CPRIT Releases Two RFAs for Product Development Research

CPRIT Product Development Programs 

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  1. Company Relocation Product Development Awards

Product Development Program Priorities

 Funding projects at Texas companies and relocating companies that are most likely to bring important products to the market

 Providing funding that promotes the translation of research at Texas institutions into new companies able to compete in the marketplace

 Identifying and funding projects to develop tools and technologies of special relevance to cancer research, treatment, and prevention

EXECUTIVE SUMMARY

CPRIT will foster the creation of high-quality new jobs in Texas by providing financial support for a wide variety of projects relevant to cancer. The award mechanism described in this RFA is designed to encourage the relocation of existing oncology-focused companies or a substantial portion of their business to Texas. CPRIT expects outcomes of supported activities to directly and indirectly benefit subsequent cancer research efforts, cancer public health policy, or the continuum of cancer care—from prevention to treatment and cure. To fulfill this vision, applications may address any product development topic or issue related to cancer biology, causation, prevention, detection or screening, treatment, or cure. The overall goal of this award program is to improve outcomes of patients with cancer by increasing the availability of Food and Drug Administration (FDA)–approved therapeutic interventions with a primary focus on Texas-centric programs.

MECHANISM OF SUPPORT

The goal of the Company Relocation Product Development Award is to finance the research and development of innovative products, services, and infrastructure with significant potential impact on patient care. These investments will provide companies or limited partnerships that are willing to relocate all or a substantial portion of their business to Texas with the opportunity to further the development of new products for the diagnosis, treatment, supportive care, or prevention of cancer; to establish infrastructure that is critical to the development of a robust industry; or to fill a treatment, industry, or research gap. This award mechanism will support companies that intend to undertake product research and development in Texas with a strong presence of Texas-based employees.

OBJECTIVES

The state of Texas seeks to attract industry partners in the field of cancer care to advance economic development and cancer care efforts in the state. The goal of this award mechanism is to recruit to Texas companies with proven management teams who are focused on exceptional product opportunities to improve cancer care. These companies must presently be domiciled outside of Texas and have sufficient personnel to operate the Texas-based research and/or development activities of the company and, along with appropriate management, must be willing to relocate to or be hired and remain in Texas for a specified period after funding. Eligible products or services include—but are not limited to—therapeutics (eg, small molecules and biologics), diagnostics, devices, and potential breakthrough technologies, including software and research discovery techniques. Eligible stages of research development include translational research, proof-of-concept studies, preclinical studies, and phase 1 or phase 2 clinical trials. By exception, phase 3 clinical trials and later-stage product development projects will be considered where circumstances warrant CPRIT investment.

CPRIT’s objectives and program priorities are established by its Oversight Committee. Consistent with the above, these priorities include, “funding projects at Texas companies and relocating companies that are most likely to bring important products to the market.” A full description of CPRIT’s program priorities may be found at http://www.cprit.state.tx.us/about-cprit/reports.

2. Texas Company Product Development Awards

2.1. Product Development Program Priorities

Legislation from the 83rd Texas Legislature requires that CPRIT’s Oversight Committee establish program priorities on an annual basis. The priorities are intended to provide transparency in how the Oversight Committee directs the orientation of the agency’s funding portfolio. The Product Development Program’s principles and priorities will also guide CPRIT staff and the Product Development Review Council on the development and issuance of program-specific Requests for Applications (RFAs) and the evaluation of applications submitted in response to those RFAs. Established Principles:

 Moving forward the development of commercial products to diagnose and treat cancer and improve the lives of patients with cancer

 Creation of good, high-paying jobs for Texans CPRIT RFA C-16-2-TXCO Texas Company Product Development Awards p.6/28 (Rev 12/28/15)

 Sound financial return on the monies invested

 Development of the Texas high-tech life sciences business environment

EXECUTIVE SUMMARY

CPRIT will foster cancer research as well as product and service development in Texas by providing financial support for a wide variety of projects relevant to cancer. This RFA solicits applications for the research and development of innovative products addressing critically important needs related to diagnosis, prevention, and/or treatment of cancer and the product development infrastructure needed to support these efforts. CPRIT encourages applicants who seek to apply or develop state-of-the-art products, services (eg, contract research organization services), technologies, tools, and/or resources for cancer research, prevention, or treatment. CPRIT expects outcomes of supported activities to directly and indirectly benefit subsequent cancer research efforts, cancer public health policy, or the continuum of cancer care—from prevention to treatment and cure. To fulfill this vision, applications may address any topic or issue related to cancer biology, causation, prevention, detection or screening, treatment, or cure.

