NEI Collaborative Clinical Vision Research Project: Coordinating Center Grant (UG1- Clinical Trial Required)

Sponsor

National Eye Institute/NIH/DHHS PAR-18-521

Deadline Date

07-Sep-2020

Funding

Not Available

Program Information

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Contact Name

Donald Everett, MA

Contact Telephone

301-451-2020

Contact Email

everettd@mail.nih.gov

Program URL

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Deadline Dates (ALL)

07-Sep-2020, 25-Sep-2020, 07-Jan-2021

Synopsis

 

National Eye Institute (NEI) invites applications for investigator-initiated large-scale clinical trials, human gene-transfer and stem cell therapy trials, and other complex or high resource- or safety-risk clinical trials. These projects are multifaceted and of high public health significance requiring clear delineation of study organization including roles and responsibilities and require careful performance oversight and monitoring. For purposes of this Funding Opportunity Announcement (FOA), the proposed study must be intended to evaluate interventions aimed at screening, diagnosing, preventing, or treating vision disorders, or to compare the effectiveness of two or more established interventions. The NEI UG1-supported studies are typically funded as a group of single-component companion grant awards including the Chair’s Grant, the Coordinating Center, and Resource Centers, when appropriate. Specifically, this FOA encourages applications for the Coordinating Center grant, which provides details of the Coordinating Center’s responsibilities and operations.  This FOA will use the NIH UG1 Clinical Research Cooperative Agreements – Single Project award mechanism.

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AHRQ Health Services Research Demonstration and Dissemination Grants (R18)

Sponsor

Agency for Healthcare Research and Quality/DHHS PA-18-793

Deadline Date

25-Sep-2020

Funding

2,000,000.00 USD

Program Information

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Contact Name

Kishena Wadhwani, Ph.D.

Contact Telephone

301-427-1556

Contact Email

Kishena.Wadhwani@ahrq.hhs.gov

Program URL

View Details

Deadline Dates (ALL)

25-Sep-2020, 25-Jan-2021

Synopsis

 

Agency for Healthcare Research and Quality (AHRQ) invites applications for discrete, specified health services research projects. The project will be performed by the named investigator and study team. The R18 research plan proposed by the applicant institution/organization must be related to the mission and priority research interests of AHRQ. This FOA will use the AHRQ R18 Research Demonstration and Disseminations Projects award mechanism.

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Development of Highly Innovative Tools and Technology for Analysis of Single Cells (SBIR) )

Sponsor

National Institutes of Health/DHHS PA-20-047

Deadline Date

05-Sep-2020

Funding

Not Available

Program Information

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Contact Name

Dr. Margaret Grabb

Contact Telephone

301-443-3563

Contact Email

mgrabb@mail.nih.gov

Program URL

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Deadline Dates (ALL)

05-Apr-2021, 05-Sep-2021, 05-Sep-2020, 05-Jan-2022, 05-Jan-2023, 05-Apr-2022, 05-Jan-2021, 05-Sep-2022

Synopsis

This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) to develop and validate next-generation single cell analysis technologies and tools. The purpose is to foster the commercialization of innovative single cell analysis technologies for their broad use in biomedical research. The novel single-cell analysis technologies will aid in obtaining a fine-grained and dynamic view of heterogeneous cellular states and intercellular interactions, thereby providing new mechanistic insight into biological processes in health and disease. Applications should define the current state of technologies and tools as a benchmark against which the new approach(es) will be measured. The new approach(es) should provide substantially improved performance in sensitivity, selectivity, spatiotemporal resolution, scalability, multiplexing capability, or non-destructive analysis of molecular or functional measures of single cells.

A companion FOA to support STTR Grants is also available see PA-20-025

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Use of gloves in healthcare and non-healthcare settings in the context of the COVID 19 pandemic

Executive summary

Key messages

In the community

  •  There is currently insufficient evidence to recommend the regular use of gloves as a preventive measure in the context of COVID-19 to the public and to people in most occupations.
  • Use of gloves in the community may lead to the misconception that hand hygiene practices can be neglected.
  • Regular use of gloves may confer the risk of dermatological side effects.
  • The generation of waste from unnecessary glove use causes environmental damage.

