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

Genomic Data Analysis Network: Visualization Genomic Data Center (U24)

RFA-CA-15-019h
Genomic Data Analysis Network: Visualization Genomic Data Center (U24)
Department of Health and Human Services
National Institutes of Health

Research Objectives and Main Requirements for This FOA

Expectations for GDACs in the Genomic Data Analysis Network. As a whole the GDACs must be able to:

  • Implement bioinformatic  pipelines using existing state-of-the-art tools for timely high-throughput processing and integrated analyses of genome-wide data;
  • Develop and implement new bioinformatic and computational tools to capture key biological parameters such as pathway analysis, data integration with visualization, and integrated cancer biology;
  • Develop pipeline and network-wide quality control methods for the system developed as a response to the goals stated above; and
  • Process/integrate analytical data from other components of the network to generate disease level findings and interpretations as well as cross-disease analyses.
  • These goals will necessitate continuous communication and interactions among the members of the network.  Each member of the GDAC group will have distinct functions and capabilities and be responsible for individual analytical components.

Interactions of GDACs with other members of the network. All GDAC awardees, including the Visualization GDAC to be supported under this FOA, must be able to accommodate their activities in the general scheme of the coordinated interactions across the various resources as outlined below.

  • Biospecimen Core Resource (BCR): The BCR serves as the tissue processing center and provides the molecular biomolecules for all CCG-approved projects. Standard operating procedures are used for clinical data collection, sample collection, pathological examination, biomolecule (e.g., DNA and RNA) extractions, quality control, laboratory data collection, and biomolecule distribution to the Cancer Genome Characterization Centers. The samples are required to have patient informed consent for the public release of data or an IRB waiver.
  • Genome Characterization Centers (GCCs): GCCs conduct high-throughput comprehensive genome-wide analyses using validated technologies (e.g., gene expression profiling, detection of chromosomal segment copy numbers alteration) to reveal the spectrum of genomic changes that exist in human tumors and to identify genomic regions for further characterization. The data generated by the characterization centers will be the main (but not only) starting point for the analyses performed by the GDACs.
  • Genomic Data Analysis Network (GDAN): The aggregated capabilities of the awardees from the present FOA and its companions (RFA-CA-15-018 and RFA-CA-15-020) will produce the bulk of the analysis required to interpret the data generated by the GCCs described above. This group will work closely and collaboratively with all other components of the pipeline and be responsive to the necessities of the analysis requests posed by the AWGs that will be formed for each CCG-approved project.
  • Data Management, Storage and Public Access:  The whole of the data generated by CCG-approved projects is presented to the scientific community though publically-available databases that contain not only the raw data and associated metadata, but all of the analysis files generated in the course of each project. At the time of this FOA, that task is performed by the DCC (through project-specific data portals) and CGHub. In the near future, these activities will be consolidated under a single entity, the GDC, where all members of the network will deposit their data.

Required Team Expertise. Each GDAC applicant team must have current expertise in computational data analysis and genomics-specific bioinformatics as well as clinical oncology and/or cancer biology. GDACs would benefit greatly by being jointly led by two investigators: (i) an expert in bioinformatics/computation and (ii) either a clinical oncologist or a cancer biologist who can help to guide the analyses and contribute to the interpretation of the results at the disease-level.

GDACs differ by the proportion of the effort devoted to the development of novel analyses, but each GDAC will be required to develop novel approaches to data analysis and data integration.  The analytical pipelines will be available as a resource to the scientific community for data integration and for advanced translational evaluation of genomic data.  The analytical pipelines may result in valid conclusions which are not 100% concordant due to the different analytical methods used.  The GDACs will need to develop annotation which will be made available along with the pipeline to explain any differences in data interpretation to the research community.

Specific Objectives for Visualization GDAC. The proposed Visualization GDAC must have all the expertise, personnel, instrumentation and throughput capabilities that will be required for the objectives defined below (with additional specific details in Section IV, under “Research Strategy”.)

