and Human Services (HHS)
EXPIRED
INTEGRATION OF HETEROGENEOUS DATA SOURCES (SBIR/STTR)
RELEASE DATE: October 14, 2004
PA NUMBER: PA-05-003 (This PA has been reissued, see PA-06-010 and PA-06-011)
(Contact change for NLM, see NOT-LM-05-006)
(see PA-03-001)
EXPIRATION DATE: October 21, 2005
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENTS OF PARTICIPATING ORGANIZATION:
National Center for Research Resources (NCRR)
(http://www.ncrr.nih.gov)
National Institute of Mental Health (NIMH)
(http://www.nimh.nih.gov)
National Cancer Institute (NCI)
(http://www.nci.nih.gov)
National Heart, Lung, and Blood Institute (NHLBI)
(http://www.nhlbi.nih.gov)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
(http://www.nibib.nih.gov)
National Library of Medicine (NLM)
(http://www.nlm.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.389, 93.242,
93.396, 93.839, 93.286 and 93.879
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 Supplementary Instructions
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 THIS PA
This PA is a reissue of PA-03-001. The purpose of this PA is to
encourage small businesses to develop innovative software for
addressing the integration of distributed cross-disciplinary data
sources into coherent knowledge bases for biomedical research.
Federating such data sources requires solving a large number of
technical, scientific, financial, social and legal issues, and new
tools are needed for aiding in almost every aspect of this problem.
Applications are expected to describe at least one biomedical research
problem that will benefit from the proposed tool or tool set, as well
as to describe how the approach will scale when applied to additional
data sources and/or to other biomedical problems. A clear description
should be provided of how the impact of these tools on biomedical
research will be measured. Finally, a reasonable mechanism for
maintenance and expansion of the software as well as integration with
existing solutions should be carefully outlined.
RESEARCH OBJECTIVES
Industry has over the past five years shown increased interest in
information technology's (IT) promise to aid in the assembling of a
corporation's knowledge that is typically distributed across
individuals and vast numbers of unconnected documents and databases
into a coherent, accessible entity known as a knowledge base. Although
much of the promise remains unfulfilled, some technologies resulting
from initial efforts appear to be moving from the research stage to
mainstream production (e.g. IBM's Discovery Link).
Like a corporation, the biomedical research community is greatly
hindered by its inability to easily access knowledge that may have
already been painstakingly acquired. Existing approaches and tools from
corporate knowledge base efforts should be employed wherever they can
to improve this situation. However, the biomedical research community
is more diverse than a typical corporation in almost every aspect, from
document and data types to philosophies of data sharing. Accordingly,
new tools and processes for knowledge integration must be developed
that facilitate cooperative approaches to solving biomedical research
problems that span a broad array of subdisciplines. These tools and
processes must be designed with openness, flexibility and extreme
scalability if they are to address the diverse needs of this community
with regard to knowledge integration, and if they are to be able to
grow and adapt with the rapidly changing developments in this field
that are expected to come.
Awards made under this PA will support software and system development
that address one or more aspects of the components necessary for
integrating knowledge across data sources that reside at multiple
laboratories and institutions and that encompass disparate data types
from multiple subdisciplines. Tools for visualization and summarization
of results from such systems may also be supported, as well as tools
for managing data security, data integrity, query efficiency, and data
ownership.
MECHANISM(S) 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_2003/NIHGPS_Part2.htm#
matching_or_cost_sharing.
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
The SBIR/STTR Omnibus Solicitation indicates the statutory guidelines
of funding support and project duration periods for SBIR and STTR Phase
I and Phase II awards. SBIR Phase I awards normally may not exceed
$100,000 total costs for a period normally not to exceed 6 months; STTR
Phase I awards normally may not exceed $100,000 total for a period of 1
year; and SBIR and STTR Phase II awards normally may not exceed
$750,000 total costs for a period normally not to exceed 2 years.
Because the duration and cost of research to develop knowledge
integration tools are likely to exceed that routinely awarded, well-
justified applications with higher budgets and longer time periods will
be considered.
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.
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/research, and financial or grants
management issues:
o Direct your questions about scientific/research issues to:
Carol A. Bean, Ph.D.
National Center for Research Resources (NCRR)
6701 Democracy Boulevard, Room 972
Bethesda, Maryland 20982
Telephone: (301) 435-0755
FAX: (301) 480-3659
Email: cabean@mail.nih.gov
Margaret Grabb, Ph.D.
National Institute of Mental Health (NIMH)
6001 Executive Blvd, Rm 7201 (MSC 9645)
Bethesda, MD 20892
Telephone: (301) 443-3563
FAX:(301) 443-1731
Email: mgrabb@mail.nih.gov
Jennifer Couch, Ph.D.