MECHANISM OF SUPPORT

The goal of the Texas Company Product Development Award is to finance the research and development of innovative products, services, and infrastructure with significant potential impact on patient care. These investments will provide companies or limited partnerships located and headquartered in Texas with the opportunity to further the research and development of new products for the diagnosis, treatment, supportive care, or prevention of cancer; to establish infrastructure that is critical to the development of a robust industry; or to fill a treatment, industry, or research gap. This award is intended to support companies that will be staffed with a majority of Texas-based employees, including C-level executives.

 OBJECTIVES

The long-term objective of this award is to support commercially oriented therapeutic and medical technology products, diagnostic- or treatment-oriented information technology products, diagnostics, tools, services, and infrastructure projects. Common to all applications under this RFA (with the exception of infrastructure applications) should be the intent to further the research and development of products that would eventually be approved for marketing for the diagnosis, prevention, and/or treatment of cancer. Eligible products or services include—but are not limited to—therapeutics (eg, small molecules and biologics), diagnostics, devices, and potential breakthrough technologies, including software and research discovery techniques. Eligible stages of research and development include translational research, proof-of-concept studies, preclinical studies, and phase 1 or phase 2 clinical trials. By exception, phase 3 clinical trials and later-stage product development projects will be considered where circumstances warrant CPRIT investment.

CPRIT’s objectives and program priorities are established by its Oversight Committee. Consistent with the above, these priorities include, “funding projects at Texas companies and relocating companies that are most likely to bring important products to the market.” A full description of CPRIT’s program priorities may be found at http://www.cprit.state.tx.us/about-cprit/reports/.

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Limited Competition for the Continuation of the Scientific Data Research Center (SDRC) for the NIDDK Gastroparesis Consortium (U24)

RFA-DK-16-507
Limited Competition for the Continuation of the Scientific Data Research Center (SDRC) for the NIDDK Gastroparesis Consortium (U24)
Department of Health and Human Services
National Institutes of Health

Background

Gastroparesis is a chronic symptomatic disorder associated with delayed gastric emptying.

Gastroparesis predominantly affects young women (females outnumber males by a ratio of 4:1, the average age is 34). The symptomatic profile of gastroparesis includes nausea (90% of patients), vomiting (>80%), bloating (75%), early satiety (60%), and abdominal pain (~50%). Symptoms in individual patients can vary in both the combination of symptoms and their severity. Because of its chronic and often intractable nature, the disorder has a tremendous impact on both patients and society. Gastroparesis remains difficult to treat, in large part, because of the lack of knowledge of the underlying pathophysiology. Several factors have impeded the progress in this field including the paucity of patients seen by any one center, the absence of uniform diagnostic criteria, and the lack of generally available and reliable methods for physiological testing. Given the complexity of the problem, and the profound degree of morbidity associated with this disorder, an important need exists to study patients in a systematic manner. Such studies can best be achieved by recruiting patients and collecting data from multiple centers as part of a network of investigators focused on this disorder. In recognition of this fact, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) established the Gastroparesis Clinical Research Consortium (GpCRC) in 2006 and renewed the consortium in 2010. Since many gaps still existed despite the progress of the consortium, in April 2015, an External Scientific Committee recommended support of the Consortium activities for another 5 years.

Research Objectives
Through the acquisition of a cohort of well-characterized patients and associated biospecimens (blood, stools and when feasible gastric  tissue), the clinical research consortium  will provide the resources and collaborative opportunities necessary for achieving many of the research objectives identified in the strategic plan of NIDDK for Gastroparesis.

The overriding objective of this research program is to pursue clinical research on Gastroparesis  (both sporadic and  associated with diabetes mellitus type 1 and 2 and obesity), by identifying and characterizing a large cohort of patients with gastroparesis to encourage translational research focusing upon elucidating the pathogenesis that will provide the basis for understanding the natural history and developing means of diagnosis, treatment and clinical management of Gastroparesis  and its sequela: chronic abdominal pain, nausea, vomiting, poor metabolic control and impaired quality of life.