  • Objective 1: Development of innovative bioinformatics and computational tools and methodologies (requires drawing clinical and biological correlations).
  • Objective 2: Conducting integrative analysis of data sets generated by GCCs using the bioinformatics tools developed by each GDAC.

Objective 3: Implementing an integrative bioinformatics approach utilizing existing bioinformatic tools for timely high-throughput processing and analyses of genome-wide data.

  • Data Sharing Requirements for GDACs:

Public availability of data/information generated by all genomics data resulting from NCI-supported initiatives will be critical to facilitate disease-relevant discoveries of clinical significance and a goal of this initiative. Therefore, sharing as a public resource all rigorously validated data resulting from GDACs is essential for this initiative. For details, see Section IV.2, under “Resource Sharing Plan”.

General Information

Document Type: Grants Notice
Funding Opportunity Number: RFA-CA-15-019
Funding Opportunity Title: Genomic Data Analysis Network: Visualization Genomic Data Center (U24)
Opportunity Category: Discretionary
Funding Instrument Type: Cooperative Agreement
Category of Funding Activity: Education
Health
Category Explanation:
Expected Number of Awards:
CFDA Number(s): 93.393 — Cancer Cause and Prevention Research
93.394 — Cancer Detection and Diagnosis Research
93.395 — Cancer Treatment Research
93.396 — Cancer Biology Research
Cost Sharing or Matching Requirement: No
Posted Date: Oct 22, 2015
Creation Date: Oct 22, 2015
Original Closing Date for Applications: Jan 27, 2016  
Current Closing Date for Applications: Jan 27, 2016  
Archive Date: Feb 27, 2016
Estimated Total Program Funding:
Award Ceiling: $660,000
Award Floor:

Eligibility

Eligible Applicants:
County 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
Others (see text field entitled “Additional Information on Eligibility” for clarification)
For profit organizations other than small businesses
Private institutions of higher education
State governments
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Small businesses
Native American tribal organizations (other than Federally recognized tribal governments)
Public housing authorities/Indian housing authorities
Independent school districts
Special district governments
Native American tribal governments (Federally recognized)
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) is a part of cancer genomics programs supported by the National Cancer Institute (NCI) and managed by its Center for Cancer Genomics (CCG). The overall goal of all CCG programs is to help elucidate the mechanisms of cancer initiation and evolution, as well as resistance to therapy by means of genomic characterization of well-annotated, high quality tumor samples. The acquired knowledge could facilitate and accelerate the development of new diagnostic and prognostic markers, new targets for pharmaceutical interventions, and new cancer prevention and treatment strategies.
Link to Additional Information: http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-15-019.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

PEPFAR Small Grants Program 2015-2016, U.S. Embassy Maseru [Communities Affected by AIDS/HIV]

DOS-MSU-PFSGP-FY16
PEPFAR Small Grants Program 2015-2016, U.S. Embassy Maseru
Department of State
U.S. Mission to Maseru-Lesotho

Everyone is Lesotho is either infected or affected by HIV/AIDS.

HL-Youth-AIDS-Day-Seotlong-Centre-2

Source: http://www.helplesotho.org/lesotho/hivaids-in-lesotho/

Criteria for Funding

Consideration will only be given to projects which:

  • Address the needs of OVC and/or support community-based HIV and AIDS palliative care and home health care
  • Have at least eight project members
  • Improve basic economic or social conditions at the local community or village level
  • Support high impact, quick implementation activities that benefit a substantial number of people within one year without requiring further assistance or funding
  • Are oriented toward communities, not individuals
  • Involve at least a 10% contribution of cash, labor, or materials by members of the local community
  • Are within the ability of the local community to operate and maintain
  • Are managed and run by local Basotho groups, e.g. community-based organizations, faith-based organizations and/or groups of people living with HIV or AIDS
  • Can be measured through tangible results and reports, e.g. number of people supported and/or trained
  • Are a direct response to the initiative and aspirations of the local community

