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
Eunice
Kennedy Shriver National Institute of Child Health
and Human Development (NICHD) (http://www.nichd.nih.gov)
National Heart
Lung and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov)
National Institute on Deafness and Other
Communication Disorders (NIDCD) (http://www.nidcd.nih.gov/)
National Institute of Diabetes
and Digestive and Kidney Diseases (NIDDK) (http://www2.niddk.nih.gov/)
National Center for Research Resources (NCRR)
(http://www.ncrr.nih.gov/)
Title: Safe
and Effective Instruments and Devices for use in the Neonatal Intensive Care
Units (SBIR [R43])
Announcement Type
New
Update: The following update relating to this announcement has been issued:
Request For Applications (RFA) Number: RFA-HD-09-017
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
IMPORTANT: A registration process in Grants.gov and eRA Commons is necessary before submission. Applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.
Catalog of Federal Domestic Assistance Number(s)
93.865,
93.838, 93.173, 93.847, 93.389
Key Dates
Release/Posted Date: May 29, 2009
Opening Date: June 30, 2009 (Earliest date an
application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): June 30, 2009
NOTE: On-time submission requires that applications be successfully
submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization).
Application Due Date(s): July
31, 2009
Peer Review Date(s): October/November
2009
Council
Review Date(s): January 2010
Earliest
Anticipated Start Date(s): April 1, 2010
Additional Information to Be Available Date (Activation
Date): Not applicable
Expiration Date: August 1, 2009
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.
Request Application Information
2.
Content and Form of Application Submission
3.
Submission Dates and Times
A. Submission,
Review, and Anticipated Start Dates
1. Letter of Intent
B. Submitting an
Application Electronically 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
3. Anticipated Announcement and Award Dates
Section VI. Award Administration Information
1.
Award Notices
2. Administrative and National Policy
Requirements
3. Reporting
Section VII. Agency Contact(s)
1.
Scientific/Research Contact(s)
2. Peer Review Contact(s)
3.
Financial/Grants Management Contact(s)
Section
VIII. Other Information - Required Federal Citations
Part
II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Purpose
This
Funding Opportunity Announcement (FOA) solicits Small Business Innovation
Research (SBIR) grant applications from small business concerns (SBCs) to
propose research to develop new devices and instruments, and/or improve existing
devices and instruments for the safe and efficacious monitoring and treatment
of newborn infants and small children.
Background
Devices and instruments developed for use in
the sick infants should be based on sound bioengineering principles. They also
need to be tested for safety, efficacy, and accuracy of functioning. Despite
major advances in biotechnology, research and development (R&D) efforts
directed at introducing new and innovative pediatric devices and instruments
(or improving the existing ones) for use in newborn infants and small children
have been limited. This may be due, in part, to infrequent collaboration
between the clinical and bioengineering scientific communities for R&D in
basic and translational efforts to develop or improve pediatric devices and
instruments.
One objective of this FOA is, therefore, to foster such collaboration between
clinical and bioengineering research communities in the field of pediatric
device development. It is anticipated that through rigorous collaborative
R&D efforts safe and effective instruments and devices can be developed for
use in newborn infants and small children.
Successful R&D in this area requires close and innovative collaboration and partnership between scientists from different specialties, especially from SBCs and clinical fields. The importance of such multi-level collaborative effort was underscored by a group of scientists in a NICHD-sponsored workshop (Pediatrics, 2005; Volume: 115; Page 468-74). The group stressed that such efforts are vital to developing new and innovative devices (or improving the existing ones) that are safe and effective in the treatment of sick infants and neonates who require routine as well as intensive care treatments.
Optimizing care for small children and infants in all clinical circumstances, including in neonatal intensive care units (NICUs), is an important component of the NICHD mission. This FOA invites SBCs to propose innovative research that can lead to development of non-invasive, or minimally invasive instruments, devices, and monitors that improve assessment, monitoring, and treatment of newborn infants and small children requiring routine as well as intensive care treatments.
Although advanced technological support
remains the backbone of NICUs, much of the equipment, instruments, and devices
used are miniaturized versions of those used for older age group patients. With
few exceptions, it is rare to find instruments and devices that have been
developed with rigorous evaluations of efficacy and safety specifically in
newborn infants and small children. This gap in R&D is particularly striking
when one considers the revolutions that are taking place in biotechnology and
bioengineering sciences and their application to medicine elsewhere. Some of
these include: genetic and proteomic-based biotechnology; microfluidics; nano
technology; laser and optical imaging; and signal processing, such as adopting
advanced mathematical computations for analyzing biological signals. Thus,
there is clearly an urgent need for R&D in improving existing devices and
instruments and introducing new devices and instruments while optimizing their
utility and safety in the neonatal intensive care setting.