General Information

Document Type: Grants Notice
Funding Opportunity Number: RFA-DK-16-507
Funding Opportunity Title: Limited Competition for the Continuation of the Scientific Data Research Center (SDRC) for the NIDDK Gastroparesis Consortium (U24)
Opportunity Category: Discretionary
Funding Instrument Type: Cooperative Agreement
Category of Funding Activity: Food and Nutrition
Health
Category Explanation:
Expected Number of Awards: 1
CFDA Number(s): 93.847 — Diabetes, Digestive, and Kidney Diseases Extramural Research
Cost Sharing or Matching Requirement: No
Posted Date: Dec 22, 2015
Creation Date: Dec 22, 2015
Original Closing Date for Applications: Mar 2, 2016  
Current Closing Date for Applications: Mar 2, 2016  
Archive Date: Apr 2, 2016
Estimated Total Program Funding: $4,300,000
Award Ceiling: $1,000,000
Award Floor:

Eligibility

Eligible Applicants:
Private institutions of higher education
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Public and State controlled institutions of higher education
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Additional Information on Eligibility: Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs) ; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Additional Information

Agency Name: National Institutes of Health
Description: This Funding Opportunity Announcement (FOA) invites an application for the Scientific Data Research Center (SDRC) of the Gastroparesis Clinical Research Consortium (GpCRC). The purpose of this FOA is to allow additional follow-up of GpCRC participants. The companion FOA, RFA-DK-16-010 will support continuation of the GpCRC Clinical Centers (CC).
Link to Additional Information: http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-16-507.html
Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

NIH OER Webmaster FBOWebmaster@OD.NIH.GOV
If you have any problems linking to this funding announcement, please contact the NIH OER Webmaster

FY17 DOD Joint Program Committee-2/Military Infectious Diseases Research Program (JPC-2/MIDRP)

Fiscal Year 2017 (FY17) funding opportunities for the Department of Defense (DOD) Joint Program Committee-2/Military Infectious Diseases Research Program (JPC-2/MIDRP) that are being managed by the office of Congressionally Directed Medical Research Programs (CDMRP).

Applied Research Award

SUBMISSION AND REVIEW DATES AND TIMES

• Pre-Application Deadline: 5:00 p.m. Eastern time (ET), January 25, 2016

• Invitation to Submit an Application: March 7, 2016

• Application Submission Deadline: 11:59 p.m. ET, May 9, 2016

• End of Application Verification Period: 5:00 p.m. ET, May 12, 2016

• Peer Review: July 2016

• Programmatic Review: August 2016

FY17 JPC-2/MIDRP Applied Research Award Focus Areas

To meet the intent of the FY17 JPC-2/MIDRP Applied Research Award (ARA) mechanism, applications MUST specifically address at least one of the FY17 JPC-2/MIDRP ARA Focus Areas related to combat-related or trauma-induced wound infections listed below. Research projects incorporating high-throughput drug screening and/or in silico modeling, as well as applications focused on areas other than those listed below will not be considered for funding.

FOCUS AREAS:

• Development of new methods for rapid multi-pathogen/multi-phenotype detection of multidrug-resistant organisms (MDROs), nosocomial pathogens, and/or rapid multipathogen/multi-phenotype characterization of antimicrobial resistance patterns.

• Development of assays for host immune response biomarkers for diagnosis or prognosis (with associated outcomes) of infection to inform clinical infection management decisions (e.g., optimal wound closure time, optimal duration of antibiotic administration for osteomyelitis).

• Development and preclinical testing of novel chemotypes (chemical classes/materials), biologics as potential therapeutics or prophylactics for wound infection, and/or biofilm formation, maintenance, or propagation. Innovative treatment approaches (e.g., chelators, antibody, phage, antimicrobial peptides, quorum-sensing inhibitors, and host immunoaugmentation, etc.) are encouraged.

APPLICABLE TO ALL FOCUS AREAS:

• Studies involving carbapenem-resistant organisms are particularly sought.

• Preference will be given to approaches that address infections with one or more MDROs, particularly, Acinetobacter baumannii, Pseudomonas aeruginosa, extendedspectrum beta-lactamase producing Enterobacteriaceae (including Escherichia coli and Klebsiella pneumoniae), and methicillin-resistant Staphylococcus aureus (MRSA), and/or invasive fungal (mold) pathogens.

• Preference will be given to studies leading toward topical treatments for prevention and management of wound infection.

Clinical Study Award

SUBMISSION AND REVIEW DATES AND TIMES

• Pre-Application Deadline: 5:00 p.m. Eastern time (ET), January 25, 2016

• Invitation to Submit an Application: March 7, 2016

• Application Submission Deadline: 11:59 p.m. ET, May 9, 2016

• End of Application Verification Period: 5:00 p.m. ET, May 12, 2016

• Peer Review: July 2016

• Programmatic Review: August 2016

FY17 JPC-2/MIDRP Clinical Study Award Focus Areas

To meet the intent of the FY17 JPC-2/MIDRP Clinical Study Award (CSA) mechanism, applications MUST contain only one clinical trial/testing with a distinct study design and address at least one of the Focus Areas listed below. Applications focused on areas other than those listed below will not be considered for funding.

