COLLABORATIVE RESEARCH IN STEM CELL BIOLOGY
RELEASE DATE: July 22, 2004
PA NUMBER: PAS-04-130
March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date,
all R03, R21, R33 and R34 applications must be submitted through Grants.gov using
the electronic SF424 (R&R) application. This announcement will stay active for
only the May 1, 2006 AIDS and AIDS-related application submission date for these
mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms
expires on the date indicated below. Other mechanisms relating to this announcement
will continue to be accepted using paper PHS 398 applications until the stated
expiration date below, or transition to electronic application submission.
A replacement R21 (PAS-06-264) funding opportunity announcement has been issued
for the submission date of June 1, 2006 and submission dates for AIDS and
non-AIDS applications thereafter.
EXPIRATION DATE for R21 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R21 AIDS and AIDS-Related Applications: May 2, 2006
EXPIRATION DATE for All R01 Applications: November 2, 2006
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENT OF PARTICIPATING ORGANIZATION:
National Institute of Neurological Disorders and Stroke (NINDS)
(http://www.ninds.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.853 (NINDS)
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS PA
This Program Announcement with Set-Aside fosters co-operation between
investigators and joint research projects to understand how fate choices are
made by stem and precursor cells in the nervous system, and to design,
refine, and improve upon the use of stem cells for diagnostic or therapeutic
applications for neurological disorders. The National Institute of
Neurological Disorders and Stroke (NINDS) is interested in supporting
research that combines the unique and complementary expertise of laboratories
from the United States and abroad, applying different disciplines,
techniques, model systems or tissues. We anticipate that such research will
ultimately lead to innovative approaches for the prevention, management and
treatment of disorders of the nervous system, and encourage collaborations
from disparate scientific areas and disciplines, including those not
traditionally supported by the NINDS. It is essential, however, that the
proposed activities be within the mission of the NINDS.
RESEARCH OBJECTIVES
Background
Among the most important biomedical questions are how complex tissues and
organs such as the nervous system develop from small founder populations of
stem cells, how organs are maintained and sometimes regenerate during adult
life, and how age and disease affect this capacity. Central to answering all
these questions is a profound understanding of the biology and behavior of
stem cells. In regenerative medicine for example, the ultimate goal is to
replace, repair and regenerate cells, tissues and organs in order to restore
biological function that has been halted or compromised by injury or disease.
Achieving this goal may require harnessing the activities of exogenous and
endogenous stem and progenitor cells, perhaps in combination with
biomolecules and biomaterials, and integrating them into host tissue while
avoiding host rejection, tumorigenesis or other adverse events.
Cell-replacement strategies are of particular interest for diseases of the
central nervous system (CNS), because, unlike many other tissues, the mature
mammalian brain and spinal cord have a limited capacity for self-repair.
Stem cell research offers potential for treating a host of congenital,
developmental or degenerative neurological diseases for which there are no
cures or treatments. In recent studies, stem cells from many different
sources have been reported to generate cells with neuronal or glial
properties, raising expectations that they could be used to replace lost
neurons and glia, repair defective circuits, and restore neurological
function. In addition to cell and tissue therapy, the ability to selectively
produce differentiated cell types from pluripotent stem cells would be of
great clinical importance in investigating the effects of drugs and
environmental factors on cell function in the human nervous system.
There are, however, serious barriers to progress in realizing the potential
of stem cells in regenerative medicine. There are currently few markers,
antibodies or probes with which to distinguish specific classes of stem or
progenitor cells, to follow their differentiation, or to facilitate their
isolation. Similarly, there is little characterization of the niches within
the host nervous system that allow regeneration, including the cell types and
molecular cues that are responsible for tissue organization. While methods
exist to allow lineage tracing in animal models, there are no well-defined
non-invasive methods and reagents with which to study the survival,
migration, fate and function of stem cells and their progeny in the living
animal or human. This limitation makes it difficult to investigate how stem
or progenitor cells might behave differently in healthy and diseased states
in vivo. The flexibility or plasticity of stem cells, coupled with their
ability to self-renew, raises the specter of unintended side effects such as
the formation of tumors or maladaptive neural circuits. Little is currently
known about the frequency or circumstances under which these events occur, or
how they could be controlled. We also need to explore avenues to avoid host
rejection of grafted cells. Finally, coaxing cells to form functional tissue
may require physical support, such as a three dimensional scaffold, in
conjunction with chemical and mechanical signals, provided at appropriate
times and places, to establish the intricate structures that characterize
native tissue. While there is some promising work using artificial matrices,
there is a pressing need to expand this research with new types and designs
of biomaterials. Success may require an approach that combines
bioengineering, stem cell biology and expertise in extracellular matrices.
It is clear that no single investigator, laboratory or institution has the
resources to tackle these complex questions. The solution lies in developing
synergy between the various scientific disciplines and investigators with
very different expertise and resources. Great opportunities are possible as
researchers combine rapidly improving technology, expertise, tools, model
systems, resources such as transgenic animals and specific disease models,
and assessment tools.
