JOINT DEGENERATION: MOUSE MODELS
RELEASE DATE: August 12, 2004
PA NUMBER: PA-04-139
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. The
non-AIDS portion of this funding opportunity expires on the date indicated below.
A replacement R21 (PA-06-450) 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
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENTS OF PARTICIPATING ORGANIZATION:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
(http://www.niams.nih.gov/)
National Institute on Aging (NIA)
(http://www.nia.nih.gov/)
National Institute of Dental and Craniofacial Research (NIDCR)
(http://www.nidcr.nih.gov/)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.846, 93.866, 93.121
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanism(s) 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 announcement solicits proposals of research employing genetically
defined and genetically modified mouse models to explore the biological
mechanisms underlying non-inflammatory joint degeneration, or osteoarthritis.
Inflammatory processes are evident in late stages of osteoarthritis, and are
likely to be major contributors to the chronic pain that is the most common
symptom of the condition. However, for the purpose of this initiative,
osteoarthritis is distinguished from diseases, such as rheumatoid arthritis,
in which inflammation arising from autoimmunity is the primary cause of
tissue damage. In contrast, the root causes of joint degeneration in
osteoarthritis remain unclear. Increasing knowledge of molecular mechanisms
in cartilage and bone biology, along with advances in the genetic
manipulation of mice, have yielded new concepts and new animal models that
may be relevant to osteoarthritis in humans. This Program Announcement is
intended to accelerate the characterization of new models and the testing of
hypotheses that could lead to improved diagnosis and treatment of
osteoarthritis.
RESEARCH OBJECTIVES
Background
Osteoarthritis is the most common form of arthritis and the major cause of
activity limitation and physical disability in older people. Current
treatments for osteoarthritis are largely palliative, and many cases
eventually require replacement of the joint with a prosthesis. Joint
replacement is costly, and the finite functional life of prostheses can make
a second replacement necessary, compounding the cost and risk for associated
morbidity. Efforts to develop methods for the surgical or biological repair
of damaged articular cartilage face major obstacles, owing to the limited
intrinsic repair capacity of the tissue. Thus, much could be gained if the
root causes of joint degeneration could be identified. Risk assessment or
diagnosis at early stages of disease progression, coupled with the
development of preventive or therapeutic interventions, could reduce health
care costs and substantially improve the quality of life for older people.
The development of preventive strategies and early-stage interventions for
osteoarthritis is likely to depend upon the identification of the molecular
and cellular mechanisms that underlie progressive deterioration of joint
structure and function.
Osteoarthritis is characterized by degeneration of the articular cartilage
surfaces of a joint. Within the cartilage environment, this degeneration is
reflected in the functional decline and apoptosis of chondrocytes, and by
elevated levels of proteases known to participate in the breakdown of
extracellular matrix. The development of osteoarthritis is strongly
correlated with age. Yet there is evidence that joint degeneration is not an
inevitable consequence of aging, and that the factors influencing joint
structure and function are complex. The knee and hip are more often affected
than other joints, and one hip or knee may be more seriously affected than
the other in the same individual. Genetic factors may predispose some
individuals to develop osteoarthritis. The mechanical history of a joint,
including both normal patterns of use and traumatic injury, is likely to be a
major factor.
Recent observations suggest that it may be helpful to consider the joint as
an integrated structure of bone and cartilage. During skeletal development,
the hypertrophic chondrocytes of growth plates normally undergo apoptosis,
and cartilage is degraded and replaced by bone. In the regions that will
become the articular surfaces of joints, cartilage is retained over a
supporting region of subchondral bone. One current hypothesis is that
osteoarthritis reflects the inappropriate recurrence of the hypertrophic
pathway in articular chondrocytes. The formation of bony outgrowths, or
osteophytes, in osteoarthritic joints is consistent with this idea. If this
hypothesis is sound, it follows that osteoarthritis may arise in part from
disruption of mechanisms that establish and maintain the boundary between
articular cartilage and subchondral bone. Thus, at least some of the causes
of osteoarthritis may lie within the complex network of mechanisms that
regulate the development and growth of the skeleton early in life.
The development of powerful methods for the genetic manipulation of mice has
led to the creation of modified strains in which the consequences of specific
genetic characteristics can be assessed in the intact animal and across the
lifespan. In some instances, it has been reported that specific gene
inactivation or over-expression results in age-related joint degeneration,
with histological similarities to osteoarthritis. Several inbred mouse
strains have also been observed to develop osteoarthritis-like joint
degeneration with age. Because both genetic and environmental factors may be
precisely defined in the laboratory, these mouse models hold the potential to
reveal the genetic factors and hence the molecular pathways that influence
the degeneration of joints.
Scope
This program will support research with the potential to reveal the
biological mechanisms underlying non-inflammatory joint degeneration in mouse
models. Research supported by this initiative will identify specific genes,
proteins, and biochemical pathways that contribute to joint degeneration.
Information to be gained will include the timing and anatomical location of
events that lead to joint degeneration, the functional characterization of
proteins identified as causal factors, and the definition of pathways by
which particular gene products contribute to joint degeneration. Objectives
include: the characterization of new models; the development and testing of
hypotheses that arise from the properties of new and existing models; and the
definition of functional roles for specific molecular entities identified as
contributing to joint degeneration.