FOCUS AREAS:

Therapeutics. Evaluation of optimum preventive or directive therapies for combatrelated or trauma-induced wound infections using Food and Drug Administration (FDA)-approved drugs, biologics, or devices either alone or in combination. Studies focusing on new indications of FDA-approved drugs/biologics/devices or investigational new drugs/biologics/devices will be accepted.

Rapid detection of pathogens and/or anti-microbial drug resistance markers. Evaluation of a functional prototype device or assay for the rapid detection of pathogens and/or anti-microbial drug resistance markers in combat-related or traumainduced wounds. Research outcomes should support the development of an FDA regulated device or assay.

  • Rapid detection of biomarkers. Evaluation of a functional prototype device or assay for the rapid detection of novel and specific in vivo or in vitro biomarkers (from wound, serum, saliva, or urine) that predict development of infection or discriminate between infection and colonization. Research outcomes should support the development of an FDA-regulated device or assay.

APPLICABLE TO ALL FOCUS AREAS:

• Studies involving carbapenem-resistant organisms are particularly sought.

• Preference will be given to approaches that address infections with one or more multidrug-resistant organisms (MDROs), particularly, Acinetobacter baumannii, Pseudomonas aeruginosa, extended-spectrum beta-lactamase producing Enterobacteriaceae (including Escherichia coli and Klebsiella pneumoniae), methicillin-resistant Staphylococcus aureus (MRSA), and/or invasive fungal (mold) pathogens.

Health Promotion and Disease Prevention Centers: Special Interest Project Competitive Supplements (SIPS)

RFA-DP-16-006
Health Promotion and Disease Prevention Centers: Special Interest Project Competitive Supplements (SIPS)
Department of Health and Human Services
Centers for Disease Control and Prevention

Background and Purpose

The purpose of the Prevention Research Centers (PRC) program’s Special Interest Projects (SIPs) mechanism is to support
supplemental projects in health promotion and disease prevention research. A major focus of this supplemental funding program is
to design, test, and disseminate effective applied public health prevention research strategies.
The US Department of Health and Human Services (HHS), Centers for Disease Control and Prevention (CDC), National Center
for Chronic Disease Prevention and Health Promotion (NCCDPHP) seeks competitive supplement cooperative agreement
applications for the Health Promotion and Disease Prevention Research Centers Program. This FOA aligns with the following
public health priorities:
1. Healthy People 2020 Objectives related to health promotion and disease prevention.
2. The National Prevention Strategy.
3. CDC’s Winnable Battles which cover health topic of reducing tobacco use.
4. The NCCDPHP Domains of (a) strategies to improve community-clinical linkages that support patient efforts to manage their
conditions or disease risk, (b) conduct surveillance to enhance prevention, and reduce premature morbidity and mortality due to
chronic diseases, (c) health systems interventions to improve the effective delivery and use of quality clinical and other
preventative services to prevent disease; detect disease early; reduce or eliminated risk factors; mitigate or manage complications;
and support patient self-management education, (d) defining and supporting evaluation and applied research activities to reduce
disparities in cancer rates among different population groups, (e) health system interventions to improve the effective delivery and
use of clinical and other preventive services, and (f) support environmental approaches that promote health and support and
reinforce healthful behaviors in worksites.

General Information

Document Type: Grants Notice
Funding Opportunity Number: RFA-DP-16-006
Funding Opportunity Title: Health Promotion and Disease Prevention Centers: Special Interest Project Competitive Supplements (SIPS)
Opportunity Category: Discretionary
Funding Instrument Type: Cooperative Agreement
Category of Funding Activity: Health
Category Explanation:
Expected Number of Awards: 8
CFDA Number(s): 93.135 — Centers for Research and Demonstration for Health Promotion and Disease Prevention
Cost Sharing or Matching Requirement: No
Posted Date: Dec 23, 2015
Creation Date: Dec 23, 2015
Original Closing Date for Applications: Feb 22, 2016  Electronically submitted applications must be submitted no later than 5:00 p.m., ET, on the listed application due date.
Current Closing Date for Applications: Feb 22, 2016   Electronically submitted applications must be submitted no later than 5:00 p.m., ET, on the listed application due date.
Archive Date: Mar 23, 2016
Estimated Total Program Funding: $3,375,000
Award Ceiling: $0
Award Floor: $0

Eligibility

Eligible Applicants:
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Additional Information on Eligibility: Competition is limited to Prevention Reseach Centers (PRCs) institutions funded under DP14-001. Special eligibility requirement(s) may apply to each SIP (see Section IX. Special Interest Project Description).

