and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
National Institute of Allergy and Infectious Diseases (NIAID), (http://www3.niaid.nih.gov/)
Title: Cooperative Research Partnerships for Influenza
Product Development (U01)
Announcement Type
New
Request For Applications (RFA) Number: RFA-AI-06-022
Catalog of Federal Domestic Assistance Number(s)
93.855, 93.856
Key Dates
Release
Date: May 11, 2006
Letters
of Intent Receipt Date(s): August 11, 2006
Application
Receipt Date(s): September12, 2006
Peer
Review Date(s): January, 2007
Council
Review Date(s): April, 2007
Earliest
Anticipated Start Date: May, 2007
Additional
Information To Be Available Date (Url Activation Date): http://www.niaid.nih.gov/ncn/budget/qa/
Expiration
Date: September 13, 2006
Due Dates for E.O. 12372
Not Applicable
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
A.
Cooperative Agreement Terms and Conditions of Award
1.
Principal Investigator Rights and Responsibilities
2.
NIH Responsibilities
3.
Arbitration Process
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
Purpose
Research supported and conducted by the National Institute
of Allergy and Infectious Diseases (NIAID), National Institutes of Health
(NIH), strives to understand, treat and ultimately prevent the myriad
infectious, immunologic, and allergic diseases that threaten millions of human
lives. The NIAID Division of Microbiology and Infectious Diseases (DMID)
supports extramural research to control and prevent diseases caused by
virtually all infectious agents. This includes basic biomedical research, such
as studies of microbial physiology and antigenic structure; immunity;
translational research, including the development of diagnostic tests,
therapeutics and vaccines; and clinical trials to evaluate experimental drugs
and vaccines.
Through this RFA, the NIAID invites research grant
applications that will lead to the development of new vaccines, adjuvants,
therapeutics, immunotherapeutics or diagnostics aimed at improving our ability
to control influenza virus infections and decreasing their impact on morbidity
and mortality. Research may include compound
screening, epitope identification, adaptation of platform technologies to
influenza applications, optimization of products, process development, early
validation and testing, preclinical evaluation, and scale-up
and production of quantities sufficient for preclinical regulatory requirements
and clinical Phase I testing or field trials.
The NIAID recognizes that the inherent nature and demands of the product development process may require funding large, complex grants with interdependent specific aims. Furthermore, some aspects of the product development process (e.g., GLP or cGMP production) are inherently not innovative. Nonetheless, technical proposals should incorporate contemporary approaches representative of the current state-of-the-art. The NIAID recognizes that product development is an iterative process and that the progress of a candidate/product through the development pathway requires ongoing evaluation to assess the likelihood of meeting the stated objectives, milestones or timelines. The NIAID staff,will be actively involved in frequent evaluations of research progress toward the agreed upon milestones and timelines. The PI and the NIAID staff may agree to modify the milestones and timelines accordingly, or the NIAID may determine that a particular candidate/product has not demonstrated sufficient potential to merit further investment by the NIAID in the development and evaluation of that candidate/product.
Research Goals and Objectives
The objective of this RFA is to support scientifically sound, original, and innovative research that will advance the development of vaccines, adjuvants, therapeutics, immunotherapeutics, and diagnostics for influenza technologies through the product development pathway. Research is not required to result in a "final" product but must advance the development of a candidate product. Applications proposing the development of a previously identified candidate therapeutic, adjuvant, or diagnostic product that has demonstrated proof-of-concept against influenza are strongly encouraged. With many influenza vaccine candidates in advanced stages of product development, only those applicants with vaccine candidates that have demonstrated proof-of-concept against influenza are encouraged.
NOTE: While clinical development strategies may be included within an overall product development plan, this RFA will NOT support clinical trials. Applications requesting support for clinical trials will be viewed as unresponsive to this RFA and will be returned to the applicant without review. Utilization of human derived materials in pre-clinical studies in support of the evaluation of proof of concept studies and/or complying with regulatory requirements is considered responsive.