The focus of this FOA is primarily targeted at introducing or improving instruments and devices for monitoring and treating sick newborn infants and small children. Many existing monitoring systems and treatment paradigms require invasive procedures. For example, indwelling intra-arterial catheters are needed for continuous measurement of systemic blood pressure and for obtaining blood samples for the analyses of blood gas and acid base status and biochemical monitoring. Intravenous catheters are threaded via a peripheral vein into the great veins near the heart for providing fluid and nutritional support. Gastric tubes are used for gavage feeding. Endotracheal (ET) tubes and nasal prongs are essential components of providing assisted ventilation and continuous positive airway pressure support, respectively.
While these devices are life saving, there are potential adverse consequences from their routine use in large cohorts of subjects. Any device that needs an invasive procedure for its introduction can cause pain and suffering at a vulnerable period in life. Long-term indwelling catheters and devices also have a potential to add to the burden of morbidity. Examples include: accidental dislodging and hemorrhage; ventilator-associated pneumonia; microbial colonization within and around the walls of indwelling catheters and tubes enhancing the risk of bacterial and fungal sepsis; thrombus formation in and around the tubes and catheters that can lead to venous obstruction or embolization to distant organs, such as the brain or extremities; and catheter migration into the heart causing perforation and cardiac tamponade. It is estimated that catheter-associated infections alone account for a huge morbidity burden, with millions of dollars added to health care costs each year.
This FOA aims to stimulate improvement in the existing devices and instruments being used in the neonatal ICU, and/or encourage the introduction of new and innovative technologies into the NICU setting. The new and improved instruments and devices developed as a result will reduce the burden of morbidity and mortality associated with such devices, as well as provides a means for the clinical community to monitor key physiological and pathological processes while treating complex disorders in newborn infants. The FOA intends to bridge the gap between the biomedical academic community and bioengineering researchers from SBCs and promote collaborative partnership. By providing set-aside funds to use researcher-initiated grants (R43), it is anticipated that a set of instruments and devices that are effective, risk-free, and marketable will be developed.
Scope
The Major topic areas for the R&D efforts to be supported under this FOA include, but are not limited to:
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
1. Mechanism(s) of Support
This
funding opportunity will use the Small Business Innovation Research (SBIR [R43]
grant mechanisms. Applications may be
submitted for support as Phase I as described in the SF424 (R&R) SBIR/STTR
Application Guide. This FOA does not support SBIR
Fast-Track, Phase II, or Phase II Competing Renewal applications.
The Project
Director/Principal Investigator (PD/PI) will be solely
responsible for planning, directing, and executing the proposed project.
This funding opportunity uses Just-in-Time
information concepts. The modular budget format is not accepted for SBIR grant
applications. Applicants must complete and submit budget requests using the
SF424 Research and Related (R&R) Budget component found in the application
package attached to this FOA in Grants.gov/Apply.
2.
Funds Available
The NICHD has set aside $900,000 total cost to support up to 4 meritorious applications; the NHLBI has set aside $450,000 total cost to support up to 2 meritorious applications; the NIDCD has set aside $225,000 total cost to support up to 1 meritorious application; the NIDDK has set aside $225,000 total cost to support up to 1 meritorious application; and the NCRR has set aside $225,000 total cost to support up to 1 meritorious application for FY 2010 under this FOA.Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. Future year amounts will depend on annual appropriations.
For this Phase I funding
opportunity, budgets up to $225,000 total costs, per year, for up to 2 years,
may be requested. Future year funding will depend upon
annual appropriations. Facilities and Administrative (F&A) 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
Only
United States small business concerns (SBCs) are eligible to submit SBIR
applications. A
small business concern is one that, at the time of award of SBIR Phase I and
Phase II, meets all of the following criteria:
1. Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor;
2. Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there can be no more than 49 percent participation by foreign business entities in the joint venture;
3. Is at least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, or it must be a for-profit business concern that is at least 51% owned and controlled by another for-profit business concern that is at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, except in the case of a joint venture, where each entity to the venture must be 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States; and;
4. Has, including its affiliates, not more than 500 employees.
SBCs must also meet the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both.
