Sample records for accelerated approval products

  1. Accelerated approval of oncology products: the food and drug administration experience.

    PubMed

    Johnson, John R; Ning, Yang-Min; Farrell, Ann; Justice, Robert; Keegan, Patricia; Pazdur, Richard

    2011-04-20

    We reviewed the regulatory history of the accelerated approval process and the US Food and Drug Administration (FDA) experience with accelerated approval of oncology products from its initiation in December 11, 1992, to July 1, 2010. The accelerated approval regulations allowed accelerated approval of products to treat serious or life-threatening diseases based on surrogate endpoints that are reasonably likely to predict clinical benefit. Failure to complete postapproval trials to confirm clinical benefit with due diligence could result in removal of the accelerated approval indication from the market. From December 11, 1992, to July 1, 2010, the FDA granted accelerated approval to 35 oncology products for 47 new indications. Clinical benefit was confirmed in postapproval trials for 26 of the 47 new indications, resulting in conversion to regular approval. The median time between accelerated approval and regular approval of oncology products was 3.9 years (range = 0.8-12.6 years) and the mean time was 4.7 years, representing a substantial time savings in terms of earlier availability of drugs to cancer patients. Three new indications did not show clinical benefit when confirmatory postapproval trials were completed and were subsequently removed from the market or had restricted distribution plans implemented. Confirmatory trials were not completed for 14 new indications. The five longest intervals from receipt of accelerated approval to July 1, 2010, without completion of trials to confirm clinical benefit were 10.5, 6.4, 5.5, 5.5, and 4.7 years. The five longest intervals between accelerated approval and successful conversion to regular approval were 12.6, 9.7, 8.1, 7.5, and 7.4 years. Trials to confirm clinical benefit should be part of the drug development plan and should be in progress at the time of an application seeking accelerated approval to prevent an ineffective drug from remaining on the market for an unacceptable time.

  2. Accelerated approval of oncology products: a decade of experience.

    PubMed

    Dagher, Ramzi; Johnson, John; Williams, Grant; Keegan, Patricia; Pazdur, Richard

    2004-10-20

    We review the regulatory history of the accelerated approval process and summarize the U.S. Food and Drug Administration experience with accelerated approvals in oncology. The accelerated approval regulations, promulgated in 1992, allow approval of drugs for serious or life-threatening diseases on the basis of a surrogate endpoint that is reasonably likely to predict clinical benefit, such as survival or symptom benefit, pending completion of studies designed to confirm clinical benefit, referred to as phase 4 commitments, which are required to be conducted with due diligence. From 1992 to 2004, 22 applications involving anticancer drugs or biologics were approved. Of these 22 applications, accelerated approval was granted to 15 on the basis of findings from studies without an active comparator (i.e., single-arm studies or studies comparing two dose levels) and to the remaining seven on the basis of one or more randomized studies. Of the 22 approved applications, six (i.e., applications for dexrazoxane, irinotecan, capecitabine, docetaxel, imatinib mesylate, and oxaliplatin) have had one or more indications converted to regular approval. This review reports information that was presented at an Oncologic Drugs Advisory Committee meeting held in March 2003; it also presents a discussion of accelerated approval study designs, the study populations evaluated in the accelerated approval and confirmatory settings, and the integration of accelerated approval into a comprehensive drug development plan.

  3. [Development of guidance for the approval process of brand-new medical products and regenerative medicine products].

    PubMed

    Niimi, Shingo

    2015-01-01

    Ministry of Health, Labour and Weltare has been conducting development of guidance for the approval process of brand-new medical products/development of guidance for medical devices in collaboration with Ministry of Economy, Trade and Industry as part of measures to promote practical use of brand-new medical products since 2005. The objective of this project is to expedite the processes from developmental process of medical devices to approval review and to introduce the medical devices to medical front quickly.. Ministry of Health, Labour and Welfare side has been making guidance for the guide in approval process of brand-new medical products and regeneration medicine products to aim at acceleration and facilitation of development and approval process of innovative medical products. Twenty-two of the guidance have been issued as director of the evaluation and licensing division. The evaluation index about safety and efficacy required for medical devices and regenerative medicine products in progress were put together in these guidance and useful for medical devices developer to understand the point at the approved review. Therefore, I think that the evaluation index could also contribute to the efficient product development. The guidance about implantable artificial heart is issued as the representative example which was useful in the approved review.

  4. Review of oncology and hematology drug product approvals at the US Food and Drug Administration between July 2005 and December 2007.

    PubMed

    Sridhara, Rajeshwari; Johnson, John R; Justice, Robert; Keegan, Patricia; Chakravarty, Aloka; Pazdur, Richard

    2010-02-24

    The Office of Oncology Drug Products (OODP) in the Center for Drug Evaluation and Research at the US Food and Drug Administration began reviewing marketing applications for oncological and hematologic indications in July 2005. We conducted an overview of products that were reviewed by the OODP for marketing approval and the regulatory actions taken during July 2005 to December 2007. We identified all applications that were reviewed by the OODP from July 1, 2005, through December 31, 2007, and reviewed the actions that OODP took. We also sought the basis for the actions taken, including the clinical trial design, endpoints used, patient accrual in the trial(s) supporting approval, and the type of regulatory approval. During the study period, the OODP reviewed marketing applications for 60 new indications and took regulatory action on 58 indications. Regulatory action was based on a risk-benefit evaluation of the data submitted with each application. Products that demonstrated efficacy and had an acceptable risk-benefit ratio were granted either regular or accelerated marketing approval for use in the specific indication that was studied. Regular approval was based on endpoints that demonstrated that the drug provided clinical benefit as evidenced by a longer or better life or a favorable effect on an established surrogate for a longer or better life. Accelerated approval was based on a less well-established surrogate endpoint that was reasonably likely to predict a longer or better life. Of the 53 new indications that were approved during the study period, 39 received regular approval, nine received accelerated approval, and five were converted from accelerated to regular approval. Five applications were not approved, and two applications were withdrawn before any regulatory action was taken. Eighteen of the 53 indications that were approved were for new molecular entities. During the study period, regulatory action was taken on 58 of the 60 marketing applications

  5. Timing and Characteristics of Cumulative Evidence Available on Novel Therapeutic Agents Receiving Food and Drug Administration Accelerated Approval.

    PubMed

    Naci, Huseyin; Wouters, Olivier J; Gupta, Radhika; Ioannidis, John P A

    2017-06-01

    Policy Points: Randomized trials-the gold standard of evaluating effectiveness-constitute a small minority of existing evidence on agents given accelerated approval. One-third of randomized trials are in therapeutic areas outside of FDA approval and less than half evaluate the therapeutic benefits of these agents but use them instead as common backbone treatments. Agents receiving accelerated approval are often tested concurrently in several therapeutic areas. For most agents, no substantial time lag is apparent between the average start dates of randomized trials evaluating their effectiveness and those using them as part of background therapies. There appears to be a tendency for therapeutic agents receiving accelerated approval to quickly become an integral component of standard treatment, despite potential shortcomings in their evidence base. Therapeutic agents treating serious conditions are eligible for Food and Drug Administration (FDA) accelerated approval. The clinical evidence accrued on agents receiving accelerated approval has not been systematically evaluated. Our objective was to assess the timing and characteristics of available studies. We first identified clinical studies of novel therapeutic agents receiving accelerated approval. We then (1) categorized those studies as randomized or nonrandomized, (2) explored whether they evaluated the FDA-approved indications, and (3) documented the available treatment comparisons. We also meta-analyzed the difference in start times between randomized studies that (1) did or did not evaluate approved indications and (2) were or were not designed to evaluate the agent's effectiveness. In total, 37 novel therapeutic agents received accelerated approval between 2000 and 2013. Our search of ClinicalTrials.gov identified 7,757 studies, which included 1,258,315 participants. Only one-third of identified studies were randomized controlled trials. Of 1,631 randomized trials with advanced recruitment status, 906 were

  6. Patient-Reported Outcomes Labeling for Products Approved by the Office of Hematology and Oncology Products of the US Food and Drug Administration (2010-2014).

    PubMed

    Gnanasakthy, Ari; DeMuro, Carla; Clark, Marci; Haydysch, Emily; Ma, Esprit; Bonthapally, Vijayveer

    2016-06-01

    To review the use of patient-reported outcome (PRO) data in medical product labeling granted by the US Food and Drug Administration (FDA) for new molecular entities and biologic license applications by the FDA Office of Hematology and Oncology Products (OHOP) between January 2010 and December 2014, to elucidate challenges faced by OHOP for approving PRO labeling, and to understand challenges faced by drug manufacturers to include PRO end points in oncology clinical trials. FDA Drug Approval Reports by Month were reviewed to obtain the number of new molecular entities and biologic license applications approved from 2010 to 2014. Drugs approved by the FDA OHOP during this period were selected for further review, focusing on brand and generic name; approval date; applicant; indication; PRO labeling describing treatment benefit, measures, end point status, and significant results; FDA reviewer feedback on PRO end points; and study design of registration trials. First in class, priority review, fast track, orphan drug, or accelerated approval status was retrieved for selected oncology drugs from 2011 to 2014. Descriptive analyses were performed by using Microsoft Excel 2010. Of 160 drugs approved by the FDA (2010-2014), 40 were approved by OHOP. Three (7.5%) of the 40 received PRO-related labeling (abiraterone acetate, ruxolitinib phosphate, and crizotinib). Compared with nononcology drugs (2011-2014), oncology drugs were more likely to be orphan and first in class. The majority of oncology drug reviews by FDA were fast track, priority, or accelerated. Although symptoms and functional decrements are common among patients with cancer, PRO labeling is rare in the United States, likely because of logistical hurdles and oncology study design. Recent developments within the FDA OHOP to capture PROs in oncology studies for the purpose of product labeling are encouraging. © 2016 by American Society of Clinical Oncology.

  7. 30 CFR 7.8 - Post-approval product audit.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Post-approval product audit. 7.8 Section 7.8... APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY General § 7.8 Post-approval product audit...-holder may observe any tests conducted during this audit. (c) An approved product shall be subject to...

  8. Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration

    PubMed Central

    Smalley, Katelyn R.; Kesselheim, Aaron S.

    2017-01-01

    Importance Drugs treating serious or life-threatening conditions can receive US Food and Drug Administration (FDA) accelerated approval based on showing an effect in surrogate measures that are only reasonably likely to predict clinical benefit. Confirmatory trials are then required to determine whether these effects translate to clinical improvements. Objective To characterize preapproval and confirmatory clinical trials of drugs granted accelerated approval. Design and Setting Publicly available FDA documents were reviewed to identify the preapproval trials leading to accelerated approval between 2009 and 2013. Information on the status and findings of required confirmatory studies was extracted from the FDA’s database of postmarketing requirements and commitments, ClinicalTrials.gov, and matched peer-reviewed publications. Follow-up ended on April 7, 2017. Exposures Granting of accelerated approval. Main Outcomes and Measures Characteristics of preapproval and confirmatory studies were compared in terms of study design features (randomization, blinding, comparator, primary end point). Subsequent regulatory decisions and estimated time between accelerated approval and fulfillment of regulatory requirements were summarized. Results The FDA granted accelerated approval to 22 drugs for 24 indications (19 for indications involving cancer treatment) between 2009 and 2013. A total of 30 preapproval studies supported the 24 indications. The median number of participants enrolled in the preapproval studies was 132 (interquartile range, 89-224). Eight studies (27%) included fewer than 100 participants and 20 (67%) included fewer than 200. At a minimum 3 years of follow-up, 19 of 38 (50%) required confirmatory studies were completed, including 18 published reports. Twenty-five of the 38 (66%) examined clinical efficacy, 7 (18%) evaluated longer follow-up, and 6 (16%) focused on safety The proportion of studies with randomized designs did not differ before and after

  9. 30 CFR 15.10 - Post-approval product audit.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Post-approval product audit. 15.10 Section 15... General Provisions § 15.10 Post-approval product audit. (a) Approved explosives and sheathed explosive... observe any tests conducted during this audit. (c) An approved explosive or sheathed explosive unit shall...

  10. 30 CFR 14.10 - Post-approval product audit.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Post-approval product audit. 14.10 Section 14... General Provisions § 14.10 Post-approval product audit. (a) Approved conveyor belts will be subject to... applicant and other persons agreed upon by MSHA and the applicant may be present during audit tests and...

  11. 30 CFR 14.10 - Post-approval product audit.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Post-approval product audit. 14.10 Section 14... General Provisions § 14.10 Post-approval product audit. (a) Approved conveyor belts will be subject to... applicant and other persons agreed upon by MSHA and the applicant may be present during audit tests and...

  12. 30 CFR 14.10 - Post-approval product audit.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Post-approval product audit. 14.10 Section 14... General Provisions § 14.10 Post-approval product audit. (a) Approved conveyor belts will be subject to... applicant and other persons agreed upon by MSHA and the applicant may be present during audit tests and...

  13. Accelerating drug development and approval.

    PubMed

    Cole, Patrick

    2010-01-01

    Regulatory agencies are the gateway between the pharma/biotech industry and patients and can serve as stimulators of new drug development. This article highlights several means of doing so implemented thus far, many with already impressive histories, such as orphan drug legislation, and others of a more experimental nature, such as the FDA's priority review voucher program. These initiatives represent different approaches to finding treatments for rare and widespread but neglected diseases, as well as speeding the development process for pharmaceutical and biological agents more generally. Commercial incentives, streamlined regulatory processing, exploratory trial designs, research assistance and cash infusions are all means of promoting drug development being explored in the United States, Europe and beyond. In some cases, such as fast track designation and priority review vouchers, regulatory agencies have turned their own processes into incentives, offering advantageous alternative routes to product approval, like a faster lane on the highway for vehicles carrying multiple passengers. In 2009, regulatory agencies and the governments they represent also had to confront two tremendous challenges: the global recession and the H1N1 influenza virus pandemic. These tests have been met with increased funding in the former case and coordinated efforts to develop, approve and stockpile H1N1 vaccines in the latter.

  14. 46 CFR 160.023-4 - Approval and production tests.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Approval and production tests. 160.023-4 Section 160.023-4 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Hand Combination Flare and Smoke Distress Signals § 160.023-4 Approval and production tests...

  15. 46 CFR 160.022-4 - Approval and production tests.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 6 2011-10-01 2011-10-01 false Approval and production tests. 160.022-4 Section 160.022-4 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Floating Orange Smoke Distress Signals (5 Minutes) § 160.022-4 Approval and production test...

  16. 46 CFR 160.023-4 - Approval and production tests.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 6 2011-10-01 2011-10-01 false Approval and production tests. 160.023-4 Section 160.023-4 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Hand Combination Flare and Smoke Distress Signals § 160.023-4 Approval and production tests...

  17. 46 CFR 160.028-4 - Approval and production tests.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Approval and production tests. 160.028-4 Section 160.028-4 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Signal Pistols for Red Flare Distress Signals § 160.028-4 Approval and production tests. (a...

  18. Drugs@FDA: FDA Approved Drug Products

    MedlinePlus

    ... Cosmetics Tobacco Products Home Drug Databases Drugs@FDA Drugs@FDA: FDA Approved Drug Products Share Tweet Linkedin Pin it More sharing ... Download Drugs@FDA Express for free Search by Drug Name, Active Ingredient, or Application Number Enter at ...

  19. 30 CFR 7.91 - Post-approval product audit.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Diesel Engines Intended for Use in... except for cause, the approval holder shall make a diesel engine available for audit at no cost to MSHA. ...

  20. 30 CFR 7.91 - Post-approval product audit.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Diesel Engines Intended for Use in... except for cause, the approval holder shall make a diesel engine available for audit at no cost to MSHA. ...

  1. 30 CFR 7.91 - Post-approval product audit.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Diesel Engines Intended for Use in... except for cause, the approval holder shall make a diesel engine available for audit at no cost to MSHA. ...

  2. 30 CFR 7.91 - Post-approval product audit.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Diesel Engines Intended for Use in... except for cause, the approval holder shall make a diesel engine available for audit at no cost to MSHA. ...

  3. 30 CFR 7.91 - Post-approval product audit.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Diesel Engines Intended for Use in... except for cause, the approval holder shall make a diesel engine available for audit at no cost to MSHA. ...

  4. 78 FR 21996 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Accelerated Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-12

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-69341; File No. SR-NASDAQ-2013-048] Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Accelerated Approval of a Proposed Rule... in a Limit State or Straddle State, and unlike normal circumstances, may not be a true reflection of...

  5. 75 FR 21688 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Accelerated Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Accelerated Approval of Proposed Rule... 20, 2010. I. Introduction On March 11, 2010, The NASDAQ Stock Market LLC (``Nasdaq'' or ``Exchange.... Strike prices for ETF options are permitted in $1 or greater intervals where the strike price is $200 or...

  6. 77 FR 27529 - Self-Regulatory Organizations; ICE Clear Credit LLC; Order Granting Accelerated Approval of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-10

    ... Organizations; ICE Clear Credit LLC; Order Granting Accelerated Approval of Proposed Rule Change to Membership Qualifications May 4, 2012. I. Introduction On April 3, 2012, ICE Clear Credit LLC (``ICC'') filed with the... limitations provided for in ICC Rule 203(b)) require such Clearing Participant to prepay and maintain with ICE...

  7. 12 CFR 1253.4 - New product approval.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... § 1253.4 New product approval. (a) Public notice. If the Director determines that the new activity is a new product, FHFA shall publish a public notice soliciting comments on the proposed product for a 30...) The Director will consider all public comments received by the closing date of the comment period. (3...

  8. 78 FR 22001 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order Granting Accelerated Approval of a...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-12

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-69344; File No. SR-Phlx-2013-29] Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order Granting Accelerated Approval of a Proposed Rule Change... not be a true reflection of the value of the series being quoted. In response to these concerns, the...

  9. Examination of the relationship between oncology drug labeling revision frequency and FDA product categorization.

    PubMed

    Berlin, Robert J

    2009-09-01

    I examined the relationship between the Food and Drug Administration's (FDA's) use of special regulatory designations and the frequency with which labels of oncology drugs are revised to explore how the FDA's designation of products relates to product development and refinement. One hundred oncology drugs, designated by the FDA as accelerated approval, priority review, orphan drug, or traditional review, were identified from publicly available information. Drug information for each product was evaluated to assess the rate at which manufacturers revised product labeling. Rates were compared between specially categorized products and traditional review products (e.g., orphan vs nonorphan drugs) to produce revision rate ratios for each special category. Labeling for accelerated approval and priority review products are revised significantly more frequently than are labels for traditional products. Accelerated approval products are approved based on surrogate endpoints; this approval process anticipates subsequent labeling refinement. Priority review products, however, are approved through a process that is ostensibly as rigorous as traditional review. Their higher than expected label revision rate may suggest deficiencies in the FDA's current priority review evaluation processes.

  10. 78 FR 21982 - Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Order Granting Accelerated Approval of a...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-12

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-69343; File No. SR-BX-2013-026] Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Order Granting Accelerated Approval of a Proposed Rule Change To Adopt... not be a true reflection of the value of the series being quoted. In response to these concerns, the...

  11. 6 CFR 25.9 - Procedures for certification of approved products for Homeland Security.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Procedures for certification of approved products for Homeland Security. (a) Application Procedure. An applicant seeking a Certification of anti-terrorism Technology as an Approved Product for Homeland Security... application for renewal must be made using the “Application for Certification of an Approved Product for...

  12. The potential investment impact of improved access to accelerated approval on the development of treatments for low prevalence rare diseases

    PubMed Central

    2011-01-01

    Background Over 95% of rare diseases lack treatments despite many successful treatment studies in animal models. To improve access to treatments, the Accelerated Approval (AA) regulations were implemented allowing the use of surrogate endpoints to achieve drug approval and accelerate development of life-saving therapies. Many rare diseases have not utilized AA due to the difficulty in gaining acceptance of novel surrogate endpoints in untreated rare diseases. Methods To assess the potential impact of improved AA accessibility, we devised clinical development programs using proposed clinical or surrogate endpoints for fifteen rare disease treatments. Results We demonstrate that better AA access could reduce development costs by approximately 60%, increase investment value, and foster development of three times as many rare disease drugs for the same investment. Conclusion Our research brings attention to the need for well-defined and practical qualification criteria for the use of surrogate endpoints to allow more access to the AA approval pathway in clinical trials for rare diseases. PMID:21733145

  13. 78 FR 29780 - Fees for Testing, Evaluation, and Approval of Mining Products

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-21

    ... Approval of Mining Products AGENCY: Mine Safety and Health Administration, Labor. ACTION: Notice. SUMMARY..., and approval of mining products; it allows MSHA to collect fees up to $2,499,000 for the testing, evaluation, and approval of certain mining equipment. MSHA is continuing to collect these fees for 2013 as...

  14. 46 CFR 160.023-4 - Approval and production tests.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 6 2012-10-01 2012-10-01 false Approval and production tests. 160.023-4 Section 160.023-4 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Hand Combination Flare and Smoke Distress...

  15. 46 CFR 160.023-4 - Approval and production tests.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 6 2013-10-01 2013-10-01 false Approval and production tests. 160.023-4 Section 160.023-4 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Hand Combination Flare and Smoke Distress...

  16. 46 CFR 160.023-4 - Approval and production tests.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 6 2014-10-01 2014-10-01 false Approval and production tests. 160.023-4 Section 160.023-4 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Hand Combination Flare and Smoke Distress...

  17. 46 CFR 160.036-4 - Approval and production tests.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 6 2011-10-01 2011-10-01 false Approval and production tests. 160.036-4 Section 160.036-4 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Hand-Held Rocket-Propelled Parachute Red Flare...

  18. 46 CFR 160.036-4 - Approval and production tests.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 6 2013-10-01 2013-10-01 false Approval and production tests. 160.036-4 Section 160.036-4 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Hand-Held Rocket-Propelled Parachute Red Flare...

  19. 46 CFR 160.036-4 - Approval and production tests.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 6 2014-10-01 2014-10-01 false Approval and production tests. 160.036-4 Section 160.036-4 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Hand-Held Rocket-Propelled Parachute Red Flare...

  20. 46 CFR 160.036-4 - Approval and production tests.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 6 2012-10-01 2012-10-01 false Approval and production tests. 160.036-4 Section 160.036-4 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Hand-Held Rocket-Propelled Parachute Red Flare...

  1. 46 CFR 160.036-4 - Approval and production tests.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Approval and production tests. 160.036-4 Section 160.036-4 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Hand-Held Rocket-Propelled Parachute Red Flare...

  2. Trial endpoints for drug approval in oncology: Chemoprevention.

    PubMed

    Beitz, J

    2001-04-01

    As with other drugs, new drug applications for marketing approval of chemopreventive drugs must include data from adequate and well-controlled clinical trials that demonstrate effectiveness and safety for the intended use. This article summarizes the regulatory requirements for traditional marketing approval, as well as for approval under the accelerated approval regulations. Unlike traditional approval, accelerated approval is based on a surrogate endpoint that is reasonably likely to predict clinical benefit. Discussions with the Food and Drug Administration (FDA) regarding the validity of trial endpoints that may serve as surrogates for clinical benefit for accelerated approval should take place as early as possible in drug development. Meetings with the FDA to discuss these issues may be requested throughout the clinical development of a new drug.

  3. 46 CFR 160.040-5 - Approval and production tests.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Rocket Type (and Equipment) § 160.040-5 Approval and production tests. (a) Approval tests. An independent... lot of rockets which fails the inspections and tests must not be represented as meeting this subpart... rockets at least once each year. The inspection must determine that the appliances and rockets are being...

  4. 46 CFR 160.040-5 - Approval and production tests.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Rocket Type (and Equipment) § 160.040-5 Approval and production tests. (a) Approval tests. An independent... lot of rockets which fails the inspections and tests must not be represented as meeting this subpart... rockets at least once each year. The inspection must determine that the appliances and rockets are being...

  5. 46 CFR 160.040-5 - Approval and production tests.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Rocket Type (and Equipment) § 160.040-5 Approval and production tests. (a) Approval tests. An independent... lot of rockets which fails the inspections and tests must not be represented as meeting this subpart... rockets at least once each year. The inspection must determine that the appliances and rockets are being...

  6. 46 CFR 160.040-5 - Approval and production tests.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Rocket Type (and Equipment) § 160.040-5 Approval and production tests. (a) Approval tests. An independent... lot of rockets which fails the inspections and tests must not be represented as meeting this subpart... rockets at least once each year. The inspection must determine that the appliances and rockets are being...

  7. 46 CFR 160.040-5 - Approval and production tests.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Rocket Type (and Equipment) § 160.040-5 Approval and production tests. (a) Approval tests. An independent... lot of rockets which fails the inspections and tests must not be represented as meeting this subpart... rockets at least once each year. The inspection must determine that the appliances and rockets are being...

  8. Approval summary: letrozole (Femara® tablets) for adjuvant and extended adjuvant postmenopausal breast cancer treatment: conversion of accelerated to full approval.

    PubMed

    Cohen, Martin H; Johnson, John R; Justice, Robert; Pazdur, Richard

    2011-01-01

    On April 30, 2010, the U.S. Food and Drug Administration converted letrozole (Femara®; Novartis Pharmaceuticals Corporation, East Hanover, NJ) from accelerated to full approval for adjuvant and extended adjuvant (following 5 years of tamoxifen) treatment of postmenopausal women with hormone receptor-positive early breast cancer. The initial accelerated approvals of letrozole for adjuvant and extended adjuvant treatment on December 28, 2005 and October 29, 2004, respectively, were based on an analysis of the disease-free survival (DFS) outcome of patients followed for medians of 26 months and 28 months, respectively. Both trials were double-blind, multicenter studies. Both trials were unblinded early when an interim analysis showed a favorable letrozole effect on DFS. In updated intention-to-treat analyses of both trials, the risk for a DFS event was lower with letrozole than with tamoxifen (hazard ratio [HR], 0.87; 95% confidence interval [CI], 0.77-0.99; p = .03) in the adjuvant trial and was lower than with placebo (HR, 0.89; 95% CI, 0.76-1.03; p = .12) in the extended adjuvant trial. The latter analysis ignores the interim switch of 60% of placebo-treated patients to letrozole. Bone fractures and osteoporosis were reported more frequently following treatment with letrozole whereas tamoxifen was associated with a higher risk for endometrial proliferation and endometrial cancer. Myocardial infarction was more frequently reported with letrozole than with tamoxifen, but the incidence of thromboembolic events was higher with tamoxifen than with letrozole. Lipid-lowering medications were required for 25% of patients on letrozole and 16% of patients on tamoxifen.

  9. Characteristics of rare disease marketing applications associated with FDA product approvals 2006-2010.

    PubMed

    Pariser, Anne R; Slack, Daniel J; Bauer, Larry J; Warner, Catherine A; Tracy, LaRee A

    2012-08-01

    New drug and biologic product marketing applications submitted to FDA's Center for Drug Evaluation and Research (CDER) between 2006 and 2010 were analyzed to identify rare disease application characteristics associated with higher approval rates. The results show that approval rates were similar for rare and common disease applications. Larger company size, prior regulatory experience and priority review designation were associated with higher approval rates. The study findings show that rare disease product development is feasible, and increased interactions between product developers and FDA in early investigational phases can facilitate product development. Published by Elsevier Ltd.

  10. Approval Summary: Letrozole (Femara® Tablets) for Adjuvant and Extended Adjuvant Postmenopausal Breast Cancer Treatment: Conversion of Accelerated to Full Approval

    PubMed Central

    Johnson, John R.; Justice, Robert; Pazdur, Richard

    2011-01-01

    On April 30, 2010, the U.S. Food and Drug Administration converted letrozole (Femara®; Novartis Pharmaceuticals Corporation, East Hanover, NJ) from accelerated to full approval for adjuvant and extended adjuvant (following 5 years of tamoxifen) treatment of postmenopausal women with hormone receptor–positive early breast cancer. The initial accelerated approvals of letrozole for adjuvant and extended adjuvant treatment on December 28, 2005 and October 29, 2004, respectively, were based on an analysis of the disease-free survival (DFS) outcome of patients followed for medians of 26 months and 28 months, respectively. Both trials were double-blind, multicenter studies. Both trials were unblinded early when an interim analysis showed a favorable letrozole effect on DFS. In updated intention-to-treat analyses of both trials, the risk for a DFS event was lower with letrozole than with tamoxifen (hazard ratio [HR], 0.87; 95% confidence interval [CI], 0.77–0.99; p = .03) in the adjuvant trial and was lower than with placebo (HR, 0.89; 95% CI, 0.76–1.03; p = .12) in the extended adjuvant trial. The latter analysis ignores the interim switch of 60% of placebo-treated patients to letrozole. Bone fractures and osteoporosis were reported more frequently following treatment with letrozole whereas tamoxifen was associated with a higher risk for endometrial proliferation and endometrial cancer. Myocardial infarction was more frequently reported with letrozole than with tamoxifen, but the incidence of thromboembolic events was higher with tamoxifen than with letrozole. Lipid-lowering medications were required for 25% of patients on letrozole and 16% of patients on tamoxifen. PMID:22089970

  11. 77 FR 2308 - Approval of Altol Petroleum Product Service, as a Commercial Gauger

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-17

    ... DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection Approval of Altol Petroleum... Security. ACTION: Notice of approval of Altol Petroleum Product Service, as a commercial gauger. SUMMARY: Notice is hereby given that, pursuant to 19 CFR 151.13, Altol Petroleum Product Service, Calle Gregorio...

  12. 75 FR 82074 - Fee Adjustment for Testing, Evaluation, and Approval of Mining Products

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-29

    ..., and Approval of Mining Products AGENCY: Mine Safety and Health Administration (MSHA), Labor. ACTION..., evaluating, and approving mining products as provided by 30 CFR part 5. MSHA charges applicants a fee to... materials manufactured for use in the mining industry. The new fee schedule, effective January 1, 2011, is...

  13. 5 CFR 1305.2 - Production prohibited unless approved.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Production prohibited unless approved. 1305.2 Section 1305.2 Administrative Personnel OFFICE OF MANAGEMENT AND BUDGET ADMINISTRATIVE PROCEDURES RELEASE OF OFFICIAL INFORMATION, AND TESTIMONY BY OMB PERSONNEL AS WITNESSES, IN LITIGATION § 1305...

  14. Cheminformatic comparison of approved drugs from natural product versus synthetic origins.

    PubMed

    Stratton, Christopher F; Newman, David J; Tan, Derek S

    2015-11-01

    Despite the recent decline of natural product discovery programs in the pharmaceutical industry, approximately half of all new drug approvals still trace their structural origins to a natural product. Herein, we use principal component analysis to compare the structural and physicochemical features of drugs from natural product-based versus completely synthetic origins that were approved between 1981 and 2010. Drugs based on natural product structures display greater chemical diversity and occupy larger regions of chemical space than drugs from completely synthetic origins. Notably, synthetic drugs based on natural product pharmacophores also exhibit lower hydrophobicity and greater stereochemical content than drugs from completely synthetic origins. These results illustrate that structural features found in natural products can be successfully incorporated into synthetic drugs, thereby increasing the chemical diversity available for small-molecule drug discovery. Copyright © 2015 Elsevier Ltd. All rights reserved.

  15. An analysis of FDA-approved drugs: natural products and their derivatives.

    PubMed

    Patridge, Eric; Gareiss, Peter; Kinch, Michael S; Hoyer, Denton

    2016-02-01

    Natural products contribute greatly to the history and landscape of new molecular entities (NMEs). An assessment of all FDA-approved NMEs reveals that natural products and their derivatives represent over one-third of all NMEs. Nearly one-half of these are derived from mammals, one-quarter from microbes and one-quarter from plants. Since the 1930s, the total fraction of natural products has diminished, whereas semisynthetic and synthetic natural product derivatives have increased. Over time, this fraction has also become enriched with microbial natural products, which represent a significant portion of approved antibiotics, including more than two-thirds of all antibacterial NMEs. In recent years, the declining focus on natural products has impacted the pipeline of NMEs from specific classes, and this trend is likely to continue without specific investment in the pursuit of natural products. Copyright © 2015 Elsevier Ltd. All rights reserved.

  16. 14 CFR 193.17 - How must design and production approval holders handle information they receive from the FAA...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false How must design and production approval... REGULATIONS PROTECTION OF VOLUNTARILY SUBMITTED INFORMATION § 193.17 How must design and production approval... under § 193.9(a)(2) to the holders of design approvals of production approvals issued by the FAA, the...

  17. Drug Discovery Prospect from Untapped Species: Indications from Approved Natural Product Drugs

    PubMed Central

    Qin, Chu; Tao, Lin; Liu, Xin; Shi, Zhe; Zhang, Cun Long; Tan, Chun Yan; Chen, Yu Zong; Jiang, Yu Yang

    2012-01-01

    Due to extensive bioprospecting efforts of the past and technology factors, there have been questions about drug discovery prospect from untapped species. We analyzed recent trends of approved drugs derived from previously untapped species, which show no sign of untapped drug-productive species being near extinction and suggest high probability of deriving new drugs from new species in existing drug-productive species families and clusters. Case histories of recently approved drugs reveal useful strategies for deriving new drugs from the scaffolds and pharmacophores of the natural product leads of these untapped species. New technologies such as cryptic gene-cluster exploration may generate novel natural products with highly anticipated potential impact on drug discovery. PMID:22808057

  18. 9 CFR 590.680 - Approval of labeling for egg products processed in exempted egg products processing plants.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Approval of labeling for egg products processed in exempted egg products processing plants. 590.680 Section 590.680 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION INSPECTION OF...

  19. 9 CFR 590.680 - Approval of labeling for egg products processed in exempted egg products processing plants.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Approval of labeling for egg products processed in exempted egg products processing plants. 590.680 Section 590.680 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION INSPECTION OF...

  20. Oil spill treatment products approval: the UK approach and potential application to the Gulf region.

    PubMed

    Kirby, Mark F; Law, Robin J

    2008-07-01

    The environmental threat from oil spills remains significant across the globe and particularly in regions of high oil production and transport such as the Gulf. The ultimate damage caused can be limited by mitigation actions that responders deploy. The responsible and appropriate use of oil spill treatment products (e.g. dispersants, sorbents etc.) can offer response options that can result in substantial net environmental benefit. However, the approval and choice of what products to use needs careful consideration. The United Kingdom has had in place a statutory approval scheme for oil spill treatment products for 30 years. It is based on measures of efficiency and environmental acceptability. Two toxicity tests form an integral part of the assessment, the Sea test and the Rocky Shore test, and work on the premise that approved products will not make the situation significantly worse when added to spilled oil. This paper outlines the UK approach and how its rationale might be applied to the approval of products specific for the Gulf region. Issues such as species choice, higher temperatures and salinity and regional environmental conditions are considered.

  1. Working with the U.S. Food and Drug Administration to obtain approval of products under the Animal Rule.

    PubMed

    Park, Glen D; Mitchel, Jules T

    2016-06-01

    While the development of medical products and approval by the U.S. Food and Drug Administration (FDA) is well known, the development of countermeasures against exposure to toxic levels of radiation, chemicals, and infectious agents requires special consideration, and there has been, to date, little experience in working with the FDA to obtain approval of these products. The FDA has published a regulation entitled "Approval of Biological Products when Human Efficacy Studies are not Ethical or Feasible." This regulation, known simply as the "Animal Rule," was designed to permit approval or licensing of drugs and biologics when efficacy studies in humans are not ethical or feasible. To date, 12 products have been approved under the Animal Rule. It is highly recommended that sponsors of products that are to be developed under the Animal Rule meet with the FDA and other government entities early in the development process to ensure that the efficacy and safety studies that are planned will meet the FDA's requirements for approval of the product. © 2016 New York Academy of Sciences.

  2. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... approval or disapproval of the machine. (a) If the qualified electrical representative recommends field..., DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.99 Notice of approval or...

  3. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... approval or disapproval of the machine. (a) If the qualified electrical representative recommends field..., DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.99 Notice of approval or...

  4. ILU industrial electron accelerators for medical-product sterilization and food treatment

    NASA Astrophysics Data System (ADS)

    Bezuglov, V. V.; Bryazgin, A. A.; Vlasov, A. Yu.; Voronin, L. A.; Panfilov, A. D.; Radchenko, V. M.; Tkachenko, V. O.; Shtarklev, E. A.