In healthcare settings

  • The use of medical gloves is recommended as part of standard precautions to reduce the risk of contamination of healthcare workers’ hands with blood and other body fluids including contact with non-intact skin and mucous membranes.
  • When indicated, use of medical gloves is recommended as part of contact precautions, to reduce the risk of pathogen dissemination to the patient’s environment, to other patients and for the protection of healthcare workers.
  • Taking into consideration the currently available types of gloves for use in healthcare settings, extended use, decontamination and reuse of single-use medical gloves is discouraged.
  • In the event of shortages, single-use medical gloves should be prioritised for use in healthcare settings.

R

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Rapid Risk Assessment: Resurgence of reported cases of COVID 19 in the EU/EEA, the UK and EU candidate and potential candidate countries

Executive summary

The COVID-19 pandemic is posing an unprecedented threat to EU/EEA countries and the UK as well as countries worldwide, many of which have been experiencing widespread transmission of the virus in the community for several months. There is still community transmission reported in most EU/EEA countries, the UK and EU candidate and potential candidate countries. Additionally, some countries are reporting a resurgence of observed cases or large localised outbreaks.

The reasons behind this apparent increase in the number or resurgence of cases observed in these countries vary. The increase in the number of cases may reflect changes in case ascertainment (e.g. increasing testing, changes in the case definition) that does not necessarily indicate increased rates of transmission, or may reflect genuine increases in transmission (e.g. associated with the easing of non-pharmaceutical interventions (NPI), large localised outbreaks), or may be due to importation of cases. Some of the observed increases, particularly in countries with a small population, are associated with just a few additional new cases. Therefore, information must be interpreted with caution.

Risk assessment

In this risk assessment, ECDC is assessing the risks associated with these reported increases of incident cases in some countries.

Currently, the risk, determined by a combination of the probability of an event occurring and of its consequences (impact) to individuals or the population, is assessed as follows:

  • The overall risk of COVID-19 in countries reporting an increase in incident COVID-19 cases and for which there is, or may shortly be, substantial ongoing community transmission and/or within which appropriate physical distancing measures are not taken, is currently considered moderate for the general population (very high probability of infection and low impact of disease) and very high for populations with defined factors associated with elevated risk for COVID-19 (very high probability of infection and very high impact of disease).
  • Provided that the increases are not merely reflecting a change in the surveillance strategy or artefacts due to small number calculations; the overall risk of COVID-19 transmission further rising in these countries with observed increase of COVID-19 incidence is considered high (very high probability of further increase and moderate impact of a further increase) if no appropriate monitoring systems and capacities for extensive testing and contact tracing are in place, and if NPIs are eased when there is still ongoing community transmission.

Options for response

In order to respond to these risks, the following measures continue to be essential to maintain a reduced level of transmission and avoid resurgence:

  • A robust monitoring framework to closely monitor the epidemiological situation, rapidly detect increased transmission, assess the impact of the interventions in place and avoid a resurgence of COVID-19.
  • An expanded testing strategy aimed at comprehensive testing of all individuals displaying symptoms compatible with COVID-19, independent from their country of origin or residency.
  • A framework for contact tracing, based on extensive testing, active case finding, early detection of cases, isolation of cases, quarantine and follow-up of contacts, possibly supported by electronic tools and applications.
  • Prompt identification and investigation of clusters/outbreaks associated with specific settings, with implementation of tailored control and prevention measures to minimise onward spread to others in the setting and to the wider community.
  • Long-term sustainable implementation of essential NPIs, irrespective of transmission rates, and the ability to amend strategies rapidly in response to indications of increased transmission, if appropriate, only restricting those to subnational areas.
  • A strong risk communication strategy should remind citizens that the pandemic is not over.

National authorities should consider carefully analysing every increase in incidence to assess whether these are associated with genuine increases in transmission and whether these involve populations with defined factors associated with elevated risk for COVID-19, including the residents of long-term care facilities (LTCFs). Identifying possible outbreaks, other foci of transmission, or sustained community transmission due to the easing of the NPIs imposed in previous months is essential to control such increases in incidence and implement tailored control measures aimed at limiting population mobility and/or reducing exposure.

