text:
Participating Organization(s) |
National Institutes of Health (NIH) |
National Cancer Institute (NCI) |
Funding Opportunity Title |
Validation of Molecular Diagnostics to Predict Patient Outcomes Using Specimens from Multi-Site Cancer Trials (R01) |
Activity Code |
R01 Research Project Grant |
Announcement Type |
Reissue of PA-08-134 |
Related Notices
Funding Opportunity Announcement (FOA) Number |
Companion FOA |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.394, 93.395 |
FOA Purpose |
This Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI), National Institutes of Health (NIH), encourages the submission of Research Project Grant (R01) applications from institutions and organizations to validate the clinical utility of new molecular diagnostics for determining prognosis or predicting response to therapy or toxicity for cancer. The Cancer Diagnosis Program (CDP) and the Cancer Therapy Evaluation Program (CTEP) at the NCI are cooperatively sponsoring this FOA with the purpose to transition of candidate biomarkers from initial correlative observations into diagnostics that are suitable for use in clinical trials to assess the clinical validity of a marker. This program will support research projects to improve clinical decision-making in the care of cancer patients and as such will support studies that use tumor specimens linked to specific treatment and clinical outcome information. This FOA is not appropriate for molecular diagnostics discovery projects. |
Posted Date |
November 16, 2011 |
Open Date (Earliest Submission Date) |
January 5, 2012 |
Letter of Intent Due Date |
Not Applicable |
Application Due Date(s) |
Standard dates apply , by 5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
Standard dates apply, by 5:00 PM local time of applicant organization. |
Scientific Merit Review |
Standard dates apply |
Advisory Council Review |
Standard dates apply |
Earliest Start Date(s) |
Standard dates apply |
Expiration Date |
January 8, 2015 |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
This Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI), National Institutes of Health (NIH), encourages the submission of Research Project Grant (R01) applications to perform validation of the clinical usefulness of new molecular diagnostics that are becoming critical components for determining prognosis or predicting response to therapy for cancer. Advances in cancer biology and powerful technologies are providing increased opportunities for analyzing aberrations in genes, proteins and molecular profiles and for developing more effective therapeutics and prognostic and predictive markers to inform their use for individual patients. However, prior to clinical laboratory implementation, the technical and analytical performance characteristics (e.g., stability, accuracy and reproducibility) of the assay for the marker need to be established. Secondly, determining clinical utility of a molecular diagnostic i.e., the evidence that the marker separates two subgroups of patients with different outcomes within a large population, requires correlation of laboratory test results with clinical parameters. Therefore, access to clinically-annotated specimens collected from multi-institutional, well-controlled clinical studies is absolutely essential for assessing the clinical usefulness of the test. The ultimate goal of this FOA is to evaluate the clinical utility of analytically validated molecular diagnostic tests to improve clinical decision-making in the care of cancer patients (e.g., to meet criteria for enrollment or to assign a specific treatment arm). This FOA is not appropriate for molecular diagnostics discovery projects.
This FOA will utilize the Research Project Grant (R01) mechanism, and is suitable for projects where proof-of-principle of the proposed technology or methodology has already been established and supportive preliminary data are available. This FOA runs in parallel with an FOA of identical scientific scope, PA-12-014, which utilizes the Exploratory/Developmental Grant (R21) mechanism.
Despite a large body of published reports on diagnostic and prognostic factors in cancer patients, the rate of acceptance of new markers to inform treatment decisions for cancer patients has been slow and very few such markers and laboratory assays are used in clinical practice. Prognostic biomarkers are indicators of the natural history of disease and the pathological process and estimation of probability of recurrence. Predictive markers are distinct from prognostic markers in that they provide an estimate of probability of response to therapy. Both types of markers are unlikely to be clinically useful unless their prognostic or therapeutic relevance is established in well-designed validation studies. The steps involved in test validation are meant to answer the key question whether the test is ready for implementation in the clinical laboratory. In order to answer this question the analytical performance characteristics must be established along with the clinical utility of the test.
Examples of Successful Predictive Markers. Recently, several anticancer therapies, including immunotherapy and targeted therapies, have provided alternative treatment options to cancer patients. A signaling pathway inhibitor Vemurafenib, which targets mutated BRAF, has conferred improved overall and progression-free survival in patients with advanced melanoma compared to standard chemotherapy, but only in those patients whose tumors harbor the mutated BRAF. Based on these results, Vemurafenib was approved by the FDA for treatment of patients whose metastatic melanoma carry BRAF V600E mutation, as determined by an FDA-approved test. The introduction of epidermal growth factor receptor (EGFR) inhibitors in the clinic led to the identification of molecular markers, i.e., EGFR activating mutations in patients with non-small-cell lung carcinoma (NSCLC) or gene amplification in patients with colorectal carcinoma, that predict sensitivity to EGFR inhibitors. Crizotinib was also recently FDA-approved to treat a small subset of NSCLC patients who have EML4-ALK fusion gene resulting in activated ALK kinase this drug targets.
Several other genetic alterations (i.e., mutations, fusion genes, insertions/deletions or gene amplifications) within a tumor directly activate an oncogene, e.g., activating mutations in KIT gene in gastrointestinal stromal tumor and ERBB4 gene in cutaneous melanoma, mutations and internal tandem duplication in the FLT3 gene in acute myeloid leukemia, BCR-ABL fusion gene in chronic myelocytic leukemia and HER2/neu gene amplification in breast carcinoma. In these examples, the presence of a specific DNA alteration within the tumor predicts a positive therapeutic response to a particular drug because the drug targets a protein encoded by oncogenic drivers that are critical for tumor growth. Another type of genetic marker predicting response is mutation downstream of the drug's target. As an example, metastatic colon cancers with mutated KRAS gene are refractory to treatment with EGFR-specific monoclonal antibody therapy. These molecular defects would inform stratification of cancer patients into actionable molecular subtypes who are likely to respond to specific treatment for their improved outcome.
Although these molecular subtypes of cancer patients selected for treatment by the presence of specific molecular marker often experience impressive responses to molecularly targeted therapy, most will suffer from disease progression and recurrence. Therefore, acquired alterations such as new mutations or gene amplification that lead to the development of drug resistance are also critical for molecularly characterizing tumors and to predict drug response.
Principles of Test Validation. Assay validation has both analytic and clinical components. It is essential that analytical performance of the assay is established before the evidence of clinical utility is obtained. Analytical performance characteristics of the assay need to address the following parameters:1) specificity and sensitivity, 2) accuracy i.e., closeness of the test result to the true value, 3) intra- and inter-assay variability, 4) upper and lower limit of detection, 5) cut-off points and 6) reproducibility. Analytical validation process should establish parameters for the assay to correctly classify biologic samples as positive or negative for the marker.
Clinical validation study design and analysis however must address the specific intended clinical use for the assay, such as determining prognosis or predicting response of the particular tumor to generic class of treatments (e.g., endocrine or chemotherapy) or specific agent (e.g., targeted therapy or immunotherapy). Thus, it requires correlation of analytically validated assay with clinical data from for example case-control studies, retrospective data collection or prospective clinical trials. The study should also address how well the marker predicts outcome, i.e., difference of outcomes for patients who are positive versus those who are negative for the marker. The magnitude of the marker effect to influence outcome or treatment decisions and cut-off points need to be validated to establish clinical utility of the test.
Clinically Annotated Specimen Collections. Availability of specimens with associated clinical annotation is an important consideration for reliably establishing the clinical utility of the prognostic or predictive markers. Specimens collected within multi-site clinical trials are especially suitable for retrospective and prospective analyses of associations between outcomes and molecular characteristics. Archived specimens from a large population of untreated patients should be adequate to estimate recurrence in marker-defined subgroups of patients. Specimens from randomized trials with a survival or progression-free survival endpoints are required to establish the clinical validity of marker for predicting response to specific treatment. Tissue specimens should be available in sufficiently large numbers to permit statistically powered analyses and to ensure that the patients included in the biomarker study are representative of the patients that will be used in clinical testing in the community. Large numbers of archived specimens (i.e., peripheral blood mononuclear cells, marrow, tumor tissue, lymph nodes, plasma/serum) from uniformly treated patients that are associated with carefully annotated demographics, diagnosis, overall and progression-free survivals, and toxicity are available from the NCI sponsored Cancer Centers and multi-institutional research programs and also the NCI Clinical Trials Cooperative Oncology Group Program, an integrated national network of clinical investigators and institutions that conduct phase II and III clinical trials. Archived specimens associated with clinical data can therefore be of great importance for establishing the medical utility of prognostic or predictive biomarkers and offer improved diagnostics for use in cancer patients care.
The objective of this FOA is to promote validation studies for molecular diagnostics to prove their clinical usefulness to improve cancer patients outcome. Therefore, the specific purpose of this FOA is to develop assays that will be suitable for validation in clinical trials to assess the clinical validity of a marker and to provide evidence that the use of marker improves outcomes.
Examples of clinical utility of molecular diagnostics include, but are not limited to the following:
Analytically Validated Tests. R01 projects should be designed to determine whether analytically valid assay results are associated with clinical endpoints using retrospective or prospective tissue collections in clinical settings similar to the proposed use of the assay. Analytical validation of the assay involves a systematic evaluation to ensure that the assay meets acceptable standards of performance to be used for analyses of clinical specimens. Applicants should demonstrate that the proposed assay has the sensitivity, specificity and reproducibility adequate to answer the clinical question. Procedures for standardization of an assay should be established and the assay should be completely developed including cut-off points to measure prediction accuracy before the clinical utility validation step.
Validation of Clinical Utility. The aim of clinical validation studies should be to define marker sensitivity and specificity for clinical endpoint determination and to support its clinical utility. Successful responses to this FOA should clearly describe the clinical question that the proposed marker will address and describe how the prognostic or predictive strategy will impact existing approaches on the care of patients.
The R01 Research Project is expected to engage investigators into fully developed validation research projects using large specimen cohorts from multi-site trials proceeding to full validation using a training set and an independent validation set of specimens with a potential for clinical application. Validation of a marker in an independent test set (samples that were not used for the initial validation) is essential to confirm the strength of the association with clinical outcome. Both training and validation step should be based on cohorts of patients that are sufficiently homogenous for therapeutically relevant assay to be developed. The applicant should provide a power analysis to indicate that the number of specimens is statistically significant to assess association between the results of the validated assay and the clinical endpoint within the context of the intended use.
Clinical Specimens. The applicant should secure the access to high-quality clinical specimens that are uniformly treated in multi-center trials so that candidate biomarkers identified in discovery research that are important for tumor prognosis or response to therapy are validated and transitioned into diagnostics to be used in subsequent clinical trials. Generally, well-annotated tumor and other biospecimen cohorts collected retrospectively during large multi-institutional treatment trials are especially suitable for these studies. Prospective collections seem more suitable in the context of ongoing projects; thus the investigators need to provide specific information about the arrangements for collection and analysis of patients outcome data especially if follow-up will be required beyond the end of the award period.
This FOA is not appropriate for molecular diagnostics discovery projects. The emphasis of this program is on the transition of discovery research into new assays for the clinical management of patients with cancer. Therefore, studies to pursue initial exploration of the relationship between candidate markers and clinical parameters are not appropriate to this FOA. Candidate assays/markers generated in exploratory study could be further validated into clinically applicable assays through the currently offered funding opportunity for an R01 type of projects or the parallel PA-12-014, using the R21 Exploratory/Developmental Research grant mechanism for the pilot projects that are useful to establish the feasibility of molecular markers.
Funding Instrument |
Grant |
Application Types Allowed |
New The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications. |
Award Budget |
Application budgets are not limited, but need to reflect actual needs of the proposed project. |
Award Project Period |
Scope of the proposed project should determine the project period. The maximum period is 5 years. |
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))
must also work with their institutional officials to register with the eRA
Commons or ensure their existing eRA Commons account is affiliated with the eRA
Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least four (4) weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.
For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple
Program Director(s)/Principal Investigator(s) Policy and submission details in
the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R)
Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Resource Sharing Plan
Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies; GWAS) as provided in the SF424 (R&R) Application Guide.
Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Foreign (non-US) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH's electronic system for grants administration.
Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
All PD(s)/PI(s) must include their eRA Commons ID in the
Credential field of the Senior/Key Person Profile Component of the SF
424(R&R) Application Package. Failure to register in the Commons and
to include a valid PD(s)/PI(s) Commons ID in the credential field will prevent
the successful submission of an electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization's profile in the eRA
Commons and for the Central Contractor Registration (CCR). Additional
information may be found in the SF424 (R&R) Application Guide.
See more
tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.
Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF 424 (R&R) Application Guide.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the strategy
establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.
Inclusion of Women, Minorities, and Children
When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
For Renewals, the committee will consider the progress made in the last funding period.
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.
Applications from Foreign Organizations
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Review assignments will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD(s)/PI(s) will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee's business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.
Any application awarded in response to this FOA will be subject to the DUNS,
CCR Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
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 and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Cooperative Agreement Terms and Conditions of Award
Not Applicable.
When multiple years are involved, 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 the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
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Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
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text:
Aquarius [January 21st to February 18th]
If you've been holding your tongue in favor of diplomacy, consideration or vaunting patience, you're ability to do that wanes, as the week waxes. This should let you know that the balance of the week (and the month) is going to be about you straightening out communication and issues that have reached their "moment." Don't hurt 'em, and I kinda mean that. I mean, have you read how Aquarian Frederick Douglass would sear flesh with words? Or how fellow Aquarian Keith Olbermann used to set folks' wigs on fire by just speaking into the camera? You can do that, even if you're mild-mannered. You have a lower threshold for foolishness, lies or inaccuracies than you think you do…and that's sometimes your problem. See yourself clearly. On a different note, you may see your money woes taper off and feel like you're getting better settled.
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subset: commoncrawl


