INNOVATIVE TECHNOLOGIES FOR ENHANCING FUNCTION FOR INDIVIDUALS WITH
DISABILITIES
RELEASE DATE: March 4, 2002
PA NUMBER: PA 02-071
EXPIRATION DATE: January 25, 2005
National Institute of Child Health and Human Development (NICHD)
(http://www.nichd.nih.gov)
National Institute on Aging (NIA)
(http://www.nia.nih.gov)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
(http://www.nibib.nih.gov)
National Institute on Deafness and Other Communication Disorders (NIDCD)
(http://www.nidcd.nih.gov)
National Eye Institute (NEI)
(http://www.nei.nih.gov)
National Institute of Mental Health (NIMH)
(http://www.nimh.nih.gov)
U.S. Department of Education, National Institute on Disability and
Rehabilitation Research (NIDRR)
(http://www.ed.gov/offices/OSERS/NIDRR/)
National Science Foundation (NSF)
(http://www.nsf.gov/pubs/2001/nsf0128rev/nsf0128rev.htm)
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanisms of Support
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 Required Federal Citations
PURPOSE OF THIS PA
This Program Announcement (PA) is to encourage small businesses to
participate in assistive technology research that facilitates the
rehabilitation of individuals with disabilities resulting from injury and
disease. The National Institutes of Health (NIH), the National Institute on
Disability and Rehabilitation Research (NIDRR) of the U.S. Department of
Education, Office of Special Education and Rehabilitative Services, and the
National Science Foundation (NSF) encourage SBIR/STTR applications in
innovative technologies for enhancing function for individuals with
disabilities within their major solicitation topics. Ultimately, the goal of
this program is to improve the physical and/or mental function of individuals
with disabilities through new technologies, delivery systems, and/or training
techniques. For this purpose, this announcement is designed to expedite the
transition of innovative technology and development into practical
applications.
RESEARCH OBJECTIVES
BACKGROUND: Assistive technology use is increasing as the population of
individuals with disabilities grows. To a large extent, consumer use is
associated with the desire to remain independent and improve and maintain
function. Within the past decade, the increase in scientific discoveries in
the biologic and engineering sciences provides the basis for the development
of a wide array of new assistive technologies. There is a need to expand on
these emerging technologies and translate the science into devices needed by
individuals with disabilities.
This PA seeks to encourage potential applicants to take full advantage of the
SBIR/STTR program mechanism for multidisciplinary rehabilitation research
projects that develop technology to reduce impairment and increase function
of individuals with disabilities resulting from injury and disease. This PA
is open to all relevant, meritorious research ideas involving the development
of innovative assistive technology where progress is likely to make a
significant contribution to improving the cognitive, emotional, and physical
health of individuals with disabilities.
Assistive technology research should be science based, developed in
collaboration with consumers, industry, and academia, and result in high-
quality products, services or training media that have been evaluated for
utilization, efficacy, and functional impact on target audiences.
Researchers should pursue the research with the safety, good health, and
welfare of the potential user of their technology in mind.
Research Scope: The following examples of projects are not all-inclusive,
but indicate the type of knowledge to be achieved through this PA.
(1) Technology
o Develop tissue science solutions to enhance the biocompatibility of
assistive technology in terms of the person/machine interface.
o Develop innovative power supplies for mobility devices.
o Develop biosensors for reducing health risks for individuals with
disabilities.
o Develop new cognitive prostheses for individuals with cognitive
impairments.
o Develop multifunction wearable computers to facilitate health status
monitoring, enhance communication, etc. for individuals with disabilities.
o Develop assistive devices, environmental modifications, and rehabilitation
strategies to minimize the impact of visual impairment in everyday life.
o Develop assistive devices, environmental modifications, and rehabilitation
strategies to minimize the impact of disordered processes of hearing,
balance, smell, taste, voice, speech, and language.
(2) Systems
o Develop consumer report types of evaluations of assistive technology.
o Develop long-term assistive technology tracking systems that monitor
outcome measures.
o Develop integrated systems of rehabilitation practice and best practices
information on appropriate use of assistive technology.
o Develop information systems on assistive technology for the public or
health care profession that give individuals with disabilities the
information they want.
