text:
Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)
Components of Participating Organizations
National Institutes on Aging (NIA) (http://www.nia.nih.gov)
Title: Consortium for Clinical Trials on Anemia in Older Persons (U01)
Announcement Type
Request for Applications (RFA) Number: RFA-AG-09-003
Catalog of Federal Domestic Assistance Number
Key Dates
Release Date: April 25, 2008
Letters of Intent Receipt Date: October 7, 2008
Application Receipt Date: November 7, 2008
Peer Review Date(s): February / March 2009
Council Review Date: May 2009
Earliest Anticipated Start Date: July 2009
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: November 8, 2008
Due Dates for E.O. 12372
Not Applicable
Overview Content
Executive Summary
Table of Contents
Part I
Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
D. Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information
Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates
Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Arbitration Process
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information - Required Federal Citations
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
Research Objectives
Anemia is a common clinical finding among the elderly, and its prevalence increases with age. About 11% of men and 10% of women ages 65 years and older and about 20% of those older than 85 years were found to have anemia in the NHANES-III survey. Causes of anemia in the elderly are divided into three broad groups: nutritional deficiency/blood loss (34% of all cases), anemia of chronic disease (32% of all cases), and unexplained anemia (34% of all cases).
Adverse physiologic consequences of anemia/low normal hemoglobin levels in the elderly include, but are not limited to decreased oxygen-carrying capacity and resulting compensatory cardiac and vascular effects and the possibility for deleterious organ function resulting from tissue hypoxia. Anemia and "low normal" levels of hemoglobin in the elderly are associated with substantial increases in risk for a variety of adverse clinical outcomes in older persons, including fall-related fractures, cognitive impairment, hospitalizations, and mortality. However, these associations do not prove a causal relationship.
In view of the potential adverse effects of anemia and low hemoglobin levels in older persons implied by epidemiologic data, and the availability of a variety of potentially efficacious treatments for differing types of anemia, there is reason to believe that clinical trials of the clinical and functional effects of treating different types of anemia or low hemoglobin could identify interventions with substantial public health benefits. In addition, since the efficacy of existing and newly developed treatments in raising hemoglobin levels is not clear for some types of anemia in older persons, there is also value in clinical trials to evaluate the hematologic effects of these interventions in specific populations of older persons.
The need for clinical trials in anemia in the elderly is further emphasized by the results of a recent meta-analysis of nine randomized controlled trials in 5,143 anemic chronic kidney disease patients aged 50 to 65 years [Phrommintikul A, Haas SJ, Elsik M, Krum H. Mortality and target haemoglobin concentrations in anaemic patients with chronic kidney disease treated with erythropoietin: a meta-analysis. Lancet 2007; 369: 381–88.] In these trials, participants were treated with recombinant human erythropoietin for 12 to 48 months to raise hemoglobin concentrations to normal levels as defined by the WHO criteria. Compared to those with hemoglobin levels maintained in the low-normal/mild anemia range (10.4 to 11.7 g/dl), there was a 17% increase in all-cause mortality in patients whose hemoglobin concentrations were raised to normal levels (12.0 to 16.0 g/dl), which is the range associated with lowest mortality in epidemiologic studies of older persons.
The implications of these findings in younger kidney disease patients regarding efficacy and safety of raising hemoglobin levels in the anemic elderly (most of whom do not have kidney disease) are unknown. In addition, it is unknown whether the increase in mortality seen in the younger chronic kidney disease patients is due to the increase in hemoglobin level or to some aspect of anemia therapy itself, the amount of erythropoiesis-stimulating agents (ESA) used and/or iron treatment that may play a causative role in increased mortality risk. The latter issue could be addressed by assessing the benefit-to-risk profiles of other available and emerging treatments for anemia in older persons. Thus, current evidence suggests that there could be substantial benefits, and/or serious risks, resulting from treating anemia or low normal hemoglobin levels in older patients. Currently, decision by practitioners on whether or not older patients with anemia or low normal hemoglobin should be treated must be made without convincing evidence about the benefits and risks that only clinical trials can provide, thus leaving it highly uncertain whether treatment (or failure to treat) does substantial good or substantial harm.
An Advisory Panel convened by NIA reviewed issues regarding the need for clinical trials in regard to a variety of types of anemia in older persons, outcomes, populations, and interventions. The panel recommended that trials be conducted on safety and efficacy of interventions for unexplained anemia in the elderly, particularly a trial in moderately frail community-dwelling persons over age 70 with mild to moderate anemia, that measures of function should be principal outcomes, and that intervention effects be measured for up to one year. Secondary outcomes could include quality of life, mortality, hospitalizations and nursing home admissions, and other. The panel indicated that several potential agents might be suitable for trials including epoietin alpha, darbepoietin, hematide, and others. After reviewing recent results from clinical trials in patients with chronic kidney disease treated with ESA, the panel confirmed the need for clinical trials on anemia in the elderly and suggested that trials could set a relatively safe upper limit for target hemoglobin levels.
Noting that the implementation of a shared outcome measures and methods is of paramount importance, the panel recommended that such trials be conducted by a consortium, which would allow research algorithms to be developed and data generated in an organized, cohesive, efficient, logical and productive manner. Each member of the consortium would participate in intergroup studies and conduct coordinated trials within the scope of the consortium. An interdisciplinary team with expertise in hematology, geriatrics, clinical trials, biostatistics, functional assessment and other fields would be the best suited to accomplish these tasks.
Objectives and Scope
This FOA seeks applications for a clinical trials consortium to design and implement several phase II clinical trials on anemia in older persons consistent with the recommendations of the NIA Advisory Panel. The consortium should include at least three clinical sites, a coordinating center (CC), and other structural components (e.g., central laboratory). During the project period, awardees can also develop and implement pilot translational and exploratory studies and perform additional analyses of data from existing databases informing designs of the future trials. NIA will issue one six year award (a Cooperative Agreement) in response to this FOA.
Applicants should propose a research plan that includes a protocol for a randomized, placebo-controlled, masked phase II intervention study that will be the first trial implemented in the consortium environment. The protocol should demonstrate knowledge of current issues in the treatment of anemia. Applicants must propose the relevant outcome(s), and number and type of participants required for proposed study based on recommendations of the NIA Advisory Panel. Applicants must provide evidence of their ability to recruit and retain adequate numbers of the elderly with anemia for clinical trials to be conducted by the consortium. Applicants are expected to describe the nature of the available participant population including race/ethnicity and the type of anemia in their geographic area and to describe strategies that would be used to recruit these participants for the proposed trials.
