Sample records for application supplement approvals

  1. Innovating by developing new uses of already-approved drugs: trends in the marketing approval of supplemental indications.

    PubMed

    DiMasi, Joseph A

    2013-06-01

    Much of the literature on trends and factors affecting biopharmaceutical innovation has focused overwhelmingly on the development and approval of never-before approved drugs and biologics. Little attention has been paid to new uses for already-approved compounds, which can be an important form of innovation. This paper aimed to determine and analyze recent trends in the number and type of new or modified US indication approvals for drugs and biologics. We also examine regulatory approval-phase times for new-use efficacy supplements and compare them to approval-phase times for original-use approvals over the same period. We developed a data set of efficacy supplements approved by the US Food and Drug Administration (FDA) from 1998 to 2011 that includes information on the type, approval-phase time (time from submission to the FDA of an application for marketing approval to approval of the application), and FDA therapeutic-significance rating for the approved application, which we obtained from an FDA Web site. This data set was merged with a Tufts Center for the Study of Drug Development (CSDD) data set of US new drug and biologics approvals. We developed descriptive statistics on trends in the number and type of new-use efficacy supplements, on US regulatory approval-phase times for the supplements, and on original new drug and biologics approvals over the study period and for the time from original- to new-use approval. The total number of new-use efficacy-supplement approvals did not exhibit a marked trend, but the number of new pediatric-indication approvals increased substantially. Approval-phase times for new-use supplements varied by therapeutic class and FDA therapeutic-significance rating. Mean approval-phase times were highest for central nervous system compounds (13.8 months) and lowest for antineoplastics (8.9 months). The mean time from original to supplement approval was substantially longer for new pediatric indications than for other new uses. Mean approval-phase time during the study period for applications that received a standard review rating from the FDA was substantially shorter for supplements compared to original uses, but the differences for applications that received a priority review rating from the FDA were negligible. Development of and regulatory approval for new uses of already-approved drugs and biologics is an important source of innovation by biopharmaceutical firms. Despite rising development costs, the output of new-use approvals has remained stable in recent years, driven largely by the pursuit of new pediatric indications. FDA approval-phase times have generally declined substantially for all types of applications since the mid-1990s following legislation that provided a new source of income for the agency. However, while the resources needed to review supplemental applications are likely lower in general than for original-use approvals, the approval-phase times for important new uses are no lower than for important original-use applications. Copyright © 2013 Elsevier HS Journals, Inc. All rights reserved.

  2. 21 CFR 314.97 - Supplements and other changes to an approved abbreviated application.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Supplements and other changes to an approved abbreviated application. 314.97 Section 314.97 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW...

  3. 21 CFR 314.97 - Supplements and other changes to an approved abbreviated application.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Supplements and other changes to an approved abbreviated application. 314.97 Section 314.97 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW...

  4. 21 CFR 314.71 - Procedures for submission of a supplement to an approved application.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Procedures for submission of a supplement to an approved application. 314.71 Section 314.71 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW...

  5. 21 CFR 314.71 - Procedures for submission of a supplement to an approved application.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Procedures for submission of a supplement to an approved application. 314.71 Section 314.71 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW...

  6. 21 CFR 314.71 - Procedures for submission of a supplement to an approved application.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Procedures for submission of a supplement to an approved application. 314.71 Section 314.71 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW...

  7. 21 CFR 314.71 - Procedures for submission of a supplement to an approved application.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Procedures for submission of a supplement to an approved application. 314.71 Section 314.71 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW...

  8. 77 FR 28604 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-15

    ... Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act... Dietary Supplement and Nonprescription Drug Consumer Protection Act.'' DATES: Submit either electronic or... Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement...

  9. 77 FR 43841 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-26

    ... Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and... Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer... the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Pub. L. 109-462, 120 Stat...

  10. 75 FR 35044 - Notice of Approval of a Supplemental New Animal Drug Application; Penicillin G Procaine Suspension

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-21

    ...] Notice of Approval of a Supplemental New Animal Drug Application; Penicillin G Procaine Suspension AGENCY... Laboratories, Ltd. The supplemental NADA provides for a revised formulation of penicillin G procaine injectable... of NOROCILLIN (penicillin G procaine) Injectable Suspension by intramuscular injection in cattle...

  11. 21 CFR 314.70 - Supplements and other changes to an approved application.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Applications... application. (1)(i) Except as provided in paragraph (a)(1)(ii) of this section, the applicant must notify FDA... of change, the applicant must notify FDA about the change in a supplement under paragraph (b) or (c...

  12. 21 CFR 314.70 - Supplements and other changes to an approved application.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Applications... application. (1)(i) Except as provided in paragraph (a)(1)(ii) of this section, the applicant must notify FDA... of change, the applicant must notify FDA about the change in a supplement under paragraph (b) or (c...

  13. 21 CFR 314.60 - Amendments to an unapproved application, supplement, or resubmission.

    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...) FDA generally assumes that when an original application, supplement to an approved application, or... the “initial review cycle.”) FDA may instead defer review of the amendment until the subsequent review...

  14. 21 CFR 314.60 - Amendments to an unapproved application, supplement, or resubmission.

    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...) FDA generally assumes that when an original application, supplement to an approved application, or... the “initial review cycle.”) FDA may instead defer review of the amendment until the subsequent review...

  15. 21 CFR 314.60 - Amendments to an unapproved application, supplement, or resubmission.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW...) FDA generally assumes that when an original application, supplement to an approved application, or... the “initial review cycle.”) FDA may instead defer review of the amendment until the subsequent review...

  16. 21 CFR 314.60 - Amendments to an unapproved application, supplement, or resubmission.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW...) FDA generally assumes that when an original application, supplement to an approved application, or... the “initial review cycle.”) FDA may instead defer review of the amendment until the subsequent review...

  17. 21 CFR 514.106 - Approval of supplemental applications.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Approval of supplemental applications. 514.106 Section 514.106 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... labeling (color, style, format, addition, deletion, or revision of certain statements, e.g., trade name...

  18. 21 CFR 514.106 - Approval of supplemental applications.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Approval of supplemental applications. 514.106 Section 514.106 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... labeling (color, style, format, addition, deletion, or revision of certain statements, e.g., trade name...

  19. 21 CFR 514.106 - Approval of supplemental applications.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Approval of supplemental applications. 514.106 Section 514.106 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... labeling (color, style, format, addition, deletion, or revision of certain statements, e.g., trade name...

  20. FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012.

    PubMed

    Rome, Benjamin N; Kramer, Daniel B; Kesselheim, Aaron S

    The US Food and Drug Administration (FDA) evaluates high-risk medical devices such as cardiac implantable electronic devices (CIEDs), including pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy devices, via the premarket approval (PMA) process, during which manufacturers submit clinical data demonstrating safety and effectiveness. Subsequent changes to approved high-risk devices are implemented via "supplements," which may not require additional clinical testing. To characterize the prevalence and characteristics of changes to CIEDs made through the PMA supplement process. Using the FDA's PMA database, we reviewed all CIEDs approved as original PMAs or supplements from 1979 through 2012. For each supplement, we collected the date approved, type of supplement (panel-track, 180-day, real-time, special, and 30-day notice), and the nature of the changes. We calculated the number of supplements approved per PMA and analyzed trends relating to different supplement regulatory categories over time. For supplements approved via the 180-day regulatory pathway, which often involve significant design changes, from 2010-2012, we identified how often additional clinical data were collected. From 1979-2012, the FDA approved 77 original and 5829 supplement PMA applications for CIEDs, with a median of 50 supplements per original PMA (interquartile range [IQR], 23-87). Excluding manufacturing changes that do not alter device design, the number of supplements approved each year was stable around a mean (SD) of 2.6 (0.9) supplements per PMA per year. Premarket approvals remained active via successive supplements over a median period of 15 years (IQR, 8-20), and 79% of the 77 original PMAs approved during our study period were the subject of at least 1 supplement in 2012. Thirty-seven percent of approved supplements involved a change to the device's design. Among 180-day supplements approved from 2010-2012, 23% (15/64) included new clinical data to support safety and effectiveness. Many CIED models currently used by clinicians were approved via the PMA supplement process, not as original PMAs. Most new device models are deemed safe and effective without requiring new clinical data, reinforcing the importance of rigorous postapproval surveillance of these devices.

  1. 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.

  2. 21 CFR 515.11 - Supplemental 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 Supplemental medicated feed mill license... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS MEDICATED FEED MILL LICENSE Applications § 515.11 Supplemental medicated feed mill license applications. (a) After approval of a medicated feed...

  3. 77 FR 50699 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-22

    ... Request; Dietary Supplement Labeling Requirements and Recommendations Under the Dietary Supplement and.... Dietary Supplement Labeling Requirements and Recommendations Under the Dietary Supplement and... reporting for dietary supplements and nonprescription drugs marketed without an approved application. The...

  4. 76 FR 6798 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-08

    ... Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions... Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and...

  5. Clinical Evidence Supporting US Food and Drug Administration Approval of Otolaryngologic Prescription Drug Indications, 2005-2014.

    PubMed

    Rathi, Vinay K; Wang, Bo; Ross, Joseph S; Downing, Nicholas S; Kesselheim, Aaron S; Gray, Stacey T

    2017-04-01

    Objective The US Food and Drug Administration (FDA) approves indications for prescription drugs based on premarket pivotal clinical studies designed to demonstrate safety and efficacy. We characterized the pivotal studies supporting FDA approval of otolaryngologic prescription drug indications. Study Design Retrospective cross-sectional analysis. Setting Publicly available FDA documents. Subjects Recently approved (2005-2014) prescription drug indications for conditions treated by otolaryngologists or their multidisciplinary teams. Drugs could be authorized for treatment of otolaryngologic disease upon initial approval (original indications) or thereafter via supplemental applications (supplemental indications). Methods Pivotal studies were categorized by enrollment, randomization, blinding, comparator type, and primary endpoint. Results Between 2005 and 2014, the FDA approved 48 otolaryngologic prescription drug indications based on 64 pivotal studies, including 21 original indications (19 drugs, 31 studies) and 27 supplemental indications (18 drugs, 33 studies). Median enrollment was 299 patients (interquartile range, 198-613) for original indications and 197 patients (interquartile range, 64-442) for supplemental indications. Most indications were supported by ≥1 randomized study (original: 20/21 [95%], supplemental: 21/27 [78%]) and ≥1 double-blinded study (original: 14/21 [67%], supplemental: 17/27 [63%]). About half of original indications (9/21 [43%]) and one-quarter of supplemental indications (7/27 [26%]) were supported by ≥1 active-controlled study. Nearly half (original: 8/21 [38%], supplemental: 14/27 [52%]) of all indications were approved based exclusively on studies using surrogate markers as primary endpoints. Conclusion The quality of clinical evidence supporting FDA approval of otolaryngologic prescription drug indications varied widely. Otolaryngologists should consider limitations in premarket evidence when helping patients make informed treatment decisions about newly approved drugs.

  6. 21 CFR 99.305 - Exemption from the requirement to file a supplemental application.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ..., BIOLOGICS, AND DEVICES FDA Action on Submissions, Requests, and Applications § 99.305 Exemption from the... exemption from the requirement of a supplemental application, FDA shall approve or deny the application. (1) If FDA does not act on the application for an exemption within the 60-day period, the application for...

  7. 21 CFR 99.305 - Exemption from the requirement to file a supplemental application.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ..., BIOLOGICS, AND DEVICES FDA Action on Submissions, Requests, and Applications § 99.305 Exemption from the... exemption from the requirement of a supplemental application, FDA shall approve or deny the application. (1) If FDA does not act on the application for an exemption within the 60-day period, the application for...

  8. 21 CFR 99.305 - Exemption from the requirement to file a supplemental application.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ..., BIOLOGICS, AND DEVICES FDA Action on Submissions, Requests, and Applications § 99.305 Exemption from the... exemption from the requirement of a supplemental application, FDA shall approve or deny the application. (1) If FDA does not act on the application for an exemption within the 60-day period, the application for...

  9. 21 CFR 99.305 - Exemption from the requirement to file a supplemental application.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ..., BIOLOGICS, AND DEVICES FDA Action on Submissions, Requests, and Applications § 99.305 Exemption from the... exemption from the requirement of a supplemental application, FDA shall approve or deny the application. (1) If FDA does not act on the application for an exemption within the 60-day period, the application for...

  10. 21 CFR 314.70 - Supplements and other changes to an approved application.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... of change, the applicant must notify FDA about the change in a supplement under paragraph (b) or (c... alternative under § 201.26 of this chapter satisfies the applicable requirements in paragraphs (a) through (c...) Notwithstanding the requirements of paragraphs (b) and (c) of this section, an applicant must make a change...

  11. 21 CFR 314.70 - Supplements and other changes to an approved application.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... of change, the applicant must notify FDA about the change in a supplement under paragraph (b) or (c... alternative under § 201.26 of this chapter satisfies the applicable requirements in paragraphs (a) through (c...) Notwithstanding the requirements of paragraphs (b) and (c) of this section, an applicant must make a change...

  12. 14 CFR 26.23 - Extended limit of validity.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... revision or supplement, as applicable, to the Airworthiness Limitations section (ALS) of the Instructions... Oversight Office for approval. The revised ALS or supplement to the ALS must include the applicable extended... documented as airworthiness limitation items in the ALS and submitted to the FAA Oversight Office for...

  13. 14 CFR 26.23 - Extended limit of validity.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... revision or supplement, as applicable, to the Airworthiness Limitations section (ALS) of the Instructions... Oversight Office for approval. The revised ALS or supplement to the ALS must include the applicable extended... documented as airworthiness limitation items in the ALS and submitted to the FAA Oversight Office for...

  14. 14 CFR 26.23 - Extended limit of validity.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... revision or supplement, as applicable, to the Airworthiness Limitations section (ALS) of the Instructions... Oversight Office for approval. The revised ALS or supplement to the ALS must include the applicable extended... documented as airworthiness limitation items in the ALS and submitted to the FAA Oversight Office for...

  15. 14 CFR 26.23 - Extended limit of validity.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... revision or supplement, as applicable, to the Airworthiness Limitations section (ALS) of the Instructions... Oversight Office for approval. The revised ALS or supplement to the ALS must include the applicable extended... documented as airworthiness limitation items in the ALS and submitted to the FAA Oversight Office for...

  16. 21 CFR 514.106 - Approval of supplemental applications.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ..., storage, expiration dates, etc). (vi) A change in promotional material for a prescription new animal drug... application. Category II supplements include the following: (i) A change in the active ingredient... specifications of the active or inactive ingredients. (iii) A change in dose (amount of drug administered per...

  17. 21 CFR 514.106 - Approval of supplemental applications.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ..., storage, expiration dates, etc). (vi) A change in promotional material for a prescription new animal drug... application. Category II supplements include the following: (i) A change in the active ingredient... specifications of the active or inactive ingredients. (iii) A change in dose (amount of drug administered per...

  18. 21 CFR 25.31 - Human drugs and biologics.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... approval of a biologic product, or a supplement to such applications, or action on an OTC monograph, if the... a supplement to such applications, or action on an OTC monograph, if the action increases the use of... an OTC monograph, for substances that occur naturally in the environment when the action does not...

  19. Bovine somatotropin supplementation of dairy cows. Is the milk safe?

    PubMed

    Daughaday, W H; Barbano, D M

    Complex, biologically active proteins (eg, enzymes and hormones) can be manufactured safely and cost-effectively through applications of biotechnology. Some of these proteins (eg, human insulin, human somatotropin, rennet for cheese manufacture) are currently approved for medical or food processing applications. Bovine somatotropin (bST) for lactating dairy cattle is another product that can be produced via biotechnology and may allow dairy farmers to produce milk at a lower cost. In 1985, based on an evaluation of toxicological data, the Food and Drug Administration concluded that milk and meat from bST-supplemented cows was safe and wholesome. The Food and Drug Administration has authorized the use of milk and meat from bST-supplemented cows in the commercial food supply. Its evaluation of the impact of bST supplementation on the long-term health of dairy cattle is near completion, and bST may be approved for commercial use in early 1991.

  20. 46 CFR 8.430 - U.S. Supplement to class rules.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... authorization to participate in the ACP, a recognized classification society must prepare, and receive Commandant (CG-521) approval of, a U.S. Supplement to the recognized classification society's class rules... of that classification society or applicable international regulations. ...

  1. 46 CFR 8.430 - U.S. Supplement to class rules.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... authorization to participate in the ACP, a recognized classification society must prepare, and receive Commandant (CG-521) approval of, a U.S. Supplement to the recognized classification society's class rules... of that classification society or applicable international regulations. ...

  2. Characteristics of efficacy evidence supporting approval of supplemental indications for prescription drugs in United States, 2005-14: systematic review.

    PubMed

    Wang, Bo; Kesselheim, Aaron S

    2015-09-23

    To characterize the types of comparators and endpoints used in efficacy trials for approvals of supplemental indications, compared with the data supporting these drugs' originally approved indications. Systematic review. Publicly accessible data on supplemental indications approved by the US Food and Drug Administration from 2005 to 2014. Types of comparators (active, placebo, historical, none) and endpoints (clinical outcomes, clinical scales, surrogate) in the efficacy trials for these drugs' supplemental and original indication approvals. The cohort included 295 supplemental indications. Thirty per cent (41/136) of supplemental approvals for new indications were supported by efficacy trials with active comparators, compared with 51% (47/93) of modified use approvals and 11% (7/65) of approvals expanding the patient population (P<0.001), almost all of which related to pediatric patients (61/65; 94%). Trials using clinical outcome endpoints led to approval for 32% (44/137) of supplemental approvals for new indications, 30% (28/93) of modified indication approvals, and 22% (14/65) of expanded population approvals (P=0.29). Orphan drugs had supplemental approvals for 40 non-orphan indications, which were supported by similar proportions of trials using active comparators (28% (11/40) for non-orphan supplemental indications versus 24% (10/42) for original orphan indications; P=0.70) and clinical outcome endpoints (25% (10/40) versus 31% (13/42); P=0.55). Wide variations were seen in the evidence supporting approval of supplemental indications, with the fewest active comparators and clinical outcome endpoints used in trials leading to supplemental approvals that expanded the patient population. © Wang et al 2015.

  3. Characteristics of efficacy evidence supporting approval of supplemental indications for prescription drugs in United States, 2005-14: systematic review

    PubMed Central

    Wang, Bo

    2015-01-01

    Objective To characterize the types of comparators and endpoints used in efficacy trials for approvals of supplemental indications, compared with the data supporting these drugs’ originally approved indications. Design Systematic review. Setting Publicly accessible data on supplemental indications approved by the US Food and Drug Administration from 2005 to 2014. Main outcome measures Types of comparators (active, placebo, historical, none) and endpoints (clinical outcomes, clinical scales, surrogate) in the efficacy trials for these drugs’ supplemental and original indication approvals. Results The cohort included 295 supplemental indications. Thirty per cent (41/136) of supplemental approvals for new indications were supported by efficacy trials with active comparators, compared with 51% (47/93) of modified use approvals and 11% (7/65) of approvals expanding the patient population (P<0.001), almost all of which related to pediatric patients (61/65; 94%). Trials using clinical outcome endpoints led to approval for 32% (44/137) of supplemental approvals for new indications, 30% (28/93) of modified indication approvals, and 22% (14/65) of expanded population approvals (P=0.29). Orphan drugs had supplemental approvals for 40 non-orphan indications, which were supported by similar proportions of trials using active comparators (28% (11/40) for non-orphan supplemental indications versus 24% (10/42) for original orphan indications; P=0.70) and clinical outcome endpoints (25% (10/40) versus 31% (13/42); P=0.55). Conclusions Wide variations were seen in the evidence supporting approval of supplemental indications, with the fewest active comparators and clinical outcome endpoints used in trials leading to supplemental approvals that expanded the patient population. PMID:26400844

  4. 21 CFR 514.8 - Supplements and other changes to an approved application.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... method(s) or an addition, deletion, or substitution of steps in an aseptic processing operation; (D... solely affecting a natural product, a recombinant DNA-derived protein/polypeptide, or a complex or...) or references to previously approved documentation; (H) For a natural product, a recombinant DNA...

  5. 21 CFR 514.8 - Supplements and other changes to an approved application.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... method(s) or an addition, deletion, or substitution of steps in an aseptic processing operation; (D... solely affecting a natural product, a recombinant DNA-derived protein/polypeptide, or a complex or...) or references to previously approved documentation; (H) For a natural product, a recombinant DNA...

  6. 21 CFR 514.8 - Supplements and other changes to an approved application.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... method(s) or an addition, deletion, or substitution of steps in an aseptic processing operation; (D... solely affecting a natural product, a recombinant DNA-derived protein/polypeptide, or a complex or...) or references to previously approved documentation; (H) For a natural product, a recombinant DNA...

  7. 76 FR 60721 - New Animal Drugs for Use in Animal Feeds; Melengestrol; Monensin

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-30

    .... FDA-2011-N-0003] New Animal Drugs for Use in Animal Feeds; Melengestrol; Monensin AGENCY: Food and... amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. The supplemental ANADA...

  8. 5 CFR 5502.107 - Supplemental disclosure of financial interests in substantially affected organizations applicable...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... clinical study involving human subjects under a clinical research protocol approved by an institutional review board. (2) Clinical research has the meaning set forth in 42 U.S.C. 284d(b). (3) Institutional... review a clinical research protocol and approve the initiation of biomedical research involving human...

  9. 75 FR 12981 - Oral Dosage Form New Animal Drugs; Tetracycline Powder

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-18

    .... FDA-2010-N-0002] Oral Dosage Form New Animal Drugs; Tetracycline Powder AGENCY: Food and Drug... amending the animal drug regulations to reflect approval of a supplemental new animal drug application... approval of this product. This change is being made to improve the accuracy of the animal drug regulations...

  10. 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...

  11. 76 FR 66944 - Agency Information Collection Activities: Form I-914; Extension of a Currently Approved...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-28

    ..., Application for T Nonimmigrant Status; Application for Immediate Family Member of T-1 Recipient; and.../Collection: Application for T Nonimmigrant Status; Supplement A: Application for Immediate Family Member of T... households. Form I- 914 permits victims of severe forms of trafficking and their immediate family members to...

  12. 14 CFR 158.27 - Review of applications.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ...) AIRPORTS PASSENGER FACILITY CHARGES (PFC'S) Application and Approval § 158.27 Review of applications. (a... statutory deadline for the Administrator's decision. Upon receipt of the supplement, the Administrator... agency and the airport at which the PFC is to be imposed; (2) A brief description of the PFC project, the...

  13. 14 CFR 158.27 - Review of applications.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ...) AIRPORTS PASSENGER FACILITY CHARGES (PFC'S) Application and Approval § 158.27 Review of applications. (a... statutory deadline for the Administrator's decision. Upon receipt of the supplement, the Administrator... agency and the airport at which the PFC is to be imposed; (2) A brief description of the PFC project, the...

  14. 14 CFR 158.27 - Review of applications.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ...) AIRPORTS PASSENGER FACILITY CHARGES (PFC'S) Application and Approval § 158.27 Review of applications. (a... statutory deadline for the Administrator's decision. Upon receipt of the supplement, the Administrator... agency and the airport at which the PFC is to be imposed; (2) A brief description of the PFC project, the...

  15. 14 CFR 158.27 - Review of applications.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ...) AIRPORTS PASSENGER FACILITY CHARGES (PFC'S) Application and Approval § 158.27 Review of applications. (a... statutory deadline for the Administrator's decision. Upon receipt of the supplement, the Administrator... agency and the airport at which the PFC is to be imposed; (2) A brief description of the PFC project, the...

  16. 14 CFR 158.27 - Review of applications.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ...) AIRPORTS PASSENGER FACILITY CHARGES (PFC'S) Application and Approval § 158.27 Review of applications. (a... statutory deadline for the Administrator's decision. Upon receipt of the supplement, the Administrator... agency and the airport at which the PFC is to be imposed; (2) A brief description of the PFC project, the...

  17. 78 FR 67985 - Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-13

    ... reference listed drug (RLD) upon submission to FDA of a ``changes being effected'' (CBE-0) supplement. The.... Effective Date VIII. Federalism IX. Request for Comments X. References Executive Summary Purpose of the.... Costs and Benefits The economic benefits to the public health from adoption of the proposed rule are not...

  18. 20 CFR 416.360 - Cancellation of a request to withdraw.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ....360 Section 416.360 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED Filing of Applications Withdrawal of Application § 416.360... received after we have approved the withdrawal, the cancellation request is filed no later than 60 days...

  19. SSI/SSDI Outreach, Access, and Recovery (SOAR): Disability Application Outcomes Among Homeless Adults.

    PubMed

    Lowder, Evan M; Desmarais, Sarah L; Neupert, Shevaun D; Truelove, Melissa A

    2017-11-01

    The SSI/SSDI Outreach, Access, and Recovery (SOAR) program has been shown to increase access to Supplemental Security Income and Social Security Disability Insurance benefits among homeless adults. However, little empirical data exist on how or for whom SOAR achieves successful application outcomes. This study investigated applicant and application characteristics associated with disability application outcomes among homeless adults. Secondary data on 6,361 SOAR-assisted applications were obtained. Multilevel models investigated between-applicant differences in application processing time and decision as a function of applicant and application characteristics. Older age and living in an institution were associated with greater odds of application approval. Female gender and receipt of public assistance were associated with longer processing time and lower odds of approval. Except for quality review, SOAR critical components were associated with greater odds of approval. Women and adults receiving public assistance appear disadvantaged in the SOAR application process. SOAR critical components promote successful disability application outcomes.