Many of the challenges to progress in stem cell biology were first identified
by investigators at several workshops and meetings held by NINDS to review
the current state of stem cell biology and to determine critical needs. This
initiative is responsive to recommendations made by the working groups of
stem cell experts to the NIH Stem Cell Task Force, by panelists at a recent
NINDS-NIMH workshop on International Networking in Stem Cell Research:
Targeting Neural Repair and Development, and by participants of the Brain
Tumor Progress Review Group.
Objectives and Scope
Applications must demonstrate that the success of the proposed research
requires the full collaboration between two or more independent groups
contributing unique yet complementary expertise or resources. The following
examples illustrate areas of research where synergy between different
disciplines is of high interest; other innovative projects are also
encouraged. These examples of research approaches are not meant to be all-
inclusive or restrictive. Plans for data and/or reagent sharing and
promulgation of results will be integral to the applications.
o Harnessing immune mechanisms to develop tolerance and overcome rejection
for use of allogenic cells in the nervous system.
o Defining the transcriptome and proteome of different stem cells and their
microenvironment or niche within the host brain and spinal cord.
o Defining co-regulated elements, so-called hub genes in stem cell
differentiation toward neuronal or glial phenotypes.
o Evaluating chemical libraries to identify small molecules for stem cell
proliferation or neural differentiation.
o Developing cell-based tools for drug discovery, or sensors for the
detection and identification of chemical and biological agents that are
important for clinical diagnostics for neurological disorders.
o Developing non-invasive methods and agents with which to visualize or track
stem cells in vivo.
o Exploring the relationship between stem cells and brain tumors, and
identifying factors influencing tumor risk in stem cell therapies.
o Investigating the use of stem cells as vehicles to deliver targeted
therapeutics to sites in the nervous system.
MECHANISM(S) OF SUPPORT
This PAS will use the NIH Exploratory/Developmental Grant (R21) and the
Research Project Grant (R01) award mechanisms. As an applicant, you will be
solely responsible for planning, directing, and executing the proposed
project. The proposed project period during which the research will be
conducted should adequately reflect the time required to accomplish the
stated goals and should be no more than 5 years for R01 grants. The R21
grants are one-time awards to support innovative, high impact research
projects that would either 1) generate pilot data to assess the feasibility
of a novel avenue of investigation, 2) involve high risk experiments that
could lead to a breakthrough in a particular field, or 3) demonstrate the
feasibility of new technologies that could have major impact in a specific
area. Support for the R21 grants is limited to two years with a cumulative
maximum of $275,000 direct costs requested for both years. This program is
appropriate both for new investigators seeking to establish independent
research careers and for established investigators wishing to explore new
areas of neuroscience or develop novel technologies. For further information
on the R21 mechanism, including Institute-specific information, see
http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html
This PAS 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/modular/modular.htm). Specifically, if
you are submitting an application with direct costs in each year of $250,000
or less, use the modular format. Otherwise follow the instructions for non-
modular 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.
FUNDS AVAILABLE
The NINDS has set aside a total of $3 million dollars to support this
initiative. The amount and timing of awards paid from set aside funds will
depend on the overall scientific merit of the applications and the
availability of funds throughout the duration of this solicitation (3 years).
Because the nature and scope of the proposed research will vary from
application to application, it is anticipated that the size and duration of
each award will also vary. Although the financial plans of the NINDS provides
support for this program, awards pursuant to this PAS are contingent upon the
availability of funds and the receipt of a sufficient number of meritorious
applications.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution has any of the
following characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals,
and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic or foreign institutions/organizations
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
Upon initiation of the program, the NINDS will sponsor an annual meeting to
encourage the exchange of information among investigators who participate in
this program. In the preparation of the budget for the grant application,
applicants should REQUEST ADDITIONAL TRAVEL FUNDS for one meeting each year
to be held in Bethesda, Maryland. For R21 applications, the total budget,
including this request for additional travel, should stay within the two
year, $275,000 limit for this mechanism. Applicants should also include a
statement in the applications indicating their willingness to participate in
such meetings. Applicants are also strongly encouraged to include plans for
data and/or reagent sharing and promulgation of results.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this PAS 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:
Arlene Y. Chiu, Ph.D.
Program Director,
Repair and Plasticity Program
National Institute of Neurological Disorders and Stroke
Neuroscience Center, Room 2207, MSC 9525
Bethesda, MD 20892-9525
Telephone: (301) 496-1447
FAX: (301) 480-1080
Email: chiua@ninds.nih.gov
o Direct your questions about financial or grants management issues to:
Gavin Wilkom
Grants Management Specialist
Grants Management Branch, DER
National Institute of Neurological Disorders and Stroke
Neuroscience Center, 6001 Executive Blvd. Room 3250, MSC 9537
Bethesda MD, 20892
Telephone: (301) 496-7480
FAX: 301-402-0219
Email: gw62m@nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). 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 D&B number can be obtained by calling (866) 705-5711 or
through the web site at http://www.dunandbradstreet.com/. The D&B 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
in an interactive format. For further assistance contact GrantsInfo,
Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.