NOTE: This RFA will NOT support research on environmental or workplace detection technologies or targets. Applications requesting support for such research will be viewed as unresponsive to this RFA and will be returned to the applicant without review. Diagnostics applications must focus on the goal of detection and identification of influenza viruses in human clinical samples.
Partnerships
A key component of this initiative is the development of partnerships between researchers from different disciplines and/or with industry. Since academic organizations are often the source of new candidate products, this RFA will also support a partnership between industry and collaborator(s) as necessary from academic and non-profit research organizations. Partnerships between academic or non-profit research organizations and industry are strongly encouraged, but not required.
The Principal Investigator of the project may be affiliated with either industry or an academic organization.
Background
NIH and other agencies in the Department of Health and Human Services (DHHS) are currently supporting extramural and intramural projects to develop new products to protect the public from the health consequences resulting from seasonal influenza (interpandemic) and the threat of pandemic influenza outbreaks. A series of meetings have recently been held to identify and prioritize research activities on influenza. In 2003, the NIAID convened a Blue Ribbon Panel to address the research priorities for influenza and other Category B and C pathogens. The research agenda that resulted from this meeting is published at: http://www.niaid.nih.gov/biodefense/research/categorybandc.pdf. In 2005, A DHHS/Institute of Medicine workshop was held to identify gaps in areas of research on pandemic influenza that included a focus on the development of diagnostics, therapeutics and immunotherapeutics and vaccines. (http://www.iom.edu/?id=25218&redirect=0). In addition, the DHHS has recently issued the HHS Pandemic Influenza Plan that outlines a strategic plan for preparing for and responding to the threat of pandemic influenza (http://www.hhs.gov/pandemicflu/plan/). This plan contains an appendix that outlines high priority research needs, including an emphasis on the development of new products to control pandemic influenza (http://www.hhs.gov/pandemicflu/plan/appendixg.html).
Research aimed at developing tools to control epidemic influenza and the increasing threat of pandemic influenza is one of NIAID's highest priorities (http://grants1.nih.gov/grants/guide/notice-files/NOT-AI-06-011.html). To meet the objectives outlined above, it is imperative that promising findings are translated rapidly into new approaches and strategies for product development. The involvement of experts from diverse disciplines (e.g., biochemists, structural biologists, protein chemists, pharmacologists, immunologists, molecular biologists, engineers and clinicians) within academia and industry in applied research and product development is needed to bring sufficient knowledge to bear on the development of well-designed candidates for vaccines, adjuvants, therapeutics, immunotherapeutics, and medical diagnostics.
Vaccines for Influenza
Vaccines are the most effective method of protecting the public against influenza. The ultimate potential of candidate vaccines should be to induce safe and protective responses in a diverse population. This RFA will only consider those applications proposing the development and testing of a vaccine that has demonstrated proof-of-concept (e.g., protection in animal models, immunogenicity). Projects in this area are limited to one or more of the following areas:
NOTE: Applications proposing projects not listed above will be viewed as unresponsive and will be returned to the applicant without review.
NOTE: Applications proposing the development and testing of a tissue culture based vaccine will be viewed as unresponsive to this RFA and will be returned to the applicant without review.
Adjuvants for Improving the Immune Response to Influenza Vaccines
The development of an enhanced immune response may require the administration or co-administration of an adjuvant or immunostimulatory compound. Adjuvants are broadly separated into two classes based upon their primary mechanism of action: vaccine delivery systems (e.g., emulsions, microparticles, iscoms, and liposomes) that target associated antigens to antigen presenting cells, and immunostimulatory adjuvants (e.g., LPS, MLP, or CpG DNA) that directly activate innate immune responses. Applications for development of novel adjuvants that could be used in conjunction with specific components of the influenza virus are encouraged. In order to advance the development of vaccine adjuvants against influenza, a high priority for this solicitation is the optimization and preclinical testing of prospective lead compounds against influenza that previously showed promise in early stages of discovery and development. Projects may include, but are not limited to, one or more of the following areas:
Therapeutics for Influenza
The need for safe and effective therapeutics against influenza viruses is a key national priority. Projects may include, but are not limited to, one or more of the following areas:
NOTE: Applications proposing the development of a therapeutic that does not focus on influenza will be viewed as unresponsive to this RFA and will be returned to the applicant without review.