Additional Information

Agency Name: Centers for Disease Control and Prevention
Description: This RFA will provide supplemental funding to Prevention Research Centers (PRCs) to design, test, and disseminate effective applied public health prevention research strategies to include behavioral interventions, environmental or system-wide solutions, and strategies that address major causes of disease and disability. Research strategies align with public health priorities such as the Healthy 2020 topic areas: Cancer, Oral Health, and Workplace Health.
Link to Additional Information:
Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

Michael Brown MAB5@cdc.gov
Grants Policy

Novel Assays to Address Translational Gaps in Treatment Development (UG3/UH3)

PAR-16-065
Novel Assays to Address Translational Gaps in Treatment Development (UG3/UH3)
Department of Health and Human Services
National Institutes of Health

Funding Opportunity Purpose

The overall goal of this initiative is to identify neurophysiological measures as potential assays for treatment development research. The FOA will support efforts to optimize and evaluate measures of neurophysiological processes that are disrupted within or across mental disorders in both healthy humans and in another species relevant to the therapeutic development pipeline.  The initiative will support initial proof of concept studies aimed at identifying measures for potential development as preclinical assays for evaluating potential new drug and device therapies and their targets. Data will also reveal assay measures where the performance between preclinical animal species and humans is dissimilar, thus establishing a firm basis for limiting speculative extrapolations of preclinical animal findings to humans. The ultimate practical goal of this FOA is to improve the efficiency of the therapeutic development process by identifying coherence of measures and inconsistencies between the preclinical screening pipeline and clinical evaluation of new treatment candidates and thereby hasten the development of more effective treatments for mental disorders.

The objectives of the FOA will be accomplished by supporting partnerships among basic and translational neuroscientists who are committed to advancing the discovery of in vivo physiological measures as tools for target validation and therapeutic development. Groups will be tasked with developing and optimizing in vivo assays of brain processes in both animals and in healthy humans. Groups will evaluate assay performance across both species in response to specific chemical, physiological, or behavioral manipulations. In this way, projects will reveal the potential of specific assays to translate from animals to humans, suggesting assays for further development as tools in the treatment development pipeline.

General Information

Document Type: Grants Notice
Funding Opportunity Number: PAR-16-065
Funding Opportunity Title: Novel Assays to Address Translational Gaps in Treatment Development (UG3/UH3)
Opportunity Category: Discretionary
Funding Instrument Type: Cooperative Agreement
Category of Funding Activity: Health
Category Explanation:
Expected Number of Awards:
CFDA Number(s): 93.242 — Mental Health Research Grants
Cost Sharing or Matching Requirement: No
Posted Date: Dec 21, 2015
Creation Date: Dec 21, 2015
Original Closing Date for Applications: Oct 24, 2018  
Current Closing Date for Applications: Oct 24, 2018  
Archive Date: Nov 24, 2018
Estimated Total Program Funding:
Award Ceiling:
Award Floor:

Eligibility

Eligible Applicants:
Special district governments
Native American tribal organizations (other than Federally recognized tribal governments)
Independent school districts
Native American tribal governments (Federally recognized)
Private institutions of higher education
Small businesses
For profit organizations other than small businesses
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
County governments
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Public and State controlled institutions of higher education
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
City or township governments
Public housing authorities/Indian housing authorities
State governments
Additional Information on Eligibility: Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.

Additional Information

Agency Name: National Institutes of Health
Description: The overall goal of this initiative is to identify neurophysiological measures as potential assays for treatment development research. The FOA will support efforts to optimize and evaluate measures of neurophysiological processes that are disrupted within or across mental disorders in both healthy humans and in another species relevant to the therapeutic development pipeline. The initiative will support initial proof of concept studies aimed at identifying measures for potential development as preclinical assays for evaluating potential new drug and device therapies and their targets. Data will also reveal assay measures where the performance between preclinical animal species and humans is dissimilar, thus establishing a firm basis for limiting speculative extrapolations of preclinical animal findings to humans. The ultimate practical goal of this FOA is to improve the efficiency of the therapeutic development process by identifying coherence of measures and inconsistencies between the preclinical screening pipeline and clinical evaluation of new treatment candidates and thereby hasten the development of more effective treatments for mental disorders.
Link to Additional Information: http://grants.nih.gov/grants/guide/pa-files/PAR-16-065.html
Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