  20. 76 FR 70768 - Biweekly Notice; Applications and Amendments to Facility Operating Licenses Involving No...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-15

    ... perform a probabilistic risk evaluation using the guidance contained in NRC approved NEI [Nuclear Energy... Issue Summary 2003-18, Supplement 2, ``Use of Nuclear Energy Institute (NEI) 99-01, Methodology for...

  1. Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements.

    PubMed

    Zheng, Sarah Y; Dhruva, Sanket S; Redberg, Rita F

    2017-08-15

    High-risk medical devices often undergo modifications, which are approved by the US Food and Drug Administration (FDA) through various kinds of premarket approval (PMA) supplements. There have been multiple high-profile recalls of devices approved as PMA supplements. To characterize the quality of the clinical studies and data (strength of evidence) used to support FDA approval of panel-track supplements (a type of PMA supplement pathway that is used for significant changes in a device or indication for use and always requires clinical data). Descriptive study of clinical studies supporting panel-track supplements approved by the FDA between April 19, 2006, and October 9, 2015. Panel-track supplement approval. Methodological quality of studies including randomization, blinding, type of controls, clinical vs surrogate primary end points, use of post hoc analyses, and reporting of age and sex. Eighty-three clinical studies supported the approval of 78 panel-track supplements, with 71 panel-track supplements (91%) supported by a single study. Of the 83 studies, 37 (45%) were randomized clinical trials and 25 (30%) were blinded. The median number of patients per study was 185 (interquartile range, 75-305), and the median follow-up duration was 180 days (interquartile range, 84-270 days). There were a total of 150 primary end points (mean [SD], 1.8 [1.2] per study), and 57 primary end points (38%) were compared with controls. Of primary end points with controls, 6 (11%) were retrospective controls and 51 (89%) were active controls. One hundred twenty-one primary end points (81%) were surrogate end points. Thirty-three studies (40%) did not report age and 25 (30%) did not report sex for all enrolled patients. The FDA required postapproval studies for 29 of 78 (37%) panel-track supplements. Among clinical studies used to support FDA approval of high-risk medical device modifications, fewer than half were randomized, blinded, or controlled, and most primary outcomes were based on surrogate end points. These findings suggest that the quality of studies and data evaluated to support approval by the FDA of modifications of high-risk devices should be improved.

  2. 77 FR 65198 - Generic Drug User Fee-Abbreviated New Drug Application, Prior Approval Supplement, and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-25

    ... FY 2013 is 1,160. The FY 2013 application fee is estimated by dividing the number of full application... in FY 2013. Dividing the DMF revenue of $14,940,000 by the estimated number of first-referenced DMFs..., Attention: Government Lockbox 979108, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This U.S. Bank...

  3. 21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? (a) You must ensure that any returned dietary supplements that are reprocessed meet all product specifications established in accordance...

  4. 21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? (a) You must ensure that any returned dietary supplements that are reprocessed meet all product specifications established in accordance...

  5. 21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? (a) You must ensure that any returned dietary supplements that are reprocessed meet all product specifications established in accordance...

  6. 21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? (a) You must ensure that any returned dietary supplements that are reprocessed meet all product specifications established in accordance...

  7. 21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? (a) You must ensure that any returned dietary supplements that are reprocessed meet all product specifications established in accordance...

  8. 75 FR 75182 - Agency Information Collection Activities: Form I-914, Extension of a Currently Approved...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-02

    ... ACTION: 30-Day Notice of Information Collection under Review: Form I- 914 and Supplements A and B, Application for T Nonimmigrant Status; Application for Immediate Family Member of T-1 Recipient; and... for a 60-day public comment period. USCIS did not receive any comments for this information collection...

  9. 77 FR 59356 - Approval and Promulgation of Implementation Plans; North Carolina: Approval of Rocky Mount...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-27

    ... Promulgation of Implementation Plans; North Carolina: Approval of Rocky Mount Supplemental Motor Vehicle... is proposing to approve a revision to the North Carolina State Implementation Plan (SIP), submitted... supplements the original redesignation request and maintenance plan for Rocky Mount 1997 8-hour ozone area...

  10. 76 FR 66086 - Agency Information Collection Activities; Proposed Collection, Comments Requested: Reinstatement...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-25

    ... Approved Collection for Which Approval Has Expired, Identity Theft Supplement (ITS) to the National Crime... approved collection for which approval has expired. (2) Title of the Form/Collection: Identity Theft... United States. The Identity Theft Supplement (ITS) to the National Crime Victimization Survey collects...

  11. The First Year of the Food and Drug Administration Oncology Center of Excellence: Landmark Approvals in a Dynamic Regulatory Environment.

    PubMed

    Goldberg, Kirsten B; Blumenthal, Gideon M; Pazdur, Richard

    The Food and Drug Administration formally established the Oncology Center of Excellence (OCE) in January 2017, as authorized by the 21st Century Cures Act, to expedite the development and review of certain drugs, biologics, and devices for the treatment of cancer. In its first year, the OCE conducted the clinical reviews for several products, including the first 2 chimeric antigen receptor T-cell therapies approved for the treatment of advanced hematologic malignancies and an in vitro diagnostic next-generation sequencing panel, FoundationOne CDx. The OCE also worked with professional societies and patient advocates on efforts to modernize clinical trial eligibility criteria, resulting in recommendations regarding minimal age, brain metastases, organ dysfunction, and human immunodeficiency virus coinfection. Altogether in 2017, the Food and Drug Administration approved 16 new drug and biologic applications, 30 supplemental drug and biologic applications, and 2 biosimilar applications in oncology.

  12. 7 CFR 1717.901 - Early approval.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 11 2011-01-01 2011-01-01 false Early approval. 1717.901 Section 1717.901 Agriculture... for Supplemental Financing Required by 7 CFR 1710.110 § 1717.901 Early approval. (a) Conditions. If... supplemental financing early in the process, before funding is available for the concurrent RUS insured loan...

  13. 76 FR 65109 - New Animal Drugs for Use in Animal Feeds; Melengestrol; Monensin; Tylosin

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-20

    .... FDA-2011-N-0003] New Animal Drugs for Use in Animal Feeds; Melengestrol; Monensin; Tylosin AGENCY...) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. The...

  14. 75 FR 54492 - Oral Dosage Form New Animal Drugs; Tiamulin

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-08

    .... FDA-2010-N-0002] Oral Dosage Form New Animal Drugs; Tiamulin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Novartis Animal...

  15. 77 FR 3836 - Supplemental Environmental Impact Statement, Mingo County, WV

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-25

    ... Mountain Surface Mine Clean Water Act Section 404 Permit Application. The FHWA and USACE are joint-lead... 2000 FEIS and approved in the 2000 ROD. The USACE is evaluating a Clean Water Act (CWA) Section 404... to surface water and groundwater resources, including aquatic habitat, water quantity and quality...

  16. Clinical trial designs to obtain marketing authorization of drugs for haematological malignancy in Japan, the EU and the US.

    PubMed

    Nagai, Sumimasa; Ozawa, Keiya

    2016-07-01

    Differences in regulatory actions between Japan, the European Union (EU) and the United States (US) regarding the approval date and primary endpoints of pivotal trials have never been analysed comprehensively. This study aimed to examine such differences in haematological malignancy indications not only in applications for new molecular entity agents but also in supplemental applications for additional indications. A total of 101 haematological malignancy indications were examined for 58 drugs. Only 30 indications were approved by the regulatory agencies of all three regions with 25, 9 and 67 indications being first approved in Japan, the EU and the US, respectively. Regarding the 18 indications approved only in the US, 13 were approved based on results of single-arm trials. The approval of all nine indications approved first in the EU was based on results of comparative trials. The primary endpoints were different between the EU and the US in 4 of 49 indications approved by both regulatory agencies, all of which were approved earlier in the US than in the EU. This analysis shows that the US Food and Drug Administration has taken the most active attitude to acceptance of surrogate endpoints in single-arm trials. Therefore, not only shorter review time but also this attitude may lead to earlier approval in US. © 2016 John Wiley & Sons Ltd.

  17. 30 CFR 250.285 - How do I submit revised and supplemental EPs, DPPs, and DOCDs?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... that the Regional Supervisor determines are likely to result in a significant change in the impacts... supplemental EPs, DPPs, and DOCDs? (a) Submittal. You must submit to the Regional Supervisor any revisions and supplements to approved EPs, DPPs, or DOCDs for approval, whether you initiate them or the Regional Supervisor...

  18. 21 CFR 814.47 - Temporary suspension of approval of a PMA.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.47 Temporary suspension of approval of a PMA. (a) Scope. (1) This section describes the procedures that FDA will follow in... the original PMA, as well as any PMA supplement(s), for a medical device. (2) FDA will issue an order...

  19. 21 CFR 814.47 - Temporary suspension of approval of a PMA.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.47 Temporary suspension of approval of a PMA. (a) Scope. (1) This section describes the procedures that FDA will follow in... the original PMA, as well as any PMA supplement(s), for a medical device. (2) FDA will issue an order...

  20. 21 CFR 814.47 - Temporary suspension of approval of a PMA.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.47 Temporary suspension of approval of a PMA. (a) Scope. (1) This section describes the procedures that FDA will follow in... the original PMA, as well as any PMA supplement(s), for a medical device. (2) FDA will issue an order...

  1. 21 CFR 514.8 - Supplements and other changes to an approved application.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... the drug as manufactured without the change; (C) Changes that may affect drug substance or drug... the proposed change; (C) The drug(s) involved; (D) The manufacturing site(s) or area(s) affected; (E...) Replacement of equipment with that of a different design that does not affect the process methodology or...

  2. 21 CFR 514.8 - Supplements and other changes to an approved application.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... the drug as manufactured without the change; (C) Changes that may affect drug substance or drug... the proposed change; (C) The drug(s) involved; (D) The manufacturing site(s) or area(s) affected; (E...) Replacement of equipment with that of a different design that does not affect the process methodology or...

  3. 75 FR 40771 - Agency Information Collection Activities: Proposed Collection; Comment Request-Supplemental...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-14

    ...) of Public Law 110-246, Food, Conservation, and Energy Act of 2008 (FCEA), renamed the Food Stamp... hours), for all 53 State agencies to generate and issue notices of approvals and denials of applications... burden hours) for State agencies to generate and issue notices. Recordkeeping Burden State agencies are...

  4. 76 FR 16534 - New Animal Drugs for Use in Animal Feeds; Florfenicol; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-24

    .... FDA-2010-N-0002] New Animal Drugs for Use in Animal Feeds; Florfenicol; Correction AGENCY: Food and...) published a document in the Federal Register of June 17, 2010 (75 FR 34361) revising the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA). That document contained...

  5. 75 FR 34361 - New Animal Drugs for Use in Animal Feeds; Florfenicol

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-17

    .... FDA-2010-N-0002] New Animal Drugs for Use in Animal Feeds; Florfenicol AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by...

  6. 76 FR 79064 - New Animal Drugs for Use in Animal Feeds; Monensin

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-21

    .... FDA-2011-N-0003] New Animal Drugs for Use in Animal Feeds; Monensin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by...

  7. 77 FR 4228 - New Animal Drugs for Use in Animal Feeds; Monensin

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-27

    .... FDA-2011-N-0003] New Animal Drugs for Use in Animal Feeds; Monensin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by...

  8. 76 FR 22610 - Implantation or Injectable Dosage Form New Animal Drugs; Enrofloxacin

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-22

    .... FDA-2011-N-0003] Implantation or Injectable Dosage Form New Animal Drugs; Enrofloxacin AGENCY: Food... amending the animal drug regulations to reflect approval of a supplemental new animal drug application... INFORMATION: Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201, filed a...

  9. 75 FR 54019 - New Animal Drugs for Use in Animal Feed; Ractopamine

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-03

    .... FDA-2010-N-0002] New Animal Drugs for Use in Animal Feed; Ractopamine AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two supplemental new animal drug applications (NADAs) filed by...

  10. 75 FR 20917 - New Animal Drugs for Use in Animal Feeds; Melengestrol, Monensin, and Ractopamine

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-22

    .... FDA-2010-N-0002] New Animal Drugs for Use in Animal Feeds; Melengestrol, Monensin, and Ractopamine... (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Div. of Ivy Animal Health, Inc. The...

  11. 75 FR 60308 - New Animal Drugs for Use in Animal Feeds; Melengestrol

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-30

    .... FDA-2010-N-0002] New Animal Drugs for Use in Animal Feeds; Melengestrol AGENCY: Food and Drug... amending the animal drug regulations to more accurately reflect the recent approval of two supplemental new animal drug applications (NADAs) filed by Pharmacia & Upjohn Co., a Division of Pfizer, Inc. The...

  12. 77 FR 4226 - Implantation or Injectable Dosage Form New Animal Drugs; Danofloxacin

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-27

    .... FDA-2011-N-0003] Implantation or Injectable Dosage Form New Animal Drugs; Danofloxacin AGENCY: Food... amending the animal drug regulations to reflect approval of a supplemental new animal drug application.... 801-808. List of Subjects in 21 CFR Part 522 Animal drugs. Therefore, under the Federal Food, Drug...

  13. 75 FR 9334 - New Animal Drugs for Use in Animal Feeds; Chlortetracycline

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-02

    .... FDA-2010-N-0002] New Animal Drugs for Use in Animal Feeds; Chlortetracycline AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by ADM...

  14. 77 FR 24138 - New Animal Drugs for Use in Animal Feeds; Tiamulin

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-23

    .... FDA-2012-N-0002] New Animal Drugs for Use in Animal Feeds; Tiamulin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by...

  15. 75 FR 54018 - Oral Dosage Form New Animal Drugs; Praziquantel and Pyrantel

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-03

    .... FDA-2010-N-0002] Oral Dosage Form New Animal Drugs; Praziquantel and Pyrantel AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by...

  16. 21 CFR 314.70 - Supplements and other changes to an approved application.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... derived from such studies; (vi) For a natural product, a recombinant DNA-derived protein/polypeptide, or a...) Changes solely affecting a natural protein, a recombinant DNA-derived protein/polypeptide or a complex or..., recombinant DNA-derived protein/polypeptide, complex or conjugate of a drug substance with a monoclonal...

  17. 78 FR 38256 - Approval and Promulgation of Air Quality Implementation Plans; Ohio; Redesignation of the Ohio...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-26

    ...EPA is issuing a supplement to its proposed approval of Ohio's request to redesignate the Ohio portion of the Parkersburg-Marietta, West Virginia-Ohio, area to attainment for the 1997 annual National Ambient Air Quality Standards (NAAQS or standard) for fine particulate matter (PM2.5). This supplemental proposal revises and expands the basis for proposing approval of the state's request, in light of developments since EPA issued its initial proposal on November 30, 2012. This supplemental proposal addresses the effects of a January 4, 2013, decision of the United States Court of Appeals for the District of Columbia (D.C. Circuit or Court) to remand to EPA two final rules implementing the 1997 PM2.5 standard. In this supplemental proposal, EPA is also proposing to approve a supplement to the emission inventories previously submitted by Ohio. EPA is proposing that the inventories for ammonia and volatile organic compounds (VOC), in conjunction with the inventories for nitrogen oxides (NOX), direct PM2.5, and sulfur dioxide (SO2) that EPA previously proposed to approve, meet the comprehensive emissions inventory requirements of the Clean Air Act (CAA or Act). EPA is seeking comment only on the issues raised in its supplemental proposal, and is not re-opening for comment other issues raised in its prior proposal.

  18. 76 FR 46820 - Proposal To Refuse To Approve a Supplemental New Drug Application for Bromday (Bromfenac...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-03

    ... contaminated with harmful bacteria if the patient accidentally causes the dropper tip to come into contact with... bacteria during the course of treatment.\\3\\ If the product were to become contaminated with bacteria... patient could transmit the bacteria from one eye to the other. \\3\\ Jokl D.H. et al., ``Bacterial...

  19. 46 CFR 126.235 - Alternate compliance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... purposes of this section, a list of authorized classification societies, including information for ordering copies of approved classification society rules and supplements, is available from Commandant (CG-5212.... Approved classification society rules and supplements are incorporated by reference into 46 CFR 8.110(b...

  20. 46 CFR 126.235 - Alternate compliance.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... purposes of this section, a list of authorized classification societies, including information for ordering copies of approved classification society rules and supplements, is available from Commandant (CG-5212.... Approved classification society rules and supplements are incorporated by reference into 46 CFR 8.110(b...

  1. 46 CFR 91.15-5 - Alternate compliance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... this section, a list of authorized classification societies, including information for ordering copies of approved classification society rules and supplements, is available from Commandant (CG-521), 2100.... Approved classification society rules and supplements are incorporated by reference into 46 CFR 8.110(b...

  2. 46 CFR 91.15-5 - Alternate compliance.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... this section, a list of authorized classification societies, including information for ordering copies of approved classification society rules and supplements, is available from Commandant (CG-521), 2100.... Approved classification society rules and supplements are incorporated by reference into 46 CFR 8.110(b...

  3. 76 FR 368 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-04

    ...] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval... Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements..., Packaging, Labeling, or Holding Operations for Dietary Supplements'' has been approved by the Office of...

  4. 78 FR 20856 - Approval and Promulgation of Air Quality Implementation Plans; Indiana; Redesignation of the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-08

    ...EPA is issuing a supplement to its proposed approval of the State of Indiana's request to redesignate the Indianapolis area to attainment for the 1997 annual National Ambient Air Quality Standards (NAAQS or standard) for fine particulate matter (PM2.5). This supplemental proposal revises and expands the basis for proposing approval of the state's request, in light of developments since EPA issued its initial proposal on September 27, 2011. This supplemental proposal addresses four issues, including the effects of two decisions of the United States Court of Appeals for the District of Columbia (D.C. Circuit or Court): the Court's August 21, 2012 decision to vacate and remand to EPA the Cross- State Air Pollution Control Rule (CSAPR) and the Court's January 4, 2013 decision to remand to EPA two final rules implementing the 1997 PM2.5 standard. In this supplemental proposal, EPA is also proposing to approve a supplement to the emission inventories previously submitted by the state. EPA is proposing that the inventories for ammonia and Volatile Organic Compounds (VOC), in conjunction with the inventories for nitrogen oxides (NOX), direct PM2.5, and sulfur dioxide (SO2) that EPA previously proposed to approve, meet the comprehensive emissions inventory requirement of the Clean Air Act (CAA). Finally, this supplemental proposal solicits comment on the state's January 17, 2013 submission of Motor Vehicle Emissions Budgets (MVEBs) developed using EPA's Motor Vehicle Emissions Simulator (MOVES) 2010a emissions model to replace the MOBILE6.2 based MVEBs previously submitted as part of the PM2.5 maintenance plan for the Indianapolis area. EPA is seeking comment only on the issues raised in its supplemental proposal, and is not re-opening for comment other issues raised in its prior proposal.

  5. 25 CFR 26.11 - What type of Job Placement and Training assistance may be approved?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 25 Indians 1 2010-04-01 2010-04-01 false What type of Job Placement and Training assistance may be... JOB PLACEMENT AND TRAINING PROGRAM General Applicability § 26.11 What type of Job Placement and... supplemental assistance that supports job placement or training activities (see subpart B of this part for Job...

  6. 77 FR 14480 - Defense Federal Acquisition Regulation Supplement: Commercial Determination Approval (DFARS Case...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-12

    ... acquisitions made pursuant to Federal Acquisition Regulation (FAR) 12.102(f)(1).'' This language clarifies that... DEPARTMENT OF DEFENSE Defense Acquisition Regulations System 48 CFR Part 212 RIN 0750-AH61 Defense Federal Acquisition Regulation Supplement: Commercial Determination Approval (DFARS Case 2011-D041) AGENCY...

  7. 76 FR 50758 - Agency Information Collection Activities: Proposed Collection; Comments Requested-Reinstatement...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-16

    ... Approved Collection for Which Approval Has Expired, Identity Theft Supplement (ITS) to the National Crime... Form/Collection: Identity Theft Supplement (ITS) to the National Crime Victimization Survey. (3) Agency... administered to persons 16 years or older in NCVS sampled households in the United States. The Identity Theft...

  8. 7 CFR 1717.901 - Early approval.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... for Supplemental Financing Required by 7 CFR 1710.110 § 1717.901 Early approval. (a) Conditions. If... supplemental financing early in the process, before funding is available for the concurrent RUS insured loan... commitment from the private lender to provide a loan for the remaining amount of financing required, with...

  9. 77 FR 43365 - Agency Information Collection Activities: Proposed Collection; Comments Requested; Reinstatement...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-24

    ... statistics on the students' victimization, perceptions of school environment, and safety at school. (5) An... Approved Collection for Which Approval Has Expired: School Crime Supplement (SCS) to the National Crime... Form/Collection: School Crime Supplement (SCS) to the National Crime Victimization Survey. (3) Agency...

  10. 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...

  11. 5 CFR 2634.103 - Executive agency supplemental regulations.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... written approval of the Office of Government Ethics, issue supplemental regulations implementing this part.... 2634.103 Section 2634.103 Administrative Personnel OFFICE OF GOVERNMENT ETHICS GOVERNMENT ETHICS... of Government Ethics as supplemental confidential reporting. Note: Supplemental regulations will not...

  12. Challenges of conducting clinical trials of natural products to combat cancer.

    PubMed

    Paller, Channing J; Denmeade, Samuel R; Carducci, Michael A

    2016-06-01

    Numerous drugs that the US Food and Drug Administration (FDA) has approved for use in cancer therapy are derived from plants, including taxanes such as paclitaxel and vinca alkaloids such as vinblastine. Dietary supplements are another category of natural products that are widely used by patients with cancer, but without the FDA-reviewed evidence of safety and efficacy--be it related to survival, palliation, symptom mitigation, and/or immune system enhancement-that is required for therapy approval. Nearly half of patients in the United States with cancer report that they started taking new dietary supplements after being given a diagnosis of cancer. Oncologists are challenged in providing advice to patients about which supplements are safe and effective to use to treat cancer or the side effects of cancer therapy, and which supplements are antagonistic to standard treatment with chemotherapy, radiation, and/or immunotherapy. Despite the large number of trials that have been launched, the FDA has not approved any dietary supplement or food to prevent cancer, halt its growth, or prevent its recurrence. In this article, we review the primary challenges faced by researchers attempting to conduct rigorous trials of natural products, including shortages of funding due to lack of patentability, manufacturing difficulties, contamination, and lack of product consistency. We also highlight the methods used by dietary supplement marketers to persuade patients that a supplement is effective (or at least safe) even without FDA approval, as well as the efforts of the US government to protect the health and safety of its citizens by ensuring that the information used to market natural products is accurate. We close with a summary of the most widely used databases of information about the safety, efficacy, and interactions of dietary supplements.

  13. Influence of the dietary supplement health and education act on consumer beliefs about the safety and effectiveness of dietary supplements.

    PubMed

    Dodge, Tonya; Litt, Dana; Kaufman, Annette

    2011-03-01

    The authors conducted two studies to examine the influence of the U.S. Dietary Supplement Health and Education Act (DSHEA) on consumer beliefs about the safety and effectiveness of dietary supplements. Study 1 manipulated information about Food and Drug Administration (FDA) approval in the context of a dietary supplement designed to improve immune system functioning. Study 2 tested the effect of an educational intervention designed to improve knowledge about the DSHEA. Results of Study 1 highlighted deficits in consumer knowledge about FDA regulation of dietary supplements. Results also showed that information about FDA approval failed to have a statistically significant effect on beliefs about safety or effectiveness of the dietary supplement. Results of Study 2 showed that participants who were educated about the regulation of dietary supplements under the DSHEA rated dietary supplements as less safe and less effective than did participants in the control condition. The authors discuss the implications for consumers in the United States and for public policy.

  14. 75 FR 8574 - Approval and Promulgation of Air Quality Implementation Plan: Kentucky; Approval Section 110(a)(1...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-25

    ... limited public review and comment of supplemental information that was provided by the Commonwealth of... that information. The July 15, 2009 supplemental information can be viewed online at http://www... comments received will be included in the public docket without change and may be made available online at...

  15. 12 CFR 1815.106 - Supplemental environmental review.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... requiring a supplemental environmental review that affect the physical environment until Fund approval for... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Supplemental environmental review. 1815.106... TREASURY ENVIRONMENTAL QUALITY § 1815.106 Supplemental environmental review. (a) The designated Fund...

  16. 42 CFR 422.102 - Supplemental benefits.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 3 2012-10-01 2012-10-01 false Supplemental benefits. 422.102 Section 422.102... (CONTINUED) MEDICARE PROGRAM (CONTINUED) MEDICARE ADVANTAGE PROGRAM Benefits and Beneficiary Protections § 422.102 Supplemental benefits. (a) Mandatory supplemental benefits. (1) Subject to CMS approval, an MA...

  17. 42 CFR 422.102 - Supplemental benefits.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 3 2013-10-01 2013-10-01 false Supplemental benefits. 422.102 Section 422.102... (CONTINUED) MEDICARE PROGRAM (CONTINUED) MEDICARE ADVANTAGE PROGRAM Benefits and Beneficiary Protections § 422.102 Supplemental benefits. (a) Mandatory supplemental benefits. (1) Subject to CMS approval, an MA...

  18. 42 CFR 422.102 - Supplemental benefits.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 3 2014-10-01 2014-10-01 false Supplemental benefits. 422.102 Section 422.102... (CONTINUED) MEDICARE PROGRAM (CONTINUED) MEDICARE ADVANTAGE PROGRAM Benefits and Beneficiary Protections § 422.102 Supplemental benefits. (a) Mandatory supplemental benefits. (1) Subject to CMS approval, an MA...

  19. 29 CFR 1952.227 - Changes to approved plans.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... plans. (a) Legislation. (1) On March 29, 1994, the Assistant Secretary approved Tennessee's revised... October 24, 1996, the Assistant Secretary approved Tennessee's plan supplement, which is generally... 61 FR 55099, Oct. 24, 1996] ...