Immunotherapeutics for Influenza
Applications to improve broad-spectrum and influenza-specific immune-based therapeutics are encouraged. Projects may include, but are not limited to, one or more of the following areas:
Diagnostics for Influenza
There is an urgent need for rapid, highly sensitive, specific, easy to use, and cost-effective medical diagnostics for public health laboratories, hospital-based clinical laboratories, and point-of-care use to diagnose individuals exposed to and/or infected with influenza viruses. The development of medical diagnostics that use multiplex platform technologies is of high priority and can include pathogens other than influenza but must be focused on rapidly distinguishing whether an individual is infected by influenza or a common infection with similar, generalized symptoms, as well as a determination of drug sensitivies.
Applications for influenza product development for medical diagnostics, including both technology and assay development specific for influenza viruses, are encouraged. Projects may include, but are not limited to, one or more of the following areas:
Tests for use on human samples may consider benchmarks required for FDA approval (http://www.fda.gov/cber/devices.htm).
See Section
VIII, Other Information - Required Federal Citations, for policies related
to this announcement.
Section
II. Award Information
1. Mechanism(s) of Support
This
funding opportunity will use the cooperative agreement (U01) award
mechanism.
As an applicant, you
will be solely responsible for planning, directing, and executing the proposed
project.
The NIH (U01) is a cooperative agreement award mechanism. In the
cooperative agreement mechanism, the Principal Investigator retains the primary
responsibility and dominant role for planning, directing, and executing the
proposed project, with NIH staff being substantially involved as a partner with
the Principal Investigator, as described under the Section
VI. 2. Administrative Requirements, "Cooperative Agreement Terms and
Conditions of Award".
Essential elements of the U01 include: (1) a single research project that may include consortium agreements; (2) a single Principal Investigator who will be scientifically and administratively responsible for the research project; and (3) a single applicant institution that will be legally and financially responsible for the use and disposition of funds awarded.
This RFA is a one-time solicitation. At this time, the
NIAID has not determined whether or how this solicitation will be continued
beyond the present RFA.
2. Funds Available
The NIAID intends to commit approximately $20 million dollars in FY 2007 to fund approximately 10-15 new grants in response to this RFA. An applicant may request a project period of up to five years. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NIAID provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.
The annual direct costs that can be requested are not limited but must be justified by the proposed research and will be evaluated by the review panel and program staff. Applicants may request up to a total of $300,000 in first-year costs for major equipment to ensure that research aims can be met and biohazards can be contained. Prior approval from program staff, listed below under Section VII. Agency Contact(s), must be obtained for requests for equipment that exceed this amount. Unapproved equipment requests that exceed $300,000 will not be considered for funding.
Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html.
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:
Institutions must be in compliance with U.S. laws and regulations and DHHS and NIH policies in effect at the time of grant award and during the period of performance of the research.
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
Cost
sharing is not required.
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
Not applicable.
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)
710-0267, Email: GrantsInfo@nih.gov.
Telecommunications
for the hearing impaired: TTY 301-451-5936.
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:
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
Applications
must be received on or before the receipt date described below (Section IV.3.A).
Submission times not applicable.
3.A. Receipt, Review and Anticipated Start Dates
Letters
of Intent Receipt Date(s): August 11, 2006
Application
Receipt Date(s): September12, 2006
Peer
Review Date(s): January, 2007
Council
Review Date(s): April, 2007
Earliest
Anticipated Start Date: May, 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:
Edward W. Schroder,
Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3136, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: (301) 435-8537
FAX: (301) 480-2310
E-mail: eschroder@niaid.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:
Edward W. Schroder,
Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3136, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: (301) 435-8537
FAX: (301) 480-2310
E-mail: eschroder@niaid.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 NIAID. 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
Research Plan
1. Research Focus
This program responds to the urgent public health need to develop new and promising high-priority products for influenza via an assistance relationship between NIAID and the award recipient for projects similar to grants in which NIAID acts as a partner in the research effort. Each application must propose a research and development project whose goal is to advance a countermeasure (vaccine, adjuvant, therapeutic, immunotherapeutic or diagnostic) specific for influenza through the product development process. It is not necessary to propose to complete the product development process up to the point of readiness for clinical trials within the time frame of this project. Applications that would significantly advance a specific product toward clinical or field usefulness are responsive.
