Department of Health and Human Services
Participating Organizations
National Institutes of
Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
National Heart, Lung, and
Blood Institute (NHLBI), (http://www.nhlbi.nih.gov)
Title: Elucidating Nature’s Solutions to Heart, Lung, and
Blood Diseases and Sleep Disorder Processes (R01)
Announcement Type
New
Update: The following update relating to this announcement has been issued:
Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government, during FY 2006 the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications electronically using Grants.gov.. For more information and an initial timeline, see http://era.nih.gov/ElectronicReceipt/. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html). Specific funding opportunity announcements will also clearly indicate if Grants.gov submission and the use of the SF424 (R&R) is required. Investigators should consult the NIH Forms and Applications Web site (http://grants.nih.gov/grants/forms.htm) for the most current information when preparing a grant application.
Program Announcement (PA) Number: PAR-06-382 Due Dates for E.O. 12372 This funding opportunity solicits studies that
elucidate the natural molecular and cellular adaptations of mammalian species
to extreme environmental conditions that would rapidly evoke life-threatening
cardiovascular or respiratory responses in other species, including humans.
Extreme environmental conditions may include food scarcity, limited access to
oxygen, or temperature extremes. The overall objective of the funding
opportunity is to identify new targets for therapeutic interventions to treat
and prevent heart, blood, and lung diseases and sleep disorders. This
initiative will not support the examination of animal models that simply mimic
the progression of human cardiovascular and respiratory diseases. Rather
support is for elucidation of mechanisms evolved in mammalian species that
survive and thrive in extreme environmental conditions. Table
of Contents Part
I Overview Information Section I. Funding Opportunity
Description 1. Research Objectives This initiative will
support studies of evolved adaptations by mammalian species to extreme
environmental conditions that evoke life-threatening cardiovascular and respiratory
responses in other species, including man. Extreme environmental conditions
may include food scarcity, limited access to oxygen, temperature extremes, high
salinity, or similarly harsh habitats. The overall objective is to identify
new targets for development of novel therapeutic interventions to treat and
prevent heart, blood, and lung diseases and sleep disorders in humans. This
initiative will not support the examination of animal models that simply mimic
the progression of human cardiovascular and respiratory diseases. Rather
support is for elucidation of mechanisms evolved in mammalian species that
survive and thrive in extreme environmental conditions. Background: Heart, lung, and blood
diseases and sleep disorders may, for example, be associated with conditions
such as hypoxia. Such conditions may contribute to or result from the disease
process. Understanding the methods evolved by some mammalian species to
overcome extreme environmental conditions, such as the limited access to oxygen,
could improve the treatment or prevention of a number of diseases and
conditions, including sleep apnea, chronic obstructive pulmonary disease,
stroke, ischemia-induced cardiac arrhythmias, out-of-hospital cardiac arrest
and traumatic injury, and reperfusion injury following acute myocardial
ischemia. Similarly, understanding the mechanism that some species have
evolved to allow them to live in high-salinity environments might be useful in
identifying novel, new ways to treat and prevent sodium-induced hypertension.
Improved understanding of the mechanisms underlying mammalian species adapted
to living in extreme environmental conditions may also lead to new strategies
for human organ preservation and improve the supply of donor organs for
patients with heart and respiratory failure. In addition, the study of diving
mammals and those that develop sub-zero body temperatures during hibernation
may lead to a better understanding of respiratory gas exchange, lung mechanics,
changes in the biochemistry of alveolar surfactants, as well as blood factors
that prevent coagulation and allow freezing of whole blood. Understanding of
diurnal and circadian rhythms in such mammalian species could also improve
prevention and treatment of some sleep disorders. For example, in seals
diving for as long as 60 minutes, the arterial oxygen tension may fall to as
low as 1.3 kPa (~10 mmHg) without indications of myocardial ischemia or
respiratory distress. Similar levels of hypoxia in humans, and most other
mammalian species, result in profound electrocardiographic alterations
associated with induction of life-threatening ventricular arrhythmias and
significant degrees of irreversible damage to the heart, lungs, and other body
organs. Thus, seals and other diving mammals have evolved defenses against
hypoxic insult. Elucidation of the molecular and cellular mechanisms involved
may provide therapeutic targets for humans that experience severe hypoxia. In addition, hibernating
mammals, such as Arctic ground squirrels, have evolved strategies that permit
them to survive extremely low temperatures without food and water. Such
mammalian species survive reductions in body temperature to below zero degrees
Celsius for several weeks, yet spontaneously arouse and recover normal body temperature
and physical activity without ill effects. The ability to mimic the
biochemical processes that permit such behavior could provide new ways to
effectively treat stroke and acute myocardial ischemia caused by a blocked
blood vessel, as well as other heart, lung, blood, and sleep diseases and
disorders. For example, studies in hibernating and non-hibernating ground
squirrels show that neurologic function in hibernating squirrels is less
sensitive to hypoxia and glucose deprivation even at normal temperatures. The
mechanisms responsible for this difference in response to hypoxic conditions as
occur in ischemia are unknown. Recent experiments also
show that mice that do not normally hibernate can be induced to hibernate and
resume normal activity upon recovery. This finding suggests that the
biochemical pathways involved in mammalian species that normally hibernate
might be translated to other non-hibernating species, including humans.