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By Greg Merritt & Jim Stoppani, Ph.D Flex
The ephedrine/caffeine stack was a staple for many bodybuilders before the ban in the U.S., but for those countries where ephedrine is still legal, here is some good news. A recent study in the journal Diabetologia examined how it would impact brown adipose tissue (BAT). In rodents, BAT activation and increased energy expenditure in response to cold and sympathomimetic drugs is of considerably greater magnitude than in humans. In a randomized, double-blinded, crossover trial, they administered 2.5mg/kg of oral ephedrine to nine lean and nine obese young men (ephedrine is sold in 10mg doses).
In this study, they gave 170mg of ephedrine for lean subjects and 287.5mg ephedrine for obese subjects. Shockingly, they found that the ephedrine activates BAT in the majority of lean, but not obese people. The really interesting fact is that ephedrine did activate brown adipose tissue in lean individuals whereas in the past scientists did not even know if this was possible in humans. The other startling fact was that it did not work in obese people. So the question is, are obese people overweight because they have the inability to activate brown adipose tissue or is it that they have a defective neurological pathway that activates brown adipose tissue? The good news is that in countries where ephedrine is still legal, it can be a great addition to your pre-contest stack to get shredded as increased activation of BAT is a potent stimulator of thermogenesis. But if you are obese, ephedrine may be a waste of money.
REFERENCE: Snyder, B.J., J Strength Cond Res., 2012 Sep;26(9):2394-400.
Source: http://www.flexonline.com/training/b…ated-ephedrine


