Significant regulatory action definition

Significant regulatory action means any regulatory action that is likely to result in a rule that may:
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Significant regulatory action under E.O. 12866 means any action that is likely to result in a rule that may:
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Significant regulatory action. ’ means, among other things, any regulatory action that is likely to result in a rule that may have an annual effect on the economy of $100 million or more, or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities. Exec. Order No. 12866, 58 Fed. Reg. No. 190 (Sept. 30, 1993), available at www.reginfo.gov/public/jsp/Utilities/EO_12866.pdf.
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Examples of Significant regulatory action in a sentence

  • Significant regulatory action against Morgan Stanley could materially adversely affect its business, financial condition or results of operations or cause Morgan Stanley significant reputational harm, which could seriously harm its business.

  • Significant regulatory action includes a new or strengthened warning such as a black box warning or action to suspend or revoke a marketing authorization.49 The regulatory authority considered in this analysis is the US FDA for actions taken after marketing authorization was issued to the manufacturer.

  • Significant regulatory action requires the preparation of a detailed cost-benefit analysis by TTB which seeks to justify the need for the legal change and analyze ways to reduce this potential economic effect.

  • Regulatory plano Significant regulatory action must give a cost-benefit analysis.

  • Significant regulatory action would include: a restriction to the approved indication, a new contra-indication, a new or strengthened warning in section 4.4 of the SPC (or equivalent) or any action to suspend or revoke a marketing authorisation.This list should be cumulative, and specify the country, action taken and the date as appropriate.


More Definitions of Significant regulatory action

Significant regulatory action means any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;
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Significant regulatory action means any regulatory action that is likely to result in a rule or guidance that is likely to have—
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Significant regulatory action means any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President’s priorities, or the principles set forth in this Executive order.
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Significant regulatory action means one with an annual impact of $100 million on the economy or have a material adverse impact on the economy; will create inter-agency inconsistency; will materially alter the budgetary impact of entitlements or grants; or will raise novel legal or policy issues.
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Related to Significant regulatory action

  • Adverse Event means any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

  • Current significant investigative information means investigative information that a licensing board, after an inquiry or investigation that includes notification and an opportunity for the audiologist or speech-language pathologist to respond, if required by state law, has reason to believe is not groundless and, if proved true, would indicate more than a minor infraction.

  • Public Procurement Regulatory Authority (PPRA) means the Government Agency responsible for oversight of public procurement.

  • Confidential communication means a communication not intended to be disclosed to third persons other than those to whom disclosure is in furtherance of the rendition of professional legal services to the client or those reasonably necessary for the transmission of the communication.

  • discriminatory action means any action or threat of action by an employer that does or would adversely affect an employee with respect to any terms or conditions of employment or opportunity for promotion, and includes termination, layoff, suspension, demotion or transfer of an employee, discontinuation or elimination of a job, change of a job location, reduction in wages, change in hours of work, reprimand, coercion, intimidation or the imposition of any discipline or other penalty but does not include:

  • Adverse action means a home or remote state action.

  • Adverse drug reaction means any undesirable or unexpected medication related event that requires discontinuing a medication or modifying the dose, requires or prolongs hospitalization, results in disability, requires supportive treatment, is life-threatening or results in death, results in congenital anomalies, or occurs following vaccination.