  20. 78 FR 46977 - Generic Drug User Fee-Abbreviated New Drug Application, Prior Approval Supplement, Drug Master...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-02

    ... costs to total FDA costs of the review of human generic drug activities for the first 3 of the preceding... review of human generic drug activities. Since the first year of the Generic Drug User Fee Program has... activities other than PC&B (see section 744B(c)(1)(C) of the FD&C Act). Table 3 of this document provides the...

  1. 29 CFR 1952.385 - Changes to approved plans.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... (CONTINUED) APPROVED STATE PLANS FOR ENFORCEMENT OF STATE STANDARDS Puerto Rico § 1952.385 Changes to... approved Puerto Rico's plan supplement, which is generally identical to the Federal Voluntary Protection... Program. (b) Legislation. (1) On March 29, 1994, the Assistant Secretary approved Puerto Rico's revised...

  2. 29 CFR 1952.385 - Changes to approved plans.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... (CONTINUED) APPROVED STATE PLANS FOR ENFORCEMENT OF STATE STANDARDS Puerto Rico § 1952.385 Changes to... approved Puerto Rico's plan supplement, which is generally identical to the Federal Voluntary Protection... Program. (b) Legislation. (1) On March 29, 1994, the Assistant Secretary approved Puerto Rico's revised...

  3. 29 CFR 1952.385 - Changes to approved plans.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... (CONTINUED) APPROVED STATE PLANS FOR ENFORCEMENT OF STATE STANDARDS Puerto Rico § 1952.385 Changes to... approved Puerto Rico's plan supplement, which is generally identical to the Federal Voluntary Protection... Program. (b) Legislation. (1) On March 29, 1994, the Assistant Secretary approved Puerto Rico's revised...

  4. Beware of Products Promising Miracle Weight Loss

    MedlinePlus

    ... a combination of healthful eating and physical activity. Dietary Supplements are not FDA-Approved Under the Federal Food, Drug and Cosmetics Act (as amended by the Dietary Supplement Health and Education Act of 1994), dietary supplement ...

  5. 76 FR 30738 - Agency Information Collection Activities: Form G-845 and Form G-845 Supplement, Revision of a...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-26

    ... Collection Activities: Form G-845 and Form G- 845 Supplement, Revision of a Currently Approved Information Collection; Comment Request ACTION: 30-Day Notice of Information Collection under Review: Form G- 845 and Form G-845 Supplement, Document Verification Request and Document Verification Request Supplement; OMB...

  6. 76 FR 20435 - Notice of Approval of the Supplemental Finding of No Significant Impact and Record of Decision...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-12

    .../Record of Decision (FONSI/ROD) for the Supplemental Environmental Assessment (EA) for changes proposed to... previously addressed in the December 2007 environmental assessment FONSI/ROD. The proposed changes include... Supplemental Finding of No Significant Impact and Record of Decision for the Supplemental Environmental...

  7. An examination of structure-function claims in dietary supplement advertising in the U.S.: 2003-2009.

    PubMed

    Avery, Rosemary J; Eisenberg, Matthew D; Cantor, Jonathan H

    2017-04-01

    Dietary supplement advertising cannot claim a causal link between the product and the treatment, prevention, or cure of a disease unless manufacturers seek approval from the FDA for a health claim. Manufacturers can make structure-function (S-F) claims without FDA approval linking a supplement to a body function or system using words such as "may help" or "promotes." These S-F claims are examined in this study in order to determine whether they mimic health claims for which the FDA requires stricter scientific evidence. Data include S-F claims in supplement advertisements (N=6179) appearing in US nationally circulated magazines (N=137) from 2003 to 2009. All advertisements were comprehensively coded for S-F claims, seals of approval, and other claims of guarantee. S-F claims associate supplements with a wide variety of health conditions, many of which are serious diseases and/or ailments. A significant number of the specific verbs used in these S-F claims are indicative of disease treatment/cure effects, thereby possibly mimicking health claims to the average consumer. The strength of the clinical associations made are largely unsubstantiated in the medical literature. Claims that a product is "scientifically proven" or "guaranteed" were largely unsubstantiated by clinical literature. Ads carrying externally validating seals of approval were highly prevalent. S-F claims that strongly mimic FDA-prohibited health claims are likely to create confusion in interpretation and possible public health concerns are discussed. Copyright © 2017 Elsevier Inc. All rights reserved.

  8. 77 FR 59666 - Agency Information Collection Activities; Extension of a Currently Approved Collection; Comments...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-28

    ..., perceptions of school environment, and safety at school. (5) An estimate of the total number of respondents... Activities; Extension of a Currently Approved Collection; Comments Requested: School Crime Supplement (SCS...: Extension of a currently approved collection. [[Page 59667

  9. 46 CFR 31.01-3 - Alternate compliance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... classification societies, including information for ordering copies of approved classification society rules and...; telephone (202) 372-1372; or fax (202) 372-1925. Approved classification society rules and supplements are...

  10. 46 CFR 31.01-3 - Alternate compliance.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... classification societies, including information for ordering copies of approved classification society rules and...; telephone (202) 372-1372; or fax (202) 372-1925. Approved classification society rules and supplements are...

  11. 76 FR 76417 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-07

    ...); biologics; medical devices; dietary supplements and other special nutritional products (e.g., infant formula... supplements under section 402 of the FD&C Act (21 U.S.C. 342). Dietary supplements do not require premarket approval by FDA and the Agency bears the burden to gather and review evidence that a dietary supplement may...

  12. Omega-3 Fatty Acid Formulations in Cardiovascular Disease: Dietary Supplements are Not Substitutes for Prescription Products.

    PubMed

    Fialkow, Jonathan

    2016-08-01

    Omega-3 fatty acid products are available as prescription formulations (icosapent ethyl, omega-3-acid ethyl esters, omega-3-acid ethyl esters A, omega-3-carboxylic acids) and dietary supplements (predominantly fish oils). Most dietary supplements and all but one prescription formulation contain mixtures of the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Products containing both EPA and DHA may raise low-density lipoprotein cholesterol (LDL-C). In clinical trials, the EPA-only prescription product, icosapent ethyl, did not raise LDL-C compared with placebo. To correct a common misconception, it is important to note that omega-3 fatty acid dietary supplements are not US FDA-approved over-the-counter drugs and are not required to demonstrate safety and efficacy prior to marketing. Conversely, prescription products are supported by extensive clinical safety and efficacy investigations required for FDA approval and have active and ongoing safety monitoring programs. While omega-3 fatty acid dietary supplements may have a place in the supplementation of diet, they generally contain lower levels of EPA and DHA than prescription products and are not approved or intended to treat disease. Perhaps due to the lack of regulation of dietary supplements, EPA and DHA levels may vary widely within and between brands, and products may also contain unwanted cholesterol or fats or potentially harmful components, including toxins and oxidized fatty acids. Accordingly, omega-3 fatty acid dietary supplements should not be substituted for prescription products. Similarly, prescription products containing DHA and EPA should not be substituted for the EPA-only prescription product, as DHA may raise LDL-C and thereby complicate the management of patients with dyslipidemia.

  13. 42 CFR 422.102 - Supplemental benefits.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Supplemental benefits. (a) Mandatory supplemental benefits. (1) Subject to CMS approval, an MA organization may require Medicare enrollees of an MA plan (other than an MSA plan) to accept or pay for services in addition to Medicare-covered services described in § 422.101. (2) If the MA organization imposes mandatory...

  14. 29 CFR 1953.6 - Review and approval of plan supplements.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 1953.6 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION...) OSHA shall review a supplement to determine whether it is at least as effective as the Federal program.... If the review reveals any defect in the supplement, or if more information is needed, OSHA shall...

  15. 29 CFR 1953.6 - Review and approval of plan supplements.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 1953.6 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION...) OSHA shall review a supplement to determine whether it is at least as effective as the Federal program.... If the review reveals any defect in the supplement, or if more information is needed, OSHA shall...

  16. 75 FR 78779 - Order Approving Public Company Accounting Oversight Board Supplemental Budget Request To...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-16

    ...; Securities Exchange Act of 1934 Release No. 63526/December 10, 2010] Order Approving Public Company... Company Accounting Oversight Board (the ``PCAOB'') to oversee the audits of companies and related matters..., subject to approval by the Commission, auditing and related attestation, quality control, ethics, and...

  17. Dietary Supplements: What You Need to Know

    MedlinePlus

    ... must notify FDA about that ingredient prior to marketing. However, the notification will only be reviewed by FDA (not approved) and only for safety, not effectiveness. Manufacturers are required to produce dietary supplements in ...

  18. 40 CFR 52.1634 - Significant deterioration of air quality.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Significant Deterioration (PSD) and its Supplemental document, is approved as meeting the requirements of part... satisfying the conditions of EPA's conditional approval of the State's PSD program on February 27, 1987 (52...

  19. 40 CFR 52.1634 - Significant deterioration of air quality.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Significant Deterioration (PSD) and its Supplemental document, is approved as meeting the requirements of part... satisfying the conditions of EPA's conditional approval of the State's PSD program on February 27, 1987 (52...

  20. 40 CFR 52.1634 - Significant deterioration of air quality.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Significant Deterioration (PSD) and its Supplemental document, is approved as meeting the requirements of part... satisfying the conditions of EPA's conditional approval of the State's PSD program on February 27, 1987 (52...

  1. 76 FR 53638 - Approval and Promulgation of Air Quality Implementation Plans; Delaware; Infrastructure State...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-29

    ...), DNREC supplemented its September 16, 2009 submittal with a technical analysis submitted to EPA for... supplemental technical analysis, for which it has requested parallel-processing, through the public notice and... submitted the technical analysis to EPA as a formal supplement to its September 16, 2009 submittal. The...

  2. 76 FR 9805 - Agency Information Collection Activities: Form G-845 and Supplement; Revision of a Currently...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-22

    ... Collection Activities: Form G-845 and Supplement; Revision of a Currently Approved Information Collection; Comment Request ACTION: 60-Day Notice of Information Collection Under Review: Form G- 845 and Supplement... other forms of information technology, e.g., permitting electronic submission of responses. Overview of...

  3. 76 FR 40624 - Approval and Promulgation of Implementation Plans; State of Kansas

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-11

    ... in the proposal, as supplemented by this notice, as its rationale for the final rule. No public... approved emissions limits with limited public process or without requiring further approval by EPA, that... on proposals for three states in Region 5). EPA notes that these public comments on another proposal...

  4. 76 FR 40619 - Approval and Promulgation of Implementation Plans; State of Missouri

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-11

    ... in the proposal as supplemented by this rule, as its rationale for the final rule. No public comments... approved emissions limits with limited public process or without requiring further approval by EPA, that... for three states in Region 5). EPA notes that these public comments on another proposal are not...

  5. 78 FR 11808 - Approval and Promulgation of Implementation Plans; Tennessee: Approve Knox County Supplemental...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-20

    ... INFORMATION: On December 18, 2012, EPA proposed to approve, through parallel processing, a draft revision to... County to account for changes in the emissions model and vehicle miles traveled projection model. EPA is... submit comments. FOR FURTHER INFORMATION CONTACT: Kelly Sheckler, Air Quality Modeling and Transportation...

  6. 77 FR 74820 - Approval and Promulgation of Implementation Plans; Tennessee: Knox County Supplemental Motor...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-18

    ... model and vehicle miles traveled (VMT) projection model. EPA is proposing approval of this draft SIP... Regional Office's normal hours of operation. The Regional Office's official hours of business are Monday... at that time, EPA approved mobile emissions and NONROAD models. New emissions data for both the new...

  7. Did FDA Decisionmaking Affect Anti-Psychotic Drug Prescribing in Children?: A Time-Trend Analysis.

    PubMed

    Wang, Bo; Franklin, Jessica M; Eddings, Wesley; Landon, Joan; Kesselheim, Aaron S

    2016-01-01

    Following Food and Drug Administration (FDA) approval, many drugs are prescribed for non-FDA-approved ("off-label") uses. If substantial evidence supports the efficacy and safety of off-label indications, manufacturers can pursue formal FDA approval through supplemental new drug applications (sNDAs). We evaluated the effect of FDA determinations on pediatric sNDAs for antipsychotic drugs on prescribing of these products in children. Retrospective, segmented time-series analysis using new prescription claims during 2003-2012 for three atypical antipsychotics (olanzapine, quetiapine, ziprasidone). FDA approved the sNDAs for pediatric use of olanzapine and quetiapine in December 2009, but did not approve the sNDA for pediatric use of ziprasidone. During the months before FDA approval of its pediatric sNDA, new prescriptions of olanzapine decreased for both children and adults. After FDA approval, the increase in prescribing trends was similar for both age groups (P = 0.47 for schizophrenia and bipolar disorder; P = 0.37 for other indications). Comparable decreases in use of quetiapine were observed between pediatrics and adults following FDA approval of its pediatric sNDA (P = 0.88; P = 0.63). Prescribing of ziprasidone decreased similarly for pediatric and adult patients after FDA non-approval of its pediatric sNDA (P = 0.61; P = 0.79). The FDA's sNDA determinations relating to use of antipsychotics in children did not result in changes in use that favored the approved sNDAs and disfavored the unapproved sNDA. Improved communication may help translate the agency's expert judgments to clinical practice.

  8. 76 FR 55919 - Agency Information Collection Activities; Proposed Collection; Comment Request; MedWatch: The...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-09

    ...; dietary supplements and other special nutritional products (e.g., infant formula and medical foods); and... regulates the safety (i.e., adulteration) of dietary supplements under section 402 of the FD&C Act (21 U.S.C. 342). Dietary supplements do not require premarket approval by FDA and the Agency bears the burden to...

  9. 76 FR 28971 - Atlanta Gas Light Company; Notice of Petition for Rate Approval

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-19

    ...] Atlanta Gas Light Company; Notice of Petition for Rate Approval Take notice that on May 9, 2011, as supplemented on May 11, 2011, Atlanta Gas Light Company (Atlanta Gas Light) filed a petition pursuant to.... Atlanta Gas Light states the rate election consists of the maximum cost-based rates approved by the...

  10. 78 FR 18973 - Bridgeline Holdings, L.P.; Notice of Petition for Rate Approval

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-28

    ... Holdings, L.P.; Notice of Petition for Rate Approval Take notice that on February 28, 2013, as supplemented on March 12, 2013, Bridgeline Holdings, L.P. filed for approval of rates for transportation services... TTY, call (202) 502-8659. Comment Date: 5:00 p.m. Eastern Time on Monday, April 1, 2013. Dated: March...

  11. 20 CFR 416.938 - What we mean by approved institutions or facilities.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false What we mean by approved institutions or facilities. 416.938 Section 416.938 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED Determining Disability and Blindness Drug Addiction and Alcoholism § 416.938 What we mean by approved...

  12. 7 CFR 58.705 - Meaning of words.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ..., GENERAL SPECIFICATIONS FOR APPROVED PLANTS AND STANDARDS FOR GRADES OF DAIRY PRODUCTS 1 General Specifications for Dairy Plants Approved for USDA Inspection and Grading Service 1 Supplemental Specifications for Plants Manufacturing, Processing and Packaging Pasteurized Process Cheese and Related Products...

  13. 7 CFR 58.705 - Meaning of words.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ..., GENERAL SPECIFICATIONS FOR APPROVED PLANTS AND STANDARDS FOR GRADES OF DAIRY PRODUCTS 1 General Specifications for Dairy Plants Approved for USDA Inspection and Grading Service 1 Supplemental Specifications for Plants Manufacturing, Processing and Packaging Pasteurized Process Cheese and Related Products...

  14. 7 CFR 58.705 - Meaning of words.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ..., GENERAL SPECIFICATIONS FOR APPROVED PLANTS AND STANDARDS FOR GRADES OF DAIRY PRODUCTS 1 General Specifications for Dairy Plants Approved for USDA Inspection and Grading Service 1 Supplemental Specifications for Plants Manufacturing, Processing and Packaging Pasteurized Process Cheese and Related Products...

  15. 7 CFR 58.705 - Meaning of words.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ..., GENERAL SPECIFICATIONS FOR APPROVED PLANTS AND STANDARDS FOR GRADES OF DAIRY PRODUCTS 1 General Specifications for Dairy Plants Approved for USDA Inspection and Grading Service 1 Supplemental Specifications for Plants Manufacturing, Processing and Packaging Pasteurized Process Cheese and Related Products...

  16. 40 CFR 52.975 - Redesignations and maintenance plans; ozone.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...; ozone. 52.975 Section 52.975 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR... and maintenance plans; ozone. (a) Approval. The Louisiana Department of Environmental Quality (LDEQ... supplemental ozone redesignation requests and revised maintenance plans. These supplemental submittals were...

  17. 40 CFR 52.975 - Redesignations and maintenance plans; ozone.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...; ozone. 52.975 Section 52.975 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR... and maintenance plans; ozone. (a) Approval. The Louisiana Department of Environmental Quality (LDEQ... supplemental ozone redesignation requests and revised maintenance plans. These supplemental submittals were...

  18. 40 CFR 52.975 - Redesignations and maintenance plans; ozone.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...; ozone. 52.975 Section 52.975 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR... and maintenance plans; ozone. (a) Approval. The Louisiana Department of Environmental Quality (LDEQ... supplemental ozone redesignation requests and revised maintenance plans. These supplemental submittals were...

  19. 40 CFR 52.975 - Redesignations and maintenance plans; ozone.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...; ozone. 52.975 Section 52.975 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR... and maintenance plans; ozone. (a) Approval. The Louisiana Department of Environmental Quality (LDEQ... supplemental ozone redesignation requests and revised maintenance plans. These supplemental submittals were...

  20. 78 FR 39704 - Agency Information Collection Activities: Revision of Approved Information Collection; Comment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-02

    ... use of automated data processing (ADP) and information retrieval systems to administer SNAP. Section... DEPARTMENT OF AGRICULTURE Food and Nutrition Service Agency Information Collection Activities: Revision of Approved Information Collection; Comment Request--Supplemental Nutrition Assistance Program...

  1. Dietary supplements in the Department of Defense: possible solutions to optimizing force readiness.

    PubMed

    Gonsalves, Stephen; Stavinoha, Trisha; Hite, Linda; Costa, Janelle; Dilly, George; Deuster, Patricia A

    2012-12-01

    Dietary supplement use is common among military service members; approximately 17 to 20% report using high-risk weight-loss, performance-enhancing, and bodybuilding supplements. To date, no overarching policy or program has been approved or implemented to inform service members or educate health care providers on the potential adverse consequences of using multiple combinations of supplements or the pros and cons of supplements per se. A review of regulations, concerns, and possible solutions is provided. Importantly, the role of third-party certification and education is emphasized.

  2. 5 CFR 6401.103 - Prior approval for outside employment.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    .... 6401.103 Section 6401.103 Administrative Personnel ENVIRONMENTAL PROTECTION AGENCY SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE ENVIRONMENTAL PROTECTION AGENCY § 6401.103 Prior approval... an organization for which a different Deputy Ethics Official has responsibility, the employee must...

  3. 5 CFR 5001.104 - Prior approval for outside employment.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    .... 5001.104 Section 5001.104 Administrative Personnel INTERSTATE COMMERCE COMMISSION SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE INTERSTATE COMMERCE COMMISSION § 5001.104 Prior approval..., an employee of the Interstate Commerce Commission, other than a Commissioner, must obtain the written...

  4. 78 FR 70025 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-22

    .... Needs and Uses: Administrative contracting officers use this information in making decisions to grant, withhold, or withdraw purchasing system approval at the conclusion of a purchasing system review. Withdrawal of purchasing system approval would necessitate Government consent to individual subcontracts...

  5. A Phase II Trial on the Effect of Low Dose versus High Dose Vitamin D Supplementation on Bone Mass in Adults with Neurofibromatosis 1 (NF1)

    DTIC Science & Technology

    2016-10-01

    USAMRMC ORP HRPO. Ethics board approval from UBC has been approved by HRPO, and U of Cincinnati is under review. The University of Hamburg is working...UBC ethics committee approval was established, and USAMRMC ORP HRPO approval was provided October 20, 2015. Additional continuing review approval in...operations, and once translated to German will be submitted to its ethics committee. The CRFs have been translated into German and will be submitted

  6. 25 CFR 170.925 - Is ERFO funding supplemental to IRR Program funding?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... RESERVATION ROADS PROGRAM Miscellaneous Provisions Emergency Relief § 170.925 Is ERFO funding supplemental to... construction and maintenance funds for FHWA-approved repairs. If IRR construction or maintenance funds are used... used to reimburse the construction or maintenance funds expended. ...

  7. 48 CFR 731.205-71 - Salary supplements for Host Government employees.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... FOR INTERNATIONAL DEVELOPMENT GENERAL CONTRACTING REQUIREMENTS CONTRACT COST PRINCIPLES AND PROCEDURES Contracts With Commercial Organizations 731.205-71 Salary supplements for Host Government employees. (a... Contracting Officer shall provide written approval to the contractor in order for such costs to be eligible...

  8. FY2007 Supplemental Appropriations for Defense, Foreign Affairs, and Other Purposes

    DTIC Science & Technology

    2007-07-02

    the House approved two bills, H.R. 2206 and H.R. 2207 , that, together provided $123.3 billion in supplemental funding. H.R. 2206 divided funding for...and a second bill, H.R. 2207 ; and (3) the final, enacted FY2007 supplemental appropriations bill, H.R. 2206. Following Table 2, this report provides...Vetoed May 10, House-Passed, H.R. 2206/H.R. 2207 Final, Enacted Supplemental, H.R. 2206/P.L. 110-28 Iraq Troop Redeployment Sec. 1904: Requires a report

  9. 5 CFR 550.1105 - Review and approval of agency regulations.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    .... 550.1105 Section 550.1105 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE... agencies must submit regulations to the Office of Personnel Management (OPM) for review in accordance with....1104, the agency may issue any supplemental regulations or instructions, consistent with its approved...

  10. 29 CFR 1902.33 - Developmental period.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR... consideration of developmental changes by OSHA. Generally, whenever a State completes a developmental step, it must submit the resulting plan change as a supplement to its plan to OSHA for approval. OSHA's approval...

  11. 29 CFR 1902.33 - Developmental period.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR... consideration of developmental changes by OSHA. Generally, whenever a State completes a developmental step, it must submit the resulting plan change as a supplement to its plan to OSHA for approval. OSHA's approval...

  12. 29 CFR 1952.374 - Final approval determination.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... plan does not cover private sector maritime employment; worksites located within Federal military... under the Federal program; to submit plan supplements in accordance with 29 CFR part 1953; to allocate..., DEPARTMENT OF LABOR (CONTINUED) APPROVED STATE PLANS FOR ENFORCEMENT OF STATE STANDARDS Virginia § 1952.374...

  13. 29 CFR 1952.313 - Final approval determination.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 1902. Accordingly, the Hawaii plan was granted final approval and concurrent Federal enforcement... employment in Hawaii. The plan does not cover maritime employment in the private sector; Federal government... effective as operations under the Federal program; to submit plan supplements in accordance with 29 CFR part...

  14. 29 CFR 1952.374 - Final approval determination.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... plan does not cover private sector maritime employment; worksites located within Federal military... under the Federal program; to submit plan supplements in accordance with 29 CFR part 1953; to allocate..., DEPARTMENT OF LABOR (CONTINUED) APPROVED STATE PLANS FOR ENFORCEMENT OF STATE STANDARDS Virginia § 1952.374...

  15. 29 CFR 1952.294 - Final approval determination.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    .... Accordingly, the Nevada plan was granted final approval and concurrent Federal enforcement authority was... Nevada. The plan does not cover Federal government employers and employees; any private sector maritime... under the Federal program; to submit plan supplements in accordance with 29 CFR Part 1953; to allocate...

  16. 29 CFR 1952.294 - Final approval determination.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    .... Accordingly, the Nevada plan was granted final approval and concurrent Federal enforcement authority was... Nevada. The plan does not cover Federal government employers and employees; any private sector maritime... under the Federal program; to submit plan supplements in accordance with 29 CFR Part 1953; to allocate...

  17. 29 CFR 1952.374 - Final approval determination.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... plan does not cover private sector maritime employment; worksites located within Federal military... under the Federal program; to submit plan supplements in accordance with 29 CFR part 1953; to allocate..., DEPARTMENT OF LABOR (CONTINUED) APPROVED STATE PLANS FOR ENFORCEMENT OF STATE STANDARDS Virginia § 1952.374...

  18. 46 CFR 71.15-5 - Alternate compliance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... list of authorized classification societies, including information for ordering copies of approved classification society rules and supplements, is available from Commandant (CG-521), 2100 2nd St. SW., Stop 7126, Washington, DC 20593-7126; telephone (202) 372-1372; or fax (202) 372-1925. Approved classification society...

  19. 46 CFR 71.15-5 - Alternate compliance.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... list of authorized classification societies, including information for ordering copies of approved classification society rules and supplements, is available from Commandant (CG-521), 2100 2nd St. SW., Stop 7126, Washington, DC 20593-7126; telephone (202) 372-1372; or fax (202) 372-1925. Approved classification society...

  20. 40 CFR 52.2850 - Approval and promulgation of implementation plans.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ..., Education, and Welfare on June 30, 1970. Supplemental information was received October 20, 1970. The... implementation plan, is adequate for attainment of the national primary ambient air quality standards for sulfur... Department of Health, Education, and Welfare on May 26, 1970. Supplemental information was submitted...

  1. 40 CFR 52.2850 - Approval and promulgation of implementation plans.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ..., Education, and Welfare on June 30, 1970. Supplemental information was received October 20, 1970. The... implementation plan, is adequate for attainment of the national primary ambient air quality standards for sulfur... Department of Health, Education, and Welfare on May 26, 1970. Supplemental information was submitted...