    2016-12-01

    Pulse linear electron accelerators of the ILU type have been developed and produced by the Institute of Nuclear Physics, Siberian Branch, Russian Academy of Sciences, for more than 30 years. Their distinctive features are simplicity of design, convenience in operation, and reliability during long work under conditions of industrial production. ILU accelerators have a range of energy of 0.7-10 MeV at a power of accelerated beam of up to 100 kW and they are optimally suitable for use as universal sterilizing complexes. The scientific novelty of these accelerators consists of their capability to work both in the electron-treatment mode of production and in the bremsstrahlung generation mode, which has high penetrating power.

  5. 9 CFR 327.6 - Products for importation; program inspection, time and place; application for approval of...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... inspection, time and place; application for approval of facilities as official import inspection... § 327.6 Products for importation; program inspection, time and place; application for approval of..., wholesome, and otherwise not adulterated at the time the products are offered for importation into the...

  6. 9 CFR 327.6 - Products for importation; program inspection, time and place; application for approval of...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... inspection, time and place; application for approval of facilities as official import inspection... § 327.6 Products for importation; program inspection, time and place; application for approval of..., wholesome, and otherwise not adulterated at the time the products are offered for importation into the...

  7. 9 CFR 327.6 - Products for importation; program inspection, time and place; application for approval of...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... inspection, time and place; application for approval of facilities as official import inspection... § 327.6 Products for importation; program inspection, time and place; application for approval of..., wholesome, and otherwise not adulterated at the time the products are offered for importation into the...

  8. 9 CFR 327.6 - Products for importation; program inspection, time and place; application for approval of...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... inspection, time and place; application for approval of facilities as official import inspection... § 327.6 Products for importation; program inspection, time and place; application for approval of..., wholesome, and otherwise not adulterated at the time the products are offered for importation into the...

  9. Production of isometric forces during sustained acceleration.

    PubMed

    Sand, D P; Girgenrath, M; Bock, O; Pongratz, H

    2003-06-01

    The operation of high-performance aircraft requires pilots to apply finely graded forces on controls. Since they are often exposed to high levels of acceleration in flight, we investigated to what extent this ability is degraded in such an environment. Twelve healthy non-pilot volunteers were seated in the gondola of a centrifuge and their performance was tested at normal gravity (1 G) and while exposed to sustained forces of 1.5 G and 3 G oriented from head to foot (+Gz). Using an isometric joystick, they attempted to produce force vectors with specific lengths and directions commanded in random order by a visual display. Acceleration had substantial effects on the magnitude of produced force. Compared with 1 G, maximum produced force was about 2 N higher at 1.5 G and about 10 N higher at 3 G. The size of this effect was constant across the different magnitudes, but varied with the direction of the prescribed force. Acceleration degrades control of force production. This finding may indicate that the motor system misinterprets the unusual gravitoinertial environment and/or that proprioceptive feedback is degraded due to increased muscle tone. The production of excessive isometric force could affect the safe operation of high-performance aircraft.

  10. 78 FR 57406 - Approval of Altol Petroleum Product Service, as a Commercial Gauger

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-18

    ..., has been approved to gauge petroleum, petroleum products, organic chemicals and vegetable oils for... products, organic chemicals and vegetable oils for customs purposes, in accordance with the provisions of...

  11. Osimertinib: First Global Approval.

    PubMed

    Greig, Sarah L

    2016-02-01

    Osimertinib (Tagrisso(™), AZD9291) is an oral, third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that is being developed by AstraZeneca for the treatment of advanced non-small cell lung cancer (NSCLC). Osimertinib has been designed to target the EGFR T790M mutation that is often present in NSCLC patients with acquired EGFR TKI resistance, while sparing wild-type EGFR. In November 2015, the tablet formulation of osimertinib was granted accelerated approval in the USA for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC (as detected by an FDA-approved test) who have progressed on or after EGFR TKI therapy. Osimertinib has also been granted accelerated assessment status for this indication in the EU, and is in phase III development for first- and second-line and adjuvant treatment of advanced EGFR mutation-positive NSCLC in several countries. Phase I trials in patients with advanced solid tumours are also being conducted. This article summarizes the milestones in the development of osimertinib leading to this first approval for NSCLC.

  12. FDA Approval Summary: Atezolizumab for the Treatment of Patients with Progressive Advanced Urothelial Carcinoma after Platinum‐Containing Chemotherapy

    PubMed Central

    Suzman, Daniel; Maher, V. Ellen; Zhang, Lijun; Tang, Shenghui; Ricks, Tiffany; Palmby, Todd; Fu, Wentao; Liu, Qi; Goldberg, Kirsten B.; Kim, Geoffrey; Pazdur, Richard

    2017-01-01

    Abstract Until recently in the United States, no products were approved for second‐line treatment of advanced urothelial carcinoma. On May 18, 2016, the U.S. Food and Drug Administration approved atezolizumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following platinum‐containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum‐containing chemotherapy. Atezolizumab is a programmed death‐ligand 1 (PD‐L1) blocking antibody and represents the first approved product directed against PD‐L1. This accelerated approval was based on results of a single‐arm trial in 310 patients with locally advanced or metastatic urothelial carcinoma who had disease progression after prior platinum‐containing chemotherapy. Patients received atezolizumab 1,200 mg intravenously every 3 weeks until disease progression or unacceptable toxicity. Key efficacy measures were objective response rate (ORR), as assessed by Independent Review per RECIST 1.1, and duration of response (DoR). With a median follow‐up of 14.4 months, confirmed ORR was 14.8% (95% CI: 11.1, 19.3) in all treated patients. Median DoR was not reached and response durations ranged from 2.1+ to 13.8+ months. Of the 46 responders, 37 patients had an ongoing response for ≥ 6 months. The most common adverse reactions (≥20%) were fatigue, decreased appetite, nausea, urinary tract infection, pyrexia, and constipation. Infection and immune‐related adverse events also occurred, including pneumonitis, hepatitis, colitis, endocrine disorders, and rashes. Overall, the benefit‐risk assessment was favorable to support accelerated approval. The observed clinical benefits need to be verified in confirmatory trial(s). Implications for Practice. This accelerated approval of atezolizumab for second‐line use in advanced urothelial carcinoma provides patients with an effective, novel treatment option for

  13. FDA Approval Summary: Atezolizumab for the Treatment of Patients with Progressive Advanced Urothelial Carcinoma after Platinum-Containing Chemotherapy.

    PubMed

    Ning, Yang-Min; Suzman, Daniel; Maher, V Ellen; Zhang, Lijun; Tang, Shenghui; Ricks, Tiffany; Palmby, Todd; Fu, Wentao; Liu, Qi; Goldberg, Kirsten B; Kim, Geoffrey; Pazdur, Richard

    2017-06-01

    Until recently in the United States, no products were approved for second-line treatment of advanced urothelial carcinoma. On May 18, 2016, the U.S. Food and Drug Administration approved atezolizumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Atezolizumab is a programmed death-ligand 1 (PD-L1) blocking antibody and represents the first approved product directed against PD-L1. This accelerated approval was based on results of a single-arm trial in 310 patients with locally advanced or metastatic urothelial carcinoma who had disease progression after prior platinum-containing chemotherapy. Patients received atezolizumab 1,200 mg intravenously every 3 weeks until disease progression or unacceptable toxicity. Key efficacy measures were objective response rate (ORR), as assessed by Independent Review per RECIST 1.1, and duration of response (DoR). With a median follow-up of 14.4 months, confirmed ORR was 14.8% (95% CI: 11.1, 19.3) in all treated patients. Median DoR was not reached and response durations ranged from 2.1+ to 13.8+ months. Of the 46 responders, 37 patients had an ongoing response for ≥ 6 months. The most common adverse reactions (≥20%) were fatigue, decreased appetite, nausea, urinary tract infection, pyrexia, and constipation. Infection and immune-related adverse events also occurred, including pneumonitis, hepatitis, colitis, endocrine disorders, and rashes. Overall, the benefit-risk assessment was favorable to support accelerated approval. The observed clinical benefits need to be verified in confirmatory trial(s). This accelerated approval of atezolizumab for second-line use in advanced urothelial carcinoma provides patients with an effective, novel treatment option for the management of their disease. This represents the first

  14. A drug's life: the pathway to drug approval.

    PubMed

    Keng, Michael K; Wenzell, Candice M; Sekeres, Mikkael A

    2013-10-01

    In the United States, drugs and medical devices are regulated by the US Food and Drug Administration (FDA). A drug must undergo rigorous testing prior to marketing to and medical use by the general public. The FDA grants marketing approval for drug products based on a comprehensive review of safety and efficacy data. This review article explains the history behind the establishment of the FDA and examines the historical legislation and approval processes for drugs, specifically in the fields of medical oncology and hematology. The agents imatinib (Gleevec, Novartis) and decitabine (Dacogen, Eisai) are used to illustrate both the current FDA regulatory process-specifically the orphan drug designation and accelerated approval process-and why decitabine failed to gain an indication for acute myeloid leukemia. The purpose and construct of the Oncologic Drugs Advisory Committee are also discussed, along with examples of 2 renal cell cancer drugs-axitinib (Inlyta, Pfizer) and tivozanib-that used progression-free survival as an endpoint. Regulatory approval of oncology drugs is the cornerstone of the development of new treatment agents and modalities, which lead to improvements in the standard of cancer care. The future landscape of drug development and regulatory approval will be influenced by the new breakthrough therapy designation, and choice of drug will be guided by genomic insights.

  15. Committee approves bill to boost NIH funding.

    PubMed

    2015-08-01

    A U.S. House of Representatives committee approved the 21st Century Cures Act. If passed by Congress, the bill would boost funding for the NIH and FDA and introduce new strategies for accelerating the approval of drugs and devices. ©2015 American Association for Cancer Research.

  16. Priority review drugs approved by the FDA and the EMA: time for international regulatory harmonization of pharmaceuticals?

    PubMed

    Alqahtani, Saad; Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Eguale, Tewodros

    2015-07-01

    The US Food and Drug Administration (FDA) priority review process applies to a drug that is considered a significant improvement over the available alternatives. The European Medicines Agency (EMA) accelerated approval applies to a product that is of major public health interest. This study assessed differences in the characteristics of priority review new molecular entities and new therapeutic biologic products approved by the FDA and the EMA. This study includes regulatory information on drug applications, approvals, indications, and orphan designations of all priority review drugs approved by the FDA and the EMA in the period 1999-2011. Descriptive statistics, t-tests, and chi-squared and Wilcoxon tests were performed. Overall, 100 FDA priority review new molecular entities and new therapeutic biologics were approved by both agencies; 87.0% of the products were first approved by the FDA. The average FDA review time (9.2 ± 8.4 months) was significantly lower than the EMA average review time (14.6 ± 4.0 months) (p < 0.0001). The FDA and the EMA granted orphan designation to 43.0% and 33.0%, respectively, of the applications. There were differences in the administration route (1.0% of all products), dosage (8.0%), strength (23%), posology (51.0%), indications (30.0%), restrictions of use (52.0%), limitations of use (19.0%), and outcomes limitations (28.0%) approved by both regulatory agencies. Significant differences exist in the characteristics of the priority review drugs approved by the FDA and the EMA. Harmonization of the US and European regulatory frameworks may facilitate timely approval of pharmaceutical products. Copyright © 2015 John Wiley & Sons, Ltd.

  17. Chronic acceleration and egg production in domestic fowl

    NASA Technical Reports Server (NTRS)

    Smith, A. H.; Besch, E. L.; Burton, R. R.

    1985-01-01

    A study of the influence of chronic acceleration on egg production of commercially raised hens placed on a large animal centrifuge at 90 days of age, was performed. S8 generation hens were stepped up from 1.25 G to 2 G, which was maintained for 30 days. Fifty percent ceased to be in the laying condition at 1.5 G, and 10.8 percent suffered oviduct prolapse above 1.8 G. S21 generation hens had no incidents of oviduct prolapse despite 170-day retention at 2 G, and, assuming a 30 percent population not in the laying condition, approximated the commercial production rate. Chronic acceleration did not appear to affect the relative sizes of albumen or yolk, but it did appear to reduce the relative shell size, consistent with a decrease in plasma calcium. Dry matter content was not affected.

  18. Status of the LCLS-II Accelerating Cavity Production

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Daly, Ed; Marhauser, Frank; Fitzpatrick, Jarrod A.

    Cavity serial production for the LCLS-II 4 GeV CM SRF linac has started. A quantity of 266 accelerating cavities has been ordered from two industrial vendors. Jefferson Laboratory leads the cavity procurement activities for the project and has successfully transferred the Nitrogen-Doping process to the industrial partners in the initial phase, which is now being applied for the production cavities. We report on the results from vendor qualification and the status of the cavity production for LCLS-II.

  19. 77 FR 26706 - Food Ingredients and Sources of Radiation Listed and Approved for Use in the Production of Meat...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-07

    ... Listed and Approved for Use in the Production of Meat and Poultry Products AGENCY: Food Safety and... the regulations prohibit for use in meat or poultry products. Under this proposal, new uses of these substances in meat or poultry products would continue to be approved by the Food and Drug Administration (FDA...

  20. Physicians' Trust in the FDA's Use of Product-Specific Pathways for Generic Drug Approval.

    PubMed

    Kesselheim, Aaron S; Eddings, Wesley; Raj, Tara; Campbell, Eric G; Franklin, Jessica M; Ross, Kathryn M; Fulchino, Lisa A; Avorn, Jerry; Gagne, Joshua J

    2016-01-01

    Generic drugs are cost-effective versions of brand-name drugs approved by the Food and Drug Administration (FDA) following proof of pharmaceutical equivalence and bioequivalence. Generic drugs are widely prescribed by physicians, although there is disagreement over the clinical comparability of generic drugs to brand-name drugs within the physician community. The objective of this survey was to assess physicians' perceptions of generic drugs and the generic drug approval process. A survey was administered to a national sample of primary care internists and specialists between August 2014 and January 2015. In total, 1,152 physicians comprising of internists with no reported specialty certification and those with specialty certification in hematology, infectious diseases, and endocrinology were surveyed. The survey assessed physicians' perceptions of the FDA's generic drug approval process, as well as their experiences prescribing six generic drugs approved between 2008 and 2012 using product-specific approval pathways and selected comparator drugs. Among 718 respondents (62% response rate), a majority were comfortable with the FDA's process in ensuring the safety and effectiveness of generic drugs overall (91%) and with letting the FDA determine which tests were necessary to determine bioequivalence in a particular drug (92%). A minority (13-26%) still reported being uncomfortable prescribing generic drugs approved using product-specific pathways. Overall, few physicians heard reports of concerns about generic versions of the study drugs or their comparators, with no differences between the two groups. Physicians tended to hear about concerns about the safety or effectiveness of generic drugs from patients, pharmacists, and physician colleagues. Physicians hold largely positive views of the FDA's generic drug approval process even when some questioned the performance of certain generic drugs in comparison to brand-name drugs. Better education about the generic drug

  1. Excipients and their role in approved injectable products: current usage and future directions.

    PubMed

    Nema, Sandeep; Brendel, Ronald J

    2011-01-01

    This review article is a current survey of excipients used in approved injectable products. Information provided includes concentration ranges, function, frequency of use, and role in dosage form. This article is an update of a paper published more than a decade ago (reference 11). Since then many new products have been approved. Safety concerning excipients has evolved as the scientific community continues to learn about their usage. New excipients are being used in early phases of clinical trials to support novel therapeutic entities like RNAi, aptamers, anti-sense, fusion proteins, monoclonal antibodies, and variant scaffolds. Because these excipients are not inert, various pharmacopoeias are responding with monographs or informational chapters addressing excipient functionality. The final sections of this article discuss new excipients, serving specific needs that traditional excipients are unable to provide and for which safety studies are necessary to support a novel excipient for marketing applications. Excipients are added to parenteral dosage forms to serve a variety of functions including stabilization and as vehicles. This review article is a survey of excipients used in approved injectable products. Information provided includes excipient concentrations, functional roles, and frequency of use. This article is an update of an article originally published over a decade ago. Since then new products have been approved and safety concerns have evolved as the scientific community has learned about the usage of excipients. In addition, new excipients are being used in early phases of clinical trials to support novel therapeutic entities such as RNAi, aptamers, anti-sense, fusion proteins, monoclonal antibodies, and variant scaffolds. Because these excipients are not inert, various pharmacopoeias are responding with monographs or informational chapters addressing excipient functionality. The final sections of this article discuss new excipients, serving

  2. Accelerator Production of Isotopes for Medical Use

    NASA Astrophysics Data System (ADS)

    Lapi, Suzanne

    2014-03-01

    The increase in use of radioisotopes for medical imaging and therapy has led to the development of novel routes of isotope production. For example, the production and purification of longer-lived position emitting radiometals has been explored to allow for nuclear imaging agents based on peptides, antibodies and nanoparticles. These isotopes (64Cu, 89Zr, 86Y) are typically produced via irradiation of solid targets on smaller medical cyclotrons at dedicated facilities. Recently, isotope harvesting from heavy ion accelerator facilities has also been suggested. The Facility for Rare Isotope Beams (FRIB) will be a new national user facility for nuclear science to be completed in 2020. Radioisotopes could be produced by dedicated runs by primary users or may be collected synergistically from the water in cooling-loops for the primary beam dump that cycle the water at flow rates in excess of hundreds of gallons per minute. A liquid water target system for harvesting radioisotopes at the National Superconducting Cyclotron Laboratory (NSCL) was designed and constructed as the initial step in proof-of-principle experiments to harvest useful radioisotopes in this manner. This talk will provide an overview of isotope production using both dedicated machines and harvesting from larger accelerators typically used for nuclear physics. Funding from Department of Energy under DESC0007352 and DESC0006862.

  3. 48 CFR 4.1302 - Acquisition of approved products and services for personal identity verification.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... products and services for personal identity verification. 4.1302 Section 4.1302 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION GENERAL ADMINISTRATIVE MATTERS Personal Identity Verification 4.1302 Acquisition of approved products and services for personal identity verification. (a) In...

  4. 48 CFR 4.1302 - Acquisition of approved products and services for personal identity verification.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... products and services for personal identity verification. 4.1302 Section 4.1302 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION GENERAL ADMINISTRATIVE MATTERS Personal Identity Verification 4.1302 Acquisition of approved products and services for personal identity verification. (a) In...

  5. 48 CFR 4.1302 - Acquisition of approved products and services for personal identity verification.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... products and services for personal identity verification. 4.1302 Section 4.1302 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION GENERAL ADMINISTRATIVE MATTERS Personal Identity Verification 4.1302 Acquisition of approved products and services for personal identity verification. (a) In...

  6. 48 CFR 4.1302 - Acquisition of approved products and services for personal identity verification.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... products and services for personal identity verification. 4.1302 Section 4.1302 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION GENERAL ADMINISTRATIVE MATTERS Personal Identity Verification 4.1302 Acquisition of approved products and services for personal identity verification. (a) In...

  7. 48 CFR 4.1302 - Acquisition of approved products and services for personal identity verification.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... products and services for personal identity verification. 4.1302 Section 4.1302 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION GENERAL ADMINISTRATIVE MATTERS Personal Identity Verification 4.1302 Acquisition of approved products and services for personal identity verification. (a) In...

  8. 30 CFR 28.20 - Certificates of approval; scope of approval.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Certificates of approval; scope of approval. 28.20 Section 28.20 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS FUSES FOR USE WITH DIRECT CURRENT IN PROVIDING SHORT-CIRCUIT...

  9. 45 CFR 1201.5 - Testimony and production of documents prohibited unless approved by appropriate Corporation...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 45 Public Welfare 4 2010-10-01 2010-10-01 false Testimony and production of documents prohibited... Relating to Public Welfare (Continued) CORPORATION FOR NATIONAL AND COMMUNITY SERVICE PRODUCTION OR... and production of documents prohibited unless approved by appropriate Corporation officials. (a...

  10. 78 FR 57407 - Approval of Altol Petroleum Product Service, as a Commercial Gauger

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-18

    ... approved to gauge petroleum, petroleum products, organic chemicals and vegetable oils for customs purposes..., organic chemicals and vegetable oils for customs purposes, in accordance with the provisions of 19 CFR 151...

  11. 22 CFR 172.4 - Testimony and production of documents prohibited unless approved by appropriate Department...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Testimony and production of documents... DEPARTMENT OF STATE ACCESS TO INFORMATION SERVICE OF PROCESS; PRODUCTION OR DISCLOSURE OF OFFICIAL... § 172.4 Testimony and production of documents prohibited unless approved by appropriate Department...

  12. 77 FR 2308 - Approval of Altol Petroleum Product Service, as a Commercial Gauger

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-17

    ...: Notice is hereby given that, pursuant to 19 CFR 151.13, Altol Petroleum Product Service, Parque Industrial Sabanetas, Edificio M- 1380-01-02, Ponce, PR 00731, has been approved to gauge petroleum...

  13. 14 CFR 21.325 - Export airworthiness approvals.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Export airworthiness approvals. 21.325... AIRCRAFT CERTIFICATION PROCEDURES FOR PRODUCTS AND PARTS Export Airworthiness Approvals § 21.325 Export airworthiness approvals. (a) Kinds of approvals. (1) Export airworthiness approval of Class I products is issued...

  14. Apparatus for nuclear transmutation and power production using an intense accelerator-generated thermal neutron flux

    DOEpatents

    Bowman, C.D.

    1992-11-03

    Apparatus for nuclear transmutation and power production using an intense accelerator-generated thermal neutron flux. High thermal neutron fluxes generated from the action of a high power proton accelerator on a spallation target allows the efficient burn-up of higher actinide nuclear waste by a two-step process. Additionally, rapid burn-up of fission product waste for nuclides having small thermal neutron cross sections, and the practicality of small material inventories while achieving significant throughput derive from employment of such high fluxes. Several nuclear technology problems are addressed including 1. nuclear energy production without a waste stream requiring storage on a geological timescale, 2. the burn-up of defense and commercial nuclear waste, and 3. the production of defense nuclear material. The apparatus includes an accelerator, a target for neutron production surrounded by a blanket region for transmutation, a turbine for electric power production, and a chemical processing facility. In all applications, the accelerator power may be generated internally from fission and the waste produced thereby is transmuted internally so that waste management might not be required beyond the human lifespan.

  15. Apparatus for nuclear transmutation and power production using an intense accelerator-generated thermal neutron flux

    DOEpatents

    Bowman, Charles D.

    1992-01-01

    Apparatus for nuclear transmutation and power production using an intense accelerator-generated thermal neutron flux. High thermal neutron fluxes generated from the action of a high power proton accelerator on a spallation target allows the efficient burn-up of higher actinide nuclear waste by a two-step process. Additionally, rapid burn-up of fission product waste for nuclides having small thermal neutron cross sections, and the practicality of small material inventories while achieving significant throughput derive from employment of such high fluxes. Several nuclear technology problems are addressed including 1. nuclear energy production without a waste stream requiring storage on a geological timescale, 2. the burn-up of defense and commercial nuclear waste, and 3. the production of defense nuclear material. The apparatus includes an accelerator, a target for neutron production surrounded by a blanket region for transmutation, a turbine for electric power production, and a chemical processing facility. In all applications, the accelerator power may be generated internally from fission and the waste produced thereby is transmuted internally so that waste management might not be required beyond the human lifespan.

  16. The application of the Accelerated Stability Assessment Program (ASAP) to quality by design (QbD) for drug product stability.

    PubMed

    Waterman, Kenneth Craig

    2011-09-01

    An isoconversion paradigm, where times in different temperature and humidity-controlled stability chambers are set to provide a fixed degradant level, is shown to compensate for the complex, non-single order kinetics of solid drug products. A humidity-corrected Arrhenius equation provides reliable estimates for temperature and relative humidity effects on degradation rates. A statistical protocol is employed to determine best fits for chemical stability data, which in turn allows for accurate estimations of shelf life (with appropriate confidence intervals) at any storage condition including inside packaging (based on the moisture vapor transmission rate of the packaging and moisture sorption isotherms of the internal components). These methodologies provide both faster results and far better predictions of chemical stability limited shelf life (expiry) than previously possible. Precise shelf-life estimations are generally determined using a 2-week, product-specific protocol. Once the model for a product is developed, it can play a critical role in providing the product understanding necessary for a quality by design (QbD) filing for product approval and enable rational control strategies to assure product stability. Moreover, this Accelerated Stability Assessment Program (ASAP) enables the coupling of product attributes (e.g., moisture content, packaging options) to allow for flexibility in how control strategies are implemented to provide a balance of cost, speed, and other factors while maintaining adequate stability.

  17. 75 FR 65565 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-26

    ... 558 [Docket No. FDA-2010-N-0002] Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications; Aklomide; Levamisole Hydrochloride; Nitromide and Sulfanitran AGENCY...) is amending the animal drug regulations by removing those portions that reflect approval of eight new...

  18. Using Kokkos for Performant Cross-Platform Acceleration of Liquid Rocket Simulations

    DTIC Science & Technology

    2017-05-08

    NUMBER (Include area code) 08 May 2017 Briefing Charts 05 April 2017 - 08 May 2017 Using Kokkos for Performant Cross-Platform Acceleration of Liquid ...ERC Incorporated RQRC AFRL-West Using Kokkos for Performant Cross-Platform Acceleration of Liquid Rocket Simulations 2DISTRIBUTION A: Approved for... Liquid Rocket Combustion Simulation SPACE simulation of rotating detonation engine (courtesy of Dr. Christopher Lietz) 3DISTRIBUTION A: Approved

  19. Accelerator-Reactor Coupling for Energy Production in Advanced Nuclear Fuel Cycles

    NASA Astrophysics Data System (ADS)

    Heidet, Florent; Brown, Nicholas R.; Haj Tahar, Malek

    This article is a review of several accelerator-reactor interface issues and nuclear fuel cycle applications of accelerator-driven subcritical systems. The systems considered here have the primary goal of energy production, but that goal is accomplished via a specific application in various proposed nuclear fuel cycles, such as breed-and-burn of fertile material or burning of transuranic material. Several basic principles are reviewed, starting from the proton beam window including the target, blanket, reactor core, and up to the fuel cycle. We focus on issues of interest, such as the impact of the energy required to run the accelerator and associated systems on the potential electricity delivered to the grid. Accelerator-driven systems feature many of the constraints and issues associated with critical reactors, with the added challenges of subcritical operation and coupling to an accelerator. Reliable accelerator operation and avoidance of beam trips are critically important. One interesting challenge is measurement of blanket subcriticality level during operation. We also review the potential benefits of accelerator-driven systems in various nuclear fuel cycle applications. Ultimately, accelerator-driven subcritical systems with the goal of transmutation of transuranic material have lower 100,000-year radioactivity than a critical fast reactor with recycling of uranium and plutonium.

  20. 75 FR 61497 - Approval Pathway for Biosimilar and Interchangeable Biological Products; Public Hearing; Request...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-05

    ..., whereas small molecule drugs are typically manufactured through chemical synthesis. Section 351(k) of the... provision for protein products that have been or will be approved under section 505 of the FD&C Act (21 U.S... certain protein products during the 10-year transition period following enactment of the BPCI Act; and the...

  1. 76 FR 27332 - Proposal To Withdraw Approval for the Breast Cancer Indication for Bevacizumab; Hearing

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-11

    ...] Proposal To Withdraw Approval for the Breast Cancer Indication for Bevacizumab; Hearing AGENCY: Food and...) proposal to withdraw approval of the breast cancer indication for bevacizumab (Avastin). Genentech is the... accelerated approval of the metastatic [[Page 27333

  2. Amprenavir, new protease inhibitor, approved.

    PubMed

    James, J S

    1999-05-07

    A new protease inhibitor, amprenavir (Agenerase), has received FDA marketing approval. The approval was based on two 24-week controlled trials and safety data in more than 1,400 patients under FDA accelerated-approval rules. Amprenavir is approved for patients 4 years of age and older. The drug is taken twice daily, with or without food. Side effects include gastrointestinal disturbances, rashes, and oral paresthesia. Severe or life-threatening rashes have occurred in 1 percent of all patients. Pregnant women should not use the drug unless necessary. The drug was developed by Vertex Pharmaceuticals Inc. and is being marketed by Glaxo Wellcome. Some studies suggest that amprenavir is less likely than other protease inhibitors to be associated with lipid metabolism problems. It may have a resistance profile different from that of other protease inhibitors, and therefore may cause different cross resistance problems. Amprenavir appears to be synergistic with abacavir (Ziagen) in laboratory tests.

  3. 6 CFR 5.44 - Testimony and production of documents prohibited unless approved by appropriate Department...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 6 Domestic Security 1 2010-01-01 2010-01-01 false Testimony and production of documents prohibited... in Litigation § 5.44 Testimony and production of documents prohibited unless approved by appropriate... or request, including in connection with any litigation, provide oral or written testimony by...

  4. Comparison of the new Japanese legislation for expedited approval of regenerative medicine products with the existing systems in the USA and European Union

    PubMed Central

    Jokura, Yoji; Yano, Kazuo

    2017-01-01

    Abstract Legislation for expedited‐approval pathways and programmes for drugs, biologics or medical devices has been enacted for rapid commercialization of innovative products in the United States of America (USA) and the European Union (EU). However, less innovative products are increasingly benefitting from these expedited‐approval pathways, and obligations to collect and report post‐marketing data on approved products are being bypassed frequently. The Japanese government recently enacted legislation for a new conditional and time‐limited approval pathway dedicated to regenerative medicine products. The current study examines this new legislation and compares it with existing US and EU regulatory frameworks, with a particular focus on how it addresses the limitations of existing systems. Regulations, guidance documents and approval information were gathered from the websites of the respective authorities in the USA, the EU and Japan, and the systems were categorized through qualitative analysis. The pathways and programmes from each region were categorized into four groups, based on the requirement of pre‐ or post‐marketing clinical data. Expedited‐approval pathways in the USA and the EU provide similar qualification criteria, such as severity of target disease; however, such criteria are not specified for the new pathway in Japan. Only the Japanese pathway stipulates a time limitation on exceptional approval, requiring post‐marketing study for conditional and time‐limited products. Continuous improvement is necessary to solve previously addressed issues within the expedited‐approval pathways and programmes and to ensure that innovative medical products are rigourously screened, but also readily available to patients in need. The time limitation of conditional approval could be a potential solution to some of these problems. Copyright © 2017 The Authors. Tissue Engineering Regenerative Medicine published by John Wiley & Sons, Ltd. PMID

  5. Comparison of the new Japanese legislation for expedited approval of regenerative medicine products with the existing systems in the USA and European Union.

    PubMed

    Jokura, Yoji; Yano, Kazuo; Yamato, Masayuki

    2018-02-01

    Legislation for expedited-approval pathways and programmes for drugs, biologics or medical devices has been enacted for rapid commercialization of innovative products in the United States of America (USA) and the European Union (EU). However, less innovative products are increasingly benefitting from these expedited-approval pathways, and obligations to collect and report post-marketing data on approved products are being bypassed frequently. The Japanese government recently enacted legislation for a new conditional and time-limited approval pathway dedicated to regenerative medicine products. The current study examines this new legislation and compares it with existing US and EU regulatory frameworks, with a particular focus on how it addresses the limitations of existing systems. Regulations, guidance documents and approval information were gathered from the websites of the respective authorities in the USA, the EU and Japan, and the systems were categorized through qualitative analysis. The pathways and programmes from each region were categorized into four groups, based on the requirement of pre- or post-marketing clinical data. Expedited-approval pathways in the USA and the EU provide similar qualification criteria, such as severity of target disease; however, such criteria are not specified for the new pathway in Japan. Only the Japanese pathway stipulates a time limitation on exceptional approval, requiring post-marketing study for conditional and time-limited products. Continuous improvement is necessary to solve previously addressed issues within the expedited-approval pathways and programmes and to ensure that innovative medical products are rigourously screened, but also readily available to patients in need. The time limitation of conditional approval could be a potential solution to some of these problems. Copyright © 2017 The Authors. Tissue Engineering Regenerative Medicine published by John Wiley & Sons, Ltd. Copyright © 2017 The Authors. Tissue

  6. Rheological and molecular weight comparisons of approved hyaluronic acid products - preliminary standards for establishing class III medical device equivalence.

    PubMed

    Braithwaite, Gavin J C; Daley, Michael J; Toledo-Velasquez, David

    2016-01-01

    Hyaluronic acid of various molecular weights has been in use for the treatment of osteoarthritis knee pain for decades. Worldwide, these products are regulated as either as drugs or devices and in some countries as both. In the US, this class of products is regulated as Class III medical devices, which places specific regulatory requirements on developers of these materials under a Pre-Market Approval process, typically requiring data from prospective randomized controlled clinical studies. In 1984 pharmaceutical manufacturers became able to file an Abbreviated New Drug Application for approval of a generic drug, thus establishing standards for demonstrating equivalence to an existing chemical entity. Recently, the first biosimilar, or 'generic biologic', was approved. Biosimilars are biological products that are approved by the FDA because they are 'highly similar' to a reference product, and have been shown to have no clinically meaningful differences from the reference product. For devices, Class II medical devices have a pathway for declaring equivalence to an existing product by filing a 510 k application for FDA clearance. However, until recently no equivalent regulatory pathway was available to Class III devices. In this paper, we consider the critical mechanical performance parameters for intra-articular hyaluronic products to demonstrate indistinguishable characteristics. Analogous to the aforementioned pathways that allow for a demonstration of equivalence, we examine these parameters for an existing, marketed device and compare molecular weight and rheological properties of multiple batches of a similar product. We propose that this establishes a scientific rationale for establishing Class III medical device equivalence.

  7. The United States Particle Accelerator School: Educating the Next Generation of Accelerator Scientists and Engineers

    NASA Astrophysics Data System (ADS)

    Barletta, William A.

    2009-03-01

    Only a handful of universities in the US offer any formal training in accelerator science. The United States Particle Accelerator School (USPAS) is National Graduate Educational Program that has developed a highly successful educational paradigm that, over the past twenty-years, has granted more university credit in accelerator/beam science and technology than any university in the world. Sessions are held twice annually, hosted by major US research universities that approve course credit, certify the USPAS faculty, and grant course credit. The USPAS paradigm is readily extensible to other rapidly developing, cross-disciplinary research areas such as high energy density physics.

  8. Accelerated oral nanomedicine discovery from miniaturized screening to clinical production exemplified by paediatric HIV nanotherapies

    NASA Astrophysics Data System (ADS)

    Giardiello, Marco; Liptrott, Neill J.; McDonald, Tom O.; Moss, Darren; Siccardi, Marco; Martin, Phil; Smith, Darren; Gurjar, Rohan; Rannard, Steve P.; Owen, Andrew

    2016-10-01

    Considerable scope exists to vary the physical and chemical properties of nanoparticles, with subsequent impact on biological interactions; however, no accelerated process to access large nanoparticle material space is currently available, hampering the development of new nanomedicines. In particular, no clinically available nanotherapies exist for HIV populations and conventional paediatric HIV medicines are poorly available; one current paediatric formulation utilizes high ethanol concentrations to solubilize lopinavir, a poorly soluble antiretroviral. Here we apply accelerated nanomedicine discovery to generate a potential aqueous paediatric HIV nanotherapy, with clinical translation and regulatory approval for human evaluation. Our rapid small-scale screening approach yields large libraries of solid drug nanoparticles (160 individual components) targeting oral dose. Screening uses 1 mg of drug compound per library member and iterative pharmacological and chemical evaluation establishes potential candidates for progression through to clinical manufacture. The wide applicability of our strategy has implications for multiple therapy development programmes.

  9. Desperately seeking cancer drugs: explaining the emergence and outcomes of accelerated pharmaceutical regulation.

    PubMed

    Davis, Courtney; Abraham, John

    2011-07-01

    Government regulators have increasingly accelerated new cancer drugs on to the market by granting them approval based on less clinical data supporting drug efficacy than permitted under standard regulations. With more lenient regulatory standards, pharmaceutical companies have keenly sought to develop cancer drugs. Focusing on the US, this article examines how the emergence and implementation of such accelerated approvals should be understood, particularly in relation to corporate bias and disease-politics theories. Drawing on longitudinal and case study data analysis, it is argued that the emergence of accelerated approval regulations for cancer drugs should be regarded primarily as part of a deregulatory regime driven by the interests of the pharmaceutical industry in partnership with all major aspects of the state, rather than as a response to patient activism in the aftermath of AIDS. Furthermore, even in cases when some patients successfully demand accelerated marketing approval of cancer drugs, such approval by regulators, while in manufacturers' interests, may not be in the interests of patients' health because the political culture of the regulatory agency is reluctant to uphold its own techno-regulatory standards of public-health protection when that would challenge the agenda-setting influence of manufacturers, including industry collaborations with patients and the medical profession. © 2011 The Authors. Sociology of Health & Illness © 2011 Foundation for the Sociology of Health & Illness/Blackwell Publishing Ltd.

