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://www.niaid.nih.gov)
Title: Partnerships for Point of Care
(POC) Diagnostic Technologies for Nontraditional Health Care Settings (U01)
Announcement Type
New
Update: The following update relating to this announcement has been issued:
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, Review and Anticipated Start Dates
1. Letter of Intent
B.
Sending an Application to the NIH
C.
Application Processing
D. Application Assignment
4. Intergovernmental
Review
5. Funding
Restrictions
6. Other Submission
Requirements and Information
Section
V. Application Review Information
1. Criteria
2. Review and
Selection Process
A.
Additional Review Criteria
B.
Additional Review Considerations
C.
Resource Sharing Plan(s)
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. Collaborative Responsibilities
4. 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, diagnose, treat and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives. NIAID 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; applied research, including the development of diagnostic tests; and clinical trials to evaluate experimental drugs and vaccines.
Through this RFA, the NIAID invites research applications for product development activities that will lead to new or improved POC diagnostic technologies for infectious disease-causing pathogens or toxins in nontraditional health care settings. Product development for POC diagnostic technologies should encompass development of new or improved methods, tools, or devices for sample collection, processing, and detection with broad applicability to a variety of body sites and/or specimens (for example the nasopharynx, genital tract, urinary tract and whole blood), and that are operational in nontraditional health care settings. Nontraditional health care settings include the home, rural and urban community public health care clinics, and temporary health care clinics established in response to a natural or man-made disaster. Examples of research may include improved self-collection methodology, single unit swab and fluid processing, non-sterile collection devices with preservation capability, and integrated collection and processing methods for use in home-based test kits and/or for public health-based POC diagnostic testing.
Basic research to support the initial development of POC diagnostic technologies will NOT be supported. The application MUST propose the development of a previously identified candidate POC diagnostic technology and include proof-of-concept data demonstrating the feasibility of the technology.
Partnerships
The goal of the NIAID partnerships programs is to stimulate industry participation in the development of vaccines, drugs and diagnostics for human infectious diseases of public health importance. A key component of this initiative is the development of partnerships between academia and industry. For the purpose of this RFA, "industry" is defined as large and small, domestic or foreign, pharmaceutical, biotechnology, bioengineering, and chemical companies. Since academic organizations are often the source of new technologies and candidate products, this RFA will support partnerships between industry and collaborator(s) from academic and non-profit research organizations. The involvement of an academic or non-profit research organization is NOT a requirement; therefore, industry does not need a collaborator to submit an application to this program. The PD/PI of the application may be affiliated with industry, an academic organization or a non-profit research organization (if academia or the non-profit is part of a partnership with industry). See information under Section III. 1.A. Eligible Institutions below.
Industry participation is mandatory. All applications must demonstrate substantive involvement by the industry partner. For the purpose of this RFA, "substantive involvement" is defined as the commitment of any one or more of the following resources: funds; personnel; or in-kind contributions of materials and/or reagents including, but not limited to, recombinant protein production, provision of animals or assays, data management resources or regulatory support. Applications that do not demonstrate substantive industry participation will be considered non-responsive and will NOT be reviewed. It is anticipated that this program will stimulate multidisciplinary approaches to develop or improve POC diagnostic technologies for use in nontraditional health care settings, which could include microbiology, clinical infectious diseases, bioengineering, and platform technologies.
Applicants are encouraged to reach early consensus with their proposed partners regarding intellectual property and other legal matters that may arise during the project.
Background
A priority goal of NIAID-supported research is to improve health care quality and access. To that end, this RFA is an attempt to address the gap between technological advances and their application and utilization for the underserved and those who have difficulty accessing healthcare (including those affected by poverty, geographical location or a natural or man-made disaster) by providing the opportunity to advance the development of POC diagnostic technologies for infectious disease-causing pathogens and toxins in nontraditional health care settings.
Numerous infectious diseases such as sexually transmitted infections (STIs), urinary tract infections (UTIs), and respiratory infections are widely prevalent and costly. Diagnostic tools utilizing sample collection and POC diagnostic technologies, such as nasopharyngeal and vaginal swabs, as well as urine testing for men and women, may help facilitate health care delivery in nontraditional health care settings by providing expedited collection and testing of samples. These types of technologies may ultimately lead to fewer healthcare visits, faster treatment, decreased morbidity, and fewer lost days of work. To ensure maximum utility, POC diagnostic technologies must be cost efficient; combine sample collection, testing and reporting in an integrated structure (such as microelectronic or fluidic models); and operational in infrastructure-poor settings (e.g., those lacking electricity and/or clean water).