  2. 40 CFR 52.2850 - Approval and promulgation of implementation plans.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ..., Education, and Welfare on June 30, 1970. Supplemental information was received October 20, 1970. The... implementation plan, is adequate for attainment of the national primary ambient air quality standards for sulfur... Department of Health, Education, and Welfare on May 26, 1970. Supplemental information was submitted...

  3. 40 CFR 52.2850 - Approval and promulgation of implementation plans.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ..., Education, and Welfare on June 30, 1970. Supplemental information was received October 20, 1970. The... implementation plan, is adequate for attainment of the national primary ambient air quality standards for sulfur... Department of Health, Education, and Welfare on May 26, 1970. Supplemental information was submitted...

  4. 78 FR 79567 - Supplemental Nutrition Assistance Program: Trafficking Controls and Fraud Investigations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-31

    ... DEPARTMENT OF AGRICULTURE Food and Nutrition Service 7 CFR Parts 271 and 274 RIN 0584-AE26 Supplemental Nutrition Assistance Program: Trafficking Controls and Fraud Investigations AGENCY: Food and Nutrition Service, USDA. ACTION: Final rule, Interim final rule; notice of approval of Information...

  5. 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...

  6. 40 CFR 52.975 - Redesignations and maintenance plans; ozone.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...; ozone. 52.975 Section 52.975 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR... and maintenance plans; ozone. Link to an amendment published at 78 FR 27062, May 9, 2013. (a) Approval..., however. The LDEQ addressed these approvability issues in supplemental ozone redesignation requests and...

  7. 5 CFR 7701.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 5 Administrative Personnel 3 2014-01-01 2014-01-01 false Prior approval for outside employment. 7701.102 Section 7701.102 Administrative Personnel INSTITUTE OF MUSEUM AND LIBRARY SERVICES SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE INSTITUTE OF MUSEUM AND LIBRARY SERVICES § 7701...

  8. 5 CFR 7701.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Prior approval for outside employment. 7701.102 Section 7701.102 Administrative Personnel INSTITUTE OF MUSEUM AND LIBRARY SERVICES SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE INSTITUTE OF MUSEUM AND LIBRARY SERVICES § 7701...

  9. 5 CFR 7701.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 5 Administrative Personnel 3 2012-01-01 2012-01-01 false Prior approval for outside employment. 7701.102 Section 7701.102 Administrative Personnel INSTITUTE OF MUSEUM AND LIBRARY SERVICES SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE INSTITUTE OF MUSEUM AND LIBRARY SERVICES § 7701...

  10. 46 CFR 189.15-5 - Alternate compliance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ..., a list of authorized classification societies, including information for ordering copies of approved classification society rules and supplements, is available from Commandant (CG-521), 2100 2nd St., SW., Stop 7126, Washington, DC 20593-7126; telephone (202) 372-1371; or fax (202) 372-1925. Approved classification society...

  11. 46 CFR 189.15-5 - Alternate compliance.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ..., a list of authorized classification societies, including information for ordering copies of approved classification society rules and supplements, is available from Commandant (CG-521), 2100 2nd St., SW., Stop 7126, Washington, DC 20593-7126; telephone (202) 372-1371; or fax (202) 372-1925. Approved classification society...

  12. 25 CFR 170.925 - Is ERFO funding supplemental to IRR Program funding?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... construction and maintenance funds for FHWA-approved repairs. If IRR construction or maintenance funds are used to address an approved claim when ERFO funds are unavailable, the next authorized ERFO funds may be used to reimburse the construction or maintenance funds expended. ...

  13. 25 CFR 170.925 - Is ERFO funding supplemental to IRR Program funding?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... construction and maintenance funds for FHWA-approved repairs. If IRR construction or maintenance funds are used to address an approved claim when ERFO funds are unavailable, the next authorized ERFO funds may be used to reimburse the construction or maintenance funds expended. ...

  14. 25 CFR 170.925 - Is ERFO funding supplemental to IRR Program funding?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... construction and maintenance funds for FHWA-approved repairs. If IRR construction or maintenance funds are used to address an approved claim when ERFO funds are unavailable, the next authorized ERFO funds may be used to reimburse the construction or maintenance funds expended. ...

  15. 25 CFR 170.925 - Is ERFO funding supplemental to IRR Program funding?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... construction and maintenance funds for FHWA-approved repairs. If IRR construction or maintenance funds are used to address an approved claim when ERFO funds are unavailable, the next authorized ERFO funds may be used to reimburse the construction or maintenance funds expended. ...

  16. 5 CFR 4501.103 - Prior approval for certain outside activities.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... activities. 4501.103 Section 4501.103 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE OFFICE OF PERSONNEL MANAGEMENT § 4501.103 Prior approval... specialized skills or the same educational background as performance of the employee's official duties; (2...

  17. 29 CFR 1956.52 - Completed developmental steps and certification.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Substances Act; and the State's independent Workplace Violence Prevention law, were approved by the Assistant...) Survey of Injuries and Illnesses to the public sector. A supplement documenting this action was approved... initially promulgated regulations for injury/illness recordkeeping, equivalent to 29 CFR part 1904, which...

  18. 29 CFR 1956.52 - Completed developmental steps and certification.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Substances Act; and the State's independent Workplace Violence Prevention law, were approved by the Assistant...) Survey of Injuries and Illnesses to the public sector. A supplement documenting this action was approved... initially promulgated regulations for injury/illness recordkeeping, equivalent to 29 CFR part 1904, which...

  19. 29 CFR 1956.52 - Completed developmental steps and certification.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Substances Act; and the State's independent Workplace Violence Prevention law, were approved by the Assistant...) Survey of Injuries and Illnesses to the public sector. A supplement documenting this action was approved... initially promulgated regulations for injury/illness recordkeeping, equivalent to 29 CFR part 1904, which...

  20. 29 CFR 1956.52 - Completed developmental steps and certification.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Substances Act; and the State's independent Workplace Violence Prevention law, were approved by the Assistant...) Survey of Injuries and Illnesses to the public sector. A supplement documenting this action was approved... initially promulgated regulations for injury/illness recordkeeping, equivalent to 29 CFR part 1904, which...

  1. 76 FR 64380 - Agency Information Collection Activities: Proposed Collection; Comments Requested; Supplemental...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-18

    ... Information on Water Quality Consideration ACTION: 30-Day Notice of Information Collection. The Department of... currently approved collection. (2) Title of the Form/Collection: Supplemental Information on Water Quality..., including the validity of the methodology and assumptions used; --Enhance the quality, utility, and clarity...

  2. 78 FR 62616 - Integrated System Power Rates

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-22

    ... sudden loss of generation or load. 1.1.5. Supplemental Operating Reserve Service provides an additional... experienced due to a sudden loss of generation or load. 1.1.5. Supplemental Operating Reserve Service provides... Deputy Secretary has approved and placed into effect on an interim basis Rate Order No. SWPA-66, which...

  3. 76 FR 35424 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-17

    ...; Defense Federal Acquisition Regulation Supplement; Acquisition of Information Technology AGENCY: Defense... techniques or other forms of information technology. The Office of Management and Budget (OMB) has approved... Information Technology, and the associated clauses at DFARS 252.239-7000 and 252.239-7006; OMB Control Number...

  4. 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...

  5. 5 CFR 6201.103 - Prior approval for outside employment.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Prior approval for outside employment. 6201.103 Section 6201.103 Administrative Personnel EXPORT-IMPORT BANK OF THE UNITED STATES SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE EXPORT-IMPORT BANK OF THE UNITED STATES § 6201.103 Prior...

  6. 14 CFR 121.162 - ETOPS Type Design Approval Basis.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false ETOPS Type Design Approval Basis. 121.162 Section 121.162 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIR CARRIERS AND OPERATORS FOR COMPENSATION OR HIRE: CERTIFICATION AND OPERATIONS OPERATING REQUIREMENTS: DOMESTIC, FLAG, AND SUPPLEMENTAL...

  7. 20 CFR 416.1525 - Request for approval of a fee.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 20 Employees' Benefits 2 2011-04-01 2011-04-01 false Request for approval of a fee. 416.1525 Section 416.1525 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY INCOME FOR THE... the representative performed; (ii) The complexity of the case; (iii) The level of skill and competence...

  8. 20 CFR 416.1525 - Request for approval of a fee.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Request for approval of a fee. 416.1525 Section 416.1525 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY INCOME FOR THE... the representative performed; (ii) The complexity of the case; (iii) The level of skill and competence...

  9. 5 CFR 8701.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    .... 8701.102 Section 8701.102 Administrative Personnel OFFICE OF MANAGEMENT AND BUDGET SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE OFFICE OF MANAGEMENT AND BUDGET § 8701.102 Prior approval... employee of the Office of Management and Budget, other than a special Government employee, must obtain the...

  10. Can claims, misleading information, and manufacturing issues regarding dietary supplements be improved in the United States?

    PubMed

    Gibson, James E; Taylor, David A

    2005-09-01

    The safety and effectiveness of over-the-counter (OTC) drugs are assessed through the Food and Drug Administration's (FDA's) OTC drug review. Prescription drugs are approved through the rigorous new drug application (NDA) process. In contrast, dietary supplements are regulated as foods, and the FDA must determine that a dietary supplement ingredient poses a "significant or unreasonable risk of illness or injury" instead of requiring the manufacturer to provide safety data. According to the FDA, there are more than 29,000 different dietary supplements available to consumers today. This momentum has its roots in consumer interest in health and self-care and suggests that Americans are searching for alternatives to conventional foods for physical and mental well being. The Committee on the Framework for Evaluating the Safety of Dietary Supplements was formed under the auspices of the Food and Nutrition Board that produced a report entitled Dietary Supplements: A Framework for Evaluating Safety. Categories of specific information identified for use are 1) human data, 2) animal studies, 3) in vitro experiments, and 4) information on related substances. Several factors were identified to guide the FDA in applying the framework. Two of these factors are expressed as follows: 1) "the appropriate scientific standard to be used to overturn this basic assumption of safety is to demonstrate significant or unreasonable risk, not prove that an ingredient is unsafe"; and 2) "approaches taken by diverse organizations and governmental bodies, both within and outside the United States, which evaluate the safety and at times efficacy of dietary supplement ingredients, vary in their relevance to the protection of the American public from risks associated with consumption of dietary supplement ingredients".

  11. 78 FR 5158 - Approval and Promulgation of Air Quality Implementation Plans; Connecticut; Regional Haze

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-24

    ... submittals on February 24, 2012 and March 12, 2012. In the March 26, 2012 rulemaking, pursuant to CT DEEP's... Connecticut SIP to address regional haze, with supplemental submittals on February 24, 2012, and March 12... Protection Agency (EPA). ACTION: Supplemental proposed rule. SUMMARY: On March 26, 2012, the Environmental...

  12. 7 CFR 1955.22 - State supplements.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... regulation to provide guidance to FmHA or its successor agency under Public Law 103-354 officials. State supplements will be submitted to the National Office for post approval in accordance with FmHA or its successor agency under Public Law 103-354 Instruction 2006-B (available in any FmHA or its successor agency...

  13. 77 FR 2521 - Integrated System Power Rates

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-18

    ... experienced due to a sudden loss of generation or load. 1.1.5. Supplemental Operating Reserve Service provides... experienced due to a sudden loss of generation or load. 1.1.5. Supplemental Operating Reserve Service provides... Secretary has approved and placed into effect on an interim basis Rate Order No. SWPA-63, which increases...

  14. 75 FR 35957 - Supplemental Standards of Ethical Conduct for Employees of the Special Inspector General for Iraq...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-24

    ... Conduct for Employees of the Special Inspector General for Iraq Reconstruction AGENCY: Special Inspector... (OGE), is issuing an interim regulation for employees of the SIGIR that supplement the executive-branch... regulation requires SIGIR employees, except special Government employees, to obtain approval before engaging...

  15. 78 FR 11754 - Approval and Promulgation of Implementation Plans; Tennessee: Knox County Supplement Motor...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-20

    ... December 18, 2012, (77 FR 74820), EPA proposed to approve through parallel processing Tennessee's October... well as changes to future vehicle mix assumptions, that influence the emission estimations. TDEC has... 2014. \\2\\ A safety margin is the difference between the attainment level of emissions from all source...

  16. 78 FR 33784 - Approval and Promulgation of Implementation Plans; Kentucky: Kentucky Portion of Cincinnati...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-05

    ... Promulgation of Implementation Plans; Kentucky: Kentucky Portion of Cincinnati-Hamilton, Supplement Motor.... SUMMARY: EPA is proposing to approve a revision to the Kentucky State Implementation Plan (SIP), submitted... maintenance plan for the Kentucky portion of the Cincinnati-Hamilton, OH-KY-IN, maintenance area for the 1997...

  17. 20 CFR 416.1225 - An approved plan to achieve self-support; general.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 20 Employees' Benefits 2 2011-04-01 2011-04-01 false An approved plan to achieve self-support; general. 416.1225 Section 416.1225 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL... achieve self-support; general. If you are blind or disabled, we will pay you SSI benefits and will not...

  18. 20 CFR 416.1225 - An approved plan to achieve self-support; general.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false An approved plan to achieve self-support; general. 416.1225 Section 416.1225 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL... achieve self-support; general. If you are blind or disabled, we will pay you SSI benefits and will not...

  19. 29 CFR 1952.224 - Final approval determination.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Federal program; to submit plan supplements in accordance with 29 CFR part 1953; to allocate sufficient..., DEPARTMENT OF LABOR (CONTINUED) APPROVED STATE PLANS FOR ENFORCEMENT OF STATE STANDARDS Tennessee § 1952.224... benchmarks as revised in 1984 in response to a Court Order in AFL-CIO v. Marshall (CA 74-406), and was...

  20. 29 CFR 1952.224 - Final approval determination.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Federal program; to submit plan supplements in accordance with 29 CFR part 1953; to allocate sufficient..., DEPARTMENT OF LABOR (CONTINUED) APPROVED STATE PLANS FOR ENFORCEMENT OF STATE STANDARDS Tennessee § 1952.224... benchmarks as revised in 1984 in response to a Court Order in AFL-CIO v. Marshall (CA 74-406), and was...

  1. 29 CFR 1952.354 - Final approval determination.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... effective as operations under the Federal program; to submit plan supplements in accordance with 29 CFR part..., DEPARTMENT OF LABOR (CONTINUED) APPROVED STATE PLANS FOR ENFORCEMENT OF STATE STANDARDS Arizona § 1952.354... benchmarks as revised in 1984 in response to a Court Order in AFL-CIO v. Marshall, (CA 74-406), and was...

  2. 29 CFR 1952.354 - Final approval determination.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... effective as operations under the Federal program; to submit plan supplements in accordance with 29 CFR part..., DEPARTMENT OF LABOR (CONTINUED) APPROVED STATE PLANS FOR ENFORCEMENT OF STATE STANDARDS Arizona § 1952.354... benchmarks as revised in 1984 in response to a Court Order in AFL-CIO v. Marshall, (CA 74-406), and was...

  3. 77 FR 3611 - Approval and Promulgation of Implementation Plans; North Carolina: Approval of Section 110(a)(1...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-25

    ... 27.73 4.94 35.88 56.14 Guilford 1.06 2.01 42.78 11.83 57.68 115.36 Total 6.07 3.83 90.62 21.11 121.63... of the 1997 8-hour ozone NAAQS through the year 2018 in the Triad Area. EPA is approving these SIP... 2018 for this attainment area. The May 18, 2011, supplemental information contained Appendix C SESARM...

  4. Adverse Effects of Nutraceuticals and Dietary Supplements.

    PubMed

    Ronis, Martin J J; Pedersen, Kim B; Watt, James

    2018-01-06

    Over 70% of Americans take some form of dietary supplement every day, and the supplement industry is currently big business, with a gross of over $28 billion. However, unlike either foods or drugs, supplements do not need to be registered or approved by the US Food and Drug Administration (FDA) prior to production or sales. Under the Dietary Supplement Health and Education Act of 1994, the FDA is restricted to adverse report monitoring postmarketing. Despite widespread consumption, there is limited evidence of health benefits related to nutraceutical or supplement use in well-nourished adults. In contrast, a small number of these products have the potential to produce significant toxicity. In addition, patients often do not disclose supplement use to their physicians. Therefore, the risk of adverse drug-supplement interactions is significant. An overview of the major supplement and nutraceutical classes is presented here, together with known toxic effects and the potential for drug interactions.

  5. 42 CFR 422.270 - Incorrect collections of premiums and cost-sharing.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... that- (A) Exceed the limits approved under § 422.262; (B) In the case of an MA private fee-for-service plan, exceed the MA monthly basic beneficiary premium or the MA monthly supplemental premium submitted under § 422.262; and (C) In the case of an MA MSA plan, exceed the MA monthly beneficiary supplemental...

  6. 42 CFR 422.270 - Incorrect collections of premiums and cost-sharing.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... that- (A) Exceed the limits approved under § 422.262; (B) In the case of an MA private fee-for-service plan, exceed the MA monthly basic beneficiary premium or the MA monthly supplemental premium submitted under § 422.262; and (C) In the case of an MA MSA plan, exceed the MA monthly beneficiary supplemental...

  7. Evaluating Supplemental Educational Service Providers: Suggested Strategies for States. A Guidebook Prepared for the Center on Innovation & Improvement. Second Edition

    ERIC Educational Resources Information Center

    Ross, Steven M.; Potter, Allison; Harmon, Jennifer

    2006-01-01

    This second edition of the Guidebook is designed to help state educational agencies (SEAs) create an effective system to evaluate state-approved supplemental educational service (SES) providers. The text includes tools and strategies that will help readers determine evaluation measures, identify possible evaluation methodologies, and address the…

  8. CLSI performance standards for antimicrobial susceptibility testing of bacteria isoloated from aquatic animals; second information supplement. CLSI document VET03/VET04-S2

    USDA-ARS?s Scientific Manuscript database

    The supplemental information presented in this document is intended for use with the antimicrobial susceptibility testing procedures published in the following Clinical and Laboratory Standards Institute (CLSI) approved documents VET03-A Methods for Antimicrobial Disk Susceptibility Testing of Bacte...

  9. 77 FR 52258 - Defense Federal Acquisition Regulation Supplement; DoD Voucher Processing (DFARS Case 2011-D054)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-29

    ... reviewed and approved by the contract auditors for provisional payment and sent to the disbursing office... a contract auditor is authorized to receive vouchers from contractors, but only may approve them... revised to state that the contract auditor is the authorized representative of the contracting officer for...

  10. 78 FR 53269 - Approval and Promulgation of Implementation Plans; Arkansas; Interstate Transport of Fine...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-29

    ...] Approval and Promulgation of Implementation Plans; Arkansas; Interstate Transport of Fine Particulate... technical supplement submitted on March 20, 2013, to address interstate transport for the 1997 and 2006 PM 2... SIP'' is amended by adding an entry at the end for ``Interstate transport for the 1997 and 2006 PM 2.5...

  11. 75 FR 16387 - Approval and Promulgation of Air Quality Implementation Plan: Kentucky; Approval Section 110(a)(1...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-01

    ... the comment period is that EPA has learned that supplemental information relating to projected... viewed online at http://www.regulations.gov using docket ID No. EPA-R04-OAR- 2007-1186-0043. Thus, EPA is...://www.regulations.gov : Follow the on-line instructions for submitting comments. 2. E-mail: benjamin...

  12. IDAAPM: integrated database of ADMET and adverse effects of predictive modeling based on FDA approved drug data.

    PubMed

    Legehar, Ashenafi; Xhaard, Henri; Ghemtio, Leo

    2016-01-01

    The disposition of a pharmaceutical compound within an organism, i.e. its Absorption, Distribution, Metabolism, Excretion, Toxicity (ADMET) properties and adverse effects, critically affects late stage failure of drug candidates and has led to the withdrawal of approved drugs. Computational methods are effective approaches to reduce the number of safety issues by analyzing possible links between chemical structures and ADMET or adverse effects, but this is limited by the size, quality, and heterogeneity of the data available from individual sources. Thus, large, clean and integrated databases of approved drug data, associated with fast and efficient predictive tools are desirable early in the drug discovery process. We have built a relational database (IDAAPM) to integrate available approved drug data such as drug approval information, ADMET and adverse effects, chemical structures and molecular descriptors, targets, bioactivity and related references. The database has been coupled with a searchable web interface and modern data analytics platform (KNIME) to allow data access, data transformation, initial analysis and further predictive modeling. Data were extracted from FDA resources and supplemented from other publicly available databases. Currently, the database contains information regarding about 19,226 FDA approval applications for 31,815 products (small molecules and biologics) with their approval history, 2505 active ingredients, together with as many ADMET properties, 1629 molecular structures, 2.5 million adverse effects and 36,963 experimental drug-target bioactivity data. IDAAPM is a unique resource that, in a single relational database, provides detailed information on FDA approved drugs including their ADMET properties and adverse effects, the corresponding targets with bioactivity data, coupled with a data analytics platform. It can be used to perform basic to complex drug-target ADMET or adverse effects analysis and predictive modeling. IDAAPM is freely accessible at http://idaapm.helsinki.fi and can be exploited through a KNIME workflow connected to the database.Graphical abstractFDA approved drug data integration for predictive modeling.

  13. TEDS-M 2008 User Guide for the International Database. Supplement 2: National Adaptations of the TEDS-M Questionnaires

    ERIC Educational Resources Information Center

    Brese, Falk, Ed.

    2012-01-01

    This supplement contains all adaptations made by countries to the international version of the TEDS-M questionnaires under careful supervision of and approval by the TEDS-M International Study Center at Michigan State University. This information provides users of the TEDS-M International Database with a guide to evaluate the availability of…

  14. 78 FR 60704 - Approval and Promulgation of Air Quality Implementation Plan; Illinois; Redesignation of the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-02

    ... Oxides (NO X ), Sulfur Dioxide (SO 2 ), Volatile Organic Compound (VOC), ammonia, and primary PM 2.5... supplemental submission to the EPA on May 6, 2013, the IEPA submitted VOC and ammonia emission inventories to... Chicago area; approve 2002 primary PM 2.5 , NO X , SO 2 , VOC, and ammonia emission inventories for the...

  15. 78 FR 53275 - Approval and Promulgation of Air Quality Implementation Plans; Ohio; Redesignation of the Ohio...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-29

    ... dioxide (SO 2 ), ammonia and volatile organic compounds (VOC) in the Parkersburg-Marietta area (Washington... provided ammonia and VOC emissions inventories to EPA to supplement the February 29, 2012, and April 16... addition, EPA is approving the 2005 NO X , SO 2 , and PM 2.5 emission inventories and 2007/2008 ammonia and...

  16. 29 CFR 1910.6 - Incorporation by reference.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...-63 Safety Standard for Non-Medical X-Ray and Sealed Gamma Ray Sources, IBR approved for § 1910.252(d...). (8) ANSI A14.2-56 Safety Code for Portable Metal Ladders, Supplemented by ANSI A14.2a-77, IBR... Conveyors, Cableways, and Related Equipment, IBR approved for §§ 1910.218(j)(3); 1910.261 (a)(3)(x), (b)(1...

  17. 30 CFR 250.283 - When must I revise or supplement the approved EP, DPP, or DOCD?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...); (2) Change the surface location of a well or production platform by a distance more than that specified by the Regional Supervisor; (3) Change the type of production or significantly increase the volume... revise your approved EP, DPP, or DOCD when you propose to: (1) Change the type of drilling rig (e.g...

  18. 21 CFR 314.160 - Approval of an application or abbreviated application for which approval was previously refused...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... of an applicant, FDA may, on the basis of new data, approve an application or abbreviated application which it had previously refused, suspended, or withdrawn approval. FDA will publish a notice in the...

  19. 21 CFR 314.160 - Approval of an application or abbreviated application for which approval was previously refused...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... of an applicant, FDA may, on the basis of new data, approve an application or abbreviated application which it had previously refused, suspended, or withdrawn approval. FDA will publish a notice in the...

  20. 21 CFR 314.160 - Approval of an application or abbreviated application for which approval was previously refused...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... of an applicant, FDA may, on the basis of new data, approve an application or abbreviated application which it had previously refused, suspended, or withdrawn approval. FDA will publish a notice in the...

  1. 21 CFR 314.160 - Approval of an application or abbreviated application for which approval was previously refused...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... of an applicant, FDA may, on the basis of new data, approve an application or abbreviated application which it had previously refused, suspended, or withdrawn approval. FDA will publish a notice in the...

  2. 21 CFR 314.160 - Approval of an application or abbreviated application for which approval was previously refused...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... of an applicant, FDA may, on the basis of new data, approve an application or abbreviated application which it had previously refused, suspended, or withdrawn approval. FDA will publish a notice in the...

  3. Regulatory and ethical issues with dietary supplements.

    PubMed

    Harris, I M

    2000-11-01

    Dietary supplements are commonly used, and many are effective or hold promise for treating various conditions. However, they do not require Food and Drug Administration (FDA) approval. Impurities and adulterants have been found in the products, mostly due to the lack of requirements for good manufacturing practices. In addition, as no standardization is required, the active ingredient may be absent or highly variable among manufacturers. The FDA published its 10-year plan for dietary supplements that addresses safety, labeling, boundaries, enforcement, research, and outreach. This endeavor, if put into place, will be instrumental in providing consumers with more confidence in the safety, composition, and labeling of dietary supplements.

  4. 49 CFR 451.1 - Application for approval.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.1 Application for approval. (a) Any owner of an existing container may apply for approval to... to any Approval Authority. (b) Each application must include the following for each container: (1...