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This Daily Devotional was sent to me by a sister that received it in her email today. She states that it also adds to what I spoke on last night... She states, "I'll say this, the Spirit is Timely and always brings a word of confirmation. "
…We declare God's wisdom, a mystery that has been hidden and that God destined for our glory before time began. None of the rulers of this age understood it, for if they had, they would not have crucified the Lord of glory. 1 Corinthians 2:7-8
Today's devotional comes from our founder and friend, Brother Andrew: Have you ever noticed the strategy Satan used throughout Old Testament history? His attacks were aimed at preventing the birth of the Messiah at Bethlehem, but, once Jesus was born, Satan's tactics changed somewhat. In some instances, he tried to kill Jesus before the Lord could reach the cross. At other times, Satan engineered numerous attempts to discredit Him—to cause Him to stumble or to sin.
But Satan met defeat at the cross. He failed to understand God's strategy, and his final blunder actually forced events so that Jesus, though innocent, was condemned to die. The Apostle Paul noted that Satan did not understand this in 1 Corinthians 2:8. Since that time, Satan's tactics have changed. He's still concerned about preventing the Word—the Word that was with God and is God (John 1:1)—from reaching people who are under Satan's dominion. His attack is now two-pronged.
First Satan concentrates on the life and name of Jesus which each and every believer bears as the Lord's representative. I believe it is important for Christians undergoing persecution to realize the attack they are under is actually directed not at them, but at the life of Jesus in them, a life which they have power to transmit to others.
Satan will make every effort to discredit you, to frighten you and to silence your witness in order that the new life in you stops with you. Sometimes Satan overreaches himself, just as he did at the cross, and sends a believer to a martyr's grave but that life lives on in other believers who continue to bear witness more gloriously and triumphantly than ever.
That the church not only survives, but grows under such persecution has been demonstrated beautifully by the church in China. After missionaries were forced to leave in 1950, and all ties were cut with the body of Christ, believers were put through the horrible experience of Mao's Cultural Revolution. Christians were killed or imprisoned, Bibles burned, and the remaining believers scattered all over China. The attack was clearly on the life and name of Jesus as manifested in believer's lives.
As these sufferers scattered, they took the life of Jesus with them, and just as was the case with the early believers in Jerusalem, "Those who were scattered went about preaching the Word" (Acts 8:4). Now we see the harvest in China as millions of Christians are identified, meeting together for fellowship and worship in remote provinces…
I want others to have the one who makes me happy—Jesus.
RESPONSE: Today I will be aware of Satan's attempts to silence my witness for Jesus and resist him!
PRAYER: Thank You, Lord, for the way You bring good from the evil tactics of the enemy of our soul. Help me stand strong against his attack on the life and name of Jesus in me.


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Users, Hypertroia Wonderland, Troy, Channel Troy, Decoded …the 5 theater play offer, within the 4 partner countries, different representations of the same idea: the legends of the past help us to understand and detect our time threats. The key to interpretation must be found in the inner sense of this metaphor: surfing the net, exchanging information, meeting false identities, leaving a virtual life, and the most dangerous enemy: "The Trojan Horse"….
From the Acropolis Museum to the European Parliament: Building a European Antibullying Network, initiatives of "The Smile the Child"


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Welcome to Garland
This section provides new residents with helpful information that promises to smooth the transition to Garland. Find important information on service providers, resources, and information about living in Garland, as well as helpful information provided by other local jurisdictions.
Gotta Have These!
Quick access for connecting the following eases the stress of moving:
- Electricity and Water
- Natural Gas
- Trash Collection
- Connectivity
The information on this page should help you connect with these important utilities.
Garland's municipally owned electric utility, Garland Power & Light (GP&L), is the sole provider of electricity service for approximately 85% of Garland residents. Garland residents who live in areas not served by GP&L may choose any electric service provider other than GP&L. If you are unsure whether you live in an area serviced by GP&L, you can email Customer Service.
Residential Water, Sewer & Sanitation
The City of Garland provides these important services. Establish a utility account for water, sewer, or sanitation services. If you live in an area served by Garland Power and Light, all services, including electricity, may be connected with this single utility application.
Trash, Recycling Schedule
Garland's Sanitation Department picks up trash and bulky items weekly and collects recyclables every other week. Visit their webpage for collection days and more information.
Natural Gas
Atmos Energy provides gas service throughout Garland.
Residents may choose from a variety of service providers for the following:
neighborhood vitality
City of Garland staff has assembled a variety of information resources to give you direct access to people in-the-know.
Neighborhood Toolbox
The Office of Neighborhood Vitality has created a Neighborhood Toolbox which provides resources useful to new and existing residents.
Neighborhoods Focus Area
The Neighborhoods Focus Area is dedicated to Garland residents seeking information about neighborhoods, including news and events, available services and resources, data, and involvement opportunities.
Streets & Alleys
If you have questions about a nearby street project, want to find out about future plans for your own street or alley or inquire about neighborhood sidewalk repairs, contact the Street Department.
Garland eAssist
Report issues, get information and submit questions online or through an app on your smartphone. Go to your favorite app store and download Garland eAssist.
My Garland
Click on the My Garland button and enter a Garland address to find out about a wide range of City resources including your City Council representation, your Neighborhood Police Officer, nearby street conditions, parks and much more.
Who to Call
Get direct access to the City of Garland phone directory of City staff who are dedicated to meeting your needs and resolving your issues quickly and courteously.
Permits & Things
Find important information about registrations and permits required by various local jurisdictions.
Building Inspection & Building Permits
Does your home improvement project require a building permit? For the sake of the safety and quality of our neighborhoods, many projects do require such permits. Visit with the folks at the Building Inspection Department to find out more.
New residents are required to do the following within 30 days of moving to Texas:
Texas residents who own a motor vehicle are legally required to annually renew their vehicle registration.
Your Pets
To find out about required vaccinations and micro-chipping visit the Garland Animal Services page.
Home Alarm Systems
The City of Garland requires alarm system users to obtain an alarm permit from the Garland Police Department.
educational opportunities
Garland Independent School District (GISD) consists of seven high schools that offer A/P, IB, and college credit courses. The district has consistently had strong graduation rates and low dropout rates. For the class of 2019, Garland had a graduation rate of 96.3% and a dropout rate of 3.5%. The district performed above the county average graduation rate of 92.3% and below the county average dropout rate of 7.5%.
Source: Texas Education Agency, 2019
Career Readiness
GISD has partnered with local colleges and businesses to offer Pathways in Technology Early College High School programs where students can earn college credit, training certificates, and even an associates degree, along with their high school diploma. Incoming freshmen can choose to go to any high school in the district, allowing them to enhance their career readiness early on. Program areas include: engineering, advanced manufacturing, criminal justice, accounting, construction technology, mortgage banking, pre-medical, pre-dental, network administration, software development, game technology, teaching, web design, electronics, and automotive technology.
Higher Education
Students graduating high school have many options both in and within a short driving distance of Garland. The city is home to Remington College, Amberton College, and Dallas College, where courses are specialized to satisfy local business job skills. Other major universities in the area, such as Southern Methodist University, University of Texas (Dallas), University of Texas (Southwestern), and many more, are within a short drive or train ride away.
Immunizations for School Attendance
The State of Texas oversees school attendance and immunization requirements for Texas children.
Maps & County records
The City offers a variety of interactive and static maps.
Many services you may expect to be provided by the City of Garland may actually be provided by Dallas County, including:
- County Court Records and Services
- Criminal Background Checks, and more
- Marriage Licenses
- Warrant Information
Visit Dallas County for more information.
fun stuff!!
Are you looking for fun things to do? Well, Garland's got it! Go to VisitGarlandTX.com to learn about great foodie and shopping destinations, unique shopping and more. Don't miss the Granville Arts Center's full slate of live theatre, music and art displays.
And check out our Parks and Recreation Department for family fitness, outdoor activities, great classes and much more.
For the golfers in you circle, check out Firewheel Golf Park - the largest, best municipal course you'll ever play!
City of Garland Closes on Purchase of Key Downtown Property
Redevelopment plans for 519 W. State St. include a mixed-use community space with dining and entertainment opportunities. Read on... -
Garland A Longtime Home Like No Other in North Texas
Garland rated as the No. 4 city in the nation, and by far the tops in North Texas, in "Cities Where Homeowners Stick." Read on... -
2024 Elections: Garland Offers Four Early voting Sites for March 5 Primaries
Following the party primaries, voters will return to the polls May 4 to decide Garland City Council seats and 17 City Charter amendment proposals. Read on...


