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: Collaborative Studies on Lung Stem Cell Biology and
Cell Based Therapy (R01)
Announcement Type
New
Request For Applications (RFA) Number: RFA-HL-07-003
Catalog of Federal Domestic Assistance Number(s)
93.838
Key Dates
Release Date: April 26, 2006
Letters of Intent
Receipt Date(s): November 10, 2006
Application Receipt Date(s): December 12, 2006
Peer Review Date(s): April or May 2007
Council Review Date(s): September 7, 2007
Earliest Anticipated
Start Date: September
28, 2007
Expiration Date: December 13,
2006
Additional
Overview Content
Executive Summary
Table of Contents
Part
I Overview Information
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 I. Funding Opportunity Description
1. Research Objectives
The objective of this
RFA is to accelerate study of cell based therapy for lung diseases. This
program will foster multidisciplinary collaborations that are required for
translational research to explore the potential efficacy and safety of using
cell based therapy for preventing and treating lung diseases. The objective of
this program is to support: applications to perform basic, translational, and
preclinical research on lung stem cell biology and cell based therapy. The
basic and preclinical research supported through this Request for Applications
(RFA) will be related to stem cell biology and cell based therapy for the
prevention and treatment of lung diseases.
In addition, initial, exploratory, and safety investigations in patients with lung disease may be supported under this announcement, when appropriate.
Nature of the research opportunity
Investigating the potential efficacy and safety of cell based therapy strategies for treating lung diseases is a high priority for the National Heart, Lung, and Blood Institute (NHLBI). Stem and progenitor cells have the potential to replace cells that are damaged or diseased, restore vital functions, and offer the promise of curing disease and ending disabilities. The potential for safe treatments, however, can only be realized if preclinical research programs provide the firm foundation and knowledge required before the potential of this new therapy can be determined. This RFA will provide an opportunity for new collaborations between stem cell biologists, and basic and clinical pulmonary investigators who will focus knowledge of basic lung stem cell biology on preclinical research on lung cell based therapy. The translation of basic knowledge of lung stem cell biology into evaluation of cell based therapy strategies in lung disease specific models should be an important part of applications submitted in response to this initiative.
Pertinent Background Information:
Recent discoveries have provided new and unprecedented opportunities for the therapeutic use of stem, progenitor, and differentiated cells for treatment of major lung diseases. Because new approaches for ameliorating/curing lung diseases are urgently needed, and because our understanding of the opportunities for cell based therapy in the lung has been limited by the complexity of lung biology, the NHLBI has released this request for Collaborative Studies on Lung Stem Cell Biology and Cell Based Therapy. The unique properties of the lung provide inherent obstacles as well as opportunities for developing successful cell based therapeutic strategies. Engraftment of reparative cells may require prior treatments or localized injury in order to create a space, or niche, for exogenously administered cells. Since the growing lung has heightened cell turnover, it may be a more amenable therapeutic target than its adult counterpart. A more complete understanding of the factors and cues that control lung cell differentiation would provide additional tools for a cell based therapeutic strategy. The multitude of cell types that comprise the intact lung also contributes to the complexity of this issue. Defining marrow sub-types that have the capacity to differentiate into particular lung cell lineages is another key issue, especially since appropriate “homing” and insertion of exogenously delivered precursor cells to specific parenchymal sites requires migration through vessel walls, basement membranes, and the extracellular space. Although the anatomical configuration of the lung suggests the possibility of direct airway delivery in conditions that are not associated with significant inflammation or alterations in barrier function, targeting and migration into specific micro-anatomical compartments remains a formidable limitation.
Information about critical elements that determine proliferation vs. differentiation is of paramount importance in devising cell based therapies for the lung and in keeping these therapies under control. Cells derived from bone marrow appear to contribute to the fibrosis seen in interstitial pulmonary fibrosis. Likewise, although a broncho-alveolar stem cell (BASC) could potentially give rise to new alveoli, thereby offering some opportunity for reversing diseases such as, bronchopulmonary dysplasia or emphysema, some of these cells have also been implicated as the putative cells of origin for adenocarcinoma of the lung.
The challenge offered by this new solicitation is to focus exploration of these and other fundamental issues towards identifying and characterizing human stem and reparative cells that could be used for treating human lung disease, as well as testing these cells in preclinical models relevant to specific lung diseases.
Objectives of this research program:
The NHLBI supports a number of studies and programs that investigate the basic biology of lung stem and reparative cells. The current need is for investment in research that can determine the potential of utilizing information on basic lung stem cell biology to advance new approaches to preventing and treating lung disease. The guiding principle of this new program is the shifting of these efforts to a central focus of research to identify and characterize reparative cells of lung therapy and investigate relevancy of a cell based approach to specific lung diseases. The translation of basic knowledge into preclinical studies and, perhaps, into clinical investigations should be the goal of applications submitted in response to this initiative.
Recent advances in the understanding of stem cell and progenitor cell biology, transplantation of autologous and allogeneic cells for the treatment of disease, the development and application of cellular imaging tools and markers, and the management of immune reconstitution after stem cell transplantation offer potential novel approaches to clinical problems in lung diseases. Investigators are encouraged to undertake multi-disciplinary approaches and to include projects with the potential to lead to early phase I clinical trials.