ECDC does not consider travel restrictions within and to the Schengen area as an efficient way to reduce transmission within the EU since community transmission is already taking place in the EU/EEA and data from The European Surveillance System (TESSy) show that, in June 2020, only 3% of confirmed cases were likely infected in a country different from the reporting country.

6 July 2020 Erratum: ECDC incorrectly stated there was a 12% decrease in 14-day incidence of reported cases between 16 and 30 June. This appeared in two places in the document; the second paragraph of the Summary on page 1 and in the text of the Event Background on page 2. This has been corrected to an 8% increase in 14-day incidence of reported cases between 16 and 30 June in the Event Background on page 2 and has been removed from the Summary on page 1.

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Updated Information for Human Cell, Tissue, or Cellular or Tissue-based Product (HCT/P) Establishments Regarding the COVID-19 Pandemic

July 2, 2020

FDA continues to work closely with CDC and other federal and international agencies to monitor the coronavirus disease 2019 (COVID-19) pandemic caused by the virus, SARS-CoV-2. Respiratory viruses, in general, are not known to be transmitted by implantation, transplantation, infusion, or transfer of human cells, tissues, or cellular or tissue-based products (HCT/Ps). To date, there have been no reported cases of transmission of COVID-19 via these products.

Routine screening measures are already in place for evaluating clinical evidence of infection in HCT/P donors.

Considerations

FDA does not recommend using laboratory tests to screen asymptomatic HCT/P donors.

FDA is aware that some HCT/P establishments in the U.S. are considering additional donor screening and testing measures in response to the COVID-19 pandemic.

The HCT/P establishment’s responsible person must determine and document the eligibility of a cell or tissue donor (21 CFR 1271.50). Based on information available at this time, establishments may wish to consider, whether, in the 28 days prior to HCT/P recovery, the donor

  • cared for, lived with, or otherwise had close contact with individuals diagnosed with or suspected of having COVID-19 infection; or
  • had been diagnosed with or suspected of having COVID-19 infection; or
  • had a positive diagnostic test (e.g., nasopharyngeal swab) for SARS-CoV-2 but never developed symptoms.

FDA will continue to monitor the situation and will issue updates as information becomes available.

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SBIR Technology Transfer

Sponsor

National Institute of Neurological Disorders and Stroke/NIH/DHHS PA-18-705

Deadline Date

05-Sep-2020

Funding

Not Available

Program Information

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Contact Name

Stephanie Fertig, M.B.A.

Contact Telephone

301-496-1447

Contact Email

fertigs@ninds.nih.gov

Program URL

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Deadline Dates (ALL)

05-Sep-2020, 05-Apr-2021

Synopsis

 

 

National Institutes of Health (NIH) and its participating Institutes and Centers invite applications for Small Business Innovation Research (SBIR) from small business concerns (SBCs) for projects to transfer technology out of the NIH intramural research labs into the private sector. If selected for SBIR funding, the SBC will be granted a royalty-free, non-exclusive patent license agreement for internal research use for the term of and within the field of use of the SBIR award to technologies held by NIH with the intent that the SBC will develop the invention into a commercial product to benefit the public. This FOA will utilize the SBIR (R43/R44) grant mechanisms for Phase I, Phase II, Direct Phase II, and Fast-Track applications.

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Wearable Alcohol Biosensors (STTR)

Sponsor

National Institute on Alcohol Abuse and Alcoholism/NIH/DHHS PA-18-785

Deadline Date

05-Sep-2020

Funding

Not Available

Program Information

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Contact Name

Kathy Jung, Ph.D.