The NIDCR is interested in supporting meritorious research targeting new
animal models of osteoarthritis that have relevance to the temporomandibular
joint (TMJ). Applications describing animal models that elucidate molecular
mechanisms of TMJ degeneration and aid in the diagnosis and treatment of TMJ
Disorders are particularly encouraged. Applications addressing unique
features of the TMJ including the presence of fibrocartilage on its
articulating surfaces and the distinctive anatomy and mechanical loading of
this joint also are of interest to the NIDCR.
Suggested research topics may include, but are not limited to:
o Molecular characterization of phenotypes of mice exhibiting joint
degeneration, for example, by correlating gene expression profiles with time
of onset, rate of progression, and severity;
o Identification of downstream effectors in pathways mediating effects of
gene inactivation or transgene expression in genetically modified mice
exhibiting joint degeneration;
o Mapping of genetic loci linked to joint degeneration in inbred mouse
strains;
o Characterization of changes at the chondro-osseous junction that precede or
accompany degradation of the articular surface in mouse models; or
o Testing of models of joint degeneration by specific antagonism of
biological functions, using anti-sense, dominant-negative, or RNAi
approaches.
MECHANISMS OF SUPPORT
This PA will use the NIH R01 and Exploratory/Developmental Research
Grant (R21) award mechanisms
(http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html). As an
applicant, you will be solely responsible for planning, directing, and
executing the proposed project. Applications using the R21 mechanism may
request a project period of up to two years with a combined budget for direct
costs of up $275,000 for the two year period, excluding the facilities and
administrative (F&A) costs requested by consortium participants. For example,
the applicant may request $100,000 in the first year and $175,000 in the
second year. The request should be tailored to the needs of the project.
Normally, no more than $200,000 may be requested in any single year.
This PA uses just-in-time concepts. It also uses the modular budgeting 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 budget format. 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.
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
o Faith-based or community-based organizations
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Individuals with the skills, knowledge, and resources necessary to carry out
the proposed research are 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.
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:
William J. Sharrock, Ph.D.
Musculoskeletal Diseases Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
NIH, DHHS
One Democracy Plaza
6701 Democracy Blvd., Suite 800
Bethesda, MD 20892-4872
Telephone: (301) 594-5055
FAX: (301) 480-4543
Email: ws19h@nih.gov
Jill L. Carrington
Musculoskeletal Biology Program
Biology of Aging Program
National Institute on Aging
NIH, DHHS
7201 Wisconsin Avenue, Suite 2C231
Bethesda, MD 20892-9205
Telephone: (301) 496-6402
FAX: (301) 402-0010
Email: carringtonj@nia.nih.gov
John W. Kusiak, Ph.D.
Director
Molecular and Cellular Neurobiology Program
Division of Basic and Translational Sciences
National Institute of Dental and Craniofacial Research
Natcher, Building 45, Room 4AN-18A
Bethesda, MD 20892-6402
Telephone: 301-594-7984
FAX: 301-480-8319
Email: kusiakj@mail.nih.gov
o Direct your questions about financial or grants management matters to:
Michael G. Morse
Deputy Chief, Grants Management Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
NIH/DHHS
One Democracy Plaza
6701 Democracy Blvd., Suite 800
Bethesda, MD 20892-4872
Phone: (301)594-3506
E-mail: morsem@mail.nih.gov
Ms. Linda Whipp
Grants and contracts Management Office
National Institute on Aging
NIH, DHHS
7201 Wisconsin Avenue, Suite 2N212
Bethesda, MD 20892-9205
Telephone: (301) 496-1472
FAX: (301) 402-3672
Email: whippl@nih.gov
Mary Daley
Chief Grants Management Officer
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
Natcher, Building 45, Room 4AN-44B
Bethesda, MD 20892-6402
Telephone: 301-594-4808
FAX: 301-480-3562
Email: daleym@mail.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) 710-0267, Email: GrantsInfo@nih.gov.
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 within one of the NIH
institutes or centers who has agreed to accept assignment of the application.
The NIAMS imposes specific requirements on the submission of applications
requesting $500,000 or more per year, superseding the NIH-wide requirements
described below. The NIAMS requirements are described in detail at
http://grants.nih.gov/grants/guide/notice-files/NOT-AR-03-004.html and at
http://www.niams.nih.gov/rtac/grantapps/guidelines.htm. Briefly, applications
are considered only for the June 1/July 1 (Cycle II) and October 1/November 1
(Cycle III) receipt dates. A potential applicant must seek NIAMS acceptance
of such an application no later than March 1, for a June 1/July 1 submission,
and no later than July 1, for an October 1/November 1 submission.
Applicants requesting more than $500,000 per year from other institutes or
centers (ICs) 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 IC will accept your
application for consideration for award; and,
3) Identify, in a cover letter sent with the application, the staff member
and IC 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 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 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 an 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?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following
items will be considered 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 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 $500,000 or more 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 will be assessed.
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
REQUIRED FEDERAL CITATIONS
ANIMAL WELFARE PROTECTION: Recipients of PHS support for activities
involving live, vertebrate animals must comply with PHS Policy on Humane Care
and Use of Laboratory Animals
(http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as
mandated by the Health Research Extension Act of 1985
(http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA
Animal Welfare Regulations
(http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable.
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 and 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 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.
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.healthypeople.gov/.
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.
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