We anticipate that the majority of work supported under this program will be focused on cell studies and animal models. Potential cell based therapies involve a variety of cell sources, such as mesenchymal cells from bone marrow, cord blood, genetically engineered cells, and endogenous lung cells. Because any approach to cell based therapy in the lung will necessarily be disease specific, the research will require a multi-disciplinary effort and involve partnerships between basic cell researchers and clinician researchers in order to ensure that the reparative cells are relevant to the targeted lung disease. Thus, the use of high-quality translational studies using preclinical models of specific lung diseases is strongly encouraged. Preclinical testing and safety data in these systems relevant to the human lung disease in question should be included.
Because new approaches for ameliorating/curing lung diseases are urgently needed, investigators in this program may proceed with design and implementation of initial, exploratory and safety investigations in patients suffering with these lung diseases, where appropriate.
It is highly recommended that prospective applicants discuss possible applications with program staff to ensure that proposed projects are appropriate to this collaborative program. The following examples of research topics are intended to provide a perspective on the scope of research that would meet the objectives of this program. It is not required that all or any of these topics be included. Applicants are encouraged to consider other topics that are relevant to the goals of the new program in Collaborative Studies for Research in Lung Stem Cell Biology and Cell Based Therapy. A unified program of clinical and basic research is needed to address such topics as:
Projects that are outside the scope of this announcement and will be considered non-responsive are:
Program organization:
The grants funded under this RFA will be R01 research grants. Collaborative interaction is required among the participating investigators within an application, and, following initiation of the program, between investigators across the participating sites. Applicants should request $50,000 direct cost per year (to be included in the budget cap) to support collaboration and communication among participating investigators, including sharing of reagents, biomarkers, and preclinical data. The NHLBI will arrange annual or biannual meetings to encourage and facilitate exchange of information among participating investigators.
An External Advisory Committee will advise the NHLBI on progress and conduct of the program.
See Section VIII, Other Information – Required Federal Citations, for policies related to this announcement.
1. Mechanism(s) of Support
This
funding opportunity will use the R01 research grant 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 the modular as well as the non-modular
budget 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 described in the PHS
398 application instructions. Otherwise, follow the instructions for
non-modular research grant applications.
2. Funds Available
The NHLBI
intends to commit approximately $20 million in total costs ($5 million in FY
2007) to fund 6-7 new research grants. An applicant may request a project
period of up to 4 years. An individual research grant application may not
request more than $500,000 direct cost in any given year. NHLBI anticipates that
individual awards will range from $200,000 to $500,000 (Direct Costs) per year.
This is in the range of funding per award experienced in previous years. The anticipated start date for
awards is September 28, 2007.
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 IC(s) 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. Eligible Applicants
1.A. Eligible Institutions
You may submit (an)
application(s) if your organization has any of the following characteristics:
Although foreign institutions are not eligible to apply, foreign collaborators may participate in this program through subcontract(s) with domestic institutions.
1.B.
Eligible Individuals
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.
2. Cost Sharing or Matching
This program does not require
cost sharing as defined in the current NIH Policy Statement
The most current Grants Policy Statement can be found
at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing
3. Other-Special Eligibility Criteria
Applicants may submit only one
application in response to this announcement.
Applicants may have consortium arrangements with foreign institutions, but they must conform to federal/NIH policy regarding protection of human subjects, animals, biohazards, and federal/NIH biosafety and biosecurity regulations.
Section IV. Application and Submission Information
1. Address to Request Application
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.
3. Submission Dates and Times
Applications must be
received on or before the receipt date described below (Section IV.3.A).
Submission times N/A.
3.A.
Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt
Date(s): November
10, 2006
Application Receipt Date(s): December 12, 2006
Peer Review Date(s): April or May
2007
Council Review
Date(s): September
7, 2007
Earliest
Anticipated Start Date: September 28, 2007
3.A.1. Letter of Intent
Prospective applicants
are asked to submit a letter of intent that includes the following information:
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 IC staff to estimate the potential review workload and plan the review.
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:
Chief, Review Branch
Division of Extramural Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Room 7214, MSC 7924 (Express zip: 20817)
Bethesda, MD 20892-7924
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov
3.B. Sending an
Application to the NIH
Applications must be prepared
using the research grant applications found in the PHS 398 instructions for
preparing a research grant application. Submit a signed, typewritten original
of the application, including the checklist, and three 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).
At the time of
submission, two additional copies of the application and all copies of the
appendix material must be sent to:
Chief, Review Branch
Division of Extramural Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Room 7214, MSC 7924 (Express zip: 20817)
Bethesda, MD 20892-7924
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov
Using the RFA
Label: The RFA label available in the PHS 398 application instructions must be affixed
to the bottom of the face page of the application. Type the RFA number on the
label. Failure to use this label could result in delayed processing of the
application such that it may not reach the review committee in time for review.
In addition, the RFA title and number must be typed on line 2 of the face page
of the application form, and the YES box must be marked. The RFA label is also
available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.