NOTE: All applications for research projects focused on diagnostics should include in the Research Plan:
2. Mandatory Meetings
Requested budgets must include funds for travel by the Principal Investigator and key personnel to an annual meeting in Bethesda, Maryland, or at a relevant scientific meeting, as determined by NIAID Program staff. See Section VI.2.A.1. Award Administration Information below.
3. Major Equipment
Applicants may request up to a total of $300,000 for major equipment to ensure that research aims can be met and biohazards can be contained. Funds for equipment must be included in the first year requested budget with justification. Prior approval from program staff, listed below in Section VII. Agency Contact(s), must be obtained for requests for equipment that exceed this amount. Unapproved equipment requests that exceed $300,000 will not be considered for funding.
4. Good Laboratory Practice
When appropriate, applicants must document in the Research Plan compliance with guidelines that govern GLP, as defined by 21 CRF (58), and cGMP, as defined by 21 CRF (211), manufacturing and/or IND enabling studies that will be performed under the project award as they would be applicable to eventual product licensure in the U.S.
5. External Advisors
External advisors may be appointed by the Principal Investigator in consultation with NIAID Program Staff to assist in progress review. Names of suggested external advisors must not be included in the application; external advisors should be identified and appointed only after award.
Additional Submission Requirements (Do not count towards page limits for Research Plan)
1. Milestones and Timeline
Applicants must provide detailed project performance and timeline objectives in a section entitled Milestones and Timeline (may not exceed 5 pages). The Milestones and Timeline section should follow the Research Plan of the application and does not count towards the page limits for the Research Plan. This section must include:
2. Product Development Plan
Applicants must include a section entitled Product Development Plan in the application (may not exceed 5 pages). The Product Development Plan should follow the Milestones and Timeline section of the application and does not count towards the page limits for the Research Plan. This section must include:
3. Physical and/or Facility Security
Applicants
must address issues related to physical or facility security and biocontainment
and biosafety (http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm)
pertinent to the specific pathogens of interest in a section entitled
Biosafety and Biocontainment in the application (may not exceed 1 page).
Guidelines for Institutional Biosafety Committees are available at: http://www4.od.nih.gov/oba/IBC/IBCindexpg.htm.
The Biosafety and Biocontainment section should follow the Product Development
Plan section of the application and does not count towards the page limits for
the Research Plan
Plan for Sharing
Research Data
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.
Applicants
requesting more than $500,000 in direct costs in any year of the proposed
research must include a plan for sharing research data in their application.
The funding organization will be responsible for monitoring the data sharing
policy (http://grants.nih.gov/grants/policy/data_sharing).
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.
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
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 NIAID 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 the 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? Is this project
likely to significantly advance the development of a vaccine, adjuvant,
therapeutic, or diagnostic against the influenza virus? If the aims of the
application are achieved, are important biomedical agents or products against
the influenza virus likely to result?
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? Is the likelihood of successful project completion high
given the current state of research and development and the technical approach? Are the proposed timeline and interim
milestones appropriate, feasible and technically sound?
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 proposed research leverage multi-disciplinary involvement to accelerate
product development. Does the approach represent the best use of current or emerging technologies and appropriate collaborations to achieve the research
objectives.
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? Are there any concerns related to physical or facility security and biocontainment and biosafety?
Milestones and Product Development Plan: Are the defined objectives/milestones and future product development plans appropriate and feasible?, Is preclinical testing for safety and efficacy in animal models appropriate and feasible?
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, reviewers will 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://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.
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
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).
The
following Terms and Conditions will be incorporated into the award statement
and will be provided to the Principal Investigator as well as to the
appropriate institutional official, at the time of award.
