Identification of Mechanisms Mediating the Effects of Sleep on Diabetes-Related Metabolism in Humans (R01)

RFA-DK-16-005
Identification of Mechanisms Mediating the Effects of Sleep on Diabetes-Related Metabolism in Humans (R01)
Department of Health and Human Services
National Institutes of Health

Section I. Funding Opportunity Description

The purpose of this FOA is to invite applications that investigate the mechanisms mediating the interactions between sleep and diabetes-related metabolism using deep metabolic phenotyping approaches in healthy human populations and those with metabolic and/or sleep disorders.diabetes

Large, epidemiological studies support an association between disrupted sleep [sleep deprivation, sleep fragmentation, short sleep, and obstructive sleep apnea (OSA)] and dysregulated metabolism, specifically increased body weight and/or glucose intolerance. Small studies conducted primarily in healthy control subjects also indicate that laboratory-induced sleep deprivation impairs insulin sensitivity and may have effects on other metabolic indices that impact insulin sensitivity and glucose tolerance including circulating inflammatory markers, lipid metabolism, autonomic nervous system activity and food intake.  Small studies conducted in clinical populations such as individuals with OSA, also show a relationship between OSA and impaired glucose tolerance or decreased insulin sensitivity relative to matched controls. However, while small studies show treatment of OSA generally seems to improve insulin sensitivity, there are minimal effects on glucose tolerance.

The mechanisms mediating impairment of glucose metabolism and insulin sensitivity by sleep disruption are not known. Current animal models of sleep disruption often do not replicate the human sleep disorders and thus limit translation of findings from rodents into humans. To date, human studies examining the effects of sleep disruption on diabetes related metabolism have not included in-depth metabolic phenotyping that would contribute to elucidating potential mediators or to identifying the tissue site (or sites) associated with disrupted metabolism. Furthermore, the majority of studies on human sleep and glucose metabolism have been conducted in healthy subjects whose sleep has been disrupted by various interventions in a controlled laboratory setting. Few studies have attempted to treat sleep disorders in populations with metabolic or sleep disorders and demonstrate improvements in glucose homeostasis or diabetes-related metabolism. Identifying a population with a known metabolic or sleep disorder and being able to demonstrate that a therapeutic sleep intervention can ameliorate abnormalities in glucose or diabetes-related metabolism would have important clinical implications.

This FOA invites applications which propose in-depth metabolic phenotyping in carefully selected clinical populations to determine how changes in sleep (improvements or disruptions) influence diabetes-related metabolism. Applications should systematically test a physiological model with the goal of elucidating possible mediators of the reported effects of sleep on glucose metabolism. Applications that propose therapeutic interventions to improve sleep and determine the consequences on diabetes-related metabolism must have preliminary data demonstrating that the proposed method for improving sleep is actually efficacious.

General Information

Document Type: Grants Notice
Funding Opportunity Number: RFA-DK-16-005
Funding Opportunity Title: Identification of Mechanisms Mediating the Effects of Sleep on Diabetes-Related Metabolism in Humans (R01)
Opportunity Category: Discretionary
Opportunity Category Explanation:  
Funding Instrument Type: Grant
Category of Funding Activity: Food and Nutrition
Health
Category Explanation:  
Expected Number of Awards:  
CFDA Number(s): 93.313 — NIH Office of Research on Women’s Health
93.847 — Diabetes, Digestive, and Kidney Diseases Extramural Research
Cost Sharing or Matching Requirement: No
Version: Synopsis 1
Posted Date: Aug 17, 2016
Last Updated Date: Aug 17, 2016
Original Closing Date for Applications: Oct 11, 2017  
Current Closing Date for Applications: Oct 11, 2017  
Archive Date: Nov 11, 2017
Estimated Total Program Funding:  
Award Ceiling: $499,999
Award Floor:  

Eligibility

Eligible Applicants: Small businesses
Public and State controlled institutions of higher education
Public housing authorities/Indian housing authorities
State governments
City or township governments
For profit organizations other than small businesses
Independent school districts
Native American tribal governments (Federally recognized)
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Private institutions of higher education
Special district governments
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Native American tribal organizations (other than Federally recognized tribal governments)
County 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; 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: The purpose of this Funding Opportunity Announcement is to invite applications that investigate the mechanisms mediating the interactions between sleep and diabetes-related metabolism using deep metabolic phenotyping approaches in healthy human populations and those with metabolic and/or sleep disorders.
Link to Additional Information: http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-16-005.html
Grantor 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