First year of the award will provide funds to finalize consortium operations and refine protocol, recruitment and screening strategies, data collection forms, and manual of procedures for the first trial. The awardee should develop processes and procedures for planning and protocol development for clinical trials that will be conducted by the consortium after initiating the first trial. The awardee may also conduct pilot studies e.g., to test recruitment strategies or validate screening and/or outcome measurement instruments for the proposed trial. In addition to the above activities for the proposed trial, the awardee should also develop plans for organizational mechanisms that Consortium would use for evaluating and conducting possible small translational exploratory studies informing designs of the future possible trials.
It is not the intent of the consortium to provide support for one or two large protocols that run for six years. It is expected that several clinical trials will be conducted over the six year project period, and that studies with different protocols will run concurrently at a given clinical site. The topics of these protocols will be decided and prioritized cooperatively by the Consortium Steering Committee (SC) and implemented after review and approval by the Data and Safety Monitoring Board and NIA.
Applicants are encouraged to include personnel with expertise in the wide range of scientific areas pertinent to this research including hematology, geriatrics, biostatistics, clinical trials design and implementation, data management, central laboratory procedures, psychology, functional assessment methodology, and others.
Project Organization
Consortium will be funded as a cooperative agreement consisting of a coordinating center, at least 3 clinical sites, and the NIA. Applicants should propose other structural components (e.g., central laboratory) for the consortium.
The NIA will assist the Coordinating Center in coordinating the organization of the consortium and NIA's Project Scientist will have significant scientific involvement with the awardee. The NIA Program Official will have administrative duties, monitor patient recruitment and study progress, ensure disclosure of conflicts of interest, and ensure adherence to NIH and NIA policies. Applicants are encouraged to nominate Consortium Chair in their application. The NIH and Consortium Chair will be responsible for ensuring that there are well-documented policies, procedures, and bylaws to guide all aspects of consortium activities and operations.
II. Coordinating Center (CC):
The CC will coordinate, administer, and support all clinical research activities of the Consortium. It will provide administrative support for the DSMB, Consortium Chair, scientific leadership and committees, organization of investigator meetings, and will acquire and distribute medications to the sites. The CC will participate in protocol development, provide statistical expertise, and prepare operational timetables. The CC will develop a data collection system and manuals of operations, randomization schemes, perform sample size calculations and data analyses.
The CC will develop quality control procedures, oversee data collection and manage the studies. It will monitor the quality and quantity of data received from clinical sites, provide relevant reports to the NIA, Consortium Chair, sites, and SC, and serve as a central repository for study data. The CC will be responsible for sites monitoring, staff training, study management, and at a minimum will visit each site at least three times in the course of the study period. The CC will prepare protocols and reports for submission to the DSMB, Institutional Review Boards, and government agencies as required. The CC will support manuscript preparation through data analysis, statistical consultation, editorial support, and meeting coordination.
III. Clinical Sites:
Clinical sites will propose and participate in the development and implementation of common protocols, recruit participants, monitor participant safety, collect and transfer study data to the CC and disseminate research findings. All individual sites are expected to participate in a cooperative and interactive manner with one another and with the CC in all aspects of the consortium.
IV. Steering Committee:
The Steering Committee (SC) will be the main governing body of the consortium. Voting members of the SC will include the Consortium Chair, the principal investigators (PIs) of clinical sites and CC, and the NIA Project Scientist. The Consortium Chair will plan consortium activities, oversee its functions, conduct SC meetings, and cast a tie-breaking vote. The SC will develop and ensure compliance with consortium policies and procedures, and develop common study protocols for submission to the DSMB and NIA for approval. The SC will ensure that studies are properly conducted and monitored, that data are appropriately analyzed and interpreted, and that study results are reported in the scientific literature in a timely manner. The SC may meet in-person as often as three to four times in the first 12 months of the study, and two to three times per year thereafter. All major scientific decisions will be determined by majority vote of the SC.
V. Data and Safety Monitoring Board:
NIA will establish a Data and Safety Monitoring board (DSMB) in accordance with NIH policies to ensure data quality and participant safety and to provide independent advice to the NIA regarding progress and the appropriateness of continuing each study. The DSMB members will be selected by NIA, and the Board will be advisory to the Director, NIA.
All study protocols developed by the consortium must be recommended by the DSMB and approved by the NIA before initiation. The recommendation of the DSMB will be based on the importance of the question to be addressed, scientific merit of the experimental design and approach, feasibility, appropriateness for the consortium and consistency with NIA missions and policies. The DSMB will provide a written report of each proposal and a final recommendation to the NIA. APPLICANTS SHOULD NOT NOMINATE PROSPECTIVE DSMB MEMBERS IN THEIR APPLICATIONS.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Mechanism of Support
This funding opportunity will use the National Institutes of Health (NIH) U01, Cooperative Agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".
This FOA is a one-time solicitation. At this time, it is not known if this FOA will be reissued. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is July 1, 2009.
This FOA uses "Just-in-Time" information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see https://grants.nih.gov/grants/funding/phs398/phs398.html).
2. Funds Available
The estimated amount of funds available is $800,000 total costs (direct plus indirect) for fiscal year 2009 and approximately $3,000,000 per year in total costs in fiscal years 2010 through 2014 to fund one six-year award submitted in response to this FOA. Future year amounts will depend on annual appropriations.
Although the
financial plans of the IC(s) provide support for this program, awards pursuant
to this funding opportunity are contingent upon the availability of funds and
the receipt of a sufficient number of meritorious applications.
Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.
NIH grants
policies as described in the NIH
Grants Policy Statement.
3. Other-Special Eligibility Criteria
Applicants are not permitted to submit a resubmission application in response to this FOA.
Renewal applications are not permitted in response to this FOA.
Applicants may not submit more than one application
Section IV. Application and Submission Information
1. Address to
Request Application Information
The PHS 398 application instructions are available at https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: email@example.com.
Telecommunications for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.
The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.
Additional information is available in the PHS 398 grant application instructions.
Submission Dates and Times
Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.
3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date: October 7, 2008
Application Receipt Date: November 7, 2008
Peer Review Date(s): February/March 2009
Council Review Date: May 2009
Earliest Anticipated Start Date: July 2009
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
Although a letter of
intent is not required, is not binding, and does not enter into the review of a
subsequent application, the information that it contains allows IC staff to
estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed in Section IV.3.A.
A copy of the letter
of intent should be sent to:
Judy Hannah, Ph.D.
Geriatrics and Clinical Gerontology Program
National Institute on Aging
7201 Wisconsin Avenue
Suite 3C307
Bethesda, MD 20892, (Courier/Express Mail ZIP 20814)
Telephone: (301) 435-0044
Email: firstname.lastname@example.com
3.B. Sending an
Application to the NIH
Applications must be prepared using the forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Personal deliveries of applications are no longer
permitted (see https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:
Ramesh Vemuri, Ph.D.