Objectives and Scope
There is a need for rapid, highly sensitive, specific, easy to use, adaptable, and cost-effective medical sampling and diagnostic tools for self and/or point-of-care use to diagnose individuals with infectious disease-causing agents or toxins in nontraditional health care settings. Based on this diagnosis, an appropriate therapeutic intervention can be implemented. Medical POC diagnostics that rapidly distinguish whether an individual is infected by a specific infectious agent and/or determine drug sensitivities are of high priority.
The objective of this RFA is to support research that will advance the development of new or improved POC diagnostic technologies for infectious disease-causing pathogens or toxins for use in nontraditional health care settings, as defined above. Infectious disease-causing pathogens or toxins that are the focus of this RFA include those causing STIs, UTIs, and respiratory infections. POC diagnostic technologies should encompass sample collection, processing, and detection. Research areas include, but are not limited to, development of new or improved self-collection methodology (e.g., utilizing nasopharyngeal swabs, vaginal swabs, urine samples, and whole blood for serological detection of particular analytes), public health-based POC diagnostic testing, and home-based test kits. Examples include single unit swab and fluid processing; non-sterile collection devices with preservation capability; and integrated collection, processing and detection methods.
Research projects funded under this RFA will be implemented in accordance with the defined project goals, interim objectives/development milestones, and the timeline for the achievement of goals and milestones. When appropriate, research projects funded under this RFA will incorporate measures that are consistent with the guidelines that govern Good Laboratory Practice (GLP as defined by 21 CFR(58)) and current Good Manufacturing Practice (cGMP as defined by 21 CFR(211)).
The NIAID recognizes that the inherent nature and demands of the product development process may require funding complex grants with interdependent specific aims. Furthermore, some aspects of the product development process (e.g., GLP or cGMP production) are inherently not innovative. Recognizing that product development is often an iterative and sequential process, and that steps early in the process may not be successful and may need to be modified or reworked, NIAID staff, through the cooperative agreement grant mechanism, will be actively involved in evaluating the milestones of awardees and determining whether continued investment in the development is warranted.
Projects for product development for POC diagnostic technologies MUST encompass and include all of the following:
And MAY encompass:
Note: While clinical development strategies may be included within an overall product development plan, and the utilization of archived or prospectively collected human samples in the early phases of development as well as in the evaluation of proposed tools in preclinical studies is considered responsive and is encouraged, this RFA will NOT support Phase I, II, and III clinical trials or field trials. Applications requesting support for clinical trials will be viewed as unresponsive to this RFA and will not be reviewed.
Note: This RFA will NOT support research on detection technologies for NIAID Category A, B and C priority pathogens. (http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/research/CatA.htm).
Note: Research to advance the development of POC diagnostic technologies can be positioned at any point in the product development pipeline, ranging from the initial transition from basic to translational research through later stages close to final product evaluation. Research leading to the improvement of an existing tool/technology/method will be responsive to this RFA.
Note: Basic research to support the initial development of POC diagnostic technologies will NOT be supported. The application MUST propose the development of a previously identified candidate POC diagnostic technology and include proof-of-concept data demonstrating the feasibility of the technology.
1. Mechanism of Support
This
funding opportunity will use the U01
cooperative agreement award mechanism(s).
The
Project Director/Principal Investigator (PD/PI) will be solely responsible for
planning, directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) 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".
This FOA is a one-time solicitation. At this time, the
NIAID has not determined whether or how this solicitation will be continued
beyond the present FOA.
2. Funds Available
The NIAID intends to commit approximately $4 million dollars in FY 2009 to fund 4-6 applications in
response to this FOA. An applicant may request a project period of up to five years and a budget for direct costs up to $500,000 dollars per year.
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.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
The
following organizations/institutions are eligible to apply:
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 as the PD/PI is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.
More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
2. Cost Sharing or Matching
This program does not require cost sharing as defined in
the current NIH
Grants Policy Statement.