Grant Conditions

PEPFAR Small Grants program funds can be used for:

  • Home-based caregiver kits and medical supplies
  • Training for caregivers and care providers
  • Equipment for OVC centers
  • Educational materials and training supplies
  • Equipment, materials and technical training for income-generation projects
  • Ongoing administrative or operating costs (but no more than 10% of total requested funds budget)
  • Structured and measurable prevention and awareness campaigns, workshops and outreach sessions

PEPFAR Small Grants program funds cannot be used for:

  • Remodeling or renovating an existing facility that is in disrepair as a result of neglect or lack of money
  • Projects managed by private businesses, private crèches or public schools
  • Food and food parcels
  • School uniforms, school fees or student bursaries
  • Salaries and/or personal expenses
  • Motorized vehicles or tractors
  • Pesticides, fungicides, and herbicides
  • Office equipment such as computers, fax machines, or photocopiers
  • Military activities (including those relating to police, prisons or other law enforcement activities)
  • Activities with unmitigated and negative environmental consequences, e.g. dams or forest roads 

Measurable Results Requirement

PEPFAR Small Grants program funds can only be used for projects which are able to measure and report on how they contribute to HIV/AIDS and OVC care.  Projects must be able to count or describe the following on a quarterly basis:

Orphans and Vulnerable Children (OVC) Projects

  • Services provided (e.g. healthcare, shelter, child protection, HIV and AIDS prevention education)
  • Number of children served
  • Number of providers and/or caregivers trained

Community-based Palliative and Home Care Projects

  • Number of individuals provided with general HIV-related palliative and home care
  • Type of care provided (such as physical, spiritual, psychological, or social support)
  • Number of caregivers trained to provide general HIV-related palliative and home care

General Information

Document Type: Grants Notice
Funding Opportunity Number: DOS-MSU-PFSGP-FY16
Funding Opportunity Title: PEPFAR Small Grants Program 2015-2016, U.S. Embassy Maseru
Opportunity Category: Discretionary
Funding Instrument Type: Grant
Category of Funding Activity: Health
Category Explanation: Health, HIV/AIDS, Orphan and Vulnerable Children (OVC)
Expected Number of Awards:
CFDA Number(s): 19.029 — The U.S. President’s Emergency Plan for AIDS Relief Programs
Cost Sharing or Matching Requirement: No

Posted Date:Oct 22, 2015

Creation Date:Oct 22, 2015

Original Closing Date for Applications:Jan 31, 2016 

 Current Closing Date for Applications:Jan 31, 2016 

 Archive Date:Mar 1, 2016

Estimated Total Program Funding:$150,000

Award Ceiling:$25,000

Award Floor:$5,000
Eligibility

Eligible Applicants:
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Additional Information on Eligibility: All applicants must be non-profit local community based organizations that address the needs of orphans and vulnerable children (OVC) and/or support community based HIV and AIDS care initiatives.

Additional Information

Agency Name: U.S. Mission to Maseru-Lesotho
Description: Funded by the U.S. President’s Emergency Plan for AIDS Relief, PEPFAR. The PEPFAR Small Grants Program is for community initaited projects which aim to strengthen health services in communities affected by HIV and AIDS. The program supports projects that support and protect vulnerable children (OVC) and adolecents, and community based HIV and AIDS care initiatives. The funds can only be used for projects which are able to measure and report on how they contribute to HIV and AIDS, and OVC care. The U.S. Embassy Maseru will prioritize proposals that present creative, original and innovative ideas and that improve basic economi or social conditions at the local community or village level.
Link to Additional Information: http://maseru.usembassy.gov/pepfar-small-grants-program.html
Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

Special Projects Office, U.S. Embassy Maseru +266 2231 2666
grantsmaseru@state.gov

Small Grant Program for NIDDK K01/K08/K23 Recipients (R03)

PAR-15-343
Limited Competition: Small Grant Program for NIDDK K01/K08/K23 Recipients (R03)
Department of Health and Human ServicesNIDDK
National Institutes of Health