  10. Accelerator Reactor Coupling for Energy Production in Advanced Nuclear Fuel Cycles

    DOE PAGES

    Brown, Nicholas R.; Heidet, Florent; Haj Tahar, Malek

    2016-01-01

    This article is a review of several accelerator–reactor interface issues and nuclear fuel cycle applications of acceleratordriven subcritical systems. The systems considered here have the primary goal of energy production, but that goal is accomplished via a specific application in various proposed nuclear fuel cycles, such as breed-and-burn of fertile material or burning of transuranic material. Several basic principles are reviewed, starting from the proton beam window including the target, blanket, reactor core, and up to the fuel cycle. We focus on issues of interest, such as the impact of the energy required to run the accelerator and associated systemsmore » on the potential electricity delivered to the grid. Accelerator-driven systems feature many of the constraints and issues associated with critical reactors, with the added challenges of subcritical operation and coupling to an accelerator. Reliable accelerator operation and avoidance of beam trips are critically important. One interesting challenge is measurement of blanket subcriticality level during operation. We also review the potential benefits of accelerator-driven systems in various nuclear fuel cycle applications. Ultimately, accelerator-driven subcritical systems with the goal of transmutation of transuranic material have lower 100,000-year radioactivity than a critical fast reactor with recycling of uranium and plutonium.« less

  11. Routes for the production of isotopes for PET with high intensity deuteron accelerators

    NASA Astrophysics Data System (ADS)

    Arias de Saavedra, F.; Porras, I.; Praena, J.

    2018-04-01

    Recent advances in accelerator science are opening new possibilities in different fields of physics. In particular, the development of compact linear accelerators that can provide charged particles of low-medium energy (few MeV) with high current (above mA) allows for the study of new possibilities in neutron production and for new routes for the production of radioisotopes. Keeping in mind how radioisotopes are actually produced in dedicated facilities, we have performed a study of alternative reactions to produce PET isotopes induced by low-energy deuterons. We have fitted the EXFOR cross sections data, used the fitted values of the stopping power by Andersen and Ziegler and calculated by numerical integration the production rate of isotopes for charged particles up to 20 MeV. The results for deuterons up to 3 MeV are compared with the ones from cyclotrons, which are able to provide higher energies to the charged projectiles but with lower intensities. Our results indicate that using linear accelerators may be a good alternative for producing PET isotopes, reducing the problem of neutron activation.

  12. 30 CFR 7.49 - Approval marking.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Battery Assemblies § 7.49 Approval marking. Each approved battery assembly shall be identified by a legible and permanent approval plate inscribed with the assigned MSHA approval number and securely attached to the battery box. ...

  13. 30 CFR 7.49 - Approval marking.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Battery Assemblies § 7.49 Approval marking. Each approved battery assembly shall be identified by a legible and permanent approval plate inscribed with the assigned MSHA approval number and securely attached to the battery box. ...

  14. 30 CFR 7.49 - Approval marking.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Battery Assemblies § 7.49 Approval marking. Each approved battery assembly shall be identified by a legible and permanent approval plate inscribed with the assigned MSHA approval number and securely attached to the battery box. ...

  15. 12 CFR Appendix to Part 1253 - Prior Approval for Enterprise Products-Instructions and Notice of New Activity Form

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Approval for Enterprise Products—Instructions and Notice of New Activity Form ER02JY09.000 ER02JY09.001... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Prior Approval for Enterprise Products-Instructions and Notice of New Activity Form Appendix to Part 1253 Banks and Banking FEDERAL HOUSING FINANCE...

  16. Production Level CFD Code Acceleration for Hybrid Many-Core Architectures

    NASA Technical Reports Server (NTRS)

    Duffy, Austen C.; Hammond, Dana P.; Nielsen, Eric J.

    2012-01-01

    In this work, a novel graphics processing unit (GPU) distributed sharing model for hybrid many-core architectures is introduced and employed in the acceleration of a production-level computational fluid dynamics (CFD) code. The latest generation graphics hardware allows multiple processor cores to simultaneously share a single GPU through concurrent kernel execution. This feature has allowed the NASA FUN3D code to be accelerated in parallel with up to four processor cores sharing a single GPU. For codes to scale and fully use resources on these and the next generation machines, codes will need to employ some type of GPU sharing model, as presented in this work. Findings include the effects of GPU sharing on overall performance. A discussion of the inherent challenges that parallel unstructured CFD codes face in accelerator-based computing environments is included, with considerations for future generation architectures. This work was completed by the author in August 2010, and reflects the analysis and results of the time.

  17. Mechanisms of force production during linear accelerations in bluegill sunfish Lepomis macrochirus

    NASA Astrophysics Data System (ADS)

    Tytell, Eric D.; Wise, Tyler N.; Boden, Alexandra L.; Sanders, Erin K.; Schwalbe, Margot A. B.

    2016-11-01

    In nature, fish rarely swim steadily. Although unsteady behaviors are common, we know little about how fish change their swimming kinematics for routine accelerations, and how these changes affect the fluid dynamic forces and the wake produced. To study force production during acceleration, particle image velocimetry was used to quantify the wake of bluegill sunfish Lepomis macrochirus and to estimate the pressure field during linear accelerations and steady swimming. We separated "steady" and "unsteady" trials and quantified the forward acceleration using inertial measurement units. Compared to steady sequences, unsteady sequences had larger accelerations and higher body amplitudes. The wake consisted of single vortices shed during each tail movement (a '2S' wake). The structure did not change during acceleration, but the circulation of the vortices increased, resulting in larger forces. A fish swimming unsteadily produced significantly more force than the same fish swimming steadily, even when the accelerations were the same. This increase is likely due to increased added mass during unsteady swimming, as a result of the larger body amplitude. Pressure estimates suggest that the increase in force is correlated with more low pressure regions on the anterior body. This work was supported by ARO W911NF-14-1-0494 and NSF RCN-PLS 1062052.

  18. Enzyme replacement therapy for Fabry disease: lessons from two alpha-galactosidase A orphan products and one FDA approval.

    PubMed

    Desnick, Robert J

    2004-07-01

    Two virtually identical products have been developed for enzyme replacement therapy for the treatment of Fabry disease, which is a rare and debilitating genetic disease caused by decreased activity of the lysosomal enzyme alpha-galactosidase A. Lack of this enzyme results in progressive tissue accumulation of globotriaosylceramide (GL-3), resulting in life-threatening renal, cardiac and cerebrovascular complications. Both enzyme replacement products, agalsidase alfa (Replagal; Transkaryotic Therapies, Cambridge, MA, USA) and agalsidase beta (Fabrazyme; Genzyme Corporation, Cambridge, MA, USA), were approved by the European Agency for the Evaluation of Medicinal Products in 2001; agalsidase alfa at a recommended dose of 0.2 mg/kg and agalsidase beta at a recommended dose of 1 mg/kg. In the US, however, orphan drug laws dictated that only one of these products could be approved. In April 2003, after a rigorous evaluation of both products by the US FDA, this approval was granted to agalsidase beta. This decision reflected clinical trial design, how dosages were determined, antibody effects and the ability of each product to demonstrate either clinical efficacy or reduction of tissue storage of GL-3 in major organs of pathology when administered at the recommended dosage. The process also highlighted important issues in the evaluation of drugs to treat life-threatening genetic diseases for which the pathological basis is well-defined.

  19. Accelerated oral nanomedicine discovery from miniaturized screening to clinical production exemplified by paediatric HIV nanotherapies

    PubMed Central

    Giardiello, Marco; Liptrott, Neill J.; McDonald, Tom O.; Moss, Darren; Siccardi, Marco; Martin, Phil; Smith, Darren; Gurjar, Rohan; Rannard, Steve P.; Owen, Andrew

    2016-01-01

    Considerable scope exists to vary the physical and chemical properties of nanoparticles, with subsequent impact on biological interactions; however, no accelerated process to access large nanoparticle material space is currently available, hampering the development of new nanomedicines. In particular, no clinically available nanotherapies exist for HIV populations and conventional paediatric HIV medicines are poorly available; one current paediatric formulation utilizes high ethanol concentrations to solubilize lopinavir, a poorly soluble antiretroviral. Here we apply accelerated nanomedicine discovery to generate a potential aqueous paediatric HIV nanotherapy, with clinical translation and regulatory approval for human evaluation. Our rapid small-scale screening approach yields large libraries of solid drug nanoparticles (160 individual components) targeting oral dose. Screening uses 1 mg of drug compound per library member and iterative pharmacological and chemical evaluation establishes potential candidates for progression through to clinical manufacture. The wide applicability of our strategy has implications for multiple therapy development programmes. PMID:27767027

  20. 21 CFR 211.86 - Use of approved components, drug product containers, and closures.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Use of approved components, drug product containers, and closures. 211.86 Section 211.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of Components and Drug...

  1. 21 CFR 211.86 - Use of approved components, drug product containers, and closures.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Use of approved components, drug product containers, and closures. 211.86 Section 211.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of Components and Drug...

  2. 21 CFR 211.86 - Use of approved components, drug product containers, and closures.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Use of approved components, drug product containers, and closures. 211.86 Section 211.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of Components and Drug...

  3. 21 CFR 211.86 - Use of approved components, drug product containers, and closures.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Use of approved components, drug product containers, and closures. 211.86 Section 211.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of Components and Drug...

  4. 21 CFR 211.86 - Use of approved components, drug product containers, and closures.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Use of approved components, drug product containers, and closures. 211.86 Section 211.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of Components and Drug...

  5. 9 CFR 590.411 - Requirement of formulas and approval of labels for use in official egg products plants.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... products than for bulk packaged egg products not for sale or distribution to household consumers, label... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Requirement of formulas and approval of labels for use in official egg products plants. 590.411 Section 590.411 Animals and Animal...

  6. 9 CFR 590.411 - Requirement of formulas and approval of labels for use in official egg products plants.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... products than for bulk packaged egg products not for sale or distribution to household consumers, label... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Requirement of formulas and approval of labels for use in official egg products plants. 590.411 Section 590.411 Animals and Animal...

  7. 78 FR 78796 - Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-27

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 314 and 601... Approved Drugs and Biological Products; Correction and Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule; correction and extension of comment period. SUMMARY: The Food and...

  8. 9 CFR 147.52 - Approved tests.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Approved tests. 147.52 Section 147.52... Approved Tests § 147.52 Approved tests. (a) The procedures for the bacteriological examination of poultry and poultry environments described in this part are approved tests for use in the NPIP. In addition...

  9. 9 CFR 147.52 - Approved tests.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Approved tests. 147.52 Section 147.52... Approved Tests § 147.52 Approved tests. (a) The procedures for the bacteriological examination of poultry and poultry environments described in this part are approved tests for use in the NPIP. In addition...

  10. 30 CFR 7.311 - Approval checklist.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Electric Motor Assemblies § 7.311 Approval checklist. Each motor assembly bearing an MSHA approval marking shall be accompanied by a list of items necessary for maintenance of the motor assembly as approved. ...

  11. 30 CFR 22.10 - Approval plate.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... MINING PRODUCTS PORTABLE METHANE DETECTORS § 22.10 Approval plate. (a) Attachment to be made by manufacturers. (1) Manufacturers shall attach, stamp, or mold an approval plate on each permissible methane... follows: Permissible Methane Detector (or Permissible Methane Indicating Detector) Approval No. ___ issued...

  12. Similar pharmacokinetics and pharmacodynamics of rapid-acting insulin lispro products SAR342434 and US- and EU-approved Humalog in subjects with type 1 diabetes.

    PubMed

    Kapitza, Christoph; Nowotny, Irene; Lehmann, Anne; Bergmann, Karin; Rotthaeuser, Baerbel; Nosek, Leszek; Becker, Reinhard H A

    2017-05-01

    To compare the pharmacokinetics (PK) and pharmacodynamics (PD) of 3 rapid-acting insulin lispro products: SAR342434 solution, United States (US)-approved Humalog and European Union (EU)-approved Humalog. In a single-centre, randomized, double-blind, 3-treatment, 3-period, 6-sequence, crossover, euglycaemic clamp study (NCT02273258), adult male subjects with type 1 diabetes were randomized to receive 0.3 U/kg of SAR342434 solution, US-approved and EU-approved Humalog under fasted conditions. PK and PD (glucose infusion rate [GIR]) were assessed up to 12 hours. Of the 30 subjects randomized, 28 completed all 3 treatment periods. Mean concentration and GIR vs time profiles were similar for all 3 products. Exposure (INS-C max , INS-AUC last and INS-AUC) and activity (GIR max and GIR-AUC 0-12h ) of SAR342434, US-approved and EU-approved Humalog were similar in all comparisons (point estimates of treatment ratios, 0.95-1.03 for PK parameters and 1.00-1.07 for PD parameters), with 90% confidence intervals for the ratios of geometric least squares means within the pre-specified bioequivalence limit (0.80-1.25) and no significant differences in time-related parameters. Within-subject variability of exposure and activity was low across the 3 clamps, indicating high day-to-day reproducibility in clamp performance, irrespective of the individual product. Adverse events were similar for all 3 products. No safety concerns were noted in vital signs or in laboratory and electrocardiogram data. The results of this study demonstrate similarity in insulin lispro exposure profiles and PD activity of SAR342434 solution to both US- and EU-approved Humalog, and between both US- and EU-approved Humalog, supporting the use of SAR342434 solution for injection as a follow-on product. © 2016 John Wiley & Sons Ltd.

  13. Applied metrology in the production of superconducting model magnets for particle accelerators

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Ferradas Troitino, Jose; Bestmann, Patrick; Bourcey, Nicolas

    2017-12-22

    The production of superconducting magnets for particle accelerators involves high precision assemblies and tight tolerances, in order to achieve the requirements for their appropriate performance. It is therefore essential to have a strict control and traceability over the geometry of each component of the system, and also to be able to compensate possible inherent deviations coming from the production process.

  14. Radiation Safety System for SPIDER Neutral Beam Accelerator

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Sandri, S.; Poggi, C.; Coniglio, A.

    2011-12-13

    SPIDER (Source for Production of Ion of Deuterium Extracted from RF Plasma only) and MITICA (Megavolt ITER Injector Concept Advanced) are the ITER neutral beam injector (NBI) testing facilities of the PRIMA (Padova Research Injector Megavolt Accelerated) Center. Both injectors accelerate negative deuterium ions with a maximum energy of 1 MeV for MITICA and 100 keV for SPIDER with a maximum beam current of 40 A for both experiments. The SPIDER facility is classified in Italy as a particle accelerator. At present, the design of the radiation safety system for the facility has been completed and the relevant reports havemore » been presented to the Italian regulatory authorities. Before SPIDER can operate, approval must be obtained from the Italian Regulatory Authority Board (IRAB) following a detailed licensing process. In the present work, the main project information and criteria for the SPIDER injector source are reported together with the analysis of hypothetical accidental situations and safety issues considerations. Neutron and photon nuclear analysis is presented, along with special shielding solutions designed to meet Italian regulatory dose limits. The contribution of activated corrosion products (ACP) to external exposure of workers has also been assessed. Nuclear analysis indicates that the photon contribution to worker external exposure is negligible, and the neutron dose can be considered by far the main radiation protection issue. Our results confirm that the injector has no important radiological impact on the population living around the facility.« less

  15. Economic and environmental effects of accelerated tariff liberalization in the forest products sector.

    Treesearch

    D.J. Brooks; J.A. Ferrante; J. Haverkamp; I. Bowles; W. Lange; D. Darr

    2001-01-01

    This study assesses the incremental economic and environmental impacts resulting from changes in the timing and scope of forest products tariff reductions as proposed in the Accelerated Tariff Liberalization (ATL) initiative in forest products. This initiative was proposed for agreement among member countries of the World Trade Organization. The analysis of...

  16. 9 CFR 592.300 - Approval of official identification.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Approval of official identification. 592.300 Section 592.300 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Identifying and Marking Products § 592.300 Approval of official...

  17. 9 CFR 592.300 - Approval of official identification.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Approval of official identification. 592.300 Section 592.300 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Identifying and Marking Products § 592.300 Approval of official...

  18. 9 CFR 592.300 - Approval of official identification.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Approval of official identification. 592.300 Section 592.300 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Identifying and Marking Products § 592.300 Approval of official...

  19. 9 CFR 592.300 - Approval of official identification.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Approval of official identification. 592.300 Section 592.300 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Identifying and Marking Products § 592.300 Approval of official...

  20. Neuromuscular Control of Rapid Linear Accelerations in Fish

    DTIC Science & Technology

    2016-06-22

    2014 30-Apr-2015 Approved for Public Release; Distribution Unlimited Final Report: Neuromuscular Control of Rapid Linear Accelerations in Fish The...it does not display a currently valid OMB control number. PLEASE DO NOT RETURN YOUR FORM TO THE ABOVE ADDRESS. Tufts University Research... Control of Rapid Linear Accelerations in Fish Report Title In this project, we measured muscle activity, body movements, and flow patterns during linear

  1. Evidence of soluble microbial products accelerating chloramine decay in nitrifying bulk water samples.

    PubMed

    Bal Krishna, K C; Sathasivan, Arumugam; Chandra Sarker, Dipok

    2012-09-01

    The discovery of a microbially derived soluble product that accelerates chloramine decay is described. Nitrifying bacteria are believed to be wholly responsible for rapid chloramine loss in drinking water systems. However, a recent investigation showed that an unidentified soluble agent significantly accelerated chloramine decay. The agent was suspected to be either natural organic matter (NOM) or soluble microbial products (SMPs). A laboratory scale reactor was fed chloraminated reverse osmosis (RO) treated water to eliminate the interference from NOM. Once nitrification had set in, experiments were conducted on the reactor and feed waters to determine the identity of the component. The study showed the presence of SMPs released by microbes in severely nitrified waters. Further experiments proved that the SMPs significantly accelerated chloramine decay, probably through catalytic reaction. Moreover, application of common protein denaturing techniques stopped the reaction implying that the compound responsible was likely to be a protein. This significant finding will pave the way for better control of chloramine in the distribution systems. Copyright © 2012 Elsevier Ltd. All rights reserved.

  2. First experimental results from 2 MeV proton tandem accelerator for neutron production.

    PubMed

    Kudryavtsev, A; Belchenko, Yu; Burdakov, A; Davydenko, V; Ivanov, A; Khilchenko, A; Konstantinov, S; Krivenko, A; Kuznetsov, A; Mekler, K; Sanin, A; Shirokov, V; Sorokin, I; Sulyaev, Yu; Tiunov, M

    2008-02-01

    A 2 MeV proton tandem accelerator with vacuum insulation was developed and first experiments are carried out in the Budker Institute of Nuclear Physics (Novosibirsk). The accelerator is designed for neutron production via reaction (7)Li(p,n)(7)Be for the boron neutron-capture therapy of the brain tumors, and for explosive detection based on 9.1724 MeV resonance gamma, which are produced via reaction (13)C(p,gamma)(14)N, absorption in nitrogen.

  3. 30 CFR 20.13 - Approval plate.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approval plate. 20.13 Section 20.13 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MINE LAMPS OTHER THAN STANDARD CAP LAMPS § 20.13 Approval plate. The...

  4. 30 CFR 7.309 - Approval marking.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Electric Motor Assemblies § 7.309 Approval marking. Each approved motor assembly shall be identified by a legible and permanent approval plate inscribed.... The plate shall be securely attached to the motor assembly in a manner that does not impair any...

  5. 30 CFR 18.11 - Approval plate.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approval plate. 18.11 Section 18.11 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES General Provisions § 18.11 Approval...

  6. Available Tools to Facilitate Early Patient Access to Medicines in the EU and the USA: Analysis of Conditional Approvals and the Implications for Personalized Medicine.

    PubMed

    Leyens, Lada; Richer, Étienne; Melien, Øyvind; Ballensiefen, Wolfgang; Brand, Angela

    2015-01-01

    Scientific knowledge and our understanding of the human body and diseases have limited any possible treatment tailoring to each patient. The technological advances enabling the integration of various data sets (e.g. '-omics', microbiome, epigenetics and environmental exposure) have facilitated a greater understanding of the human body, the molecular basis of disease and all the factors influencing disease onset, progression and response to treatment, thereby ushering in the era of personalized medicine. We evaluate the regulatory approaches available to facilitate early patient access to efficacious and safe compounds in the EU and the USA in order to make more informed recommendations in the future as to the gaps in regulations for early patient access. An in-depth analysis of conditional approvals (EU) and accelerated approvals (USA) is performed based on the publicly available information (European public assessment reports and a summary review of products approved under both programmes). The types of product, indications, time to approval and type of evidence submitted were analysed. Between 2007 and early 2015, 17 products were conditionally approved in the EU and 25 in the USA, most of them in the area of oncology and based on evidence from phase II clinical trial data. Early approval of promising products based on data from early phases of development is already possible in the EU and the USA. Some of the improvements could entail implementing a rolling assessment of evidence in Europe and extending the scope of early dialogues. © 2015 S. Karger AG, Basel.

  7. Sprint Acceleration Mechanics: The Major Role of Hamstrings in Horizontal Force Production

    PubMed Central

    Morin, Jean-Benoît; Gimenez, Philippe; Edouard, Pascal; Arnal, Pierrick; Jiménez-Reyes, Pedro; Samozino, Pierre; Brughelli, Matt; Mendiguchia, Jurdan

    2015-01-01

    Recent literature supports the importance of horizontal ground reaction force (GRF) production for sprint acceleration performance. Modeling and clinical studies have shown that the hip extensors are very likely contributors to sprint acceleration performance. We experimentally tested the role of the hip extensors in horizontal GRF production during short, maximal, treadmill sprint accelerations. Torque capabilities of the knee and hip extensors and flexors were assessed using an isokinetic dynamometer in 14 males familiar with sprint running. Then, during 6-s sprints on an instrumented motorized treadmill, horizontal and vertical GRF were synchronized with electromyographic (EMG) activity of the vastus lateralis, rectus femoris, biceps femoris, and gluteus maximus averaged over the first half of support, entire support, entire swing and end-of-swing phases. No significant correlations were found between isokinetic or EMG variables and horizontal GRF. Multiple linear regression analysis showed a significant relationship (P = 0.024) between horizontal GRF and the combination of biceps femoris EMG activity during the end of the swing and the knee flexors eccentric peak torque. In conclusion, subjects who produced the greatest amount of horizontal force were both able to highly activate their hamstring muscles just before ground contact and present high eccentric hamstring peak torque capability. PMID:26733889

  8. 30 CFR 7.51 - Approval checklist.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Battery Assemblies § 7.51 Approval checklist. Each battery assembly bearing an MSHA approval plate shall be accompanied by a description of what is necessary to maintain the battery assembly as approved. [53 FR 23500, June 22, 1988, as amended at 60 FR 33723...

  9. 30 CFR 7.51 - Approval checklist.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Battery Assemblies § 7.51 Approval checklist. Each battery assembly bearing an MSHA approval plate shall be accompanied by a description of what is necessary to maintain the battery assembly as approved. [53 FR 23500, June 22, 1988, as amended at 60 FR 33723...

  10. 30 CFR 7.51 - Approval checklist.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Battery Assemblies § 7.51 Approval checklist. Each battery assembly bearing an MSHA approval plate shall be accompanied by a description of what is necessary to maintain the battery assembly as approved. [53 FR 23500, June 22, 1988, as amended at 60 FR 33723...

  11. 30 CFR 14.7 - Approval marking and distribution records.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ..., EVALUATION, AND APPROVAL OF MINING PRODUCTS REQUIREMENTS FOR THE APPROVAL OF FLAME-RESISTANT CONVEYOR BELTS General Provisions § 14.7 Approval marking and distribution records. (a) An approved conveyor belt must be marketed only under the name specified in the approval. (b) Approved conveyor belt must be legibly and...

  12. 30 CFR 7.29 - Approval marking.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Brattice Cloth and Ventilation Tubing § 7.29 Approval marking. (a) Approved brattice cloth shall be legibly and permanently marked with the assigned MSHA...

  13. 30 CFR 7.29 - Approval marking.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Brattice Cloth and Ventilation Tubing § 7.29 Approval marking. (a) Approved brattice cloth shall be legibly and permanently marked with the assigned MSHA...

  14. 30 CFR 7.29 - Approval marking.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Brattice Cloth and Ventilation Tubing § 7.29 Approval marking. (a) Approved brattice cloth shall be legibly and permanently marked with the assigned MSHA...

  15. 30 CFR 7.29 - Approval marking.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Brattice Cloth and Ventilation Tubing § 7.29 Approval marking. (a) Approved brattice cloth shall be legibly and permanently marked with the assigned MSHA...

  16. 30 CFR 7.29 - Approval marking.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Brattice Cloth and Ventilation Tubing § 7.29 Approval marking. (a) Approved brattice cloth shall be legibly and permanently marked with the assigned MSHA...

  17. Avelumab: First Global Approval.

    PubMed

    Kim, Esther S

    2017-05-01

    Avelumab (Bavencio ® ) is an intravenously administered programmed cell death ligand-1-blocking human antibody initially developed by EMD Serono Inc. (the biopharmaceutical division of Merck KGaA, Darmstadt, Germany) [now jointly developed and commercialized by EMD Serono Inc. and Pfizer] for the treatment of various tumours. It has received accelerated approval in the USA for the treatment of metastatic Merkel cell carcinoma (mMCC) in adults and paediatric patients aged ≥12 years. The marketing authorization application for avelumab in the treatment of mMCC is undergoing regulatory review in the EU, the biologics license application for avelumab in the treatment of urothelial carcinoma is undergoing priority review by the FDA, and avelumab is in various stages of development internationally for a variety of cancers. This article summarizes the milestones in the development of avelumab leading to this first approval for mMCC.

  18. 12 CFR 1253.8 - Availability of new product to an Enterprise after it has been approved for the other Enterprise.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Availability of new product to an Enterprise... HOUSING FINANCE AGENCY ENTERPRISES PRIOR APPROVAL FOR ENTERPRISE PRODUCTS § 1253.8 Availability of new... a new product for one Enterprise or the new product is otherwise available to that Enterprise under...

  19. 9 CFR 590.411 - Requirement of formulas and approval of labels for use in official egg products plants.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION INSPECTION... distributor. When the distributor is shown, it shall be qualified by such terms as “packed for,” “distributed... the reasons for the denial on a form approved by the Administrator. If the person using or proposing...

  20. 9 CFR 590.411 - Requirement of formulas and approval of labels for use in official egg products plants.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION INSPECTION... distributor. When the distributor is shown, it shall be qualified by such terms as “packed for,” “distributed... the reasons for the denial on a form approved by the Administrator. If the person using or proposing...

  1. Nutrition recommendations and the Children's Food and Beverage Advertising Initiative's 2014 approved food and beverage product list.

    PubMed

    Schermbeck, Rebecca M; Powell, Lisa M

    2015-04-23

    We compare the Children's Food and Beverage Advertising Initiative's (CFBAI's) April 2014 list of food and beverage products approved to be advertised on children's television programs with the federal Interagency Working Group's nutrition recommendations for such advertised products. Products were assessed by using the nutrients to limit (saturated fat, trans fat, sugar, and sodium) component of the Interagency Working Group's recommendations. Fifty-three percent of the listed products did not meet the nutrition recommendations and, therefore, were ineligible to be advertised. We recommend continued monitoring of food and beverage products marketed to children.

  2. Reaction Acceleration in Thin Films with Continuous Product Deposition for Organic Synthesis.

    PubMed

    Wei, Zhenwei; Wleklinski, Michael; Ferreira, Christina; Cooks, R Graham

    2017-08-01

    Thin film formats are used to study the Claisen-Schmidt base-catalyzed condensation of 6-hydroxy-1-indanone with substituted benzaldehydes and to compare the reaction acceleration relative to the bulk. Relative acceleration factors initially exceeded 10 3 and were on the order of 10 2 at steady state, although the confined volume reaction was not electrostatically driven. Substituent effects were muted compared to those in the corresponding bulk and microdroplet reactions and it is concluded that the rate-limiting step at steady state is reagent transport to the interface. Conditions were found that allowed product deposition from the thin film to occur continuously as the reaction mixture was added and as the solvent evaporated. Yields of 74 % and production rates of 98 mg h -1 were reached in a very simple experimental system that could be multiplexed to greater scales. © 2017 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.

  3. Radiological Hazard of Spallation Products in Accelerator-Driven System

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Saito, M.; Stankovskii, A.; Artisyuk, V.

    The central issue underlying this paper is related to elucidating the hazard of radioactive spallation products that might be an important factor affecting the design option of accelerator-driven systems (ADSs). Hazard analysis based on the concept of Annual Limit on Intake identifies alpha-emitting isotopes of rare earths (REs) (dysprosium, gadolinium, and samarium) as the dominant contributors to the overall toxicity of traditional (W, Pb, Pb-Bi) targets. The matter is addressed from several points of view: code validation to simulate their yields, choice of material for the neutron producing targets, and challenging the beam type. The paper quantitatively determines the domainmore » in which the toxicity of REs exceeds that of polonium activation products broadly discussed now in connection with advertising lead-bismuth technology for the needs of ADSs.« less

  4. 30 CFR 22.9 - How approvals are granted.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false How approvals are granted. 22.9 Section 22.9 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS PORTABLE METHANE DETECTORS § 22.9 How approvals are granted. All approvals are...

  5. 30 CFR 19.11 - How approvals are granted.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... APPROVAL OF MINING PRODUCTS ELECTRIC CAP LAMPS § 19.11 How approvals are granted. (a) All approvals are... engineers judge that the lamp has met the requirements of the part and MSHA's records concerning the lamp...

  6. 30 CFR 19.11 - How approvals are granted.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... APPROVAL OF MINING PRODUCTS ELECTRIC CAP LAMPS § 19.11 How approvals are granted. (a) All approvals are... engineers judge that the lamp has met the requirements of the part and MSHA's records concerning the lamp...

  7. 30 CFR 19.11 - How approvals are granted.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... APPROVAL OF MINING PRODUCTS ELECTRIC CAP LAMPS § 19.11 How approvals are granted. (a) All approvals are... engineers judge that the lamp has met the requirements of the part and MSHA's records concerning the lamp...

  8. 30 CFR 19.11 - How approvals are granted.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... APPROVAL OF MINING PRODUCTS ELECTRIC CAP LAMPS § 19.11 How approvals are granted. (a) All approvals are... engineers judge that the lamp has met the requirements of the part and MSHA's records concerning the lamp...

  9. 30 CFR 19.11 - How approvals are granted.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... APPROVAL OF MINING PRODUCTS ELECTRIC CAP LAMPS § 19.11 How approvals are granted. (a) All approvals are... engineers judge that the lamp has met the requirements of the part and MSHA's records concerning the lamp...

  10. Sterile products: advances and challenges in formulation, manufacturing and regulatory aspects--a regulatory review perspective.

    PubMed

    Hussong, David

    2010-09-01

    For several decades, the FDA has undertaken many initiatives to improve the quality and safety of sterile drug products. In recent years, efforts have also been undertaken to accelerate the rate for application approval by adding earlier involvement of microbiology reviewers in drug development. Product and manufacturing process development, as well as safe use and product design, are among the elements of enhanced technical involvement. An overview of the product quality microbiology aspects for sterile drugs is provided.

  11. Constructing target product profiles (TPPs) to help vaccines overcome post-approval obstacles

    PubMed Central

    Lee, Bruce Y.; Burke, Donald S.

    2012-01-01

    As history has demonstrated, post-approval obstacles can impede a vaccine’s use and potentially lead to its withdrawal. Addressing these potential obstacles when changes in a vaccine’s technology can still be easily made may improve a vaccine’s chances of success. Augmented vaccine target product profiles (TPPs) can help vaccine scientists better understand and anticipate these obstacles and galvanize conversations among various vaccine stakeholders (e.g., scientists, marketers, business development managers, policy makers, public health officials, health care workers, third party payors, etc.) earlier in a vaccine’s development. PMID:19782109

  12. 30 CFR 22.9 - How approvals are granted.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... APPROVAL OF MINING PRODUCTS PORTABLE METHANE DETECTORS § 22.9 How approvals are granted. All approvals are granted by official letter from MSHA. A detector will be approved under this part only when the testing..., including drawings from the manufacturer that show the detector as it is to be commercially made. No verbal...

  13. 30 CFR 22.9 - How approvals are granted.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... APPROVAL OF MINING PRODUCTS PORTABLE METHANE DETECTORS § 22.9 How approvals are granted. All approvals are granted by official letter from MSHA. A detector will be approved under this part only when the testing..., including drawings from the manufacturer that show the detector as it is to be commercially made. No verbal...

  14. 30 CFR 22.9 - How approvals are granted.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... APPROVAL OF MINING PRODUCTS PORTABLE METHANE DETECTORS § 22.9 How approvals are granted. All approvals are granted by official letter from MSHA. A detector will be approved under this part only when the testing..., including drawings from the manufacturer that show the detector as it is to be commercially made. No verbal...

  15. 30 CFR 22.9 - How approvals are granted.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... APPROVAL OF MINING PRODUCTS PORTABLE METHANE DETECTORS § 22.9 How approvals are granted. All approvals are granted by official letter from MSHA. A detector will be approved under this part only when the testing..., including drawings from the manufacturer that show the detector as it is to be commercially made. No verbal...

  16. 27 CFR 24.26 - Authority to approve.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2011-04-01 2011-04-01 false Authority to approve. 24.26 Section 24.26 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU...)) (Approved by the Office of Management and Budget under control number 1512-0292) [T.D. ATF-299, 55 FR 24989...

  17. 27 CFR 24.26 - Authority to approve.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Authority to approve. 24.26 Section 24.26 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU...)) (Approved by the Office of Management and Budget under control number 1512-0292) [T.D. ATF-299, 55 FR 24989...

  18. 78 FR 58273 - Approval for Manufacturing (Production) Authority, Foreign-Trade Zone 284, Liberty Pumps, Inc...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-23

    ... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1915] Approval for Manufacturing (Production) Authority, Foreign-Trade Zone 284, Liberty Pumps, Inc. (Submersible and Water Pumps), Bergen, New York Pursuant to its authority under the Foreign-Trade Zones Act of June 18, 1934, as amended (19 U.S.C. 81a-81u), the Foreign-Trade Zones Boar...

  19. 40 CFR 152.114 - Approval of registration under FIFRA sec. 3(c)(7)-Products that contain a new active ingredient.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... sec. 3(c)(7)-Products that contain a new active ingredient. 152.114 Section 152.114 Protection of...)(7)—Products that contain a new active ingredient. An application for registration of a pesticide containing an active ingredient not in any currently registered product may be conditionally approved for a...

  20. 40 CFR 152.114 - Approval of registration under FIFRA sec. 3(c)(7)-Products that contain a new active ingredient.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... sec. 3(c)(7)-Products that contain a new active ingredient. 152.114 Section 152.114 Protection of...)(7)—Products that contain a new active ingredient. An application for registration of a pesticide containing an active ingredient not in any currently registered product may be conditionally approved for a...

  1. 21 CFR 211.84 - Testing and approval or rejection of components, drug product containers, and closures.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Testing and approval or rejection of components, drug product containers, and closures. 211.84 Section 211.84 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING...

  2. 21 CFR 211.84 - Testing and approval or rejection of components, drug product containers, and closures.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Testing and approval or rejection of components, drug product containers, and closures. 211.84 Section 211.84 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING...

  3. 21 CFR 211.84 - Testing and approval or rejection of components, drug product containers, and closures.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Testing and approval or rejection of components, drug product containers, and closures. 211.84 Section 211.84 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING...

  4. 21 CFR 211.84 - Testing and approval or rejection of components, drug product containers, and closures.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Testing and approval or rejection of components, drug product containers, and closures. 211.84 Section 211.84 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING...

  5. 21 CFR 211.84 - Testing and approval or rejection of components, drug product containers, and closures.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Testing and approval or rejection of components, drug product containers, and closures. 211.84 Section 211.84 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING...

  6. Postmarket Safety Outcomes for New Molecular Entity (NME) Drugs Approved by the Food and Drug Administration Between 2002 and 2014.