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Ancillary Studies to Identify Behavioral and/or Psychological Phenotypes Contributing to Obesity (R01)

PAR-16-304
Ancillary Studies to Identify Behavioral and/or Psychological Phenotypes Contributing to Obesity (R01)
Department of Health and Human Services
National Institutes of Health

obesity

Section I. Funding Opportunity Description

The drivers of obesity are complex and individual behavioral factors are not independent from genes, physiology, the brain, and the influence of the environment. For example, there is general agreement that a permissive food environment, low levels of physical activity and sedentary lifestyle contribute to obesity. However, environmental factors, alone, are unlikely to fully explain differential risk for obesity development or response to treatment.  Within similar environments there is considerable individual variability in weight or weight gain trajectory. Further, despite the evidence that behavioral weight loss can be efficacious and lead to meaningful health outcomes, there is wide variability in response to prevention and treatment interventions, and varying degrees of maintenance of weight loss following an intervention. Underlying genetic, epigenetic, and metabolic factors interacting with the environment likely contribute to this individual variability. To better understand this complexity, there is a need to improve the depth of our understanding about the contributing factors at the various levels of analysis; including individual behaviors and psychological factors that contribute to endophenotypes.

For the purposes of funding opportunity, a behavioral or psychological phenotype is defined as a pattern of behavior or psychological characteristics that are measurable/quantifiable and distinct (explains individual variation). An endophenotype is an intermediate phenotype that is the result of the combination of what is inherited and the environment.  The goal of this initiative is to identify the behavioral and/or psychological expression (phenotype) of this interaction that meaningfully explains individual variability in weight gain trajectory, response to prevention or treatment, and treatment engagement and adherence. The identification of these phenotypes should improve treatment matching or identify novel targets for more efficacious individual and population level approaches for weight management.

Types of ancillary studies might include, but are not limited to:

  • Addition of objective measurement of weight, BMI, and/or body composition to studies that are already obtaining detailed measurement of psychological characteristics hypothesized to be related to individual weight variability including obesity development and response to interventions.
  • Addition of measures of psychological factors and/or an objective measurement of eating behavior in studies that are already objectively measuring weight, BMI and/or body composition.

Addition of measurement in a domain already covered in the parent (e.g.; a new body composition measure in a study that already includes measures of body composition), is not consistent with the intent of this funding announcement. The goal is to support the addition of new measurement in domains other than those covered in the parent grant as a means of elucidating the behavioral and psychological factors that may explain individual differences in weight status.

Studies can be ancillary to longitudinal observational research or intervention trials.  Applicants can propose ancillary studies to ongoing R01 or equivalent studies as well as major ongoing clinical trials or longitudinal observational epidemiological studies. Studies can be ancillary to research funded at agencies other than the NIH but, regardless of the funder, applicants must clearly demonstrate approval and cooperation from the PD/PI or study team of the parent grant for the activities proposed in response to the funding opportunity announcement.

Regardless of the type of study design, there must be a plan to measure the variables of interest in the same cohort at a minimum of two well justified time points. Cross sectional and purely correlative research is not consistent with the goals of this initiative.

Studies with well-articulated mechanistic hypotheses are encouraged. We would also encourage research that examines how the behavioral or psychological factors measured interact with measures of brain processes, physiological variables thought to drive obesity, genetic, and environmental or social influences. Studies include collaborations between experts in psychological/behavioral measurement and metabolic phenotyping are encouraged.

Behavioral and/or psychological characteristics of interest include, but are not limited to:

  • Objective observation of eating behavior such as quantity, selection/quality, and speed of intake.
  • Underlying psychological processes of self-regulation thought to be related to obesity prevention or treatment response.  Self-regulation is the process of managing emotional, motivational and cognitive resources to align mental states and behavior with energy intake goals. Additional measures proposed should already be well validated for the population and mode of assessment.

Examples include:

  • Disinhibited eating such as loss of control, dietary restraint, and response to external or internal food cues;
  • Learning/motivational processes such as reward sensitivity, model-free and model-based reward learning, and reward maximization and effort minimization;
  • Cognitive processes such as simple and complex attention; executive function and working memory, including mental set-shifting, goal updating and monitoring, and cognitive control (response selection, inhibition, or selection); and
  • Affective /emotional characteristics such as high/low valence and arousal or patterns of approach and avoidance.