Section I. Funding Opportunity Description

The NIDDK encourages recipients of NIDDK-supported mentored career development awards (K01/K08/K23) to apply for grant support during the final two years of their awards through the NIDDK Small Grant Program (R03).  This additional support will enable K awardees to either expand their current research objectives or to branch out to a closely related pilot study, thus demonstrating their growth as investigators and their independence.  This should facilitate the transition to fully independent investigator status.  The added grant support in the latter years of a K award is expected to have the following benefits:

  • Increased fiscal independence for the award recipient as a precursor to complete independence.
  • An opportunity for the recipient to generate additional publications and data to support a subsequent R01 application.
  • An opportunity for the awardee to demonstrate additional success in the peer review process during the course of their career development award.

The NIDDK encourages every NIDDK-supported K01/K08/K23 recipient to apply for R01, or equivalent, grant support during the course of their career awards. According to NIH policy, K awardees may now receive concurrent salary support from an NIH career development award and a research grant under certain circumstances (http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-08-065.html ).  However, any K01/K08/K23 recipient who receives an R01, or equivalent, grant will no longer be eligible to receive an R03 grant under this R03 program.  The definition of ‘equivalent’ R01 grant is also in NOT-OD-08-065.

General Information

Document Type: Grants Notice
Funding Opportunity Number: PAR-15-343
Funding Opportunity Title: Limited Competition: Small Grant Program for NIDDK K01/K08/K23 Recipients (R03)
Opportunity Category: Discretionary
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: Sep 9, 2015
Creation Date: Sep 9, 2015
Original Closing Date for Applications: Sep 7, 2018  
Current Closing Date for Applications: Sep 7, 2018  
Archive Date: Oct 8, 2018
Estimated Total Program Funding:
Award Ceiling:
Award Floor:

Eligibility

Eligible Applicants:
State governments
For profit organizations other than small businesses
Others (see text field entitled “Additional Information on Eligibility” for clarification)
City or township governments
Native American tribal governments (Federally recognized)
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Private institutions of higher education
Independent school districts
Public housing authorities/Indian housing authorities
Small businesses
County governments
Special district governments
Nonprofits that do not have 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 and State controlled 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 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) announces a program that provides NIDDK-supported K01, K08, and K23 recipients the opportunity to apply for Small Grant (R03) support at some point during the final two years of their K award. Through the use of this mechanism, the NIDDK is seeking to enhance the capability of its K01, K08, and K23 award recipients to conduct research as they complete their transition to fully independent investigator status. The R03 grant mechanism supports different types of projects, including pilot and feasibility studies; secondary analysis of existing data; small, self-contained research projects; development of research methodology; and development of new research technology. The R03 is, therefore, intended to support research projects that can be carried out in a short period of time with limited resources and that may provide preliminary data to support a subsequent R01, or equivalent, application.
Link to Additional Information: http://grants.nih.gov/grants/guide/pa-files/PAR-15-343.html

NIDCR Small Research Grants for Oral Health Data Analysis and Statistical Methodology Development (R03)

PAR-15-344
NIDCR Small Research Grants for Oral Health Data Analysis and Statistical Methodology Development (R03)oral health data analysis
Department of Health and Human Services
National Institutes of Health

Research Objectives

The NIDCR supports a broad portfolio of clinical trials and large-scale epidemiologic research projects that collect extensive data to fulfill each project’s specific aims. The resultant wealth of data generated by these studies often provides unique, cost-effective opportunities to investigate additional research questions or develop improved analytical approaches secondary to a project’s originally intended purpose.

The Small Research Grants for Data Analysis and Statistical Methodology Development (R03) program is designed to provide investigators with the support necessary to conduct such secondary data analyses or to develop new statistical methods for analyzing oral health data utilizing existing database resources. Research aims in these applications may be related to, but must be distinct from, the specific aims of the original data collection. The oral and craniofacial data may be derived from NIDCR-funded studies or from other sources.