(3) Training
o Develop training modules for health professionals on the appropriate use
of assistive technology and to help individuals with disabilities make better
choices.
o Develop training modules on assistive technology for caregivers to clarify
risks and reduce disparities in demand for, access to, and use of assistive
technology.
o Develop training modules on the appropriate use of assistive technology to
increase function, facilitate adaptation, and clarify expectations regarding
function and costs for persons with disabilities.
MECHANISMS OF SUPPORT
This PA will use the NIH Small Business Innovation Research (SBIR) and Small
Business Technology Transfer (STTR) award mechanisms. As an applicant, you
will be solely responsible for planning, directing, and executing the
proposed project. NIH and NSF participate in the SBIR and STTR Programs;
NIDRR participates only in the SBIR Program.
ELIGIBLE INSTITUTIONS
You may submit an application if your institution meets the relevant agency's
SBIR/STTR Program and application requirements. Agency-specific SBIR/STTR
information, including eligibility requirements, mechanism of support, award
levels, and application preparation requirements, is located at the following
websites:
NIH: http://grants.nih.gov/grants/funding/sbir.htm
U.S. Department of Education: http://www.ed.gov/offices/OERI/SBIR/
NSF: http://www.eng.nsf.gov/sbir/.
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.
SPECIAL REQUIREMENTS
The following information is specific only to NIH applicants:
This PA must be read in conjunction with the current NIH Omnibus Solicitation
for SBIR/STTR Grant Applications, which may be accessed at
http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf.
Because the length of time and cost of research involving technology projects
may exceed that normally awarded for NIH SBIR/STTR grants, the NICHD, NIA,
NIBIB, NIDCD, NEI and NIMH will allow well-justified Phase I applications
with a project period of up to two years and a budget, including fixed fees,
not to exceed $100,000 per year total costs (maximum of $200,000 total costs
for two years). 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 previously funded Phase I award need not have been
awarded under this PA, but the Phase II application must be a logical
extension of the Phase I research. The NICHD and NIA will consider Phase II
projects with a project period up to three years and a budget not to exceed
$400,000 per year total costs, including fixed fees.
All of the instructions within the NIH Omnibus Solicitation for SBIR/STTR
Grant Applications apply, including Fast-Track applications, with the
following exceptions:
o Opportunity for two years of Phase I support with a budget not to exceed
$100,000 in total costs including fixed fees, per year;
o Opportunity for three years of Phase II support with a budget not to
exceed $400,000 in total costs, including fixed fees, per year.
INDIVIDUAL PHASE I APPLICATIONS: Phase I applications in response to this PA
will be funded as Phase I SBIR Grants (R43) or Phase I STTR Grants (R41) with
modifications as described below. For Phase I applications, applicants are
strongly encouraged to highlight the innovation of their proposed research
and to clearly state the milestones that will be used to demonstrate
feasibility. Applications for Phase I grants should be prepared using the
PHS 398 (rev. 5/2001) forms in accordance with Section VI of the PHS 398
instructions. See http://grants.nih.gov/grants/funding/phs398/phs398.html.
Well-justified Phase I applications with a project period up to two years and
a budget not to exceed $100,000 per year total cost, including fixed fees,
(maximum of $200,000 total costs for two years) will be allowed.
INDIVIDUAL PHASE II APPLICATIONS: Phase II applications in response to this
PA will be awarded as Phase II SBIR Grants (R44) or Phase II STTR Grants
(R42) with modifications as described below. For Phase II applications, the
demonstration of feasibility accomplished in Phase I should be clearly
indicated. Phase II applications 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 and must
be responsive to this PA.
Applications for Phase II SBIR or STTR awards should be prepared using the
PHS 398 forms in accordance with Section VI of the PHS 398 instructions. See
http://grants.nih.gov/grants/funding/phs398/phs398.html.
Well-justified Phase II applications with a project period up to three years
and a budget not to exceed $400,000 in total costs, including fixed fees, per
year will be allowed.
This PA uses just-in-time concepts. It also uses the modular as well as the
non-modular budgeting formats
(see http://grants.nih.gov/grants/funding/phs398/instructions2/p1_SBIRSTTR_general_instructions.htm).
Specifically, if you are submitting an application with total costs in each
year of $100,000 or less, use the modular format. Otherwise follow the
instructions for non-modular SBIR/STTR grant applications.
WHERE TO SEND INQUIRES
We encourage your inquiries concerning this PA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into two
areas: scientific /research and financial or grants management issues:
o Direct your questions about scientific/research issues to:
Louis Quatrano, Ph.D.