  5. 49 CFR 451.1 - Application for approval.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.1 Application for approval. (a) Any owner of an existing container may apply for approval to... to any Approval Authority. (b) Each application must include the following for each container: (1...

  6. 49 CFR 451.1 - Application for approval.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.1 Application for approval. (a) Any owner of an existing container may apply for approval to... to any Approval Authority. (b) Each application must include the following for each container: (1...

  7. A Descriptive Study of Enrollment in Supplemental Educational Services in the Four RRE Appalachia Region States. REL 2012-No.109

    ERIC Educational Resources Information Center

    Ford, James; Harrison, Lynn; Mokher, Christine; Franceschini, Louis; Zoblotsky, Todd

    2012-01-01

    The supplemental educational services program is a core provision of the No Child Left Behind (NCLB) Act of 2001. The program offers free tutoring in reading/language arts and math from state-approved providers outside of regular school hours. This report explores differences across states and school urban and rural locales in providing…

  8. Warfighter Sustainability: Maximizing Human Performance in Hostile Environments

    DTIC Science & Technology

    2008-10-01

    Study 4: Effects of Beta Glucan on Symptoms of Upper Tract Infection in Wildland Firefighters. ix Approved for public release...Study 4: Effects of Beta Glucan on Symptoms of Upper Tract Infection in Wildland Firefighters. The use of a beta glucan supplement may decrease...reduce the required fluid intake during extended operations without compromising work output. In addition, the ingestion of a beta glucan supplement may

  9. 76 FR 71455 - Approval and Promulgation of Implementation Plans and Designation of Areas for Air Quality...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-18

    ...EPA is taking final action to approve a request submitted on December 18, 2009, and supplemented on December 22, 2010, from the State of North Carolina, through the North Carolina Department of Environment and Natural Resources (NC DENR), Division of Air Quality (DAQ), to redesignate the Greensboro-Winston-Salem-High Point fine particulate matter (PM2.5) nonattainment area (hereafter the ``Greensboro Area'' or ``Area'') to attainment for the 1997 Annual PM2.5 National Ambient Air Quality Standards (NAAQS). The Greensboro Area is comprised of Davidson and Guilford Counties in their entireties. EPA's approval of the redesignation request is based on the determination that the State of North Carolina has met the criteria for redesignation to attainment set forth in the Clean Air Act (CAA or Act), including the determination that the Greensboro Area has attained the 1997 Annual PM2.5 NAAQS by its applicable attainment date of April 5, 2010. Additionally, EPA is approving a revision to the North Carolina State Implementation Plan (SIP) to include the 1997 Annual PM2.5 maintenance plan for the Greensboro Area that contains the new 2011 and 2021 motor vehicle emission budgets (MVEBs) for nitrogen oxides (NOX) and PM2.5 for both Davidson and Guilford Counties. This action also approves the emissions inventory submitted with the maintenance plan. Further, EPA is correcting a typographical error for the citation associated with a previous adequacy finding the Agency made for the NOX and PM2.5 MVEBs for both Davidson and Guilford Counties.

  10. 49 CFR 451.1 - Application for approval.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.1 Application for approval. (a) Any owner of an existing container may apply for approval to.... (b) Each application must include the following for each container: (1) Date and place of manufacture...

  11. 49 CFR 451.1 - Application for approval.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.1 Application for approval. (a) Any owner of an existing container may apply for approval to.... (b) Each application must include the following for each container: (1) Date and place of manufacture...

  12. 14 CFR 121.921 - Training devices and simulators.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... REQUIREMENTS: DOMESTIC, FLAG, AND SUPPLEMENTAL OPERATIONS Advanced Qualification Program § 121.921 Training... provide for its serviceability and fitness to perform its intended function as approved by the FAA. ...

  13. Automated Neuropsychological Assessment Metrics, Version 4 (ANAM4): Examination of Select Psychometric Properties and Administration Procedures

    DTIC Science & Technology

    2016-12-01

    2017 was approved in August 2016. The supplemental project has 2 primary objectives: • Recommend cognitive assessment tools/approaches ( toolkit ) from...strategies for use in future military-relevant environments The supplemental project has two primary deliverables: • Proposed Toolkit of cognitive...6 Vet Final Report and Cognitive performance recommendations through Steering Committee Task 7 Provide Toolkit Report 16 Months 8-12 Task 8

  14. 49 CFR 451.12 - Application for approval by design type.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 6 2013-10-01 2013-10-01 false Application for approval by design type. 451.12... Approval of New Containers § 451.12 Application for approval by design type. (a) For approval of new containers by design type, each application must include the following: (1) Engineering drawings and plans...

  15. 49 CFR 451.12 - Application for approval by design type.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 6 2014-10-01 2014-10-01 false Application for approval by design type. 451.12... Approval of New Containers § 451.12 Application for approval by design type. (a) For approval of new containers by design type, each application must include the following: (1) Engineering drawings and plans...

  16. 49 CFR 451.12 - Application for approval by design type.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 6 2012-10-01 2012-10-01 false Application for approval by design type. 451.12... Approval of New Containers § 451.12 Application for approval by design type. (a) For approval of new containers by design type, each application must include the following: (1) Engineering drawings and plans...

  17. 49 CFR 451.12 - Application for approval by design type.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 6 2010-10-01 2010-10-01 false Application for approval by design type. 451.12... Approval of New Containers § 451.12 Application for approval by design type. (a) For approval of new containers by design type, each application must include the following: (1) Engineering drawings and plans...

  18. 49 CFR 451.12 - Application for approval by design type.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 6 2011-10-01 2011-10-01 false Application for approval by design type. 451.12... Approval of New Containers § 451.12 Application for approval by design type. (a) For approval of new containers by design type, each application must include the following: (1) Engineering drawings and plans...

  19. Optimizing collection of adverse event data in cancer clinical trials supporting supplemental indications.

    PubMed

    Kaiser, Lee D; Melemed, Allen S; Preston, Alaknanda J; Chaudri Ross, Hilary A; Niedzwiecki, Donna; Fyfe, Gwendolyn A; Gough, Jacqueline M; Bushnell, William D; Stephens, Cynthia L; Mace, M Kelsey; Abrams, Jeffrey S; Schilsky, Richard L

    2010-12-01

    Although much is known about the safety of an anticancer agent at the time of initial marketing approval, sponsors customarily collect comprehensive safety data for studies that support supplemental indications. This adds significant cost and complexity to the study but may not provide useful new information. The main purpose of this analysis was to assess the amount of safety and concomitant medication data collected to determine a more optimal approach in the collection of these data when used in support of supplemental applications. Following a prospectively developed statistical analysis plan, we reanalyzed safety data from eight previously completed prospective randomized trials. A total of 107,884 adverse events and 136,608 concomitant medication records were reviewed for the analysis. Of these, four grade 1 to 2 and nine grade 3 and higher events were identified as drug effects that were not included in the previously established safety profiles and could potentially have been missed using subsampling. These events were frequently detected in subsamples of 400 patients or larger. Furthermore, none of the concomitant medication records contributed to labeling changes for the supplemental indications. Our study found that applying the optimized methodologic approach, described herein, has a high probability of detecting new drug safety signals. Focusing data collection on signals that cause physicians to modify or discontinue treatment ensures that safety issues of the highest concern for patients and regulators are captured and has significant potential to relieve strain on the clinical trials system.

  20. Twenty Years of the Dietary Supplement Health and Education Act--How Should Dietary Supplements Be Regulated?

    PubMed

    Wallace, Taylor C

    2015-08-01

    The Dietary Supplement Health and Education Act (DSHEA) of 1994 defines the FDA's statutory authority to regulate dietary supplement products in the United States. The dietary supplement industry has rapidly expanded since 1994, presenting an obvious need for "DSHEA 2.0." Current regulations surrounding dietary supplements have been increasingly and reasonably scrutinized, given their widespread use by over one-half of the US population as well as highly publicized safety concerns over the past 20 y. As the market continues to expand and evolve, so too must the laws that protect consumers from potential harm and misleading communication. This article is meant to begin a scientific dialogue on how regulations may be improved to provide both ease of access and safer products to the consumer by focusing on 4 topics: premarket approval, label claims, current Good Manufacturing Practices, and adverse event reporting. © 2015 American Society for Nutrition.

  1. SOAR Online Course Increases Capacity for Assisting Individuals with Disabilities in the US.

    PubMed

    Lupfer, Kristin; Elder, Jen

    2016-01-01

    For adults with disabilities who are experiencing homelessness, chances of being approved for social security disability benefits are very low, without assistance. Assisting with the Supplemental Security Income (SSI)/Social Security Disability Insurance (SSDI) application process can be challenging for case managers who lack capacity and expertise. Training caseworkers to document disability and submit complete, high-quality applications using the SSI/SSDI Outreach, Access and Recovery (SOAR) model improves efficiency and outcomes. Nationally, 65% of applications using the SOAR model are approved, with decisions received in an average of 81 days in 2015. The SOAR Online Course was created to expand training opportunities for individuals to learn how to effectively assist with SSI/SSDI applications for individuals experiencing or at risk for homelessness. From October 1, 2014 to September 30, 2015, 1049 individuals from 49 states, Washington, DC, and Puerto Rico successfully completed the SOAR Online Course. The course is a unique public health training model; in that, it incorporates a realistic and multimodal practice SSI/SSDI application with comprehensive feedback provided by experts. Local SOAR leaders around the county are trained to facilitate and guide groups through the course. This study evaluated data on online course usage, user experience, and the translation from learning to practice for online course trainees. We found that successful course completions were most concentrated in areas that had local SOAR leaders, trainees through the online course had higher data entry rates about case outcomes in the SOAR Online Application Tracking system, and that trainees reported a high satisfaction rate with the course and comprehensive feedback. The evaluation found that key success factors for online training models include the integration of a practice case component (or other generative learning activity), support from local facilitators, and feedback and technical assistance for trainees.

  2. 77 FR 2682 - Defense Federal Acquisition Regulation Supplement; DoD Voucher Processing

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-19

    ... selected using sampling methodologies will be reviewed and approved by the contract auditors for... Disallowing costs after incurrence. * * * * * (b) * * * (i) The contract auditor is the authorized...

  3. 78 FR 58611 - Agency Information Collection (Application for Supplemental Service Disabled Veterans Insurance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-24

    ... (Application for Supplemental Service Disabled Veterans Insurance) Activity Under OMB Review AGENCY: Veterans....'' SUPPLEMENTARY INFORMATION: Title: Application for Supplemental Service Disabled Veterans Insurance (SRH), VA Form 29-0188 and 29-0189, and Application for Supplemental Service Disabled Veterans (RH) Life...

  4. 21 CFR 314.105 - Approval of an application and an abbreviated application.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA...) FDA will approve an application and issue the applicant an approval letter on the basis of draft... labeling changes exactly as directed, and upon the applicant submitting to FDA a copy of the final printed...

  5. 21 CFR 314.105 - Approval of an application and an abbreviated application.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA...) FDA will approve an application and issue the applicant an approval letter on the basis of draft... labeling changes exactly as directed, and upon the applicant submitting to FDA a copy of the final printed...

  6. 21 CFR 314.105 - Approval of an application and an abbreviated application.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA...) FDA will approve an application and issue the applicant an approval letter on the basis of draft... labeling changes exactly as directed, and upon the applicant submitting to FDA a copy of the final printed...

  7. 21 CFR 314.105 - Approval of an application and an abbreviated application.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA...) FDA will approve an application and issue the applicant an approval letter on the basis of draft... labeling changes exactly as directed, and upon the applicant submitting to FDA a copy of the final printed...

  8. 21 CFR 314.105 - Approval of an application and an abbreviated application.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA...) FDA will approve an application and issue the applicant an approval letter on the basis of draft... labeling changes exactly as directed, and upon the applicant submitting to FDA a copy of the final printed...

  9. 49 CFR 451.15 - Application for individual approval.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ..., DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.15 Application for individual approval. (a) For approval of new containers... the container. ...

  10. 49 CFR 451.15 - Application for individual approval.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ..., DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.15 Application for individual approval. (a) For approval of new containers... the container. ...

  11. 49 CFR 451.15 - Application for individual approval.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ..., DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.15 Application for individual approval. (a) For approval of new containers... the container. ...

  12. 49 CFR 451.15 - Application for individual approval.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ..., DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.15 Application for individual approval. (a) For approval of new containers... the container. ...

  13. 49 CFR 451.15 - Application for individual approval.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ..., DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.15 Application for individual approval. (a) For approval of new containers... the container. ...

  14. Consumers' perceptions of the dietary supplement health and education act: implications and recommendations.

    PubMed

    Dodge, Tonya

    2016-01-01

    In 1994, the United States Congress passed the Dietary Supplement Health and Education Act (DSHEA). The regulatory framework for dietary supplements created by DSHEA has led to significant misperceptions regarding consumers' understanding of the safety and efficacy of supplements. Research shows that consumers erroneously believe that: (1) supplements are approved by the government, (2) supplements have been tested for safety and effectiveness, (3) the content of supplements is analyzed, and (4) manufacturers are required to disclose known adverse effects to consumers. Furthermore, labelling requirements that are intended to provide transparency to consumers are relatively ineffective. The following four recommendations are offered for reforming DSHEA: (1) only allow structure-function claims that are supported by research evidence, (2) require manufacturers to list known adverse effects on the labels of dietary supplements, (3) require that the Food and Drug Administration analyzes the content of dietary supplements and (4) restrict the definition of dietary ingredients. These recommendations would bring DSHEA to more closely align with consumer expectations regarding the regulation of dietary supplements and would likely provide a safer landscape for the use of supplements. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

  15. 75 FR 68037 - Proposed Information Collection (Application for Supplemental Service Disabled Veterans Insurance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-04

    ... (Application for Supplemental Service Disabled Veterans Insurance) Activity: Comment Request AGENCY: Veterans...: Application for Supplemental Service Disabled Veterans Insurance (SRH), VA Form 29-0188 and 29-0189, and Application for Supplemental Service Disabled Veterans (RH) Life Insurance, VA Form 29- 0190. OMB Control...

  16. [Liquid biopsy analysis using cell-free DNA (cfDNA): Opportunities and limitations].

    PubMed

    Dahl, E; Kloten, V

    2015-11-01

    Molecular biological analysis of nucleic acids in blood or other bodily fluids (i.e. liquid biopsy analyses) may supplement the pathologists' diagnostic armamentarium in a reasonable way-particularly in cancer precision medicine. Within the field of oncology, liquid biopsy can potentially be used to monitor tumor burden in the blood and to early detect emerging resistance in the course of targeted cancer therapies. An already approved application of liquid biopsy is the detection of epidermal growth factor receptor (EGFR) driver mutations in blood samples of lung cancer patients in those cases where no tissue biopsy is available. However, there is still currently considerable insecurity associated with blood-based DNA analytic methods that must be solved before liquid biopsy can be implemented for broader routine application in the diagnosis of cancer. In this article, the current state of development of liquid biopsy in molecular diagnostics from a pathology point of view is presented.

  17. 45 CFR 12a.10 - Action on approved applications.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... REAL PROPERTY TO ASSIST THE HOMELESS § 12a.10 Action on approved applications. (a) Unutilized and underutilized properties. (1) When HHS approves an application, it will so notify the applicant and forward a... 45 Public Welfare 1 2011-10-01 2011-10-01 false Action on approved applications. 12a.10 Section...

  18. 45 CFR 12a.10 - Action on approved applications.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... REAL PROPERTY TO ASSIST THE HOMELESS § 12a.10 Action on approved applications. (a) Unutilized and underutilized properties. (1) When HHS approves an application, it will so notify the applicant and forward a... 45 Public Welfare 1 2010-10-01 2010-10-01 false Action on approved applications. 12a.10 Section...

  19. 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...

  20. 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...

  1. 40 CFR 62.8102 - Identification of plan.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF STATE PLANS FOR DESIGNATED FACILITIES AND POLLUTANTS New York Sulfuric Acid... Plants” of Title 6 of the New York Code of Rules and Regulations effective May 10, 1984. (2) Supplemental...

  2. 78 FR 22593 - Sunshine Act Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-16

    ... Welcome Old Business Approval of minutes of February 14, 2013, Board Meeting New Business 1. Report from... Committee 5. Report of the Finance, Rates, and Portfolio Committee A. Supplement to contract with Day and...

  3. 7 CFR 247.23 - State provision of administrative funds to local agencies.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS COMMODITY SUPPLEMENTAL FOOD... funds will be used to achieve program objectives. (Approved by the Office of Management and Budget under...

  4. 7 CFR 247.23 - State provision of administrative funds to local agencies.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS COMMODITY SUPPLEMENTAL FOOD... funds will be used to achieve program objectives. (Approved by the Office of Management and Budget under...

  5. 7 CFR 247.23 - State provision of administrative funds to local agencies.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS COMMODITY SUPPLEMENTAL FOOD... funds will be used to achieve program objectives. (Approved by the Office of Management and Budget under...

  6. 7 CFR 247.23 - State provision of administrative funds to local agencies.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS COMMODITY SUPPLEMENTAL FOOD... funds will be used to achieve program objectives. (Approved by the Office of Management and Budget under...

  7. 7 CFR 247.23 - State provision of administrative funds to local agencies.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS COMMODITY SUPPLEMENTAL FOOD... funds will be used to achieve program objectives. (Approved by the Office of Management and Budget under...

  8. 27 CFR 26.50 - Formulas for liquors.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ....C. 5232, the formula shall include a statement to that effect. If any product contains liquors made... 698 Supplemental, in accordance with § 26.54. (Approved by the Office of Management and Budget under...

  9. 76 FR 71452 - Approval and Promulgation of Implementation Plans and Designation of Areas for Air Quality...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-18

    ...EPA is taking final action to approve a request submitted on December 18, 2009, and supplemented on December 22, 2010, from the State of North Carolina, through the North Carolina Department of Environment and Natural Resources (NC DENR), Division of Air Quality (DAQ), to redesignate the Hickory-Morganton-Lenoir fine particulate matter (PM2.5) nonattainment area (hereafter the ``Hickory Area'' or ``Area'') to attainment for the 1997 Annual PM2.5 National Ambient Air Quality Standards (NAAQS). The Hickory Area is comprised of Catawba County in its entirety. EPA's approval of the redesignation request is based on the determination that the State of North Carolina has met the criteria for redesignation to attainment set forth in the Clean Air Act (CAA or Act), including the determination that the Hickory Area has attained the 1997 Annual PM2.5 NAAQS by its applicable attainment date of April 5, 2010. Additionally, EPA is approving a revision to the North Carolina State Implementation Plan (SIP) to include the 1997 Annual PM2.5 maintenance plan for the Hickory Area that contains the new motor vehicle emission budgets (MVEBs) for nitrogen oxides (NOX) for the years 2011 and 2021 for Catawba County and the mobile insignificance determination for direct PM2.5 for the Hickory Area. This action also approves the emissions inventory submitted with the maintenance plan. Further, EPA is correcting a typographical error for the citation associated with a previous adequacy determination the Agency made for the NOX MVEBs for Catawba County and the mobile source insignificance determination for direct PM2.5 for the Hickory Area.

  10. A Tale of Two Citizens: A State Attorney General and a Hematologist Facilitate Translation of Research Into US Food and Drug Administration Actions—A SONAR Report

    PubMed Central

    Chen, Brian; Restaino, John; Norris, LeAnn; Xirasagar, Sudha; Qureshi, Zaina P.; McKoy, June M.; Lopez, Isaac S.; Trenery, Alyssa; Murday, Alanna; Kahn, Adam; Mattison, Donald R.; Ray, Paul; Sartor, Oliver; Bennett, Charles L.

    2012-01-01

    Purpose: Pharmaceutical safety is a public health issue. In 2005, the Connecticut Attorney General (AG) raised concerns over adverse drug reactions in off-label settings, noting that thalidomide was approved to treat a rare illness, but more than 90% of its use was off label. A hematologist had reported thalidomide with doxorubicin or dexamethasone was associated with venous thromboembolism (VTE) rates of 25%. We review US Food and Drug Administration (FDA) and manufacturer responses to a citizen petition filed to address these thalidomide safety issues. Methods: Case study. Results: The AG petitioned the FDA requesting thalidomide-related safety actions. Coincidentally, the manufacturer submitted a supplemental New Drug Approval (sNDA), requesting approval to treat multiple myeloma with thalidomide-dexamethasone. FDA safety officers reviewed the petition and the literature and noted that VTE risks with thalidomide were not appropriately addressed in the existing package insert. In the sNDA application, the manufacturer reported thalidomide-associated toxicities for multiple myeloma were primarily somnolence and neurotoxicity, and a proposed package insert did not focus on VTE risks. In October, the FDA informed the Oncology Drug Division that VTE risks with thalidomide were poorly addressed in the existing label. After reviewing this memorandum, an Oncology Drug Division reviewer informed the manufacturer that approval of the sNDA would be delayed until several thalidomide-associated VTE safety actions, including revisions of the package insert, were implemented. The manufacturer and FDA agreed on these actions, and the sNDA was approved. Conclusion: New approaches addressing off-label safety are needed. The conditions that facilitated the successful response to this citizen petition are uncommon. PMID:23598851

  11. A tale of two citizens: a State Attorney General and a hematologist facilitate translation of research into US Food and Drug Administration actions--a SONAR report.

    PubMed

    Chen, Brian; Restaino, John; Norris, LeAnn; Xirasagar, Sudha; Qureshi, Zaina P; McKoy, June M; Lopez, Isaac S; Trenery, Alyssa; Murday, Alanna; Kahn, Adam; Mattison, Donald R; Ray, Paul; Sartor, Oliver; Bennett, Charles L

    2012-11-01

    Pharmaceutical safety is a public health issue. In 2005, the Connecticut Attorney General (AG) raised concerns over adverse drug reactions in off-label settings, noting that thalidomide was approved to treat a rare illness, but more than 90% of its use was off label. A hematologist had reported thalidomide with doxorubicin or dexamethasone was associated with venous thromboembolism (VTE) rates of 25%. We review US Food and Drug Administration (FDA) and manufacturer responses to a citizen petition filed to address these thalidomide safety issues. Case study. The AG petitioned the FDA requesting thalidomide-related safety actions. Coincidentally, the manufacturer submitted a supplemental New Drug Approval (sNDA), requesting approval to treat multiple myeloma with thalidomide-dexamethasone. FDA safety officers reviewed the petition and the literature and noted that VTE risks with thalidomide were not appropriately addressed in the existing package insert. In the sNDA application, the manufacturer reported thalidomide-associated toxicities for multiple myeloma were primarily somnolence and neurotoxicity, and a proposed package insert did not focus on VTE risks. In October, the FDA informed the Oncology Drug Division that VTE risks with thalidomide were poorly addressed in the existing label. After reviewing this memorandum, an Oncology Drug Division reviewer informed the manufacturer that approval of the sNDA would be delayed until several thalidomide-associated VTE safety actions, including revisions of the package insert, were implemented. The manufacturer and FDA agreed on these actions, and the sNDA was approved. New approaches addressing off-label safety are needed. The conditions that facilitated the successful response to this citizen petition are uncommon.

  12. 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...

  13. 78 FR 19714 - User Fees and Refunds for Premarket Approval Applications and Device Biologics License...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-02

    ...] User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications... availability of the guidance entitled ``User Fees and Refunds for Premarket Approval Applications (PMAs) and... for single copies of the guidance document entitled ``User Fees and Refunds for Premarket Approval...

  14. Over-the-Counter Weight-Loss Pills: Do They Work?

    MedlinePlus

    ... supplements The standards for regulating the production and marketing of these two types of treatments are different. ... t subject to FDA review or approval before marketing. Also, the type or quality of research used ...

  15. 49 CFR 451.11 - Application for approval-general.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.11 Application for approval-general. (a) An owner of a new container, or a...

  16. 49 CFR 451.11 - Application for approval-general.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.11 Application for approval-general. (a) An owner of a new container, or a...

  17. 49 CFR 451.11 - Application for approval-general.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.11 Application for approval-general. (a) An owner of a new container, or a...

  18. 49 CFR 451.11 - Application for approval-general.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.11 Application for approval-general. (a) An owner of a new container, or a...

  19. 49 CFR 451.11 - Application for approval-general.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.11 Application for approval-general. (a) An owner of a new container, or a...

  20. 21 CFR 314.107 - Effective date of approval of a 505(b)(2) application or abbreviated new drug application under...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... application for a drug product becomes effective on the date FDA issues an approval letter under § 314.105 for... on the date FDA issues an approval letter under § 314.105 if the applicant certifies under § 314.50(i...

  1. 21 CFR 314.107 - Effective date of approval of a 505(b)(2) application or abbreviated new drug application under...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... application for a drug product becomes effective on the date FDA issues an approval letter under § 314.105 for... on the date FDA issues an approval letter under § 314.105 if the applicant certifies under § 314.50(i...

  2. 21 CFR 314.107 - Effective date of approval of a 505(b)(2) application or abbreviated new drug application under...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... application for a drug product becomes effective on the date FDA issues an approval letter under § 314.105 for... on the date FDA issues an approval letter under § 314.105 if the applicant certifies under § 314.50(i...

  3. 21 CFR 314.107 - Effective date of approval of a 505(b)(2) application or abbreviated new drug application under...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... application for a drug product becomes effective on the date FDA issues an approval letter under § 314.105 for... on the date FDA issues an approval letter under § 314.105 if the applicant certifies under § 314.50(i...

  4. 21 CFR 314.107 - Effective date of approval of a 505(b)(2) application or abbreviated new drug application under...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... application for a drug product becomes effective on the date FDA issues an approval letter under § 314.105 for... on the date FDA issues an approval letter under § 314.105 if the applicant certifies under § 314.50(i...

