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. See: Executive Order 12866 of September 30, 1993, 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 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.

  • It has been determined by OMB and EPA that this action is not a Significant regulatory action under the terms of Executive Order 12866 and is therefore not subject to OMB review under the Executive Order.

  • Significant regulatory action" shall have the same meaning as in section 3(f) of Executive Order 12866.

  • 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.


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 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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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 any regulatory action that is likely to result in a rule or guidance that is likely to have—
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Related to Significant regulatory action

  • Regulatory Action means an administrative, regulatory, or judicial enforcement action, proceeding, investigation or inspection, FDA Form 483 notice of inspectional observation, warning letter, untitled letter, other notice of violation letter, recall, seizure, Section 305 notice or other similar written communication, injunction or consent decree, issued by the FDA or a federal or state court.

  • Plant regulator means any substance or mixture of

  • 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.

  • Material Compliance Matter has the same meaning as the term defined in Rule 38a-1, and includes any compliance matter that involves: (1) a violation of the federal securities laws by Distributor (or its officers, directors, employees, or agents); (2) a violation of Distributor's Rule 38a-1 policies and procedures; or (3) a weakness in the design or implementation of Distributor's Rule 38a-1 policies and procedures.

  • Relevant Regulator means the PRA or any successor entity or other entity primarily responsible for the prudential supervision of the Issuer.

  • Retaliatory action means action which includes, but is not limited to, the refusal to continue an agreement, or a material reduction in the quality of service or quantity of products available to a wholesaler under an agreement, which refusal or reduction is not made in good faith.

  • 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.

  • information gathering measures means laws and administrative or judicial procedures that enable a Contracting Party to obtain and provide the requested information;

  • Contractor Sensitive Information means any information provided by the Contractor to the Authority (disregarding any protective marking or assertion of confidentiality) which: is specified as Contractor Sensitive Information in Schedule 7 and has not lost its sensitivity according to the justifications and durations set out in that Schedule; and is exempt information pursuant to sections 33(1) or 36, 38 or 39 of FOISA (having regard for that purpose to the public interest there might be in disclosing such information as referred to in section 2(1)(b) of FOISA).

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

  • Commercially Sensitive Information Schedule means the Schedule containing a list of the Commercially Sensitive Information.

  • 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 shall occur if:

  • 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.

  • Material of Environmental Concern means and includes pollutants, contaminants, hazardous wastes, and toxic, radioactive, caustic or otherwise hazardous substances, including petroleum, its derivatives, by-products and other hydrocarbons, or any substance having any constituent elements displaying any of the foregoing characteristics.

  • regulatory action level RBC means the product of 1.5 and its authorized control level RBC;

  • Authority's Confidential Information means all Personal Data and any information, however it is conveyed, that relates to the business, affairs, developments, trade secrets, know-how, personnel, and suppliers of the Authority, including all IPRs, together with all information derived from any of the above, and any other information clearly designated as being confidential (whether or not it is marked "confidential") or which ought reasonably be considered to be confidential;

  • Confidential commercial information means records provided to the govern- ment by a submitter that arguably contain material exempt from release under Exemption 4 of the Freedom of Information Act, 5 U.S.C. 552(b)(4), be- cause disclosure could reasonably be expected to cause substantial competi- tive harm.

  • Commercially Sensitive Information means the Information (i) listed in the Commercially Sensitive Information Schedule; or (ii) notified to the Authority in writing (prior to the commencement of this Contract) which has been clearly marked as Commercially Sensitive Information comprised of information:

  • Confidential commercial or financial information means any business information (other than trade secrets) which is exempt from the mandatory disclosure requirement of the Freedom of Information Act, 5 U.S.C. 552. Exemptions from mandatory disclosure which may be applicable to business information contained in proposals include exemption (4), which covers “commercial and financial information obtained from a person and privileged or confidential,” and exemption (9), which covers “geological and geophysical information, including maps, concerning wells.”

  • Material safety data sheet or "MSDS" means the chemical, physical, technical, and safety information document supplied by the manufacturer of the coating, solvent, or other chemical product, usually through the distribution network or retailers.

  • relevant regulations means, at any time, any requirements of Austrian law or contained in the regulations, requirements, guidelines or policies of the Competent Authority, the European Parliament and/or the European Council, then in effect in the Republic of Austria and applicable to the BAWAG Regulatory Group and/or (as the case may be) the Issuer, including but not limited to the provisions of the BWG, the CRD, the CRR, the CDR and the SSM Regulation, in each case as amended from time to time, or such other law, regulation or directive as may come into effect in place thereof.

  • Imminent danger to the health and safety of the public means the existence of any condition or practice, or any violation of a permit or other requirement of this chapter in a surface coal mining and reclamation operation, which condition, practice, or violation could reasonably be expected to cause substantial physical harm to persons outside the permit area before such condition, practice, or violation can be abated. A reasonable expectation of death or serious injury before abatement exists if a rational person, subjected to the same conditions or practices giving rise to the peril, would not expose the person's self to the danger during the time necessary for abatement.

  • Other Confidential Consumer Information The Contractor agrees to comply with the requirements of AHS Rule No. 08-048 concerning access to information. The Contractor agrees to comply with any applicable Vermont State Statute, including but not limited to 12 VSA §1612 and any applicable Board of Health confidentiality regulations. The Contractor shall ensure that all of its employees and subcontractors performing services under this agreement understand the sensitive nature of the information that they may have access to and sign an affirmation of understanding regarding the information’s confidential and non- public nature.

  • DXC Sensitive Information means DXC Confidential Information, Intellectual Property, PHI, DXC Customer data, and Personal Information.