Studies such as this represent the initial steps required to benefit people
suffering from cardiovascular, respiratory, blood, and sleep diseases and
disorders. Elucidating the naturally evolved defense mechanisms used by
mammals to overcome extreme environmental stresses may allow the identification
of new effector targets in humans. Therapies and prevention strategies based
on these novel targets would likely improve morbidity and mortality in patients
with ischemia, arrhythmia development, lung dysfunction, and blood stagnation. Research Scope: Examples of research
activities that could be supported by this program include, but are not limited
to: See Section
VIII, Other Information - Required Federal Citations, for policies related
to this announcement. 1. Mechanism(s) of Support 1. Eligible Applicants 1.B. Eligible Individuals 2. Cost Sharing or Matching 1. Address to Request Application Information Proposed research should provide special opportunities for furthering
research programs through the use of unusual talent, resources, populations, or
environmental conditions in other countries that are not readily available in
the United States or that augment existing U.S. resources. 3. Submission Dates and Times 3.A.1. Letter of Intent Although
a letter of intent is not required, is not binding, and does not enter into the
review of a subsequent application, the information that it contains allows
NHLBI staff to estimate the potential review workload and plan the review. 3.B. Sending an
Application to the NIH Applications
requesting up to $250,000 per year in direct costs must be submitted in a
modular budget format. The modular budget 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 at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Applicants must
use the currently approved version of the PHS 398. Additional information on
modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm. Specific Instructions for Applications Requesting
$500,000 (direct costs) or More per Year. Applicants requesting
$500,000 or more in direct costs for any year must carry out the following
steps: 2) Obtain agreement from the IC staff that the IC will accept your
application for consideration for award; and, 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. Plan for Sharing Research Data 1. Criteria The
goals of NIH supported research are to advance our understanding of biological
systems, to improve the control of disease, and to enhance health. In their
written critiques, reviewers will be asked to comment on each of the following
criteria in order to judge the likelihood that the proposed research will have
a substantial impact on the pursuit of these goals. Each of these criteria will
be addressed and considered in assigning the overall score, weighting them as
appropriate for each application. Note that an 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. Approach: Are the conceptual or
clinical framework, design, methods, and analyses adequately developed, well
integrated, well reasoned, and appropriate to the aims of the project? Does the
applicant acknowledge potential problem areas and consider alternative tactics? 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
Form 398 research grant application instructions will be assessed. 1. Award Notices We
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research, peer review, and financial or grants
management issues: 2. Peer Review Contacts: 3. Financial or Grants Management Contacts: Section
VIII. Other Information Required Federal Citations
Catalog of Federal Domestic Assistance Number(s)
93.837, 93.838, 93.839,
93.233
Key Dates
Release Date: May 1, 2006
Letter of Intent Receipt
Date(s): August
21, 2006, August 21, 2007, and August 21, 2008; December 19, 2007, December 19,
2008, and December 21, 2009; April 16, 2007, April 16, 2008, and April 16, 2009
Application
Receipt or Submission Date(s): September 19, 2006, September 19, 2007, and September 19, 2008; January 16, 2007, January 16, 2008, and January 16, 2009; May 15,
2007, May 15, 2008, and May 15, 2009
Peer
Review Date(s): Standard
dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm for details
Council
Review Date(s): Standard
dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm for details
Earliest
Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm for details
Additional
Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date for R01 Non-AIDS Applications: November 2, 2006
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007
Not
applicable
Additional Overview
Content
Executive Summary
Part
II Full Text of Announcement
Section
I. Funding Opportunity Description
1. Research Objectives
Section
II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section
III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section
IV. Application and Submission Information
1. Address to Request Application
Information
2. Content and Form of Application
Submission
3. Submission Dates and Times
A. Receipt and Review and
Anticipated Start Dates
1. Letter of
Intent
B. Sending an Application to
the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section
V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review
Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award
Dates
Section
VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy
Requirements
3. Reporting
Section
VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section
VIII. Other Information - Required Federal Citations
Part II
- Full Text of Announcement
Section
II. Award Information
This funding opportunity
will use the R01 award mechanism(s).