  5. First identification and quantification of lorcaserin in an herbal slimming dietary supplement.

    PubMed

    Hachem, Rabab; Malet-Martino, Myriam; Gilard, Véronique

    2014-09-01

    The weight-loss drug lorcaserin, a FDA approved anorectic drug, was isolated from the dietary supplement "Lose quickly" claimed to be a pure natural fast slimming diet pill. After its purification by means of preparative liquid chromatography, its structure was characterized using LC-UV, NMR, MS, MS/MS, and IR spectroscopy. The amount of lorcaserin measured by qNMR was 6.6mg/capsule. Copyright © 2014 Elsevier B.V. All rights reserved.

  6. 75 FR 68039 - Agency Information Collection (Application for Supplemental Service Disabled Veterans Insurance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-04

    ... (Application for Supplemental Service Disabled Veterans Insurance) Activity Under OMB Review AGENCY: Veterans... INFORMATION: Title: Application for Supplemental Service Disabled Veterans Insurance, (SRH) Life Insurance, VA... applying for Supplemental Service Disabled Veterans Insurance. VA uses the information collected to...

  7. Accession Medical Standards Analysis and Research Activity (AMSARA) 2014, Annual Report, and four Supplemental Applicants and Accessions Tables for: Army, Air Force, Marine, and Navy

    DTIC Science & Technology

    2016-02-02

    275 1.8 20 0.2 Contact dermatitis and other eczema 1,624 2.0 1,148 2.3 275 1.8 196 2.0 Total considerations* 82,398 15,620 Total of approved...musculoskeletal and connective tissue injuries 328 2.4 267 2.6 50 2.1 46 2.2 Contact dermatitis and other eczema 349 2.5 257 2.5 49 2.0 47 2.2 Total...78 3.6 Affective psychoses 669 4.2 411 4.1 112 3.1 43 2.0 Contact dermatitis and other eczema 450 2.9 174 1.8 101 2.8 24 1.1 Hearing loss 660 4.2

  8. [Principles for molecular identification of traditional Chinese materia medica using DNA barcoding].

    PubMed

    Chen, Shi-Lin; Yao, Hui; Han, Jian-Ping; Xin, Tian-Yi; Pang, Xiao-Hui; Shi, Lin-Chun; Luo, Kun; Song, Jing-Yuan; Hou, Dian-Yun; Shi, Shang-Mei; Qian, Zhong-Zhi

    2013-01-01

    Since the research of molecular identification of Chinese Materia Medica (CMM) using DNA barcode is rapidly developing and popularizing, the principle of this method is approved to be listed in the Supplement of the Pharmacopoeia of the People's Republic of China. Based on the study on comprehensive samples, the DNA barcoding systems have been established to identify CMM, i.e. ITS2 as a core barcode and psbA-trnH as a complementary locus for identification of planta medica, and COI as a core barcode and ITS2 as a complementary locus for identification of animal medica. This article introduced the principle of molecular identification of CMM using DNA barcoding and its drafting instructions. Furthermore, its application perspective was discussed.

  9. 76 FR 19373 - The 14th Annual Food and Drug Administration-Orange County Regulatory Affairs Educational...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-07

    ... (OCRA). The conference is intended to provide the drug, device, biologics, and dietary supplement... will be product approval, compliance, and risk management in the three medical product areas. Industry...

  10. 75 FR 29559 - The 13th Annual Food and Drug Administration-Orange County Regulatory Affairs Educational...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-26

    ... and dietary supplement industries with an opportunity to interact with FDA reviewers and compliance... interactive conference will be product approval, compliance, and risk management in the four medical product...

  11. 77 FR 24721 - The 15th Annual Food and Drug Administration-Orange County Regulatory Affairs Educational...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-25

    ... Group (OCRA). The conference is intended to provide the drug, device, biologics, and dietary supplement... product approval, compliance, and risk management in the three medical product areas. Industry speakers...

  12. Measure A County Transportation Expenditure Plan

    DOT National Transportation Integrated Search

    1996-01-01

    In 1988, the voters of Sacramento County approved Measure A, a twenty-year, halfcent sales tax to supplement existing revenues for local transportation improvements. When a retail transactions and use tax such as this is enacted, the Local Transporta...

  13. Chromium picolinate intake and risk of type 2 diabetes: an evidence-based review by the United States Food and Drug Administration.

    PubMed

    Trumbo, Paula R; Ellwood, Kathleen C

    2006-08-01

    The labeling of both health claims that meet significant scientific agreement (SSA) and qualified health claims on conventional foods and dietary supplements requires pre-market approval by the US Food and Drug Administration (FDA). Approval by the FDA involves, in part, a thorough review of the scientific evidence to support an SSA or a qualified health claim. This article discusses FDA's evidence-based review of the scientific evidence on the role of chromium picolinate supplements in reducing the risk of type 2 diabetes. Based on this evidence-based review, FDA issued a letter of enforcement discretion for one qualified health claim on chromium picolinate and risk of insulin resistance, a surrogate endpoint for type 2 diabetes. The agency concluded that the relationship between chromium picolinate intake and insulin resistance is highly uncertain.

  14. Priapism caused by 'Tribulus terrestris'.

    PubMed

    Campanelli, M; De Thomasis, R; Tenaglia, R L

    2016-01-01

    A 36-year-old Caucasian man was diagnosed with a 72-h-lasting priapism that occurred after the assumption of a Herbal supplement based on Tribulus terrestris, which is becoming increasingly popular for the treatment of sexual dysfunction. The patient underwent a cavernoglandular shunt (Ebbehoj shunt) in order to obtain complete detumescence, from which derived negative post-episode outcomes on sexual function. All patients consuming non-FDA-approved alternative supplements such as Tribulus terrestris should be warned about the possible serious side effects.

  15. Differences between dietary supplement and prescription drug omega-3 fatty acid formulations: a legislative and regulatory perspective.

    PubMed

    Collins, Nancy; Tighe, Ann P; Brunton, Stephen A; Kris-Etherton, Penny M

    2008-12-01

    The medical management of many diseases and conditions can include either restriction or provision of specific essential nutrients. When such nutrients are needed, there are often both prescription and nonprescription products available, as in the case of nicotinic acid or omega-3 fatty acids. Although they may seem to contain similar ingredients, there may be important differences between the prescription and dietary-supplement preparations. The manufacturing of prescription pharmaceutical products is regulated by the US Food and Drug Administration (FDA), which mandates standards for consistency and quality assurance. Dietary supplements are available to consumers under the provisions of the Dietary Supplement Health and Education Act of 1994, for which the FDA has the burden of proving a dietary supplement is harmful rather than requiring the manufacturer prove that the supplement is safe. Consumers and medical professionals should be aware of the important qualitative and quantitative differences between the FDA-approved prescription formulations and dietary supplements, particularly when an essential nutrient is part of the medical management of a disease or condition.

  16. Hepatotoxicity of Herbal Supplements Mediated by Modulation of Cytochrome P450

    PubMed Central

    Chen, Taosheng

    2017-01-01

    Herbal supplements are a significant source of drug-drug interactions (DDIs), herb-drug interactions, and hepatotoxicity. Cytochrome P450 (CYP450) enzymes metabolize a large number of FDA-approved pharmaceuticals and herbal supplements. This metabolism of pharmaceuticals and supplements can be augmented by concomitant use of either pharmaceuticals or supplements. The xenobiotic receptors constitutive androstane receptor (CAR) and the pregnane X receptor (PXR) can respond to xenobiotics by increasing the expression of a large number of genes that are involved in the metabolism of xenobiotics, including CYP450s. Conversely, but not exclusively, many xenobiotics can inhibit the activity of CYP450s. Induction of the expression or inhibition of the activity of CYP450s can result in DDIs and toxicity. Currently, the United States (US) Food and Drug Administration does not require the investigation of the interactions of herbal supplements and CYP450s. This review provides a summary of herbal supplements that inhibit CYP450s, induce the expression of CYP450s, and/or whose toxicity is mediated by CYP450s. PMID:29117101

  17. Dietary supplementation with a superoxide dismutase-melon concentrate reduces stress, physical and mental fatigue in healthy people: a randomised, double-blind, placebo-controlled trial.

    PubMed

    Carillon, Julie; Notin, Claire; Schmitt, Karine; Simoneau, Guy; Lacan, Dominique

    2014-06-19

    We aimed to investigate effects of superoxide dismutase (SOD)-melon concentrate supplementation on psychological stress, physical and mental fatigue in healthy people. A randomized, double-blind, placebo-controlled trial was performed on 61 people divided in two groups: active supplement (n = 32) and placebo (n = 29) for 12 weeks. Volunteers were given one small hard capsule per day. One capsule contained 10 mg of SOD-melon concentrate (140 U of SOD) and starch for the active supplement and starch only for the placebo. Stress and fatigue were evaluated using four psychometric scales: PSS-14; SF-36; Stroop tests and Prevost scale. The supplementation with SOD-melon concentrate significantly decreased perceived stress, compared to placebo. Moreover, quality of life was improved and physical and mental fatigue were reduced with SOD-melon concentrate supplementation. SOD-melon concentrate supplementation appears to be an effective and natural way to reduce stress and fatigue. trial approved by the ethical committee of Poitiers (France), and the ClinicalTrials.gov Identifier is NCT01767922.

  18. Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000-2012.

    PubMed

    Sacks, Leonard V; Shamsuddin, Hala H; Yasinskaya, Yuliya I; Bouri, Khaled; Lanthier, Michael L; Sherman, Rachel E

    Some new drug applications fail because of inadequate drug performance and others are not approved because the information submitted to the US Food and Drug Administration (FDA) is unsatisfactory to make that determination. Resubmission of failed applications is costly, delaying marketing approval and the availability of new drugs to patients. To identify the reasons that FDA marketing approval for new drugs was delayed or denied. A retrospective review of FDA documents and extraction of data were performed. We examined all drug applications first submitted to the FDA between 2000 and 2012 for new molecular entities (NMEs), which are active ingredients never before marketed in the United States in any form. Using FDA correspondence and reviews, we investigated the reasons NMEs failed to obtain FDA approval. Reasons for delayed FDA approval or nonapproval of NME applications. Of the 302 identified NME applications, 151 (50%) were approved when first submitted and 222 (73.5%) were ultimately approved. Seventy-one applications required 1 or more resubmissions before approval, with a median delay to approval of 435 days following the first unsuccessful submission. Of the unsuccessful first-time applications, 24 (15.9%) included uncertainties related to dose selection, 20 (13.2%) choice of study end points that failed to adequately reflect a clinically meaningful effect, 20 (13.2%) inconsistent results when different end points were tested, 17 (11.3%) inconsistent results when different trials or study sites were compared, and 20 (13.2%) poor efficacy when compared with the standard of care. The frequency of safety deficiencies was similar among never-approved drugs compared with those with delayed approval (43 of 80 never approved [53.8%] vs 37 of 71 eventually approved [52.1%]; difference, 1.7% [95% CI, -14.86% to 18.05%]; P = .87). However, efficacy deficiencies were significantly more frequent among the never-approved drugs than among those with delayed approvals (61 of 80 never approved [76.3%] vs 28 of 71 eventually approved [39.4%]; difference, 36.9% [95% CI, 20.25% to 50.86%]; P < .001). Several potentially preventable deficiencies, including failure to select optimal drug doses and suitable study end points, accounted for significant delays in the approval of new drugs. Understanding the reasons for previous failures is helpful to improve the efficiency of clinical development for new drugs.

  19. 24 CFR 581.10 - Action on approved applications.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 24 Housing and Urban Development 3 2011-04-01 2010-04-01 true Action on approved applications. 581... URBAN DEVELOPMENT COMMUNITY FACILITIES USE OF FEDERAL REAL PROPERTY TO ASSIST THE HOMELESS § 581.10 Action on approved applications. (a) Unutilized and underutilized properties. (1) When HHS approves an...

  20. 77 FR 60116 - Notice of Proposed Information Collection Requests; State Plan for Vocational Rehabilitation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-02

    ... Rehabilitation Services Administration a State Plan for the Vocational Rehabilitation (VR) Services program and... approved VR State Plan and SE supplement form the basis upon which a state participates in programs under...

  1. 75 FR 1274 - Implantation or Injectable Dosage Form New Animal Drugs; Hyaluronate Sodium

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-11

    ... safety warning for use of hyaluronate sodium injectable solution in horses. DATES: This rule is effective... human food safety warning on product labeling. The supplemental NADA is approved as of December 11, 2009...

  2. 49 CFR 107.709 - Processing of an application for approval, including an application for renewal or modification.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 2 2010-10-01 2010-10-01 false Processing of an application for approval..., Registrations and Submissions § 107.709 Processing of an application for approval, including an application for... before the disposition of an application. (b) At any time during the processing of an application, the...

  3. 21 CFR 314.125 - Refusal to approve an application.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications... the application under section 505(d) of the act, if: (1) FDA sends the applicant a complete response... question of whether the application is approvable; and (3) FDA finds that any of the reasons given in...

  4. 21 CFR 314.125 - Refusal to approve an application.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications... the application under section 505(d) of the act, if: (1) FDA sends the applicant a complete response... question of whether the application is approvable; and (3) FDA finds that any of the reasons given in...

  5. 21 CFR 314.125 - Refusal to approve an application.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications... the application under section 505(d) of the act, if: (1) FDA sends the applicant a complete response... question of whether the application is approvable; and (3) FDA finds that any of the reasons given in...

  6. 21 CFR 314.125 - Refusal to approve an application.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications... the application under section 505(d) of the act, if: (1) FDA sends the applicant a complete response... question of whether the application is approvable; and (3) FDA finds that any of the reasons given in...

  7. 21 CFR 314.125 - Refusal to approve an application.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications... the application under section 505(d) of the act, if: (1) FDA sends the applicant a complete response... question of whether the application is approvable; and (3) FDA finds that any of the reasons given in...

  8. 78 FR 76829 - Approval of Application Submitted by Eastern Shoshone Tribe and Northern Arapaho Tribe for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-19

    ... regulatory authority under the Clean Air Act. DATES: EPA's decision approving the Tribes' TAS application was... Decision Document, Attachment 1 (Legal Analysis of the Wind River Indian Reservation Boundary), Attachment... decision to approve the application does not approve, Tribal authority to implement any Clean Air Act...

  9. 21 CFR 314.152 - Notice of withdrawal of approval of an application or abbreviated application for a new drug.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.152 Notice of... Administration withdraws approval of an application or abbreviated application for a new drug, FDA will publish a...

  10. 21 CFR 314.152 - Notice of withdrawal of approval of an application or abbreviated application for a new drug.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.152 Notice of... Administration withdraws approval of an application or abbreviated application for a new drug, FDA will publish a...

  11. 21 CFR 314.152 - Notice of withdrawal of approval of an application or abbreviated application for a new drug.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.152 Notice of... Administration withdraws approval of an application or abbreviated application for a new drug, FDA will publish a...

  12. 21 CFR 314.152 - Notice of withdrawal of approval of an application or abbreviated application for a new drug.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.152 Notice of... Administration withdraws approval of an application or abbreviated application for a new drug, FDA will publish a...

  13. 21 CFR 314.152 - Notice of withdrawal of approval of an application or abbreviated application for a new drug.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.152 Notice of... Administration withdraws approval of an application or abbreviated application for a new drug, FDA will publish a...

  14. 21 CFR 314.150 - Withdrawal of approval of an application or abbreviated application.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.150 Withdrawal of approval of an... abbreviated application for a new drug on a finding that there is an imminent hazard to the public health. FDA...

  15. 21 CFR 314.150 - Withdrawal of approval of an application or abbreviated application.

    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 FDA Action on Applications and Abbreviated Applications § 314.150 Withdrawal of approval of an... abbreviated application for a new drug on a finding that there is an imminent hazard to the public health. FDA...

  16. 21 CFR 314.150 - Withdrawal of approval of an application or abbreviated application.

    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 FDA Action on Applications and Abbreviated Applications § 314.150 Withdrawal of approval of an... abbreviated application for a new drug on a finding that there is an imminent hazard to the public health. FDA...

  17. 21 CFR 314.150 - Withdrawal of approval of an application or abbreviated application.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.150 Withdrawal of approval of an... abbreviated application for a new drug on a finding that there is an imminent hazard to the public health. FDA...

  18. 21 CFR 314.150 - Withdrawal of approval of an application or abbreviated application.

    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 FDA Action on Applications and Abbreviated Applications § 314.150 Withdrawal of approval of an... abbreviated application for a new drug on a finding that there is an imminent hazard to the public health. FDA...

  19. 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. Fifty-three applications were approved. A variety of clinical trial endpoints were used in the approval trials.

  20. 78 FR 38648 - Approval and Promulgation of Air Quality Implementation Plans; State of New Jersey; Redesignation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-27

    ... ) and Volatile Organic Compounds (VOC) that were submitted as part of the supplement, in conjunction...] that volatile organic compounds and NH 3 are not PM 2.5 precursors, as subpart 4 expressly governs...

  1. 75 FR 1363 - Integrated System Power Rates

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-11

    ... service load immediately when disturbance conditions are experienced due to a sudden loss of generation or... conditions are experienced due to a sudden loss of generation or load. ``Supplemental Operating Reserve... Secretary has approved and placed into effect on an [[Page 1364

  2. 77 FR 48523 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Public...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-14

    ... future of CHIP. Going beyond facts and basic descriptive information, it will gather insights about the... supplement two other data collection efforts which received clearance on December 12, 2011 (a survey of CHIP...

  3. 76 FR 10082 - 60-Day Notice of Proposed Information Collection: DS-157, Supplemental Nonimmigrant Visa Application

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-23

    ... Information Collection: DS-157, Supplemental Nonimmigrant Visa Application ACTION: Notice of request for...: Supplemental Nonimmigrant Visa Application. OMB Control Number: 1405-0134. Type of Request: Extension of a...). Form Number: DS-157. Respondents: Nonimmigrant visa applicants legally required to provide additional...

  4. Applications for approval to market a new drug; complete response letter; amendments to unapproved applications. Final rule.

    PubMed

    2008-07-10

    The Food and Drug Administration (FDA) is amending its regulations on new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for approval to market new drugs and generic drugs (drugs for which approval is sought in an ANDA). The final rule discontinues FDA's use of approvable letters and not approvable letters when taking action on marketing applications. Instead, we will send applicants a complete response letter to indicate that the review cycle for an application is complete and that the application is not ready for approval. We are also revising the regulations on extending the review cycle due to the submission of an amendment to an unapproved application and starting a new review cycle after the resubmission of an application following receipt of a complete response letter. In addition, we are adding to the regulations on biologics license applications (BLAs) provisions on the issuance of complete response letters to BLA applicants. We are taking these actions to implement the user fee performance goals referenced in the Prescription Drug User Fee Amendments of 2002 (PDUFA III) that address procedures and establish target timeframes for reviewing human drug applications.

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

    United States. Bonneville Power Administration.

    This progress report broadly defines the scope of supplementation plans and activities in the Columbia Basin. It provides the foundation for more detailed analysis of supplementation in subsequent reports in this series. Topics included in this report are: definition of supplementation, project diversity, objectives and performance standards, uncertainties and theory. Since this is a progress report, the content is subject to modification with new information. The supplementation theory will continue to evolve throughout the duration of RASP and beyond. The other topics in this report are essentially complete and are not expected to change significantly. This is the first ofmore » a series of four reports which will summarize information contained in the larger, RASP progress and completion reports. Our goal is to make the findings of RASP more accessible by grouping related topics into smaller but complete narratives on important aspects of supplementation. We are planning to publish the following reports under the general title Supplementation in the Columbia River Basin: Part 1, Background, Description, Performance Measures, Uncertainty and Theory; Part 2, Theoretical Framework and Models; Part 3, Planning Guidelines; and Part 4, Regional Coordination of Research and Monitoring. Supplementation is expected to be a major contributor to the planned increase in salmon and steelhead production in the Columbia Basin. The Fish and Wildlife Program of the Northwest Power Planning Council (NPPC) uses three approaches to protect and enhance salmon and steelhead in the Columbia Basin: (1) enhance fish production; (2) improve passage in the mainstem rivers; and (3) revise harvest management to support the rebuilding of fish runs (NPPC 1987). The fish production segment calls for a three-part approach focused on natural production, hatchery production, and supplementation. Supplementation is planned to provide over half of the total production increases. The Regional Assessment of Supplementation Project (RASP) was initiated as a result of a request by NPPC to address long-standing concerns about the need to coordinate supplementation research, monitoring and evaluation. Such coordination was also recommended by the Supplementation Technical Work Group. In August 1990, the NPPC gave conditional approval to proceed with the final design of the Yakima Production Project. The Council called on the Bonneville Power Administration (BPA) to fund immediately a supplementation assessment to reevaluate, prioritize and coordinate all existing and planned supplementation monitoring and evaluation activities in the basin. Providing for the participation of the fishery agencies and tribes and others having expertise in this area. RASP addresses four principal objectives: (1) provide an overview of ongoing and planned supplementation activities and identify critical uncertainties associated with supplementation, (2) construct a conceptual framework and model which estimates the potential benefits and risks of supplementation and prioritizes uncertainties, (3) provide guidelines for the development of supplementation projects, (4) develop a plan for regional coordination of research and monitoring. These objectives, once attained, will provide the technical tools fishery managers need to carry out the Council's direction to protect and enhance salmon and steelhead. RASP has further divided the four broad objectives into 12 technical topics: (1) definition of supplementation; (2) description of the diversity of supplementation projects; (3) objectives and performance standards; (4) identification of uncertainties; (5) supplementation theory; (6) development of a conceptual model of supplemented populations; (7) development of spreadsheet model of risks and benefits of supplementation; (8) classification of stocks, streams, and supplementation strategies; (9) regional design of supplementation evaluation and monitoring; (10) guidelines for planning supplementation projects (11) application of the spreadsheet model to supplementation planning; and (12) experimental design and decision making with uncertainty.« less

  6. 41 CFR 102-75.660 - What happens if DOI does not approve any applications or does not submit an assignment...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... not approve any applications or does not submit an assignment recommendation? 102-75.660 Section 102-75.660 Public Contracts and Property Management Federal Property Management Regulations System... approve any applications or does not submit an assignment recommendation? If DOI does not approve any...

  7. Funding community medicines by exception: a descriptive epidemiological study from New Zealand.

    PubMed

    Rasiah, Dilky; Edwards, Richard; Crampton, Peter

    2012-02-24

    To assess rates of approval and identify factors associated with successful applications for funding to the New Zealand Community Exceptional Circumstances (CEC) scheme. Descriptive quantitative analysis of data in CEC applications database. The main outcome was initial application approval rate. Analysis included calculation of unadjusted and adjusted associations between potential determinants (for example patient age, gender) and outcomes using logistic regression analysis. All CEC applications with a decision about approval or decline 1 October 2001 to 30 September 2008 were included. Application numbers were high, but had reduced since 2001. A small number of medicines (11) and indications comprised about a third of the applications to the scheme. While some common applications were clearly outside the remit of the scheme, many applications were for patients who fitted the scheme's eligibility criteria. The overall initial application approval rate was 16% and the renewal application approval rate was 88%. Approval rates varied widely by type of medicine, therapeutic group and indication. After adjusting for other potential determinants there were no statistically significant differences in initial approval rates by gender, ethnicity or socioeconomic status of the patient. There were however, significant differences in initial application approval by age of the patient, type of applicant doctor and by geographical location of the applicant doctor. There was no evidence that gender, ethnicity and socioeconomic status of patients were factors associated with successful applications. However, applications for younger patients, those made by specialists, and those made by applying clinicians from the Auckland District Health Board area were more likely to be successful. It is possible that this may to some degree be appropriate, but requires further research.

  8. Sanofi Pharmaceuticals, Inc., et al.; withdrawal of approval of 21 new drug applications and 62 abbreviated new drug applications--FDA. Notice.

    PubMed

    1998-05-12

    The Food and Drug Administration (FDA) is withdrawing approval of 21 new drug applications (NDA's) and 62 abbreviated new drug applications (ANDA's). The holders of the applications notified the agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

  9. Cyclodextrins in Food Technology and Human Nutrition: Benefits and Limitations.

    PubMed

    Fenyvesi, É; Vikmon, M; Szente, L

    2016-09-09

    Cyclodextrins are tasteless, odorless, nondigestible, noncaloric, noncariogenic saccharides, which reduce the digestion of carbohydrates and lipids. They have low glycemic index and decrease the glycemic index of the food. They are either non- or only partly digestible by the enzymes of the human gastrointestinal (GI) tract and fermented by the gut microflora. Based on these properties, cyclodextrins are dietary fibers useful for controlling the body weight and blood lipid profile. They are prebiotics, improve the intestinal microflora by selective proliferation of bifidobacteria. These antiobesity and anti-diabetic effects make them bioactive food supplements and nutraceuticals. In this review, these features are evaluated for α-, β- and γ-cyclodextrins, which are the cyclodextrin variants approved by authorities for food applications. The mechanisms behind these effects are reviewed together with the applications as solubilizers, stabilizers of dietary lipids, such as unsaturated fatty acids, phytosterols, vitamins, flavonoids, carotenoids and other nutraceuticals. The recent applications of cyclodextrins for reducing unwanted components, such as trans-fats, allergens, mycotoxins, acrylamides, bitter compounds, as well as in smart active packaging of foods are also overviewed.

  10. 77 FR 5305 - Hazardous Materials: Special Permit and Approval Applicant Fitness Determinations; Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-02

    .... PHMSA-2011-0283; Notice No. 12-2] Hazardous Materials: Special Permit and Approval Applicant Fitness... conduct a public meeting to discuss Special Permit and Approval applicant fitness determinations. The... used when determining an applicant's minimum level of fitness. DATES: Public Meeting: Wednesday...