Applications may propose to test new hypotheses in oral and craniofacial health, including oral and craniofacial health economics, using existing data. However, hypothesis-generating research in the absence of hypothesis testing will be considered for funding only if carefully described and justified.  Priority will be given to studies that address causality between risk factors and the oral health outcome(s) of interest. Studies simply describing correlations or associations between risk factors and oral health, especially when such associations have been demonstrated previously, are of lower program priority. Health economics studies could include natural history studies on the impact of changes in health care policy upon craniofacial-related treatment services delivery and quality, or comparative effectiveness research to evaluate variations in the cost and cost-effectiveness across types of treatment interventions for craniofacial diseases and disorders.

Applications may also propose new statistical methodologies for analyzing oral and craniofacial health data. However, the need for and applicability of any proposed new statistical methodologies to oral and craniofacial research must be justified, and the new methodology must be applied to an oral health dataset.

For applications focusing on behavioral and social sciences, priority will be given to studies that help to identify the mechanisms of behavior change or mechanisms of action of an intervention as opposed to correlates, predictors, mediators, moderators, risk and protective factors, etc., which may be candidate mechanisms, but have not been demonstrated as having a causal link with the outcome(s) of interest. This emphasis on identifying causal mechanisms means that certain local, state or national surveys may not be appropriate sources of data for some research projects. Also, applicants are encouraged to consider a range of data sources to test causal explanations for oral health behavior, for example, audiotaped or videotaped sessions, provided informed consents/assents are secured. Given that behavioral and social factors important in oral health are also important in other health conditions, data sets about nutrition, health education or promotion, parenting, tobacco use, adherence to provider recommendations, organizational behavior, etc., also may be relevant data sources. Additional information about the priorities of NIDCR’s Behavioral and Social Sciences Research Branch can be found here: http://www.nidcr.nih.gov/research/DER/BSSRB/.

General Information

Document Type: Grants Notice
Funding Opportunity Number: PAR-15-344
Funding Opportunity Title: NIDCR Small Research Grants for Oral Health Data Analysis and Statistical Methodology Development (R03)
Opportunity Category: Discretionary
Funding Instrument Type: Grant
Category of Funding Activity: Health
Category Explanation:
Expected Number of Awards:
CFDA Number(s): 93.121 — Oral Diseases and Disorders Research
Cost Sharing or Matching Requirement: No
Posted Date: Sep 9, 2015
Creation Date: Sep 9, 2015
Original Closing Date for Applications: Sep 7, 2018  
Current Closing Date for Applications: Sep 7, 2018  
Archive Date: Oct 8, 2018
Estimated Total Program Funding:
Award Ceiling:
Award Floor:

Eligibility

Eligible Applicants:
Private institutions of higher education
Public housing authorities/Indian housing authorities
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Native American tribal organizations (other than Federally recognized tribal governments)
For profit organizations other than small businesses
Native American tribal governments (Federally recognized)
State governments
County governments
Public and State controlled institutions of higher education
Independent school districts
Small businesses
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)
Special district 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: The goal of this funding opportunity announcement is to support meritorious research projects that involve secondary data analyses of existing oral or craniofacial database resources, or to develop needed statistical methodology for analyzing oral and craniofacial data using existing oral or craniofacial databases. The R03 grant mechanism supports research limited in time and amount for studies in categorical program areas.
Link to Additional Information: http://grants.nih.gov/grants/guide/pa-files/PAR-15-344.html

AIDS-Science Track Award for Research Transition (R03)

A group advocating AIDS research marches down Fifth Avenue during the 14th annual Lesbian and Gay Pride parade in New York, June 27, 1983. This year’s parade is dedicated to victims of the incurable disease AIDS which primarily afflicts homosexual men. (AP Photo/Mario Suriani)
A group advocating AIDS research marches down Fifth Avenue during the 14th annual Lesbian and Gay Pride parade in New York, June 27, 1983.  (AP Photo/Mario Suriani)

PA-15-290

AIDS-Science Track Award for Research Transition (R03)

Department of Health and Human Services
National Institutes of Health

Research Objectives

This FOA seeks to promote the entry of new investigators into research on drug abuse and HIV who will conduct studies on: the prevention of HIV acquisition and transmission; HIV treatment including toward a cure research; co-morbidities, co-infections, and complications; and behavioral and social science research to advance treatment and prevention, especially to address the Continuum of Care.