Behavioral Sciences and Rehabilitation Engineering
National Institute of Child Health and Human Development
National Institutes of Health
6100 Executive Boulevard, Room 2A03, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 402-4221
FAX: (301) 496-0832
E-mail: quatranl@exchange.nih.gov
Sidney M. Stahl, Ph.D.
National Institute on Aging
National Institutes of Health
Gateway Building, Room 533
7201 Wisconsin Avenue
Bethesda, MD 20892-9205
Telephone: (301) 402-4156
Fax: (301) 402-0051
E-mail: StahlS@nia.nih.gov
Joan T. Harmon, Ph.D.
Senior Advisor for Program
National Institute of Biomedical Imaging and Bioengineering
National Institutes of Health
6707 Democracy Boulevard, Room 697
Bethesda, MD 20892
Telephone: (301) 594-8813
FAX: (301) 480-3503
E-mail: joan_harmon@nih.gov
Lana Shekim, Ph.D.
Director, Voice & Speech Program
Scientific Programs Branch, DER
National Institute on Deafness and Other Communication Disorders
National Institutes of Health
6120 Executive Boulevard, EPS-400-C, MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 496-5061
FAX: (301) 402-6251
E-mail: shekiml@nidcd.nih.gov
Dr. Michael D. Oberdorfer
Director, Low Vision and Its Rehabilitation Program
National Eye Institute
National Institutes of Health
6120 Executive Boulevard, Suite 350, MSC 7164
Bethesda, MD 20892-7164
Telephone: (301) 496-5301
FAX: (301) 402-0528
E-mail: oberdorfer@nei.nih.gov
Enid Light, Ph.D.
Division of Services and Interventions Research
National Institute of Mental Health
National Institutes of Health
6001 Executive Boulevard, Room 7155, MSC 9635
Bethesda, MD 20892-9635
Telephone: (301) 443-3599
FAX: (301) 594-6784
E-mail: elight@nih.gov
Kristi Wilson, Ph.D., Program Officer
Constance Pledger, Ed.D., Associate Director, Division of Research Sciences
National Institute on Disability and Rehabilitation Research
Office of Special Education and Rehabilitative Services
U.S. Department of Education
Telephone: (202) 260-0988
FAX: (202) 205-8515
E-mail: Connie.pledger@ed.gov
Dr. Joseph E. Hennessey
Acting Director, SBIR/STTR
National Science Foundation
4201 Wilson Boulevard, Room 570.10
Arlington, VA 22210
Telephone: (703) 292-7069
FAX: (703) 292-9057
E-mail: jhenness@nsf.gov
o Direct your questions about financial or grants management matters to:
Christopher Myers
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 435-6996
FAX: (301) 402-0915
E-mail: cm143g@nih.gov
Deborah Stauffer
Grants and Contracts Management Office
National Institute on Aging
Gateway Building, Suite 2N212
7201 Wisconsin Avenue
Bethesda, MD 20892
Telephone: (301) 496-1472
FAX: (301) 402-3672
E-mail: Staufferd@exchange.nih.gov
Annette Hanopole, CRA
Grants Management Branch
National Institute of Biomedical Imaging and Bioengineering
31 Center Drive, Room 1B37, MSC 2077
Bethesda, Maryland 20892-2077
Telephone: (301) 451-6768
FAX: (301) 480-4515
E-mail: Hanopola@mail.nih.gov
Sara Stone
Chief, Grants Management Branch
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400B, MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 402-0909
FAX: (301) 402-1758
E-mail: stones@nidcd.nih.gov
William W. Darby
Grants Management Officer
National Eye Institute
6120 Executive Boulevard, Suite 350, MSC 7164
Bethesda, MD 20892-7164
Telephone: (301) 496-5884
FAX: (301) 496-9997
E-mail: wwd@nei.nih.gov
Diana S. Trunnell
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2805
FAX: (301) 443-6885
E-mail: Diana_Trunnell@nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The PHS 398 is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
Email: GrantsInfo@nih.gov.
APPLICATION RECEIPT DATES: Applications submitted in response to this
program announcement will be accepted at the standard SBIR/STTR application
deadlines, which are available at http://grants.nih.gov/grants/dates.htm.
Application deadlines are also indicated in the PHS 398 application kit.