  11. 15 CFR 921.31 - Supplemental acquisition and development awards.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... AND COASTAL RESOURCE MANAGEMENT NATIONAL ESTUARINE RESEARCH RESERVE SYSTEM REGULATIONS Reserve... Estuarine Research Reserve designation, and as specified in the approved management plan, a coastal state... interests identified in the management plan as necessary to strengthen protection of key land and water...

  12. 15 CFR 921.31 - Supplemental acquisition and development awards.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... AND COASTAL RESOURCE MANAGEMENT NATIONAL ESTUARINE RESEARCH RESERVE SYSTEM REGULATIONS Reserve... Estuarine Research Reserve designation, and as specified in the approved management plan, a coastal state... interests identified in the management plan as necessary to strengthen protection of key land and water...

  13. 15 CFR 921.31 - Supplemental acquisition and development awards.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... AND COASTAL RESOURCE MANAGEMENT NATIONAL ESTUARINE RESEARCH RESERVE SYSTEM REGULATIONS Reserve... Estuarine Research Reserve designation, and as specified in the approved management plan, a coastal state... interests identified in the management plan as necessary to strengthen protection of key land and water...

  14. 15 CFR 921.31 - Supplemental acquisition and development awards.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... AND COASTAL RESOURCE MANAGEMENT NATIONAL ESTUARINE RESEARCH RESERVE SYSTEM REGULATIONS Reserve... Estuarine Research Reserve designation, and as specified in the approved management plan, a coastal state... interests identified in the management plan as necessary to strengthen protection of key land and water...

  15. 15 CFR 921.31 - Supplemental acquisition and development awards.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... AND COASTAL RESOURCE MANAGEMENT NATIONAL ESTUARINE RESEARCH RESERVE SYSTEM REGULATIONS Reserve... Estuarine Research Reserve designation, and as specified in the approved management plan, a coastal state... interests identified in the management plan as necessary to strengthen protection of key land and water...

  16. 76 FR 28045 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-13

    ...] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for... Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements'' has been...

  17. 34 CFR 200.47 - SEA responsibilities for supplemental educational services.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... high quality, research-based, and specifically designed to increase the academic achievement of... State's approved provider list; (ii) Parent recommendations or results from parent surveys, if any... results from parent surveys regarding the success of the provider's instructional program in increasing...

  18. 23 CFR 655.603 - Standards.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... includes toll roads and roads within shopping centers, airports, sports arenas, and other similar business... access is restricted at all times are not included in this definition. Parking areas, driving aisles... Program shall approve other Federal land management agencies MUTCDs and supplements that are in...

  19. 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...

  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. Rucaparib: a new treatment option for ovarian cancer.

    PubMed

    Sabatucci, Ilaria; Maltese, Giuseppa; Lepori, Stefano; Tripodi, Elisa; Bogani, Giorgio; Lorusso, Domenica

    2018-05-01

    Approximately 50% of high-grade serous ovarian cancers present a deficiency in the pathways involved in homologous recombination (HR). PARP inhibitors prevent single-strand DNA damage repair and determine a progression of the defect towards double-strand breaks, which results in a process known as 'synthetic lethality'. Areas covered: In this review, the authors discuss the efficacy and toxicity of rucaparib either as a single agent or as a maintenance treatment for ovarian cancer. This includes the NGS Foundation Medicine evaluation of the role of this drug in the treatment algorithm of ovarian cancer. Moreover, perspectives on the future development of this drug are presented. Expert opinion: The FDA has approved this drug for the treatment of recurrent BRCA-mutated ovarian cancers, which were previously treated with at least two chemotherapies and has accepted the supplemental new drug application for maintenance use in patients who respond to platinum-based chemotherapy via the Prescription Drug User Fee Act (PDUFA) on 6 April 2018. European Medicines Agency (EMA) approval in the same setting is awaited. The possibility of using PARP inhibitors as a maintenance therapy, as a front-line therapy to combat recurrence, and in combination with anti-angiogenic agents and immune-therapies appears to be of particular interest.

  2. 75 FR 45205 - Proposed Information Collection (Application for Educational Assistance to Supplement Tuition...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-02

    ... techniques or the use of other forms of information technology. Title: Application for Educational Assistance... (Application for Educational Assistance to Supplement Tuition Assistance) Activity: Comment Request AGENCY... information needed to determine claimants' eligibility for educational assistance to supplement tuition...

  3. 78 FR 29437 - Proposed Information Collection (Application for Educational Assistance To Supplement Tuition...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-20

    ... techniques or the use of other forms of information technology. Title: Application for Educational Assistance... (Application for Educational Assistance To Supplement Tuition Assistance) Activity: Comment Request AGENCY... information needed to determine claimants' eligibility for educational assistance to supplement tuition...

  4. Common use of dietary supplements for bipolar disorder: a naturalistic, self-reported study.

    PubMed

    Bauer, Michael; Glenn, Tasha; Conell, Jörn; Rasgon, Natalie; Marsh, Wendy; Sagduyu, Kemal; Munoz, Rodrigo; Lewitzka, Ute; Bauer, Rita; Pilhatsch, Maximilian; Monteith, Scott; Whybrow, Peter C

    2015-12-01

    Dietary supplements are taken by about half of Americans. Knowledge of dietary supplement use is important because they may interact with prescription drugs or other supplements, cause adverse reactions including psychiatric symptoms, or contain inherently toxic ingredients or contaminants. This study explores the use of dietary supplements by patients with bipolar disorder in the US. Data were obtained from an ongoing, naturalistic study of patients with bipolar disorder who received pharmacological treatment as usual. The patients self-reported their daily mood, sleep, and medications taken, including all drugs prescribed for bipolar disorder or that the patient felt impacted their mood. These included other prescribed drugs, over-the-counter drugs and dietary supplements. Drugs that received premarketing approval from the FDA were not included as dietary supplements. Patient demographics and daily medication use were characterized. Data were available from 348 patients in the US who returned a mean 249.5 days of data. In addition to prescribed psychiatric drugs, 101 of the 348 patients (29 %) used a dietary supplement for at least 7 days and 69 (20 %) used a supplement long term (for at least 50 % of days). Of the 101 supplement users, 72 (71.3 %) took one supplement daily. The 101 patients tried over 40 different supplements, and the long-term users took 19 different supplements. The most commonly taken supplements for both groups were fish oil, B vitamins, melatonin, and multivitamins. Patients using supplements were more likely to be white (p < 0.001), older (p = 0.009), and ill for more years (p = 0.025). Many patients with bipolar disorder use dietary supplements in addition to prescribed drugs. Physicians should obtain detailed information about all dietary supplements taken by patients with bipolar disorder.

  5. 18 CFR 1304.4 - Application review and approval process.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 18 Conservation of Power and Water Resources 2 2010-04-01 2010-04-01 false Application review and... ALTERATIONS Procedures for Approval of Construction § 1304.4 Application review and approval process. (a) TVA... the application as appropriate. (b) If a hearing is held for any of the reasons described in paragraph...

  6. 7 CFR 3300.19 - Application for approval.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... and telephone number of the testing station, and name and title of person in charge of the station. (c... of Testing Stations § 3300.19 Application for approval. An application by an officer of the... the Form, Application for Approval as a U.S. ATP Testing Station, may be obtained by a request to the...

  7. 7 CFR 3300.19 - Application for approval.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... and telephone number of the testing station, and name and title of person in charge of the station. (c... of Testing Stations § 3300.19 Application for approval. An application by an officer of the... the Form, Application for Approval as a U.S. ATP Testing Station, may be obtained by a request to the...

  8. Production test IP-376-D, Supplement B Irradiation of MGCR-HDR-3 Test Element

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

    Baars, R.E.

    The objective of this supplement to PT-IP-376-D, Irradiation of MGCR-HDR-3 Test Element is to authorize 1000 hours of operation at a maximum test specimen surface temperature of 1700 F. The original production test authorized a test duration of four months at a maximum specimen surface temperature of 1500 F; supplement A authorized extension of the test duration to ten months. The desired increase in surface temperature is requested to demonstrate the general feasibility of operation of the fuel element at 1700 F, and to obtain specific information on the performance of Hastelloy-X cladding and fuel bodies. The increased temperature hasmore » been approved by the Atomic Energy Commission.« less

  9. 77 FR 14584 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-12

    ... square yards). Modify supplemental wind cones. Runway 8/26 pavement rejuvenation. Purchase snow removal equipment--high-speed snow plow. Master plan/land use. Design passenger terminal remodel. Install runway... lighting and cable rehabilitation. Construct improvements of terminal building. Design reconstruction of...

  10. 7 CFR 1580.302 - Technical assistance and services.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... Initial Business Plan recommended by NIFA and approved by the Administrator (FAS) before receiving an... by the Administrator (FAS), the producer shall be entitled to receive an amount not to exceed $8,000...) The Administrator (FAS) may authorize supplemental assistance necessary to defray reasonable...

  11. 7 CFR 1580.302 - Technical assistance and services.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... Initial Business Plan recommended by NIFA and approved by the Administrator (FAS) before receiving an... by the Administrator (FAS), the producer shall be entitled to receive an amount not to exceed $8,000...) The Administrator (FAS) may authorize supplemental assistance necessary to defray reasonable...

  12. 7 CFR 1580.302 - Technical assistance and services.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... Initial Business Plan recommended by NIFA and approved by the Administrator (FAS) before receiving an... by the Administrator (FAS), the producer shall be entitled to receive an amount not to exceed $8,000...) The Administrator (FAS) may authorize supplemental assistance necessary to defray reasonable...

  13. 77 FR 9617 - Defense Federal Acquisition Regulation Supplement; DoD Voucher Processing (DFARS Case 2011-D054)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-17

    ... risk-based sampling methodologies will be reviewed and approved by the contract auditors for... the disbursing office. All interim vouchers are subject to an audit of actual costs incurred after... process currently referenced [[Page 9618

  14. 7 CFR 247.30 - Claims.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... of the Department of Agriculture (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS COMMODITY SUPPLEMENTAL FOOD PROGRAM § 247.30 Claims. (a) What happens if a... accordance with § 247.29. (Approved by the Office of Management and Budget under control number 0584-0293) ...

  15. 7 CFR 247.30 - Claims.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... of the Department of Agriculture (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS COMMODITY SUPPLEMENTAL FOOD PROGRAM § 247.30 Claims. (a) What happens if a... accordance with § 247.29. (Approved by the Office of Management and Budget under control number 0584-0293) ...

  16. 7 CFR 247.30 - Claims.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... of the Department of Agriculture (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS COMMODITY SUPPLEMENTAL FOOD PROGRAM § 247.30 Claims. (a) What happens if a... accordance with § 247.29. (Approved by the Office of Management and Budget under control number 0584-0293) ...

  17. 7 CFR 247.26 - Return of administrative funds.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... Agriculture Regulations of the Department of Agriculture (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS COMMODITY SUPPLEMENTAL FOOD PROGRAM § 247.26 Return of administrative... legislatively mandated grant per assigned caseload slot. (Approved by the Office of Management and Budget under...

  18. 7 CFR 247.19 - Dual participation.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... Regulations of the Department of Agriculture (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS COMMODITY SUPPLEMENTAL FOOD PROGRAM § 247.19 Dual participation. (a) What must... with § 247.30(c). (Approved by the Office of Management and Budget under control number 0584-0293) ...

  19. 7 CFR 247.19 - Dual participation.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... Regulations of the Department of Agriculture (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS COMMODITY SUPPLEMENTAL FOOD PROGRAM § 247.19 Dual participation. (a) What must... with § 247.30(c). (Approved by the Office of Management and Budget under control number 0584-0293) ...

  20. 7 CFR 247.30 - Claims.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... of the Department of Agriculture (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS COMMODITY SUPPLEMENTAL FOOD PROGRAM § 247.30 Claims. (a) What happens if a... accordance with § 247.29. (Approved by the Office of Management and Budget under control number 0584-0293) ...

  1. 7 CFR 247.26 - Return of administrative funds.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... Agriculture Regulations of the Department of Agriculture (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS COMMODITY SUPPLEMENTAL FOOD PROGRAM § 247.26 Return of administrative... legislatively mandated grant per assigned caseload slot. (Approved by the Office of Management and Budget under...

  2. 7 CFR 247.26 - Return of administrative funds.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... Agriculture Regulations of the Department of Agriculture (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS COMMODITY SUPPLEMENTAL FOOD PROGRAM § 247.26 Return of administrative... legislatively mandated grant per assigned caseload slot. (Approved by the Office of Management and Budget under...

  3. 7 CFR 247.26 - Return of administrative funds.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Agriculture Regulations of the Department of Agriculture (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS COMMODITY SUPPLEMENTAL FOOD PROGRAM § 247.26 Return of administrative... legislatively mandated grant per assigned caseload slot. (Approved by the Office of Management and Budget under...

  4. 7 CFR 247.19 - Dual participation.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... Regulations of the Department of Agriculture (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS COMMODITY SUPPLEMENTAL FOOD PROGRAM § 247.19 Dual participation. (a) What must... with § 247.30(c). (Approved by the Office of Management and Budget under control number 0584-0293) ...

  5. 7 CFR 247.29 - Reports and recordkeeping.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... Agriculture Regulations of the Department of Agriculture (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS COMMODITY SUPPLEMENTAL FOOD PROGRAM § 247.29 Reports and recordkeeping... FNS. (Approved by the Office of Management and Budget under control numbers 0584-0025, 0584-0293) [70...

  6. 7 CFR 247.29 - Reports and recordkeeping.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... Agriculture Regulations of the Department of Agriculture (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS COMMODITY SUPPLEMENTAL FOOD PROGRAM § 247.29 Reports and recordkeeping... FNS. (Approved by the Office of Management and Budget under control numbers 0584-0025, 0584-0293) [70...

  7. 7 CFR 247.26 - Return of administrative funds.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... Agriculture Regulations of the Department of Agriculture (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS COMMODITY SUPPLEMENTAL FOOD PROGRAM § 247.26 Return of administrative... legislatively mandated grant per assigned caseload slot. (Approved by the Office of Management and Budget under...

  8. 7 CFR 247.29 - Reports and recordkeeping.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... Agriculture Regulations of the Department of Agriculture (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS COMMODITY SUPPLEMENTAL FOOD PROGRAM § 247.29 Reports and recordkeeping... FNS. (Approved by the Office of Management and Budget under control numbers 0584-0025, 0584-0293) [70...

  9. 7 CFR 247.30 - Claims.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... of the Department of Agriculture (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS COMMODITY SUPPLEMENTAL FOOD PROGRAM § 247.30 Claims. (a) What happens if a... accordance with § 247.29. (Approved by the Office of Management and Budget under control number 0584-0293) ...

  10. 7 CFR 247.19 - Dual participation.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... Regulations of the Department of Agriculture (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS COMMODITY SUPPLEMENTAL FOOD PROGRAM § 247.19 Dual participation. (a) What must... with § 247.30(c). (Approved by the Office of Management and Budget under control number 0584-0293) ...

  11. 76 FR 14899 - Notice of Intent To Seek Approval To Collect Information

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-18

    ... collection relating to existing nutrition education and training materials targeting low-income persons. This voluntary form gives Supplemental Nutrition Assistance Program Education (SNAP-Ed) providers the opportunity... Information Center (FNIC) identify existing nutrition education and training resources for review and...

  12. 7 CFR 4280.24 - Revolved funds.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 15 2010-01-01 2010-01-01 false Revolved funds. 4280.24 Section 4280.24 Agriculture... Programs § 4280.24 Revolved funds. Rural Development and the Intermediary's supplemental funds will be... from revolved funds will not require prior approval of Rural Development for creditworthiness or...

  13. 7 CFR 4280.24 - Revolved funds.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 15 2011-01-01 2011-01-01 false Revolved funds. 4280.24 Section 4280.24 Agriculture... Programs § 4280.24 Revolved funds. Rural Development and the Intermediary's supplemental funds will be... from revolved funds will not require prior approval of Rural Development for creditworthiness or...

  14. 75 FR 52066 - Proposed Information Collection (Application for Supplemental Service Disabled Veterans Insurance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-24

    ... (Application for Supplemental Service Disabled Veterans Insurance) Activity: Comment Request AGENCY: Veterans... Disabled Veterans Insurance (SRH), VA Form 29-0188 and 29-0189, and Application for Supplemental Service Disabled Veterans (RH) Life Insurance, VA Form 29- 0190. OMB Control Number: 2900-0539. Type of Review...

  15. 78 FR 36830 - Proposed Information Collection (Application for Supplemental Service Disabled Veterans Insurance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-19

    ... (Application for Supplemental Service Disabled Veterans Insurance) Activity: Comment Request AGENCY: Veterans... Disabled Veterans Insurance (SRH), VA Form 29-0188 and 29-0189, and Application for Supplemental Service Disabled Veterans (RH) Life Insurance, VA Form 29- 0190. OMB Control Number: 2900-0539. Type of Review...

  16. 29 CFR 3.7 - Applications for the approval of the Secretary of Labor.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 29 Labor 1 2012-07-01 2012-07-01 false Applications for the approval of the Secretary of Labor. 3.7 Section 3.7 Labor Office of the Secretary of Labor CONTRACTORS AND SUBCONTRACTORS ON PUBLIC... Applications for the approval of the Secretary of Labor. Any application for the making of payroll deductions...

  17. 27 CFR 70.416 - Application for approval of interlocking directors and officers under section 8 of the Federal...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... the appropriate TTB officer. Applications for such permission to take office must be prepared and... 27 Alcohol, Tobacco Products and Firearms 2 2010-04-01 2010-04-01 false Application for approval... Beer § 70.416 Application for approval of interlocking directors and officers under section 8 of the...

  18. 21 CFR 314.127 - Refusal to approve an abbreviated new drug application.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA... application. (a) FDA will refuse to approve an abbreviated application for a new drug under section 505(j) of... FDA with respect to the active ingredient, route of administration, dosage form, or strength that is...

  19. 21 CFR 314.127 - Refusal to approve an abbreviated new drug application.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA... application. (a) FDA will refuse to approve an abbreviated application for a new drug under section 505(j) of... FDA with respect to the active ingredient, route of administration, dosage form, or strength that is...

  20. 21 CFR 314.127 - Refusal to approve an abbreviated new drug application.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA... application. (a) FDA will refuse to approve an abbreviated application for a new drug under section 505(j) of... FDA with respect to the active ingredient, route of administration, dosage form, or strength that is...

  1. 21 CFR 314.127 - Refusal to approve an abbreviated new drug application.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA... application. (a) FDA will refuse to approve an abbreviated application for a new drug under section 505(j) of... FDA with respect to the active ingredient, route of administration, dosage form, or strength that is...

  2. 21 CFR 314.127 - Refusal to approve an abbreviated new drug application.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA... application. (a) FDA will refuse to approve an abbreviated application for a new drug under section 505(j) of... FDA with respect to the active ingredient, route of administration, dosage form, or strength that is...

  3. Athletes and Supplements: Prevalence and Perspectives.

    PubMed

    Garthe, Ina; Maughan, Ronald J

    2018-03-01

    In elite sport, where opponents are evenly matched, small factors can determine the outcome of sporting contests. Not all athletes know the value of making wise nutrition choices, but anything that might give a competitive edge, including dietary supplements, can seem attractive. Between 40% and 100% of athletes typically use supplements, depending on the type of sport, level of competition, and the definition of supplements. However, unless the athlete has a nutrient deficiency, supplementation may not improve performance and may have a detrimental effect on both performance and health. Dietary supplements are classified as a subcategory of food, so manufacturers are not required to provide evidence of product safety and efficacy, nor obtain approval from regulatory bodies before marketing supplements. This creates the potential for health risks, and serious adverse effects have been reported from the use of some dietary supplements. Athletes who compete in sports under an anti-doping code must also realize that supplement use exposes them to a risk of ingesting banned substances or precursors of prohibited substances. Government systems of regulations do not include specific laboratory testing for banned substances according to the WADA list, so a separate regulatory framework to evaluate supplements for their risk of provoking a failed doping test is needed. In the high-performance culture typical of elite sport, athletes may use supplements regardless of possible risks. A discussion around medical, physiological, cultural, and ethical questions may be warranted to ensure that the athlete has the information needed to make an informed choice.

  4. 45 CFR 1326.21 - Application approval.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ..., DEPARTMENT OF HEALTH AND HUMAN SERVICES THE ADMINISTRATION ON AGING, OLDER AMERICANS PROGRAMS GRANTS TO INDIAN TRIBES FOR SUPPORT AND NUTRITION SERVICES § 1326.21 Application approval. (a) Approval of any...

  5. 45 CFR 1326.21 - Application approval.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ..., DEPARTMENT OF HEALTH AND HUMAN SERVICES THE ADMINISTRATION ON AGING, OLDER AMERICANS PROGRAMS GRANTS TO INDIAN TRIBES FOR SUPPORT AND NUTRITION SERVICES § 1326.21 Application approval. (a) Approval of any...

  6. 45 CFR 1326.21 - Application approval.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ..., DEPARTMENT OF HEALTH AND HUMAN SERVICES THE ADMINISTRATION ON AGING, OLDER AMERICANS PROGRAMS GRANTS TO INDIAN TRIBES FOR SUPPORT AND NUTRITION SERVICES § 1326.21 Application approval. (a) Approval of any...

  7. 45 CFR 1326.21 - Application approval.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ..., DEPARTMENT OF HEALTH AND HUMAN SERVICES THE ADMINISTRATION ON AGING, OLDER AMERICANS PROGRAMS GRANTS TO INDIAN TRIBES FOR SUPPORT AND NUTRITION SERVICES § 1326.21 Application approval. (a) Approval of any...

  8. 45 CFR 1326.21 - Application approval.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ..., DEPARTMENT OF HEALTH AND HUMAN SERVICES THE ADMINISTRATION ON AGING, OLDER AMERICANS PROGRAMS GRANTS TO INDIAN TRIBES FOR SUPPORT AND NUTRITION SERVICES § 1326.21 Application approval. (a) Approval of any...

  9. 24 CFR 581.10 - Action on approved applications.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 24 Housing and Urban Development 3 2010-04-01 2010-04-01 false Action on approved applications... HOUSING AND URBAN DEVELOPMENT COMMUNITY FACILITIES USE OF FEDERAL REAL PROPERTY TO ASSIST THE HOMELESS § 581.10 Action on approved applications. (a) Unutilized and underutilized properties. (1) When HHS...

  10. 19 CFR 115.28 - Application for approval.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers by Design Type § 115.28 Application for approval. Each application by a... inspection; and (e) A statement signed by the manufacturer that: (1) A container of the design type concerned...

  11. 19 CFR 115.28 - Application for approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers by Design Type § 115.28 Application for approval. Each application by a... inspection; and (e) A statement signed by the manufacturer that: (1) A container of the design type concerned...

  12. 19 CFR 115.28 - Application for approval.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers by Design Type § 115.28 Application for approval. Each application by a... inspection; and (e) A statement signed by the manufacturer that: (1) A container of the design type concerned...

  13. 19 CFR 115.28 - Application for approval.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers by Design Type § 115.28 Application for approval. Each application by a... inspection; and (e) A statement signed by the manufacturer that: (1) A container of the design type concerned...

  14. 19 CFR 115.28 - Application for approval.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers by Design Type § 115.28 Application for approval. Each application by a... inspection; and (e) A statement signed by the manufacturer that: (1) A container of the design type concerned...

  15. 5 CFR 6801.109 - Prior approval for compensated outside employment.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... SYSTEM SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE BOARD OF GOVERNORS OF THE FEDERAL... designee) and the concurrence of the Board's Designated Agency Ethics Official before engaging in... employment or business relationship involving the provision of personal services by the employee. It includes...

  16. Identification and quantification of Vinpocetine from dietary supplements

    USDA-ARS?s Scientific Manuscript database

    Vinpocetine and picamilon are drugs prescribed in many countries to treat a variety of cerebrovascular disorders. In the United States (US), vinpocetine and picamilon have never been approved by the US Food and Drug Administration, but they are both available for sale directly to consumers as dieta...

  17. 5 CFR 7701.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... teaching a course which is part of the established curriculum of an accredited institution of higher.... 7701.102 Section 7701.102 Administrative Personnel INSTITUTE OF MUSEUM AND LIBRARY SERVICES SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE INSTITUTE OF MUSEUM AND LIBRARY SERVICES § 7701...

  18. 5 CFR 7701.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... teaching a course which is part of the established curriculum of an accredited institution of higher.... 7701.102 Section 7701.102 Administrative Personnel INSTITUTE OF MUSEUM AND LIBRARY SERVICES SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE INSTITUTE OF MUSEUM AND LIBRARY SERVICES § 7701...

  19. Milk Thistle (PDQ®)—Patient Version

    Cancer.gov

    Milk thistle is available in the United States as a dietary supplement and small studies have been done in several cancers. The U.S. Food and Drug Administration has not approved milk thistle as a treatment for cancer or other medical conditions. Learn more in this expert-reviewed summary.

  20. 14 CFR 121.423 - Pilot: Extended Envelope Training.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 3 2014-01-01 2014-01-01 false Pilot: Extended Envelope Training. 121.423... REQUIREMENTS: DOMESTIC, FLAG, AND SUPPLEMENTAL OPERATIONS Training Program § 121.423 Pilot: Extended Envelope Training. (a) Each certificate holder must include in its approved training program, the extended envelope...

  1. 78 FR 43880 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Notice...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-22

    ... personal information provided, unless the comment includes profanity, threats, information claimed to be... ENVIRONMENTAL PROTECTION AGENCY [EPA-OPP-2012-0544; FRL-9534-8] Information Collection Request... Environmental Protection Agency has submitted an information collection request (ICR), ``Notice of Supplemental...