The title and number of this program announcement must be typed on line 2 of
the face page of the application form and the YES box must be checked.
APPLICATION RECEIPT DATES: Applications submitted in response to this program
announcement will be accepted at the standard application deadlines, which
are available at http://grants.nih.gov/grants/dates.htm. Application
deadlines are also indicated in the PHS 398 application kit.
SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS: Applications
requesting up to $250,000 per year in direct costs must be submitted in a
modular budget grant format. The modular budget grant format simplifies the
preparation of the budget in these applications by limiting the level of
budgetary detail. Applicants request direct costs in $25,000 modules.
Section C of the research grant application instructions for the PHS 398
(rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html
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.
SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR:
Applications requesting $500,000 or more in direct costs for any year must
include a cover letter identifying the NIH staff member who has agreed to
accept assignment of the application.
Applicants requesting more than $500,000 must carry out the following steps:
1) Contact the IC program staff at least 6 weeks before submitting the
application, i.e., as you are developing plans for the study;
2) Obtain agreement from the IC staff that the NINDS will accept your
application for consideration for award; and,
3) Identify, in a cover letter sent with the application, the IC staff
member who agreed to accept assignment of the application.
This policy applies to all investigator-initiated new (type 1), competing
continuation (type 2), competing supplement, or any amended or revised
version of these grant application types. Additional information on this
policy is available in the NIH Guide for Grants and Contracts, October 19,
2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
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 mailed on or 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 PAS 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 PAS 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 evaluate application in
order to judge the likelihood that the proposed research will have a
substantial impact on the pursuit of these goals. The scientific review
group will address and consider each of the following criteria in assigning
the application's overall score, weighting them as appropriate for each
application.
o Significance
o Approach
o Innovation
o Investigator
o Environment
The 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, an investigator may propose to carry out important work
that by its nature is not innovative but is essential to move a field
forward.
SIGNIFICANCE: Does this study address an important problem? If the aims of
the application are achieved, how will scientific knowledge be advanced? What
will be the effect of these studies on the concepts or methods that drive
this field?
APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics?
INNOVATION: Does the project employ novel concepts, approaches or methods?
Are the aims original and innovative? Does the project challenge existing
paradigms or develop new methodologies or technologies?
INVESTIGATOR: Is the investigator appropriately trained and well suited to
carry out this work? Is the work proposed appropriate to the experience level
of the principal investigator and other researchers (if any)?
ENVIRONMENT: Does the scientific 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? Is there evidence of institutional support?
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 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 will be assessed. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria in the sections on
Federal Citations, below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to
be used in the project, the five items described under Section f of the PHS
398 research grant application instructions (rev. 5/2001) will be assessed.
ADDITIONAL REVIEW CONSIDERATIONS
Sharing Research Data: Applicants requesting more than $500,000 in direct
costs in any year of the proposed research are expected to 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 and the requested period
of support in relation to the proposed research.
AWARD CRITERIA
Applications submitted in response to a PA will compete for available funds
with all other recommended 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
An additional consideration will be the demonstration that the proposed
research requires the full collaboration of two or more independent groups
contributing unique and non-overlapping expertise and resources.
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: Data and safety monitoring is required for
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II), efficacy,
effectiveness and comparative trials (phase III). The establishment of data
and safety monitoring boards (DSMBs) is required for multi-site clinical
trials involving interventions that entail potential risk to the
participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for
Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
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 WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of
the NIH that women and members of minority groups and their sub-populations
must be included in all NIH-supported clinical research projects unless a
clear and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of
the research. This policy results from the NIH Revitalization Act of
1993(Section 492B of Public Law 103-43).
All investigators proposing clinical research should read the "NIH Guidelines
for Inclusion of Women and Minorities as Subjects in Clinical Research -
Amended, October, 2001," published in the NIH Guide for Grants and Contracts
on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable;
and b) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy that children (i.e., individuals under the age of
21) must be included in all human subjects research, conducted or supported
by the NIH, unless there are scientific and ethical reasons not to include
them.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as participants in
research involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH proposals for research involving human
subjects. You will find this policy announcement in the NIH Guide for Grants
and Contracts Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research
on hESCs can be found at http://stemcells.nih.gov/index.asp and at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only
research using hESC lines that are registered in the NIH Human Embryonic Stem
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).
It is the responsibility of the applicant to provide, in the project
description and elsewhere in the application as appropriate, the official NIH
identifier(s for the hESC line(s)to be used in the proposed research.
Applications that do not provide this information will be returned without
review.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2)
cited publicly and officially by a Federal agency in support of an action
that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this 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 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.
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