3. Other-Special Eligibility Criteria
Applications must demonstrate substantive involvement
by the industry partner. For the purpose of
this RFA, "substantive involvement" is defined as the commitment of
any one or more of the following resources: funds; personnel; or in-kind
contributions of materials and/or reagents including, but not limited to,
recombinant protein production, provision of animals or assays, data management
resources or regulatory support. Applications that do not demonstrate
substantive industry participation will be considered non-responsive and will
NOT be reviewed.
Applicants are not permitted to submit a resubmission application in response to this FOA.
Renewal applications are not permitted in response to this FOA.
Applicants may submit more than one application, provided each application is scientifically distinct.
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 lines 1 and 2 of
the face page of the application form and the YES box must be checked.
Foreign Organizations (Non-domestic (non-U.S.) Entity)
NIH policies concerning grants to foreign (non-U.S.)
organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from foreign organizations must:
In addition, for applications from 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.
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a 3h for all PD/PIs. NIH requires one PD/PI be designated as the contact PD/PI for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the Contact PD/PI, et. al. The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.
All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.
Additional information is available in the PHS 398 grant application instructions.
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
Letters of Intent Receipt Date: May 30, 2008
Application Receipt Date: June 30, 2008
Peer Review Date: October 2008
Council Review Date: January 2009
Earliest Anticipated
Start Date: April 2009
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 in Section IV.3.A.
The letter of intent should be sent to:
Gregory P. Jarosik, Ph.D.
Division of Extramural Activities
National
Institute of Allergy and Infectious Diseases
Room 3134, MSC-7616
6700-B Rockledge Dr.
Bethesda, MD 20892-7616 (U.S. Postal Service or regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Phone: 301-496-0695
Fax: 301-480-2310
email: gjarosik@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:
Gregory
P. Jarosik, Ph.D.
Division of Extramural Activities
National
Institute of Allergy and Infectious Diseases
Room 3134, MSC-7616
6700-B Rockledge Dr.
Bethesda, MD 20892-7616 (U.S. Postal Service or regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Phone: 301-496-0695
Fax: 301-480-2310
email: gjarosik@niaid.nih.gov
3.C. Application
Processing
Applications
must be received on or before the application receipt date) described
above (Section IV.3.A.). If an application is
received after that date, the application may be delayed in the review process
or not reviewed. Upon receipt, applications will be evaluated for
completeness by the CSR and for responsiveness by the reviewing Institute
Incomplete and/or 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 NIH Grants
Policy Statement.
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 award if such
costs: 1) are necessary to conduct the project, and 2) 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 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 and Information
1. Research Plan
1A. Project Description
In addition to the content stipulated by PHS398, the Research Plan must include:
1B. Good Laboratory Practice/current Good Manufacturing 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).
Additional Submission Requirements (Do not count towards page limits for Research Plan)
2. 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. This section must include:
Note: Applications that do not include a Milestones and Timeline section will be considered non-responsive and will not be reviewed.
3. Product Development Plan
Applicants must include a section entitled Product Development Plan in the application (may not exceed 5 pages). The complexity and detail provided in the Product Development Plan should be commensurate with the phase(s) of the product development pathway where the proposed studies occur. The Product Development Plan should follow the Milestones and Timeline section of the application. This section must include:
Note: Applications that do not include a Product Development Plan will be considered non-responsive and will not be reviewed.
4. Mandatory Meetings
Requested budgets must include funds for travel by the PD/PI(s) and key personnel to participate in 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.
5. External Advisors
External Advisors may be appointed by the PD/PI(s) in consultation with NIAID Program Staff to assist in progress review. Names of suggested External Advisors must NOT be included in the application or in the (optional) letter of intent; External Advisors should not be recruited or contacted prior to review and award.
Awardees must agree to the Cooperative Agreement Terms and Conditions of Award in Section VI.2.A Award Administration Information .
Research Plan Page Limitations
Items 2-5 may not exceed 25 pages.
Appendix Materials
All paper PHS 398 applications submitted for May 25, 2008 and subsequent due dates must provide appendix material on CD only, and include five identical CDs in the same package with the application. Paper applications submitted for due dates prior to May 25, 2008 may voluntarily provide the appendix on five identical CDs; if submitting CDs it is not necessary to include a paper appendix. (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
Resource Sharing Plan(s)NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.