Chief Scientific Review Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2C212
Bethesda, MD 20892
Telephone: (301) 402-7700
Email: email@example.com
3.C. Application
Applications must be received on or before the application receipt date) described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute Incomplete and/or non-responsive applications will not be reviewed.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.
Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
4. Intergovernmental Review
This initiative is not subject to intergovernmental
5. Funding Restrictions
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at NIH Grants Policy Statement.
Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.
The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.)
For the first trial, recruitment for this award will be restricted until an NIA-approved DSMB has met and approved the study's IRB-approved protocol and consent from. Before the start of recruitment, the PI will provide to the NIA Program Official a timeline of projected participant accrual, randomization, retention, and completion of intervention. Beginning three months after the start of recruitment, the PI will also, on a quarterly basis, provide updates of this timeline, indicating actual participant accrual, randomization, retention, and completion of intervention, in relationship to projected numbers.
6. Other Submission Requirements and Information
Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information".
Supplementary Instructions
1. Each application for the consortium should propose at least three clinical sites, a coordinating center (CC), and other structural components (e.g., central laboratory, reading centers, etc.). Applications proposing select structural components of the Consortium (e.g., coordinating center without clinical sites and / or other structural components) will be considered unresponsive to this FOA.
2. The proposed applicant team should include personnel from multiple institutions.
3. Consortium will be a collaborative effort that will require the coordinating center, clinical sites and other structural components to participate in a cooperative and interactive manner with each other and with the NIA. Applicants should explicitly state their willingness to: participate in Steering Committee meetings, site visits, and regular telephone conference calls; serve as both members and chairpersons on subcommittees within the consortium; cooperate in the development and design of research protocols; abide by study policies and common definitions, protocols, procedures, and quality assurance measures as chosen by majority vote of the SC. Applicants should agree to actively implement each protocol recommended by the DSMB and approved by the NIA. They should explicitly state their acceptance of the Cooperative Agreement Terms and Conditions of Award which are found in Section VI, Award Administration Information.
4. Applicants should propose a research plan that includes a protocol for a randomized, placebo-controlled, masked phase II intervention study that will be the first trial implemented in the consortium environment. Applications requesting support for one or two large protocols that run for the entire six years will be considered unresponsive to this FOA.
5. Applicants should present a table of organization for the consortium and describe the processes and procedures for planning and protocol development for clinical trials that will be conducted by the consortium after initiating the first trial. The applicants should provide a time line indicating key milestones for the project.
6. The Coordinating Center should have significant prior experience with multicenter clinical trials, including protocol and data collection systems development, study management, quality assurance and data analysis. The CC must have demonstrated ability and expertise to provide quality logistical and information support to the consortium. In order to ensure that data analysis is done independently of data acquisition, the CC cannot have the same PI as any of the clinical sites. In addition, there should be no overlap in personnel between the CC and the clinical sites.
7. The PI and research team at each clinical site must have demonstrated prior experience with clinical intervention research, including IRB submissions, DSMB participation, participant recruitment and retention, and human subject protection. Documentation of institutional support for the clinical trials should be provided in the form of letters of support from the appropriate institution officials.
8. The application must reflect
adequate time commitment of personnel. The commitment for the Consortium Chair
should be no less than 2.4 months.
9. Budget Information: In first year of the award, applicants should budget for at least four in-person meetings of the major investigators in Bethesda, MD / metropolitan Washington, DC area and for costs associated with organizing these meetings. In years 2 through 6, applicants should budget for at least two in-person meetings of the major investigators in Bethesda, MD / metropolitan Washington, DC area and for costs associated with organizing these meetings.
10. Clinical Trial Agreement (CTA): When a pharmaceutical or device collaborator (third party) provides a study agent/device to the Consortium, a CTA will be negotiated describing respective responsibilities and rights. The agreement will include, but is not limited to, Investigational New Drug/Investigational Device Exemption (IND/IDE) sponsorship, safety and data monitoring, and access to data. Third party agreements must be developed and implemented by the DCC with approval from the NIA.
Research Plan Page Limitations
Research plan shall not exceed 35 pages
Appendix Materials
All paper PHS 398 applications submitted for May 25, 2008 and subsequent due dates must provide appendix material on CD only, and include five identical CDs in the same package with the application. Paper applications submitted for due dates prior to May 25, 2008 may voluntarily provide the appendix on five identical CDs; if submitting CDs it is not necessary to include a paper appendix. (see https://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.Resource Sharing Plan(s)
NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See https://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and https://grants.nih.gov/grants/gwas/.
Section V. Application Review Information
1. Criteria
Only the review criteria described below will be considered in the review process.
2. Review and Selection Process
Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIA and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.
As part of the scientific peer review, all applications will:
The following will be considered in making funding decisions:
The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.
Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Approach: Are the conceptual or clinical framework, design,
methods, and analyses adequately developed, well integrated, well reasoned, and
appropriate to the aims of the project? Does the applicant acknowledge
potential problem areas and consider alternative tactics? Is a protocol
for a phase II trial proposed in the application? Does the application include
structural components such as a CC, clinical sites, central laboratory,
etc.? Is a table of organization for the planning/protocol development
and a time line for the key project milestones provided? Does the application
describe the processes and procedures for planning and protocol development for
clinical trials that will be conducted by the consortium after initiating the
first trial?
Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?
Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? Does the application reflect adequate time commitment for the Consortium Chair of at least 20%?
Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? Does the CC have the experience to coordinate, administer, and support all clinical research activities of the Consortium? How adequate are the facilities, equipment, and organizational structure of the CC to effectively support the coordination of Consortium activities and provide assistance to clinical sites in developing and implementing protocols, and collecting and managing high-quality data? Does the environment at clinical sites provide good access to potential study populations? Do investigators indicate that they understand the U01 mechanism and agree to participate with NIA in the development and completion of these studies?
Additional Review Criteria:
In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the rating:
Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan section on Human Subjects in the PHS 398 instructions).
Inclusion of Women and Minorities in Research: The adequacy of plans to include subjects from both genders and all racial and ethnic groups (and subgroups), as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan section on Human Subjects in the PHS 398 instructions).
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five points described in the Vertebrate Animals section of the Research Plan will be assessed.
Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.
2.B. Additional Review Considerations
Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.
2.C. Resource Sharing Plan(s)
When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.
3. Anticipated Announcement and Award
Not applicable
Section VI. Award Administration Information
1. Award Notices
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant. For
details, applicants may refer to the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.
Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).
The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.
Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
2. A.1. Principal Investigator Rights and Responsibilities
The Principal Investigator will have the primary responsibility for identifying priority areas for research with input from the Steering Committee, the DSMB and NIA and developing and implementing protocols. The awardee will have lead responsibilities in all aspects of the study, including any modification of study design, conduct of the study, quality control, data analysis and interpretation, preparation of publications, and collaboration with other investigators, unless otherwise provided for in these terms or by action of the Steering Committee. Investigators are expected to: participate in Steering Committee (SC) meetings, site visits, and regular telephone conference calls; serve as both members and chairpersons on subcommittees within the Consortium; cooperate with other sites in the design and development of research protocols; abide by common definitions, common methods for participant selection and enrollment, and common protocols, procedures, tests, and reporting forms as chosen by majority vote of the SC. The awardee will actively implement each protocol approved by the Data and Safety Monitoring Board (DSMB) and the NIA; comply with study policies and quality assurance measures approved by the SC; agree to oversight of studies by the DSMB; and report all adverse events in accordance with procedures and policies established by the SC, the DSMB and the NIH/NIA.
The collaborative protocols and governance policies will call
for the continued submission of data to the coordinating center for a
collaborative database; procedures for data analysis, reporting and
publication; procedures to protect and ensure the privacy of medical
information and records of individuals. The NIA Project Scientist, on behalf of
the NIA, will have the same access, privileges and responsibilities regarding
the collaborative data as the other members of the Steering Committee.
Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.
A.2. NIH Responsibilities
An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. Specifically, the NIA Project Scientist will:
The NIA will appoint a Program Official, who apart from the Project Scientist, will be responsible for normal program stewardship of the award, monitoring of patient recruitment and study progress, and ensuring disclosure of conflicts of interest, and adherence to NIA policies. Specifically the Program Officer will:
Perform other duties required for normal program stewardship of grants.
2.A.3. Collaborative Responsibilities
The management of the Consortium for Clinical Trials on Anemia in Older Persons includes committees with the following functions:
Steering Committee
The Steering Committee will consist of the Consortium Chair, principal investigators (PIs) of the clinical sites and CC, and the NIA Project Scientist. The Consortium Chair will plan consortium activities, oversee its functions, conduct SC meetings, and cast a tie-breaking vote. The SC will be the main governing body of the Consortium for Clinical Trials on Anemia in Older Persons and will establish and implement policies and procedures that govern Consortium operations. The SC will have primary responsibility for developing research protocols, supervising the conduct of the studies, and reporting results. It will ensure that studies are properly conducted and monitored, that data are appropriately analyzed and interpreted, and that study results are reported in the scientific literature in a timely manner. The SC will develop and ensure compliance with Consortium policies and procedures, identify and prioritize topics for investigation, evaluate protocols proposed by the investigators, and develop consensus protocols for submission to the DSMB for approval. Each full SC member will have one vote. All major scientific decisions will be determined by majority vote of the SC. The SC may meet in person as often as three to four times in the first 12 months of the study, and two to three times per year thereafter. In-person meetings of the Steering Committee will be held in the Bethesda MD/ metropolitan Washington DC area.
A member of the NIA Grants and Contracts Management Office and/or the NIA Program Official advises the Steering Committee on funding matters.
Data and Safety Monitoring Board (DSMB)
NIA will establish a DSMB in accordance with NIH policies to ensure data quality and participant safety and to provide independent advice to the NIA and the SC regarding progress and the appropriateness of continuing each study. The DSMB, in collaboration with the investigators, will develop stopping rules as necessary for each protocol. When appropriate, the DSMB will review interim data analyses regarding the potential need to terminate studies, and make recommendations to the Director of the NIA and the Steering Committee. In addition, the DSMB will evaluate planned Consortium protocols, with an emphasis on participant safety, and with additional ad hoc scientific and/or clinical experts as needed. Members of the DSMB will be appointed by the Director of the NIA who will be provided a list of nominees identified by the Steering Committee. Each member of the DSMB will have one vote. The Principal Investigator of the CC and the NIA Project Scientist will attend open sessions of DSMB meetings as non-voting members. Meetings of the DSMB will ordinarily be held in the Bethesda MD/ metropolitan Washington DC area. Because the Board serves as an independent group advisory to the NIA, study investigators will not directly communicate with Board members regarding any issues relevant to the Consortium. All study protocols developed by the consortium must be recommended by the DSMB and approved by the NIA before initiation. The recommendation of the DSMB will be based on the importance of the question to be addressed, scientific merit of the experimental design and approach, feasibility, appropriateness for the consortium and consistency with NIA missions and policies. The DSMB will provide a written report of each proposal and a final recommendation to the NIA.
Additional Provisions
Support or other involvement of the pharmaceutical industry or any other third party in the study; involvement of study resources or citing the name of the study or NIH support; or special access to study results, data, findings or resources -- may be advantageous and appropriate. However, except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification of and concurrence by NIA.
2.A.4. Arbitration Process
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIA may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have a designee of the Steering Committee chosen without NIA staff voting, one NIA designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.
3. Reporting
Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research, peer review, and financial or grants
management issues:
1. Scientific/Research Contacts:
Judy Hannah, Ph.D.
Geriatrics and Clinical Gerontology Program
National Institute on Aging
7201 Wisconsin Avenue
Suite 3C307
Bethesda, MD 20892
Telephone: (301) 435-0044
2. Peer Review Contacts:
Ramesh Vemuri, Ph.D., Chief
Scientific Review Office
National Institute on Aging
7201 Wisconsin Avenue
Suite 2C212
Bethesda, MD 20892
Telephone: (301) 402-7700
3. Financial or Grants Management Contacts:
Joe Ellis Jr.
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Avenue
Suite 2N212
Bethesda, MD 20892
Telephone: (301) 402-7731
Section VIII. Other Information
Required Federal Citations
Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (https://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (https://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.
Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, https://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (https://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.
Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see https://grants.nih.gov/grants/gwas/.
to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.
Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see https://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement https://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.
Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.
Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.
NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator's NIH award. For more information, see the Public Access webpage at http://publicaccess.nih.gov/.
for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.
People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at https://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
Office of Extramural
Research (OER)
National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
Department of Health
and Human Services (HHS)
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text:
There were so many A-listers in this Movie 43 thing, so why did it flop? And don't say "because it was bad," because Valentine's Day was bad too.
—Waterloo Father X, via Twitter
I actually kinda liked Valentine's Day, but we digress.
Yep, Movie 43 disgusted critics, and it also failed to make ordinary folk whip out their wallets.
But you're right: Movie 43, which also starred Gerard Butler, Halle Berry and a bowl of guacamole, Seth McFarlane, Kate Winslet, Uma Thurman, Elizabeth Banks and Richard Gere, and many others, did not flop because of mere badness.