NIH OER Webmaster FBOWebmaster@OD.NIH.GOV
If you have any problems linking to this funding announcement, please contact the NIH OER Webmaster

UTSW JUNIOR FACULTY: The Inaugural SOAR Intensive Junior Faculty R-Grant Writers Workshop June 2016 NIH Submission Deadline

Overview:

The “Successfully Obtaining an R” (SOAR) Program Medicine (http://www.utsouthwestern.edu/research/translational-medicine/education/grant-writing/r-grant/index.html) is offered jointly by the Center for Translational Medicine and the Office of Faculty Diversity and Development/Women’s Careers. The goals of the UT Southwestern SOAR program are to:

  1. Increase the number of NIH grant applications submissions by junior faculty
  2. Increase the number of grant application success rates
  3. Decrease the number of grant resubmissions

As part of the SOAR program, we will launch a pilot “Intensive Junior Faculty R-Grant Writers Workshop” in March 2016 that is targeted for the June 2016 NIH submission cycle. Participants will attend 6 weekly 2-hour long sessions in which they are engaged in peer review of each other’s target grant sections for that week. The sessions will be moderated by Helen L. Yin, PhD (http://profiles.utsouthwestern.edu/profile/18242/helen-yin.html). In addition, there will be a mock “Grant Review Study Session” four weeks prior to the final NIH submission deadline.

This announcement is intended to give you sufficient time to plan to fulfill the prerequisites for applying for the Workshop (deadline of Feb. 2016).

Expectations:

  1. Be actively writing your NIH R series research grant (such as R01, R03, R21 etc.) and have a working draft before the Workshop begins.
  2. Commit time outside of the Workshop in order to:
    1. Write and turn in your section for the week no later than the date listed below in Microsoft Word format
    2. Read and critique each other’s sections prior to the session date, and offer constructive verbal feedback at each session
    3. Work on other sections of the grant not included in the workshop (e.g. budget, letters of collaboration, resources, cover letter etc.)
  3. Attend and be actively engaged in all session discussions
    1. You must arrange your schedule accordingly
    2. Missing more than one session (without substantial and unavoidable justifications) will dismiss you from the Workshop and exclude you from enrollment in future Workshops
  4. Have a complete “as close to final as possible” draft (including all sections not covered by the Workshop) by 4/18/2016 for submission to the Mock Study Section.
  5. Submit an evaluation on the form to be provided for the Workshop
  6. Notify us when you receive your grant review scores, and/or obtain this or other types of grants.

We will be tracking your progress, to determine if the Soar R-Grant Writers Workshop achieves its stated goals and justifies institutional investment in the Program.

Workshop Schedule:

table 1

 

 

Application and Selection Criteria:

  1. Candidate and Prerequisites: This Workshop is designed for serious NIH R-series research grant writers. You must already have a working draft of your grant application by the start of the Workshop. The reason is that unless you already have a draft of your grant by the start date, it will be difficult to keep up with the pace of the workshop and to benefit maximally.
  2. Application Procedure: The anticipated application and acceptance timeline are summarized in Table 2.

table 2

 

A completed application has 4 parts:

  1. The Application form in RedCap.
  2. A draft of your Specific Aims page, with proposed grant title.
  3. A draft of your NIH biosketch in the current NIH-mandated format.
  4. A letter of recommendation from your division chief/or department chair/or center director, stating that he/she supports your enrollment and that you will have protected time to write the grant. Additional details will be provided in the SOARRWriters website (to be published)

Items 1-3 should be uploaded to RedCap by the candidate by 2/4/2016 (Table 2); item 4 should be sent by your supervisors directly to SOARRWriters@UTSouthwestern.edu by 2/9/2016.

  1. Candidate Selection. We welcome your applications. In the event that there is a high demand beyond our ability to accommodate 8 participants per cycle, we may regrettably have to admit a subset of applicants for this inaugural workshop.