Contact Telephone

301-443-8744

Contact Email

jungma@mail.nih.gov

Program URL

View Details

Deadline Dates (ALL)

05-Sep-2020, 05-Jan-2021, 05-Apr-2021

Synopsis

 

National Institute on Alcohol Abuse and Alcoholism (NIAAA) invites Small Business Technology Transfer (STTR)  applications from eligible small business concerns proposing to design and produce a non-invasive, discreet, wearable device to monitor blood alcohol levels in real time. Methods that quantify alcohol in blood or interstitial fluid as opposed to detection of alcohol that has exuded through the skin are of highest priority. This FOA will utilize the R41/R42 Small Business Technology Transfer (STTR) Grant – Phase I, Phase II, and Fast-Track applications.

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Lab to Marketplace: Tools for Brain and Behavioral Research

Sponsor

National Institute of Mental Health/NIH/DHHS PA-18-819

Deadline Date

05-Sep-2020

Funding

Not Available

Program Information

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Contact Name

Margaret Grabb, Ph.D.

Contact Telephone

301-443-3563

Contact Email

mgrabb@mail.nih.gov

Program URL

View Details

Deadline Dates (ALL)

05-Sep-2020, 05-Jan-2021

Synopsis

 

National Institute of Mental Health (NIMH) encourages the translation of technologies for brain or behavioral research from academic and other non-small business research sectors to the marketplace. Encouraged from Small Business Concerns (SBCs) are Small Business Innovation Research (SBIR) grant applications that propose to further develop, make more robust, and make more user-friendly such technologies in preparation for commercial dissemination. It is expected that this activity will require partnerships and close collaboration between the original developers of these technologies and SBCs, which may be accomplished in any of a number of ways, including the use of multiple program directors/principal investigators. This FOA will use the R43/R44 Small Business Innovation Research (SBIR) Grant – Phase I, Phase II, and Fast-Track award mechanisms.

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Better Defining Growth Medium to Improve Reproducibility of Cell Culture

Sponsor

National Institute of General Medical Sciences/NIH/DHHS PA-18-815

Deadline Date

05-Sep-2020

Funding

Not Available

Program Information

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Contact Name

Amanda Melillo, Ph.D.

Contact Telephone

301-594-0943

Contact Email

melilloaa@mail.nih.gov

Program URL

View Details

Deadline Dates (ALL)

05-Sep-2020, 05-Jan-2021, 05-Apr-2021

Synopsis

 

Fetal bovine serum (FBS) is the most widely used growth supplement for cell culture because it cost-effectively supports the survival and growth of many cell lines.  Although serum is an effective growth promotor, it is highly variable in its composition, activity, and physiological effects on cells. This variability introduces inconsistencies into cell culture research. National Institute of General Medical Sciences (NIGMS) invites applications for Small Business Innovation Research (SBIR) from small business concerns (SBCs) to develop novel, reliable, and cost-effective tools that will make it easier for researchers to standardize or replace serum in cell culture. This FOA will utilize the SBIR (R43/R44) grant mechanisms for Phase I, Phase II, and Fast-Track applications

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Better Defining Growth Medium to Improve Reproducibility of Cell Culture (STTR)

Sponsor

National Institute of General Medical Sciences/NIH/DHHS PA-18-816

Deadline Date

05-Sep-2020

Funding

Not Available

Program Information

View Details

Contact Name

Amanda Melillo, Ph.D.

Contact Telephone

301-594-0943

Contact Email

melilloaa@mail.nih.gov

Program URL

View Details

Deadline Dates (ALL)

05-Sep-2020, 05-Jan-2021, 05-Apr-2021

Synopsis

 

Fetal bovine serum (FBS) is the most widely used growth supplement for cell culture because it cost-effectively supports the survival and growth of many cell lines.  Although serum is an effective growth promotor, it is highly variable in its composition, activity, and physiological effects on cells. This variability introduces inconsistencies into cell culture research. National Institute of General Medical Sciences (NIGMS) invites Small Business Technology Transfer (STTR) grant applications from small business concerns (SBCs) to develop novel, reliable, and cost-effective tools that will make it easier for researchers to standardize or replace serum in cell culture. This FOA will utilize the R41/R42 Small Business Technology Transfer (STTR) Grant for Phase I, Phase II, and Fast-Track applications.