NIAID recognizes that the data and information generated through the Partnerships Program will be extremely valuable to other researchers and that the rapid sharing of these data will be essential in advancing research to facilitate the development of therapeutics, vaccines and diagnostics. Sharing of data and information with the broad scientific community relies upon the awardees making such data and information available by depositing them into publicly accessible data repositories. NIAID has established data release guidelines for other programs, including the Centers of Excellence for Influenza Research and Surveillance http://www3.niaid.nih.gov/research/resources/ceirs/ and the Microbial Sequencing Centers http://www.niaid.nih.gov/dmid/genomes/mscs/default.htm.
Genomic sequences data sets generated with Partnerships funding are required to follow the NIAID Data Release and Usage Plan (http://www.niaid.nih.gov/dmid/genomes/mscs/data_release.htm), which provides for releasing sequence data within 45 calendar days of being generated to Genbank, a publicly searchable, international database of genetic sequences provided by the NIH National Center for Biotechnology and Information.
Other genome-wide or proteome-wide data sets including, but not limited to, functional genomics, proteomics, metabolomics, glycomics data sets should be made available through a publicly accessible web site(s), such as one of the NIAID Bioinformatics Resource Center or other relevant sites as determined by the NIAID Program Officers; this must be done within 2 months of publication or within 1 year of generation, whichever comes first. Examples of genomics or proteomics data sets that should be made available to the broad scientific community include annotation and functional characterization of genes and their products, gene and protein expression data, mass spectrometry data, siRNA data, SNPs and other genetic variation data, genotype and phenotype associations.
All applicants must include a plan for sharing genomics, proteomics and other types of research data in their application. Those responding to this funding opportunity announcement must include a description of how such research data will be shared, or explain why data sharing is not possible.
The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.
Final details of the data release plan must be negotiated between NIAID and each awardee to assure that the planned data releases are consistent with the guiding principles stated above. Final approval for the data release plans will be given by NIAID prior to award. Updates to the Plan will have to be submitted to NIAID as part of the Annual Progress Report. The NIAID Program Staff will review the updated Plan for approval with modifications as needed.
It is recognized that
each scientific project may pose specific opportunities or challenges with
respect to public data release. Therefore efforts will be made to tailor
the data release guidelines to accommodate specific situations and needs as
plans are negotiated between awardees and NIAID program staff.
Section
V. Application Review Information
1. Criteria
Only
the review criteria described below will be considered in the review process.
2. Review and Selection Process
Applications that are
complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review
group convened by NIAID and in accordance with
NIH peer review procedures (http://grants1.nih.gov/grants/peer/),
using the review criteria stated below.
As part of the scientific peer review, all applications will:
The following will be considered in making funding decisions:
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 meritorious 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? Is this
project likely to significantly advance the development of a POC diagnostic
technology to detect infectious disease-causing pathogens or toxins in a
nontraditional health care setting, which may include the home, rural and urban community public health care
clinics, and temporary health care clinics established in response to a natural
or man-made disaster?
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?
For applications designating multiple PDs/PIs, is the leadership approach,
including the designated roles and responsibilities, governance, and
organizational structure, consistent with and justified by the aims of the
project and the expertise of each of the PDs/PIs? Is the likelihood of successful
project completion high given the current state of research and development and
the technical approach?
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? Many aspects of product development are not inherently innovative. 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 PD/PI(s) and
other key personnel 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 PD/PI(s) and investigative team
bring complementary and integrated expertise to the project (if applicable)?
Environment: Do(es) the scientific
environment(s) 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?
In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the priority score.
Timelines, Milestones and Product Development Plan: Are the timelines and interim milestones well-defined, appropriate, and feasible for the specific aims of the proposed research? If appropriate, are alternate strategies suggested to ensure completion of milestones? Is the Product Development Plan feasible and indicative of future development of the technology?
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 rating:
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 on Human
Subjects in the PHS 398 instructions).
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 on Human
Subjects in the PHS 398 instructions).
Care
and Use of Vertebrate Animals in Research: If
vertebrate animals are to be used in the project, the five points described in
the Vertebrate Animals section of the Research Plan 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.
Applications from Foreign
Organizations: Whether the project presents
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 will be assessed.
2.C. Resource Sharing Plan(s)
When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.
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.
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.