2.A. Cooperative Agreement Terms
and Conditions of Award
The
following special terms of award are in addition to, and not in lieu of,
otherwise applicable OMB administrative guidelines, HHS grant administration
regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and
local Governments are eligible to apply), and other HHS, PHS, and NIH grant
administration policies.
The administrative
and funding instrument used for this program will be the cooperative agreement
(U01), an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial NIH programmatic
involvement with the awardees is anticipated during the performance of the
activities. Under the cooperative agreement, the NIH purpose is to support and
stimulate the recipients' activities by involvement in and otherwise working
jointly with the award recipients in a partnership role; it is not to assume
direction, prime responsibility, or a dominant role in the activities.
Consistent with this concept, the dominant role and prime responsibility
resides with the awardees for the project as a whole, although specific tasks
and activities may be shared among the awardees and the NIH as defined above.
2.A.1. Principal Investigator Rights and Responsibilities
The Principal Investigator will have the primary responsibility for: defining the research objectives, approaches and details of the projects within the guidelines of the RFA and for performing the scientific activity. Specifically, awardees have primary responsibility as described below.
The Principal Investigator retains primary responsibility for the performance of the scientific activity, and agrees to accept close assistance in coordination, cooperation and participation of NIAID staff in scientific and technical management of the project in accordance with the terms formally and mutually agreed upon prior to the award. The responsibility for the planning, direction, and execution of the proposed project will be solely that of the Principal Investigator.
Intellectual Property
The successful development of high priority products for influenza will require substantial investment and support of private sector industries and may also involve collaborations with multiple organizations, including academic and/or non-profit research institutions. It is the intent of this initiative to support the formation of the appropriate public-private partnerships that are essential to meet these urgent public health needs. NIAID recognizes that intellectual property rights are likely to play an important role in achieving the goals of this program. To this end, all awardees understand and acknowledge the following:
Awardees are expected to make new information and materials known to the research community in a timely manner through publications, web announcements, and reports to the NIAID or other mechanisms.
Select Agents
All U.S. awardees must be in compliance with the U.S. Select Agent Regulations (http://www.cdc.gov/od/sap/) and NIH Guidelines for Research Involving Recombinant DNA Molecules (http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html).
Award to a U.S. Institution: Before using NIH funds, the awardee must complete registration with CDC (or USDA, depending on the agent). No funds can be used for research involving Select Agents if the final registration certificate is denied.
Award to a Foreign Institution: Before using NIH funds for any work directly involving the Select Agents, the awardee must provide information to the NIAID that a process equivalent to that described in 42 CFR 73 for U.S. institutions is in place and will be administered on behalf of all Select Agent work sponsored by these funds. All foreign laboratories are inspected to determine if the site has minimum biosafety and biosecurity procedures in place for working with Select Agents. During inspections the awardee must be willing to address the following key elements appropriate for their institutions: safety, security, training, procedures for ensuring that only approved/appropriate individuals have access to the Select Agents. If available, the awardee will be asked to provide copies of any applicable laws, regulations and policies equivalent to 42 CFR 73.
Award to U.S. Institution with Foreign Institution Participation: Before using NIH funds for any work directly involving the Select Agent at the US institution, the awardee must complete registration with CDC (or USDA, depending on the agent). No funds can be used for research involving Select Agents if the final registration certificate is denied. Before using NIH funds for any work directly involving the Select Agents at the foreign institution, the US awardee must provide information from the foreign institution to the NIAID that a process equivalent to that described in 42 CFR 73 for US institutions is in place and will be administered on behalf of all Select Agent work sponsored by these funds. All foreign laboratories are inspected to determine if the site has minimum biosafety and biosecurity procedures in place for working with Select Agents. During inspections the awardee must be willing to address the following key elements appropriate for the foreign institution: safety, security, training, procedures for ensuring that only approved/appropriate individuals have access to the Select Agents, If available, the awardee will be asked to provide copies of any applicable laws, regulations and policies equivalent to 42 CFR 73.