As an applicant, you
will be solely responsible for planning, directing, and executing the proposed
project.
This funding opportunity
uses just-in-time concepts. It also uses modular and non-modular budget formats
(see the Modular Applications and Awards section of the NIH Grants Policy Statement: http://grants.nih.gov/grants/policy/policy.htm#gps).
Specifically, if you are submitting an application with direct costs in each
year of $250,000 or less (excluding consortium F&A costs), use the Modular
Budget Component provided in the SF424 (R&R) Application Package and
Instructions Guide (See specifically the Modular Budget Component). Otherwise,
follow the instructions for non-modular research grant applications.
2. Funds Available
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 NHLBI provide support for this program, awards
pursuant to this funding opportunity are contingent upon the availability of
funds and the receipt of a sufficient number of meritorious applications.
Facilities and
administrative costs requested by consortium participants are not included in
the direct cost limitation, see NOT-OD-05-004.
Section
III. Eligibility Information
1.A. Eligible Institutions
You may submit (an)
application(s) if your organization has any of the following characteristics:
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 support.
This program
does not require cost sharing as defined the current NIH
Grants Policy Statement.
3. Other-Special Eligibility Criteria
Applicants may
submit more than one application, provided they are scientifically distinct.
Section
IV. Application and Submission Information
The PHS 398 application
instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.
Telecommunications for
the hearing impaired: TTY 301-451-0088.
2. Content and Form of Application Submission
Applications must be
prepared using the most current PHS 398 research grant application instructions
and forms. 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 D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/.
The D&B number should be entered on line 11 of the face page of the PHS 398
form.
The title and number of this funding opportunity must
be typed on line 2 of the face page of the application form and the YES box
must be checked.
Foreign Organizations
Several special provisions apply to applications
submitted by foreign organizations:
See Section IV.3.A for
details.
3.A. Receipt, Review and
Anticipated Start Dates
Letters of Intent
Receipt Date(s): August 21, 2006, August 21, 2007, and August 21, 2008; December 19,
2007, December 19, 2008, and December 21, 2009; April 16, 2007, April 16, 2008,
and April 16, 2009
Application Receipt
Date(s): September
19, 2006, September 19, 2007, and September 19, 2008; January 16, 2007, January
16, 2008, and January 16, 2009; May 15, 2007, May 15, 2008, and May 15, 2009
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm for details
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm for details
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm for details
Prospective applicants
are asked to submit a letter of intent that includes the following information:
The letter of intent is to be sent by the date listed
at the beginning of this document.
The letter of intent
should be sent to:
David Lathrop, Ph.D.
Division
of Heart and Vascular Disease, NHLBI
National
Institutes of Health
6701
Rockledge Drive
Room
9192, MSC 7940
Bethesda, MD 20892-7934
Telephone:
(301) 435-0504
FAX:
(301) 480-1335
Email: LathropD@nhlbi.nih.gov
Applications must be
prepared using the research grant application forms found in the PHS 398
instructions for preparing a research grant application. 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 (U.S. Postal Service Express
or regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Personal deliveries of
applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
3.C.
Application Processing
Applications must be received on or before the application
receipt/submission date(s) described above (Section
IV.3.A.). If an application is received after that date, it will be
returned to the applicant without review .
Upon receipt
applications will be evaluated for completeness by CSR. Incomplete applications
will not be reviewed.
The NIH will not accept
any application in response to this funding opportunity that is essentially the
same as one currently pending initial merit review unless the applicant
withdraws the pending application. The NIH will not accept any application that
is essentially the same as one already reviewed. This does not preclude the
submission of a substantial revision of an application already reviewed, but
such application must include an Introduction addressing the previous critique.