Primary outcomes must include weight, BMI, body composition or objective measures of eating behavior. Self-reported measures of dietary intake will not be sufficient as a primary outcome. For the purposes of this FOA, a focus on energy intake must include objective measures of energy intake such as doubly labelled water, direct observation of energy intake, use of technology to record aspects of eating in real world settings such as use of photography or monitors that capture eating episodes, or other validated technologies from which calculation of energy intake reliably can be derived, such as doubly labeled water. Psychological or behavioral measures should have demonstrated validity and reliability. Where possible, use of existing and well validated measurement tools is encouraged (e.g.; HealthMeasures (http://www.healthmeasures.net/)  such as PROMIS, NIH Toolbox, and Neuro-QoL or PhenX https://www.phenxtoolkit.org/ )).

Research is encouraged in populations across the life course and identifying behavioral or psychological phenotypes in high risk or underserved populations is also a priority.

Research submitted to this FOA should be in human subjects. Research in animals is not consistent with the aims of this FOA.

General Information

Document Type: Grants Notice
Funding Opportunity Number: PAR-16-304
Funding Opportunity Title: Ancillary Studies to Identify Behavioral and/or Psychological Phenotypes Contributing to Obesity (R01)
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Grant
Category of Funding Activity: Food and Nutrition
Health
Category Explanation:
Expected Number of Awards:
CFDA Number(s): 93.847 — Diabetes, Digestive, and Kidney Diseases Extramural Research
Cost Sharing or Matching Requirement: No
Posted Date: Jun 01, 2016
Last Updated Date: Jun 01, 2016
Original Closing Date for Applications: Feb 28, 2019  
Current Closing Date for Applications: Feb 28, 2019  
Archive Date: Mar 31, 2019

Eligibility

Eligible Applicants:
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Small businesses
Special district governments
City or township governments
Independent school districts
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Public and State controlled institutions of higher education
Private institutions of higher education
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
State governments
County governments
Public housing authorities/Indian housing authorities
Native American tribal governments (Federally recognized)
For profit organizations other than small businesses
Native American tribal organizations (other than Federally recognized tribal 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; 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: The purpose of this Funding Opportunity Announcement (FOA) is to encourage grant applications to support the addition of measures of psychological and/or behavioral constructs or weight-related variables (e.g.; BMI, body composition) to existing or new research studies in humans with the goal of elucidating behavioral or psychological phenotypes that explain individual variability in weight trajectory or response to obesity prevention or treatment interventions. The intent is to support the addition of new measurement in domains other than those covered in the parent grant as a means of elucidating the behavioral and psychological factors that may explain individual differences in weight status. For the purposes of this FOA, behavioral factors related to energy intake include overt actions/behavior (e.g.; objective observation of eating event including measures such as quantity, selection/quality, and speed of intake) and underlying psychological processes related to self-regulation of intake such as cognitive control, affective response, learning, and motivation. The rationale is that an improved understanding of the individual characteristics and processes that explain energy intake patterns can lead to better matching of individuals to prevention or treatment approaches and identify novel targets for more efficacious individual and population level approaches to weight management.
Link to Additional Information: http://grants.nih.gov/grants/guide/pa-files/PAR-16-304.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

Methodology and Measurement in the Behavioral and Social Sciences (R01)

PAR-16-260
Methodology and Measurement in the Behavioral and Social Sciences (R01)
Department of Health and Human Services
National Institutes of Health

Scintific_Methods

Purpose

The behavioral and social sciences offer significant fundamental insights into the comprehensive understanding of human health, including disease etiology, prevention, treatment, and the promotion of health and well-being. To advance the investigation of behavioral and social factors in health and disease, and enhance the rigor and reproducibility of study results, the participating Institutes and Centers (ICs) invite qualified researchers to submit research grant applications on methodology and measurement in the behavioral and social sciences relevant to the missions of the NIH ICs.