    PubMed

    Pinnow, Ellen; Amr, Sania; Bentzen, Søren M; Brajovic, Sonja; Hungerford, Laura; St George, Diane Marie; Dal Pan, Gerald

    2017-12-20

    We ascertained a comprehensive list of postmarket safety outcomes, defined as a safety-related market withdrawal or an update to a safety-related section of product label for 278 new molecular entity drugs (NMEs) with a follow-up period of up to 13 years. At least one safety-related update was added to 195 (70.1%) labels of the drugs studied. Updates occurred as early as 160 days after approval and throughout the follow-up period. The period between the second and eighth postapproval year was the most active, with a slight attenuation thereafter. The times to the first safety outcome were significantly shorter for NMEs approved with a fast-track designation (P = 0.02) or under an accelerated approval using a surrogate endpoint (P = 0.03). Our findings underscore the importance of a robust safety surveillance system throughout a drug's lifecycle and for practitioners and patients to remain updated on drug safety profiles. © 2017, The American Society for Clinical Pharmacology and Therapeutics.

  7. Plasma production for electron acceleration by resonant plasma wave

    NASA Astrophysics Data System (ADS)

    Anania, M. P.; Biagioni, A.; Chiadroni, E.; Cianchi, A.; Croia, M.; Curcio, A.; Di Giovenale, D.; Di Pirro, G. P.; Filippi, F.; Ghigo, A.; Lollo, V.; Pella, S.; Pompili, R.; Romeo, S.; Ferrario, M.

    2016-09-01

    Plasma wakefield acceleration is the most promising acceleration technique known nowadays, able to provide very high accelerating fields (10-100 GV/m), enabling acceleration of electrons to GeV energy in few centimeter. However, the quality of the electron bunches accelerated with this technique is still not comparable with that of conventional accelerators (large energy spread, low repetition rate, and large emittance); radiofrequency-based accelerators, in fact, are limited in accelerating field (10-100 MV/m) requiring therefore hundred of meters of distances to reach the GeV energies, but can provide very bright electron bunches. To combine high brightness electron bunches from conventional accelerators and high accelerating fields reachable with plasmas could be a good compromise allowing to further accelerate high brightness electron bunches coming from LINAC while preserving electron beam quality. Following the idea of plasma wave resonant excitation driven by a train of short bunches, we have started to study the requirements in terms of plasma for SPARC_LAB (Ferrario et al., 2013 [1]). In particular here we focus on hydrogen plasma discharge, and in particular on the theoretical and numerical estimates of the ionization process which are very useful to design the discharge circuit and to evaluate the current needed to be supplied to the gas in order to have full ionization. Eventually, the current supplied to the gas simulated will be compared to that measured experimentally.

  8. 27 CFR 26.55 - Previously approved formulas.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... BUREAU, DEPARTMENT OF THE TREASURY ALCOHOL LIQUORS AND ARTICLES FROM PUERTO RICO AND THE VIRGIN ISLANDS Formulas for Products From Puerto Rico § 26.55 Previously approved formulas. Any formula approved on Form...

  9. 27 CFR 26.55 - Previously approved formulas.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... BUREAU, DEPARTMENT OF THE TREASURY LIQUORS LIQUORS AND ARTICLES FROM PUERTO RICO AND THE VIRGIN ISLANDS Formulas for Products From Puerto Rico § 26.55 Previously approved formulas. Any formula approved on Form...

  10. 27 CFR 26.55 - Previously approved formulas.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... BUREAU, DEPARTMENT OF THE TREASURY ALCOHOL LIQUORS AND ARTICLES FROM PUERTO RICO AND THE VIRGIN ISLANDS Formulas for Products From Puerto Rico § 26.55 Previously approved formulas. Any formula approved on Form...

  11. 27 CFR 26.55 - Previously approved formulas.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... BUREAU, DEPARTMENT OF THE TREASURY LIQUORS LIQUORS AND ARTICLES FROM PUERTO RICO AND THE VIRGIN ISLANDS Formulas for Products From Puerto Rico § 26.55 Previously approved formulas. Any formula approved on Form...

  12. 27 CFR 26.55 - Previously approved formulas.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... BUREAU, DEPARTMENT OF THE TREASURY LIQUORS LIQUORS AND ARTICLES FROM PUERTO RICO AND THE VIRGIN ISLANDS Formulas for Products From Puerto Rico § 26.55 Previously approved formulas. Any formula approved on Form...

  13. 77 FR 24724 - Sanofi-aventis, U.S., LLC; Withdrawal of Approval of a New Drug Application for OFORTA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-25

    ... withdrawing approval of a new drug application (NDA) for OFORTA (fludarabine phosphate) Tablets held by sanofi... (fludarabine phosphate) Tablets on December 18, 2008, under the Agency's accelerated approval regulations, 21..., 2011, FDA requested that sanofi-aventis voluntarily withdraw OFORTA (fludarabine phosphate) Tablets...

  14. Switch-backs associated with generic drugs approved using product-specific determinations of therapeutic equivalence.

    PubMed

    Gagne, Joshua J; Polinski, Jennifer M; Jiang, Wenlei; Dutcher, Sarah K; Xie, Jing; Lii, Joyce; Fulchino, Lisa A; Kesselheim, Aaron S

    2016-08-01

    US Food and Drug Administration approval for generic drugs relies on demonstrating pharmaceutical equivalence and bioequivalence; however, some drug products have unique attributes that necessitate product-specific approval pathways. We evaluated rates of patients' switching back to brand-name versions from generic versions of four drugs approved via such approaches. We used data from Optum LifeSciences Research Database to identify patients using a brand-name version of a study drug (acarbose tablets, salmon calcitonin nasal spray, enoxaparin sodium injection, and venlafaxine extended release tablets) or a control drug. We followed patients to identify switching to generic versions and then followed those who switched to identify whether they switched back to brand-name versions. We calculated switch and switch-back rates and used Kaplan-Meier and log-rank tests to compare rates between study and control drugs. Our cohort included 201 959 eligible patients. Brand-to-generic switch rates ranged from 66 to 106 switches per 100 person-years for study drugs and 80 to 110 for control drugs. Rates of switch-back to brand-name versions ranged from 5 to 37 among study drugs and 3 to 53 among control drugs. Switch-back rates were higher for venlafaxine vs. sertraline (p < 0.01) and calcitonin vs. alendronate (p = 0.01). Switch-back rates were lower for venlafaxine vs. paroxetine (p < 0.01) and acarbose vs. nateglinide (p < 0.01). Rates were similar for acarbose vs. glimepiride (p = 0.97) and for enoxaparin vs. fondiparinux (p = 0.11). As compared to control drugs, patients were not more likely to systematically switch back from generic to brand-name versions of the four study drugs. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  15. Study of muon-induced neutron production using accelerator muon beam at CERN

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Nakajima, Y.; Lin, C. J.; Ochoa-Ricoux, J. P.

    2015-08-17

    Cosmogenic muon-induced neutrons are one of the most problematic backgrounds for various underground experiments for rare event searches. In order to accurately understand such backgrounds, experimental data with high-statistics and well-controlled systematics is essential. We performed a test experiment to measure muon-induced neutron production yield and energy spectrum using a high-energy accelerator muon beam at CERN. We successfully observed neutrons from 160 GeV/c muon interaction on lead, and measured kinetic energy distributions for various production angles. Works towards evaluation of absolute neutron production yield is underway. This work also demonstrates that the setup is feasible for a future large-scale experimentmore » for more comprehensive study of muon-induced neutron production.« less

  16. 30 CFR 22.10 - Approval plate.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... MINING PRODUCTS PORTABLE METHANE DETECTORS § 22.10 Approval plate. (a) Attachment to be made by... detector. The plate shall bear the emblem of the Mines Safety and Health Administration and be inscribed as follows: Permissible Methane Detector (or Permissible Methane Indicating Detector) Approval No. ___ issued...

  17. 30 CFR 22.10 - Approval plate.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... MINING PRODUCTS PORTABLE METHANE DETECTORS § 22.10 Approval plate. (a) Attachment to be made by... detector. The plate shall bear the emblem of the Mines Safety and Health Administration and be inscribed as follows: Permissible Methane Detector (or Permissible Methane Indicating Detector) Approval No. ___ issued...

  18. 30 CFR 22.10 - Approval plate.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... MINING PRODUCTS PORTABLE METHANE DETECTORS § 22.10 Approval plate. (a) Attachment to be made by... detector. The plate shall bear the emblem of the Mines Safety and Health Administration and be inscribed as follows: Permissible Methane Detector (or Permissible Methane Indicating Detector) Approval No. ___ issued...

  19. 30 CFR 22.10 - Approval plate.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... MINING PRODUCTS PORTABLE METHANE DETECTORS § 22.10 Approval plate. (a) Attachment to be made by... detector. The plate shall bear the emblem of the Mines Safety and Health Administration and be inscribed as follows: Permissible Methane Detector (or Permissible Methane Indicating Detector) Approval No. ___ issued...

  20. 75 FR 24394 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-05

    ... [Docket No. FDA-2010-N-0002] Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug Application; Buquinolate; Coumaphos AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations by...

  1. 30 CFR 19.6 - Specific requirements for approval.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Specific requirements for approval. 19.6 Section 19.6 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC CAP LAMPS § 19.6 Specific requirements for approval. (a...

  2. 30 CFR 33.11 - Approval plates.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Approval plates. 33.11 Section 33.11 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS DUST COLLECTORS FOR USE IN CONNECTION WITH ROCK DRILLING IN COAL MINES General Provisions...

  3. 30 CFR 33.11 - Approval plates.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approval plates. 33.11 Section 33.11 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS DUST COLLECTORS FOR USE IN CONNECTION WITH ROCK DRILLING IN COAL MINES General Provisions...

  4. 30 CFR 33.11 - Approval plates.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Approval plates. 33.11 Section 33.11 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS DUST COLLECTORS FOR USE IN CONNECTION WITH ROCK DRILLING IN COAL MINES General Provisions...

  5. 30 CFR 33.11 - Approval plates.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Approval plates. 33.11 Section 33.11 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS DUST COLLECTORS FOR USE IN CONNECTION WITH ROCK DRILLING IN COAL MINES General Provisions...

  6. 30 CFR 33.11 - Approval plates.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Approval plates. 33.11 Section 33.11 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS DUST COLLECTORS FOR USE IN CONNECTION WITH ROCK DRILLING IN COAL MINES General Provisions...

  7. 7 CFR 52.53 - Approved identification.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ...; (2) Have been produced or packed in an approved plant. (3) Are truthfully and accurately labeled. (4.... The official marks approved for use by plants operating under USDA continuous inspection service...: Provided, That the official marks illustrated by figures 8 and 9 are limited to products packed by plants...

  8. 30 CFR 7.90 - Approval marking.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Diesel Engines Intended for Use in Underground Coal Mines § 7.90 Approval marking. Each approved diesel engine shall be identified by a legible and... diesel engine. The marking shall also contain the following information: (a) Ventilation rate. (b) Rated...

  9. 30 CFR 7.90 - Approval marking.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Diesel Engines Intended for Use in Underground Coal Mines § 7.90 Approval marking. Each approved diesel engine shall be identified by a legible and... diesel engine. The marking shall also contain the following information: (a) Ventilation rate. (b) Rated...

  10. 30 CFR 7.90 - Approval marking.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Diesel Engines Intended for Use in Underground Coal Mines § 7.90 Approval marking. Each approved diesel engine shall be identified by a legible and... diesel engine. The marking shall also contain the following information: (a) Ventilation rate. (b) Rated...

  11. 30 CFR 7.90 - Approval marking.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Diesel Engines Intended for Use in Underground Coal Mines § 7.90 Approval marking. Each approved diesel engine shall be identified by a legible and... diesel engine. The marking shall also contain the following information: (a) Ventilation rate. (b) Rated...

  12. 30 CFR 7.90 - Approval marking.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Diesel Engines Intended for Use in Underground Coal Mines § 7.90 Approval marking. Each approved diesel engine shall be identified by a legible and... diesel engine. The marking shall also contain the following information: (a) Ventilation rate. (b) Rated...

  13. Are government-approved products containing new psychoactive substances perceived to be safer and more socially acceptable than alcohol, tobacco and illegal drugs? Findings from a survey of police arrestees in New Zealand.

    PubMed

    Rychert, Marta; Wilkins, Chris; Parker, Karl; Witten, Karen

    2018-03-01

    In July 2013, New Zealand passed the Psychoactive Substances Act (PSA), which established a legal regulated market for government-approved products containing new psychoactive substances (NPS). One of the aims of the PSA was to separate the market for approved NPS products from unapproved products and illegal drugs. The aim of this study was to explore perceived health risks and social acceptability of government-approved NPS compared to unapproved NPS and other drugs. About 834 police arrestees were surveyed about the health risks and social acceptability of regularly using nine drug types, including approved and unapproved synthetic cannabinoids (SC) and 'party pills' (PP) under the interim PSA regime. Statistical analyses included fitted analysis of variance and logistic ordinal regression models. Approved SC were considered riskier to health than (natural) cannabis, alcohol, approved and unapproved PP, tobacco and ecstasy, but safer than unapproved SC and methamphetamine. Younger participants (16-29 years) were more likely than older participants (30+ years) to give approved SC a high health-risk score. Approved SC were considered less socially acceptable than alcohol, tobacco and cannabis, but more socially acceptable than methamphetamine, unapproved SC and unapproved PP. Frequent SC users were more likely to rate the social acceptability of approved legal SC higher than other drug users. Approved PP received more positive health and social acceptability scores than approved SC. The PSA was partially successful at separating approved NPS from other drugs. High health-risk and low social acceptability scores for approved SC may reflect the absence of product testing during the interim PSA market. © 2017 Australasian Professional Society on Alcohol and other Drugs.

  14. 76 FR 11330 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, and... Moines, IA 50322. BANMINTH Premix (pyrantel tartrate). Truow Nutrition, Inc., 1590 Todd Farm Dr., Elgin... Approval of Five NADAs by Truow Nutrition, Inc. NADA No. product 21 CFR section affected (sponsor drug...

  15. 78 FR 55056 - Approval for Manufacturing (Production) Authority; Foreign-Trade Zone 141; Firth Rixson, Inc. d/b...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-09

    ... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1913] Approval for Manufacturing (Production) Authority; Foreign-Trade Zone 141; Firth Rixson, Inc. d/b/a Firth Rixson Monroe (Aircraft Turbine Components); Rochester, New York Pursuant to its authority under the Foreign-Trade Zones Act of June 18, 1934...

  16. Streamlining workflow and automation to accelerate laboratory scale protein production.

    PubMed

    Konczal, Jennifer; Gray, Christopher H

    2017-05-01

    Protein production facilities are often required to produce diverse arrays of proteins for demanding methodologies including crystallography, NMR, ITC and other reagent intensive techniques. It is common for these teams to find themselves a bottleneck in the pipeline of ambitious projects. This pressure to deliver has resulted in the evolution of many novel methods to increase capacity and throughput at all stages in the pipeline for generation of recombinant proteins. This review aims to describe current and emerging options to accelerate the success of protein production in Escherichia coli. We emphasize technologies that have been evaluated and implemented in our laboratory, including innovative molecular biology and expression vectors, small-scale expression screening strategies and the automation of parallel and multidimensional chromatography. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  17. Accelerated hydrolysis of substituted cellulose for potential biofuel production: kinetic study and modeling.

    PubMed

    Mu, Bingnan; Xu, Helan; Yang, Yiqi

    2015-11-01

    In this work, kinetics of substitution accelerated cellulose hydrolysis with multiple reaction stages was investigated to lay foundation for mechanism study and molecular design of substituting compounds. High-efficiency hydrolysis of cellulose is critical for cellulose-based bioethanol production. It is known that, substitution could substantially decrease activation energy and increase reaction rate of acidic hydrolysis of glycosidic bonds in cellulose. However, reaction kinetics and mechanism of the accelerated hydrolysis were not fully revealed. In this research, it was proved that substitution therefore accelerated hydrolysis only occurred in amorphous regions of cellulose fibers, and was a process with multiple reaction stages. With molar ratio of substitution less than 1%, the overall hydrolysis rate could be increased for around 10 times. We also quantified the relationship between the hydrolysis rate of individual reaction stage and its major influences, including molar ratio of substitution, activation energy of acidic hydrolysis, pH and temperature. Copyright © 2015 Elsevier Ltd. All rights reserved.

  18. 30 CFR 18.93 - Application for field approval; filing procedures.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Application for field approval; filing... TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.93 Application for field approval; filing...

  19. 30 CFR 18.93 - Application for field approval; filing procedures.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Application for field approval; filing... TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.93 Application for field approval; filing...

  20. 9 CFR 354.38 - Suspension of plant approval.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Suspension of plant approval. 354.38... Inspection Service § 354.38 Suspension of plant approval. (a) Any plant approval given pursuant to the regulations in this part may be suspended by the Administrator for: (1) Failure to maintain plant and...

  1. 9 CFR 354.38 - Suspension of plant approval.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Suspension of plant approval. 354.38... Inspection Service § 354.38 Suspension of plant approval. (a) Any plant approval given pursuant to the regulations in this part may be suspended by the Administrator for: (1) Failure to maintain plant and...

  2. 9 CFR 354.38 - Suspension of plant approval.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Suspension of plant approval. 354.38... Inspection Service § 354.38 Suspension of plant approval. (a) Any plant approval given pursuant to the regulations in this part may be suspended by the Administrator for: (1) Failure to maintain plant and...

  3. 9 CFR 590.161 - Termination of plant approval.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Termination of plant approval. 590.161... Service § 590.161 Termination of plant approval. When inspection service is not performed at any plant for a period of at least 90 days, plant approval shall terminate upon notice by the Administrator...

  4. 9 CFR 354.38 - Suspension of plant approval.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Suspension of plant approval. 354.38... Inspection Service § 354.38 Suspension of plant approval. (a) Any plant approval given pursuant to the regulations in this part may be suspended by the Administrator for: (1) Failure to maintain plant and...

  5. 9 CFR 354.38 - Suspension of plant approval.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Suspension of plant approval. 354.38... Inspection Service § 354.38 Suspension of plant approval. (a) Any plant approval given pursuant to the regulations in this part may be suspended by the Administrator for: (1) Failure to maintain plant and...

  6. 9 CFR 590.161 - Termination of plant approval.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Termination of plant approval. 590.161... Service § 590.161 Termination of plant approval. When inspection service is not performed at any plant for a period of at least 90 days, plant approval shall terminate upon notice by the Administrator...

  7. 9 CFR 590.161 - Termination of plant approval.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Termination of plant approval. 590.161... Service § 590.161 Termination of plant approval. When inspection service is not performed at any plant for a period of at least 90 days, plant approval shall terminate upon notice by the Administrator...

  8. 9 CFR 590.161 - Termination of plant approval.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Termination of plant approval. 590.161... Service § 590.161 Termination of plant approval. When inspection service is not performed at any plant for a period of at least 90 days, plant approval shall terminate upon notice by the Administrator...

  9. Study on radiation production in the charge stripping section of the RISP linear accelerator

    NASA Astrophysics Data System (ADS)

    Oh, Joo-Hee; Oranj, Leila Mokhtari; Lee, Hee-Seock; Ko, Seung-Kook

    2015-02-01

    The linear accelerator of the Rare Isotope Science Project (RISP) accelerates 200 MeV/nucleon 238U ions in a multi-charge states. Many kinds of radiations are generated while the primary beam is transported along the beam line. The stripping process using thin carbon foil leads to complicated radiation environments at the 90-degree bending section. The charge distribution of 238U ions after the carbon charge stripper was calculated by using the LISE++ program. The estimates of the radiation environments were carried out by using the well-proved Monte Carlo codes PHITS and FLUKA. The tracks of 238U ions in various charge states were identified using the magnetic field subroutine of the PHITS code. The dose distribution caused by U beam losses for those tracks was obtained over the accelerator tunnel. A modified calculation was applied for tracking the multi-charged U beams because the fundamental idea of PHITS and FLUKA was to transport fully-ionized ion beam. In this study, the beam loss pattern after a stripping section was observed, and the radiation production by heavy ions was studied. Finally, the performance of the PHITS and the FLUKA codes was validated for estimating the radiation production at the stripping section by applying a modified method.

  10. FDA Approval: Ibrutinib for Patients with Previously Treated Mantle Cell Lymphoma and Previously Treated Chronic Lymphocytic Leukemia.

    PubMed

    de Claro, R Angelo; McGinn, Karen M; Verdun, Nicole; Lee, Shwu-Luan; Chiu, Haw-Jyh; Saber, Haleh; Brower, Margaret E; Chang, C J George; Pfuma, Elimika; Habtemariam, Bahru; Bullock, Julie; Wang, Yun; Nie, Lei; Chen, Xiao-Hong; Lu, Donghao Robert; Al-Hakim, Ali; Kane, Robert C; Kaminskas, Edvardas; Justice, Robert; Farrell, Ann T; Pazdur, Richard

    2015-08-15

    On November 13, 2013, the FDA granted accelerated approval to ibrutinib (IMBRUVICA capsules; Pharmacyclics, Inc.) for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. On February 12, 2014, the FDA granted accelerated approval for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. Ibrutinib is a first-in-class Bruton's tyrosine kinase (BTK) inhibitor that received all four expedited programs of the FDA: Fast-Track designation, Breakthrough Therapy designation, Priority Review, and Accelerated Approval. Both approvals were based on overall response rate (ORR) and duration of response (DOR) in single-arm clinical trials in patients with prior treatment. In MCL (N = 111), the complete and partial response rates were 17.1% and 48.6%, respectively, for an ORR of 65.8% [95% confidence interval (CI), 56.2%-74.5%]. The median DOR was 17.5 months (95% CI, 15.8-not reached). In CLL (N = 48), the ORR was 58.3% (95% CI, 43.2%-72.4%), and the DOR ranged from 5.6 to 24.2 months. The most common adverse reactions (≥ 30% in either trial) were thrombocytopenia, diarrhea, neutropenia, bruising, upper respiratory tract infection, anemia, fatigue, musculoskeletal pain, peripheral edema, and nausea. ©2015 American Association for Cancer Research.

  11. 9 CFR 592.180 - Suspension of plant approval.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Suspension of plant approval. 592.180... Suspension of plant approval. (a) Any plant approval pursuant to the regulations in this part may be suspended for: (1) Failure to maintain plant and equipment in a satisfactory state of repairs; (2) The use...

  12. 9 CFR 592.180 - Suspension of plant approval.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Suspension of plant approval. 592.180... Suspension of plant approval. (a) Any plant approval pursuant to the regulations in this part may be suspended for: (1) Failure to maintain plant and equipment in a satisfactory state of repairs; (2) The use...

  13. 9 CFR 592.180 - Suspension of plant approval.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Suspension of plant approval. 592.180... Suspension of plant approval. (a) Any plant approval pursuant to the regulations in this part may be suspended for: (1) Failure to maintain plant and equipment in a satisfactory state of repairs; (2) The use...

  14. 9 CFR 592.180 - Suspension of plant approval.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Suspension of plant approval. 592.180... Suspension of plant approval. (a) Any plant approval pursuant to the regulations in this part may be suspended for: (1) Failure to maintain plant and equipment in a satisfactory state of repairs; (2) The use...

  15. Accelerating the domestication of forest trees in a changing world.

    PubMed

    Harfouche, Antoine; Meilan, Richard; Kirst, Matias; Morgante, Michele; Boerjan, Wout; Sabatti, Maurizio; Scarascia Mugnozza, Giuseppe

    2012-02-01

    In light of impending water and arable land shortages, population growth and climate change, it is more important than ever to examine how forest tree domestication can be accelerated to sustainably meet future demands for wood, biomass, paper, fuel and biomaterials. Because of long breeding cycles, tree domestication cannot be rapidly achieved through traditional genetic improvement methods alone. Integrating modern genetic and genomic techniques with conventional breeding will expedite tree domestication. Breeders will only embrace these technologies if they are cost-effective and readily accessible, and forest landowners will only adopt end-products that meet with regulatory approval and public acceptance. All parties involved must work together to achieve these objectives for the benefit of society. Copyright © 2011 Elsevier Ltd. All rights reserved.

  16. Roadmap for the international, accelerator-based neutrino programme

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Cao, J.; de Gouvêa, A.; Duchesneau, D.

    In line with its terms of reference the ICFA Neutrino Panel has developed a roadmap for the international, accelerator-based neutrino programme. A "roadmap discussion document" was presented in May 2016 taking into account the peer-group-consultation described in the Panel's initial report. The "roadmap discussion document" was used to solicit feedback from the neutrino community---and more broadly, the particle- and astroparticle-physics communities---and the various stakeholders in the programme. The roadmap, the conclusions and recommendations presented in this document take into account the comments received following the publication of the roadmap discussion document. With its roadmap the Panel documents the approved objectivesmore » and milestones of the experiments that are presently in operation or under construction. Approval, construction and exploitation milestones are presented for experiments that are being considered for approval. The timetable proposed by the proponents is presented for experiments that are not yet being considered formally for approval. Based on this information, the evolution of the precision with which the critical parameters governinger the neutrino are known has been evaluated. Branch or decision points have been identified based on the anticipated evolution in precision. The branch or decision points have in turn been used to identify desirable timelines for the neutrino-nucleus cross section and hadro-production measurements that are required to maximise the integrated scientific output of the programme. The branch points have also been used to identify the timeline for the R&D required to take the programme beyond the horizon of the next generation of experiments. The theory and phenomenology programme, including nuclear theory, required to ensure that maximum benefit is derived from the experimental programme is also discussed.« less

  17. 30 CFR 19.5 - General requirements for approval.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ..., AND APPROVAL OF MINING PRODUCTS ELECTRIC CAP LAMPS § 19.5 General requirements for approval. Electric cap lamps shall be complete units. They shall be durable in construction, practical in operation, and...

  18. Overview of Accelerator Applications in Energy

    NASA Astrophysics Data System (ADS)

    Garnett, Robert W.; Sheffield, Richard L.

    An overview of the application of accelerators and accelerator technology in energy is presented. Applications span a broad range of cost, size, and complexity and include large-scale systems requiring high-power or high-energy accelerators to drive subcritical reactors for energy production or waste transmutation, as well as small-scale industrial systems used to improve oil and gas exploration and production. The enabling accelerator technologies will also be reviewed and future directions discussed.

  19. Trends in global approvals of biotech crops (1992-2014).

    PubMed

    Aldemita, Rhodora R; Reaño, Ian Mari E; Solis, Renando O; Hautea, Randy A

    2015-01-01

    With the increasing number of genetically modified (GM) events, traits, and crops that are developed to benefit the global population, approval of these technologies for food, feed, cultivation and import in each country may vary depending on needs, demand and trade interest. ISAAA established a GMO Approval Database to document global approvals of biotech crops. GM event name, crops, traits, developer, year of approval for cultivation, food/feed, import, and relevant dossiers were sourced from credible government regulatory websites and biosafety clearinghouses. This paper investigates the trends in GM approvals for food, feed and cultivation based on the number of approving countries, GM crops, events, and traits in the last 23 y (1992-2014), rationale for approval, factors influencing approvals, and their implications in GM crop adoption. Results show that in 2014, there was an accumulative increase in the number of countries granting approvals at 29 (79% developing countries) for commercial cultivation and 31 (70% developing countries) for food and 19 (80% developing developing) for feed; 2012 had the highest number of approving countries and cultivation approvals; 2011 had the highest number of country approvals for feed, and 2014 for food approvals. Herbicide tolerance trait had the highest events approved, followed by insect tolerance traits. Approvals for food product quality increased in the second decade. Maize had the highest number of events approved (single and stacked traits), and stacked traits product gradually increased which is already 30% of the total trait approvals. These results may indicate understanding and acceptance of countries to enhance regulatory capability to be able to benefit from GM crop commercialization. Hence, the paper provided information on the trends on the growth of the GM crop industry in the last 23 y which may be vital in predicting future GM crops and traits.

  20. Highly Productive Application Development with ViennaCL for Accelerators

    NASA Astrophysics Data System (ADS)

    Rupp, K.; Weinbub, J.; Rudolf, F.

    2012-12-01

    The use of graphics processing units (GPUs) for the acceleration of general purpose computations has become very attractive over the last years, and accelerators based on many integrated CPU cores are about to hit the market. However, there are discussions about the benefit of GPU computing when comparing the reduction of execution times with the increased development effort [1]. To counter these concerns, our open-source linear algebra library ViennaCL [2,3] uses modern programming techniques such as generic programming in order to provide a convenient access layer for accelerator and GPU computing. Other GPU-accelerated libraries are primarily tuned for performance, but less tailored to productivity and portability: MAGMA [4] provides dense linear algebra operations via a LAPACK-comparable interface, but no dedicated matrix and vector types. Cusp [5] is closest in functionality to ViennaCL for sparse matrices, but is based on CUDA and thus restricted to devices from NVIDIA. However, no convenience layer for dense linear algebra is provided with Cusp. ViennaCL is written in C++ and uses OpenCL to access the resources of accelerators, GPUs and multi-core CPUs in a unified way. On the one hand, the library provides iterative solvers from the family of Krylov methods, including various preconditioners, for the solution of linear systems typically obtained from the discretization of partial differential equations. On the other hand, dense linear algebra operations are supported, including algorithms such as QR factorization and singular value decomposition. The user application interface of ViennaCL is compatible to uBLAS [6], which is part of the peer-reviewed Boost C++ libraries [7]. This allows to port existing applications based on uBLAS with a minimum of effort to ViennaCL. Conversely, the interface compatibility allows to use the iterative solvers from ViennaCL with uBLAS types directly, thus enabling code reuse beyond CPU-GPU boundaries. Out-of-the-box support

  1. [Production of a compost accelerator inoculant].

    PubMed

    Medina Lara, M Socorro; Quintero Lizaola, Roberto; Espinosa Victoria, David; Alarcón, Alejandro; Etchevers Barra, Jorge D; Trinidad Santos, Antonio; Conde Martínez, F Víctor

    2017-10-26

    Composting was performed using a mixture of ovine manure and straw. Inoculum was extracted at five different phases of the composting process (18, 23, 28, 33 and 38 days after the start of the composting process) and its effect on reducing biotransformation time was evaluated in the composted ovine manure. The samples were preserved in a deep freezer, then lyophilized to obtain the inoculum, 50g of which was added to each treatment in the second experimental phase. Six treatments were established; C=straw (P)+ovine manure (E), T1=P+ E+inoculum 18 days after the start of the composting process (I18), T2=P+E+I23, T3=P+E+I28, T4=P+E+I33, T5=P+E+I38, with three replications. Treatments were placed in a controlled-environment chamber at 45% relative humidity and 30°C along with flasks containing 50g of material to measure daily production, CO 2 accumulation, temperature, pH, electric conductivity (dS/m), organic matter (%), total nitrogen (%), total carbon (%), C: N ratio, particle size (Tp) and bulk density (g/l). CO 2 production (mg) showed a significant difference (p ≤.05) of treatments T2 and T5 with respect to the others, which demonstrated that the inoculum of these treatments accelerated the dynamics of microorganisms and the composting process. The quality and maturity of the compost are guaranteed as the amount of CO 2 decreases. Copyright © 2017 Asociación Argentina de Microbiología. Publicado por Elsevier España, S.L.U. All rights reserved.

  2. 9 CFR 381.132 - Labeling approval.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Labeling approval. 381.132 Section 381.132 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY PRODUCTS INSPECTION AND VOLUNTARY INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION...

  3. Production of 64Cu and 67Cu radiopharmaceuticals using zinc target irradiated with accelerator neutrons

    NASA Astrophysics Data System (ADS)

    Kawabata, Masako; Hashimoto, Kazuyuki; Saeki, Hideya; Sato, Nozomi; Motoishi, Shoji; Nagai, Yasuki

    2014-09-01

    Copper radioisotopes have gained a lot of attention in radiopharmaceuticals owing to their unique decay characteristics. The longest half-life β emitter, 67Cu, is thought to be suitable for targeted radio-immunotherapy. Adequate production of 67Cu to meet the demands of clinical studies has not been fully established. Another attractive copper isotope, 64Cu has possible applications as a diagnostic imaging tracer combined with a therapeutic effect. This work proposes a production method using accelerator neutrons in which two copper radioisotopes can be produced: 1) 68Zn(n,x)67Cu and 2) 64Zn(n,p)64Cu using ~14 MeV neutrons generated by natC(d, n) reaction, both from natural or enriched zinc oxides. The generated 64,67Cu were separated from the target zinc oxide using a chelating and an anion exchange columns and were labelled with two widely studied chelators where the labelling efficiency was found to be acceptably good. The major advantage of this method is that a significant amount of 64,67Cu with a very few impurity radionuclides are produced which also makes the separation procedure simple. Provided an accelerator supplying an Ed = ~ 40 MeV, a wide application of 64,67Cu based drugs in nuclear medicine is feasible in the near future. We will present the characteristics of this production method using accelerator neutrons including the chemical separation processes.

  4. Energy Production and Transmutation of Nuclear Waste by Accelerator Driven Systems

    NASA Astrophysics Data System (ADS)

    Zhivkov, P. K.

    2018-05-01

    There is a significant amount of highly radiotoxic long-life nuclear waste (NW) produced by NPP (Nuclear Power Plants). Transmutation is a process which transforms NW into less radiotoxic nuclides with a shorter period of half-life by spallation neutrons or radiative capture of neutrons produced by ADS (Accelerator Driven System). In the processes of transmutation new radioactive nuclides are produced. ADS is big energy consumer equipment. It is a method for production of a high-flux and high-energy neutron field. All these processes occur in ADS simultaneously. ADS is able to transmute actinides and produce energy simultaneously. The article considers the energy production problems in ADS. Several ideas are developed regarding the solution of the global energy supply.

  5. 30 CFR 20.12 - How approvals are granted.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... APPROVAL OF MINING PRODUCTS ELECTRIC MINE LAMPS OTHER THAN STANDARD CAP LAMPS § 20.12 How approvals are... part only when the testing engineers judge that the lamp has met the requirements of this part and...

  6. 30 CFR 20.12 - How approvals are granted.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... APPROVAL OF MINING PRODUCTS ELECTRIC MINE LAMPS OTHER THAN STANDARD CAP LAMPS § 20.12 How approvals are... part only when the testing engineers judge that the lamp has met the requirements of this part and...

  7. 30 CFR 20.12 - How approvals are granted.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... APPROVAL OF MINING PRODUCTS ELECTRIC MINE LAMPS OTHER THAN STANDARD CAP LAMPS § 20.12 How approvals are... part only when the testing engineers judge that the lamp has met the requirements of this part and...

  8. 30 CFR 20.12 - How approvals are granted.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... APPROVAL OF MINING PRODUCTS ELECTRIC MINE LAMPS OTHER THAN STANDARD CAP LAMPS § 20.12 How approvals are... part only when the testing engineers judge that the lamp has met the requirements of this part and...

  9. 30 CFR 20.12 - How approvals are granted.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... APPROVAL OF MINING PRODUCTS ELECTRIC MINE LAMPS OTHER THAN STANDARD CAP LAMPS § 20.12 How approvals are... part only when the testing engineers judge that the lamp has met the requirements of this part and...

  10. 9 CFR 317.5 - Generically approved labeling.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... Section 317.5 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE..., without such labeling being submitted for approval to the Food Safety and Inspection Service in Washington... particular. (2) The Food Safety and Inspection Service shall select samples of generically approved labeling...

  11. Nutrition Recommendations and the Children’s Food and Beverage Advertising Initiative’s 2014 Approved Food and Beverage Product List

    PubMed Central

    Powell, Lisa M.

    2015-01-01

    We compare the Children’s Food and Beverage Advertising Initiative’s (CFBAI’s) April 2014 list of food and beverage products approved to be advertised on children’s television programs with the federal Interagency Working Group’s nutrition recommendations for such advertised products. Products were assessed by using the nutrients to limit (saturated fat, trans fat, sugar, and sodium) component of the Interagency Working Group’s recommendations. Fifty-three percent of the listed products did not meet the nutrition recommendations and, therefore, were ineligible to be advertised. We recommend continued monitoring of food and beverage products marketed to children. PMID:25906434

  12. Slow positron beam production by a 14 MeV C.W. electron accelerator

    NASA Astrophysics Data System (ADS)

    Begemann, M.; Gräff, G.; Herminghaus, H.; Kalinowsky, H.; Ley, R.