Information on the status of an
application should be checked by the Principal Investigator in the eRA Commons
at: https://commons.era.nih.gov/commons/.
4. Intergovernmental Review
This initiative is not
subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement. The Grants Policy Statement can
be found at http://grants.nih.gov/grants/policy/policy.htm.
Pre-Award Costs are
allowable. A grantee may, at its own risk and without NIH prior approval, incur
obligations and expenditures to cover costs up to 90 days before the beginning
date of the initial budget period of a new or competing continuation award if
such costs: are necessary to conduct the project, and would be allowable under
the grant, if awarded, without NIH prior approval. If specific expenditures
would otherwise require prior approval, the grantee must obtain NIH approval
before incurring the cost. NIH prior approval is required for any costs to be
incurred more than 90 days before the beginning date of the initial budget
period of a new or competing continuation award.
The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. NIH expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.
See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements
Specific
Instructions for Modular Grant applications.
1) Contact the IC
program staff at least 6 weeks before submitting the application, i.e., as you
are developing plans for the study;
3) Include a cover letter with the application that
identifies the staff member and IC who agreed to accept assignment of the
application.
The precise content of the data-sharing plan will vary,
depending on the data being collected and how the investigator is planning to
share the data. Applicants who are planning to share data may wish to describe
briefly the expected schedule for data sharing, the format of the final
dataset, the documentation to be provided, whether or not any analytic tools
also will be provided, whether or not a data-sharing agreement will be required
and, if so, a brief description of such an agreement (including the criteria
for deciding who can receive the data and whether or not any conditions will be
placed on their use), and the mode of data sharing (e.g., under their own
auspices by mailing a disk or posting data on their institutional or personal
website, through a data archive or enclave). Investigators choosing to share
under their own auspices may wish to enter into a data-sharing agreement.
References to data sharing may also be appropriate in other sections of the
application.
All applicants must
include a plan for sharing research data in their application. The data sharing
policy is available at http://grants.nih.gov/grants/policy/data_sharing.
All investigators responding to this funding opportunity should include a
description of how final research data will be shared, or explain why data
sharing is not possible.
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 the priority score.
Sharing Research Resources
NIH policy requires that
grant awardee recipients make unique research resources readily available for
research purposes to qualified individuals within the scientific community
after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan for
sharing research resources addressing how unique research resources will be
shared or explain why sharing is not possible.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm).
See Section
VI.3. Reporting.
Section
V. Application Review Information
Only the review criteria
described below will be considered in the review process.
2. Review and Selection Process
Applications submitted
for this funding opportunity will be assigned to the ICs on the basis of
established PHS referral guidelines.
Appropriate scientific review groups convened by CSR 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:
The following will
be considered in making funding decisions:
Significance: Does this study address an
important problem? If the aims of the application are achieved, how will
scientific knowledge or clinical practice be advanced? What will be the effect
of these studies on the concepts, methods, technologies, treatments, services,
or preventative interventions that drive this field?
Innovation: Is the project original and
innovative? For example: Does the project challenge existing paradigms or
clinical practice; address an innovative hypothesis or critical barrier to
progress in the field? Does the project develop or employ novel concepts,
approaches, methodologies, tools, or technologies for this area?
Investigators: Are the investigators
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? Does the investigative team bring complementary and
integrated expertise to the project (if applicable)?
Environment: Does the scientific
environment in which the work will be done contribute to the probability of
success? Do the proposed studies benefit from unique features of the scientific
environment, or subject populations, or employ useful collaborative
arrangements? Is there evidence of institutional support?
2.A. Additional Review
Criteria:
In addition to the above
criteria, the following items will continue to 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 the Research Plan, Section E on
Human Subjects in the PHS Form 398).
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 the Research Plan, Section E on Human Subjects in
the PHS Form 398).
Biohazards: If materials or procedures
are proposed that are potentially hazardous to research personnel and/or the
environment, determine if the proposed protection is adequate.
2.B. Additional Review
Considerations
Budget: The reasonableness of the
proposed budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the
budget.
2.C. Sharing Research Data
Data Sharing Plan: 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 the priority score.
The presence of a data sharing plan will be part of the terms and conditions of
the award. The funding organization will be responsible for monitoring the data
sharing policy.