National Cancer Institute (NCI)
SBMAB, DCB
Bethesda, MD 20892
Telephone: (301) 435-5226
FAX: (301) 480-2854
Email: couchj@mail.nih.gov
Jane Ye, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Rockledge II, Room 9148
6701 Rockledge Drive, MSC 7940
Bethesda, MD 20892
Telephone: (301) 435-0513
FAX: (301) 480-1335
Email: yej@nhlbi.nih.gov
Grace C.Y. Peng, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
6707 Democracy Blvd, Suite 200, MSC 5469
Bethesda, MD 20892
Telephone: (301) 451-4778
FAX:(301) 480-4973
Email: penggr@mail.nih.gov
Dr. Hua-Chuan Sim (Contact changed, see NOT-LM-05-006)
6705 Rockledge Drive
Suite 301, MSC 7968
Bethesda, MD 20892-7968
Bethesda, MD 20817 (for courier/express service)
Telephone: (301) 496-4253
FAX: (301) 402-2952
Email: simh@mail.nih.gov
o Direct your questions about financial or grants management matters to:
Holly Atherton
Office of Grants Management National Center for Research Resources
6701 Democracy Boulevard
Bethesda, Maryland 20982
Telephone: (301) 435-0844
FAX: (301) 480-3777
Email: ha5i@nih.gov
Brian Albertini
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6134, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-0004
FAX: (301) 443-6885
Email: albertib2@mail.nih.gov
Shane Woodward
Grants Administration Branch National Cancer Institute Executive Plaza
South, Room 243
Bethesda, MD 20892-7150
Telephone: (301) 496-8649
FAX: (301) 496-8601
Email: Shane_Woodward@nih.gov
Edward (Gene) McGeehan
Grants Management
National Heart, Lung, and Blood Institute (NHLBI)
6701 Rockledge Drive, Room 7044
Bethesda, MD 20892
Telephone: (301) 435-0148
FAX: (301) 480-3659
Email: McGeehaE@nhlbi.nih.gov
Karen Shields
Office of Grants Management
National Institute of Biomedical Imaging
and Bioengineering
6707 Democracy Blvd, Suite 900
Bethesda, MD 20892-5469
Telephone: (301) 451-4791
FAX: (301) 480-4974
Email: shieldsk@mail.nih.gov
Dwight Mowery
Chief Grants Management Officer
Division of Extramural Programs
National Library of Medicine
Telephone: (301) 496-4222
FAX: (301) 402-0421
Email: moweryd@mail.nih.gov
SUBMITTING AN APPLICATION
The PHS 398 research grant application must be used for all SBIR/STTR
Phase I, Phase II and Fast-Track applications (new and revised.)
Effective October 1, 2003, applications must have a 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.dnb.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) 710-0267, Email: GrantsInfo@nih.gov.
The title and number of this PA must be typed on line 2 of the face
page of the application.
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
ALL SBIR/STTR APPLICATIONS
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).
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy
of plans to include subjects from both genders, all racial and ethnic
groups (and subgroups), and children as appropriate for the scientific
goals of the research. Plans for the recruitment and retention of
subjects will also be evaluated. (See additional information and
Inclusion Criteria in the sections on Federal Citations, below).
Human Subjects:
1. Protection of Human Subjects from Research Risks - for all studies
involving human subjects. See instructions and "Guidance for Preparing
the Human Subjects Research Section." If an exemption is claimed, is it
appropriate for the work proposed? If no exemption is claimed, are the
applicant's responses to the six required points appropriate? Are human
subjects placed at risk by the proposed study? If so, are the risks
reasonable in relation to the anticipated benefits to the subjects and
others? Are the risks reasonable in relation to the importance of the
knowledge that reasonably may be expected to be gained? Are the plans
proposed for the protection of human subjects adequate?
2. Inclusion of Women Plan - for clinical research only. Does the
applicant propose a plan for the inclusion of both genders that will
provide their appropriate representation? Does the applicant provide
appropriate justification when representation is limited or absent?
Does the applicant propose appropriate and acceptable plans for
recruitment/outreach and retention of study participants?
3. Inclusion of Minorities Plan - for clinical research only. Does the
applicant propose a plan for the inclusion of minorities that will
provide their appropriate representation? Does the applicant provide
appropriate justification when representation is limited or absent?
Does the applicant propose appropriate and acceptable plans for
recruitment/outreach and retention of study participants?
4. Inclusion of Children Plan- for all studies involving human
subjects. Does the applicant describe an acceptable plan in which the
representation of children of all ages (under the age of 21) is
scientifically appropriate and recruitment/retention is addressed
realistically? If not, does the applicant provide an appropriate
justification for their exclusion?
5. Data and Safety Monitoring Plan for clinical trials only. Does
the applicant describe a Data and Safety Monitoring Plan that defines
the general structure of the monitoring entity and mechanisms for
reporting Adverse Events to the NIH and the IRB?
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals
are to be used in the project, the required five items described under
Vertebrate Animals (section f of the Research Plan instructions) will
be assessed.
BIOHAZARDS: Is the use of materials or procedures that are potentially
hazardous to research personnel and/or the environment proposed? Is the
proposed protection adequate?
ADDITIONAL REVIEW CONSIDERATIONS: The following items may 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. 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?
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 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 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
SHARING RESEARCH DATA: 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 CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN
SUBJECTS: The NIH maintains a policy that children (i.e., individuals
under the age of 21) must be included in all human subjects research,
conducted or supported by the NIH, unless there are scientific and
ethical reasons not to include them.
All investigators proposing research involving human subjects should
read the "NIH Policy and Guidelines" on the inclusion of children as
participants in research involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject
participants for all investigators submitting NIH proposals for
research involving human subjects. You will find this policy
announcement in the NIH Guide for Grants and Contracts Announcement,
dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
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).
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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