NIDA research on HIV/AIDS is broad-based and includes both domestic and international studies and ranges from basic research, including studies using animal models, in vitro, and ex vivo systems, to clinical research to implementation science research. A-START applications are welcome across the breadth of NIDA research.

Drug-using populations tend to be marginalized and difficult-to-reach, but achieving an AIDS-free generation will not be possible without understanding the issues facing these populations and developing and implementing effective interventions for them.  The drug-using populations that NIDA studies include both injection and non-injection drug users, youth, racial/ethnic/sexual minorities, and criminal justice populations.

Information about NIDA’s HIV/AIDS priority research areas is available at: http://www.nida.nih.gov/about/organization/arp/. Applications to A-START should address high priority HIV/AIDS research at the intersection of drug abuse and HIV research.

Investigators are encouraged, when appropriate, to utilize the Clinical Trials Network (CTN) (http://www.drugabuse.gov/CTN/Index.htm) infrastructure as a platform for their studies.

Special Considerations

HIV/AIDS Counseling and Testing Policy for the National Institute on Drug Abuse:  In light of recent significant advances in rapid testing for HIV and in effective treatments for HIV, NIDA has revised its 2001 policy on HIV counseling and testing.  NIDA-funded researchers are strongly encouraged to provide and/or refer research subjects to HIV risk reduction education and education about the benefits of HIV treatment, counseling and testing, referral to treatment, and other appropriate interventions to prevent acquisition and transmission of HIV.  This policy applies to all NIDA funded research conducted domestically or internationally.  For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-07-013.html.

National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects:  The National Advisory Council on Drug Abuse (NACDA) recognizes the importance of research involving the administration of drugs with abuse potential, and dependence or addiction liability, to human subjects.   Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects.  The guidelines are available on NIDA’s Web site at http://www.nida.nih.gov/about/organization/nacda/CouncilStatement.html.

Points to Consider Regarding Tobacco Industry Funding of NIDA Applicants: The National Advisory Council on Drug Abuse (NACDA) encourages NIDA and its grantees to consider the points it has set forth with regard to existing or prospective sponsored research agreements with tobacco companies or their related entities and the impact of acceptance of tobacco industry funding on NIDA’s credibility and reputation within the scientific community.  Please see (http://ww2.drugabuse.gov/about/organization/nacda/points-to-consider.html) for details.

Data Harmonization for Substance Abuse and Addiction via the PhenX Toolkit:  NIDA strongly encourages investigators involved in human-subjects studies to employ a common set of tools and resources that will promote the collection of comparable data across studies and to do so by incorporating the measures from the Core and Specialty collections, which are available in the Substance Abuse and Addiction Collection of the PhenX Toolkit (www.phenxtoolkit.org).  Please see NOT-DA-12-008 (http://grants.nih.gov/grants/guide/notice-files/NOT-DA-12-008.html) for further details.

General Information

Document Type: Grants Notice
Funding Opportunity Number: PA-15-290
Funding Opportunity Title: AIDS-Science Track Award for Research Transition (R03)
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: Sep 9, 2015
Creation Date: Sep 9, 2015
Original Closing Date for Applications: Sep 7, 2018  
Current Closing Date for Applications: Sep 7, 2018  
Archive Date: Oct 8, 2018
Estimated Total Program Funding:
Award Ceiling: $100,000
Award Floor:

Eligibility

Eligible Applicants:
Special district governments
Native American tribal governments (Federally recognized)
Independent school districts
Public housing authorities/Indian housing authorities
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Private institutions of higher education
County governments
State governments
Public and State controlled institutions of higher education
City or township governments
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
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.