Applicants planning to submit an SBIR or STTR Phase I or Phase II application
AFTER April receipt dates should check the NIH Small Business Funding
Opportunities website http://grants.nih.gov/grants/funding/sbir.htm for more
specific details and instructions.
The title and number of this program announcement must be entered on line 2
of the face page of the application (PHS 398) form and the YES box must be
marked.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications
requesting up to $100,000 per year in direct costs must be submitted in a
modular grant format. The modular grant format simplifies the preparation of
the budget in these applications by limiting the level of budgetary detail.
Section C of the SBIR/STTR grant application instructions for the PHS 398
(rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/instructions2/p1_preparing_SBIR_STTR_app.htm
includes step-by-step guidance for preparing modular grants. Additional
information on modular grants is available at
http://grants.nih.gov/grants/funding/modular/modular.htm.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of
the application, including the checklist, and five signed photocopies in one
package to:
CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)
APPLICATION PROCESSING: Applications must be received by or mailed before the
receipt dates described at
http://grants.nih.gov/grants/funding/submissionschedule.htm. 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 application already reviewed, but
such application must include an Introduction addressing the previous
critique.
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 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 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 your application in order to judge the likelihood that the
proposed research will have a substantial impact on the pursuit of these
goals:
o Significance
o Approach
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these criteria
in assigning your application's overall score, weighting them as appropriate
for each application. Your application does not need to be strong in all
categories to be judged likely to have major scientific impact and thus
deserve a high priority score. For example, you may propose to carry out
important work that by its nature is not innovative but is essential to move
a field forward.
(1) SIGNIFICANCE: Does your study address an important problem? If the aims
of your application are achieved, how do they advance scientific knowledge?
What will be the effect of these studies on the concepts or methods that
drive this field?
2) APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the aims of the
project? Do you acknowledge potential problem areas and consider alternative
tactics?
(3) INNOVATION: Does your project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does your project challenge
existing paradigms or develop new methodologies or technologies?
(4) INVESTIGATOR: Are you appropriately trained and well suited to carry out
this work? Is the work proposed appropriate to your experience level as the
principal investigator and to that of other researchers (if any)?
(5) ENVIRONMENT: Does the scientific environment in which your work will be
done contribute to the probability of success? Do the proposed experiments
take advantage of unique features of the scientific environment or employ
useful collaborative arrangements? Is there evidence of institutional
support?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your
application will also be reviewed with respect to the following:
PROTECTIONS: The adequacy of the proposed protection for humans, animals, or
the environment, to the extent they may be adversely affected by the project
proposed in the application.
INCLUSION: The adequacy of plans to include subjects from both genders, all
racial and ethnic groups (and subgroups), and children as appropriate for the
scientific goals of the research. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria included in the
section on Federal Citations, below).
DATA SHARING: The adequacy of the proposed plan to share data.
BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
OTHER REVIEW CRITERIA:
In addition to the above criteria, Phase II applications will be evaluated
with respect to the following:
(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 Product Development Plan that
adequately addresses the four areas described in the Research Plan, item J?
(3) Does the project carry a high degree of commercial potential, as
described in the Product Development Plan?
In addition to the above criteria, the following criterion will be applied to
revised applications:
(1) Are the responses to comments from the previous SRG review adequate? 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 Product Development Plan that
adequately addresses the four 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 Product Development 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/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.
REQUIRED FEDERAL CITATIONS
MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components
involving Phase I and II clinical trials must include provisions for
assessment of patient eligibility and status, rigorous data management,
quality assurance, and auditing procedures. In addition, it is NIH policy
that all clinical trials require data and safety monitoring, with the method
and degree of monitoring being commensurate with the risks (NIH Policy for
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12,
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of
the NIH that women and members of minority groups and their sub-populations
must be included in all NIH-supported clinical research projects unless a
clear and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of
the research. This policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43).
All investigators proposing clinical research should read the AMENDMENT "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research - Amended, October, 2001," published in the NIH Guide for Grants and
Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-
files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is
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.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2)
cited publicly and officially by a Federal agency in support of an action
that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this PA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the
application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in 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 Nos. 93.837, 93.838, 93.839, 93.866, 93.867,
93.173, 93.286, 93.287, and 93.242 and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under authorization of Sections 301
and 405 of the Public Health Service Act as amended (42 USC 241 and 284)and
administered under NIH grants policies described at
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations
42 CFR 52 and 45 CFR Parts 74 and 92.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
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