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Create a Website Account - Manage notification subscriptions, save form progress and more.
Project Overview
The Evergreen Playfield Complex is located in the heart of the city. Evergreen Playfield #1, the furthest north field in the complex is a dirt multipurpose field with wood poles and metal halide lighting designed and constructed in the late 1970's. The city has ranked this project near the top of its list for years as a target for improvements, not only because of its age but also because it serves as an important entry point to the city. The city was awarded multiple grants in 2018 and 2019 to finally make this local dream a reality. This project will include a conversion from the current dirt surface to an synthetic turf surface with drainage, underlayment, infill material, new LED lights, new field fencing, improved pathways and field amenities such as soccer goals, bleachers and corner flags.
Project Timeline and Costs
Completed in May 2021
Total cost: $2.178 million


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Today's card share is inspired by this week's challenge over at Freshly Made Sketches and Fab Friday.My card uses Delightful Dijon as its base which I dry embossed using the Softly Falling embossing folder.
Then I layered Very Vanilla on Emerald Envy and stamped the larger tree from the Foxy Friends in Emerald Envy and then the smaller tree in Emerald Envy (stamping off first). I used the masking technique to give a sense of depth to the trees.
Lastly I cut out a strip of the Delightful Dijon Ribbon from the Trio Pack and after deciding the placement of it, I stamped the sentiment from the Stitched with Cheer in Delightful Dijon above it. These colors felt like a cozy fall evening which is why I chose that sentiment. Fall is in the air!!
I love, love, love hosting classes, both locally and online. I enjoy spending time together with friends and also making new crafting friends over a stamping project. I would love to have you join any of my classes. There's no commitment, just good ole stampin' fun! For a detailed description of all the classes I offer, please click on the Classes Tab above.
In October, I'm offering a Product Based Class using Cellophane Bags. These bags make gift giving really fun and add an extra sentimental element. Whether you're local or online, I'd love to have you join me!!! RSVP on my Facebook page and I'll e-mail you with how to make the PayPal payment.
Use this host code when your order is $50 or more (before shipping and taxes) and receive a free gift from me! If your order is over $150, please do not use this code, but you'll still get the free gift. The free gift is your choice of any item valued up to $8.00 in the 2016-2017 Annual Catalog. See something you like? Check out my store.
If you aren't familiar with my Stars Rewards Program, click here. It's a great way to earn free product!


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From Prison Planet:
It is no exaggeration to say that the TSA is manned by an army of perverts and sexual deviants. The amount of stories that have emerged documenting this phenomenon is staggering. Here is yet another.
When it was revealed earlier this month that Miami International Airport had fired more TSA screeners this month for theft than at any other airport in the nation, the Miami New Times did some digging around to find out who was running the show down there.
The free weekly newspaper discovered that one of the head screeners at the airport, Juan Garcia, was fired in 2000 from an 18 year role as a cop. Why? Because he attempted to buy sex from a prostitute who, unfortunately for him, turned out to be one of his undercover colleagues.
Internal affairs records state that Garcia offered officer Ella Moore $60 for a "f*** and a suck".
Needless to say, Garcia was arrested and charged with soliciting a prostitute, and conduct unbecoming an officer. He resigned from the Miami Police Department shortly thereafter.
Now, Garcia is in charge of overseeing the metal-detectors, body scanners and full body-patdowns used and conducted by TSA screeners at MIA.
Garcia was said to have been hired not too long after his exit from the police department, and according to a TSA spokesperson, the agency had full knowledge of his sexual misdemeanors.
"[Garcia] fully disclosed the charge on his application." a statement sent to the Miami New Times by the TSA reads.
"As part of a full background check, TSA determined the charge had been dropped and therefore did not violate any hiring qualifications."
So, in this instance the TSA did perform a background check, and concluded that it didn't matter that someone who likes to buy sex illegally would be groping the genitals of law abiding Americans on a daily basis.
Earlier this year, a television station in Atlanta reported, however, that the TSA is so backlogged that it is simply forgoing background checks, and hiring just about anybody to grope and irradiate the public.
"In a move that could affect security at airports around the nation, the Transportation Security Administration confirmed Wednesday it had such a backlog of background security checks, airport employers were allowed to hire any employee needed," WSBTV reported. "TSA officials said the background checks are delayed, but they are processing them as fast as they can."
This could explain why the has TSA been found to consistently hire sexual deviants and even pedophiles.


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Frank Serpico
Law Officer / Speaker
Date Of Birth:
14 April 1936
Place Of Birth:
Brooklyn, New York
Best Known As:
Whistleblowing New York cop who inspired a 1973 movie
Former New York City cop Frank Serpico is famous for his 1971 Knapp Commission testimony which called attention to widespread corruption within the city's police department. Serpico had been a cop since 1960, but had operated outside the widespread system of bribery and kickbacks. His complaints of corruption went unheeded by superiors for years until 1970, when a special commission was formed to investigate the problem. Serpico testified before the Knapp Commission in 1971, earning national headlines and the enmity of his fellow officers. (During an arrest after he testified, Serpico was shot in the face and fellow officers did not come to his assistance.) Serpico retired from the police department and lived abroad for many years, returning to New York in the 1980s. His story was turned into a best-selling book by Peter Maas, which in turn became the hit movie Serpico (1973), starring Al Pacino.
Copyright © 1998-2017 by Who2?, LLC. All rights reserved.
See also:


