NIAID's Spending Plan for Supplemental Zika Funding
As part of the Zika Response and Preparedness Act, 2017 (H.R. 5325), NIAID received $152 million in emergency supplemental funding. These funds will allow the Institute to continue progress made with an investment of more than $92 million in fiscal year 2016 that used repurposed Ebola funds, the HHS Secretary’s transfer of funds from other NIH institutes, and NIAID’s FY 16 appropriation.
Here's a look at how the Institute plans to use the supplemental Zika funds.
A total of $129 million will be directed to the critical development of vaccines, including the discovery and development of new and existing candidates, manufacturing activities, preclinical testing, establishing clinical trials sites in endemic regions, and conducting clinical trials to evaluate the safety, immunogenicity, and efficacy of vaccine candidates.
Currently, NIAID is advancing five lead candidates and will continue to support the discovery and development of additional potential vaccine platforms and candidates, such as virus-like particle and other virus-vectored vaccines.
Zika in Infants and Pregnancy (ZIP)
The Institute is providing $7 million to continue efforts of the ZIP study. Begun in FY 16, the study aims to enroll and follow approximately 10,000 women throughout their pregnancies as well as their infants for at least one year after birth at 15 sites.
FY 17 funding will go towards enrolling participants and sustaining operations at clinical sites in Brazil, Colombia, Guatemala, Nicaragua, and Puerto Rico, and will include funding for ongoing monitoring of infants to provide critical answers about the range and risk of congenital abnormalities caused by the virus.
Diagnostics, Therapeutics, Vector Control, and Other Interventions
NIAID is devoting $16 million to the discovery, development, and evaluation of diagnostics, therapeutics, vector control, and other countermeasures.
Support for these research areas will be funded through intramural and extramural mechanisms, including contract and grant supplements. Research project grants will include a combination of awards made in response to funding opportunity announcements such as Rapid Assessment of Zika Virus (ZIKV) Complications (R21)(link is external), as well as unsolicited (investigator-initiated) applications.
Funds will support the development and validation of new and better molecular and serological diagnostics, including research to develop rapid, specific, and low-cost Zika virus diagnostic tests, which will have increased sensitivity to more accurately distinguish Zika virus infection from other related viruses such as dengue.
NIAID and its partners are also supporting several approaches to therapeutics. These include screening of FDA-approved and investigational antiviral drugs for potential use in treatment or prophylaxis, as well as evaluating in animal models potential therapeutics such as BCX4430 and monoclonal antibodies (mAbs) against Zika.
Opportunities and Resources
Small Businesses: Help Develop Delivery Vehicles for Nucleic Acids
We are particularly interested in applications proposing platform technologies that deliver nucleic acids in a sequence-independent manner to treat infectious, immunologic, and allergic diseases. In addition, we encourage proposals for technologies to co-deliver nucleic acids with other therapeutics, such as proteins, lipids, or small molecule drugs.
Examples of nucleic acid delivery vehicles include the following:
Exosomes: small vesicles that are secreted by cells into which nucleic acids can be incorporated for delivery
Nanoparticles or liposomes, which may be targeted to specific organs or cell types by the inclusion of a targeting molecule
Condensates: molecules that condense nucleic acids into a physical state that can enter cells
See the FOAs linked below for additional examples. These initiatives will not support applications proposing technologies solely for research purposes or for delivering nucleic acids into cells ex vivo (i.e., in tissue culture).
For a Phase I application, your budget is limited to $300,000 in total costs each year for up to two years. In a Phase II or Phase IIB application, you can request a maximum budget of $1 million in total costs annually for up to three years with appropriate justification.
Leverage Phylodynamic Analysis To Monitor HIV Transmission
Apply for an R01 grant to use phylodynamic analysis of HIV genotyping databases to monitor HIV transmission networks in near real-time. Unlike traditional phylogenetics, phylodynamics adds a time element to identify transmission clusters as they emerge and expand.
The long-term objective of this funding opportunity is to leverage existing HIV genotyping databases to monitor HIV transmission network dynamics within a geographic area. This would allow better targeting of testing, treatment, and prevention interventions for key populations.
Areas of Research Interest
NIH will support research fostering strong interdisciplinary collaborations with public health departments, HIV genotyping laboratories, or other entities engaged in public health within a geographic area of interest.