Background

Methodology encompasses research design, measurement, data collection, and data analysis techniques. Research design addresses selection of appropriate study designs, inclusion/exclusion criteria, sampling plan, study subject protections, participant engagement and recruitment, and procedures and measures to accomplish the research goals and ensure internal and external validity. Measurement addresses the quantification and characterization of study variables relevant to the research hypotheses, in a manner that maximizes the validity, reliability, and utility of the data.  Data collection techniques are the tools and procedures for acquiring, integrating and curating data from a wide range of sources, such as self-reports, geocoded mobile devices, sensors, biomarker assay platforms, and complex large-scale datasets. Analytic methods address the conceptual and technical aspects of analyzing, interpreting and reporting data to improve hypothesis testing and prediction. Advancement of methodologic research in design, measurement, data collection and data analysis will enhance the quality and power of human and animal data in health-related behavioral and social science.

Research Objectives

Applicants are encouraged but not required to address methodologic issues related to:

  • interdisciplinary, multimethod, and multilevel approaches in behavioral and social science research, including broadly applicable approaches that foster integration with biomedical, physical, or computational science research or engineering.
  • Integrating, mining and modeling behavioral and social science data in combination with genetic, epigenetic, biomarker and imaging data.
  • research in diverse populations that are distinctive by virtue of demographics, cultural or linguistic characteristics, sexual orientation or gender identity, health system, mental or physical abilities, underrepresentation in research or other factors, where the outcome would have a significant impact on improving health in that population.
  • the study of sensitive health-related behaviors in the context of healthcare, the social environment, and local/state/national policies.
  • ethics in research, such as informed consent, enrollment of minors including assent, assessment of risk and benefit, selection and retention of participants, privacy and confidentiality.

General Information

Document Type: Grants Notice
Funding Opportunity Number: PAR-16-260
Funding Opportunity Title: Methodology and Measurement in the Behavioral and Social Sciences (R01)
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Grant
Category of Funding Activity: Education
Health
Category Explanation:
Expected Number of Awards:
CFDA Number(s): 93.173 — Research Related to Deafness and Communication Disorders
93.213 — Research and Training in Complementary and Integrative Health
93.273 — Alcohol Research Programs
93.313 — NIH Office of Research on Women’s Health
93.393 — Cancer Cause and Prevention Research
93.399 — Cancer Control
93.853 — Extramural Research Programs in the Neurosciences and Neurological Disorders
93.866 — Aging Research
93.867 — Vision Research
Cost Sharing or Matching Requirement: No
Posted Date: May 16, 2016
Last Updated Date: May 16, 2016
Original Closing Date for Applications: Sep 07, 2019  
Current Closing Date for Applications: Sep 07, 2019  
Archive Date: Oct 08, 2019
Estimated Total Program Funding:  Not Listed
Award Ceiling:  Not Listed
Award Floor:

Eligibility

Eligible Applicants:
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Small businesses
For profit organizations other than small businesses
City or township governments
Public and State controlled institutions of higher education
Independent school districts
County governments
Special district governments
State governments
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Native American tribal organizations (other than Federally recognized tribal governments)
Public housing authorities/Indian housing authorities
Native American tribal governments (Federally recognized)
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Private 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 invite qualified researchers to submit grant applications aimed at improving and developing methodology in the behavioral and social sciences through innovations in research design, measurement, data collection and data analysis techniques.
Link to Additional Information: http://grants.nih.gov/grants/guide/pa-files/PAR-16-260.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

For Information on the R21 associated with this grant please click the following link:
http://www.grants.gov/web/grants/view-opportunity.html?oppId=283874

Adult Maturational Changes and Dysfunctions in Emotion Regulation (R01)

RFA-MH-17-405
Adult Maturational Changes and Dysfunctions in Emotion Regulation (R01)
Department of Health and Human Services
National Institutes of Health

brain

Background

Research suggests that, for many adults, normal aging is associated with general trends toward improved emotion regulation (e.g., as evidenced by increasing positive and decreasing negative affect, greater emotional stability, higher life satisfaction, a “positivity effect” in information-processing).  As compared with younger adults, older adults often show superior emotion regulation capacities, employ different strategies for executive control of emotional information, and recruit different neural networks in performing affective tasks.  Such patterns have been variously hypothesized to stem from increased motivation to maintain emotional well-being, learning of more skillful and efficient emotion processing strategies, or compensatory adaptations to age-related brain changes. A number of hypotheses regarding the strategies older adults employ to regulate emotion and the neurobiological systems that support them remain untested.  There is also considerable evidence that men and women process emotions differently, though, to date, evidence is scarce regarding whether and how sex differences may be modulated during the aging process.