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Requirement for Electronic Submission of All NIH Administrative Supplements

We just announced three important updates to our administrative supplement submission policies:

  1. Effective immediately, NIH will begin accepting administrative supplement applications for multi-project awards electronically. Since the administrative supplement applies to the parent award as a whole, the single-project application form package used for research grants and cooperative agreements will be used for these submissions (e.g., Competition ID= “FORMS-F-ADMINSUPP-RESEARCH.”)
  2. Effective July 25, 2020, the streamlined submission method through the eRA Commons will be discontinued and replaced with the option to initiate the administrative supplement application within eRA Commons and leverage technology available in NIH ASSIST to complete submission.
  3. Effective July 25, 2020, all supplement applications to existing single and multi-project awards must be submitted electronically through Grants.gov using NIH ASSIST, Grants.gov Workspace, or institutional system-to-system (S2S) solutions.

See NOT-OD-20-128 for additional details.

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What Is a “Rolling” Submission Date?

Most funding opportunity announcements (FOAs) and notices of special interest (NOSIs) provide specific due dates or point to our table of standard due dates. Recently, we’ve posted a growing number of funding opportunities indicating “applications will be accepted on a rolling basis.” This practice is not new, but it is more common with “emergency” or “urgent” funding opportunities meant to get funding to the community as quickly as possible to address a critical need (e.g., COVID-19 Funding Opportunities Specific to COVID-19).

You may see a statement in the funding opportunity like …

Applications will be accepted on a rolling basis through April 15, 2021 by 5:00 PM local time of the applicant organization. [Excerpt from NOT-AA-20-011 posted April 16.]

The Key Dates section in this NOSI indicates the first available due date is May 15, 2020. For this example, the earliest you could submit was May 15, 2020 and you can submit any day up to and including April 15, 2021. The notice expires April 16, 2021.

Or, something like …

[Excerpts from Key Dates section of  PAR-20-092]

  • Open Date – January 24, 2020
  • Application Due Date(s) – Applications will be accepted on a rolling basis, beginning on February 24, 2020.
  • Scientific Merit Review

Applications received by May 1, 2020 will be reviewed by August 1, 2020;

Applications received by September 1, 2020 will be reviewed by December 1, 2020;

Applications received by January 1, 2021 will be reviewed by April 1, 2021;

Applications received by May 1, 2021 will be reviewed by August 1, 2021;

Applications received by September 1, 2021 will be reviewed by December 1, 2021;

Applications received by January 1, 2022 will be reviewed by April 1, 2022;

Applications received by May 1, 2022 will be reviewed by August 1, 2022;

Applications received by September 1, 2022 will be reviewed by December 1, 2022.

  • Expiration Date – September 02, 2022

In this example, applications can be submitted any time from January 24, 2020 up to and including September 1, 2022. Applications submitted on or before February 24, 2020 through May 1, 2020 will be reviewed by August 1, 2020. Applications submitted between May 2, 2020 and September 1, 2020 will be reviewed by December 1, 2020. And, so on.

With “rolling” submission dates, we define the first and last days applications will be accepted and you pick the day between them to submit your application.

As always, when in doubt – reach out. Each funding opportunity includes institute contacts ready to assist you with application, review and award timeline questions.

For more frequently asked questions on applying, see our FAQ page.

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Will NIH Accept Late Applications for New Awards From Applicants Affected by COVID-19?

NIH has announced an updated late policy for the parent institutional training grants which have just a single due date each year. In addition, some NIH ICs have issued late notices for specific funding opportunities, which are posted on the Coronavirus Disease 2019 (COVID-19): Information for NIH Applicants and Recipients of NIH Funding website. For all other Funding Opportunity Announcements NIH is taking a very flexible stance for applications submitted within the standard two week late policy. Applicants should include a cover letter with an explanation for the late submission.

Find this and more frequently asked questions on our COVID-19 Flexibilities FAQ page.

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Many New and Updated COVID-19 FAQs

All COVID-19 FAQs were reviewed and revised to align with NIH Implementation of OMB Memorandum M-20-26. Impacted FAQs are marked as new/updated.

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