Annual Progress Review Meetings
The Principal Investigator and one or two key personnel designated by the Principal Investigator of each grant awarded under this RFA shall participate, with NIAID Program staff and any external advisors (when applicable), in annual meetings to review progress and aid in program development. These annual meetings shall be held at the NIAID offices in Bethesda, Maryland, at one of the awardee institutions, at a scientific meeting, or at another site determined by NIAID Program staff. Additional meetings, which may be necessary for coordination of cooperative agreement activities, may be scheduled if necessary.
Publications
The Principal Investigator will be responsible for the timely submission of all abstracts, manuscripts and reviews (co)authored by members of the grant and supported in part or in total under this Cooperative Agreement. Manuscripts shall be submitted to the NIAID Program Officer within two weeks of acceptance for publication. Publications or oral presentations of work performed under this Cooperative Agreement will require appropriate acknowledgement of NIAID support. Timely publication of major findings is encouraged.
Data
Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.
2.A.2 NIH Responsibilities
An NIH Project Scientist will have substantial
programmatic involvement that is above and beyond the normal stewardship role
in awards, as described below.
The NIH Project Scientist will serve as a
liaison/facilitator between the awardee, pharmaceutical and biotechnology
industries, and other government agencies (e.g., FDA, USDA, CDC), and will
serve as a resource of scientific and policy information related to the goals
of the awardee's research. The NIH Project Scientist will also facilitate
coordination of project activities during the course of the project and assist
the awardee with access to other NIAID-supported resources and services,
including resources for preclinical development such as animal models,
screening facilities, standardized research reagents, and a genomics resource
center, where available.
Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
2.A.3. Arbitration Process
Any disagreements that
may arise in scientific or programmatic matters (within the scope of the award)
between award recipients and the NIH may be brought to arbitration. An
Arbitration Panel composed of three members will be convened. It will have
three members: one designated by the awardee, one NIH designee, and
a third designee with expertise in the relevant area who is chosen by the other
two. This special arbitration procedure in no way affects the awardee's right
to appeal an adverse action that is otherwise appealable in accordance with PHS
regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.
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:
Direct inquires regarding general scientific, technical, and programmatic issues
to:
Dr. David Cho
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room 5077, MSC-6604
6610 Rockledge Drive
Bethesda, MD 20892-6604
Telephone: (301) 496-5305
FAX: (301) 496-8030
E-Mail: choda@niaid.nih.gov
Direct inquires regarding general issues relating to cooperative research partnerships to:
Dr.
Michael Schaefer
Division
of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room
4066, MSC-6604
6610
Rockledge Drive
Bethesda, MD 20892-6604
Telephone:
(301) 451-3758
Fax:
(301) 402-2508
E-Mail: mschaefer@niaid.nih.gov
Direct your questions about scientific/research issues on VACCINES, THERAPEUTICS and IMMUNOTHERAPEUTICS to:
Dr. David Cho
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room 5077, MSC-6604
6610 Rockledge Drive
Bethesda, MD 20892-6604
Telephone: (301) 496-5305
FAX: (301) 496-8030
E-Mail: choda@niaid.nih.gov
Direct your questions about scientific/research issues on ADJUVANTS to:
Ms. Sonnie Kim
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room 5034, MSC-6604
6610 Rockledge Drive
Bethesda, MD 20892-6604
Telephone: (301) 496-5305
FAX: (301) 301-496-8030
E-Mail:skim@niaid.nih.gov
Direct your questions about scientific/research issues on DIAGNOSTICS to:
Dr. Karen Lacourciere
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room 5032,
MSC-6604
6610 Rockledge Drive
Bethesda, MD 20892-6604
Telephone: (301) 496-5305
FAX: (301) 496-8030
E-Mail: lacourcierek@niaid.nih.gov
2.
Peer Review Contacts:
Edward W. Schroder,
Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3136, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: (301) 435-8537
FAX: (301) 480-2310
E-mail: eschroder@niaid.nih.gov
3. Financial or Grants Management
Contacts:
Ms. Ann Devine
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2114, MSC-7614
6700-B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: (301) 402-5601
FAX: (301) 480-3780
Email: adevine@niaid.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: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in 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/ in the following citations: No. 93.855, Allergy,
Immunology and Transplantation Research and No. 93.856, Microbiology and Infectious Diseases Research,
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
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