    1982-10-01

    A 14 MeV c.w. electron accelerator is used for pair production in a tungsten target of 0.7 radiation lengths thickness. A small fraction of the positrons is thermalized and diffuses out of the surface ofsurface of a well annealed tungsten foil coated with MgO which is positioned immediately behind the target. The slow positrons are extracted from the target region and magnetically guided over a distance of 10 m onto a channelplate multiplier at the end of an S-shaped solenoid. The positrons are identified by their annihilation radiation using two NaI-detectors. The intensity of the slow positrons is proportional to the accelerator electron beam current. The maximum intensity of 2.2 × 10 5 slow positrons per second reaching thedetector at an accelerator current of 15 μA was limited by the power deposited in the uncooled target. The energy of the positrons is concentrated in a small region at about 1 eV and clearly demonstrates the emission of thermal positrons.

  13. 27 CFR 4.93 - Approval of grape variety names.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2012-04-01 2012-04-01 false Approval of grape variety..., DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF WINE American Grape Variety Names § 4.93 Approval of grape variety names. (a) Any interested person may petition the Administrator for the approval...

  14. 27 CFR 4.93 - Approval of grape variety names.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2011-04-01 2011-04-01 false Approval of grape variety..., DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF WINE American Grape Variety Names § 4.93 Approval of grape variety names. (a) Any interested person may petition the Administrator for the approval...

  15. 27 CFR 4.93 - Approval of grape variety names.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2014-04-01 2014-04-01 false Approval of grape variety..., DEPARTMENT OF THE TREASURY ALCOHOL LABELING AND ADVERTISING OF WINE American Grape Variety Names § 4.93 Approval of grape variety names. (a) Any interested person may petition the Administrator for the approval...

  16. 27 CFR 4.93 - Approval of grape variety names.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2013-04-01 2013-04-01 false Approval of grape variety..., DEPARTMENT OF THE TREASURY ALCOHOL LABELING AND ADVERTISING OF WINE American Grape Variety Names § 4.93 Approval of grape variety names. (a) Any interested person may petition the Administrator for the approval...

  17. Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010.

    PubMed

    Downing, Nicholas S; Shah, Nilay D; Aminawung, Jenerius A; Pease, Alison M; Zeitoun, Jean-David; Krumholz, Harlan M; Ross, Joseph S

    2017-05-09

    Postmarket safety events of novel pharmaceuticals and biologics occur when new safety risks are identified after initial regulatory approval of these therapeutics. These safety events can change how novel therapeutics are used in clinical practice and inform patient and clinician decision making. To characterize the frequency of postmarket safety events among novel therapeutics approved by the US Food and Drug Administration (FDA), and to examine whether any novel therapeutic characteristics known at the time of FDA approval were associated with increased risk. Cohort study of all novel therapeutics approved by the FDA between January 1, 2001, and December 31, 2010, followed up through February 28, 2017. Novel therapeutic characteristics known at the time of FDA approval, including drug class, therapeutic area, priority review, accelerated approval, orphan status, near-regulatory deadline approval, and regulatory review time. A composite of (1) withdrawals due to safety concerns, (2) FDA issuance of incremental boxed warnings added in the postmarket period, and (3) FDA issuance of safety communications. From 2001 through 2010, the FDA approved 222 novel therapeutics (183 pharmaceuticals and 39 biologics). There were 123 new postmarket safety events (3 withdrawals, 61 boxed warnings, and 59 safety communications) during a median follow-up period of 11.7 years (interquartile range [IQR], 8.7-13.8 years), affecting 71 (32.0%) of the novel therapeutics. The median time from approval to first postmarket safety event was 4.2 years (IQR, 2.5-6.0 years), and the proportion of novel therapeutics affected by a postmarket safety event at 10 years was 30.8% (95% CI, 25.1%-37.5%). In multivariable analysis, postmarket safety events were statistically significantly more frequent among biologics (incidence rate ratio [IRR] = 1.93; 95% CI, 1.06-3.52; P = .03), therapeutics indicated for the treatment of psychiatric disease (IRR = 3.78; 95% CI, 1.77-8.06; P < .001

  18. A Statistical Perspective on Highly Accelerated Testing

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Thomas, Edward V.

    Highly accelerated life testing has been heavily promoted at Sandia (and elsewhere) as a means to rapidly identify product weaknesses caused by flaws in the product's design or manufacturing process. During product development, a small number of units are forced to fail at high stress. The failed units are then examined to determine the root causes of failure. The identification of the root causes of product failures exposed by highly accelerated life testing can instigate changes to the product's design and/or manufacturing process that result in a product with increased reliability. It is widely viewed that this qualitative use ofmore » highly accelerated life testing (often associated with the acronym HALT) can be useful. However, highly accelerated life testing has also been proposed as a quantitative means for "demonstrating" the reliability of a product where unreliability is associated with loss of margin via an identified and dominating failure mechanism. It is assumed that the dominant failure mechanism can be accelerated by changing the level of a stress factor that is assumed to be related to the dominant failure mode. In extreme cases, a minimal number of units (often from a pre-production lot) are subjected to a single highly accelerated stress relative to normal use. If no (or, sufficiently few) units fail at this high stress level, some might claim that a certain level of reliability has been demonstrated (relative to normal use conditions). Underlying this claim are assumptions regarding the level of knowledge associated with the relationship between the stress level and the probability of failure. The primary purpose of this document is to discuss (from a statistical perspective) the efficacy of using accelerated life testing protocols (and, in particular, "highly accelerated" protocols) to make quantitative inferences concerning the performance of a product (e.g., reliability) when in fact there is lack-of-knowledge and uncertainty concerning

  19. 30 CFR 18.81 - Field modification of approved (permissible) equipment; application for approval of modification...

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES... and Certification Center, 765 Technology Drive, Triadelphia, WV 26059. (b) Proposed modifications...

  20. 14 CFR 21.8 - Approval of articles.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 1 2014-01-01 2014-01-01 false Approval of articles. 21.8 Section 21.8 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT CERTIFICATION PROCEDURES FOR PRODUCTS AND PARTS General § 21.8 Approval of articles. If an article is required to be...

  1. 14 CFR 21.8 - Approval of articles.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 1 2013-01-01 2013-01-01 false Approval of articles. 21.8 Section 21.8 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT CERTIFICATION PROCEDURES FOR PRODUCTS AND PARTS General § 21.8 Approval of articles. If an article is required to be...

  2. 14 CFR 21.8 - Approval of articles.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 1 2011-01-01 2011-01-01 false Approval of articles. 21.8 Section 21.8 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT CERTIFICATION PROCEDURES FOR PRODUCTS AND PARTS General § 21.8 Approval of articles. If an article is required to be...

  3. 14 CFR 21.8 - Approval of articles.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Approval of articles. 21.8 Section 21.8 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT CERTIFICATION PROCEDURES FOR PRODUCTS AND PARTS General § 21.8 Approval of articles. If an article is required to be...

  4. 14 CFR 21.8 - Approval of articles.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 1 2012-01-01 2012-01-01 false Approval of articles. 21.8 Section 21.8 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT CERTIFICATION PROCEDURES FOR PRODUCTS AND PARTS General § 21.8 Approval of articles. If an article is required to be...

  5. 30 CFR 18.4 - Electrical equipment for which approval is issued.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES General Provisions § 18.4 Electrical equipment for which approval is issued. An approval will be issued... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Electrical equipment for which approval is...

  6. 30 CFR 19.12 - Wording, purpose, and use of approval plate.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ..., EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC CAP LAMPS § 19.12 Wording, purpose, and use of approval... Administration and be inscribed as follows: “Permissible Electric Cap Lamp. Approval No. ____ issued to the...

  7. A strategy to accelerate protein production from a pool of clones in Chinese hamster ovary cells for toxicology studies.

    PubMed

    Hu, Zhilan; Hsu, Wendy; Pynn, Abby; Ng, Domingos; Quicho, Donna; Adem, Yilma; Kwong, Zephie; Mauger, Brad; Joly, John; Snedecor, Bradley; Laird, Michael W; Andersen, Dana C; Shen, Amy

    2017-11-01

    In the biopharmaceutical industry, a clonally derived cell line is typically used to generate material for investigational new drug (IND)-enabling toxicology studies. The same cell line is then used to generate material for clinical studies. If a pool of clones can be used to produce material for IND-enabling toxicology studies (Pool for Tox (PFT) strategy) during the time a lead clone is being selected for clinical material production, the toxicology studies can be accelerated significantly (approximately 4 months at Genentech), leading to a potential acceleration of 4 months for the IND submission. We explored the feasibility of the PFT strategy with three antibodies-mAb1, mAb2, and mAb3-at the 2 L scale. For each antibody, two lead cell lines were identified that generated material with similar product quality to the material generated from the associated pool. For two antibody molecules, mAb1 and mAb2, the material generated by the lead cell lines from 2 L bioreactors was tested in an accelerated stability study and was shown to have stability comparable to the material generated by the associated pool. Additionally, we used this approach for two antibody molecules, mAb4 and mAb5, at Tox and GMP production. The materials from the Tox batch at 400 L scale and three GMP batches at 2000 L scale have comparable product quality attributes for both molecules. Our results demonstrate the feasibility of using a pool of clonally derived cell lines to generate material of similar product quality and stability for use in IND-enabling toxicology studies as was derived from the final production clone, which enabled significant acceleration of timelines into clinical development. © 2017 American Institute of Chemical Engineers Biotechnol. Prog., 33:1449-1455, 2017. © 2017 American Institute of Chemical Engineers.

  8. A fresh perspective on comparing the FDA and the CHMP/EMA: approval of antineoplastic tyrosine kinase inhibitors

    PubMed Central

    Shah, Rashmi R; Roberts, Samantha A; Shah, Devron R

    2013-01-01

    We compared and determined the reasons for any differences in the review and approval times of tyrosine kinase inhibitors (TKIs) by the US Food and Drug Administration (FDA) and the European EMA/CHMP. Applications for these novel cancer drugs were submitted to them within a mean of 31.2 days of each other, providing a fair basis for comparison. The FDA had granted priority review to 12 TKIs but the EMA/CHMP did not grant the equivalent accelerated assessment to any. The FDA granted accelerated approvals to six (38%) and CHMP granted (the equivalent) conditional approvals to four (29%) of these agents. On average, the review and approval times were 205.3 days in the US compared with 409.6 days in the European Union (EU). The active review times, however, were comparable (225.4 days in the EU and 205.3 days in the US). Since oncology drug development lasts about 7 years, the 20 days difference in review times between the two agencies is inconsequential. Clock stops during review and the time required to issue an approval had added the extra 184.2 days to review time in the EU. We suggest possible solutions to expedite the EU review and approval processes. However, post-marketing emergence of adverse efficacy and safety data on gefitinib and lapatinib, respectively, indicate potential risks of expedited approvals. We challenge the widely prevalent myth that early approval translates into early access or beneficial impact on public health. Both the agencies collaborate closely but conduct independent assessments and make decisions based on distinct legislation, procedures, precedents and societal expectations. PMID:23362829

  9. Plutonium (TRU) transmutation and 233U production by single-fluid type accelerator molten-salt breeder (AMSB)

    NASA Astrophysics Data System (ADS)

    Furukawa, Kazuo; Kato, Yoshio; Chigrinov, Sergey E.

    1995-09-01

    For practical/industrial disposition of Pu(TRU) by accelerator facility, not only physical soundness and safety but also the following technological rationality should be required: (1) few R&D items including radiation damage, heat removal and material compatibility: (2) few operation/maintenance/processing works; (3) few reproduction of radioactivity; (4) effective energy production in parallel. This will be achieved by the new modification of Th-fertilizing Single-Fluid type Accelerator Molten-Salt Breeder (AMSB), by which a global nuclear energy strategy for next century might be prepared.

  10. 7 CFR 58.124 - Denial or suspension of plant approval.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 3 2013-01-01 2013-01-01 false Denial or suspension of plant approval. 58.124 Section... (CONTINUED) GRADING AND INSPECTION, GENERAL SPECIFICATIONS FOR APPROVED PLANTS AND STANDARDS FOR GRADES OF DAIRY PRODUCTS 1 General Specifications for Dairy Plants Approved for USDA Inspection and Grading...

  11. High Frequency, High Gradient Dielectric Wakefield Acceleration Experiments at SLAC and BNL

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Rosenzweig, James; /UCLA; Travish, Gil

    Given the recent success of >GV/m dielectric wakefield accelerator (DWA) breakdown experiments at SLAC, and follow-on coherent Cerenkov radiation production at the UCLA Neptune, a UCLA-USC-SLAC collaboration is now implementing a new set of experiments that explore various DWA scenarios. These experiments are motivated by the opportunities presented by the approval of FACET facility at SLAC, as well as unique pulse-train wakefield drivers at BNL. The SLAC experiments permit further exploration of the multi-GeV/m envelope in DWAs, and will entail investigations of novel materials (e.g. CVD diamond) and geometries (Bragg cylindrical structures, slab-symmetric DWAs), and have an over-riding goal ofmore » demonstrating >GeV acceleration in {approx}33 cm DWA tubes. In the nearer term before FACET's commissioning, we are planning measurements at the BNL ATF, in which we drive {approx}50-200 MV/m fields with single pulses or pulse trains. These experiments are of high relevance to enhancing linear collider DWA designs, as they will demonstrate potential for efficient operation with pulse trains.« less

  12. Changing innovation into a registered product: From concept to regulatory approval.

    PubMed

    Rhodes, Linda

    2018-05-01

    Innovation in animal health pharmaceuticals is important to address unmet and underserved medical needs, and often comes from products initially developed for human medicine. The purpose of the review is to help readers understand how breakthroughs from human biotechnology may be developed for use in veterinary medicine, while understanding the key drivers to success, the difficulties of regulatory approval, and the realistic risks and rewards of developing applications for animals. The types of human drugs which may be useful for veterinary applications are reviewed, including examples. The regulatory path is discussed, with a review of the various oversight agencies, and the categories of data required to be submitted, including safety, efficacy, manufacturing, environmental impact and human food safety. In conclusion, the cost, development time, and barriers to innovation in veterinary medical pharmaceuticals are discussed. Copyright © 2017 Elsevier Inc. All rights reserved.

  13. Trends in global approvals of biotech crops (1992–2014)

    PubMed Central

    Aldemita, Rhodora R; Reaño, Ian Mari E; Solis, Renando O; Hautea, Randy A

    2015-01-01

    ABSTRACT With the increasing number of genetically modified (GM) events, traits, and crops that are developed to benefit the global population, approval of these technologies for food, feed, cultivation and import in each country may vary depending on needs, demand and trade interest. ISAAA established a GMO Approval Database to document global approvals of biotech crops. GM event name, crops, traits, developer, year of approval for cultivation, food/feed, import, and relevant dossiers were sourced from credible government regulatory websites and biosafety clearinghouses. This paper investigates the trends in GM approvals for food, feed and cultivation based on the number of approving countries, GM crops, events, and traits in the last 23 y (1992–2014), rationale for approval, factors influencing approvals, and their implications in GM crop adoption. Results show that in 2014, there was an accumulative increase in the number of countries granting approvals at 29 (79% developing countries) for commercial cultivation and 31 (70% developing countries) for food and 19 (80% developing developing) for feed; 2012 had the highest number of approving countries and cultivation approvals; 2011 had the highest number of country approvals for feed, and 2014 for food approvals. Herbicide tolerance trait had the highest events approved, followed by insect tolerance traits. Approvals for food product quality increased in the second decade. Maize had the highest number of events approved (single and stacked traits), and stacked traits product gradually increased which is already 30% of the total trait approvals. These results may indicate understanding and acceptance of countries to enhance regulatory capability to be able to benefit from GM crop commercialization. Hence, the paper provided information on the trends on the growth of the GM crop industry in the last 23 y which may be vital in predicting future GM crops and traits. PMID:26039675

  14. Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study.

    PubMed

    Kesselheim, Aaron S; Wang, Bo; Franklin, Jessica M; Darrow, Jonathan J

    2015-09-23

    To evaluate the use of special expedited development and review pathways at the US Food and Drug Administration over the past two decades. Cohort study. FDA approved novel therapeutics between 1987 and 2014. Publicly available sources provided each drug's year of approval, their innovativeness (first in class versus not first in class), World Health Organization Anatomic Therapeutic Classification, and which (if any) of the FDA's four primary expedited development and review programs or designations were associated with each drug: orphan drug, fast track, accelerated approval, and priority review. Logistic regression models evaluated trends in the proportion of drugs associated with each of the four expedited development and review programs. To evaluate the number of programs associated with each approved drug over time, Poisson models were employed, with the number of programs as the dependent variable and a linear term for year of approval. The difference in trends was compared between drugs that were first in class and those that were not. The FDA approved 774 drugs during the study period, with one third representing first in class agents. Priority review (43%) was the most prevalent of the four programs, with accelerated approval (9%) the least common. There was a significant increase of 2.6% per year in the number of expedited review and approval programs granted to each newly approved agent (incidence rate ratio 1.026, 95% confidence interval 1.017 to 1.035, P<0.001), and a 2.4% increase in the proportion of drugs associated with at least one such program (odds ratio 1.024, 95% confidence interval 1.006 to 1.043, P=0.009). Driving this trend was an increase in the proportion of approved, non-first in class drugs associated with at least one program for drugs (P=0.03 for interaction). In the past two decades, drugs newly approved by the FDA have been associated with an increasing number of expedited development or review programs. Though expedited programs

  15. The approval process for biosimilar erythropoiesis-stimulating agents.

    PubMed

    Wish, Jay B

    2014-09-05

    A biosimilar drug or follow-on biologic drug is defined by the Public Health Service Act as a product that is "highly similar to the reference product notwithstanding minor differences in clinically active components and there are no clinically meaningful differences between the biologic product and the reference product in terms of the safety, purity and potency of the product." The advantage of biosimilar drugs is that they are significantly less expensive than the reference products, allowing for increased accessibility and cost savings. Recognizing these advantages, the US Congress passed the Biologics Price Competition and Innovation Act in 2009 as part of health care reform. The Biologics Price Competition and Innovation Act allows sponsors of biosimilar agents to seek approval by showing structural and functional similarity to the reference agent, with the extent of required clinical studies to be determined on the basis of the degree of biosimilarity with the reference product. The goal is to bring biosimilar agents to the market more efficiently while still protecting the safety of the public. The European Union has had such a process in place for a number of years. Two biosimilar epoetin agents have been approved in the European Union since 2007, and their companies are conducting trials to seek approval in the United States, because Amgen's patent protection for epoetin alfa expires in 2014. Trials completed for European Union approval of both agents showed similar efficacy and safety to the reference epoetin alfa. As with all biologics, immunogenicity concerns may persist because of the fragility of the manufacturing process and the worldwide experience with pure red cell aplasia as a result of epoetin therapy. The uptake of biosimilar epoetins after approval in the United States will depend on the balance of cost advantage against safety concerns. Competition in the marketplace will likely decrease the cost of the reference agent as well. Copyright

  16. Shielding calculations for industrial 5/7.5MeV electron accelerators using the MCNP Monte Carlo Code

    NASA Astrophysics Data System (ADS)

    Peri, Eyal; Orion, Itzhak

    2017-09-01

    High energy X-rays from accelerators are used to irradiate food ingredients to prevent growth and development of unwanted biological organisms in food, and by that extend the shelf life of the products. The production of X-rays is done by accelerating 5 MeV electrons and bombarding them into a heavy target (high Z). Since 2004, the FDA has approved using 7.5 MeV energy, providing higher production rates with lower treatments costs. In this study we calculated all the essential data needed for a straightforward concrete shielding design of typical food accelerator rooms. The following evaluation is done using the MCNP Monte Carlo code system: (1) Angular dependence (0-180°) of photon dose rate for 5 MeV and 7.5 MeV electron beams bombarding iron, aluminum, gold, tantalum, and tungsten targets. (2) Angular dependence (0-180°) spectral distribution simulations of bremsstrahlung for gold, tantalum, and tungsten bombarded by 5 MeV and 7.5 MeV electron beams. (3) Concrete attenuation calculations in several photon emission angles for the 5 MeV and 7.5 MeV electron beams bombarding a tantalum target. Based on the simulation, we calculated the expected increase in dose rate for facilities intending to increase the energy from 5 MeV to 7.5 MeV, and the concrete width needed to be added in order to keep the existing dose rate unchanged.

  17. 77 FR 3828 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Granting Approval of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-25

    ... Organizations; The Options Clearing Corporation; Order Granting Approval of Accelerated Delivery of Supplement to the Options Disclosure Document Reflecting Certain Changes to Disclosure Regarding Relative Performance Options January 19, 2012. On August 15, 2011, The Options Clearing Corporation (``OCC'') submitted...

  18. 9 CFR 381.133 - Generically approved labeling.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Generically approved labeling. 381.133 Section 381.133 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY PRODUCTS INSPECTION AND VOLUNTARY INSPECTION AND CERTIFICATION POULTRY PRODUCT...

  19. Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010

    PubMed Central

    Downing, Nicholas S.; Shah, Nilay D.; Aminawung, Jenerius A.; Pease, Alison M.; Zeitoun, Jean-David; Krumholz, Harlan M.

    2017-01-01

    Importance Postmarket safety events of novel pharmaceuticals and biologics occur when new safety risks are identified after initial regulatory approval of these therapeutics. These safety events can change how novel therapeutics are used in clinical practice and inform patient and clinician decision making. Objectives To characterize the frequency of postmarket safety events among novel therapeutics approved by the US Food and Drug Administration (FDA), and to examine whether any novel therapeutic characteristics known at the time of FDA approval were associated with increased risk. Design and Setting Cohort study of all novel therapeutics approved by the FDA between January 1, 2001, and December 31, 2010, followed up through February 28, 2017. Exposures Novel therapeutic characteristics known at the time of FDA approval, including drug class, therapeutic area, priority review, accelerated approval, orphan status, near–regulatory deadline approval, and regulatory review time. Main Outcomes and Measures A composite of (1) withdrawals due to safety concerns, (2) FDA issuance of incremental boxed warnings added in the postmarket period, and (3) FDA issuance of safety communications. Results From 2001 through 2010, the FDA approved 222 novel therapeutics (183 pharmaceuticals and 39 biologics). There were 123 new postmarket safety events (3 withdrawals, 61 boxed warnings, and 59 safety communications) during a median follow-up period of 11.7 years (interquartile range [IQR], 8.7-13.8 years), affecting 71 (32.0%) of the novel therapeutics. The median time from approval to first postmarket safety event was 4.2 years (IQR, 2.5-6.0 years), and the proportion of novel therapeutics affected by a postmarket safety event at 10 years was 30.8% (95% CI, 25.1%-37.5%). In multivariable analysis, postmarket safety events were statistically significantly more frequent among biologics (incidence rate ratio [IRR] = 1.93; 95% CI, 1.06-3.52; P = .03), therapeutics indicated for

  20. 30 CFR 23.7 - Specific requirements for approval.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ..., EVALUATION, AND APPROVAL OF MINING PRODUCTS TELEPHONES AND SIGNALING DEVICES § 23.7 Specific requirements for... apply. (g) Line powered telephones and signaling devices or systems shall be equipped with standby power... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Specific requirements for approval. 23.7...

  1. 30 CFR 23.7 - Specific requirements for approval.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ..., EVALUATION, AND APPROVAL OF MINING PRODUCTS TELEPHONES AND SIGNALING DEVICES § 23.7 Specific requirements for... apply. (g) Line powered telephones and signaling devices or systems shall be equipped with standby power... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Specific requirements for approval. 23.7...

  2. 30 CFR 23.7 - Specific requirements for approval.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ..., EVALUATION, AND APPROVAL OF MINING PRODUCTS TELEPHONES AND SIGNALING DEVICES § 23.7 Specific requirements for... apply. (g) Line powered telephones and signaling devices or systems shall be equipped with standby power... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Specific requirements for approval. 23.7...

  3. 15 CFR 995.11 - Government review and approval.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 15 Commerce and Foreign Trade 3 2013-01-01 2013-01-01 false Government review and approval. 995.11 Section 995.11 Commerce and Foreign Trade Regulations Relating to Commerce and Foreign Trade (Continued... HYDROGRAPHIC PRODUCTS Certification and Procedures § 995.11 Government review and approval. (a) An application...

  4. 15 CFR 995.11 - Government review and approval.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 15 Commerce and Foreign Trade 3 2011-01-01 2011-01-01 false Government review and approval. 995.11 Section 995.11 Commerce and Foreign Trade Regulations Relating to Commerce and Foreign Trade (Continued... HYDROGRAPHIC PRODUCTS Certification and Procedures § 995.11 Government review and approval. (a) An application...

  5. 15 CFR 995.11 - Government review and approval.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 15 Commerce and Foreign Trade 3 2010-01-01 2010-01-01 false Government review and approval. 995.11 Section 995.11 Commerce and Foreign Trade Regulations Relating to Commerce and Foreign Trade (Continued... HYDROGRAPHIC PRODUCTS Certification and Procedures § 995.11 Government review and approval. (a) An application...

  6. 15 CFR 995.11 - Government review and approval.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 15 Commerce and Foreign Trade 3 2012-01-01 2012-01-01 false Government review and approval. 995.11 Section 995.11 Commerce and Foreign Trade Regulations Relating to Commerce and Foreign Trade (Continued... HYDROGRAPHIC PRODUCTS Certification and Procedures § 995.11 Government review and approval. (a) An application...

  7. 9 CFR 592.300 - Approval of official identification.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Approval of official identification. 592.300 Section 592.300 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Identifying and Marking Products...

  8. First vaccine approval under the FDA Animal Rule

    PubMed Central

    Beasley, David W C; Brasel, Trevor L; Comer, Jason E

    2016-01-01

    The US Food and Drug Administration’s Animal Rule was established to facilitate licensure of new products for life-threatening conditions when traditional efficacy trials in humans are unethical or impractical. In November, 2015 BioThrax became the first vaccine to receive approval for a new indication via this pathway. The basis for this approval and use of Animal Rule or other non-traditional approval pathways for licensure of vaccines for serious conditions are discussed. PMID:29263855

  9. Results of Accelerated Life Testing of LCLS-II Cavity Tuner Motor

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Huque, Naeem; Daly, Edward; Pischalnikov, Yuriy

    An Accelerated Life Test (ALT) of the Phytron stepper motor used in the LCLS-II cavity tuner has been conducted at JLab. Since the motor will reside inside the cryomodule, any failure would lead to a very costly and arduous repair. As such, the motor was tested for the equivalent of 30 lifetimes before being approved for use in the production cryomodules. The 9-cell LCLS-II cavity is simulated by disc springs with an equivalent spring constant. Plots of the motor position vs. tuner position ' measured via an installed linear variable differential transformer (LVDT) ' are used to measure motor motion.more » The titanium spindle was inspected for loss of lubrication. The motor passed the ALT, and is set to be installed in the LCLS-II cryomodules.« less

  10. RESULTS OF ACCELERATED LIFE TESTING OF LCLS-II CAVITY TUNER MOTOR

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Huque, Naeem; Daly, Edward F.; Pischalnikov, Yuriy

    An Accelerated Life Test (ALT) of the Phytron stepper motor used in the LCLS-II cavity tuner has been conducted at JLab. Since the motor will reside inside the cryomodule, any failure would lead to a very costly and arduous repair. As such, the motor was tested for the equivalent of 30 lifetimes before being approved for use in the production cryomodules. The 9-cell LCLS-II cavity is simulated by disc springs with an equivalent spring constant. Plots of the motor position vs. tuner position ' measured via an installed linear variable differential transformer (LVDT) ' are used to measure motor motion.more » The titanium spindle was inspected for loss of lubrication. The motor passed the ALT, and is set to be installed in the LCLS-II cryomodules.« less

  11. 75 FR 30451 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Granting Approval of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-01

    ... May 14, 2010. The ODD currently contains general disclosures on the characteristics and risks of...-linked securities. Accordingly, the ODD disclosure only covers the characteristics and risks of options...; Order Granting Approval of Accelerated Delivery of Supplement to the Options Disclosure Document...

  12. The Human Kinome Targeted by FDA Approved Multi-Target Drugs and Combination Products: A Comparative Study from the Drug-Target Interaction Network Perspective.

    PubMed

    Li, Ying Hong; Wang, Pan Pan; Li, Xiao Xu; Yu, Chun Yan; Yang, Hong; Zhou, Jin; Xue, Wei Wei; Tan, Jun; Zhu, Feng

    2016-01-01

    The human kinome is one of the most productive classes of drug target, and there is emerging necessity for treating complex diseases by means of polypharmacology (multi-target drugs and combination products). However, the advantages of the multi-target drugs and the combination products are still under debate. A comparative analysis between FDA approved multi-target drugs and combination products, targeting the human kinome, was conducted by mapping targets onto the phylogenetic tree of the human kinome. The approach of network medicine illustrating the drug-target interactions was applied to identify popular targets of multi-target drugs and combination products. As identified, the multi-target drugs tended to inhibit target pairs in the human kinome, especially the receptor tyrosine kinase family, while the combination products were able to against targets of distant homology relationship. This finding asked for choosing the combination products as a better solution for designing drugs aiming at targets of distant homology relationship. Moreover, sub-networks of drug-target interactions in specific disease were generated, and mechanisms shared by multi-target drugs and combination products were identified. In conclusion, this study performed an analysis between approved multi-target drugs and combination products against the human kinome, which could assist the discovery of next generation polypharmacology.

  13. 9 CFR 147.48 - Approval of conference recommendations by the Department.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Approval of conference recommendations by the Department. 147.48 Section 147.48 Animals and Animal Products ANIMAL AND PLANT HEALTH... Department for incorporation into the provisions of the NPIP. The Department reserves the right to approve or...

  14. 9 CFR 147.48 - Approval of conference recommendations by the Department.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Approval of conference recommendations by the Department. 147.48 Section 147.48 Animals and Animal Products ANIMAL AND PLANT HEALTH... Department for incorporation into the provisions of the NPIP. The Department reserves the right to approve or...

  15. 9 CFR 147.48 - Approval of conference recommendations by the Department.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Approval of conference recommendations by the Department. 147.48 Section 147.48 Animals and Animal Products ANIMAL AND PLANT HEALTH... Department for incorporation into the provisions of the NPIP. The Department reserves the right to approve or...

  16. 9 CFR 147.48 - Approval of conference recommendations by the Department.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Approval of conference recommendations by the Department. 147.48 Section 147.48 Animals and Animal Products ANIMAL AND PLANT HEALTH... Department for incorporation into the provisions of the NPIP. The Department reserves the right to approve or...

  17. 40 CFR 152.130 - Distribution under approved labeling.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Distribution under approved labeling... Registrants § 152.130 Distribution under approved labeling. (a) A registrant may distribute or sell a... provide sufficient time for product in channels of trade to be distributed or sold to users or otherwise...

  18. 9 CFR 590.640 - Application for exemption; approval.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... AGRICULTURE EGG PRODUCTS INSPECTION INSPECTION OF EGGS AND EGG PRODUCTS (EGG PRODUCTS INSPECTION ACT) Exempted Egg Products Plants § 590.640 Application for exemption; approval. Any person desiring to process egg..., a Supervisory Egg Products Inspector will make a survey and inspection of the premises and plant to...

  19. 9 CFR 590.640 - Application for exemption; approval.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... AGRICULTURE EGG PRODUCTS INSPECTION INSPECTION OF EGGS AND EGG PRODUCTS (EGG PRODUCTS INSPECTION ACT) Exempted Egg Products Plants § 590.640 Application for exemption; approval. Any person desiring to process egg..., a Supervisory Egg Products Inspector will make a survey and inspection of the premises and plant to...

  20. Uniformly accelerated black holes

    NASA Astrophysics Data System (ADS)

    Letelier, Patricio S.; Oliveira, Samuel R.

    2001-09-01

    The static and stationary C metric are examined in a generic framework and their interpretations studied in some detail, especially those with two event horizons, one for the black hole and another for the acceleration. We find that (i) the spacetime of an accelerated static black hole is plagued by either conical singularities or a lack of smoothness and compactness of the black hole horizon, (ii) by using standard black hole thermodynamics we show that accelerated black holes have a higher Hawking temperature than Unruh temperature of the accelerated frame, and (iii) the usual upper bound on the product of the mass and acceleration parameters (<1/27) is just a coordinate artifact. The main results are extended to accelerated rotating black holes with no significant changes.

  1. Plutonium (TRU) transmutation and {sup 233}U production by single-fluid type accelerator molten-salt breeder (AMSB)

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Furukaw, Kazuo; Kato, Yoshio; Chigrinov, Sergey E.

    1995-10-01

    For practical/industrial disposition of Pu(TRU) by accelerator facility, not only physical soundness and safety but also the following technological rationality should be required: (1) few R&D items including radiation damage, heat removal and material compatibility; (2) few operation/maintenance/processing works: (3) few reproduction of radioactivity; (4) effective energy production in parallel. This will be achieved by the new modification of Th-fertilizing Single-Fluid type Accelerator Molten-Salt Breeder (AMSB), by which a global nuclear energy strategy for next century might be prepared.

  2. Preliminary consideration of a double, 480 GeV, fast cycling proton accelerator for production of neutrino beams at Fermilab

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Piekarz, Henryk; Hays, Steven; /Fermilab

    We propose to build the DSF-MR (Double Super-Ferric Main Ring), 480 GeV, fast-cycling (2 second repetition rate) two-beam proton accelerator in the Main Ring tunnel of Fermilab. This accelerator design is based on the super-ferric magnet technology developed for the VLHC, and extended recently to the proposed LER injector for the LHC and fast cycling SF-SPS at CERN. The DSF-MR accelerator system will constitute the final stage of the proton source enabling production of two neutrino beams separated by 2 second time period. These beams will be sent alternately to two detectors located at {approx} 3000 km and {approx} 7500more » km away from Fermilab. It is expected that combination of the results from these experiments will offer more than 3 order of magnitudes increased sensitivity for detection and measurement of neutrino oscillations with respect to expectations in any current experiment, and thus may truly enable opening the window into the physics beyond the Standard Model. We examine potential sites for the long baseline neutrino detectors accepting beams from Fermilab. The current injection system consisting of 400 MeV Linac, 8 GeV Booster and the Main Injector can be used to accelerate protons to 45 GeV before transferring them to the DSF-MR. The implementation of the DSF-MR will allow for an 8-fold increase in beam power on the neutrino production target. In this note we outline the proposed new arrangement of the Fermilab accelerator complex. We also briefly describe the DSF-MR magnet design and its power supply, and discuss necessary upgrade of the Tevatron RF system for the use with the DSF-MR accelerator. Finally, we outline the required R&D, cost estimate and possible timeline for the implementation of the DSF-MR accelerator.« less

  3. 46 CFR 160.076-17 - Approval of design or material changes.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... approval before changing PFD production methods. (b) Determinations of equivalence of design, construction... 46 Shipping 6 2010-10-01 2010-10-01 false Approval of design or material changes. 160.076-17... Flotation Devices § 160.076-17 Approval of design or material changes. (a) The manufacturer must submit any...

  4. Plutonium (TRU) transmutation and {sup 233}U production by single-fluid type accelerator molten-salt breeder (AMSB)

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Furukawa, Kazuo; Kato, Yoshio; Chigrinov, Sergey E.

    1995-09-15

    For practical/industrial disposition of Pu(TRU) by accelerator facility, not only physical soundness and safety but also the following technological rationality should be required: (1) few R and D items including radiation damage, heat removal and material compatibility: (2) few operation/maintenance/processing works; (3) few reproduction of radioactivity; (4) effective energy production in parallel. This will be achieved by the new modification of Th-fertilizing Single-Fluid type Accelerator Molten-Salt Breeder (AMSB), by which a global nuclear energy strategy for next century might be prepared.

  5. Electron Acceleration and Ionization Production in High-Power Heating Experiments at HAARP

    NASA Astrophysics Data System (ADS)

    Mishin, E. V.; Pedersen, T.

