aging.

12. Development of biological or other methods (e.g., neuropsychological) for 
early pre-symptomatic diagnosis of age-related cognitive decline, Alzheimer's 
disease, and other dementias of aging

13. Development of devices for the amelioration of age-related changes in 
human sensory and motor systems.

14. Development of methods for screening, diagnosis, and mechanisms of action 
of prions in the transmissible spongiform encephalopathies in the aging 
organism.

15. Development of biomaterials and methods for nervous system tissue 
regeneration (e.g., growth factors, gene therapy vectors, transplant methods) 
in aging and age-related diseases of the nervous system.

16. Development of methods, reagents, biomaterials, etc. to identify and 
monitor neural stem cells in brain aging and age-related neurodegenerative 
disorders.

MECHANISM 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. 
Otherwise follow the instructions for non-modular budget research grant 
applications.  This program does not require cost sharing as defined in the 
current NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.

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; the 
SBIR/STTR FAST-TRACK option; or as an SBIR/STTR Phase II competing 
continuation 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.  Phase II 
competing continuations will ONLY be accepted by NIA’s Neuroscience and 
Neuropsychology of Aging (NNA) Program.  NNA will accept Phase II competing 
continuations SBIR/STTR grant applications from Phase II SBIR/STTR awardees 
ONLY for the purpose of continuing the process of developing products that 
require approval of a Federal regulatory agency (e.g., FDA). For further 
information regarding Phase II competing continuations, contact Dr. Neil 
Buckholtz (contact information below). 

PROJECT PERIOD AND AMOUNT OF AWARD

The SBIR/STTR Omnibus Solicitation (see: 
http://grants.nih.gov/grants/funding/sbir.htm) indicates the statutory 
guidelines of funding support and project duration periods for SBIR and STTR 
Phase I and Phase II awards. For Phase II competing continuations, budgets up 
to $750,000 total costs per year and time periods up to 2 years may be 
requested. Total costs include direct costs, F&A, and fee/profit in 
accordance with the current SBIR guidelines. 

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 the 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 (PI) 

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 PI must 
have her/his 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. 

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into two 
areas: scientific and financial or grants management issues:

o Direct your questions about scientific/research issues with primary 
emphasis on the biology of aging to:

Rebecca Fuldner, Ph.D.
Biology of Aging Program 
National Institute on Aging 
Gateway Building, Suite 2C231
7201 Wisconsin Avenue
Bethesda, MD  20892-9205
Telephone:  (301) 496-6402
Email: fuldnerr@nia.nih.gov

o Direct your questions about scientific/research issues with primary 
emphasis on behavioral and social research on aging to:

Elayne Heisler, Ph.D. 
Behavioral and Social Research Program
National Institute on Aging
Gateway Building, Suite 533
Bethesda, MD 20892-9205
Telephone: (301) 496-3138
heislere@nia.nih.gov

o Direct your questions about scientific/research issues with primary 
emphasis on geriatric and clinical gerontological research to:

Winifred K. Rossi, M.A.
Geriatrics and Clinical Gerontology Program                                         
National Institute on Aging                
Gateway Building, Suite 3E327 
7201 Wisconsin Avenue
Bethesda MD 20892-9205
Telephone: (301) 496-6761
Email: rossiw@nia.nih.gov

o Direct your questions about scientific/research issues with primary 
emphasis on the neuroscience and neuropsychology of aging to:

Neil Buckholtz, Ph.D. 
Neuroscience and Neuropsychology of Aging Program
National Institute on Aging
Gateway Building, Suite 3C307
7201 Wisconsin Avenue
Bethesda, MD   20892-9205
Telephone:  (301) 496-9350
Email: buckholn@nia.nih.gov

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

Cynthia Riddick, M.A.
Grants and Contracts Management Office
National Institute on Aging 
Gateway Building, Room 2N212
Bethesda, MD  20892-9205
Telephone:  (301) 496-1472
Email: riddickc@nia.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 of the face page of the PHS 398 form. 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 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. 

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 (FOR USPS EXPRESS or REGULAR MAIL)
Bethesda, MD  20817 (FOR EXPRESS/COURIER NON-USPS SERVICE)

APPLICATION PROCESSING:  Applications must be received by or mailed on or 
before the receipt dates described on the first page of this program 
announcement. The 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 unfunded version 
of an application already reviewed, but such 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 that are complete will be assigned on the 
basis of established PHS referral guidelines.  Appropriate scientific review 
groups 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 Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a written critique
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:

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 AND MINORITIES IN RESEARCH: The adequacy of plans to 
include subjects from both genders, and all racial and ethnic groups (and 
subgroups) 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. 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 be also be 
considered by reviewers but will not be included in the determination of 
scientific merit.

SHARING RESEARCH DATA:  Applicants requesting $500,000 or more in direct 
costs in any year of the proposed research must include a data sharing plan 
in their application.  (See  
http://grants.nih.gov/grants/policy/data_sharing.)    The reasonableness of 
the data sharing plan or the rationale for not sharing research data will be 
assessed by the reviewers.  However, reviewers will not factor the proposed 
data sharing plan into the determination of scientific merit or priority 
score. 

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 APPLICATIONS: 

In addition to the above review 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 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? 

TYPE 2 PHASE II COMPETING CONTINUATION APPLICATIONS:

In addition to the above review criteria, the following items will be applied 
to ALL Type 2 Competing Continuation Phase II applications in the 
determination of scientific merit and the priority score:

O  Does the activity as proposed address issues related to Federal regulatory 
approval processes?

o  Did the applicant submit a concise Commercialization Plan that adequately 
addresses the specific areas described in Item j of the Phase II research 
plan?

o  Does the project carry a high degree of commercial potential as described 
in the Commercialization Plan?

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 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 this 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 http://grants.nih.gov/grants/funding/sbirsttr_receipt_dates.htm 

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

DATA AND SAFETY MONITORING PLAN:  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).  

SHARING RESEARCH DATA:  Starting with the October 1, 2003 receipt date, 
investigators submitting an NIH application seeking $500,000 or more in 
direct costs in any single year are expected to include a plan for data 
sharing or state why this is not possible. 
http://grants.nih.gov/grants/policy/data_sharing    Investigators should seek 
guidance from their institutions, on issues related to institutional 
policies, local IRB rules, as well as local, state and Federal laws and 
regulations, including the Privacy Rule. Reviewers will consider the data 
sharing plan but will not factor the plan into the determination of the 
scientific merit or the priority score.

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of 
the research. This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43).

All investigators proposing clinical research should read the "NIH Guidelines 
for Inclusion of Women and Minorities as Subjects in Clinical Research - 
Amended, October, 2001," published in the NIH Guide for Grants and Contracts 
on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html );
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable; 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

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 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:  
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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Research (OER)
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and Human Services (HHS)
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