2.D. Sharing Research
Resources
NIH policy requires that
grant awardee recipients make unique research resources readily available for
research purposes to qualified individuals within the scientific community
after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://ott.od.nih.gov/policy/rt_guide_final.html). Investigators responding to
this funding opportunity should include a sharing research resources plan
addressing how unique research resources will be shared or explain why sharing
is not possible.
Program staff will be
responsible for the administrative review of the plan for sharing research
resources.
The adequacy of the
resources sharing plan will be considered by Program staff of the funding
organization when making recommendations about funding applications. Program
staff may negotiate modifications of the data and resource sharing plans with
the awardee before recommending funding of an application. The final version of
the data and resource sharing plans negotiated by both will become a condition
of the award of the grant. The effectiveness of the resource sharing will be evaluated
as part of the administrative review of each non-competing Grant Progress
Report (PHS 2590). See Section
VI.3. Reporting.
3. Anticipated Announcement and Award Dates
Not applicable
Section
VI. Award Administration Information
After the peer review of
the application is completed, the PD/PI will be able to access his or her
Summary Statement (written critique) via the eRA Commons.
If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant. For
details, applicants may refer to the NIH Grants Policy Statement Part II: Terms
and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
A formal notification in the form of a Notice
of Award (NoA) will be provided to the applicant organization. The NoA
signed by the grants management officer is the authorizing document. Once all
administrative and programmatic issues have been resolved, the NoA will be
generated via email notification from the awarding component to the grantee
business official (designated in item 12 on the Application Face Page). If a
grantee is not email enabled, a hard copy of the NoA will be mailed to the
business official.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the NoA
are at the recipient's risk. These costs may be reimbursed only to the extent
considered allowable pre-award costs. See Also Section
IV.5. Funding Restrictions.
2. Administrative and National
Policy Requirements
All NIH grant and
cooperative agreement awards include the NIH Grants Policy Statement as part of
the NoA. For these terms of award, see the NIH Grants Policy Statement Part II:
Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
3. Reporting
Awardees will be
required to submit the PHS Non-Competing Grant Progress Report, Form 2590
annually (http://grants.nih.gov/grants/funding/2590/2590.htm)
and financial statements as required in the NIH Grants Policy Statement.
1. Scientific/Research Contacts:
David Lathrop, Ph.D.
Division
of Heart and Vascular Disease, NHLBI
National
Institutes of Health
6701
Rockledge Drive
Room
9192, MSC 7940
Bethesda, MD 20892-7934
Telephone:
(301) 435-0504
FAX:
(301) 480-1335
Email: LathropD@nhlbi.nih.gov
Not applicable
David Reiter
Grants
Operations Branch
National
Heart, Lung, and Blood Institute
Rockledge
II, Room 7172
6701
Rockledge Drive
Bethesda, MD 20892
Telephone:
(301) 435-0170
FAX: (301) 480-3310
Email: reiterd@nhlbi.nih.gov
Use of Animals in
Research:
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).
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). Monitoring should
be commensurate with risk. The establishment of data and safety monitoring
boards (DSMBs) is required for multi-site clinical trials involving
interventions that entail potential risks to the participants (NIH Policy for
Data and Safety Monitoring, NIH Guide for Grants and Contracts, 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 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.
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 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 funding opportunity 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.
Sharing of Model
Organisms:
NIH is committed to
support efforts that encourage sharing of important research resources
including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.
NIH Public Access
Policy:
NIH-funded investigators
are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov/) at PubMed
Central (PMC) an electronic version of the author's final manuscript upon
acceptance for publication, resulting from research supported in whole or in
part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.
NIH is requesting that
authors submit manuscripts resulting from 1) currently funded NIH research
projects or 2) previously supported NIH research projects if they are accepted
for publication on or after May 2, 2005. The NIH Public Access Policy applies
to all research grant and career development award mechanisms, cooperative
agreements, contracts, Institutional and Individual Ruth L. Kirschstein
National Research Service Awards, as well as NIH intramural research studies.
The Policy applies to peer-reviewed, original research publications that have
been supported in whole or in part with direct costs from NIH, but it does not
apply to book chapters, editorials, reviews, or conference proceedings.
Publications resulting from non-NIH-supported research projects should not be
submitted.
For more information
about the Policy or the submission process please visit the NIH Public Access
Policy Web site at http://publicaccess.nih.gov/ and
view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).
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.
Loan Repayment Programs:
NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40 hour week) for two years to the research. For further
information, please see: http://www.lrp.nih.gov/.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
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