In fact, in a way, you can blame the one person who wasn't in the movie: Will Ferrell.
In case you don't know what Movie 43 is, it's actually a bunch of little vignettes put together—sorta like Valentine's Day.
A screenwriter manically pitches a bunch of ideas to a movie executive, and we see each of those ideas as short stories. (Overseas, the structure of the film is different; a bunch of kids seek out the most banned flick in the world—sounds better, maybe?)
And therein lies the movie's biggest fault, says box office analyst Jeff Bock of Exhibitor Relations explain.
"[Movie 43 studio] Relativity took a pretty big risk releasing a compilation comedy in wide release, especially one aimed at the YouTube generation," Bock points out. "As everyone knows, short comedies are readily available for free on Web sites like Funny or Die.
"Asking people to pay for that sort of content—no matter how big the stars—is sort of like pretending the Internet doesn't exist."
And, as we know, Ferrell is a co-founder of Funny or Die and...eh, you get it.
Relativity Media
All that said, just because the film is a flop, having brought in only $5 million so far, don't write it off as a failure.
"Although it seems like a massive bomb, the film only cost $6 million, so Relatively will probably make a profit on this since they hold worldwide rights," Bock reveals. "In fact the film already made $8.5 million in Russia...further proof that comedy just doesn't translate."
Is that a joke? If so, it's a lot funnier than anything in Movie 43.

subset: commoncrawl


text:
Train Took us on a Musical Journey
6 Comments
Hey, thanks for the comment. I'm hoping JR sticks with the lineup for a few days. The Pirates have really been struggling to score runs this year. Your right a switch-up could be what the guys need. McCutchen is so much fun to watch. He's already a great player, and will continue to get even more better.
That is sweet that Train had a concert at the Ballpark! I'm a huge fan of theirs. Looks like you had a great time. Congrats on having another great year. I am a big fan of the Rays and how the organization has been ran the past few years. You guys have a lot of great talented players. I'm rooting for you to make the playoffs. How is the ballpark there? I was thinking about making a trip down for a few games before the season ended.
The ballpark is not really as bad as the local and Natrional media make it out to be….
The Pirates could always adopt the Rays style of their farm system and grow their talent within…But we all know it takes time foir that vine to mature….Hopefully the Buccos have a winning season in them in the next few years…..I will cross my fingers for you.
Rays Renegade
I have to admit that the Rays are pulling off some amazing promotions through the concert series. Los Lobos…Train…wow! Any excuse to play indoors in front of a captive crowd is good for these band coming through. Good on the Rays' front office!
I agree with Randy. The Rays really do a great job with these concerts, bringing in people who might otherwise not come to the ballpark as well as diehard fans like you. Good job by them!
Nice tongue in cheek comment on playing indoors, but then again you have not heard the thunder outside at 6:30 pm before the start of a Rays game, or seen a 60 mph gust toss the cloth fabric under the Teflon roof during a contest.
Do not believe the hype 36,000+ yesterday is not a fluke….This region only seems to come out after the kids get ready to go back to school.
Rays Renegade
All I am going to say about Randy's comment is do not always believe the hype and propaganda coming from the Fourth Ward.
Rays Renegade


text:
Oregon Coast Range > Kings Mountain > Climber's Log
Kings Mountain Climber's Log
[ Sign the Climber's Log ]
|Birthday summit
Date Climbed: Sep 2, 2017
|I carried my 24-pound son up all 2,500 feet for my birthday. It would have been pretty interesting if I forgot my trekking poles. Beautiful forest and scenery.
|Posted Sep 7, 2017 5:38 pm
|Picked a funny day
Date Climbed: Oct 23, 2016
|to do this one. There was a trail run going on that started on Elk, so there were runners flying down the mountain while we were heading up. It was a nice cool, foggy day, and even with extra breaks for runners to pass, Maddie and I summited in an hour and twenty minutes. The view was nice, yet partly obscured. Will be coming back for Elk!
|Posted Oct 23, 2016 10:58 pm
|Kings Mountain
Date Climbed: Jun 21, 2016
|Gorgeous views of the coast range up there. There's a trail log at the top too.
|Posted Oct 19, 2016 12:46 am
|Nice spring hike
Date Climbed: Apr 21, 2016
|Nice spring hike. Great dramatic views for a 3200 foot mountain.
|Posted Apr 21, 2016 3:22 pm
|great January traverse
Date Climbed: Jan 19, 2014
|This was a great winter conditioner- no snow, and it felt like a summer day up there. Combined with Elk Mt, it made for a solid 5 hour tromp.
|Posted Jan 21, 2014 1:21 am
|Mazama BCEP Hike
Date Climbed: Apr 23, 2011
|I hiked to the top as part of a conditioning hike with the Mazamas Basic Climber Education Program (BCEP) class.
|Posted Apr 20, 2012 10:09 am
|first hot day of 2011
Date Climbed: Jun 4, 2011
|Had some time on Saturday so went for a hike to my favorite trail.
up 48min 30 sec.
down 27 min
I shouldn't rushed since I haven't hiked for about 10 months but daylight was closing on me so I had no choice.
wearing five fingers made my entire leg work extremely hard which resulted in an extreme soar 3 days later. Feet and knees felt great tho.
Since this is only 60 minute car ride for me from home to trail I like to do this hike 2-3 times a year on the nice day to enjoy the reward on top.I take all out of town guests on this hike to show what Oregon has to offer in it's northwest corner.
|Posted Jun 7, 2011 3:00 am
Date Climbed: Jun 27, 2010
|Steep, but well worth the effort. The wildflowers were in bloom, the sky was clear, and the temperature was mild... all in all, a perfect day!
|Posted Jun 28, 2010 8:07 pm
|First Time Up
Date Climbed: Mar 29, 2009
|Great hike! There was about 2" of snow from about 1600 feet until about 3000 feet, the last 200 feet had over a foot of snow. The hike is very green at the bottom, and the trail is extremely vertical with surprisingly few switchbacks. I will do this hike again.
|Posted Mar 30, 2009 12:47 am
|First time
Date Climbed: Mar 21, 2009
|Hiked up with my Dad. Lots of Mazamas working on the trails today and at the summit. They offered me Clif Bars and stuff but my Dad wouldn't let me have any. Was fun in the snow but my Dad was too slow. Hey, that rhymes!
|Posted Mar 22, 2009 2:31 am
|First Hike of the New Year
Date Climbed: Jan 10, 2009
|Started out with headlamps at 6:30. Forcast called for a good day turned out to be somewhat right. Made the summit with snow the whole way up, with trail easy to follow. Sun broke out when at the summit. Nice work out and hope for many more this year.