Not all adults demonstrate the positive emotion regulation profiles that characterize adaptive aging.  To date, there has been little mechanistic research focused on sources of individual variability in development and maturation of emotional regulatory functions. Mood and anxiety disorders are considered examples of affect dysregulation.  However, knowledge tends to be limited about the specific emotion processing deficits involved, and how these may change with maturation.  Few studies employing affective neuroscience methods have examined adult maturational processes relative to mental disorder.  There has been little scientific investigation of the extent to which adults with affective disorders manifest or fail to show the normative maturational shifts, or at what point(s) during the adult lifespan they may tend to traverse divergent emotion regulation trajectories.

In addition, significant gaps remain in our understanding of successful emotion regulation in adults aging without mental disorders.  It is paradoxical that, despite normative cognitive declines with age, many aspects of emotional function improve with age.  Though attributed to improved emotional regulatory strategies, such strategies frequently rely on the same cognitive control capacities that decline with aging.  Numerous questions remain regarding the role of cognitive control in adaptive emotional aging, alternative strategies that older adults might employ to regulate emotion, the cognitive processes that undergird those strategies, and the causes of individual variation in the ability to engage these strategies with advancing age.

General Information

Document Type: Grants Notice
Funding Opportunity Number: RFA-MH-17-405
Funding Opportunity Title: Adult Maturational Changes and Dysfunctions in Emotion Regulation (R01)
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Grant
Category of Funding Activity: Health
Category Explanation:
Expected Number of Awards:
CFDA Number(s): 93.242 — Mental Health Research Grants
93.866 — Aging Research
Cost Sharing or Matching Requirement: No
Posted Date: Mar 29, 2016
Last Updated Date: Mar 29, 2016
Original Closing Date for Applications: Jul 22, 2016  
Current Closing Date for Applications: Jul 22, 2016  
Archive Date: Aug 22, 2016
Estimated Total Program Funding:
Award Ceiling:
Award Floor:

Eligibility

Eligible Applicants:
State governments
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Small businesses
Independent school districts
For profit organizations other than small businesses
Public and State controlled institutions of higher education
Private institutions of higher education
Native American tribal governments (Federally recognized)
Public housing authorities/Indian housing authorities
Special district governments
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Others (see text field entitled “Additional Information on Eligibility” for clarification)
County governments
Native American tribal organizations (other than Federally recognized tribal governments)
City or township 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: This funding opportunity announcement (FOA) invites applications for mechanistic research on how age- and sex-related changes in emotion processing develop over the adult life course and how these changes may interact with and inform the understanding of affective dysregulation in adult mental disorders and Alzheimer’s disease.In particular, research is sought that will leverage the already established normative backdrop of generally improved emotion regulation with aging, as well as research that will expand this evidence base.One aim is to clarify the trajectories of change in emotion processing and linked neurobiological and neurobehavioral factors in aging adults who experience mood and anxiety disorders.Equally important aims are to advance understanding of the factors involved in normative maturational shifts in these processes and of sources of individual variation therein, and to clarify how such shifts (or lack thereof) may relate to irregularities in the integrative neural-behavioral mechanisms of affect regulation seen in these adult mental disorders and in Alzheimer’s disease.It is anticipated that such studies may identify novel targets for mental health interventions or prevention efforts, or provide clues as to which available intervention strategies might be optimally applied to normalize emotion dysregulation or to strengthen emotional resilience at particular stages of the adult life cycle.
Link to Additional Information: http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-17-405.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

B Cell Immunology Program for HIV-1 Vaccine Development (BCIP) (R01)

B Cell Immunology Program for HIV-1 Vaccine Development (BCIP) (R01)maxresdefault

Research Objectives

Emerging research findings about B cell biology need to be harnessed for developing rationally-designed vaccines against HIV-1. This FOA will support mechanistic studies with the goal of informing novel immunization strategies for generating optimal/preferable B cell responses against HIV-1.

This FOA will also support studies focused on acquiring a deeper understanding of the mechanisms by which current HIV-1 vaccine platforms induce Ab responses and the development of strategies to improve these responses. HIV-1 vaccine research is entering a time of great opportunity, and integrated approaches that dissect the mechanisms governing vaccine-induced, antigen-specific immune responses in humans will be valuable in developing an effective HIV-1 vaccine.