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Measurements from high-energy collisions lead to better understanding of why meson particles disappear
For several years, physicists at the Relativistic Heavy Ion Collider (RHIC) at Brookhaven National Laboratory (BNL), USA, have studied an unusual state of matter called the quark–gluon plasma, which they believe mimics the hot, dense particle soup that existed immediately after the big bang. Now, the PHENIX collaboration at RHIC reports findings about a particle called the J/ψ meson that will help physicists distinguish the properties of the quark–gluon plasma (QGP) from those of normal matter.
To create a QGP, physicists crash gold nuclei together at close to the speed of light. This provides enough energy to break apart the protons and neutrons in the nuclei into their constituent quarks and gluons, which mediate the force between quarks. In this energetic mash up, a host of short-lived particles can form, including mesons, which are made up of a quark and an anti-quark.
When collisions of gold nuclei yield fewer J/ψ mesons than expected from theoretical predictions, it indicates that a QGP has formed. Suppressed meson production can occur because the QGP weakens the binding force between the two quarks in the J/ψ particle. The PHENIX collaboration's detector (Fig. 1) counts the number of J/ψ mesons created in collisions by detecting the electrons and muons—particles with the same charge, but more mass, than electrons—produced from J/ψ decays.
Effects other than the formation of the QGP, however, can also suppress the yield of J/ψ particles, which makes interpreting gold–gold collisions "ambiguous", says Yasuyuki Akiba, a scientist at the RIKEN BNL Research Center and a member of the PHENIX collaboration.
To isolate these other effects, the PHENIX team analyzed data taken in 2003 and 2008 from collisions between deuterium—a proton and neutron—and gold, since these collisions cannot form a QGP. Even in the absence of a QGP, the team found the production of J/ψ particles was more suppressed than expected at the highest relative velocities between the deuterium and the gold collisions. "Conventional models cannot describe the data," says Akiba.
The team thinks the unexplained suppression may be related to how the apparent density of gluons in the gold nuclei, which determines the rate of J/ψ production, varies with the speed of the deuterium.
More analysis is needed to determine whether this explanation is correct, but this work "gives a precise baseline that will be very useful for separating the quark–gluon plasma effects in gold–gold collisions," says Akiba.
More information: Adare, A.,, et al. Cold nuclear matter effects on J/ψ yields as a function of rapidity and nuclear geometry in d + A collisions at √sNN = 200 GeV. Physical Review Letters 107, 142301 (2011).
Provided by RIKEN


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During health facility assessments, NURHI realized that many potential family planning clients visited High Volume Sites (HVS) for antenatal care, childhood immunization services, labor and delivery, post abortion care or HIV services. Yet, these clients were rarely counseled about family planning, nor were they provided family planning services. To address these missed opportunities, NURHI embarked on a program of "Active Referrals" for family planning services from points where women of reproductive age group access care in a health care facility and these became points of integration. According to the MLE Midterm Survey, these integration efforts have resulted in substantial increases in the proportion of women and HIV clients receiving family planning information.
Planning for Integration. NURHI drafted a strategy for integrating family planning counseling, services and referrals with MNCH and HIV services, which it shared with heads of HVS, State Ministry of Health, and Federal Ministry of Health for inputs. It was agreed that to promote family planning information, counseling and services, clients attending antenatal care (ANC), delivery, post-natal care (PNC), immunization clinics, post abortion care (PAC), HIV counseling and testing (HCT), and Antiretroviral Therapy services would be referred to the FP clinic. The Integration Strategy was revised accordingly.
Training FP Providers at Integration Sites. NURHI conducted a 10-day training in family planning counseling for service providers working in ANC, PNC, labour and delivery, immunization, ART, and HCT wards at HVS, and provided IEC materials. Service providers working in labour wards were trained to counsel clients in the immediate post-delivery period while those providing PAC services were trained to provide family planning methods.
Establishing Post-Partum IUD Services. NURHI selected one HVS per city with the highest volume of labor and delivery clients to provide post-partum IUDs insertions. From these, midwives and doctors were trained on post-partum IUD insertion. Providers working in ANC counseled in post partum IUD and registered those interested with the labour and delivery ward. A system for ensuring adequate supplies of IUDs and the necessary equipment were also provided.
Monitoring and Tracking Integration. Monitoring of family planning services referrals provided through integration sites is an important aspect of referrals. NURHI established a referral system with color-coded referral cards to track sources of referrals within health facilities, from social mobilization, community health workers, or from other facilities. Through this system, NURHI is able to monitor the number of referrals for family planning services, as well as the numbers of clients at each integration sites who were counseled for family planning. Using this information, supervisors can provide targeted interventions to address performance gaps as they arise.
© Copyright 2013 - NURHI Nigerian Urban Reproductive
Health Initiative, All Rights Reserved


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C10 Exhaust Gaskets
Exhaust Gaskets
Changing the exhaust system on your Chevy C10 is definitely an exciting process, but it's important not to forget about the small details. For example, your header collector gasket may need to be replaced to ensure that you don't have any leaks. Check out our selection of C10 Exhaust Gaskets to get the affordable parts that you'll need to keep your pickup running reliably with no issues.
With every component of your decades-old Chevy C10 being subject to wear and tear, as well as exposure to the elements, leave no stone unturned when it comes to restoration. If you're already making exhaust modifications or implementing a new system, add a header collector gasket to your list to ensure leak-free operation of your exhaust and engine. With high-quality construction, easy installation, and affordable prices, these replacement parts are a simple fix that can save you many a headache down the road.


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Concerning the shipping costs we have chosen to keep it simple. The size and weight of your order does not matter, we use only 1 tariff for each area. These are the tariffs:
All parcels for outside the Netherlands are sent with priority mail (and if the weight is less then 2 kilo also registered). We get that if you do a small order the shipping costs are rather high, but if you have a large order you also can gain this way much advantage. If we ship your order in multiple parts we will carry the extra shipping costs.
When you did an order in our webshop and everything went well, you get an conformation by email. When you pay with paypal you must pay a little attention. After you have done your payment you must click on the button "back to trader" to finish your order. If you don't don that we will receive your payment and we don't know what you did order. In case this should happen we always can reach you because we have your email-address. So this problem can always be solved.
Payment by bank: For Dutch customers at accountnumber : 133535185, accountholder : Bizzare These are the international bankdetails:
After we have received your payment we try to process your order as soon as possible. Usually we do this within 24 hours. We can do so because we have most of our items in stock. We need this stock also for our "real" shop in Maastricht. As one or several articles of your order are out of stock (what of course always can happen) we usual can deliver within 14 days. We generally wait with shipping until your entire order is fulfilled. As maximum delivery period we try to use 21 working days. In some cases the delivery period is longer (like for example with some models New Rock boots) but then that is mentioned. Then you don't need to pay the full amount when you make an order but just an account. As soon as your package has been put on the mail you will receive an email. We send the parcels with TPG Post priority mail. Delivery time:
Of course we will contact you about this. In most of the cases we can deliver again rapidly but if the delivery period would be too long we look together for an appropriate solution.
Yes certainly, no problem. You may exchange any items that you are not completely satisfied with, as long as they are returned to us within 30 days after receiving your order. You can choose for another article, another size or your money back.
The conditions are:
Simply let us know as soon as possible (but anyway within 14 days). It is always a good idea to check the articles when you recieve them, just to be sure. Mistakes can always be made, by us, but also during the production. In most of the cases we will ask you to send the item back to us (you will receive a refund for the shipping costs). When possible we will replace the article if this isn't possible you will get a refund .
Easiest way is by email : [email protected] We always try to get back to you as soon as possible. When you are not sure about sizes it is no problem to measure some pieces for you, please send us an e-mail with your request. Our phone-number is +31 (0)43 - 323 32 32 (on working days between 10.30 and 18.00). You are of course also always most welcome in our shop (Rechtstraat 44, Maastricht, The Netherlands).
You need to register for an account first (for free of course). At your account information you can choose the option subsribe from newletters.
We will only send a newsletter when we really have news. That can be about new items and collections and special offers. So be the first one to know!
Monday : gesloten
Tuesday : 10.30 - 17.00 uur
Wednesday : 10.30 - 17.00 uur
Thursday : 10.30 - 17.00 uur
Friday : 10.30 - 17.00 uur
Saturday : 10.30 - 17.00 uur
In this case you can send us an email, tell us in which item you are interested and which size you need. We let you know by email if the item is in stock or not and when necessary we will order it again for you.
Well, at first a big part from our collection is hand work (all corsets from Bizzare, all items from Paulien Berkelaar, the biggest part of our leather collection). As an advantage these items can be made to measure, but they are a lot of work to make so you can see that in the price. Because our clothing is intented for people with a special taste and not for the masses, there are not so many pieces made. It is a big difference if a label makes thousands of an item in for example China or dozens here in Europe. We also pay a lot of attention to quality. Frequently we can buy similar clothing pieces cheaper but generally the quality is less. In these case we go for quality and not for the price. We think it is important that you have long pleasure of your purchases. Finally you can find at some webshops also simular items also cheaper. In most of these case they work in a totally different way as us. We have a hughe stock (also need that for our real shop in Maastricht). There are some webshops which order the items at their suppliers after you have paid for your order. In other words, our delivery period is generally much faster.