|Posted Jan 11, 2009 6:48 pm
|Regular hike
|I hike this every other week or so just to keep in shape. Great training hike for bigger things and a wonderful place to watch the sun set.
|Posted Aug 31, 2008 5:06 am
Date Climbed: May 18, 2008
|Short, rewarding trip to the summit; it was hot.
|Posted May 19, 2008 6:45 pm
|Hiked the creek between Kings and Elk. Then Up to summit via some easy scrambling and some vertical grass climbing. Fun! trying to find some technical rock. didn't find anything out of the ordinary.
|Posted Oct 7, 2007 1:12 am
|Elk/King Loop
|I love the CAUTION sign on the stump as you skirt around the cliffs on the traverse from Elk Mountain. There's lots of good scrambling above this section of trail that's worthy of a return visit.
|Posted Aug 22, 2007 1:27 am
Date Climbed: Mar 4, 2007
|Hiked up with Brian. Lots of snow up top. Great views.
|Posted Aug 6, 2007 6:44 pm
|My buddy and I were running short on time, but still wanted to get a good hike in. We ended up hiking Kings, which is good and steep. We then too the much smaller trail over to Elks Peak, at which point we had to run to get back in time. All in all, we ran a ton of the trail, and running down Elks was crazy and scary and fun. I was definitely sore from using my downhill muscles.
|Posted Jul 23, 2007 12:11 am
|Kings Mountain Trail
Date Climbed: Jul 7, 2007
|Hiked Kings Mountain Trail to the summit and back. The weather was perfect--great views and a good workout.
|Posted Jul 8, 2007 10:28 am
|Snowing at the Top!
Date Climbed: Apr 14, 2007
|A great day, doing the traverse from Elk to Kings. Started out beautiful with the sun out. At the top of Kings, it was snowing -just for a moment, then sunny again!
|Posted Apr 15, 2007 10:57 am
|Karl Helser
|Kings after Elk...
Date Climbed: Feb 10, 2007
|I Tagged Kings after tagging Elk. Weather was dry. No volcano views. If you've got nothing else going on, this is a great conditioning hike. Don't forget you trekking poles.
|Posted Feb 13, 2007 1:37 pm


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The Senate and the House have each introduced bills in recent weeks that would establish a Government Transformation Commission. The bills' purpose is to assess, transform and demonstrate results in the efficiency, effectiveness and economy of government programs. If the legislation is enacted, the commission would be the first entity created expressly to ensure that our government's programs save money and are operated effectively.
Government programs have not been assessed at this level of detail so that meaningful and measurable action could be taken. At this difficult time of budget deficits, major cuts are being made and Congress is facing tough decisions with regard to social insurance, tax reform and civil service reform, among others. The operation and management of agency programs must also be addressed to capture efficiency and savings, and to strengthen the government's service to the American people.
Agency leaders would be well served by such a commission. In the current political environment — with its short election cycles and the need to address major domestic and world issues — it is difficult for agency leaders to maintain their focus on efficiency, effectiveness and economy. With Congress frozen by politics and turnover at all levels, lawmakers are largely unable to keep up with government programs and determine if they are effective, efficient, duplicative or outdated. Such oversight is a necessary part of savings and deficit reduction.
The status quo will no longer do. Given the size of the federal government, attention to program efficiency could result in billions of dollars in savings.
The commission, therefore, would become a valuable tool that supports government leaders and provides the resources agencies need to do their work for the American people. For the first time, agency leaders would be able to:
• Have their programs assessed and implement changes without direct cost to the agencies.
• Have employees participate in the effort through reimbursed detail assignments to the commission, where they would collaborate with experts and develop skills they can take back to their agencies.
• Share in cost savings by allowing funds to be applied where they are critically needed.
• Have a Web portal through which agency employees and others can become part of the solution by offering suggestions for improvement and change.
By supporting the hardworking employees, managers and leaders who keep the trains running every day, the commission would provide the perfect opportunity to get the job done. With a dedicated entity responsible for results and accountable to the president and Congress, transparency would be assured.
Given the size of the federal government, attention to program efficiency could result in billions of dollars in savings.
The Hoover Commission did a great job of addressing government efficiency in the 1940s, and the National Performance Review started the dialogue again in the 1990s. It's now time for a statutory tool to finish the work. Under the proposed legislation, the commission would have the authority to assess and make needed changes, in collaboration with agency leaders. It would have the power to conduct hearings, take testimony, and gather necessary data and information. It would be required to report on its progress every six months and on its results every year.
Recommendations requiring legislative action would be subject to a time-limited up-or-down vote for speed and action. Other recommendations would go to the president, and the commission would work collaboratively with agency leaders.
There is no better time to enact this legislation. Our government must become more efficient so that across-the-board budget cuts are not necessary, the American people are best served, their money is used wisely, and federal jobs are not lost or employees furloughed.
About the Author
Steve Goodrich is president of the Center for Organizational Excellence and a Government Transformation Initiative board member.
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Large parts of the federal government will shutter at least temporarily as Congress fails to enact a four-week stopgap spending bill. As agencies prepare to power down, officials say cybersecurity is being given a higher priority than it was in the 2013 shutdown.
An individual's walking gait will be the first biometric used to continuously authenticate mobile warfighters.
The former chairman of the House Oversight and Government Reform Committee and the lead sponsor of the IT procurement bill FITARA is calling it quits.
Pentagon acquisition chief Ellen Lord has been replaced as the chair of the group overseeing the massive cloud initiative known as the Joint Enterprise Defense Infrastructure.
Government application of the ledger technology lags behind the hype, but expect more experiments to take off in the coming months.
After a 2017 filled with uncertainty and slipped deadlines, the Census Bureau faces a critical 2018 that could make or break the constitutionally mandated count.
Government restructuring commission bills have been going in Congress for twenty years. The problems of growth in redundant programs to satisfy constituent needs are a result of political processes. Politicians rarely make budgeting decisions on the basis of good management, let alone any that risk disenfranchising any politician's stakeholders. It is too easy to twist the messaging in the battle for resources to have the budgeting process yield rational results. Rather, funds travel to those in power and their supporters. The real need for a Commission is in overhauling Congressional appropriations processes and structures. As any student of Goldratt and the Theory of Binding Constraints should know, actions that make sense (such as this Commission) will not have any impact unless they address the binding constraints. Congressional leadership has repeatedly show an unwillingness to transfer power needed to deal with the binding constraint here...the political control over allocation of federal funds. Kill or consolidate all the departments into one and you may save 10% of the budget, while 50-90% of the budget is allocated on the basis of buying votes by handing out dollars. Simply look at the success of the President's campaign in targeting specific promises to constituencies, and notice how almost all of the 2014 campaigns are adopting the same model. A Commission is going to reverse that...really?