Specific Areas of Research Interest

This FOA is restricted to hypothesis-driven mechanistic studies. Applicants are strongly encouraged to contact, well in advance of submission, the Scientific/Research Contact  to discuss the appropriateness of the scope of the proposed project.

Areas of interest include, but are not limited to, the following:

  • Acquire a better understanding of the consequences of modulating innate and/or T cell pathways on the humoral immune response against HIV-1.
  • Explore approaches to direct B cell fate for the generation of long-term memory and persistent Ab production.  Examples may include previously established adjuvants, immunomodulators, and antigen delivery systems, either alone or in combination.
  • Identify ways to induce and maintain B cell lineages in relevant anatomical niches following vaccination against HIV-1.
  • Acquire an understanding of the relationship between the subpopulations of B cells generated during vaccination and affinity maturation or the durability of the anti-HIV-1 Ab response.
  • Studies that benchmark the response to HIV-1 immunogens against the response to other infectious agents or model systems.
  • Studies that employ multiparametric analysis (e.g. specificity, class, affinity, post-translational modifications) for profiling Ab responses to HIV-1 immunogens and the application of this knowledge to regulate desirable B cell responses in improved HIV-1 vaccine platforms.
  • Acquire an understanding of the antigenic variation, vaccine design (e.g. protein vs. DNA vs. live vector) and immunization strategies (e.g. prime-boost, differential dosing and number of immunizations, and intervals) for programming Ag-specific B cells at prime and/or during recall.
  • Studies designed to harness the role of B cells in regulating T cell immunity against HIV-1.
  • Studies to modulate desirable Ab-effector functions with durable protective properties against HIV-1 acquisition.
  • Studies exploring immunocomplexes for the maturation of the antibody response against HIV-1.

SOURCE: National Institute of Allergy and Infectious Diseases (NIAID)
APPLICATION DEADLINE: Letter of Intent: 2/17/16. Application: 3/17/16 by 5 pm local time of applicant organization.
$ AVAILABLE: NIAID intends to commit $2 million in FY2017 to fund two to three awards.
ELIGIBILITY: * Public/state/private controlled institutions of higher education.
* Hispanic-serving institutions.
* Historically Black Colleges and Universities (HBCUs).
* Tribally Controlled Colleges and Universities (TCCUs).
* Alaska native and native Hawaiian serving institutions.
* Asian American Native American Pacific Islander Serving Institutions (AANAPISIs).
* Nonprofits with or without 501(c)(3) IRS status (other than institutions of higher education).
* Small businesses.
* For-profit organizations (other than small businesses).
* State governments.
* County governments.
* City or township governments.
* Special district governments.
* Indian/Native American tribal governments (federally recognized and other than federally recognized).
* Eligible agencies of the federal government.
* U.S. territories or possessions.
* Independent school districts.
* Public housing authorities/Indian housing authorities.
* Native American tribal organizations (other than federally recognized tribal governments).
* Faith-based or community-based organizations.
* Regional organizations.
* Non-domestic (non-U.S.) entities (foreign institutions).
PURPOSE: The objective of this Funding Opportunity Announcement (FOA) is to solicit hypothesis-driven, multidisciplinary research to elucidate the complexities and developmental plasticity of B cells associated with the induction of potent, durable, adaptive immune responses against HIV-1.
CFDA: 93.855, 93.856
CONTACT: Please see URL for multiple contacts.

For more information see http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-15-055.html
From CDC National Prevention Information Network’s (NPIN) HIV/Hepatitis/STD/TB Funding Information email, 10/29/15icon
Subject(s) HIV/AIDS research

Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)

Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01): RFA-FD-15-001
SOURCE: U.S. Food and Drug Administration (FDA), Office of Orphan Products Development (OPD)
APPLICATION DEADLINE: 2/3/16, 2/1/17, 2/7/18.
$ AVAILABLE: $14.1 million in FY2016, FY2017, FY2018, and FY2019.

orphan-drugs-acts-past-and-current-scenario-with-upcoming-drugs-20-638
Background

The OPD was created to identify and promote the development of orphan products. Orphan products are drugs, biologics, medical devices, and medical foods that are indicated for a rare disease or condition. The term “rare disease or condition” is defined in 21 U.S.C. 360ee.  As a practical way to implement the statutory definition, for devices and foods as well as for drugs, FDA considers drugs, devices, and medical foods potentially eligible for grants under the OPD grant program if they are indicated for a disease or condition that has a prevalence, not incidence, of fewer than 200,000 people in the United States. Diagnostics and vaccines are considered potentially eligible for such grants only if the U.S. population to whom they will be administered is fewer than 200,000 people in the United States per year.