    2012-12-01

    Recent ionospheric modification experiments with the 3.6 MW transmitter at the High Frequency Active Auroral Research Program (HAARP) facility in Alaska led to discovery of artificial ionization descending from the nominal interaction altitude in the background F-region ionosphere by ~60-80 km. Artificial ionization production is indicated by significant 427.8 nm emissions from the 1st negative band of N2+ and the appearance of transmitter-induced bottomside traces in ionosonde data during the periods of most intense optical emissions. However, the exact mechanisms producing the artificial plasmas remain to be determined. Yet the only existing theoretical models explain the development of artificial plasma as an ionizing wavefront moving downward due to ionization by electrons accelerated by HF-excited strong Langmuir turbulence (SLT) generated near the plasma resonance, where the pump frequency matches the plasma frequency. However, the observations suggest also the significance of interactions with upper hybrid and electron Bernstein waves near multiples of the electron gyrofrequency. We describe recent observations and discuss suitable acceleration mechanisms.

  6. 76 FR 70795 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice and Order Granting Accelerated...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-15

    ...-Regulatory Organizations; New York Stock Exchange LLC; Notice and Order Granting Accelerated Approval to..., New York Stock Exchange LLC (``NYSE'' or ``Exchange'') filed with the Securities and Exchange... 70796

  7. Gadolinium-148 and other spallation production cross section measurements for accelerator target facilities

    NASA Astrophysics Data System (ADS)

    Kelley, Karen Corzine

    At the Los Alamos Neutron Science Center accelerator complex, protons are accelerated to 800 MeV and directed to two tungsten targets, Target 4 at the Weapons Neutron Research facility and the 1L target at the Lujan Center. The Department of Energy requires hazard classification analyses to be performed on these targets and places limits on certain radionuclide inventories in the targets to avoid characterizing the facilities as "nuclear facilities." Gadolinium-148 is a radionuclide created from the spallation of tungsten. Allowed isotopic inventories are particularly low for this isotope because it is an alpha-particle emitter with a 75-year half-life. The activity level of Gadolinium-148 is low, but it encompasses almost two-thirds of the total dose burden for the two tungsten targets based on present yield estimates. From a hazard classification standpoint, this severely limits the lifetime of these tungsten targets. The cross section is not well-established experimentally and this is the motivation for measuring the Gadolinium-148 production cross section from tungsten. In a series of experiments at the Weapons Neutron Research facility, Gadolinium-148 production was measured for 600- and 800-MeV protons on tungsten, tantalum, and gold. These experiments used 3 mum thin tungsten, tantalum, and gold foils and 10 mum thin aluminum activation foils. In addition, spallation yields were determined for many short-lived and long-lived spallation products with these foils using gamma and alpha spectroscopy and compared with predictions of the Los Alamos National Laboratory codes CEM2k+GEM2 and MCNPX. The cumulative Gadolinium-148 production cross section measured from tantalum, tungsten, and gold for incident 600-MeV protons were 15.2 +/- 4.0, 8.31 +/- 0.92, and 0.591 +/- 0.155, respectively. The average production cross sections measured at 800 MeV were 28.6 +/- 3.5, 19.4 +/- 1.8, and 3.69 +/- 0.50 for tantalum, tungsten, and gold, respectively. These cumulative

  8. The physical and chemical stability of anti-tuberculosis fixed-dose combination products under accelerated climatic conditions.

    PubMed

    Bhutani, H; Mariappan, T T; Singh, S

    2004-09-01

    To determine the physical and chemical stability of anti-tuberculosis fixed-dose combinations (FDC) of rifampicin (RMP), isoniazid (INH), pyrazinamide (PZA) and ethambutol (EMB) sold on the Indian market. The products were stored for 3 months under ICH/WHO accelerated conditions (40 degrees C / 75% RH), with and without the original packaging in the presence and absence of light. The initial RMP, INH and PZA content was found to be within the range of 90-110% of the label claim. However, the products were found to have some chemical instability even initially; one of the tablets also showed physical instability. Under accelerated conditions, the unpackaged products underwent severe changes, whereas both physical and chemical changes were also observed in the packaged formulations. The physical changes were stronger under lighted conditions. A significant finding is that PZA and perhaps EMB may play a catalytic role in the interaction between INH and RMP. This study suggests that, unless they are packed in barrier packaging, anti-tuberculosis FDC formulations should be considered unstable, and due consideration should be given to their development pharmaceutics, packaging and stability testing.

  9. Accelerated Stress Testing of Multi-Source LED Products: Horticulture Lamps and Tunable-White Modules

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Davis, Lynn; Rountree, Kelley; Mills, Karmann

    This report discusses the use of accelerated stress testing (AST) to provide insights into the long-term behavior of commercial products utilizing different types of mid-power LEDs (MP-LEDs) integrated into the same LED module. Test results are presented from two commercial lamps intended for use in horticulture applications and one tunable-white LED module intended for use in educational and office lighting applications. Each of these products is designed to provide a custom spectrum for their targeted applications and each achieves this goal in different ways. Consequently, a comparison of the long-term stability of these devices will provide insights regarding approaches thatmore » could be used to possibly lengthen the lifetime of SSL products.« less

  10. 30 CFR 18.15 - Changes after approval or certification.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Changes after approval or certification. 18.15 Section 18.15 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES General...

  11. 14 CFR 21.95 - Approval of minor changes in type design.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Approval of minor changes in type design... TRANSPORTATION AIRCRAFT CERTIFICATION PROCEDURES FOR PRODUCTS AND PARTS Changes to Type Certificates § 21.95 Approval of minor changes in type design. Minor changes in a type design may be approved under a method...

  12. 14 CFR 21.95 - Approval of minor changes in type design.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 1 2012-01-01 2012-01-01 false Approval of minor changes in type design... TRANSPORTATION AIRCRAFT CERTIFICATION PROCEDURES FOR PRODUCTS AND PARTS Changes to Type Certificates § 21.95 Approval of minor changes in type design. Minor changes in a type design may be approved under a method...

  13. 14 CFR 21.95 - Approval of minor changes in type design.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 1 2013-01-01 2013-01-01 false Approval of minor changes in type design... TRANSPORTATION AIRCRAFT CERTIFICATION PROCEDURES FOR PRODUCTS AND PARTS Changes to Type Certificates § 21.95 Approval of minor changes in type design. Minor changes in a type design may be approved under a method...

  14. 14 CFR 21.95 - Approval of minor changes in type design.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 1 2014-01-01 2014-01-01 false Approval of minor changes in type design... TRANSPORTATION AIRCRAFT CERTIFICATION PROCEDURES FOR PRODUCTS AND PARTS Changes to Type Certificates § 21.95 Approval of minor changes in type design. Minor changes in a type design may be approved under a method...

  15. 14 CFR 21.95 - Approval of minor changes in type design.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 1 2011-01-01 2011-01-01 false Approval of minor changes in type design... TRANSPORTATION AIRCRAFT CERTIFICATION PROCEDURES FOR PRODUCTS AND PARTS Changes to Type Certificates § 21.95 Approval of minor changes in type design. Minor changes in a type design may be approved under a method...

  16. Assessment of candidates for target window material in accelerator-driven molybdenum-99 production

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Strons, Philip; Bailey, James; Makarashvili, Vakhtang

    2016-10-01

    NorthStar Medical Technologies is pursuing production of an important medical isotope, Mo-99, through a photo-nuclear reaction of a Mo-100 target using a high-power electron accelerator. The current target utilizes an Inconel 718 window. The purpose of this study was to evaluate other candidate materials for the target window, which separates the high-pressure helium gas inside the target from the vacuum inside the accelerator beamline and is subjected to significant stress. Our initial analysis assessed the properties (density, thermal conductivity, maximum stress, minimum window thickness, maximum temperature, and figure of merit) for a range of materials, from which the three mostmore » promising were chosen: Inconel 718, 250 maraging steel, and standard-grade beryllium. These materials were subjected to further analysis to determine the effects of thermal and mechanical strain versus beam power at varying thicknesses. Both beryllium and the maraging steel were calculated to withstand more than twice as high beam power than Inconel 718.« less

  17. Recommendations for the development of rare disease drugs using the accelerated approval pathway and for qualifying biomarkers as primary endpoints.

    PubMed

    Kakkis, Emil D; O'Donovan, Mary; Cox, Gerald; Hayes, Mark; Goodsaid, Federico; Tandon, P K; Furlong, Pat; Boynton, Susan; Bozic, Mladen; Orfali, May; Thornton, Mark

    2015-02-10

    For rare serious and life-threatening disorders, there is a tremendous challenge of transforming scientific discoveries into new drug treatments. This challenge has been recognized by all stakeholders who endorse the need for flexibility in the regulatory review process for novel therapeutics to treat rare diseases. In the United States, the best expression of this flexibility was the creation of the Accelerated Approval (AA) pathway. The AA pathway is critically important for the development of treatments for diseases with high unmet medical need and has been used extensively for drugs used to treat cancer and infectious diseases like HIV.In 2012, the AA provisions were amended to enhance the application of the AA pathway to expedite the development of drugs for rare disorders under the Food and Drug Administration Safety and Innovation Act (FDASIA). FDASIA, among many provisions, requires the development of a more relevant FDA guidance on the types of evidence that may be acceptable in support of using a novel surrogate endpoint. The application of AA to rare diseases requires more predictability to drive greater access to appropriate use of AA for more rare disease treatments that might not be developed otherwise.This white paper proposes a scientific framework for assessing biomarker endpoints to enhance the development of novel therapeutics for rare and devastating diseases currently without adequate treatment and is based on the opinions of experts in drug development and rare disease patient groups. Specific recommendations include: 1) Establishing regulatory rationale for increased AA access in rare disease programs; 2) Implementing a Biomarker Qualification Request Process to provide the opportunity for an early determination of biomarker acceptance; and 3) A proposed scientific framework for qualifying biomarkers as primary endpoints. The paper's final section highlights case studies of successful examples that have incorporated biomarker endpoints into

  18. 30 CFR 28.24 - Revocation of certificates of approval.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Revocation of certificates of approval. 28.24 Section 28.24 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS FUSES FOR USE WITH DIRECT CURRENT IN PROVIDING SHORT-CIRCUIT...

  19. 30 CFR 33.10 - Certificates of approval or performance.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Certificates of approval or performance. 33.10 Section 33.10 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS DUST COLLECTORS FOR USE IN CONNECTION WITH ROCK DRILLING IN COAL...

  20. 30 CFR 33.10 - Certificates of approval or performance.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Certificates of approval or performance. 33.10 Section 33.10 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS DUST COLLECTORS FOR USE IN CONNECTION WITH ROCK DRILLING IN COAL...

  1. 30 CFR 33.10 - Certificates of approval or performance.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Certificates of approval or performance. 33.10 Section 33.10 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS DUST COLLECTORS FOR USE IN CONNECTION WITH ROCK DRILLING IN COAL...

  2. 30 CFR 33.10 - Certificates of approval or performance.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Certificates of approval or performance. 33.10 Section 33.10 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS DUST COLLECTORS FOR USE IN CONNECTION WITH ROCK DRILLING IN COAL...

  3. 30 CFR 33.10 - Certificates of approval or performance.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Certificates of approval or performance. 33.10 Section 33.10 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS DUST COLLECTORS FOR USE IN CONNECTION WITH ROCK DRILLING IN COAL...

  4. 46 CFR 160.057-4 - Approval and production tests.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Floating Orange Smoke Distress Signals (15... period of 24 hours. (ii) Smoke emitting time. Ignite specimen according to the directions printed on the signal and place signal in tub or barrel of water. The smoke emitting time of a specimen shall be...

  5. 46 CFR 160.022-4 - Approval and production tests.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Floating Orange Smoke Distress Signals (5... period of 24 hours. (ii) Smoke emitting time. Ignite specimen according to the directions printed on the signal and place signal in tub or barrel of water. The smoke emitting time of a specimen shall be...

  6. 46 CFR 160.022-4 - Approval and production tests.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Floating Orange Smoke Distress Signals (5... period of 24 hours. (ii) Smoke emitting time. Ignite specimen according to the directions printed on the signal and place signal in tub or barrel of water. The smoke emitting time of a specimen shall be...

  7. 46 CFR 160.022-4 - Approval and production tests.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Floating Orange Smoke Distress Signals (5... period of 24 hours. (ii) Smoke emitting time. Ignite specimen according to the directions printed on the signal and place signal in tub or barrel of water. The smoke emitting time of a specimen shall be...

  8. 46 CFR 160.057-4 - Approval and production tests.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Floating Orange Smoke Distress Signals (15... period of 24 hours. (ii) Smoke emitting time. Ignite specimen according to the directions printed on the signal and place signal in tub or barrel of water. The smoke emitting time of a specimen shall be...

  9. 46 CFR 160.057-4 - Approval and production tests.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Floating Orange Smoke Distress Signals (15... period of 24 hours. (ii) Smoke emitting time. Ignite specimen according to the directions printed on the signal and place signal in tub or barrel of water. The smoke emitting time of a specimen shall be...

  10. 21 CFR 530.13 - Extralabel use from compounding of approved new animal and approved human drugs.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... of a product from approved animal or human drugs by a veterinarian or a pharmacist on the order of a... pharmacist or veterinarian within the scope of a professional practice; (4) Adequate procedures and processes...

  11. 21 CFR 530.13 - Extralabel use from compounding of approved new animal and approved human drugs.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... of a product from approved animal or human drugs by a veterinarian or a pharmacist on the order of a... pharmacist or veterinarian within the scope of a professional practice; (4) Adequate procedures and processes...

  12. 21 CFR 530.13 - Extralabel use from compounding of approved new animal and approved human drugs.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... of a product from approved animal or human drugs by a veterinarian or a pharmacist on the order of a... pharmacist or veterinarian within the scope of a professional practice; (4) Adequate procedures and processes...

  13. 21 CFR 530.13 - Extralabel use from compounding of approved new animal and approved human drugs.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... of a product from approved animal or human drugs by a veterinarian or a pharmacist on the order of a... pharmacist or veterinarian within the scope of a professional practice; (4) Adequate procedures and processes...

  14. 21 CFR 530.13 - Extralabel use from compounding of approved new animal and approved human drugs.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... of a product from approved animal or human drugs by a veterinarian or a pharmacist on the order of a... pharmacist or veterinarian within the scope of a professional practice; (4) Adequate procedures and processes...

  15. 9 CFR 590.435 - Wholesomeness and approval of materials.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ..., DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION INSPECTION OF EGGS AND EGG PRODUCTS (EGG PRODUCTS INSPECTION ACT) Entry of Material into Official Egg Products Plants § 590.435 Wholesomeness and approval of materials. (a) Substances and ingredients used in the manufacture or preparation of any egg product capable...

  16. Accelerating regenerative medicine: the Japanese experiment in ethics and regulation.

    PubMed

    Lysaght, Tamra

    2017-09-01

    In 2014, the Japanese National Diet introduced new laws aimed at promoting the clinical translation of stem cells and regenerative medicine. The basic action of these laws is to allow the early introduction of regenerative medicine products into the Japanese market through an accelerated approval process, while providing patients with access to certain types of stem cell and cell-based therapies in the context of private clinical practice. While this framework appears to offer enormous opportunities for the translation of stem cell science, it raises ethical challenges that have not yet been fully explored. This paper critically analyzes this framework with respect to the prioritization of safety over clinical benefit, distributive justice and public trust in science and medicine. It is argued that the framework unfairly burdens patients and strained healthcare systems without any clear benefits, and may undermine the credibility of the regenerative medicine field as it emerges.

  17. FDA's Flexibility in Subpart H Approvals: Assessing Quantum of Effectiveness Evidence.

    PubMed

    Sasinowski, Frank J; Varond, Alexander J

    2016-08-01

    This article examines the strength of scientific and clinical evidence for FDA's nineteen non-AIDS, non-cancer Subpart H approval determinations over the Accelerated Approval program's twenty-four year existence. The authors researched the bases for FDA's determinations when an unvalidated surrogate or intermediate clinical endpoint is "reasonably likely to predict clinical benefit." The four key factors set forth in FDA's "Guidance for Industry, Expedited Programs for Serious Conditions - Drugs and Biologics" were applied to past Subpart H approvals. For the nineteen precedents, the authors found wide variances between the quantum and quality of evidence on each of the four factors, indicating that a lack of evidence on any single factor was not disqualifying in and of itself. The results of this study, therefore, show that FDA exercises extraordinarily more regulatory flexibility than either FDA's foundational statutes or even FDA' s most recent 2014 Expedited Programs Guidance explicitly express. Given recent legislative exhortations and the increasing promise of personalized medicine and translational sciences, the authors conclude that Subpart H should be further explored and utilized. The authors provide a detailed analysis of the orecedents established in the nineteen approvals.

  18. 9 CFR 355.34 - Labels, approval of, by Administrator.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Labels, approval of, by Administrator..., CERTIFICATION, AND IDENTIFICATION AS TO CLASS, QUALITY, QUANTITY, AND CONDITION Labeling § 355.34 Labels, approval of, by Administrator. (a) Except as provided in paragraph (c) of this section, no label shall be...

  19. Gender-specific Regulatory Challenges to Product Approval: a panel discussion.

    PubMed

    McGregor, Alyson J; Barr, Helen; Greenberg, Marna R; Safdar, Basmah; Wildgoose, Peter; Wright, David W; Hollander, Judd E

    2014-12-01

    On May 13, 2014, a 1-hour panel discussion session titled "Gender-specific Regulatory Challenges to Product Approval" was held during the Academic Emergency Medicine consensus conference, "Gender-specific Research in Emergency Medicine: Investigate, Understand, and Translate How Gender Affects Patient Outcomes." The session sought to bring together leaders in emergency medicine (EM) research, authors, and reviewers in EM research publications, as well as faculty, fellows, residents, and students engaged in research and clinical practice. A panel was convened involving a representative from the Office of Women's Health of the U.S. Food and Drug Administration, two pharmaceutical executives, and a clinical EM researcher. The moderated discussion also involved audience members who contributed significantly to the dialogue. Historical background leading up to the session along with the main themes of the discussion are reproduced in this article. These revolve around sex- and gender-specific research, statistical analysis of sex and gender, clinical practice, financial costs associated with pharmaceutical development, adaptive design, and specific recommendations on the regulatory process as it affects the specialty of EM. © 2014 by the Society for Academic Emergency Medicine.

  20. 49 CFR 451.16 - Action by approval authority-individual approval.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.16 Action by approval authority-individual approval. (a) The...

  1. 49 CFR 451.16 - Action by approval authority-individual approval.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.16 Action by approval authority-individual approval. (a) The...

  2. 49 CFR 451.16 - Action by approval authority-individual approval.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.16 Action by approval authority-individual approval. (a) The...

  3. 49 CFR 451.16 - Action by approval authority-individual approval.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.16 Action by approval authority-individual approval. (a) The...

  4. 49 CFR 451.16 - Action by approval authority-individual approval.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.16 Action by approval authority-individual approval. (a) The...

  5. Era of faster FDA drug approval has also seen increased black-box warnings and market withdrawals.

    PubMed

    Frank, Cassie; Himmelstein, David U; Woolhandler, Steffie; Bor, David H; Wolfe, Sidney M; Heymann, Orlaith; Zallman, Leah; Lasser, Karen E

    2014-08-01

    After approval, many prescription medications that patients rely on subsequently receive new black-box warnings or are withdrawn from the market because of safety concerns. We examined whether the frequency of these safety problems has increased since 1992, when the Prescription Drug User Fee Act, legislation designed to accelerate the drug approval process at the Food and Drug Administration, was passed. We found that drugs approved after the act's passage were more likely to receive a new black-box warning or be withdrawn than drugs approved before its passage (26.7 per 100.0 drugs versus 21.2 per 100.0 drugs at up to sixteen years of follow-up). We could not establish causality, however. Our findings suggest the need for reforms to reduce patients' exposure to unsafe drugs, such as a statement or symbol in the labeling, medication guides for patients, and marketing materials indicating that a drug was approved only recently. Project HOPE—The People-to-People Health Foundation, Inc.

  6. 30 CFR 20.0 - Compliance with the requirements necessary for obtaining approval.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MINE LAMPS OTHER THAN STANDARD CAP LAMPS § 20.0 Compliance with the requirements necessary for obtaining approval. To receive approval of MSHA for any electric mine lamps other than standard cap lamps a manufacturer must comply with the...

  7. 30 CFR 20.0 - Compliance with the requirements necessary for obtaining approval.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MINE LAMPS OTHER THAN STANDARD CAP LAMPS § 20.0 Compliance with the requirements necessary for obtaining approval. To receive approval of MSHA for any electric mine lamps other than standard cap lamps a manufacturer must comply with the...

  8. 30 CFR 20.0 - Compliance with the requirements necessary for obtaining approval.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MINE LAMPS OTHER THAN STANDARD CAP LAMPS § 20.0 Compliance with the requirements necessary for obtaining approval. To receive approval of MSHA for any electric mine lamps other than standard cap lamps a manufacturer must comply with the...

  9. 30 CFR 20.0 - Compliance with the requirements necessary for obtaining approval.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MINE LAMPS OTHER THAN STANDARD CAP LAMPS § 20.0 Compliance with the requirements necessary for obtaining approval. To receive approval of MSHA for any electric mine lamps other than standard cap lamps a manufacturer must comply with the...

  10. 7 CFR 58.122 - Approved plants under USDA inspection and grading service.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 3 2011-01-01 2011-01-01 false Approved plants under USDA inspection and grading... FOR GRADES OF DAIRY PRODUCTS 1 General Specifications for Dairy Plants Approved for USDA Inspection and Grading Service 1 Purpose § 58.122 Approved plants under USDA inspection and grading service. (a...

  11. 7 CFR 58.122 - Approved plants under USDA inspection and grading service.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 3 2014-01-01 2014-01-01 false Approved plants under USDA inspection and grading... FOR GRADES OF DAIRY PRODUCTS 1 General Specifications for Dairy Plants Approved for USDA Inspection and Grading Service 1 Purpose § 58.122 Approved plants under USDA inspection and grading service. (a...

  12. 7 CFR 58.122 - Approved plants under USDA inspection and grading service.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 3 2012-01-01 2012-01-01 false Approved plants under USDA inspection and grading... FOR GRADES OF DAIRY PRODUCTS 1 General Specifications for Dairy Plants Approved for USDA Inspection and Grading Service 1 Purpose § 58.122 Approved plants under USDA inspection and grading service. (a...

  13. 7 CFR 58.122 - Approved plants under USDA inspection and grading service.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 3 2013-01-01 2013-01-01 false Approved plants under USDA inspection and grading... FOR GRADES OF DAIRY PRODUCTS 1 General Specifications for Dairy Plants Approved for USDA Inspection and Grading Service 1 Purpose § 58.122 Approved plants under USDA inspection and grading service. (a...

  14. 7 CFR 58.122 - Approved plants under USDA inspection and grading service.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 3 2010-01-01 2010-01-01 false Approved plants under USDA inspection and grading... FOR GRADES OF DAIRY PRODUCTS 1 General Specifications for Dairy Plants Approved for USDA Inspection and Grading Service 1 Purpose § 58.122 Approved plants under USDA inspection and grading service. (a...

  15. 46 CFR 160.031-5 - Approval and production tests.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Line-Throwing Appliance, Shoulder Gun Type (and... test. The operational test must be conducted as follows: (1) Three rounds must be fired by the gun, at... of the projectile must be in accordance with § 160.031-3(d) the gun must fire each round properly and...

  16. 46 CFR 160.031-5 - Approval and production tests.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Line-Throwing Appliance, Shoulder Gun Type (and... test. The operational test must be conducted as follows: (1) Three rounds must be fired by the gun, at... of the projectile must be in accordance with § 160.031-3(d) the gun must fire each round properly and...

  17. 46 CFR 160.031-5 - Approval and production tests.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Line-Throwing Appliance, Shoulder Gun Type (and... test. The operational test must be conducted as follows: (1) Three rounds must be fired by the gun, at... of the projectile must be in accordance with § 160.031-3(d) the gun must fire each round properly and...

  18. 46 CFR 160.031-5 - Approval and production tests.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Line-Throwing Appliance, Shoulder Gun Type (and... test. The operational test must be conducted as follows: (1) Three rounds must be fired by the gun, at... of the projectile must be in accordance with § 160.031-3(d) the gun must fire each round properly and...

  19. 46 CFR 160.031-5 - Approval and production tests.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Line-Throwing Appliance, Shoulder Gun Type (and... test. The operational test must be conducted as follows: (1) Three rounds must be fired by the gun, at... of the projectile must be in accordance with § 160.031-3(d) the gun must fire each round properly and...

  20. How to Seek EPA Approval for Pesticide Applicator Soil Fumigation Exams

    EPA Pesticide Factsheets

    Registrants of soil fumigant products offer EPA-approved training for certified pesticide applicators. Although not required, state lead agencies (SLAs) may seek EPA’s approval and provide applicators with an alternative to registrant-sponsored training.

  1. Recent drug approvals from the US FDA and EMEA: what the future holds.

    PubMed

    Pevarello, Paolo

    2009-04-01

    The decreased productivity of the pharmaceutical industry in terms of new medical entities approved by the US FDA and the European Medicines Agency (EMEA) on a yearly basis has long been debated. This review will analyze overall new drug applications (NDAs) approved by both the FDA and EMEA in 2007, with the aim of finding trends (also looking at the past) that can be used to predict what the future may be. After a general introduction to the regulatory terminology, NDA approvals in 2007 are divided into categories (new applications of old medicines, metabolites, enantiomers and prodrugs, biological products, natural products and small organic molecule new molecular entities) and discussed. General aspects of the NDA approvals, such as historical trends, the length of the drug-discovery process, geography, differences among therapeutic areas, and the relative role of biotech and pharma industries are also outlined. From this analysis, a perspective is gained on some aspects that will probably influence future drug approvals. The conclusion is that 2007 may represent an inflexion point, in terms of quality if not quantity of new approvals, and that the future may be brighter than previously forecast.

  2. Do the EMA accelerated assessment procedure and the FDA priority review ensure a therapeutic added value? 2006-2015: a cohort study.

    PubMed

    Boucaud-Maitre, Denis; Altman, Jean-Jacques

    2016-10-01

    The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have both implemented procedures in order to shorten review time for marketing authorizations with potential therapeutic added value, called priority review and accelerated assessment procedure, respectively. The aim of this study is to compare the new molecular entities (NME) assessed in shorter review time by both agencies and to investigate whether granting a shorter review time status subsequently predicts its therapeutic value attributed by a health technology assessment agency, the French Haute Autorité de Santé (HAS). All NME approved by the EMA and the FDA with a therapeutic added value between 2007 and June 30, 2015 were extracted. We assessed the sensibility, the positive predictive value, and the EMA review time. One hundred seventy-eight NME were approved by the FDA and the EMA and a therapeutic value was available for 160 NME. Eighty-eight (55.0 %) NME were on FDA priority review, 24 (15.0 %) on EMA accelerated procedure and 43 (26.9 %) were considered of high clinical added value. The sensibility was 86.0 % for the FDA and 30.2 % for the EMA. The positive predictive value was, respectively, 42.0 and 54.2 %. Twenty-five NME on FDA priority review and of high therapeutic added value were not on EMA accelerated assessment procedure, leading to a supplementary mean EMA review time of 146 days. The EMA was restrictive to grant a shorten review time status for products with therapeutic interest during the study period.

  3. 77 FR 65917 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Granting Accelerated...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-31

    ... Organizations; The Options Clearing Corporation; Order Granting Accelerated Approval of Proposed Rule Change To Accommodate Equity Options That Have a Unit of Trading of 10 Shares October 25, 2012. I. Introduction On September 12, 2012, the Options Clearing Corporation (``OCC'') filed with the Securities and Exchange...

  4. 30 CFR 18.91 - Electric equipment for which field approvals will be issued.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Electric equipment for which field approvals... OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.91 Electric equipment...

  5. 30 CFR 18.91 - Electric equipment for which field approvals will be issued.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Electric equipment for which field approvals... OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.91 Electric equipment...

  6. 30 CFR 18.16 - Withdrawal of approval, certification, or acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Withdrawal of approval, certification, or acceptance. 18.16 Section 18.16 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES...

  7. 7 CFR 205.622 - Review of approved State organic programs.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ...) ORGANIC FOODS PRODUCTION ACT PROVISIONS NATIONAL ORGANIC PROGRAM Administrative State Organic Programs § 205.622 Review of approved State organic programs. The Secretary will review a State organic program... 7 Agriculture 3 2010-01-01 2010-01-01 false Review of approved State organic programs. 205.622...

  8. Investigation of product quality between extemporaneously compounded progesterone vaginal suppositories and an approved progesterone vaginal gel.

    PubMed

    Mahaguna, Vorapann; McDermott, J Mario; Zhang, Feng; Ochoa, Felipe

    2004-01-01

    The purpose of this investigation was to compare quality parameters, including product appearance, content uniformity, pH, weight uniformity, microbial limit testing and preservative effectiveness testing on extemporaneously compounded progesterone vaginal suppositories obtained from 10 randomly chosen compounding pharmacies (90 suppositories each) across the United States, to the Food and Drug Administration (FDA) approved prescription progesterone gel product (Prochieve/Crinone) which is manufactured in a cGMP regulated facility. The content uniformity and pH were determined using qualified methods. The microbial limits testing and preservative effectiveness testing were conducted according to compendial methods. Only one pharmacy provided suppositories that were all within the potency limits required for the prescription progesterone gel product. The other pharmacies provided at least some suppositories where progesterone content was either subpotent or superpotent for progesterone. The pH of most of the compounded suppository products was in the range of 4.22 to 7.68 with a median of 6.30 (normal vaginal pH is <5), whereas the gel product was 2.80. For compounded product from one of the pharmacies, microbial limits testing indicated CDC group IVC-2 and Comamonas acidovorans were detected. This data indicates that pharmacy compounded delivery systems for progesterone should be used with caution.

  9. 9 CFR 317.4 - Labeling approval.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Devices, except for generically approved labeling authorized for use in § 317.5(b). The management of the... carcass ink brands and meat food product ink and burning brands, which comply with parts 312 and 316 of...

  10. 78 FR 65293 - Collection of Information; Proposed Extension of Approval; Comment Request-Publicly Available...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-31

    ... Extension of Approval; Comment Request--Publicly Available Consumer Product Safety Information Database... Publicly Available Consumer Product Safety Information Database. The Commission will consider all comments... intention to seek extension of approval of a collection of information for a database on the safety of...

  11. 12 CFR 1253.6 - Certifying and nullifying an approval.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... this paragraph, an Enterprise's authority to offer a new product or engage in a new activity by reason... PRODUCTS § 1253.6 Certifying and nullifying an approval. (a) An Enterprise shall certify, through an...

  12. Determination of lutein from green tea and green tea by-products using accelerated solvent extraction and UPLC.

    PubMed

    Heo, Ji-Young; Kim, Suna; Kang, Jae-Hyun; Moon, Bokyung

    2014-05-01

    We aimed to identify the optimum conditions for the extraction of lutein from green tea using accelerated solvent extraction, and achieve improved analytical resolution and sensitivity between lutein and zeaxanthin using an ultra performance liquid chromatography (UPLC) system. The optimized method employed 80% ethanol as the extraction solvent, 160 °C as the temperature, 2 static cycles, and 5 min of static time. In the validation of the UPLC method, recovery was found to be in the range approximately 93.73 to 108.79%, with a correlation coefficient of 0.9974 and a relative standard deviation of <9.29% in inter- and intraday precision analyses. Finally, the lutein contents of green tea and green tea by-products were measured as 32.67 ± 0.70 and 18.18 ± 0.68 mg/100g dw, respectively. Furthermore, we verified that green tea by-products, which are discarded after producing green tea beverages, might be used as a great resource for massive lutein production. We have demonstrated that the common problem of inadequate resolution between lutein and zeaxanthin during carotenoid analyses can be overcome by optimizing the combined techniques of accelerated solvent extraction and ultra performance liquid chromatography (UPLC). UPLC was highly effective for saving time, solvent, and labor, as well as providing better resolution. The results in this study demonstrated that green tea by-products could be used as new sources for industrial lutein production owing to their massive production during the extraction of green tea beverages. © 2014 Institute of Food Technologists®

  13. The European Medicines Agency's approval of new medicines for type 2 diabetes.

    PubMed

    Blind, Eberhard; Janssen, Heidi; Dunder, Kristina; de Graeff, Pieter A

    2018-05-08

    Since 2005, more than 40 new medicines for the treatment of type 2 diabetes have been introduced on the market. These consist of 15 new active substances establishing three new classes of non-insulin products, and several new or modified insulin products and combinations. The approval of these products in Europe is regulated via the centralized procedure at the European Medicines Agency. Demonstration of benefit with regard to improved glucose control remains the principal outcome required from confirmatory studies to demonstrate efficacy. For the majority of these new medicines approved since 2005, cardiovascular outcome trials have now been completed, and have invariably supported the cardiovascular safety of these products. In some of these trials additional important benefits have been observed, for instance, a reduction in major adverse cardiovascular events and improvement of renal outcome. The existing regulatory framework and the continuous adaption of regulatory requirements to emerging developments will continue to guide the approval of new products in the future. © 2018 John Wiley & Sons Ltd.

  14. 78 FR 66758 - Accreditation and Approval of AMSPEC Services, LLC, as a Commercial Gauger

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-06

    ... approved to gauge petroleum and petroleum products, organic chemicals and vegetable oils for customs... INFORMATION: Notice is hereby given pursuant to 19 CFR 151.13, AmSpec Services, LLC, Chemical Division, 11725 Port Road, Seabrook, TX 77586, has been approved to gauge petroleum and petroleum products, organic...

  15. 9 CFR 355.34 - Labels, approval of, by Administrator.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Labels, approval of, by Administrator. 355.34 Section 355.34 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF... INSPECTION AND CERTIFICATION CERTIFIED PRODUCTS FOR DOGS, CATS, AND OTHER CARNIVORA; INSPECTION...

  16. Tanning accelerators: prevalence, predictors of use, and adverse effects.

    PubMed

    Herrmann, Jennifer L; Cunningham, Rachel; Cantor, Alan; Elewski, Boni E; Elmets, Craig A

    2015-01-01

    Tanning accelerators are topical products used by indoor tanners to augment and hasten the tanning process. These products contain tyrosine, psoralens, and/or other chemicals. We sought to better define the population using accelerators, identify predictors of their use, and describe any related adverse effects. This cross-sectional study surveyed 200 indoor tanners about their tanning practices and accelerator use. Primary analysis compared accelerator users with nonusers with respect to questionnaire variables. Descriptive statistics and χ(2) contingency tables were applied to identify statistically significant variables. Of respondents, 53% used accelerators; 97% were female and 3% were male with a median age of 22 years (range: 19-67). Users were more likely to spray tan, tan frequently, and be addicted to tanning. Acne and rashes were more common in accelerator users. Adverse reactions to accelerators prevented their further use 31% of the time. A limited adult population was evaluated; exact accelerator ingredients were not examined. Tanning accelerator users are high-risk indoor tanners who tan more frequently and who are more likely addicted to tanning. Acne and rashes are more common with these products and act as only mild deterrents to continued use. Additional research should investigate accelerators' longer-term health effects. Copyright © 2014 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

  17. 14 CFR 21.303 - Approval of materials, parts, processes, and appliances.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 1 2011-01-01 2011-01-01 false Approval of materials, parts, processes, and appliances. 21.303 Section 21.303 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT CERTIFICATION PROCEDURES FOR PRODUCTS AND PARTS Approval of Materials...

  18. 27 CFR 17.133 - Food product formulas.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2012-04-01 2012-04-01 false Food product formulas. 17... PRODUCTS Formulas and Samples Approval of Formulas § 17.133 Food product formulas. Formulas for nonbeverage food products on TTB Form 5154.1 may be approved if they are unfit for beverage purposes. Approval does...

  19. 27 CFR 17.133 - Food product formulas.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Food product formulas. 17... PRODUCTS Formulas and Samples Approval of Formulas § 17.133 Food product formulas. Formulas for nonbeverage food products on TTB Form 5154.1 may be approved if they are unfit for beverage purposes. Approval does...

  20. 27 CFR 17.133 - Food product formulas.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2014-04-01 2014-04-01 false Food product formulas. 17... PRODUCTS Formulas and Samples Approval of Formulas § 17.133 Food product formulas. Formulas for nonbeverage food products on TTB Form 5154.1 may be approved if they are unfit for beverage purposes. Approval does...

  1. 27 CFR 17.133 - Food product formulas.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2013-04-01 2013-04-01 false Food product formulas. 17... PRODUCTS Formulas and Samples Approval of Formulas § 17.133 Food product formulas. Formulas for nonbeverage food products on TTB Form 5154.1 may be approved if they are unfit for beverage purposes. Approval does...