Your research must involve U.S. populations that are routinely genotyped as standard of care. NIH is most interested in studies of key populations with high rates of HIV transmission.
In your application, clearly describe how the proposed research addresses the domestic U.S. HIV epidemic. For examples of appropriate or unsupported topics, see the funding opportunity announcement.
Budget and Application Information
NIH will accept applications from U.S. organizations only. Foreign components are allowed.
Your application budget is limited to $499,999 each year in direct costs for a project period of no more than five years.
For fiscal year 2018, NIH intends to fund four to seven R01 grants for a total of $4.39 million. Future year amounts will depend on annual budget appropriations.
Applications are due on March 15 of 2017, 2018, and 2019.
Sex and Gender Minorities Recognized as Health Disparity Population
Last month, Eliseo Pérez-Stable, director of the National Institute on Minority Health and Health Disparities, announced in a Director’s Message(link is external)the formal designation of sexual and gender minorities (SGMs) as a specific health disparity population for NIH research.
The announcement signals NIH’s recognition that SGM populations have unique health challenges, less access to health care, and higher burdens for certain diseases, such as depression, cancer, and HIV/AIDS.
Also, keep your eyes open for an SGM health-related opportunity sometime in fiscal year 2017 that allows NIH-funded investigators to apply for administrative supplements to expand the scope of ongoing research.
Use Parent FOAs To Propose Bioethics and Legal Research
NIH is interested in empirical and conceptual research to address high-priority bioethical, legal, and societal challenges impacting biomedical research. Your best strategy for funding is to apply using the parent funding opportunity announcements, as explained in the October 25, 2016 Guide notice(link is external).
Emily Linde To Lead NIAID Grants Management Program
Next month, Ms. Emily Linde(link is external) will become the director of NIAID’s Grants Management Program (GMP) and chief grants management officer, after having served as the deputy director for the past 2½ years. She has 18 years in grants management at NIH, including several years in the Office of Policy for Extramural Research Administration. Emily will be key to resolving grants management issues at the institutional level and in conducting site visits.
We owe many thanks to outgoing GMP Director Mary Kirker for 41 years of outstanding federal service at NIH, including 25 years at NIAID where 23 were spent in her position leading GMP. Last year, our grants management specialists awarded nearly 5,000 competing and noncompeting grants, obligating approximately $2.8 billion in total research grants, including some of the most complex and multinational grants awarded at NIH.
Your application received a score within our published payline, you're waiting for your Notice of Award and want to start your project, but you need money to get it underway. One option you have is to ask your institutional business office for preaward spending approval.
Getting permission before you spend is absolutely essential since your institution is responsible for your expenses in the event that we reduce your award or cannot issue your grant.
It's also important to keep in mind these key points:
Incurring preaward costs in anticipation of a competing or noncompeting award does not put NIH under any obligation 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 preaward costs incurred.
Preaward costs result in borrowing against future support. This 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.
If your institution gives you the green light to use its money, the only preaward spending costs you can incur are those that: 1) are needed to conduct the project and 2) would be allowable under the grant, if awarded, without NIH prior approval.
For competing grants, you can charge allowable preaward costs incurred up to 90 days before your initial Notice of Award's budget period start date.
For noncompeting grants, you may incur preaward costs before the beginning date of a budget period without regard to the time parameters above. Check to see what expenses your business office will allow.
If you have any questions, contact your grants management specialist.
“Do most reviewers read my application before the review?”—anonymous reader
Not usually. Aside from your primary, secondary, and tertiary reviewer, other reviewers may not read your entire application before the initial peer review meeting. Rather, they scan it for its key parts.
“What does ‘just-in-time’ refer to?”—anonymous reader
Just-in-time refers to information that we ask you to send us after your application goes through initial peer review and is within the range of possible funding. NIH needs this information before making an award but does not require it with your application.
In fact, if you send other support information before we request it, NIH may delay processing your application or return it without peer review.
Examples of information we request include human welfare assurance, genomic data sharing plan certification, and an account of other support.
ver historia personal en: www.cerasale.com.ar [dado de baja por la Cancillería Argentina por temas políticos, propio de la censura que rige en nuestro medio]//
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