Control can be exercised through common ownership, common management, and contractual relationships. The term "affiliates" is defined in greater detail in 13 C.F.R. 121.3-2(a). The term "number of employees" is defined in 13 C.F.R. 121.3-2(t).
Business concerns include, but are not limited to, any individual (sole proprietorship), partnership, corporation, joint venture, association, or cooperative. Further information may be obtained by contacting the Small Business Administration Office of Size Standards (http://sba.gov/size).
One of the circumstances that would lead to a finding that an organization is controlling or has the power to control another organization involves sharing common office space and/or employees and/or other facilities (e.g., laboratory space). Access to special facilities or equipment in another organization is permitted (as in cases where the awardee organization has entered into a subcontractual agreement with another organization for a specific, limited portion of the research project). However, research space occupied by an SBIR awardee organization must be space that is available to and under the control of the SBIR awardee for the conduct of its portion of the proposed project.
Title 13 CFR 121.3 also states that control or the power to control exists when key employees of one concern organize a new concern ... and serve as its officers, directors, principal stockholders, and/or key employees, and one concern is furnishing or will furnish the other concern with subcontracts, financial or technical assistance, and/or other facilities, whether for a fee or otherwise. Where there is indication of sharing of common employees, a determination will be made on a case-by-case basis of whether such sharing constitutes control or the power to control.
For purposes of the SBIR program, personnel obtained through a Professional Employer Organization or other similar personnel leasing company may be considered employees of the awardee. This is consistent with SBA’s size regulations, 13 CFR 121.106 Small Business Size Regulations.
Note regarding affiliation arising under stock options, convertible securities, and agreements to merge: In determining size, SBA considers stock options, convertible securities, and agreements to merge (including agreements in principle) to have a present effect on the power to control a concern. SBA treats such options, convertible securities, and agreements as though the rights granted have been exercised. See http://edocket.access.gpo.gov/cfr_2005/janqtr/pdf/13cfr121.103.pdf.
All SBIR grant applications will be examined with the above eligibility considerations in mind. If it appears that an applicant organization does not meet the eligibility requirements, NIH will request a size determination by the SBA. If eligibility is unclear, NIH will not make an SBIR award until the SBA provides a determination.
Note: An applicant organization that has been determined previously by SBA to be other than small for a size standard of not more than 500 employees or for purposes of the SBIR/STTR program, must be recertified by the SBA prior to any future SBIR/STTR awards.
1.B. Eligible Individuals
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization 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.
More than one PD/PI (i.e., 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 and 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 electronic Research Administration (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 grant 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. 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.
As defined in 42 CFR 52, the PD/PI is the single individual designated by the grantee in the grant application who is responsible for the scientific and technical direction of the project. When the proposed PD/PI clearly does not have sufficient qualifications to assume this role, the application is not likely to receive a favorable evaluation.
Under the SBIR program, for both Phase I and Phase II, the primary employment of the PD/PI must be with the small business concern at the time of award and during the conduct of the proposed project. For projects with multiple PD/PIs, at least one must meet the primary employment requirement. That individual will serve as the Contact PD/PI. Primary employment means that more than one half of the PD/PI’s time is spent in the employ of the small business concern. Primary employment with a small business concern precludes full-time employment at another organization. Occasionally, deviations from this requirement may occur. Such deviations must be approved in writing by the grants management officer after consultation with the NIH SBIR/STTR Program Coordinator.
If the application has the likelihood for funding, the awarding component will require documentation to verify the eligibility of the Contact PD/PI, if at the time of submission of the application, the Contact PD/PI is a less-than-full-time employee of the small business concern, is concurrently employed by another organization, or gives the appearance of being concurrently employed by another organization, whether for a paid or unpaid position.
If the Contact PD/PI is employed or appears to be employed by an organization other than the applicant organization in a capacity such as Research Fellow, Consultant, Adjunct Professor, Clinical Professor, Clinical Research Professor, or Associate, a letter must be provided by each employing organization confirming that, if an SBIR grant is awarded to the applicant small business concern, the Contact PD/PI is or will become a less-than-half-time employee of such organization and will remain so for the duration of the SBIR project. If the Contact PD/PI is employed by a university, such a letter must be provided by the Dean's office or equivalent; for other organizations, the letter must be signed by a corporate official.
All current employment and all other appointments of the Contact PD/PI must be identified in his or her Biographical Sketch required as part of the application. Be certain that correct beginning and ending dates are indicated for each employment record listed.
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
Resubmissions. Resubmissions are not permitted under this FOA.
Renewals. SBIR Phase II Competing Renewal applications are not permitted in response to this FOA.