Additional Information

Agency Name: National Institutes of Health
Description: This funding opportunity announcement (FOA) seeks to facilitate the entry of both newly independent and early career investigators to the area of drug abuse research on HIV/AIDS. This FOA, AIDS-Science Track Award for Research Transition (A-START), encourages Small Research Grant (R03) applications to support research projects on drug abuse and HIV/AIDS that can be carried out in a short period of time with limited resources. Applications under this FOA are welcomed from all areas of HIV/AIDS research that NIDA supports.
Link to Additional Information: http://grants.nih.gov/grants/guide/pa-files/PA-15-290.html

Psychological Health/Traumatic Brain Injury Research Program – Comprehensive Universal Prevention/Health Promotion Interventions Award

Psychological Health/Traumatic Brain Injury Research Program

DoD PH/TBI Comprehensive Universal Prevention/Health Promotion Interventions AwardPsychological-Assessments-and-Counselling
Department of Defense
Dept. of the Army — USAMRAA

B. Award Description
The intent of the FY15 PH/TBI Comprehensive Universal Prevention/Health Promotion Interventions (CUP/HPI) Award is to support research focused on the development, adaptation, efficiency or optimization, and testing of comprehensive universal prevention/health promotion interventions and systems-level approaches for use within the military context. This Program Announcement/Funding Opportunity seeks research applications that are designed to have positive effects on multiple target behaviors and outcomes.

Research should address shared common antecedents or precursors and shared risk and protective factors and interventions that have an effect on multiple outcomes. Interventions and systems-level approaches should increase protective factors and positive outcomes and reduce risk factors and negative outcomes that are relevant to the needs of Service members, their families, and their communities. Applications should be limited to prevention interventions and systems-level approaches that are within the military’s legal and operational control. Examples of negative outcome targets of interest include, but are not limited to:
• Risky behaviors (e.g., substance use, misuse, and abuse [including alcohol, tobacco, and other substance use, non-medical use, misuse, and abuse of prescription drugs], aggressive and other unsafe driving, and health-risking sexual behaviors [HRSB] related to HIV/AIDS)
• Aggression/violence
• Sexual assault
• Suicidal ideation and behaviors
• Depression
• Anxiety
• Sleep

General Information

Document Type: Grants Notice
Funding Opportunity Number: W81XWH-15-PHTBIRP-CUPHPI
Funding Opportunity Title: DoD PH/TBI Comprehensive Universal Prevention/Health Promotion Interventions Award
Opportunity Category: Discretionary
Funding Instrument Type: Cooperative Agreement
Grant
Category of Funding Activity: Science and Technology and other Research and Development
Category Explanation:
Expected Number of Awards: 4
CFDA Number(s): 12.420 — Military Medical Research and Development
Cost Sharing or Matching Requirement: No
Posted Date: Sep 2, 2015
Creation Date: Sep 2, 2015
Original Closing Date for Applications: Jan 14, 2016  
Current Closing Date for Applications: Jan 14, 2016  
Archive Date: Feb 13, 2016
Estimated Total Program Funding: $7,500,000
Award Ceiling:
Award Floor:

Eligibility

Eligible Applicants:
Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility”
Additional Information on Eligibility:

Additional Information

Agency Name: Dept. of the Army — USAMRAA
Description: The intent of the FY15 PH/TBI Comprehensive Universal Prevention/Health Promotion Interventions (CUP/HPI) Award is to support research focused on the development, adaptation, efficiency or optimization, and testing of comprehensive universal prevention/health promotion interventions and systems-level approaches for use within the military context. This Program Announcement/Funding Opportunity seeks research applications that are designed to have positive effects on multiple target behaviors and outcomes.

Link to Additional Information: http://www.grants.gov/web/grants/view-opportunity.html?oppId=278830