 

Selection criteria include, but are not limited to, the following:

  1. Whether you are submitting your first R-series research grant.
  2. Whether you are resubmitting an R-series research grant.
  3. Our assessment of
    1. your readiness to submit a competitive grant, based on your specific aims, publication records, and grant funding history (from your NIH biosketch)
    2. your commitment to the Workshop
  4. Consideration will be given to assemble a diverse group of writers, from a variety of disciplines.
  5. Candidate Notification and Letter of Commitment. Accepted candidates will be notified on 2/16/2016, and letter of commitment by the accepted candidate will be due on 2/25/2016 (Table 2). Those not immediately accepted will waitlisted, and notified should there be an unexpected opening.

Thank you very much for your support!

 

APPLICATION FORM – Click here to open application

 

 

Seek, Test, Treat and Retain For Youth and Young Adults Living with or at High Risk for Acquiring HIV (R01)

RFA-DA-16-010
Seek, Test, Treat and Retain For Youth and Young Adults Living with or at High Risk for Acquiring HIV (R01)
Department of Health and Human Services
National Institutes of Health

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Section I. Funding Opportunity Description
Background

The “Seek, Test, Treat, and Retain” (STTR) approach to HIV prevention involves reaching out to high-risk, hard-to-reach groups who have not been recently tested for HIV (Seek), engaging them in HIV testing (Test), initiating, monitoring, and maintaining antiretroviral therapy (ART) for those testing HIV+ positive (Treat) and retaining patients in HIV and other relevant care (Retain) to impact HIV transmission on a population basis. The STTR paradigm has demonstrated efficacy in reducing HIV transmission at a population level among various key populations. Limited and inconsistent focus has been placed on the STTR paradigm among adolescents and young adults (defined in this RFA as 13-25 years of age) in the United States and internationally, particularly among substance using youth.  Youth generally are less likely to know their HIV status as compared to older populations. Consistent antiretroviral use and virologic suppression among adolescents and young adults are troublingly low as compared to adults in the US, with estimates that under 10% of all HIV+ youth are suppressed.  Similar findings have been observed in foreign settings.

Numerous individual and structural factors contribute to the challenges facing adolescent and young adult populations at risk for or living with HIV. If these factors are not addressed, the likelihood of STTR approaches making a difference in HIV incidence will be limited, at best. Younger populations at-risk for HIV may be members of groups that experience health care disparities, such as sexual minorities and, in the US, ethnic/racial minorities. High rates of substance use/abuse, particularly marijuana, alcohol, and stimulants, as well as are seen among youth in many locales and these are associated with risky sexual behavior (e.g., condomless sex) among both HIV- and HIV+ youth and young adults. Substance use prevention has demonstrated a  role in reducing HIV sexual risk and consequences such as sexual transmitted infections (STIs) is likely to serve as a facilitator of HIV treatment adherence. Youth may be more difficult to reach because adolescence and young adulthood are periods of transition, which may include repeated geographic moves, changes in educational or work status, and changing eligibility for entitlements and health insurance. HIV+ youth may transition from pediatric and adolescent health settings to adult health care settings with little systematic transfer of health records and clinical follow-up. Laws that govern the role of parents in the health care of youth and the autonomy of minors vary greatly within the US and across countries. These laws affect the ability of youth to seek HIV testing services, as well as services for substance use problems. Laws also may affect autonomy to participate in parts of STTR (e.g., initial screening and perhaps treatment of collateral, contributory problems such as STIs or substance abuse). Cultural norms may lead to parent or guardian involvement in health care decisions after youth reach majority in many places.  Therefore, involvement of parents and guardians needs to be a continuing consideration.

Because adolescents and young adults have not achieved full physical or cognitive maturity, linking and retaining HIV+ youth in care can be challenging. There is a dearth of HIV-specialty care geared toward adolescents and a lack of attention to their developmental needs. Where adolescent services exist there often is an absence of seamless transition to adult-based health care when they become adults. Beyond reproductive health care for young women, there is no systematic focus for routine and preventive health care among youth (regardless of HIV status) and young people realistically may perceive that they are at low risk for many of the most common chronic conditions like HIV, and may only engage health care for accidents or obvious clinical symptoms.

There are a small number of HIV or substance use providers who target youth, whereas most services are designed for adults. Simply promoting utilization of these adult-focused services by youth may fail to surmount the structural and other factors that govern the health behavior of younger people. Because youth may access HIV testing at community sites outside of the health care system, linkage between organizations that target and service youth (e.g., non-governmental organizations, social service, juvenile justice) and health care systems is important, as well as coordination of collateral services, as needed, for comorbid conditions that interfere with treatment adherence or virologic response (e.g., substance use disorders, STIs).