Number of Applications. Applicants may submit more than one application, provided that each application is scientifically distinct. The NIH will accept as many "different" applications as the applicant organization chooses. However, the NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization. This includes derivative or multiple applications that propose to develop a single product, process, or service that, with non-substantive modifications, can be applied to a variety of purposes. Applicants may not simultaneously submit identical/essentially identical applications under both this SBIR funding opportunity and any other HHS FOA, including the current SBIR and STTR Parent FOAs.
Likewise, identical or essentially identical grant applications submitted by different organizations will not be accepted. Applicant organizations should ascertain and assure that the materials they are submitting on behalf of the principal investigator are the original work of the principal investigator and have not been used elsewhere in the preparation and submission of a similar grant application. Applications to the NIH are grouped by scientific discipline for review by individual Scientific Review Groups and not by disease or disease state. The reviewers can thus easily identify multiple grant applications for essentially the same project. In these cases, application processing may be delayed or the application(s) may be returned to the applicant without review.
It is unlawful to enter into contracts or grants requiring essentially equivalent work or effort. Essentially equivalent work or effort occurs when (1) substantially the same research is proposed for funding in more than one contract proposal or grant application submitted to the same Federal agency; (2) substantially the same research is submitted to two or more different Federal agencies for review and funding consideration; or (3) a specific research objective and the research design for accomplishing an objective are the same or closely related in two or more proposals or awards, regardless of the funding source. If there is any question concerning essentially equivalent work or effort, it must be disclosed to the soliciting agency or agencies before award.
Section IV. Application and Submission Information
To download a SF424 (R&R) Application
Package and SF424 (R&R) SBIR/STTR Application Guide for completing the
SF424 (R&R) forms for this FOA, use the Apply for Grant Electronically
button in this FOA or link to http://www.grants.gov/Apply/ and follow
the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.
Several additional separate actions are required before an applicant SBC can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Registered
2) Organizational/Institutional Registration in the eRA Commons
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
To affiliate the PD/PI with the applicant small business concern:
Both the PD/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Several of the steps of the registration process could take four (4) weeks or more. Therefore, applicants should immediately check with their business official to determine whether their institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request Application Information
Applicants
must download the SF424 (R&R) application forms and SF424 (R&R)
SBIR/STTR Application Guide for this FOA using the Apply for Grant
Electronically button in this FOA or through Grants.gov/Apply.
Note: Only the forms
package directly attached to a specific FOA can be used. You will not be able
to use any other SF424 (R&R) forms (e.g., sample forms, forms from another
FOA), although some of the "Attachment" files may be useable for more
than one FOA.
For
further assistance contact GrantsInfo -- Telephone 301-710-0267, Email: [email protected].
Telecommunications
for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Prepare all SBIR applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) SBIR/STTR Application Guide.
The SF424 (R&R) SBIR/STTR Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Failure to include this data field will cause the application to be rejected.
Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:
Required
Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project
Information
Research & Related Senior/Key Person
Research & Related Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
SBIR/STTR Information
Optional
Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The Contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.
Information for the Contact PD/PI should be entered in item 15 of the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.
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 (Item 14 of the PHS398 Research Plan component of the SF424 (R&R) application), 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 (NoA).
3. Submission Dates and Times
See Section
IV.3.A. for
details.
3.A.
Submission, Review, and Anticipated Start Dates
Opening Date: June 30, 2009 (Earliest date an application may be submitted to
Grants.gov)
Letters of Intent Receipt Date(s): June 30, 2009
NOTE: On-time submission requires that applications be successfully
submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization).
Application Due Date(s): July
31, 2009
Peer Review Date(s): October/November
2009
Council
Review Date(s): January 2010
Earliest
Anticipated Start Date(s): April 1, 2010
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:
Tonse N. K.
Raju, MD
Pregnancy and Perinatology Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Blvd, Room 4B03-D
Bethesda, MD 20892-MS7510
For FedEx: Rockville, MD 20852
Phone : 301-402-1872
E-mail : [email protected]
3.B.
Submitting an Application Electronically to the NIH
To
submit an application in response to this FOA, applicants should access this
FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow Steps 1-4.
Note: Applications must only be submitted electronically.
PAPER APPLICATIONS WILL NOT BE ACCEPTED.
3.C. Application Processing
Applications may be submitted on or after the opening date and must be
successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See
Section IV.3.A. for all dates.) If an
application is not submitted by the due date(s) and time, the application may
be delayed in the review process or not reviewed.
Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the application image to determine if any further action is necessary.
Upon receipt, applications will be evaluated
for completeness by the Center for Scientific Review (CSR) and responsiveness
by the NICHD. Incomplete and non-responsive
applications will not be reviewed.
There will be an acknowledgement of receipt of
applications from Grants.gov and the Commons https://commons.era.nih.gov/commons/. The
submitting AOR receives the Grants.gov acknowledgments. The AOR and the PD/PI
receive Commons acknowledgments. Information related to the assignment of an
application to a Scientific Review Group is also in the Commons.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.
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.
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.
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 renewal 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 renewal
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 the NIH Grants Policy Statement.
6. Other
Submission Requirements
If available, applications should include: a) preliminary findings from animal studies for device/product safety and accuracy; b) pilot human tests; c) use of prototype devices/products in related clinical settings to demonstrate efficacy and safety; and d) the nature and type of studies, and their feasibility that would lead to successful product/device development.
PD/PI Credential (e.g., Agency Login)
The NIH requires each PD/PI to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.
Organizational DUNS
The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
PHS398 Research Plan Component Sections
Page limitations of the PHS398 Research Plan component must be followed as outlined in the SF424 (R&R) SBIR/STTR Application Guide. While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
All application instructions outlined in the SF424 (R&R) SBIR/STTR Application Guide are to be followed, incorporating "Just-in-Time" information concepts, with the following requirements.
SBIR Phase I applications
This FOA does not support SBIR Phase II, SBIR Competing Renewals, or SBIR Fast-Track applications.
Appendix Materials
Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) SBIR/STTR Application Guide (see http://grants.nih.gov/grants/funding/424/index.htm).
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. Phase I SBIR/STTR Appendix materials are not permitted unless specifically requested by NIH.
Resource Sharing Plan(s)NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the 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 the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm).
(a) Data Sharing Plan: Not Applicable
(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 (e.g., 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 (go to NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.)
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 this FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NICHD and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.
As part of the initial merit review, all applications will:
Applications submitted in response to this FOA will compete for available funds with all other recommended SBIR applications submitted in response to this FOA. The following will be considered in making funding decisions:
Enhanced Review Criteria
The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
All Phase I SBIR Application Review Criteria
Overall Impact. Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).
Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance. Does the proposed project have commercial potential to lead to a marketable product, process or service? Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the proposed project address one or more of the major topic areas specified in this FOA for developing devices and instruments for use in newborn infants and small children? Is the proposed device/instrument non-invasive or minimally invasive? If the proposed project is successful, might it lead to one or more device development and clinical studies for demonstrating efficacy and safety, with potentials for commercialization?
Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?
Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
2.A.
Additional Review Criteria
As
applicable for the project proposed, reviewers will consider the following
additional items in the determination of scientific and technical merit, but
will not give separate scores for these items.
Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.
Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.
Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.
Resubmission Applications. Resubmissions are not permitted under this FOA.
Renewal Applications. Renewals are not permitted under this FOA.
Revision Applications. Revision applications are not permitted under this FOA.
Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
2.B.
Additional Review Considerations
As applicable
for the project proposed, reviewers will address each of the following items,
but will not give scores for these items and should not consider them in
providing an overall impact score.
Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Select Agent Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:
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 NIH 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.
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 Section IV.5., Funding
Restrictions.
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.
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 and Part II: Terms and Conditions of NIH Grant
Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees,
and Activities.
3. Reporting
NIH
requires that SBIR/STTR grantees submit
the following reports within 90 days of the end of the grant budget period unless the grantee is under an extension.
Financial Status Report (OMB 269, http://www.whitehouse.gov/omb/grants/grants_forms.html)
Final Progress Report
Final Invention Statement and Certification (HHS 568)
Annual Invention Utilization Reports
Final Cash Transaction Report (PSC 272, http://www.dpm.psc.gov/Reports.aspx)
Phase II Data Collection Requirement for Government Tech-Net Database (http://technet.sba.gov)
Failure to submit timely final reports may affect future funding to the organization or awards with the same principal investigator.
For details about each specific required report, see the section on Award Guidelines, Reporting Requirements, and Other Considerations, in the SF 424 (R&R) SBIR/STTR Application Guide.Section VII. Agency Contact(s)
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:
Tonse N. K. Raju, MD
Medical Officer, Pregnancy and Perinatology
Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Blvd, 4B03D
Bethesda, MD 20892-MS7510
For FedEx: Rockville, MD 20852
Phone: 301-402-1872
E-mail: [email protected]
Carol J. Blaisdell, M.D., F.A.A.P.