Research Objectives

The goal of FDA’s OPD grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the proposed product will be superior to the existing therapy. FDA provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products. Applicants must include in the application’s Background and Significance section documentation to support that the estimated prevalence of the orphan disease or condition in the United States is less than 200,000 (or in the case of a vaccine or diagnostic, information to support that the product will be administered to fewer than 200,000 people in the United States per year),and an explanation of how the proposed study will either help support product approval or provide essential data needed for product development.  Additional information may be required upon request, for example, regarding population estimate and rationale.  This additional information may be required, in part, to assure that human clinical trials of drugs are eligible to receive funding under the OPD grant program.  21 U.S.C. 360ee(b)(1)(A).See Section VIII, Other Information – Required Federal Citations, for policies related to this announcement.

– See more at: http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-15-001.html#sthash.KSPsucAw.dpuf
ELIGIBILITY: * Public/state/private controlled institutions of higher education.
* Hispanic-serving institutions.
* Historically Black Colleges and Universities (HBCUs).
* Tribally Controlled Colleges and Universities (TCCUs).
* Alaska native and native Hawaiian serving institutions.
* Asian American Native American Pacific Islander Serving Institutions (AANAPISIs).
* Nonprofits with or without 501(c)(3) IRS status (other than institutions of higher education).
* Small businesses.
* For-profit organizations (other than small businesses).
* State governments.
* County governments.
* City or township governments.
* Special district governments.
* Indian/Native American tribal governments (federally recognized and other than federally recognized).
* U.S. territories or possessions.
* Independent school districts.
* Public housing authorities/Indian housing authorities.
* Native American tribal organizations (other than federally recognized tribal governments).
* Faith-based or community-based organizations.
* Regional organizations.
PURPOSE: The goal of FDA’s OPD grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the product being developed will be superior to the existing therapy.
CFDA: 93.103
CONTACT: Please see URL for multiple contacts.

For more information see http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-15-001.html
From U.S. Department of Health and Human Services, Office of Minority Health FYI Weekly Health Resources email, 10/21/15icon
Subject(s) medical research, minority health

Examination of Survivorship Care Planning Efficacy and Impact (R01) and (R21)

PA-16-012
Examination of Survivorship Care Planning Efficacy and Impact (R01)
Department of Health and Human Services
National Institutes of Healthplan_beyond_cancer-slider

Specific Research Objectives

Applications are expected to assess whether care planning renders added benefits in terms of reducing morbidity, increasing adherence to follow-up guidelines, better self-management of late effects, appropriate utilization of follow-up care, and reduced cost.  The proposed research should also evaluate the pathways and processes through which such benefit is derived and clarify to whom such benefits accrue (survivors, clinicians, delivery systems, payers). Transdisciplinary approaches that link health services and health economics research with clinical, behavioral, and social science disciplines are encouraged. Studies documenting the organizational context and key processes through which successful care planning occurs are invited, including those that study how the generation and use of survivorship care plans intersects with processes of care delivery, inter-provider communication, patient-provider communication, and meaningful use of informatics. Studies linking care planning to use of electronic medical records, and exploring ways to harness electronic platforms, tools and applications are encouraged. Studies of how successful care planning initiatives are implemented in a variety of healthcare and community practice settings are encouraged. Studies may include family and caregiver outcomes in addition to survivor outcomes. Studies that will be considered for funding are limited to those that focus on individuals diagnosed with cancer at age 21 or older.