Research Objectives

The purpose of this FOA is to examine delivery models of HIV-focused services (testing, linkage, engagement and retention in care) for high risk or already HIV+ infected youth and young adults, with the ultimate goal of preventing HIV acquisition or onward transmission. Applications should incorporate substance use into study aims; objectives should address access to substance use prevention, screening, and/or treatment, as appropriate. Applications examining interventions that focus only on individual-level behavior and outcomes will be considered non-responsive, given the systemic and structural determinants of serostatus screening, treatment retention and viral suppression, which are the most striking areas of deficit among youth in the HIV continuum of care. The developmental, structural, and systemic factors related to serving youth need to be clearly incorporated into study aims, rather than simply refocusing existing interventions to younger people. Projects do not need to address the complete STTR continuum but should clearly address areas of particularly significant deficits for serving youth. Merely providing referrals to specialty care settings – without structural supports to ensure receipt of the referred service and ongoing coordination of care among service providers – is insufficient to be responsive to this FOA. Applications should demonstrate empirically that the target population is at high risk for HIV acquisition or has elevated rates of current HIV infection, and is therefore of high priority for testing, screening, or linkage. Integration of collateral services (e.g., substance use or STI treatment; prevention or early intervention for substance use) needs to be clearly integrated into the STTR framework, but should not be the primary focus of the study outcomes.

Because youth are likely to be early in their sexual development and can be exposed to the HIV virus over the course of years of subsequent sexual activity, it is imperative that projects that include screening also provide effective prevention modalities to HIV-negative youth. The purpose of this FOA is not to develop new prevention modalities, but projects are expected to incorporate, implement, and evaluate efficacious interventions with consideration to biologic as well as behavioral approaches. Projects should provide an evidence-based rationale for how their approach will lead to the expected outcomes, utilizing behavioral, social, organizational systems or other applicable theory.

Projects need not encompass the full age range covered by this FOA (ages 13-25) but a rationale should be provided for the age range that is chosen, and the components of the proposed project should be developmentally appropriate to that age group and their HIV and substance use epidemiology. Applicable laws regarding the participation of minors in research and clinical care vary widely, however, this should not preclude consideration of younger age groups, nor should it exclude consideration of parent or guardian roles among youth of any age.

Projects should take into account NIH HIV/AIDS research priorities http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-137.html

General Information

Document Type: Grants Notice
Funding Opportunity Number: RFA-DA-16-010
Funding Opportunity Title: Seek, Test, Treat and Retain For Youth and Young Adults Living with or at High Risk for Acquiring HIV (R01)
Opportunity Category: Discretionary
Funding Instrument Type: Grant
Category of Funding Activity: Education
Health
Category Explanation:
Expected Number of Awards:
CFDA Number(s): 93.279 — Drug Abuse and Addiction Research Programs
Cost Sharing or Matching Requirement: No
Posted Date: Dec 8, 2015
Creation Date: Dec 8, 2015
Original Closing Date for Applications: Mar 2, 2016  
Current Closing Date for Applications: Mar 2, 2016  
Archive Date: Apr 2, 2016
Estimated Total Program Funding: $3,000,000
Award Ceiling:
Award Floor:

Eligibility

Eligible Applicants:
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Independent school districts
Native American tribal governments (Federally recognized)
Public housing authorities/Indian housing authorities
State governments
Native American tribal organizations (other than Federally recognized tribal governments)
For profit organizations other than small businesses
Private institutions of higher education
Special district governments
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Public and State controlled institutions of higher education
Small businesses
County governments
City or township governments
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Additional Information on Eligibility: Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.

Additional Information

Agency Name: National Institutes of Health
Description: The purpose of this Funding Opportunity Announcement (FOA) is to examine seek, test, treat and retain approaches among youth and young adults (ages 13-25) who are at high risk for HIV acquisition or have already acquired HIV. Applications should incorporate substance use into study aims; objectives should address substance use prevention, screening, and/or treatment in ways that facilitate use of HIV prevention and treatment services. Youth are the target of this RFA because they demonstrate lower levels of screening and engagement across the HIV continuum of care and HIV+ youth are less likely to achieve viral suppression than those at older ages. These disparities are evident in US and foreign populations. The developmental, structural, and systemic factors related to serving youth need to be clearly incorporated into study aims, rather than simple incremental refocusing of existing interventions to younger people. Both domestic and international projects will be supported
Link to Additional Information: http://grants.nih.gov/grants/guide/rfa-files/RFA-DA-16-010.html
Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

NIH OER Webmaster FBOWebmaster@OD.NIH.GOV
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