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Hi Bellas!
I wanted to show you pics of the Indian Wedding I did before I left for vacation. I finally had a chance to put them up. For this event, I was contacted by one of my YouTube viewers all the way in New Jersey. She wanted to get made over for her brother's wedding which was taking place in Atlanta. At the same time, I would be doing her mother and sister in law. This was a two look gig...one look for the day and another for the night. I had so much fun working with Gunjan and I wish her the best for her own upcoming wedding in Jersey!
Here is Gunjan's first look. Her priority was to even out her skin which had been going through a few tough months of breakouts. My cinema secrets came in handy for that! In terms of the colors, we pretty much wanted to do looks to compliments the gorgeous Saris they were wearing.
Since this was a daytime look, I went for a light pink with a little bit of maroon in the outer v for a bit of dimension. We went with a subtle mauve gloss to top it off.
I also did a look for Gunjan's Sister in Law. She actually had really nice skin. Her skincare regimen consists of the use of a lot of Indian herbs and spices mixed into a paste. I have seen this done before and it really does work! In terms of the colors, she favors a darker tone, so went for a berry shade apporpriate for day time. As for eyes, I coordinated the look to match her Maroon/Gold/Black Sari.
Lastly, I was able to do the mama. Gunjan informed me that she is pretty natural with only one preference - red lipstick! I focused on evening out her skin tone. On the eyes, I used very natural eyeshadows and emphasized the shape with individual lashes and kohl liner. On her lips, I applied MAC Brick Red lipliner and Dubonnet lipstick. I chose these colors since they're a little deeper and went well with her coloring.
Now comes the night looks! Gunjan's sister in law actually wanted something a little more subtle for the evening. I stuck with gold's and bronzes to coordinate with her Mustard Colored outfit. We replaced the strip lashes with individuals and again went for a berry lip with a pop of gold in the center.
For Gunjan's evening look, she definitely wanted to have a bit of teal on her eyes to match her gorgeous outfit. I combined the teal with gold eyeshadow and the same Red Cherry lashes. A shimmery pink gloss to complete the look. FYI, this look was a little on the dramatic side for Gunjan, so I easily toned it down by applying a neutral shadow like MAC's llama to a blending brush and just blended the shadows to soften the color.
Till next time, Ciao Bellas!
Atlanta Makeup Artist


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Hocking County, Ohio's recount whistleblower, Sherole Eaton --- who was recently fired without explanation in the wake of having reported on a voting company employee tampering with the hard-drive of a central tabulating computer and offering "cheat-sheets" prior to the recount of the November 2004 Presidential Election --- received some support yesterday from both a Court Order and several dozen backers at a dramatic Board of Elections meeting.
Attorney Cliff Arnebeck, one of the attorneys who filed a case in Ohio to have the November Election results set aside due to evidence of fraud, served County Board of Elections officials with a court order mandating Eaton not be replaced until further court orders are issued.
"Yesterday was the first of what I hope are many victories for Sherole," Karla VanBibber told us via Email earlier today. VanBibber, who is Sherole's niece attended the meeting, and described the moment when Arnebeck arrived with the court order: "The expressions on the board members faces when given the court injunction was priceless."
VanBibber also gave us her take on the reactions from the Board Members in the face of questions from supporters about Eaton's dismissal, which she says is illegal under Ohio law. "Their sputtering and faultering and lying was unbelievable," she said. "It's amazing how the arrogance we see in the Bush administrations has filtered down to the local level as it has."
Apparently, they won't be giving up the fight for Eaton, who is recovering from recent brain surgery, but attended the hearing "in apparently good spirits and seemingly good health - full of energy and zeal and very appreciative of the support," according to Evan Davis's detailed account of the meeting at Ray Beckerman's blog.
Said VanBibber, "We knocked them down a few notches yesterday, we won't give up until they're on their knees and Sherole has her job back."
Eaton's firing, and her dramatic appearance at another recent Board of Election hearing, just two days surgery, was covered in this previous BRAD BLOG report.
Hocking County's Logan Daily News also had a report today on yesterday's meeting. "[Sherole] was so happy this morning when she received her paper," VanBibber said, "she came over and was so excited and for the first time in awhile was optomistic."
Logan Daily News described Arnebeck's dramatic appearance at the meeting...
Then Arnebeck asked to address the board "on a point of order."
"We filed a complaint for a declaratory judgment and preliminary and permanent injunctive relief against any action to terminate or replace Sherole Eaton as deputy director," Arnebeck said. "All I want to do is serve the board with a copy of the order to restrain it from taking any further action on this matter until further action of the court."
Spectators in the room applauded as Arnebeck lay the order on the desk before Robinette.
Apparently Board of Elections officials have yet to go on record as to the cause of Eaton's firing. According to Davis, the most the Board has said is that they "weren't satisfied with her performance."
At the meeting on Tuesday, however, VanBibber painted a different picture in her direct questioning of the board's chair, Gerald Robinette. "You praised her personally at the Democrat meeting until the incident with the TRIAD technician. She was competent, and did a great job, and suddenly she became incompetent?"
The board refused to answer, according to Logan Daily News.
Eaton's firing has drawn national attention. Rep. John Conyers' (D-MI) was quoted in a Daily News article in May, describing Eaton as having come forward "bravely" to report on the tampering by Triad employees during the recount. He told the paper that "Absent any other explanation, and having been told at the time of the incident that Ms. Eaton was an excellent employee, I can only conclude that Ms. Eaton's firing was solely out of retaliation."
Much has been made, of late, regarding the supposedly "bi-partisan" Boards of Election in Ohio. Mostly by the Secretary of State J. Kenneth Blackwell in defending the November Election debacle and its subsequently spoiled recount. Blackwell, in charge of elections in Ohio, and incidentally the co-chair for the Bush/Cheney Re-Election Committee, has repeatedly claimed that the "bi-partisan" nature of the boards precludes any chicanery favoring one side or the other.
Nonetheless, a great deal of evidence has surfaced of late to suggest that the "Democrats" on many of these boards are Democrats in name only.
In describing information that Davis received from Eaton, who "intimated" to him that a replacement for her has already been chosen, the replacement is described as "A part-time BOE employee who has been an active Republican but who registered as a Democrat in the last primary election, presumably in order to qualify as a candidate for Sherole's position."
Davis spoke with Robinette after the meeting to discuss the new mandate by Blackwell to purchase touch-screen voting machines made by Diebold, Inc. in Ohio. He asked about how votes on such machines could be verified in the event of a recount. According to Davis, Robinette told him, "You're more knowledgeable than I am on that. I really don't know. All I know is that they're certified by the federal government and they're being mandated by the Secretary of State."
Davis also said that Robinette went on to say "that the old punchcard system was perfectly adequate in his view and that he resented the Sec. of State. 'pushing (the county) in to something ( DRE's ) that wasn't really necessary.'"
The dramatic hearing also reportedly resulted in an admission by one of the Republican members of the Board, Lisa Schwartze, that she conducted Republican Party business during working hours and on Board of Election property.
While Schwartze admitted to some of the charges, she contested others and the issue was tabled by the chair for a further meeting.
VanBibber also told The BRAD BLOG today that Harpers Magazine would be running an article on Eaton in their August issue, and that she's "received a call from the BBC expressing an interest in doing a movie about her battle."
Eaton was a recent guest on a The BRAD SHOW. The interview we conducted with her, in which she describes the Triad incident, her recent firing and the subsequent support she's received from the community, can be heard here in MP3 format.