  2. 76 FR 64065 - Approval and Promulgation of Implementation Plans; Oklahoma; Interstate Transport of Pollution

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-17

    ... Promulgation of Implementation Plans; Oklahoma; Interstate Transport of Pollution AGENCY: Environmental... Rule (CSAPR or Transport Rule) and proposed determination within the Supplemental Notice of Proposed... four distinct requirements related to the impacts of interstate transport. The SIP must prevent sources...

  3. 14 CFR 21.119 - Privileges.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... for installation on certificated aircraft; and (c) Obtain a production certificate for the change in the type design that was approved by that supplemental type certificate. Effective Date Note: By Amdt... production certificate in accordance with the requirements of subpart G of this part for the change in the...

  4. 75 FR 26739 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; Part 244...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-12

    .... Needs and Uses: Administrative contracting officers use this information in making decisions to grant, withhold, or withdraw purchasing system approval at the conclusion of a purchasing system review... for correcting deficiencies or making improvements to its purchasing system. Ynette R. Shelkin, Editor...

  5. 40 CFR 52.2850 - Approval and promulgation of implementation plans.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Kansas City Intrastate Air Quality Control Region was received by the Department of Health, Education... the Philadelphia Interstate Air Quality Control Region was received by the Department of Health, Education, and Welfare on June 30, 1970. Supplemental information was received October 20, 1970. The...

  6. 77 FR 20869 - Self-Regulatory Organizations; NYSE Amex LLC; Order Approving a Proposed Rule Change Amending the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-06

    ... Equities Definition of Approved Person To Exclude Foreign Affiliates, Eliminating the Application Process... Equities definition of approved person to exclude foreign affiliates, eliminate the application process for... amend the NYSE Amex Equities definition of ``approved person'' to exclude foreign affiliates, eliminate...

  7. 75 FR 77634 - Approval of Test Marketing Exemptions for Certain New Chemicals

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-13

    ... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPPT-2010-0990; FRL-8857-3] Approval of Test Marketing...: This notice announces EPA's approval of applications for test marketing exemptions (TMEs) under section... test marketing conditions are described in the TME applications and in this notice. DATES: Approval of...

  8. 49 CFR 1522.109 - TSA review and approval.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ..., DEPARTMENT OF HOMELAND SECURITY SECURITY RULES FOR ALL MODES OF TRANSPORTATION TSA-APPROVED VALIDATION FIRMS AND VALIDATORS TSA-Approved Validation Firms and Validators for the Certified Cargo Screening Program... that the applicant is qualified to be a validation firm. (b) Notice.—(1) Approval. If an application is...

  9. 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.

  10. 10 CFR 25.17 - Approval for processing applicants for access authorization.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Approval for processing applicants for access... Authorizations § 25.17 Approval for processing applicants for access authorization. (a) Access authorizations... request by a letter that includes the name, Social Security number and level of access authorization. (c...

  11. 19 CFR 115.63 - Application for approval.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... of the design type and the serial number of the vehicle in the type series manufacturer's number; and... Procedures for Approval of Road Vehicles by Design Type § 115.63 Application for approval. Each application by a manufacturer for certification of a road vehicle by design type must include: (a) Three copies...

  12. 19 CFR 115.63 - Application for approval.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... of the design type and the serial number of the vehicle in the type series manufacturer's number; and... Procedures for Approval of Road Vehicles by Design Type § 115.63 Application for approval. Each application by a manufacturer for certification of a road vehicle by design type must include: (a) Three copies...

  13. 19 CFR 115.63 - Application for approval.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... of the design type and the serial number of the vehicle in the type series manufacturer's number; and... Procedures for Approval of Road Vehicles by Design Type § 115.63 Application for approval. Each application by a manufacturer for certification of a road vehicle by design type must include: (a) Three copies...

  14. 19 CFR 115.63 - Application for approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... of the design type and the serial number of the vehicle in the type series manufacturer's number; and... Procedures for Approval of Road Vehicles by Design Type § 115.63 Application for approval. Each application by a manufacturer for certification of a road vehicle by design type must include: (a) Three copies...

  15. 19 CFR 115.63 - Application for approval.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... of the design type and the serial number of the vehicle in the type series manufacturer's number; and... Procedures for Approval of Road Vehicles by Design Type § 115.63 Application for approval. Each application by a manufacturer for certification of a road vehicle by design type must include: (a) Three copies...

  16. 77 FR 10621 - Changes to the In-Bond Process

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-22

    ... submit in-bond applications electronically using a CBP-approved electronic data interchange (EDI) system... electronically submit the in-bond application to CBP via a CBP-approved EDI system. \\6\\ Due to the unique... as the CBP-approved EDI system for submitting the in-bond application and other information that is...

  17. 7 CFR 3300.19 - Application for approval.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... BE USED FOR SUCH CARRIAGE (ATP); INSPECTION, TESTING, AND CERTIFICATION OF SPECIAL EQUIPMENT Approval... the Form, Application for Approval as a U.S. ATP Testing Station, may be obtained by a request to the ATP manager. The following information must be supplied in the application: (a) A statement that the...

  18. 7 CFR 3300.19 - Application for approval.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... BE USED FOR SUCH CARRIAGE (ATP); INSPECTION, TESTING, AND CERTIFICATION OF SPECIAL EQUIPMENT Approval... the Form, Application for Approval as a U.S. ATP Testing Station, may be obtained by a request to the ATP manager. The following information must be supplied in the application: (a) A statement that the...

  19. 7 CFR 3300.19 - Application for approval.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... BE USED FOR SUCH CARRIAGE (ATP); INSPECTION, TESTING, AND CERTIFICATION OF SPECIAL EQUIPMENT Approval... the Form, Application for Approval as a U.S. ATP Testing Station, may be obtained by a request to the ATP manager. The following information must be supplied in the application: (a) A statement that the...

  20. 75 FR 62633 - Agency Information Collection (Application for Approval of a Licensing or Certification and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-12

    ....'' SUPPLEMENTARY INFORMATION: Title: Application for Approval of a Licensing or Certification and Organization or... DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-0697] Agency Information Collection (Application for Approval of a Licensing or Certification and Organization or Entity) Activity Under OMB Review...

  1. 6 CFR 37.3 - Definitions.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... resident status in the United States; who has an approved application for asylum in the United States or... United States; who has a pending application for asylum in the United States; who has a pending or approved application for temporary protected status (TPS) in the United States; who has approved deferred...

  2. 6 CFR 37.3 - Definitions.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... resident status in the United States; who has an approved application for asylum in the United States or... United States; who has a pending application for asylum in the United States; who has a pending or approved application for temporary protected status (TPS) in the United States; who has approved deferred...

  3. 77 FR 12637 - Self-Regulatory Organizations; NYSE Amex LLC; Notice of Filing of Proposed Rule Change Amending...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-01

    ... Equities Definition of Approved Person To Exclude Foreign Affiliates, Eliminating the Application Process..., eliminate the application process for approved persons, and make related technical and conforming changes..., eliminate the application process for approved persons, and make related technical and conforming changes...

  4. 49 CFR 107.705 - Registrations, reports, and applications for approval.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Hazardous Materials Safety (Attention: Approvals, PHH-32), Pipeline and Hazardous Materials Safety... registration, report, or application is made and, if different, the person making the filing; (5) If the person... approval until a final decision on the application for renewal has been made. Operation under an expired...

  5. 75 FR 9276 - Harvard Illinois Bancorp, Inc., Harvard, Illinois; Approval of Conversion Application

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-01

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-35: OTS No. H-4649] Harvard Illinois Bancorp, Inc., Harvard, Illinois; Approval of Conversion Application Notice is hereby given that on February 12, 2010, the Office of Thrift Supervision approved the application of Harvard Savings Bank...

  6. 75 FR 31511 - Ideal Federal Savings Bank, Baltimore, MD; Approval of Conversion Application

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-03

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-46: OTS No. 08283] Ideal Federal Savings Bank, Baltimore, MD; Approval of Conversion Application Notice is hereby given that on May 24, 2010, the Office of Thrift Supervision approved the application of Ideal Federal Savings Bank...

  7. 75 FR 51167 - Northfield Bancorp, Inc., Staten Island, NY; Approval of Conversion Application

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-18

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-47: OTS No. H-4732] Northfield Bancorp, Inc., Staten Island, NY; Approval of Conversion Application Notice is hereby given that on August 9, 2010, the Office of Thrift Supervision approved the application of Northfield Bancorp, MHC and...

  8. 75 FR 70081 - Home Federal Bancorp, Inc., Shreveport, LA; Approval of Conversion Application

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-16

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-52: OTS No. H-4749] Home Federal Bancorp, Inc., Shreveport, LA; Approval of Conversion Application Notice is hereby given that on November 5, 2010, the Office of Thrift Supervision approved the application of Home Federal Mutual Holding...

  9. 76 FR 9407 - Fraternity Federal Savings & Loan Association, Baltimore, MD; Approval of Conversion Application

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-17

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-58 OTS No. 01292 and H 4762] Fraternity Federal Savings & Loan Association, Baltimore, MD; Approval of Conversion Application Notice is hereby given that on February 10, 2011, the Office of Thrift Supervision approved the application of...

  10. 75 FR 71187 - Wolverine Bank, MI; Approval of Conversion Application

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-22

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-55: OTS Nos. 02620 and H4753] Wolverine Bank, MI; Approval of Conversion Application Notice is hereby given that on November 12, 2010, the Office of Thrift Supervision approved the application of Wolverine Bank, Midland, Michigan, to convert to...

  11. 76 FR 27753 - American Eagle Savings Bank, Boothwyn, PA; Approval of Conversion Application

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-12

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-61: OTS Nos. 07212] American Eagle Savings Bank, Boothwyn, PA; Approval of Conversion Application Notice is hereby given that on May 3, 2011, the Office of Thrift Supervision approved the application of American Eagle Savings Bank, Boothwyn...

  12. 76 FR 10088 - Sunshine Financial, Inc., Tallahassee Florida; Approval of Conversion Application

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-23

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-60: OTS Nos. H-4757, H-4519, and 17971] Sunshine Financial, Inc., Tallahassee Florida; Approval of Conversion Application Notice is hereby given that on February 11, 2011, the Office of Thrift Supervision approved the application of Sunshine...

  13. 75 FR 71187 - Atlantic Coast Financial Corporation, Waycross, GA; Approval of Conversion Application

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-22

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-56 OTS No. H-4438] Atlantic Coast Financial Corporation, Waycross, GA; Approval of Conversion Application Notice is hereby given that on November 12, 2010, the Office of Thrift Supervision approved the application of Atlantic Coast Federal, MHC...

  14. 75 FR 70363 - Minden Bancorp, Inc., Minden, LA; Approval of Conversion Application

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-17

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-53: OTS No. H-4756] Minden Bancorp, Inc., Minden, LA; Approval of Conversion Application Notice is hereby given that on November 9, 2010, the Office of Thrift Supervision approved the application of Minden Mutual Holding Company and MBL...

  15. 75 FR 24774 - Fairmount Bank, Baltimore, MD; Approval of Conversion Application

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-05

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-36 OTS Nos. 08193 and H4677] Fairmount Bank, Baltimore, MD; Approval of Conversion Application Notice is hereby given that on April 15, 2010, the Office of Thrift Supervision approved the application of Fairmount Bank, Baltimore, Maryland, to...

  16. 77 FR 52135 - Hamilton Bank, Baltimore, Maryland; Approval of Conversion Application

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-28

    ... DEPARTMENT OF THE TREASURY Office of the Comptroller of the Currency [OCC Charter Number 701904] Hamilton Bank, Baltimore, Maryland; Approval of Conversion Application Notice is hereby given that on August 13, 2012, the Office of the Comptroller of the Currency (OCC) approved the application of Hamilton...

  17. 75 FR 30481 - Jacksonville Bancorp, Inc., Jacksonville, IL; Approval of Conversion Application

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-01

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-42: OTS No. H-4706] Jacksonville Bancorp, Inc., Jacksonville, IL; Approval of Conversion Application Notice is hereby given that on May 14, 2010, the Office of Thrift Supervision approved the application of Jacksonville Bancorp, MHC, and...

  18. 30 CFR 285.913 - What happens if I fail to comply with my approved decommissioning application?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... approved decommissioning application? 285.913 Section 285.913 Mineral Resources MINERALS MANAGEMENT SERVICE, DEPARTMENT OF THE INTERIOR OFFSHORE RENEWABLE ENERGY ALTERNATE USES OF EXISTING FACILITIES ON THE OUTER CONTINENTAL SHELF Decommissioning Compliance with An Approved Decommissioning Application § 285.913 What...

  19. 77 FR 5306 - Proposed Collection; Comment Request for Form 4461, 4461-A, and 4461-B

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-02

    ... comments concerning Form 4461, Application for Approval of Master or Prototype Defined Contribution Plan..., Application for Approval of Master or Prototype Plan, Mass Submitter Adopting Sponsor. DATES: Written comments... or Prototype Defined Contribution Plan; Form 4461-A, Application for Approval of Master [[Page 5307...

  20. 30 CFR 285.913 - What happens if I fail to comply with my approved decommissioning application?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 2 2011-07-01 2011-07-01 false What happens if I fail to comply with my... Decommissioning Application § 285.913 What happens if I fail to comply with my approved decommissioning application? If you fail to comply with your approved decommissioning plan or application: (a) The MMS may...

  1. 30 CFR 585.913 - What happens if I fail to comply with my approved decommissioning application?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 30 Mineral Resources 2 2012-07-01 2012-07-01 false What happens if I fail to comply with my... Application § 585.913 What happens if I fail to comply with my approved decommissioning application? If you fail to comply with your approved decommissioning plan or application: (a) BOEM may call for the...

  2. 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...

  3. 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...

  4. 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...

  5. 78 FR 52219 - State of Georgia Relinquishment of Sealed Source and Device Evaluation and Approval Authority

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-22

    ... NUCLEAR REGULATORY COMMISSION [NRC-2013-0196] State of Georgia Relinquishment of Sealed Source and... evaluate and approve sealed source and device (SS&D) applications in the State of Georgia and approved the... regulatory authority for evaluating and approving sealed source and device applications on August 20, 2013...

  6. 77 FR 64039 - Limited Approval and Disapproval of Air Quality Implementation Plans; Nevada; Clark County...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-18

    ... Approval and Disapproval of Air Quality Implementation Plans; Nevada; Clark County; Stationary Source... limited approval and limited disapproval of revisions to the Clark County portion of the applicable state... limited approval and limited disapproval action is to update the applicable SIP with current Clark County...

  7. 75 FR 38589 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Granting Approval of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-02

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34--62161; File No. SR--ODD--2010--01] Self... of Supplement to the Options Disclosure Document Reflecting Certain Changes to Disclosure Regarding Options on Conventional Index-Linked Securities and Amendment to the Options Disclosure Document Inside...

  8. 76 FR 3684 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Granting Approval of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-20

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63711; File No. SR-ODD-2011-01] Self-Regulatory... to the Options Disclosure Document Reflecting Certain Changes to Disclosure Regarding Credit Default Options in, and Making Certain Technical Amendments to, the June 2007 Supplement to the Options Disclosure...

  9. 78 FR 38247 - Approval and Promulgation of Air Quality Implementation Plans; Ohio; Redesignation of the Ohio...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-26

    ... proposing that the inventories for ammonia and volatile organic compounds (VOC), in conjunction with the... and Evaluation of Precursors B. Ammonia and VOC Comprehensive Emissions Inventories IV. Summary of..., and Ohio's supplemental submission of comprehensive ammonia and VOC emissions inventories. On January...

  10. 75 FR 60690 - Defense Federal Acquisition Regulation Supplement (DFARS); Electronic Ordering Procedures (DFARS...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-01

    ... event of conflict between a delivery order or task order and this contract, the contract shall control.... This change will ultimately help improve the management and promotion of electronic Government services... impose any information collection requirements that require the approval of the Office of Management and...

  11. 14 CFR 121.125 - Flight following system.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 3 2012-01-01 2012-01-01 false Flight following system. 121.125 Section... Operations § 121.125 Flight following system. (a) Each certificate holder conducting supplemental operations must show that it has— (1) An approved flight following system established in accordance with subpart U...

  12. 14 CFR 121.141 - Airplane flight manual.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 3 2011-01-01 2011-01-01 false Airplane flight manual. 121.141 Section 121... REQUIREMENTS: DOMESTIC, FLAG, AND SUPPLEMENTAL OPERATIONS Manual Requirements § 121.141 Airplane flight manual. (a) Each certificate holder shall keep a current approved airplane flight manual for each type of...

  13. 14 CFR 121.125 - Flight following system.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 3 2013-01-01 2013-01-01 false Flight following system. 121.125 Section... Operations § 121.125 Flight following system. (a) Each certificate holder conducting supplemental operations must show that it has— (1) An approved flight following system established in accordance with subpart U...

  14. 14 CFR 121.125 - Flight following system.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Flight following system. 121.125 Section... Operations § 121.125 Flight following system. (a) Each certificate holder conducting supplemental operations must show that it has— (1) An approved flight following system established in accordance with subpart U...

  15. 14 CFR 121.141 - Airplane flight manual.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 3 2012-01-01 2012-01-01 false Airplane flight manual. 121.141 Section 121... REQUIREMENTS: DOMESTIC, FLAG, AND SUPPLEMENTAL OPERATIONS Manual Requirements § 121.141 Airplane flight manual. (a) Each certificate holder shall keep a current approved airplane flight manual for each type of...

  16. 14 CFR 121.141 - Airplane flight manual.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 3 2013-01-01 2013-01-01 false Airplane flight manual. 121.141 Section 121... REQUIREMENTS: DOMESTIC, FLAG, AND SUPPLEMENTAL OPERATIONS Manual Requirements § 121.141 Airplane flight manual. (a) Each certificate holder shall keep a current approved airplane flight manual for each type of...

  17. 14 CFR 121.125 - Flight following system.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 3 2014-01-01 2014-01-01 false Flight following system. 121.125 Section... Operations § 121.125 Flight following system. (a) Each certificate holder conducting supplemental operations must show that it has— (1) An approved flight following system established in accordance with subpart U...

  18. 14 CFR 121.125 - Flight following system.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 3 2011-01-01 2011-01-01 false Flight following system. 121.125 Section... Operations § 121.125 Flight following system. (a) Each certificate holder conducting supplemental operations must show that it has— (1) An approved flight following system established in accordance with subpart U...

  19. 14 CFR 121.141 - Airplane flight manual.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 3 2014-01-01 2014-01-01 false Airplane flight manual. 121.141 Section 121... REQUIREMENTS: DOMESTIC, FLAG, AND SUPPLEMENTAL OPERATIONS Manual Requirements § 121.141 Airplane flight manual. (a) Each certificate holder shall keep a current approved airplane flight manual for each type of...

  20. 78 FR 57916 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-20

    ... Relating to Amendments to the Discovery Guide Used in Customer Arbitration Proceedings, as Modified by... update the Discovery Guide (``Guide'') used in customer arbitration proceedings.\\1\\ According to FINRA, the Guide supplements the discovery rules contained in the FINRA Code of Arbitration Procedure for...

  1. 14 CFR 36.1501 - Procedures, noise levels and other information.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... airplane (rotorcraft) flight manual. (b) Where supplemental test data are approved for modification or extension of an existing flight data base, such as acoustic data from engine static tests used in the..., weights, configurations, and other information or data employed for obtaining the certified noise levels...

  2. 14 CFR 36.1501 - Procedures, noise levels and other information.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... airplane (rotorcraft) flight manual. (b) Where supplemental test data are approved for modification or extension of an existing flight data base, such as acoustic data from engine static tests used in the..., weights, configurations, and other information or data employed for obtaining the certified noise levels...

  3. 14 CFR 36.1501 - Procedures, noise levels and other information.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... airplane (rotorcraft) flight manual. (b) Where supplemental test data are approved for modification or extension of an existing flight data base, such as acoustic data from engine static tests used in the..., weights, configurations, and other information or data employed for obtaining the certified noise levels...

  4. 14 CFR 36.1501 - Procedures, noise levels and other information.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... airplane (rotorcraft) flight manual. (b) Where supplemental test data are approved for modification or extension of an existing flight data base, such as acoustic data from engine static tests used in the..., weights, configurations, and other information or data employed for obtaining the certified noise levels...

  5. 14 CFR 36.1501 - Procedures, noise levels and other information.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... airplane (rotorcraft) flight manual. (b) Where supplemental test data are approved for modification or extension of an existing flight data base, such as acoustic data from engine static tests used in the..., weights, configurations, and other information or data employed for obtaining the certified noise levels...

  6. 76 FR 4858 - Submission for OMB Review; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-27

    ... such as equine infectious anemia, as well as to take action to prevent and to manage exotic diseases... Infectious Anemia Laboratory Test; VS 10- 12, Equine Infectious Anemia Supplemental Investigation; and VS 1... infectious anemia. Regulations also require the use an Agreement for Approved Livestock Facilities, Request...

  7. 31 CFR 16.3 - Basis for civil penalties and assessments.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Development or the Secretary of Agriculture; (vii) Benefits under the special supplemental food program for women, infants, and children established under section 17 of the Child Nutrition Act of 1966; (viii... the Social Security Act; (xii) Aid to families with dependent children under a State plan approved...

  8. 31 CFR 16.3 - Basis for civil penalties and assessments.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Development or the Secretary of Agriculture; (vii) Benefits under the special supplemental food program for women, infants, and children established under section 17 of the Child Nutrition Act of 1966; (viii... the Social Security Act; (xii) Aid to families with dependent children under a State plan approved...

  9. 31 CFR 16.3 - Basis for civil penalties and assessments.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Development or the Secretary of Agriculture; (vii) Benefits under the special supplemental food program for women, infants, and children established under section 17 of the Child Nutrition Act of 1966; (viii... the Social Security Act; (xii) Aid to families with dependent children under a State plan approved...

  10. 31 CFR 16.3 - Basis for civil penalties and assessments.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Development or the Secretary of Agriculture; (vii) Benefits under the special supplemental food program for women, infants, and children established under section 17 of the Child Nutrition Act of 1966; (viii... the Social Security Act; (xii) Aid to families with dependent children under a State plan approved...

  11. 31 CFR 16.3 - Basis for civil penalties and assessments.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Development or the Secretary of Agriculture; (vii) Benefits under the special supplemental food program for women, infants, and children established under section 17 of the Child Nutrition Act of 1966; (viii... the Social Security Act; (xii) Aid to families with dependent children under a State plan approved...

  12. Internet Survey of Nutrition Claim Knowledge

    ERIC Educational Resources Information Center

    Camire, Mary E.; Dougherty, Michael P.

    2005-01-01

    Consumer interest in healthy foods has spurred approval of several health claims for foods and dietary supplements. Although undergraduate and graduate food science curricula address food laws and regulations, nutrition claims may not be fully addressed. We posted a survey on the Internet for 2 mo for food industry professionals and others…

  13. 30 CFR 75.222 - Roof control plan-approval criteria.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... systems. (1) Systematic supplemental support should be installed throughout— (i) The tailgate entry of the first longwall panel prior to any mining; and (ii) In the proposed tailgate entry of each subsequent... should address— (i) Notification of miners that the travelway is blocked; (ii) Re-instruction of miners...

  14. 30 CFR 75.222 - Roof control plan-approval criteria.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... systems. (1) Systematic supplemental support should be installed throughout— (i) The tailgate entry of the first longwall panel prior to any mining; and (ii) In the proposed tailgate entry of each subsequent... should address— (i) Notification of miners that the travelway is blocked; (ii) Re-instruction of miners...

  15. 30 CFR 75.222 - Roof control plan-approval criteria.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... systems. (1) Systematic supplemental support should be installed throughout— (i) The tailgate entry of the first longwall panel prior to any mining; and (ii) In the proposed tailgate entry of each subsequent... should address— (i) Notification of miners that the travelway is blocked; (ii) Re-instruction of miners...

  16. 48 CFR 1815.306 - Exchanges with offerors after receipt of proposals. (NASA supplements paragraphs (c), (d), and (e))

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Federal Acquisition Regulations System NATIONAL AERONAUTICS AND SPACE ADMINISTRATION CONTRACTING METHODS... proposals shall be a working goal in establishing the competitive range. Field installations may establish procedures for approval of competitive range determinations commensurate with the complexity or dollar value...

  17. 75 FR 61655 - Airworthiness Directives; Piper Aircraft, Inc. Model PA-28-161 Airplanes

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-06

    ... (FADEC) backup battery, replacing the supplement pilot's operating handbook and FAA approved airplane... can allow the FADEC to shut down or reset if the main battery is depleted and the electrical charging... service information describes procedures for installation of a FADEC backup battery. FAA's Determination...

  18. 5 CFR 6301.102 - Prior approval for certain outside activities.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... activities. 6301.102 Section 6301.102 Administrative Personnel DEPARTMENT OF EDUCATION SUPPLEMENTAL STANDARDS...: (i) To participate in the activities of a: (A) Social, fraternal, civic, or political entity; (B... organization at the employee's child's school or day care center, other than as a member of a board of...

  19. 78 FR 17186 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement (DFARS...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-20

    ... Requirements for Critical Safety Items AGENCY: Defense Acquisition Regulations System, Department of Defense... of the burden of the proposed information collection; (c) ways to enhance the quality, utility, and... technology. The Office of Management and Budget (OMB) has approved this information collection for use...

  20. 14 CFR 21.441 - Procedure manual.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... manual. (a) No DAS may exercise any authority under this subpart unless it submits, and obtains approval... limitations or Aircraft Flight Manuals, and sign supplemental type certificates. (b) No DAS may continue to perform any DAS function affected by any change in facilities or staff necessary to continue to meet the...

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