As I see it, this program will be successful to the extent that it provides a mechanism for unbiased program evaluations that will lead to cutting the waste, as the previous commenter suggests
Another costly program to supposedly make the Government more efficient. We have had plenty of them and look at where we still are. Every organization is still clammoring for more money despite our ever increasing spending. We even had sequestration and STILL spending more. This will likely be another one of those programs where we spend dollars to save dimes - and that is being optimistic. Many spend dollars to save pennies. I am sure some people will get promotions and all sorts of recognition at the beginning for putting the program together, then it will be implemented and slowly forgotten as it turns into another annual line item that adds to the cost of government. When will people learn that if you really want to cut costs you got to cut the inefficient programs - not add new programs.
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Lee irked about warming up before rainout
By Jake Kaplan / MLB.com
Lee didn't throw his warm-up pitches before the game, which was delayed from the start. But when the rain briefly subsided about an hour later and a new start time was set for 8:45 p.m. ET, Lee was told to warm up and threw 30-40 pitches in the bullpen to get ready to start the game. Then, the rain started to fall again and the game was eventually called at 9:53 p.m. ET.
"I could've had my son look at the radar and he could've told me it was gonna rain," Lee said on Saturday. "Somebody got that wrong. I don't know who it was, but it was pretty obvious it was gonna rain. Somebody up there was really adamant about us playing."
Lee added that he looked at the radar twice, once before the game was set to originally start and again before warming up in the bullpen.
"It was pretty obvious that it was gonna rain," he said.
Lee (0-3, 3.48 ERA) will now start the 6:35 p.m. ET game on Sunday, the second game of the twin bill. Cole Hamels (10-3, 3.25 ERA) will pitch in the first game, slated to start at 1:05 p.m. ET.
Kyle Kendrick (2-7, 5.29 ERA) took the mound on Saturday against Tampa Bay's James Shields (7-4, 3.72 ERA), who was scheduled to start for Tampa Bay on Friday.
Pitching coach Rich Dubee said the Phillies decided to have Lee start Sunday's evening game instead of the afternoon game to give him a little extra recovery time after warming up on Friday.
"You've got to make the adjustment," Lee said. "It is what it is. There's nothing I can do about it. I've got to get ready to pitch [on Sunday]."
Victorino gets day off to clear his mind
PHILADELPHIA -- Phillies manager Charlie Manuel stuck with the same lineup on Saturday that he was set to use before Friday's series opener against the Rays was rained out. That included giving Shane Victorino a day off so the center fielder could relax and clear his head.
"There's no apparent reason," Victorino said before Friday's game. "I've played every game, and I'll be ready to go tonight if they need me defensively or [to] pinch-hit. I'll be ready to go. It's just a day for me to get a day off, nothing more than that."
Victorino has played in all 71 games thus far, more than any player in the Major Leagues. The 31-year-old is hitting .252 and owns a .319 on base percentage, both well below his career averages of .277 and .342. He has eight home runs and 33 RBIs.
Victorino is a switch-hitter, but is hitting just .226 in 208 at-bats from the left side of the plate.
"The thing I see him doing, especially on the left side, his stride's real quick, he gets out in front and they take the sting out of his bat," Manuel said on Friday. "I don't particularly like sitting him, because when he's hitting good, he gives us a chance to win the game. He's played every day so far, but at the same time, the reason that we're resting him is because he's struggled a little bit from the left side."
John Mayberry Jr. started in center field and hit seventh on Saturday.
Utley reportedly may be activated Wednesday
PHILADELPHIA -- Chase Utley, who has yet to play this season because of chondromalacia in his left knee, could be activated by the Phillies on Wednesday, according to a CSNPhilly.com report.
The report, which cites an anonymous source, says that Utley is expected to return to Philadelphia for the last portion of his rehabilitation assignment -- which might include one last rehab game with Triple-A Lehigh Valley on Tuesday -- before he is activated. Utley has played in nine games with Class A Clearwater, where he's 5-for-32 with one home run and five RBIs.
The 33-year-old went 0-for-3 with a sacrifice fly and played eight innings at second base on Saturday night, marking the first time during his rehab that he took the field on back-to-back nights. He played all nine innings at second base for the Threshers on Friday night.
The fact that Utley played the field two days in a row is a positive sign. Saturday was the 12th day of Utley's rehab stint. Position players on rehab assignments have 20 days to be activated by their Major League ballclub, so it would make sense that Utley could return this week. Barring any type of setback, Utley has until July 2 to be activated.
The Phillies play a four-game series with the Pirates at Citizens Bank Park starting on Monday.
Stutes set for shoulder surgery on Tuesday
PHILADELPHIA -- Right-hander Michael Stutes will undergo arthroscopic surgery on his right shoulder on Tuesday, the Phillies announced on Saturday. Dr. Lewis Yocum will perform the surgery.
Stutes had not been progressing as the Phillies would've liked, and general manager Ruben Amaro Jr. had said on Tuesday that there was a chance the reliever would have some type of exploratory surgery.
Stutes pitched in only six games this season (0-0, 6.35 ERA) before going on the disabled list on April 22 with what was described as right shoulder inflammation. In 2011, his rookie season, Stutes was 6-2 with a 3.63 ERA in 57 games.
The Phillies' bullpen is also without the services of David Herndon, who had season-ending Tommy John surgery, and Jose Contreras, who is likely out for the season with an elbow injury that will also require surgery.
Worth noting
Roy Halladay, who is recovering from a strained right latissimus dorsi, continues to throw long toss and is "doing fine," Dubee said. Dubee said the club has an idea when Halladay will begin throwing off a mound, but didn't disclose any more details.
A Phillies win and a Marlins loss on Saturday would put Philadelphia in fourth place in the National League East for the first time since May 28.
With Friday's game postponed until Sunday, Saturday's game marks the first time the Rays are playing a game at Citizens Bank Park since Game 5 of the 2008 World Series, when Brad Lidge closed the game by striking out Eric Hinske.
After hitting the ball extremely well with Class A Clearwater, Cody Asche was promoted to Double-A Reading on Saturday. Asche, a third baseman, hit .349 with two home runs and 25 RBIs in 62 games for the Threshers.
Manuel was one win from his 900th career victory entering Saturday.