3.C. Application
Processing
Applications must be received on or before the
application receipt 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 the CSR and
responsiveness by the (NHLBI Incomplete and non-responsive 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 review, unless the
applicant withdraws the pending application. However, when a previously
unfunded application, originally submitted as an investigator-initiated
application, is to be submitted in response to a funding opportunity, it is to
be prepared as a NEW application. That is, the application for the funding
opportunity must not include an Introduction describing the changes and
improvements made, and the text must not be marked to indicate the changes from
the previous unfunded version of the application.
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
NHLBI Proteomics Centers
(http://www.nhlbi.nih.gov/resources/medres/proteomics/index.htm).
NHLBI Somatic Cell Therapy Processing Facilities (RFP under BAA-HB-03-06) and the Somatic Cell Therapy Processing Administrative Center (RFP under NHLBI-HB-03-07) for the development of clinical, Good Manufacturing Practices (GMP) grade cell products
(http://www.nhlbi.nih.gov/funding/inits/archive/hb03-06a1.htm)
In addition, new non-invasive imaging technologies to be developed by the program for “Cellular and Molecular Imaging of the Pulmonary System” would also support activities (http://grants1.nih.gov/grants/guide/rfa-files/RFA-HL-04-003.html).
Specific
Instructions for Modular Grant applications
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.
Plan for Sharing Research
Data
All applications responsive to this RFA must include a plan for sharing research data along with a statement that the plan will be followed unless it is superseded by an NIH- or NHLBI-wide policy on sharing research data that is established prior to the date of award, in which case the NIH- or NHLBI-wide policy will be followed. The precise content of the plan may vary, depending upon the data being collected and how the data are to be shared, but elements to consider include: the expected schedule for data sharing; the format of the final dataset; the documentation to be provided; what, if any, analytical tools will be provided, whether or not a data-sharing agreement will be required and, if so, a brief outline of the likely terms of an agreement that addresses the criteria for determining who can receive the data and what, if any, conditions will be imposed 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).
For applications requesting more than $500,000 in direct costs in any year of the proposed research, the NHLBI will monitor compliance with the data sharing plan and/or the NIH or NHLBI-wide policy as appropriate.
Although the reasonableness of the plan for sharing research data will not influence the determination of scientific merit or the priority score, it may be assessed as part of the scientific review and will definitely be an important consideration in selection of applications for funding.
Sharing Research
Resources
NIH policy requires that
grant award 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.
A plan for disseminating
cells, reagents, markers, and models must be included in the application, with
appropriate timelines. A
plan for managing intellectual property issues while ensuring rapid public
dissemination of research data, models, and resources must be included.
Section
V. Application Review Information
1. Criteria
Only the review criteria
described below will be considered in the review process.
The following will be
considered in making funding decisions:
2. Review and Selection Process
Applications that are
complete and responsive to the RFA will be evaluated for scientific and
technical merit by an appropriate peer review group convened by NHLBI in
accordance with the review criteria stated below.
As part of the initial
merit review, all applications will:
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.
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?
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?
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? Does the application include strong
collaborative interactions between basic and preclinical components and a clear
plan for transfer of potential findings from basic to preclinical studies?
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).
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.
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 may 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 funding organization will be responsible for monitoring the data sharing
policy. http://grants.nih.gov/grants/policy/data_sharing.
2.D. Sharing Research
Resources
NIH policy requires that
grant award 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://www.ott.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.
A plan for
disseminating cells, reagents, markers, and models must be included in the
application, with appropriate timelines. A plan for managing intellectual
property issues while ensuring rapid public dissemination of research data,
reagents, markers, and models, must be included.
3. Anticipated Announcement and Award Dates
Not applicable.
Section VI. Award Administration Information
1. Award Notices
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.
Section
VII. Agency Contacts
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:
1. Scientific/Research Contacts:
Mary Anne Berberich,
Ph.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Suite 10018
Bethesda, MD 20892
Telephone: (301) 435-0222
FAX: (301) 480-3557
Email: berberim@nhlbi.nih.gov
Dorothy B. Gail, Ph.D.
Division
of Lung Diseases
National
Heart, Lung, and Blood Institute
6701
Rockledge Drive Suite 10018
Bethesda, MD 20892
Telephone:
(301) 435-0222
FAX:
(301) 480-3557
Email: gaild@nhlbi.nih.gov
2. Peer Review Contacts:
Chief, Review Branch
Division of Extramural Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Room 7214, MSC 7924
Bethesda , MD 20892-7924 (Express zip: 20817)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov
3. Financial or Grants Management Contacts:
Robert Pike
Grants Operations Branch
National Heart, Lung, and Blood Institute
Rockledge II, Building Number, Room Number
6701 Rockledge Drive
Bethesda, MD 20892
Telephone: (301) 435-0166
FAX: (301) 435-3059
Email: piker@nhlbi.nih.gov
Section
VIII. Other Information
Required Federal Citations
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.
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” (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: (1)
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 (2)
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 Clinical Research:
The NIH maintains a
policy that children (i.e., individuals under the age of 21) must be included
in all clinical 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 (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 applications for research involving human subjects and
individuals designated as key personnel. The policy is available 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 (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.
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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