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Hertfordshire punks Gallows are one of the hottest guitar acts in the UK thanks to their 2006 debut
Orchestra Of Wolves
The band is currently in the studio working on the follow-up with producer Garth Richardson, and guitarists Laurent 'Lags' Barnard and Steph Carter will be checking in with TG every two weeks to update us with their progress!
If you'd like to ask the rude bois a question e-mail us at email@example.com
Hey TG readers!
It´s been 3 weeks since Garth has been in England and we spent week one together working on pre-production. This was a definite first for Gallows and we didn´t really know what was meant to happen in this short period...! Metaphorically speaking, pre-production is the dress rehearsal before the first night performance. You make sure you have everything you need and know exactly what to do when you hit the studio.
We moved into Rak studios on the 8th September and we´re currently living among the "A-listers" in St Johns Wood. Being in such a sweet location meant a few late nights in the first week but we eventually settled in and got hard at work with the drums. There´s so much preparation in getting everything to sound just right that most of the time you´re doing more listening than playing.
We´re currently working on the bass guitars. Stu´s nailing the tracks pretty swiftly and my only fear is when he´s done I might get coaxed into going out with him to celebrate, then wake up with a hangover and have to start cranking some amps. Not sure my head could handle that.
So far its been a really amazing experience. We´re all really happy working with Garth Richardson and his engineer Ben Kaplin. The hardest thing is waiting to record guitars simply because Steph and I can´t physically wait much longer!
Check out more Gallows stuff online at www.gallows.co.uk or www.myspace.com/gallows


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By Next Step Products
Model # SV30015K
Alternate Part #'s SV300-15K
Can I use Super Vision Fiber optic cable with a Fiberstars illuminator?
Both companies' cable will work with either the Fiberstars or Super Vision illuminator. You will need to make sure that you have the proper perimeter track in your pool to accommodate the appropriate cable.


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Airplane peanuts
Airplane peanuts are a very strange form of apparently partially-sentient peanut which seem to have some sort of primitive negotiating or bargaining abilities. Airplane peanuts are largely identical to regular peanuts, except for the fact that man seems to have stricken some sort of mutual arrangement with these mysterious legumes. Even stranger still, nobody seems to know exactly what the agreement was, or what sort of consequences it entailed for either party; only that such a deal does, in fact, exist.
There are many theories as to what the aforementioned deal is regarding, although the true answer is probably lost forever in the sands of time. One theory indicates that humans possibly received some sort of benefit (possibly the power of observation, some scientists theorize) in exchange for extra toughness of the airplane peanuts' natural protective bag. This makes the protective layer significantly more difficult to break open than that of conventional peanuts. This theory is the most widely accepted one, although given the negotiating parties, it remains unclear exactly whom the airplane peanuts were attempting to keep from penetrating its protection.
Many great thinkers have pondered the issue for years, such as the famous philosopher Jerry Seinfeld. While no conclusive answer is ever expected to be reached, pondering the issue is, for some, a zen-like state of meditation. Although masturbation produces the same results, the peanuts are to small for my woman.
The airplane peanut is its own variety of the species. They possess the ability to become disgusting at will. Very few have ever lived to tell the tale about when the flight attendant was successfuly thanked by the passenger. Scientists have decided that these peanuts have telepathy. They can instantly order a flight attendant to become hostile. This is when the enraged stewardess will carry the peanuts along the aisle. Symptoms include:
- Hostility
- Hostile actions
- Enexplained flatulence
- Post PMS PMS
- Explosions
- Hostile language
- Snakes probably on a plane somewhere
This is when the flight attendant will WHAP the peanut bag onto your tray. If you don't have your tray down, directly at your testicles. If the WHAP recipient wasn't killed by the initial blast, he/she/it will attack all ajacent passengers (including the WHAP recipient) with the remaining cans of soda left by rude passengers who don't want to have bad gas on their 5 hour flight.


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From NPR News, this is ALL THINGS CONSIDERED. I'm Melissa Block.
And I'm Audie Cornish. Egyptian voters go back to the polls tomorrow for the runoff in the country's historic presidential election. The leader of the Muslim Brotherhood is facing off against a man who was prime minister under the now-imprisoned former President Hosni Mubarak.
A top court ruled just yesterday that the former prime minister can run, allowing the election to proceed. At the same time, the court also issued a ruling that shocked much of the country, dissolving Egypt's Islamist-dominated parliament. Merrit Kennedy reports from Cairo.
MERRIT KENNEDY, BYLINE: The rulings from the Supreme Constitutional Court raised the stakes in the struggle between the ruling military council and the Muslim Brotherhood that will play out at the ballot boxes this weekend. The ruling that allowed former Prime Minister Ahmed Shafiq to stay in the race was widely expected, but the one dissolving parliament took many here by surprise.
Omar Ashour is a visiting fellow at the Brookings Doha Center.
OMAR ASHOUR: So put it all together, and I think it's a coup with a legal framework, and until now it's bloodless, so - but we'll see the reactions on the street.
KENNEDY: He points to a decree by the justice ministry that allows the military to arrest civilians on charges as minimal as disrupting traffic or insulting the state. Ahmed Shafiq lauded the ruling that allows him to stay in the race.
AHMED SHAFIQ: (Speaking foreign language).
KENNEDY: In a televised news conference, he vowed not to repeat the mistakes of the past regime. He emphasized his plans for an honest government and a return of stability and security, which many Egyptians feel was lost with the revolution that ousted Mubarak.
MOHAMMED MORSI: (Speaking foreign language).
KENNEDY: The Muslim Brotherhood candidate Mohammed Morsi also said he will respect the court rulings, even though he didn't agree with them. But in a television interview last night, he warned that the people's will for a break from the past regime is stronger than any court.
Many analysts are predicting a lower turnout for the two-day runoff vote than in the first round last night, when Morsi and Shafiq beat out 11 other candidates by slim margins.
Ziad Akl, a senior analyst at the Ahram Center For Political and Strategic Studies, says many Egyptians have become more disillusioned about the election process since then.
ZIAD AKL: Now what you have is the old structure all over again. Now you have simply a fight of traditional political forces in Egyptian society.
KENNEDY: Activists have launched a movement to boycott the final round of the election. Tarek Shalaby, a Web designer and activist, is involved in the boycott campaign, which has been dubbed the third option.
TAREK SHALABY: The military would never allow us to have elections that would bring about real change because they're the ones in control, and they're the ones that have controlled the outcome and know that if the outcome is not in their favor, they're not going to go ahead with it.
KENNEDY: But many Egyptians are eager to cast their votes. In a Cairo street full of shops selling auto parts, Ali Ramadan points to a banner for candidate Ahmed Shafiq, which he says he paid for himself.
ALI RAMADAN: (Speaking foreign language).
KENNEDY: He says Shafiq's experience in government and with the military is what Egypt needs right now. The ruling military council has long said that the presidential election will mark the end of the turbulent transitional period, but for many Egyptians, this week's events have only added to the uncertainty about the future. For NPR News, I'm Merrit Kennedy in Cairo. Transcript provided by NPR, Copyright NPR.