It's possible a 26th man could be in uniform for the Phillies on Sunday against the Rays at Citizens Bank Park. In a rule established in the most recent collective bargaining agreement, clubs can have 26 players on the roster for day-night doubleheaders that occur at least two days after the original game is rained out. The Phillies have not yet said if they will take advantage of the rule. If they do, they would likely promote a player from Triple-A Lehigh Valley, which is currently in the midst of a three-game series at Columbus.
Jake Kaplan is an associate reporter for MLB.com. This story was not subject to the approval of Major League Baseball or its clubs.


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Scouting Report Nice mixture of Terrence Cody (huge body size) and Jesse Williams (bench presses 500 +). Prototypical 3-4 NT. He's a space eater who can penetrate the offensive backfield and attract 2 blockers to free up linebackers.
BigEasyTider's Take
runtheoption22's Take As you'll see when we post our individual rankings, I am very high on Frazier. Extremely strong before Cochran ever gets a hand on him. Plays the NT position well. Doesn't just clog holes, but gets a push- even against double teams. This could be the fixture of the middle of the line for the next 3 years, at least as he learns the game this season.
WMack4Bama's Take I'm excited and thankful that we made him our top priority as a NT. He got a ton of pressure about leaving his home state to play for a divison rival. But, in my opinon, he's without question our answer there for the next 3-4 years. Sure, he'll more than likely have to come out on 3rd downs, but the message that Coach Saban has been sending since SEC Media Days has been "The time is now to resurrect the identity of the Alabama football program" . That starts with Josh Frazier. He will be the physical presence in the middle of our rugged defense that allows our linebackers to be terrors all over the field. He'll be great before he leaves.


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Busted Knuckles - 2003 Chevy Silverado
Welding Madness Gone Right
Scanning over the tech sheet we supply each feature owner with, we couldn't help but notice one reoccurring theme. Roman Garza is very appreciative of his friends' help and his parents allowing him to use the family workshop to build his '03 Silverado. Roman has a lot to be thankful for as his Chevy features a 3-inch body drop, 24-inch Raceline wheels, and a newer 2006 Silverado front clip installed. Best part of those flashy stats is the fact he did nearly all of the work himself. Built in a workshop by this 20-year-old young gun, the under construction ride you see here should be completed by the time you're reading this.
Starting with an '03 Silverado, Roman and buddy Juan De La Hoya used 2x4x¼-inch rectangular tubing to create the back half. A basic two-link with Dominator 2600 'bags in front of the axle provide the lift out back, while McGaughys drop spindles and an Ekstensive front arm kit slam the nose. Beautiful 24-inch Raceline Blast wheels are wrapped in 275/30R24 Kumho tires. The rearend was narrowed a total of 10 inches and will allow the shaved bed to swallow the 24s.
Updating the look of his Chevy, Roman bolted on the front fenders, hood, and grille shell from an '06 Silverado. As you can see in the rendering, the truck will be green with a simple, yet aggressive graphic down the side. The inside of the bed will be completely metal worked and provide a large opening for the custom suspension tubing. Fully shaved, the Silverado will be nice and slick. Roman hasn't decided at time of print what will be done inside the extended cab, but expects something clean and usable.
When asked about things he would change, he told us, "Buying the 24s, because I want to go bigger." The custom truck snowball is always rolling downhill, and we can't wait to see Roman's truck all wrapped up.


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SDK Beta Release 844703 for DM365 Leopard Board
This is not the most current Leopard Board 365 release - please see SDK Release for DM365 Leopard Board.
General Information
Release Information
- Product Name: Evaluation SDK for DM365 Leopard Board.
- Version: Beta Release 844703.
- Date: 03-12-2010.
- Download link: RidgeRun Download Center.
Copyright Notice
This document and the software described in it are furnished under license with RidgeRun, and as such, may be used or copied only in accordance with the terms of the license. The contents of this document are furnished for informational purposes only and are subject to change without notice. RidgeRun, assumes no responsibility or liability for any errors or inaccuracies that may exist in this document. No part of this document may be reproduced, stored in a retrieval system, or transmitted in any form, without the prior written consent of RidgeRun.
Please read the full license agreement for the RidgeRun Evaluation SDKs here.
ARM is a registered trademark of ARM Limited. Linux is a registered trademark of Linus Torvalds in the United States and other countries and is used by RidgeRun under license. Instruments and TI are registered trademarks of Texas Instruments Incorporated. All other trademarks are the property of their respective owners.
Revision History
|Initial Version
- General SDK documentation:
- DM365 Leopard Board related documentation:
What's new?
There is no previous SDK for the DM365 Leopard Board SDK.
Supported Operating Systems
Linux Distribution Ubuntu 9.04 and 9.10 in 32 bits.
SDK Details
SDK 844703 is a Evaluation Linux SDK build for Texas Instruments DM365 System on Chip.
This SDK is designed to run on the DM365 Leopard Board.
This SDK includes:
- ARM toolchain: gcc 4.2.4.
- U-Boot 2009.11 with a set of patches for support the Leopard DM365 (The SDK bootloader installation is not supported, please DO NOT run the target "make installbootloader", or your board will get bricked).
- Linux LSP kernel 2.6.18 + Real Time patches. DM365 support for the following drivers:
- Sensor MT9T031 for 5MP camera.
- Video output support: DVI, Component and Composite.
- MTD (NAND flash).
- Watchdog timer.
- Real time clock.
- USB (host and gadget).
- VPBE Framebuffer.
- Ethernet.
- AutoFocus (AF).
- Auto Exposure/Auto White Balance (AEW).
- Integration with some of TI's newest packages for the DaVinci platforms, including:
- XDCTools 3.15.01.59.
- Please ensure to download and install these packages in your home directory before build the SDK. These packages can be download from the TI's site here.
Known Bugs
- Video quality of the captured video by the 5MP camera. The video captured by the camera looks with a purple tone, so it seems that there is an issue related to the color space transformation between UYVY and NV12.
- Framerate when Gstreamer is used. When the camera is used to capture video in gstreamer the framerate is around 1/25 fps. However some tests where done by using a custom V4L2 application and the framerate is around 25fps to 30fps.
- The audio codec AIC3104 is not supported yet. The main issue found is the audio codec doesn't use an external clock, instead is uses a clockout from the DM365 SoC, so it needs to be configured to provide the clock signal to the audio codec and the AIC driver configuration needs to be modified to make it match with the frequency provided by the DM365.
- The bootloader installation is not supported so if you run the target "make installbootloader", your board will get bricked.
Support Information
This SDK doesn't include support services.
RidgeRun Developer SDK for DM365 provides handful of debug and profile tools, professional Linux development support and a wider range of DM365 drivers. Contact RidgeRun at email@example.com for information and pricing on Developers SDK for DM365 platforms.