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 tools for POC technologies to diagnose infectious diseases 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 this critical public health need. 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 encouraged to reach early consensus with their proposed partners regarding intellectual property and other legal matters that may arise during the project. In addition, awardees are expected to exercise their Bayh-Dole rights in a manner that does not conflict with the goals of this award or the intent of the Bayh-Dole Act to promote the utilization, commercialization and availability of U.S. Government-funded inventions for public benefit. Finally, 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.
Annual Progress Review Meetings
The PD/PI(s) and one or two key personnel designated by the PD/PI(s) 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.
Publications
The PD/PI(s) 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.
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. The
assigned program director may also serve as an NIH Project Scientist.
2.A.3. Collaborative Responsibilities
The specific timelines, milestones and funding levels agreed to by the awardee and the NIAID shall be included in the terms and conditions of award. Given the nature of product development, it is recognized that timelines and interim objectives may require revision and renegotiation during the course of the project period. The PD/PI(s) and NIAID must agree to all such revisions. Release of each funding increment by NIAID will be based on a NIAID review of progress towards achieving the previously agreed upon interim objective. In order to advance the development of a POC diagnostic technology for infectious diseases for use in nontraditional health care settings, NIAID may ask awardees to collaborate or cooperate with other NIAID-funded projects and/or U.S. government agencies, for example CDC, FDA, and/or USDA.
External Advisors
External advisors may be appointed by the PD/PI(s) in consultation with NIAID Program Staff to assist in progress review. External advisors will be identified and appointed only AFTER award.
2.A.4. 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: a designee of the Steering Committee
chosen without NIH staff voting, one NIH designee, and a third designee with
expertise in the relevant area who is chosen by the other two; in the case of
individual disagreement, the first member may be chosen by the individual
awardee. 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 Non-Competing Continuation
Grant Progress Report (PHS 2590) annually and financial statements as
required in the NIH Grants Policy
Statement.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
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:
Hagit David, Ph.D.
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room 5026, MSC-6603
6610
Rockledge Drive
Bethesda, MD 20892-6603
If using FedEx or UPS, please use zip
code 20817
Phone: (301) 402-4596
Fax: (301) 480-3617
Email: hd29e@nih.gov
2. Peer Review Contacts:
Gregory P. Jarosik, Ph.D.
Division of Extramural Activities
National
Institute of Allergy and Infectious Diseases
Room 3134, MSC-7616
6700-B Rockledge Dr.
Bethesda, MD 20892-7616 (U.S. Postal Service or regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Phone: 301-496-0695
Fax: 301-480-2310
email: gjarosik@niaid.nih.gov
3. Financial or Grants Management Contacts:
Kathryn Ellis
Division of Extramural Activities
National
Institute of Allergy and Infectious Diseases
Room 2240, MSC-7614
6700-B Rockledge Drive
Bethesda, MD 20892
Phone:
(301) 451-2687
FAX: (301)
493-0597
Email: kellis@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.
Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide
association studies (GWAS) to identify common genetic factors that influence
health and disease through a centralized GWAS data repository. For the purposes
of this policy, a genome-wide association study is defined as any study of
genetic variation across the entire human genome that is designed to identify
genetic associations with observable traits (such as blood pressure or weight),
or the presence or absence of a disease or condition. All applications,
regardless of the amount requested, proposing a genome-wide association study
are expected to provide a plan for submission of GWAS data to the
NIH-designated GWAS data repository, or provide an appropriate explanation why
submission to the repository is not possible. Data repository management
(submission and access) is governed by the Policy for Sharing of Data Obtained
in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/.
Access to Research Data through the Freedom of Information
Act:
The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a project
that is supported in whole or in part with Federal funds and (2) cited publicly
and officially by a Federal agency in support of an action that has the force
and effect of law (i.e., a regulation) may be accessed through FOIA. It is
important for applicants to understand the basic scope of this amendment. NIH
has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this 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 Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final,
peer-reviewed manuscripts that arise from NIH funds and are accepted for
publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly
available no later than 12 months after publication. As of May 27, 2008,
investigators must include the PubMed Central reference number when citing an
article in NIH applications, proposals, and progress reports that fall under
the policy, and was authored or co-authored by the investigator or arose from
the investigator’s NIH award. For more information, see the Public
Access webpage at http://publicaccess.nih.gov/.
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. For publications listed in the appendix and/or
Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for 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 FOA 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
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