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[The Day Dixie Died: The Battle of Atlanta by Gary Ecelbarger (Thomas Dunne Books, 2010). Hardcover, 13 maps, illustrations, OB, notes, bibliography, index. Pages main/total:249/317. ISBN:978-0-312-56399-8 $26.99]
Gary Ecelbarger's The Day Dixie Died: The Battle of Atlanta is the first full length treatment of the bloody July 21-22 fight east of the city, remarkable for the death of Union Army of the Tennessee commander James B. McPherson and intense clashes around local landmarks like Bald Hill and the "white house" of the Widow Pope. Professional and avocational historians alike have been remarkably reluctant to write histories of the battles that together comprise the 1864 Atlanta Campaign. In some ways, it is understandable in the sense that the battles were often chronologically close together and only decisive in a cumulative sense, but far smaller and less significant Civil War fights have been treated to impressive works of military historical value. Ecelbarger does not say so in so many words but his study impresses upon the reader the truth that Confederate general John Bell Hood's Army of Tennessee, at best, had the strength remaining for one coordinated assault capable of crushing a portion of General Sherman's army group. July 22, 1864 was that effort and The Day Dixie Died demonstrates well its author's assertion that it was the most decisive battle of arguably the war's most decisive campaign.
Ecelbarger begins his study with a brief description of the fighting atop Bald Hill two miles east of Atlanta between the Confederate divisions of Patrick Cleburne and Joseph Wheeler and a pair of divisions from Frank Blair's 17th Corps under Giles A. Smith and Mortimer Leggett. It was an episode characterized less by a brilliant defense than excessive caution (again in a critical moment of the campaign) on the part of James B. McPherson. His army strongly positioned against Hood's weakest flank, he failed to move aggressively, likely forfeiting a golden opportunity to capture Atlanta.
All phases of the next day's battle are well documented in the book. The original plan of having William J. Hardee's corps conduct a night march around McPherson's southern flank, capture Decatur, and move west to attack the federal left rear, proved to be unrealistic. The alternate plan, fixed on the fly, was for Hardee's force (four divisions led by W.H.T. Walker, Patrick Cleburne, William Bate, and George Maney) to hit the Union left directly at its southern terminus, while Wheeler's cavalry division moved northeast to capture the federal trains at Decatur. Additionally, Benjamin Cheatham's corps (the divisions of Carter L. Stevenson, John C. Brown, and Henry Clayton's) together with Gustavus Smith's four brigades of Georgia militia, would launch a diversionary attack directly east from Atlanta.
The cavalry under Wheeler fulfilled their mission of capturing Decatur, but failed to prevent the escape of the Army of the Tennessee's immense wagon train (estimated at 1,600 teams). The infantry attack went even worse, with Walker's division wasted in frontal brigade sized assaults against the unexpected presence of Grenville Dodge's understrength16th Corps (a pair of well led divisions under the Thomas Sweeny and John Fuller). Cleburne's division advanced west of Walker, passing through a gaping wooded gap between 16th and 17th Corps and striking the division of Giles Smith. Smith's bluecoats manned the refused flank of the Union army a half mile south of Bald Hill. Maney's division deployed on Cleburne's left and rear, and together they drove the Union forces from the lower works and back on Bald Hill. There, with the aid of timely reinforcements, the defenders stiffened.
The circumstances surrounding the death of McPherson inside the wooded area in Cleburne's front is covered well by Ecelbarger, as well as its consequences, short lived as they may have been, to army cohesion. The ascension of 15th Corps commander John A. Logan to head the Army of the Tennessee in mid battle sent ripples down the chain of command caused a temporary confusion within an army already back on its heels from relentless, if badly disjointed, Confederate assaults.
Cheatham's "diversion" was then launched en echelon from right to left, penetrating the Union line in two places, at the point where the Georgia Railroad and Decatur Road passed through the works1 and through a short section works one half mile to the south. Both breakthroughs were effectively contained and eliminated by the determined efforts of Logan and his subordinates. A final Confederate evening assault by a division sized force assembled ad-hoc by Patrick Cleburne failed to break the federal left and the battle finally ended.
Ecelbarger rightly points toward coordination problems, either through early leadership casualties, terrain difficulties, or typical command failures, for the inability of Confederate forces to achieve more on July 22 to compensate for the loss of approximately 6,000 men (against less than 4,000 for U.S. forces). Heat and exhaustion from the long march led to heavy straggling, as well. The author's enumeration of leadership casualties, with 30 general and field grade officers lost in a single day, is testament to the ferocity of the battle and the degree to which the fighting decapitated Hardee's Corps, crippling its effectiveness for the rest of the campaign.
The author also clears up some the popular mythology surrounding the battle, especially the notion that Sherman withheld reinforcements to the Army of the Tennessee, preferring to allow them to avenge McPherson's death on their own. In truth, substantial reinforcements were present or immediately available. Ecelbarger's timing of events also highlights the implausibility of claims that Union defenders frequently hopped back and forth across their own breastworks, repelling simultaneous assaults from both directions.
The battle narrative in The Day Dixie Died is presented at a mixture of brigade and regimental scales. Some readers might wish for more regimental level detail, but even the most demanding students of tactical minutiae will be largely satisfied with Ecelbarger's writing. The maps, thirteen excellent full page creations by noted cartographer George Skoch, match the scale presented in the text in terms of troop positions and movements, with terrain features also finely rendered.
In the nitpicking department, a pair of important commanders left the narrative a bit soon. Hardee disappears once the fighting begins, and Wheeler similarly leaves the scene after his capture of Decatur and attenuated pursuit. Perhaps the author subconsciously subscribes to Thomas Schott's2 contention that Civil War historians place too much emphasis on a corps commander's ability to influence events after the first bullets fly. It's also unclear if the failure to detect Dodge's 16th Corps was a reconnaissance omission on Wheeler's part or a consequence of an altered plan leaving no mounted units to spare for screening the infantry advance. Regardless, Confederate intelligence gathering was abysmal.
On the spectrum of tactical depth, The Day Dixie Died lies somewhere in between that found in popular military non-fiction and the author's previous work on the Battles of Kernstown and Winchester/Front Royal. Generally speaking, it is a very workable compromise that should satisfy readers in both camps. The essential canon of Atlanta Campaign military studies, pitifully small as it may be, has a significant addition with this highly recommended study.
1 - This is the scene depicted in the famous cyclorama painting, a part of which is reproduced in the book.
2 - Published in essay form in Confederate Generals in the Western Theater, Vol. 2: Essays on America's Civil War edited by Lawrence Lee Hewitt and Arthur W. Bergeron, Jr. (University of Tennessee Press, 2010).
Friday, December 3, 2010
1 comment:
- Chris EvansDecember 6, 2010 at 5:09 PM
Excellent review. I think many more books should be written on individual battles of the Atlanta campaign.
Bragg and Hood were the two most aggressive commanders of the Army of the Tennessee and the most luckless (for the most part). Too bad there couldn't be a new book comparing and contrasting their leadership of the Army of Tennessee.
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