  2. 27 CFR 17.133 - Food product formulas.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2011-04-01 2011-04-01 false Food product formulas. 17... PRODUCTS Formulas and Samples Approval of Formulas § 17.133 Food product formulas. Formulas for nonbeverage food products on TTB Form 5154.1 may be approved if they are unfit for beverage purposes. Approval does...

  3. Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011.

    PubMed

    Rathi, Vinay K; Krumholz, Harlan M; Masoudi, Frederick A; Ross, Joseph S

    2015-08-11

    The US Food and Drug Administration (FDA) approves high-risk medical devices, those that support or sustain human life or present potential unreasonable risk to patients, via the Premarket Approval (PMA) pathway. The generation of clinical evidence to understand device safety and effectiveness is shifting from predominantly premarket to continual study throughout the total product life cycle. To characterize the clinical evidence generated for high-risk therapeutic devices over the total product life cycle. All clinical studies of high-risk therapeutic devices receiving initial market approval via the PMA pathway in 2010 and 2011 identified through ClinicalTrials.gov and publicly available FDA documents as of October 2014. Studies were characterized by type (pivotal, studies that served as the basis of FDA approval; FDA-required postapproval studies [PAS]; or manufacturer/investigator-initiated); premarket or postmarket; status (completed, ongoing, or terminated/unknown); and design features, including enrollment, comparator, and longest duration of primary effectiveness end point follow-up. In 2010 and 2011, 28 high-risk therapeutic devices received initial marketing approval via the PMA pathway. We identified 286 clinical studies of these devices: 82 (28.7%) premarket and 204 (71.3%) postmarket, among which there were 52 (18.2%) nonpivotal premarket studies, 30 (10.5%) pivotal premarket studies, 33 (11.5%) FDA-required PAS, and 171 (59.8%) manufacturer/investigator-initiated postmarket studies. Six of 33 (18.2%) PAS and 20 of 171 (11.7%) manufacturer/investigator-initiated postmarket studies were reported as completed. No postmarket studies were identified for 5 (17.9%) devices; 3 or fewer were identified for 13 (46.4%) devices overall. Median enrollment was 65 patients (interquartile range [IQR], 25-111), 241 patients (IQR, 147-415), 222 patients (IQR, 119-640), and 250 patients (IQR, 60-800) for nonpivotal premarket, pivotal, FDA-required PAS, and manufacturer

  4. 9 CFR 112.5 - Review and approval of labeling.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Review and approval of labeling. 112.5 Section 112.5 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PACKAGING AND LABELING...

  5. 9 CFR 112.5 - Review and approval of labeling.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Review and approval of labeling. 112.5 Section 112.5 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PACKAGING AND LABELING...

  6. 9 CFR 112.5 - Review and approval of labeling.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Review and approval of labeling. 112.5 Section 112.5 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PACKAGING AND LABELING...

  7. 9 CFR 112.5 - Review and approval of labeling.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Review and approval of labeling. 112.5 Section 112.5 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PACKAGING AND LABELING...

  8. 9 CFR 112.5 - Review and approval of labeling.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Review and approval of labeling. 112.5 Section 112.5 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PACKAGING AND LABELING...

  9. Acceleration of Aglycone Isoflavone and γ-Aminobutyric Acid Production from Doenjang Using Whole-Cell Biocatalysis Accompanied by Protease Treatment.

    PubMed

    Li, Yincong; Ku, Seockmo; Park, Myeong Soo; Li, Zhipeng; Ji, Geun Eog

    2017-11-28

    Recently, soybean isoflavone aglycones ( i.e. , daidzein and genistein) and γ-aminobutyric acid (GABA) have begun to receive considerable consumer attention owing to their potential as nutraceuticals. To produce these ingredients, multiple microorganisms and their enzymes are commonly used for catalysis in the nutraceutical industry. In this work, we introduce a novel fermentation process that uses whole-cell biocatalysis to accelerate GABA and isoflavone aglycone production in doenjang (a traditional Korean soybean paste). Microbial enzymes transform soybean isoflavone glycosides ( i.e. , daidzin and genistin) and monosodium glutamate into soybean isoflavone aglycones and GABA. Lactobacillus brevis GABA 100 and Aspergillus oryzae KACC 40250 significantly reduced the production time with the aid of a protease. The resulting levels of GABA and daidzein were higher, and genistein production resembled the levels in traditional doenjang fermented for over a year. Concentrations of GABA, daidzein, and genistein were measured as 7,162, 60, and 59 μg/g, respectively on the seventh day of fermentation. Our results demonstrate that the administration of whole-cell L. brevis GABA 100 and A. oryzae KACC 40250 paired with a protease treatment is an effective method to accelerate GABA, daidzein, and genistein production in doenjang.

  10. 46 CFR 160.176-6 - Procedure for approval of design or material revision.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Procedure for approval of design or material revision... Lifejackets § 160.176-6 Procedure for approval of design or material revision. (a) Each change in design, material, or construction must be approved by the Commandant before being used in lifejacket production. (b...

  11. Beyond injection: Trojan horse underdense photocathode plasma wakefield acceleration

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Hidding, B.; Rosenzweig, J. B.; Xi, Y.

    2012-12-21

    An overview on the underlying principles of the hybrid plasma wakefield acceleration scheme dubbed 'Trojan Horse' acceleration is given. The concept is based on laser-controlled release of electrons directly into a particle-beam-driven plasma blowout, paving the way for controlled, shapeable electron bunches with ultralow emittance and ultrahigh brightness. Combining the virtues of a low-ionization-threshold underdense photocathode with the GV/m-scale electric fields of a practically dephasing-free beam-driven plasma blowout, this constitutes a 4th generation electron acceleration scheme. It is applicable as a beam brightness transformer for electron bunches from LWFA and PWFA systems alike. At FACET, the proof-of-concept experiment 'E-210: Trojanmore » Horse Plasma Wakefield Acceleration' has recently been approved and is in preparation. At the same time, various LWFA facilities are currently considered to host experiments aiming at stabilizing and boosting the electron bunch output quality via a trojan horse afterburner stage. Since normalized emittance and brightness can be improved by many orders of magnitude, the scheme is an ideal candidate for light sources such as free-electron-lasers and those based on Thomson scattering and betatron radiation alike.« less

  12. Radioactive ion beam acceleration at MAFF

    NASA Astrophysics Data System (ADS)

    Pasini, M.; Kester, O.; Habs, D.; Groß, M.; Sieber, T.; Maier, H. J.; Assmann, W.; Krüken, R.; Faestermann, T.; Schempp, A.; Ratzinger, U.; Safvan, C. P.

    2004-12-01

    In April 2003, the German safety commission has given the final approval for the oper- ation of the high flux reactor FRM-II. This is an important step towards the development and installation of the Munich accelerator for fission fragments (MAFF), which will deliver highest intensities of neutron rich fission fragments. The acceleration chain of MAFF [1] consists of a charge breeder, which will deliver the ions with a mass to charge ratio of A/q ⩽ 6.3 irrespective of the mass range, and with a repetition rate of maximum 50 Hz. The LINAC operating at 10% duty cycle is composed of a 101.28 IH-RFQ, which will boost up the energy from 2.5 up to 300 keV/u, three IH-tanks that will deliver an energy of 5.4 MeV/u and 2 seven gap IH-resonators that are used to vary the final energy up to a maximum of 5.9 MeV/u. Currently beam dynamics revisions are in progress especially in the low energy section, since the experimental program has requested specific time structures of the beam for TOF experiments. The status of the beam dynamics studies as well as the status of the single components of the accelerator will be presented in this paper.

  13. 9 CFR 592.180 - Suspension of plant approval.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Suspension of plant approval. 592.180 Section 592.180 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE..., and all labels, seals, tags, or packaging material bearing official identification shall, under the...

  14. 42 CFR 84.30 - Certificates of approval; scope of approval.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 1 2011-10-01 2011-10-01 false Certificates of approval; scope of approval. 84.30 Section 84.30 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Approval and...

  15. 42 CFR 84.30 - Certificates of approval; scope of approval.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 1 2013-10-01 2013-10-01 false Certificates of approval; scope of approval. 84.30 Section 84.30 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Approval and...

  16. 42 CFR 84.30 - Certificates of approval; scope of approval.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 1 2012-10-01 2012-10-01 false Certificates of approval; scope of approval. 84.30 Section 84.30 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Approval and...

  17. 42 CFR 84.30 - Certificates of approval; scope of approval.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 1 2014-10-01 2014-10-01 false Certificates of approval; scope of approval. 84.30 Section 84.30 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Approval and...

  18. 42 CFR 84.30 - Certificates of approval; scope of approval.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Certificates of approval; scope of approval. 84.30 Section 84.30 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Approval and...

  19. Beam line shielding calculations for an Electron Accelerator Mo-99 production facility

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Mocko, Michal

    2016-05-03

    The purpose of this study is to evaluate the photon and neutron fields in and around the latest beam line design for the Mo-99 production facility. The radiation dose to the beam line components (quadrupoles, dipoles, beam stops and the linear accelerator) are calculated in the present report. The beam line design assumes placement of two cameras: infra red (IR) and optical transition radiation (OTR) for continuous monitoring of the beam spot on target during irradiation. The cameras will be placed off the beam axis offset in vertical direction. We explored typical shielding arrangements for the cameras and report themore » resulting neutron and photon dose fields.« less

  20. 49 CFR 451.13 - Action by approval authority-approval by design type.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ...) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.13 Action by approval authority-approval by design type. (a) The... of safety approval plates to the containers. Absence of individual inspections will not relieve the...

  1. 49 CFR 451.13 - Action by approval authority-approval by design type.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.13 Action by approval authority-approval by design type. (a) The... of safety approval plates to the containers. Absence of individual inspections will not relieve the...

  2. 49 CFR 451.13 - Action by approval authority-approval by design type.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ...) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.13 Action by approval authority-approval by design type. (a) The... of safety approval plates to the containers. Absence of individual inspections will not relieve the...

  3. 49 CFR 451.13 - Action by approval authority-approval by design type.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ...) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.13 Action by approval authority-approval by design type. (a) The... of safety approval plates to the containers. Absence of individual inspections will not relieve the...

  4. 49 CFR 451.13 - Action by approval authority-approval by design type.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ...) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.13 Action by approval authority-approval by design type. (a) The... of safety approval plates to the containers. Absence of individual inspections will not relieve the...

  5. 21 CFR 515.20 - Approval of medicated feed mill license applications.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Approval of medicated feed mill license... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS MEDICATED FEED MILL LICENSE Administrative Actions on Licenses § 515.20 Approval of medicated feed mill license applications. Within 90 days after an...

  6. [Interchangeability of biological drugs: considerations about the approval of biogeneric formulations in Chile].

    PubMed

    Saavedra S, Iván; Quiñones S, Luis

    2006-12-01

    Once drug patents expire, the health authorities can approve the registry of similar products. They must request to the manufacturer, the bibliographic background of the original product and the analytical results that certify drug quality. An inspection of the premises of the manufacturer is also required. The main goal of this approval is to decrease cost, considering that the original product is usually more expensive. This is a current situation due to the imminent expiration of the patents of many biopharmaceutical products. Therefore, in Chile, the Public Health (ISP) and the Ministry of Health should consider that for this kind of products, until now, there are no interchangeable generic drugs, and that the similar drugs that are offered have a different chemical composition, since they have been manufactured through different processes. In the case of biological drugs (e.g. erythropoietir, somatotropin, heparin) the quality and homogeneity depend from the manufacture process. Its complete composition can not be absolutely elucidated; therefore small impurities or conformational variants can elicit an altered immune response or unexpected adverse reactions. This indicates that the approval of a biogeneric drug requires in addition to pharmacokinetic studies, preclinical and clinical analytical studies such as physicochemical assays, biological and immunological test. This issues have been established by WHO and have been incorporated for the main drug registry entities all over the world (FDA, EMEA, ANVISA) to approve biogeneric products.

  7. Supplements and other changes to an approved application. Final rule.

    PubMed

    2004-04-08

    The Food and Drug Administration (FDA) is amending its regulations on supplements and other changes to an approved application to implement the manufacturing changes provision of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The final rule requires manufacturers to assess the effects of manufacturing changes on the identity, strength, quality, purity, and potency of a drug or biological product as those factors relate to the safety or effectiveness of the product. The final rule sets forth requirements for changes requiring supplement submission and approval before the distribution of the product made using the change, changes requiring supplement submission at least 30 days prior to the distribution of the product, changes requiring supplement submission at the time of distribution, and changes to be described in an annual report.

  8. 7 CFR 70.50 - Approval of official identification and wording on labels.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... INSPECTION ACT (CONTINUED) VOLUNTARY GRADING OF POULTRY PRODUCTS AND RABBIT PRODUCTS Grading of Poultry Products and Rabbit Products Identifying and Marking Products § 70.50 Approval of official identification... CFR part 381. Poultry Products Inspection Regulations. Labeling requirements for ready-to-cook rabbits...

  9. 78 FR 6828 - Accreditation and Approval of Saybolt LP, as a Commercial Gauger and Laboratory

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-31

    ... been approved to gauge and accredited to test petroleum and petroleum products, organic chemicals and... 90810, has been approved to gauge and accredited to test petroleum and petroleum products, organic chemicals and vegetable oils for customs purposes, in accordance with the provisions of 19 CFR 151.12 and 19...

  10. 78 FR 40090 - Notice of Request for Revision of a Currently Approved Information Collection (Interstate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-03

    ... Request for Revision of a Currently Approved Information Collection (Interstate Shipment of Meat and...: Interstate Shipment of Meat and Poultry Products. Type of Request: Revision of an approved information... Federal Meat Inspection Act (FMIA) (21 U.S.C. 601, et seq.) and the Poultry Products Inspection Act (PPIA...

  11. FDA Approval Summary: Pembrolizumab for the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with Disease Progression on or After Platinum‐Containing Chemotherapy

    PubMed Central

    Blumenthal, Gideon M.; Yuan, Weishi; He, Kun; Sridhara, Rajeshwari; Subramaniam, Sriram; Zhao, Hong; Liu, Chao; Yu, Jingyu; Goldberg, Kirsten B.; McKee, Amy E.; Keegan, Patricia; Pazdur, Richard

    2017-01-01

    Abstract On August 5, 2016, the U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA injection, Merck Sharp & Dohme Corp., Kenilworth, NJ) for treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum‐containing chemotherapy. Approval was based on the objective response rate (ORR) and duration of response (DoR) in a cohort of patients in a nonrandomized multi‐cohort trial (KEYNOTE‐012) that included 174 patients with recurrent or metastatic HNSCC who had disease progression on or after platinum‐containing chemotherapy. Patients received either intravenous pembrolizumab 10 mg/kg every 2 weeks or 200 mg every 3 weeks. ORR was determined by independent review according to Response Evaluation Criteria in Solid Tumors 1.1. ORR was 16% (95% confidence interval 11, 22) with a complete response rate of 5%. DoR ranged from 2.4+ months to 27.7+ months. Twenty‐three of 28 responding patients (82%) had response durations of ≥6 months. Safety was evaluated in 192 patients with HNSCC receiving at least one dose of pembrolizumab. Frequent (≥2%) serious adverse reactions were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. Clinically significant immune‐mediated adverse reactions included pneumonitis, colitis, hepatitis, adrenal insufficiency, diabetes mellitus, skin toxicity, myositis, and thyroid disorders. The benefit‐risk profile of pembrolizumab was considered acceptable in this patient population. As a condition of accelerated approval, Merck is required to conduct a confirmatory trial; this trial, KEYNOTE‐040, is ongoing. Implications for Practice. This accelerated approval expands the U.S. Food and Drug Administration‐approved indications for pembrolizumab, providing health care providers with new information regarding pembrolizumab for the treatment of patients with recurrent or

  12. 21 CFR 314.610 - Approval based on evidence of effectiveness from studies in animals.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.610 Approval... establish that the drug product is reasonably likely to produce clinical benefit in humans. In assessing the...

  13. 21 CFR 314.610 - Approval based on evidence of effectiveness from studies in animals.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.610 Approval... establish that the drug product is reasonably likely to produce clinical benefit in humans. In assessing the...

  14. 21 CFR 314.610 - Approval based on evidence of effectiveness from studies in animals.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.610 Approval... establish that the drug product is reasonably likely to produce clinical benefit in humans. In assessing the...

  15. 30 CFR 250.293 - What operations require approval of the DWOP?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Plans and Information Deepwater Operations Plans (dwop) § 250.293 What operations require approval of the DWOP? You may not begin production... 30 Mineral Resources 2 2010-07-01 2010-07-01 false What operations require approval of the DWOP...

  16. TSO C-129 approvals and anticipated approvals

    DOT National Transportation Integrated Search

    2001-01-01

    This document contains a table of the approvals and anticipated approvals of TSO-C129a equipment (the technical standard order (TSO) for Airborne Supplemental Navigation Equipment Using the Global Positioning System (GPS)). This TSO prescribes the mi...

  17. A variable acceleration calibration system

    NASA Astrophysics Data System (ADS)

    Johnson, Thomas H.

    2011-12-01

    A variable acceleration calibration system that applies loads using gravitational and centripetal acceleration serves as an alternative, efficient and cost effective method for calibrating internal wind tunnel force balances. Two proof-of-concept variable acceleration calibration systems are designed, fabricated and tested. The NASA UT-36 force balance served as the test balance for the calibration experiments. The variable acceleration calibration systems are shown to be capable of performing three component calibration experiments with an approximate applied load error on the order of 1% of the full scale calibration loads. Sources of error are indentified using experimental design methods and a propagation of uncertainty analysis. Three types of uncertainty are indentified for the systems and are attributed to prediction error, calibration error and pure error. Angular velocity uncertainty is shown to be the largest indentified source of prediction error. The calibration uncertainties using a production variable acceleration based system are shown to be potentially equivalent to current methods. The production quality system can be realized using lighter materials and a more precise instrumentation. Further research is needed to account for balance deflection, forcing effects due to vibration, and large tare loads. A gyroscope measurement technique is shown to be capable of resolving the balance deflection angle calculation. Long term research objectives include a demonstration of a six degree of freedom calibration, and a large capacity balance calibration.

  18. 9 CFR 592.330 - Unauthorized use or disposition of approved labels.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Unauthorized use or disposition of approved labels. 592.330 Section 592.330 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Identifying and...

  19. 9 CFR 592.140 - Application for inspection in official plants; approval.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Application for inspection in official plants; approval. 592.140 Section 592.140 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Application for...

  20. Accelerator tube construction and characterization for a tandem-electrostatic-quadrupole for accelerator-based boron neutron capture therapy.

    PubMed

    Cartelli, D; Vento, V Thatar; Castell, W; Di Paolo, H; Kesque, J M; Bergueiro, J; Valda, A A; Erhardt, J; Kreiner, A J

    2011-12-01

    The accelerator tubes are essential components of the accelerator. Their function is to transport and accelerate a very intense proton or deuteron beam through the machine, from the ion source to the neutron production target, without significant losses. In this contribution, we discuss materials selected for the tube construction, the procedures used for their assembly and the testing performed to meet the stringent requirements to which it is subjected. Copyright © 2011 Elsevier Ltd. All rights reserved.

  1. 78 FR 6129 - Approval of Petrospect, Inc., as a Commercial Gauger

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-29

    ..., petroleum products, organic chemicals and vegetable oils for customs purposes for the next three years as of..., Honolulu, HI 96817, has been approved to gauge petroleum, petroleum products, organic chemicals and...

  2. 10 CFR 725.15 - Requirements for approval of applications.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... and/or operation of production or manufacturing facilities and offers reasonable assurance of adequacy... Production will be approved only if the application demonstrates also that the applicant: (i) Is directly engaged in a substantial effort to develop, design, build or operate a chemical processing plant or other...

  3. 27 CFR 479.64 - Procedure for approval of application.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 3 2010-04-01 2010-04-01 false Procedure for approval of application. 479.64 Section 479.64 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES...

  4. 27 CFR 479.64 - Procedure for approval of application.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 3 2013-04-01 2013-04-01 false Procedure for approval of application. 479.64 Section 479.64 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES...

  5. 27 CFR 479.64 - Procedure for approval of application.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 3 2014-04-01 2014-04-01 false Procedure for approval of application. 479.64 Section 479.64 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES...

  6. 27 CFR 479.64 - Procedure for approval of application.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 3 2011-04-01 2010-04-01 true Procedure for approval of application. 479.64 Section 479.64 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES...

  7. 27 CFR 479.64 - Procedure for approval of application.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 3 2012-04-01 2010-04-01 true Procedure for approval of application. 479.64 Section 479.64 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES...

  8. Applications of High Intensity Proton Accelerators

    NASA Astrophysics Data System (ADS)

    Raja, Rajendran; Mishra, Shekhar

    2010-06-01

    Superconducting radiofrequency linac development at Fermilab / S. D. Holmes -- Rare muon decay experiments / Y. Kuno -- Rare kaon decays / D. Bryman -- Muon collider / R. B. Palmer -- Neutrino factories / S. Geer -- ADS and its potential / J.-P. Revol -- ADS history in the USA / R. L. Sheffield and E. J. Pitcher -- Accelerator driven transmutation of waste: high power accelerator for the European ADS demonstrator / J. L. Biarrotte and T. Junquera -- Myrrha, technology development for the realisation of ADS in EU: current status & prospects for realisation / R. Fernandez ... [et al.] -- High intensity proton beam production with cyclotrons / J. Grillenberger and M. Seidel -- FFAG for high intensity proton accelerator / Y. Mori -- Kaon yields for 2 to 8 GeV proton beams / K. K. Gudima, N. V. Mokhov and S. I. Striganov -- Pion yield studies for proton driver beams of 2-8 GeV kinetic energy for stopped muon and low-energy muon decay experiments / S. I. Striganov -- J-Parc accelerator status and future plans / H. Kobayashi -- Simulation and verification of DPA in materials / N. V. Mokhov, I. L. Rakhno and S. I. Striganov -- Performance and operational experience of the CNGS facility / E. Gschwendtner -- Particle physics enabled with super-conducting RF technology - summary of working group 1 / D. Jaffe and R. Tschirhart -- Proton beam requirements for a neutrino factory and muon collider / M. S. Zisman -- Proton bunching options / R. B. Palmer -- CW SRF H linac as a proton driver for muon colliders and neutrino factories / M. Popovic, C. M. Ankenbrandt and R. P. Johnson -- Rapid cycling synchrotron option for Project X / W. Chou -- Linac-based proton driver for a neutrino factory / R. Garoby ... [et al.] -- Pion production for neutrino factories and muon colliders / N. V. Mokhov ... [et al.] -- Proton bunch compression strategies / V. Lebedev -- Accelerator test facility for muon collider and neutrino factory R&D / V. Shiltsev -- The superconducting RF linac for muon

  9. [Collaborative study on regulatory science for facilitating clinical development of gene therapy products for genetic diseases].

    PubMed

    Uchida, Eriko; Igarashi, Yuka; Sato, Yoji

    2014-01-01

    Gene therapy products are expected as innovative medicinal products for intractable diseases such as life-threatening genetic diseases and cancer. Recently, clinical developments by pharmaceutical companies are accelerated in Europe and the United States, and the first gene therapy product in advanced countries was approved for marketing authorization by the European Commission in 2012. On the other hand, more than 40 clinical studies for gene therapy have been completed or ongoing in Japan, most of them are conducted as clinical researches by academic institutes, and few clinical trials have been conducted for approval of gene therapy products. In order to promote the development of gene therapy products, revision of the current guideline and/or preparation of concept paper to address the evaluation of the quality and safety of gene therapy products are necessary and desired to clearly show what data should be submitted before First-in-Human clinical trials of novel gene therapy products. We started collaborative study with academia and regulatory agency to promote regulatory science toward clinical development of gene therapy products for genetic diseases based on lentivirus and adeno-associated virus vectors; National Center for Child Health and Development (NCCHD), Nippon Medical School and PMDA have been joined in the task force. At first, we are preparing pre-draft of the revision of the current gene therapy guidelines in this project.

  10. New Opioid Analgesic Approvals and Outpatient Utilization of Opioid Analgesics in the United States, 1997 through 2015.

    PubMed

    Chai, Grace; Xu, Jing; Osterhout, James; Liberatore, Mark A; Miller, Kathleen L; Wolff, Carolyn; Cruz, Marisa; Lurie, Peter; Dal Pan, Gerald

    2018-05-01

    The opioid epidemic, driven in part by increased prescribing, is a public health emergency. This study examines dispensed prescription patterns and approvals of new opioid analgesic products to investigate whether the introduction of these new drugs increases prescribing. Prescribing patterns based on dispensed prescription claims from the U.S. retail setting were assessed with new brand and generic opioid analgesic products approved in the United States from 1997 through 2015. From 1997 through 2015, the U.S. Food and Drug Administration (Silver Spring, Maryland) approved 263 opioid analgesic products, including 33 brand products. Dispensed prescriptions initially increased 80% from 145 million prescriptions in 1997 to a peak of 260 million prescriptions in 2012 before decreasing by 12% to 228 million prescriptions in 2015. Morphine milligram equivalents dispensed per prescription increased from 486 in 1997 to a peak of 950 in 2010, before decreasing to 905 in 2015. In 2015, generic products accounted for 96% (218/228 million prescriptions) of all opioid analgesic prescriptions dispensed. The remaining prescriptions were dispensed for brand products, of which nearly half were dispensed for one brand product (OxyContin, Purdue, USA). There has been a dramatic increase in prescriptions dispensed for opioid analgesics since 1997 and an increasing number of opioid analgesic approvals; however, the number of prescriptions dispensed has declined since 2012 despite an increasing number of approvals. Examination of dispensed prescriptions shows a shifting and complex market where multiple factors likely influence prescribing; the approval of new products alone may not be sufficient to be a primary driver of increased prescribing. An online visual overview is available for this article at http://links.lww.com/ALN/B705.

  11. High brightness gamma-ray production at Fermilab Accelerator Science and Technology (FAST) facility

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Mihalcea, Daniel; Jacobson, B.; Murokh, A.

    Electron beams with energies of the order of a few 100's of MeV and low transverse emittance, in combination with powerful infrared lasers, allow for the production of high quality gamma rays through Inverse Compton Scattering (ICS). At Fermilab Accelerator Science and Technology (FAST) facility, a 300 MeV beam will be used to generate gamma rays with maximum photon energies of up to ~1.5 MeV and brightness of the order of 10 21 photons/[s-(mm-mrad) 2- 0.1%BW]. Due to the low electron-beam transverse emittance, the relative bandwidth of the scattered radiation is expected to be ≤ 1%. A key challenge towardmore » the production of high radiation dose and brightness is to enhance the energy of the infrared 3 ps laser pulses to the joule level. Finally, in this contribution, we present the plans for the experimental setup, along with comprehensive numerical simulations of the ICS process.« less

  12. High brightness gamma-ray production at Fermilab Accelerator Science and Technology (FAST) facility

    DOE PAGES

    Mihalcea, Daniel; Jacobson, B.; Murokh, A.; ...

    2017-03-01

    Electron beams with energies of the order of a few 100's of MeV and low transverse emittance, in combination with powerful infrared lasers, allow for the production of high quality gamma rays through Inverse Compton Scattering (ICS). At Fermilab Accelerator Science and Technology (FAST) facility, a 300 MeV beam will be used to generate gamma rays with maximum photon energies of up to ~1.5 MeV and brightness of the order of 10 21 photons/[s-(mm-mrad) 2- 0.1%BW]. Due to the low electron-beam transverse emittance, the relative bandwidth of the scattered radiation is expected to be ≤ 1%. A key challenge towardmore » the production of high radiation dose and brightness is to enhance the energy of the infrared 3 ps laser pulses to the joule level. Finally, in this contribution, we present the plans for the experimental setup, along with comprehensive numerical simulations of the ICS process.« less

  13. A system of {sup 99m}Tc production based on distributed electron accelerators and thermal separation

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Bennett, R.G.; Christian, J.D.; Petti, D.A.

    1999-04-01

    A system has been developed for the production of {sup 99m}Tc based on distributed electron accelerators and thermal separation. The radioactive decay parent of {sup 99m}Tc, {sup 99}Mo, is produced from {sup 100}Mo by a photoneutron reaction. Two alternative thermal separation processes have been developed to extract {sup 99m}Tc. Experiments have been performed to verify the technical feasibility of the production and assess the efficiency of the extraction processes. A system based on this technology enables the economical supply of {sup 99m}Tc for a large nuclear pharmacy. Twenty such production centers distributed near major metropolitan areas could produce the entiremore » US supply of {sup 99m}Tc at a cost less than the current subsidized price.« less

  14. 16 CFR 1028.113 - Suspension or termination of IRB approval of research.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... research. 1028.113 Section 1028.113 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL PROTECTION OF HUMAN SUBJECTS § 1028.113 Suspension or termination of IRB approval of research. An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance...

  15. On Quantizing Ride Comfort and Allowable Accelerations

    DTIC Science & Technology

    1976-07-01

    UnImited and approved for Public release. ,.Io. 7 D5Xt4WX.AX..JL.1.X.1LJ -’a~ft IF I.,, I. ’W No 1 -0.U /cM Report) MAR 3 19M0 III. SUPPLEMENTARY NOTES...vehicle’s habitability for a given tive. This is for three main reasons: acceleration-time history. These indices are: Mankind is very variable, and even an...though the limits may not be entirely "correct" in an absolute sense,.e ~utIY* review the l~steryof an analogousawL I Hey~ f .,B 7 -tisom e To better

  16. 78 FR 7442 - Accreditation and Approval of Chemical and Petrochemical Inspections, LP, as a Commercial Gauger...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-01

    ... approved to gauge and accredited to test petroleum and petroleum products, organic chemicals and vegetable... approved to gauge and accredited to test petroleum and petroleum products, organic chemicals and vegetable... Chemical and Petrochemical Inspections, LP, as a Commercial Gauger and Laboratory AGENCY: U.S. Customs and...

  17. 9 CFR 381.137 - Evidence of labeling and devices approval.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Evidence of labeling and devices approval. 381.137 Section 381.137 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY PRODUCTS INSPECTION AND VOLUNTARY INSPECTION AND CERTIFICATION...

  18. 9 CFR 590.435 - Wholesomeness and approval of materials.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... materials. (a) Substances and ingredients used in the manufacture or preparation of any egg product capable... purpose of its use. (c) Chemical additives to be used in the preparation of egg products will be approved... adulterated or unwholesome. Scientific data acceptable to the Administrator showing that the additive meets...

  19. ACHIEVING THE REQUIRED COOLANT FLOW DISTRIBUTION FOR THE ACCELERATOR PRODUCTION OF TRITIUM (APT) TUNGSTEN NEUTRON SOURCE

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    D. SIEBE; K. PASAMEHMETOGLU

    The Accelerator Production of Tritium neutron source consists of clad tungsten targets, which are concentric cylinders with a center rod. These targets are arranged in a matrix of tubes, producing a large number of parallel coolant paths. The coolant flow required to meet thermal-hydraulic design criteria varies with location. This paper describes the work performed to ensure an adequate coolant flow for each target for normal operation and residual heat-removal conditions.

  20. 9 CFR 592.330 - Unauthorized use or disposition of approved labels.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Unauthorized use or disposition of approved labels. 592.330 Section 592.330 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Identifying and Marking Products § 592.330 Unauthorized use...

  1. 9 CFR 592.330 - Unauthorized use or disposition of approved labels.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Unauthorized use or disposition of approved labels. 592.330 Section 592.330 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Identifying and Marking Products § 592.330 Unauthorized use...

  2. 9 CFR 592.330 - Unauthorized use or disposition of approved labels.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Unauthorized use or disposition of approved labels. 592.330 Section 592.330 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Identifying and Marking Products § 592.330 Unauthorized use...

  3. 9 CFR 592.330 - Unauthorized use or disposition of approved labels.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Unauthorized use or disposition of approved labels. 592.330 Section 592.330 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Identifying and Marking Products § 592.330 Unauthorized use...

  4. 78 FR 66757 - Accreditation and Approval of Amspec Services, LLC, as a Commercial Gauger and Laboratory

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-06

    ... Services, LLC, has been approved to gauge and accredited to test petroleum and petroleum products, organic chemicals and vegetable oils for customs purposes for the next three years as of February 20, 2013. DATES... 07036, has been approved to gauge and accredited to test petroleum and petroleum products, organic...

  5. The Spallation Neutron Source accelerator system design

    NASA Astrophysics Data System (ADS)

    Henderson, S.; Abraham, W.; Aleksandrov, A.; Allen, C.; Alonso, J.; Anderson, D.; Arenius, D.; Arthur, T.; Assadi, S.; Ayers, J.; Bach, P.; Badea, V.; Battle, R.; Beebe-Wang, J.; Bergmann, B.; Bernardin, J.; Bhatia, T.; Billen, J.; Birke, T.; Bjorklund, E.; Blaskiewicz, M.; Blind, B.; Blokland, W.; Bookwalter, V.; Borovina, D.; Bowling, S.; Bradley, J.; Brantley, C.; Brennan, J.; Brodowski, J.; Brown, S.; Brown, R.; Bruce, D.; Bultman, N.; Cameron, P.; Campisi, I.; Casagrande, F.; Catalan-Lasheras, N.; Champion, M.; Champion, M.; Chen, Z.; Cheng, D.; Cho, Y.; Christensen, K.; Chu, C.; Cleaves, J.; Connolly, R.; Cote, T.; Cousineau, S.; Crandall, K.; Creel, J.; Crofford, M.; Cull, P.; Cutler, R.; Dabney, R.; Dalesio, L.; Daly, E.; Damm, R.; Danilov, V.; Davino, D.; Davis, K.; Dawson, C.; Day, L.; Deibele, C.; Delayen, J.; DeLong, J.; Demello, A.; DeVan, W.; Digennaro, R.; Dixon, K.; Dodson, G.; Doleans, M.; Doolittle, L.; Doss, J.; Drury, M.; Elliot, T.; Ellis, S.; Error, J.; Fazekas, J.; Fedotov, A.; Feng, P.; Fischer, J.; Fox, W.; Fuja, R.; Funk, W.; Galambos, J.; Ganni, V.; Garnett, R.; Geng, X.; Gentzlinger, R.; Giannella, M.; Gibson, P.; Gillis, R.; Gioia, J.; Gordon, J.; Gough, R.; Greer, J.; Gregory, W.; Gribble, R.; Grice, W.; Gurd, D.; Gurd, P.; Guthrie, A.; Hahn, H.; Hardek, T.; Hardekopf, R.; Harrison, J.; Hatfield, D.; He, P.; Hechler, M.; Heistermann, F.; Helus, S.; Hiatt, T.; Hicks, S.; Hill, J.; Hill, J.; Hoff, L.; Hoff, M.; Hogan, J.; Holding, M.; Holik, P.; Holmes, J.; Holtkamp, N.; Hovater, C.; Howell, M.; Hseuh, H.; Huhn, A.; Hunter, T.; Ilg, T.; Jackson, J.; Jain, A.; Jason, A.; Jeon, D.; Johnson, G.; Jones, A.; Joseph, S.; Justice, A.; Kang, Y.; Kasemir, K.; Keller, R.; Kersevan, R.; Kerstiens, D.; Kesselman, M.; Kim, S.; Kneisel, P.; Kravchuk, L.; Kuneli, T.; Kurennoy, S.; Kustom, R.; Kwon, S.; Ladd, P.; Lambiase, R.; Lee, Y. Y.; Leitner, M.; Leung, K.-N.; Lewis, S.; Liaw, C.; Lionberger, C.; Lo, C. C.; Long, C.; Ludewig, H.; Ludvig, J.; Luft, P.; Lynch, M.; Ma, H.; MacGill, R.; Macha, K.; Madre, B.; Mahler, G.; Mahoney, K.; Maines, J.; Mammosser, J.; Mann, T.; Marneris, I.; Marroquin, P.; Martineau, R.; Matsumoto, K.; McCarthy, M.; McChesney, C.; McGahern, W.; McGehee, P.; Meng, W.; Merz, B.; Meyer, R.; Meyer, R.; Miller, B.; Mitchell, R.; Mize, J.; Monroy, M.; Munro, J.; Murdoch, G.; Musson, J.; Nath, S.; Nelson, R.; Nelson, R.; O`Hara, J.; Olsen, D.; Oren, W.; Oshatz, D.; Owens, T.; Pai, C.; Papaphilippou, I.; Patterson, N.; Patterson, J.; Pearson, C.; Pelaia, T.; Pieck, M.; Piller, C.; Plawski, T.; Plum, M.; Pogge, J.; Power, J.; Powers, T.; Preble, J.; Prokop, M.; Pruyn, J.; Purcell, D.; Rank, J.; Raparia, D.; Ratti, A.; Reass, W.; Reece, K.; Rees, D.; Regan, A.; Regis, M.; Reijonen, J.; Rej, D.; Richards, D.; Richied, D.; Rode, C.; Rodriguez, W.; Rodriguez, M.; Rohlev, A.; Rose, C.; Roseberry, T.; Rowton, L.; Roybal, W.; Rust, K.; Salazer, G.; Sandberg, J.; Saunders, J.; Schenkel, T.; Schneider, W.; Schrage, D.; Schubert, J.; Severino, F.; Shafer, R.; Shea, T.; Shishlo, A.; Shoaee, H.; Sibley, C.; Sims, J.; Smee, S.; Smith, J.; Smith, K.; Spitz, R.; Staples, J.; Stein, P.; Stettler, M.; Stirbet, M.; Stockli, M.; Stone, W.; Stout, D.; Stovall, J.; Strelo, W.; Strong, H.; Sundelin, R.; Syversrud, D.; Szajbler, M.; Takeda, H.; Tallerico, P.; Tang, J.; Tanke, E.; Tepikian, S.; Thomae, R.; Thompson, D.; Thomson, D.; Thuot, M.; Treml, C.; Tsoupas, N.; Tuozzolo, J.; Tuzel, W.; Vassioutchenko, A.; Virostek, S.; Wallig, J.; Wanderer, P.; Wang, Y.; Wang, J. G.; Wangler, T.; Warren, D.; Wei, J.; Weiss, D.; Welton, R.; Weng, J.; Weng, W.-T.; Wezensky, M.; White, M.; Whitlatch, T.; Williams, D.; Williams, E.; Wilson, K.; Wiseman, M.; Wood, R.; Wright, P.; Wu, A.; Ybarrolaza, N.; Young, K.; Young, L.; Yourd, R.; Zachoszcz, A.; Zaltsman, A.; Zhang, S.; Zhang, W.; Zhang, Y.; Zhukov, A.