Research Applications are particularly encouraged to consider the following issues in the Research Strategy:

  • Inclusion of at least one survivor-level outcome (behavioral, physical and/or psychosocial morbidity) and at least one provider or system-level outcome (service use, time use, knowledge) related to care delivery or cost.
  • Studies assessing the impact of care planning or identifying effective models of care are expected to use comparative designs (randomized controlled trials, quasi-experimental, case-control, interrupted time series, or similar designs) that allow comparison of care planning strategies.
  • Adjunctive qualitative or quantitative observational approaches are encouraged in the context of the above designs.
  • Because the standard of care is not yet consistently established, investigators are expected to carefully document and describe the care planning protocol studied in all inquiries. Studies are encouraged to use care plans that include, but are not limited to, Institute of Medicine-recommended content for survivorship care plans.
  • Studies focused on the development and testing of instruments to evaluate survivorship care planning may use the R01 mechanism or the companion R21 mechanism, as appropriate.

Research areas of interest include, but are not limited, to:

  • What are the best constructs and outcomes for evaluating survivorship care planning and which metrics are best suited to measure these?
  • What is the impact of survivorship care planning on cancer survivors’ post-treatment psychosocial and physiologic morbidity?
  • What is the effect of survivorship care planning on adherence to screening recommendations, preventive behaviors, and self-management of late and long-term effects of cancer?
  • What is the optimal timing for delivery of survivorship care planning?
  • Does survivorship care planning decrease unnecessary health care resource utilization?
  • What are the differential costs associated with the generation and implementation of care plans versus usual care, and what value is added, if any?
  • How do care plans affect the number of patients seen/day, the length of patient visits, number of patient visits to oncology and/or primary care, information systems, and reimbursements?
  • Who should be involved, and how, in the development and delivery of care plans? What are the respective roles of oncology and primary care physicians, nurses, social workers, and other allied health professionals in the care planning process?
  • What systems, organizational and provider-level factors influence the generation, transmission, communication, usability, and ultimate consistent use of survivorship care plans?
  • What incentives and barriers affect adoption of survivorship care planning across diverse healthcare practice settings?
  • What economic strategies could encourage implementation of care planning?
  • Does provider participation in the development of care plans and the care planning process affect implementation of care planning?
  • How can electronic platforms, tools, and applications be harnessed to optimize patient knowledge, patient preparation, and/or care coordination in survivorship care planning?
  • What costs are associated with face-to-face vs. hybrid, automated, or wiki-supported approaches to survivorship care planning?

General Information

Document Type: Grants Notice
Funding Opportunity Number: PA-16-012
Funding Opportunity Title: Examination of Survivorship Care Planning Efficacy and Impact (R01)
Opportunity Category: Discretionary
Funding Instrument Type: Grant
Category of Funding Activity: Education
Health
Category Explanation:
Expected Number of Awards:
CFDA Number(s): 93.399 — Cancer Control
Cost Sharing or Matching Requirement: No
Posted Date: Oct 23, 2015
Creation Date: Oct 23, 2015
Original Closing Date for Applications: Jan 7, 2019  
Current Closing Date for Applications: Jan 7, 2019  
Archive Date: Feb 7, 2019
Estimated Total Program Funding:
Award Ceiling:
Award Floor:

Eligibility

Eligible Applicants:
Independent school districts
Small businesses
Others (see text field entitled “Additional Information on Eligibility” for clarification)
For profit organizations other than small businesses
Public housing authorities/Indian housing authorities
Public and State controlled institutions of higher education
Native American tribal governments (Federally recognized)
Native American tribal organizations (other than Federally recognized tribal governments)
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
County governments
City or township governments
Special district governments
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Private institutions of higher education
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 purpose of this Funding Opportunity Announcement (FOA) is to stimulate research evaluating the effect of care planning on self-management of late effects of cancer therapy; adherence to medications, cancer screening, and health behavior guidelines; utilization of follow-up care; survivors’ health and psychosocial outcomes. How organizational-level factors influence the implementation of care planning and its associated costs is also of interest. Specifically, the FOA aims to stimulate research that will: 1) develop and test metrics for evaluating the impact of survivorship care planning; 2) evaluate the impact of survivorship care planning on cancer survivors’ morbidity, self-management and adherence to care recommendations, utilization of follow-up care; 3) evaluate effects of planning on systems outcomes, such as associated costs and impact on providers and organizations implementing the care planning; and 4) identify models and processes of care that promote effective survivorship care planning. The ultimate goal of this FOA is to generate a body of science that will inform the development and delivery of interventions that improve follow-up care for cancer survivors.
Link to Additional Information: http://grants.nih.gov/grants/guide/pa-files/PA-16-012.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