Medical Officer, Division of Lung Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Dr., 10042
Bethesda, MD 20892
Phone: 301-435-0222
Email: [email protected]
Jonathan Kaltman, M.D.
Medical Officer, Heart Development and
Structural Diseases Branch
Division of Cardiovascular Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 8222
Bethesda, MD 20892
Phone: 301-435-0528
Email: [email protected]
Roger Miller, Ph.D.
Program Director
National Institute on Deafness and Other
Communication Disorders
6120 Executive Blvd., MSC 7180
Bethesda, MD 20852-7180
Phone: 301-402-3458
Fax: 301-402-6251
Email: [email protected]
Dr. Guillermo Arreaza-Rubin
Program Director, Clinical Immunology of
Diabetes
Diabetes, Endocrinology, & Metabolic
Diseases
National Institute of Diabetes and Digestive
and Kidney Diseases
6707 Democracy Blvd. Building 2DEM, Room 6101
Bethesda, MD 20892
Phone: 301-594-4724
Fax: 301-480-3503
Email: [email protected]
Rosemarie Filart MD, MPH, MBA
Program Officer, Division for Clinical
Research Resources
National Center for Research Resources
One Democracy Plaza
6701 Democracy Boulevard, MSC 4874
Bethesda, Maryland 20892-4874
Telephone: 301-435-0178
Fax: 301-480-3661
Email: [email protected]
2. Peer Review Contacts:
Robert Stretch, PhD
Director, Division of Scientific Review
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Blvd, 5B01D
Bethesda, MD 20892-MS7510
For FedEx: Rockville, MD 20852
Phone: 301-496-1485
E-mail: [email protected]
2. Financial or Grants Management
Contacts:
Bryan S. Clark, MBA
Chief, Grants Management Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Blvd, 8A01
Bethesda, MD 20892-MS7510
For FedEx: Rockville, MD 20852
Phone: 301-435-6975
E-mail: [email protected]
Ted Williams
Grants Management Specialist
Eunice Kennedy Shriver National Institute of
Child Health and Human Development
6100 Executive Blvd, 8A07E
Bethesda, MD 20892-MS7510
For FedEx: Rockville, MD 20852
Phone - (301) 435-6996
E-mail: [email protected]
Charmaine Parsad-Rafulowitz
Grants Management Specialist, Lung Team
Office of Grants Management
National Institute of Heart, Lung, and Blood
6701 Rockledge Drive, 7th Floor, Room 7138,
MSC 7926
Bethesda, Maryland 20892-7926
Phone- 301-435-0152
Email: [email protected]
Christopher P. Myers
Grants Management Officer
National Institute on Deafness and Other
Communication Disorders
6120 Executive Blvd, MSC-7180
Phone: (301) 435-0713
Fax: 301-402-1758
Email: [email protected]
Mary K. Rosenberg
Grants Management Branch
National Institute of Diabetes and Digestive
and Kidney Diseases
6707 Democracy Boulevard, Room 722
Bethesda, MD 20892-5456
Phone: (301) 594-8891
Fax: (301) 480-3504
Email: [email protected]
Ms. Quadira Huff
Office of Grants Management
National Center for Research Resources
6701 Democracy Blvd. Bldg 1, Room 1062
MSC 4874
Bethesda, MD 20892-4874
Telephone: (301) 435-0852
Fax: (301) 480-3777
Email: [email protected]
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 (45 CFR 46) 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 institutional review board (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/
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. Beginning October 1, 2004, all investigators submitting
an NIH application or contract proposal 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.
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.
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 SF424 (R&R) application; 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.
NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators
funded by the NIH must submit or have submitted for them to the National
Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an
electronic version of their final, peer-reviewed manuscripts upon acceptance
for publication, to be made publicly available no later than 12 months after
the official date of publication. The NIH Public Access Policy is
available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). 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 (HHS) 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 HHS
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) or PubMed Central (PMC) submission identification numbers must be used
for publicly accessible on-line journal articles. Publicly accessible
on-line journal articles or PMC articles/manuscripts accepted for publication
that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference
in either the Bibliography & References Cited section, the Progress Report
Publication List section, or the Biographical Sketch section of the NIH grant
application. A URL or PMC submission identification number citation may be
repeated in each of these sections as appropriate. There is no limit to the
number of URLs or PMC submission identification numbers that can be cited.
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. 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 Part 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 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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