    2014-11-01

    The Spallation Neutron Source (SNS) was designed and constructed by a collaboration of six U.S. Department of Energy national laboratories. The SNS accelerator system consists of a 1 GeV linear accelerator and an accumulator ring providing 1.4 MW of proton beam power in microsecond-long beam pulses to a liquid mercury target for neutron production. The accelerator complex consists of a front-end negative hydrogen-ion injector system, an 87 MeV drift tube linear accelerator, a 186 MeV side-coupled linear accelerator, a 1 GeV superconducting linear accelerator, a 248-m circumference accumulator ring and associated beam transport lines. The accelerator complex is supported by ~100 high-power RF power systems, a 2 K cryogenic plant, ~400 DC and pulsed power supply systems, ~400 beam diagnostic devices and a distributed control system handling ~100,000 I/O signals. The beam dynamics design of the SNS accelerator is presented, as is the engineering design of the major accelerator subsystems.

  6. 78 FR 66759 - Approval of American Cargo Assurance, as a Commercial Gauger

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-06

    ... gauge petroleum, petroleum products, organic chemicals and vegetable oils for customs purposes for the... 70663, has been approved to gauge petroleum, petroleum products, organic chemicals and vegetable oils...

  7. 9 CFR 592.140 - Application for inspection in official plants; approval.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Application for inspection in official plants; approval. 592.140 Section 592.140 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Application for Service § 592.140 Application for...

  8. 9 CFR 592.140 - Application for inspection in official plants; approval.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Application for inspection in official plants; approval. 592.140 Section 592.140 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Application for Service § 592.140 Application for...

  9. 9 CFR 592.140 - Application for inspection in official plants; approval.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Application for inspection in official plants; approval. 592.140 Section 592.140 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Application for Service § 592.140 Application for...

  10. 9 CFR 592.140 - Application for inspection in official plants; approval.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Application for inspection in official plants; approval. 592.140 Section 592.140 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Application for Service § 592.140 Application for...

  11. Particle acceleration on a chip: A laser-driven micro-accelerator for research and industry

    NASA Astrophysics Data System (ADS)

    Yoder, R. B.; Travish, G.

    2013-03-01

    Particle accelerators are conventionally built from radio-frequency metal cavities, but this technology limits the maximum energy available and prevents miniaturization. In the past decade, laser-powered acceleration has been intensively studied as an alternative technology promising much higher accelerating fields in a smaller footprint and taking advantage of recent advances in photonics. Among the more promising approaches are those based on dielectric field-shaping structures. These ``dielectric laser accelerators'' (DLAs) scale with the laser wavelength employed and can be many orders of magnitude smaller than conventional accelerators; DLAs may enable the production of high-intensity, ultra-short relativistic electron bunches in a chip-scale device. When combined with a high- Z target or an optical-period undulator, these systems could produce high-brilliance x-rays from a breadbox-sized device having multiple applications in imaging, medicine, and homeland security. In our research program we have developed one such DLA, the Micro-Accelerator Platform (MAP). We describe the fundamental physics, our fabrication and testing program, and experimental results to date, along with future prospects for MAP-based light-sources and some remaining challenges. Supported in part by the Defense Threat Reduction Agency and National Nuclear Security Administration.

  12. RAMI modeling of selected balance of plant systems for the proposed Accelerator Production of Tritium (APT) project

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Radder, J.A.; Cramer, D.S.

    1997-06-01

    In order to meet Department of Energy (DOE) Defense Program requirements for tritium in the 2005-2007 time frame, new production capability must be made available. The Accelerator Production of Tritium (APT) Plant is being considered as an alternative to nuclear reactor production of tritium, which has been the preferred method in the past. The proposed APT plant will use a high-power proton accelerator to generate thermal neutrons that will be captured in {sup 3}He to produce tritium (3H). It is expected that the APT Plant will be built and operated at the DOE`s Savannah River Site (SRS) in Aiken, Southmore » Carolina. Discussion is focused on Reliability, Availability, Maintainability, and Inspectability (RAMI) modeling of recent conceptual designs for balance of plant (BOP) systems in the proposed APT Plant. In the conceptual designs for balance of plant (BOP) systems in the proposed APT Plant. In the conceptual design phase, system RAMI estimates are necessary to identify the best possible system alternative and to provide a valid picture of the cost effectiveness of the proposed system for comparison with other system alternatives. RAMI estimates in the phase must necessarily be based on generic data. The objective of the RAMI analyses at the conceptual design stage is to assist the designers in achieving an optimum design which balances the reliability and maintainability requirements among the subsystems and components.« less

  13. 27 CFR 4.93 - Approval of grape variety names.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Approval of grape variety names. 4.93 Section 4.93 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF WINE American Grape Variety Names § 4.93...

  14. Biosimilars approval process.

    PubMed

    Zuñiga, Leyre; Calvo, Begoña

    2010-04-01

    For similar biological medicinal products, the so-called biosimilars, clinical trials are required rather than just the bioequivalence studies required to support the registration of a generic small molecule drug product. The EU Directive 2001/83/EC, as amended, stated that where a biological medicinal product which is similar to a reference biological product, does not meet the conditions in the definition of generic medicinal products the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided. The challenge is to determine the exact nature of the non-clinical and clinical programme required to gain regulatory approval. The applicant is encouraged to provide a detailed description of the strategy used to demonstrate the biosimilar and the reference product have similar profiles in terms of quality, safety and efficacy. The extent to which comparability can be proven will have quite an impact on how many non-clinical and clinical studies the biosimilar applicant will be required to conduct. The dossier submitted by the applicant to the EMEA should cover all aspects of the comparability assessment and must include data on possible unwanted immune reactions to the therapeutic protein. Post-marketing pharmacovigilance plans are also expected to be included in the biosimilar dossier. Copyright 2009 Elsevier Inc. All rights reserved.

  15. Market withdrawal of new molecular entities approved in the United States from 1980 to 2009.

    PubMed

    Qureshi, Zaina P; Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Stevenson, Kurt B; Szeinbach, Sheryl L

    2011-07-01

    Economic factors, market dynamics, and safety issues are largely responsible for decisions to withdraw pharmaceutical products from the market. In this study, new molecular entities (NMEs) approved by the Food and Drug Administration (FDA) were examined in the USA from 1980 to 2009. Data were obtained from the FDA, Micromedex, Medline, and Lexis-Nexis. Descriptive analyses were used to classify product discontinuations by therapeutic category, time frame for discontinuation, and reason for withdrawal. There were 740 NMEs approved by the FDA during the study period. As of 1 December 2010, the number of drugs discontinued was 118 (15.9%). Discontinuations were the highest for antiparasitic products, insecticides, and repellents (6, 33.3% of approvals), systemic hormonal preparations excluding sex hormones and insulins (5, 33.3%), musculo-skeletal system (11, 32.4%), diagnostic agents (16, 28.1%), and anti-infectives for systemic use (27, 25.2%). Safety was the primary reason for withdrawing 26 drugs (3.5% of approvals). Approximately one in seven approved NMEs were discontinued from the market in the period of 1980-2009. Less than one-quarter (22%) of the total withdrawals were attributed to safety reasons. An ongoing evaluation of new drugs throughout their product life cycle is important to determine their efficacy, safety, and value to society. Copyright © 2011 John Wiley & Sons, Ltd.

  16. 7 CFR 70.34 - Application for grading service in official plants; approval.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... INSPECTION ACT (CONTINUED) VOLUNTARY GRADING OF POULTRY PRODUCTS AND RABBIT PRODUCTS Grading of Poultry Products and Rabbit Products Application for Grading Service § 70.34 Application for grading service in... plant survey for poultry or rabbit grading has been completed and approved in accordance with the...

  17. 7 CFR 70.34 - Application for grading service in official plants; approval.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... INSPECTION ACT (CONTINUED) VOLUNTARY GRADING OF POULTRY PRODUCTS AND RABBIT PRODUCTS Grading of Poultry Products and Rabbit Products Application for Grading Service § 70.34 Application for grading service in... plant survey for poultry or rabbit grading has been completed and approved in accordance with the...

  18. 30 CFR 746.14 - Approval, disapproval or conditional approval, of mining plan.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ..., of mining plan. 746.14 Section 746.14 Mineral Resources OFFICE OF SURFACE MINING RECLAMATION AND ENFORCEMENT, DEPARTMENT OF THE INTERIOR FEDERAL LANDS PROGRAM REVIEW AND APPROVAL OF MINING PLANS § 746.14 Approval, disapproval or conditional approval, of mining plan. The Secretary shall approve, disapprove or...

  19. Companion diagnostics: a regulatory perspective from the last 5 years of molecular companion diagnostic approvals.

    PubMed

    Roscoe, Donna M; Hu, Yun-Fu; Philip, Reena

    2015-01-01

    Companion diagnostics are essential for the safe and effective use of the corresponding therapeutic products. The US FDA has approved a number of companion diagnostics used to select cancer patients for treatment with contemporaneously approved novel therapeutics. The processes of co-development and co-approval of a therapeutic product and its companion diagnostic have been a learning experience that continues to evolve. Using several companion diagnostics as examples, this article describes the challenges associated with the scientific, clinical and regulatory hurdles faced by FDA and industry alike. Taken together, this discussion is intended to assist manufacturers toward a successful companion diagnostics development plan.

  20. Shielding evaluation for IMRT implementation in an existing accelerator vault

    PubMed Central

    Price, R. A.; Chibani, O.; Ma, C.‐M.

    2003-01-01

    A formalism is developed for evaluating the shielding in an existing vault to be used for IMRT. Existing exposure rate measurements are utilized as well as a newly developed effective modulation scaling factor. Examples are given for vaults housing 6, 10 and 18 MV linear accelerators. The use of an 18 MV Siemens linear accelerator is evaluated for IMRT delivery with respect to neutron production and the effects on individual patients. A modified modulation scaling factor is developed and the risk of the incurrence of fatal secondary malignancies is estimated. The difference in neutron production between 18 MV Varian and Siemens accelerators is estimated using Monte Carlo results. The neutron production from the Siemens accelerator is found to be approximately 4 times less than that of the Varian accelerator resulting in a risk of fatal secondary malignancy occurrence of approximately 1.6% when using the SMLC delivery technique and our measured modulation scaling factors. This compares with a previously published value of 1.6% for routine 3D CRT delivery on the Varian accelerator. PACS number(s): 87.52.Ga, 87.52.Px, 87.53.Qc, 87.53.Wz PMID:12841794

  1. The production of radionuclides for nuclear medicine from a compact, low-energy accelerator system.

    PubMed

    Webster, William D; Parks, Geoffrey T; Titov, Dmitry; Beasley, Paul

    2014-05-01

    The field of nuclear medicine is reliant on radionuclides for medical imaging procedures and radioimmunotherapy (RIT). The recent shut-downs of key radionuclide producers have highlighted the fragility of the current radionuclide supply network, however. To ensure that nuclear medicine can continue to grow, adding new diagnostic and therapy options to healthcare, novel and reliable production methods are required. Siemens are developing a low-energy, high-current - up to 10 MeV and 1 mA respectively - accelerator. The capability of this low-cost, compact system for radionuclide production, for use in nuclear medicine procedures, has been considered. The production of three medically important radionuclides - (89)Zr, (64)Cu, and (103)Pd - has been considered, via the (89)Y(p,n), (64)Ni(p,n) and (103)Rh(p,n) reactions, respectively. Theoretical cross-sections were generated using TALYS and compared to experimental data available from EXFOR. Stopping power values generated by SRIM have been used, with the TALYS-generated excitation functions, to calculate potential yields and isotopic purity in different irradiation regimes. The TALYS excitation functions were found to have a good agreement with the experimental data available from the EXFOR database. It was found that both (89)Zr and (64)Cu could be produced with high isotopic purity (over 99%), with activity yields suitable for medical diagnostics and therapy, at a proton energy of 10MeV. At 10MeV, the irradiation of (103)Rh produced appreciable quantities of (102)Pd, reducing the isotopic purity. A reduction in beam energy to 9.5MeV increased the radioisotopic purity to 99% with only a small reduction in activity yield. This work demonstrates that the low-energy, compact accelerator system under development by Siemens would be capable of providing sufficient quantities of (89)Zr, (64)Cu, and (103)Pd for use in medical diagnostics and therapy. It is suggested that the system could be used to produce many other

  2. Trends for Electron Beam Accelerator Applications in Industry

    NASA Astrophysics Data System (ADS)

    Machi, Sueo

    2011-02-01

    Electron beam (EB) accelerators are major pieces of industrial equipment used for many commercial radiation processing applications. The industrial use of EB accelerators has a history of more than 50 years and is still growing in terms of both its economic scale and new applications. Major applications involve the modification of polymeric materials to create value-added products, such as heat-resistant wires, heat-shrinkable sheets, automobile tires, foamed plastics, battery separators and hydrogel wound dressing. The surface curing of coatings and printing inks is a growing application for low energy electron accelerators, resulting in an environmentally friendly and an energy-saving process. Recently there has been the acceptance of the use of EB accelerators in lieu of the radioactive isotope cobalt-60 as a source for sterilizing disposable medical products. Environmental protection by the use of EB accelerators is a new and important field of application. A commercial plant for the cleaning flue gases from a coal-burning power plant is in operation in Poland, employing high power EB accelerators. In Korea, a commercial plant uses EB to clean waste water from a dye factory.

  3. Accelerators for E-beam and X-ray processing

    NASA Astrophysics Data System (ADS)

    Auslender, V. L.; Bryazgin, A. A.; Faktorovich, B. L.; Gorbunov, V. A.; Kokin, E. N.; Korobeinikov, M. V.; Krainov, G. S.; Lukin, A. N.; Maximov, S. A.; Nekhaev, V. E.; Panfilov, A. D.; Radchenko, V. N.; Tkachenko, V. O.; Tuvik, A. A.; Voronin, L. A.

    2002-03-01

    During last years the demand for pasteurization and desinsection of various food products (meat, chicken, sea products, vegetables, fruits, etc.) had increased. The treatment of these products in industrial scale requires the usage of powerful electron accelerators with energy 5-10 MeV and beam power at least 50 kW or more. The report describes the ILU accelerators with energy range up to 10 MeV and beam power up to 150 kW.The different irradiation schemes in electron beam and X-ray modes for various products are described. The design of the X-ray converter and 90° beam bending system are also given.

  4. 27 CFR 4.91 - List of approved prime names.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false List of approved prime names. 4.91 Section 4.91 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF WINE American Grape Variety Names § 4.91 List...

  5. 30 CFR 18.10 - Notice of approval or disapproval.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ..., EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES General... assembly of an electrical machine or accessory, MSHA will issue to the applicant either a written notice of...

  6. 9 CFR 381.133 - Generically approved labeling.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... change in quantity of ingredients complies with any minimum or maximum limits for the use of such... Section 381.133 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... inspection system, in accordance with subpart T of this part, is authorized to use generically approved...

  7. Pharma Success in Product Development—Does Biotechnology Change the Paradigm in Product Development and Attrition.

    PubMed

    Evens, Ronald P

    2016-01-01

    The biotechnology segment of the overall biopharma industry has existed for only about 40–45 years, as a driver of new product development. This driving force was initiated with the FDA approval of recombinant human insulin in 1982, originating from the Genentech company. The pharma industry in the early years of 1970s and 1980s engaged with biotechnology companies only to a small extent with their in-licensing of a few recombinant molecules, led by Roche, Eli Lilly, and Johnson and Johnson. However, subsequently and dramatically over the last 25 years, biotechnology has become a primary driver of product and technology innovation and has become a cornerstone in new product development by all biopharma companies. This review demonstrates these evolutionary changes regarding approved products, product pipelines, novelty of the products, FDA approval rates, product sales, financial R&D investments in biotechnology, partnerships, mergers and acquisitions, and patent issues. We now have about 300 biotechnology products approved in USA covering 16 medical disciplines and about 250 indications, with the engagement of 25 pharma companies, along with their biotechnology company innovators and partners. The biotechnology pipeline involves over 1000 molecules in clinical trials, including over 300 molecules associated with the top 10 pharma companies. Product approval rates by the FDA for biotechnology products are over double the rate for drugs. Yes, the R&D paradigm has changed with biotechnology now as one of the major focuses for new product development with novel molecules by the whole biopharma industry.

  8. Schedules of Controlled Substances: Placement of FDA-Approved Products of Oral Solutions Containing Dronabinol [(-)-delta-9-transtetrahydrocannabinol (delta-9-THC)] in Schedule II. Interim final rule, with request for comments.

    PubMed

    2017-03-23

    On July 1, 2016, the U.S. Food and Drug Administration (FDA) approved a new drug application for Syndros, a drug product consisting of dronabinol [(-)-delta-9-trans-tetrahydrocannabinol (delta-9-THC)] oral solution. Thereafter, the Department of Health and Human Services (HHS) provided the Drug Enforcement Administration (DEA) with a scheduling recommendation that would result in Syndros (and other oral solutions containing dronabinol) being placed in schedule II of the Controlled Substances Act (CSA). In accordance with the CSA, as revised by the Improving Regulatory Transparency for New Medical Therapies Act, DEA is hereby issuing an interim final rule placing FDA-approved products of oral solutions containing dronabinol in schedule II of the CSA.

  9. 76 FR 16533 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-24

    ... portions that reflect approval of eight new animal drug applications. The final rule inadvertently failed... approval of eight new animal drug applications. The final rule inadvertently failed to add conforming...

  10. 76 FR 72236 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-22

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: ACSEP Evaluation... information collection. The information is collected from holders of FAA production approvals and selected...

  11. Applications of the Strategic Defense Initiative's compact accelerators

    NASA Technical Reports Server (NTRS)

    Montanarelli, Nick; Lynch, Ted

    1991-01-01

    The Strategic Defense Initiative's (SDI) investment in particle accelerator technology for its directed energy weapons program has produced breakthroughs in the size and power of new accelerators. These accelerators, in turn, have produced spinoffs in several areas: the radio frequency quadrupole linear accelerator (RFQ linac) was recently incorporated into the design of a cancer therapy unit at the Loma Linda University Medical Center, an SDI-sponsored compact induction linear accelerator may replace Cobalt-60 radiation and hazardous ethylene-oxide as a method for sterilizing medical products, and other SDIO-funded accelerators may be used to produce the radioactive isotopes oxygen-15, nitrogen-13, carbon-11, and fluorine-18 for positron emission tomography (PET). Other applications of these accelerators include bomb detection, non-destructive inspection, decomposing toxic substances in contaminated ground water, and eliminating nuclear waste.

  12. Simulation prediction and experiment setup of vacuum laser acceleration at Brookhaven National Lab-Accelerator Test Facility

    NASA Astrophysics Data System (ADS)

    Shao, L.; Cline, D.; Ding, X.; Ho, Y. K.; Kong, Q.; Xu, J. J.; Pogorelsky, I.; Yakimenko, V.; Kusche, K.

    2013-02-01

    This paper presents the pre-experiment plan and prediction of the first stage of vacuum laser acceleration (VLA) collaborating by UCLA, Fudan University and ATF-BNL. This first stage experiment is a proof-of-principle to support our previously posted novel VLA theory. Simulations show that based on ATF's current experimental conditions the electron beam with initial energy of 15 MeV can get net energy gain from an intense CO2 laser beam. The difference in electron beam energy spread is observable by the ATF beam line diagnostics system. Further, this energy spread expansion effect increases along with an increase in laser intensity. The proposal has been approved by the ATF committee and the experiment will be our next project.

  13. 21 CFR 515.21 - Refusal to approve a medicated feed mill license application.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Refusal to approve a medicated feed mill license... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS MEDICATED FEED MILL LICENSE Administrative Actions on Licenses § 515.21 Refusal to approve a medicated feed mill license application. (a) The...

  14. 46 CFR 160.077-7 - Procedure for approval of design or material revision.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... being used in any production of PFDs. (b) Determinations of equivalence of design, construction, and... 46 Shipping 6 2010-10-01 2010-10-01 false Procedure for approval of design or material revision... Personal Flotation Devices § 160.077-7 Procedure for approval of design or material revision. (a) Each...

  15. 78 FR 52557 - Approval of SGS North America, Inc., as a Commercial Gauger

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-23

    ... petroleum, petroleum products, organic chemicals and vegetable oils for customs purposes for the next three... 77541, has been approved to gauge petroleum, petroleum products, organic chemicals and vegetable oils...

  16. EDITORIAL: Laser and plasma accelerators Laser and plasma accelerators

    NASA Astrophysics Data System (ADS)

    Bingham, Robert

    2009-02-01

    by Chen et al where the driver, instead of being a laser, is a whistler wave known as the magnetowave plasma accelerator. The application to electron--positron plasmas that are found around pulsars is studied in the paper by Shukla, and to muon acceleration by Peano et al. Electron wakefield experiments are now concentrating on control and optimisation of high-quality beams that can be used as drivers for novel radiation sources. Studies by Thomas et al show that filamentation has a deleterious effect on the production of high quality mono-energetic electron beams and is caused by non-optimal choice of focusing geometry and/or electron density. It is crucial to match the focusing with the right plasma parameters and new types of plasma channels are being developed, such as the magnetically controlled plasma waveguide reported by Froula et al. The magnetic field provides a pressure profile shaping the channel to match the guiding conditions of the incident laser, resulting in predicted electron energies of 3GeV. In the forced laser-wakefield experiment Fang et al show that pump depletion reduces or inhibits the acceleration of electrons. One of the earlier laser acceleration concepts known as the beat wave may be revived due to the work by Kalmykov et al who report on all-optical control of nonlinear focusing of laser beams, allowing for stable propagation over several Rayleigh lengths with pre-injected electrons accelerated beyond 100 MeV. With the increasing number of petawatt lasers, attention is being focused on different acceleration regimes such as stochastic acceleration by counterpropagating laser pulses, the relativistic mirror, or the snow-plough effect leading to single-step acceleration reported by Mendonca. During wakefield acceleration the leading edge of the pulse undergoes frequency downshifting and head erosion as the laser energy is transferred to the wake while the trailing edge of the laser pulse undergoes frequency up-shift. This is commonly known

  17. Prospects for Accelerator Technology

    NASA Astrophysics Data System (ADS)

    Todd, Alan

    2011-02-01

    Accelerator technology today is a greater than US$5 billion per annum business. Development of higher-performance technology with improved reliability that delivers reduced system size and life cycle cost is expected to significantly increase the total accelerator technology market and open up new application sales. Potential future directions are identified and pitfalls in new market penetration are considered. Both of the present big market segments, medical radiation therapy units and semiconductor ion implanters, are approaching the "maturity" phase of their product cycles, where incremental development rather than paradigm shifts is the norm, but they should continue to dominate commercial sales for some time. It is anticipated that large discovery-science accelerators will continue to provide a specialty market beset by the unpredictable cycles resulting from the scale of the projects themselves, coupled with external political and economic drivers. Although fraught with differing market entry difficulties, the security and environmental markets, together with new, as yet unrealized, industrial material processing applications, are expected to provide the bulk of future commercial accelerator technology growth.

  18. Acceleration modules in linear induction accelerators

    NASA Astrophysics Data System (ADS)

    Wang, Shao-Heng; Deng, Jian-Jun

    2014-05-01

    The Linear Induction Accelerator (LIA) is a unique type of accelerator that is capable of accelerating kilo-Ampere charged particle current to tens of MeV energy. The present development of LIA in MHz bursting mode and the successful application into a synchrotron have broadened LIA's usage scope. Although the transformer model is widely used to explain the acceleration mechanism of LIAs, it is not appropriate to consider the induction electric field as the field which accelerates charged particles for many modern LIAs. We have examined the transition of the magnetic cores' functions during the LIA acceleration modules' evolution, distinguished transformer type and transmission line type LIA acceleration modules, and re-considered several related issues based on transmission line type LIA acceleration module. This clarified understanding should help in the further development and design of LIA acceleration modules.

  19. 38 CFR 17.65 - Approvals and provisional approvals of community residential care facilities.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... approvals of community residential care facilities. 17.65 Section 17.65 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS MEDICAL Community Residential Care § 17.65 Approvals and provisional approvals of community residential care facilities. (a) An approval of a facility meeting all of...

  20. Simultaneous Multislice Echo Planar Imaging With Blipped Controlled Aliasing in Parallel Imaging Results in Higher Acceleration: A Promising Technique for Accelerated Diffusion Tensor Imaging of Skeletal Muscle.

    PubMed

    Filli, Lukas; Piccirelli, Marco; Kenkel, David; Guggenberger, Roman; Andreisek, Gustav; Beck, Thomas; Runge, Val M; Boss, Andreas

    2015-07-01

    The aim of this study was to investigate the feasibility of accelerated diffusion tensor imaging (DTI) of skeletal muscle using echo planar imaging (EPI) applying simultaneous multislice excitation with a blipped controlled aliasing in parallel imaging results in higher acceleration unaliasing technique. After federal ethics board approval, the lower leg muscles of 8 healthy volunteers (mean [SD] age, 29.4 [2.9] years) were examined in a clinical 3-T magnetic resonance scanner using a 15-channel knee coil. The EPI was performed at a b value of 500 s/mm2 without slice acceleration (conventional DTI) as well as with 2-fold and 3-fold acceleration. Fractional anisotropy (FA) and mean diffusivity (MD) were measured in all 3 acquisitions. Fiber tracking performance was compared between the acquisitions regarding the number of tracks, average track length, and anatomical precision using multivariate analysis of variance and Mann-Whitney U tests. Acquisition time was 7:24 minutes for conventional DTI, 3:53 minutes for 2-fold acceleration, and 2:38 minutes for 3-fold acceleration. Overall FA and MD values ranged from 0.220 to 0.378 and 1.595 to 1.829 mm2/s, respectively. Two-fold acceleration yielded similar FA and MD values (P ≥ 0.901) and similar fiber tracking performance compared with conventional DTI. Three-fold acceleration resulted in comparable MD (P = 0.199) but higher FA values (P = 0.006) and significantly impaired fiber tracking in the soleus and tibialis anterior muscles (number of tracks, P < 0.001; anatomical precision, P ≤ 0.005). Simultaneous multislice EPI with blipped controlled aliasing in parallel imaging results in higher acceleration can remarkably reduce acquisition time in DTI of skeletal muscle with similar image quality and quantification accuracy of diffusion parameters. This may increase the clinical applicability of muscle anisotropy measurements.

  1. Application accelerator system having bunch control

    DOEpatents

    Wang, Dunxiong; Krafft, Geoffrey Arthur

    1999-01-01

    An application accelerator system for monitoring the gain of a free electron laser. Coherent Synchrotron Radiation (CSR) detection techniques are used with a bunch length monitor for ultra short, picosec to several tens of femtosec, electron bunches. The monitor employs an application accelerator, a coherent radiation production device, an optical or beam chopping device, an infrared radiation collection device, a narrow-banding filter, an infrared detection device, and a control.

  2. 42 CFR 488.61 - Special procedures for approval and re-approval of organ transplant centers.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Approval. Centers that have lost their Medicare approval may seek re-entry into the Medicare program at any... 42 Public Health 5 2012-10-01 2012-10-01 false Special procedures for approval and re-approval of... ENFORCEMENT PROCEDURES Special Requirements § 488.61 Special procedures for approval and re-approval of organ...

  3. 42 CFR 488.61 - Special procedures for approval and re-approval of organ transplant centers.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Approval. Centers that have lost their Medicare approval may seek re-entry into the Medicare program at any... 42 Public Health 5 2011-10-01 2011-10-01 false Special procedures for approval and re-approval of... ENFORCEMENT PROCEDURES Special Requirements § 488.61 Special procedures for approval and re-approval of organ...

  4. 42 CFR 488.61 - Special procedures for approval and re-approval of organ transplant centers.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Approval. Centers that have lost their Medicare approval may seek re-entry into the Medicare program at any... 42 Public Health 5 2013-10-01 2013-10-01 false Special procedures for approval and re-approval of... ENFORCEMENT PROCEDURES Special Requirements § 488.61 Special procedures for approval and re-approval of organ...

  5. 42 CFR 488.61 - Special procedures for approval and re-approval of organ transplant centers.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Approval. Centers that have lost their Medicare approval may seek re-entry into the Medicare program at any... 42 Public Health 5 2010-10-01 2010-10-01 false Special procedures for approval and re-approval of... ENFORCEMENT PROCEDURES Special Requirements § 488.61 Special procedures for approval and re-approval of organ...

  6. 21 CFR 601.91 - Approval based on evidence of effectiveness from studies in animals.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS LICENSING Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible § 601.91 Approval based on evidence of effectiveness from... reasonably likely to produce clinical benefit in humans. In assessing the sufficiency of animal data, the...

  7. 21 CFR 601.91 - Approval based on evidence of effectiveness from studies in animals.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS LICENSING Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible § 601.91 Approval based on evidence of effectiveness from... reasonably likely to produce clinical benefit in humans. In assessing the sufficiency of animal data, the...

  8. 21 CFR 601.91 - Approval based on evidence of effectiveness from studies in animals.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS LICENSING Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible § 601.91 Approval based on evidence of effectiveness from... reasonably likely to produce clinical benefit in humans. In assessing the sufficiency of animal data, the...

  9. 9 CFR 147.48 - Approval of conference recommendations by the Department.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Approval of conference recommendations by the Department. 147.48 Section 147.48 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE LIVESTOCK IMPROVEMENT AUXILIARY PROVISIONS ON NATIONAL POULTRY...

  10. Particle acceleration and production of energetic photons in SN1987A

    NASA Technical Reports Server (NTRS)

    Gaisser, T. K.; Stanev, Todor; Harding, Alice

    1987-01-01

    A pulsar wind model for the acceleration of particles in SN1987A is discussed. The expected photon flux is investigated in terms of the spectrum of parent protons and electrons, the nature of the region in which they propagate after acceleration, and the magnetic field and radiation environment which determines the subsequent fate of produced photons. The model is found to produce observable signals if the spin period of the pulsar is 10 ms or less.

  11. Bacteria-eating virus approved as food additive.

    PubMed

    Bren, Linda

    2007-01-01

    Not all viruses harm people. The Food and Drug Administration has approved a mixture of viruses as a food additive to protect people. The additive can be used in processing plants for spraying onto ready-to-eat meat and poultry products to protect consumers from the potentially life-threatening bacterium Listeria monocytogenes (L. monocytogenes).

  12. 76 FR 24060 - Proposed Extension of Existing Information Collection; Testing, Evaluation, and Approval of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-29

    ... Extension of Existing Information Collection; Testing, Evaluation, and Approval of Mining Products AGENCY... Reduction Act of 1995 [44 U.S.C. 3506(c)(2)(A)]. This program helps to ensure that requested data can be..., testing, approval and certification, and quality control of mining equipment and components, materials...

  13. 77 FR 3829 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Order Granting Accelerated...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-25

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66192; File No. SR-NYSEArca-2012-02] Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Order Granting Accelerated Approval of a Proposed Rule Amendments to NYSE Arca Rule 9.4 and NYSE Equities Inc. Rules 5.3(d) and 9.4 Relating to Discretionary Proxy Voting on Executive...

  14. The IMPELA TM 10 MeV, 50 kW electron linac: launching an industrial accelerator product

    NASA Astrophysics Data System (ADS)

    Stirling, Andrew J.

    1991-05-01

    In the previous conferences there has been no shortage of ideas, experiments and prototypes for industrial accelerators. Indeed, physicists propose new ideas at a rate faster than industry can get irradiators to the market. Certainly, the basic physics design must be sound, but this is a far from sufficient condition for an accelerator to succeed. Good physics design is needed to provide a good combination of electrical efficiency and useable power within the scan width. It may, however, be counterproductive if high performance compromises inherent reliability. From the engineering discipline is required an engineered control interface, an engineered product control and dosimetry system and traceable quality assurance. Just as important, the industrial client seeks an irradiator that is built quickly, and will be supported over a long service life (10-20 years). It is also necessary to assist the client in facility design, licencing and process verification. Providing these additional functions is a challenge for the business champions which equals what the technical champions face in obtaining full beam power.

  15. 48 CFR 45.606-1 - Contractor with an approved scrap procedure.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... production or testing under this contract without Government approval. However, if the scrap requires... schedule. (b) For scrap from other than production or testing, the contractor may prepare scrap lists in..., flight safety critical aircraft parts, and scrap that— (1) Requires demilitarization; (2) Is a classified...

  16. 48 CFR 45.606-1 - Contractor with an approved scrap procedure.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... production or testing under this contract without Government approval. However, if the scrap requires... schedule. (b) For scrap from other than production or testing, the contractor may prepare scrap lists in..., flight safety critical aircraft parts, and scrap that— (1) Requires demilitarization; (2) Is a classified...

  17. 77 FR 50514 - Post-Approval Studies 2012 Workshop: Design, Methodology, and Role in Evidence Appraisal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-21

    ...] Post-Approval Studies 2012 Workshop: Design, Methodology, and Role in Evidence Appraisal Throughout the... Administration (FDA) is announcing the following public workshop entitled ``Post-Approval Studies 2012 Workshop: Design, Methodology, and Role in Evidence Appraisal Throughout the Total Product Life Cycle.'' The topics...

  18. 77 FR 37000 - Proposed Extension of Approval of Information Collection; Comment Request-Baby Bouncers and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-20

    ... CONSUMER PRODUCT SAFETY COMMISSION Proposed Extension of Approval of Information Collection... of 3 years from the date of approval by the Office of Management and Budget (OMB), of information... walker- jumpers. The collection of information consists of requirements that manufacturers and importers...

  19. Application accelerator system having bunch control

    DOEpatents

    Wang, D.; Krafft, G.A.

    1999-06-22

    An application accelerator system for monitoring the gain of a free electron laser is disclosed. Coherent Synchrotron Radiation (CSR) detection techniques are used with a bunch length monitor for ultra short, picosec to several tens of femtosec, electron bunches. The monitor employs an application accelerator, a coherent radiation production device, an optical or beam chopping device, an infrared radiation collection device, a narrow-banding filter, an infrared detection device, and a control. 1 fig.

  20. Product Review

    EPA Pesticide Factsheets

    Resources and guidelines to develop and get approved communications products at EPA; including print items, Web content standards, video production and submission, interactive maps, and social media policies.