Summary of the Major Provisions of the Regulatory Action Sample Clauses

Summary of the Major Provisions of the Regulatory Action. After holding a public meeting and consulting with CDC and the National Institutes of Health (NIH), and considering the factors specified in section 505E(f)(2)(B)(i) of the FD&C Act, FDA proposed on June 12, 2013, that the following pathogens comprise the list of ‘‘qualifying pathogens:’’ Acinetobacter species, Aspergillus species, Burkholderia cepacia complex, Campylobacter species, Candida species, Clostridium difficile, Enterobacteriaceae (e.g., Klebsiella pneumoniae), Enterococcus species, Mycobacterium tuberculosis complex, Neisseria gonorrhoeae, N. meningitidis, Non-tuberculous mycobacteria species, Pseudomonas species, Staphylococcus aureus, Streptococcus agalactiae, S. pneumoniae, S. pyogenes, and Vibrio cholerae. The preamble to the proposed rule describes the factors FDA considered and the methodology FDA used to develop this list of qualifying pathogens. After analyzing comments to the proposed rule, FDA has decided to retain the previously proposed methodology for developing the list of qualifying pathogens and will include the pathogens identified in the proposed rule on the list of qualifying pathogens. FDA also has applied the methodology set forth in the proposed rule to additional pathogens suggested by comments to the proposed rule. Based on these analyses, FDA also will add Coccidioides species, Cryptococcus species, and Helicobacter pylori to the list of qualifying pathogens. The table below describes the pathogen lists for the proposed and final rule for comparison: Proposed rule Final rule
Sample 1
AutoNDA by SimpleDocs
Summary of the Major Provisions of the Regulatory Action. The proposed part 1120 is organized into seven subparts, each of which addresses a major element or subelement of the standard award format that the part establishes. Those elements and subelements of the standard award format are the: • Award cover pages (addressed in subpart A of the proposed part). • Award-specific terms and conditions (addressed in subpart B). • General terms and conditions (addressed in subpart C), the four subelements of which (addressed in subparts D through G) are the: (i) Preamble; (ii) administrative requirements; (iii) national policy requirements; and (iv) programmatic requirements. Sections I.B.1 through I.B.7 of this SUPPLEMENTARY INFORMATION section describe these elements and subelements of the standard award format. Sections I.B.1 and I.B.2 describe the award cover pages and award- specific terms and conditions, respectively. Section I.B.3 describes the general terms and conditions as a whole and sections I.B.4 through 7 separately describe its four subelements.
Sample 1
Summary of the Major Provisions of the Regulatory Action. After holding a public meeting and consulting with CDC and the National Institutes of Health (NIH), and considering the factors specified in section 505E(f)(2)(B)(i) of the FD&C Act, FDA proposed on June 12, 2013, that the following pathogens comprise the list of ‘‘qualifying pathogens:’’ Acinetobacter species, Aspergillus species, Burkholderia cepacia complex, Campylobacter species, Candida species, Clostridium difficile, Enterobacteriaceae (e.g., Klebsiella pneumoniae), Enterococcus species, Mycobacterium tuberculosis complex, Neisseria gonorrhoeae, N. meningitidis, Non-tuberculous mycobacteria species, Pseudomonas species, Staphylococcus aureus, Streptococcus agalactiae, S. pneumoniae, S. pyogenes, and Vibrio cholerae. The preamble to the proposed rule describes the factors FDA considered and the methodology FDA used to develop this list of qualifying pathogens. After analyzing comments to the proposed rule, FDA has decided to retain the previously proposed methodology for developing the list of qualifying pathogens and will include the pathogens identified in the proposed rule on the list of qualifying pathogens. FDA also has applied the methodology set forth in the proposed rule to additional pathogens suggested by comments to the proposed rule. Based on these analyses, FDA also will add Coccidioides species, Cryptococcus species, and Helicobacter pylori to the list of qualifying pathogens. The table below describes the pathogen lists for the proposed and final rule for comparison: Proposed rule Final rule Acinetobacter species .............................................................................. Acinetobacter species. Aspergillus species ................................................................................... Aspergillus species. Burkholderia cepacia complex ................................................................. Burkholderia cepacia complex. Campylobacter species ............................................................................ Campylobacter species. Candida species ....................................................................................... Candida species.
Sample 1

Related to Summary of the Major Provisions of the Regulatory Action

  • NOTIFICATION OF PUBLIC EVENTS AND MEETINGS 2 A. CONTRACTOR shall notify ADMINISTRATOR of any public event or meeting funded in 3 whole or in part by the COUNTY, except for those events or meetings that are intended solely to serve 4 clients or occur in the normal course of business.

  • Regulatory and Special Allocations Notwithstanding the provisions of Section 5.01:

  • Prohibition on Transfers, Other Actions Stockholder hereby represents, warrants, covenants and agrees not to, during the Restricted Period, directly or indirectly, in one or a series of related transactions: (i) Transfer or offer, agree, commit or consent to Transfer any of the Covered Shares or any right, title or interest (including voting, economic or otherwise) therein, unless such Transfer is a Permitted Transfer; (ii) enter into any Contract, arrangement or understanding with any Person, or take any other action or omit to take any action, that violates or conflicts with (or could reasonably be expected to conflict with or violate) Stockholder’s covenants and obligations under this Agreement; or (iii) take any action or omit to take any action that would restrict (or could reasonably be expected to restrict) Stockholder’s legal power, authority and right to comply with and perform its covenants and obligations under this Agreement or make any of its representations or warranties contained in this Agreement untrue or incorrect, nor has Stockholder done any of the foregoing. Stockholder agrees that it shall not seek to indirectly accomplish anything which it is not permitted to accomplish directly under this Agreement. Any action, omission or attempted circumvention in violation of this Section 4.1 will be void ab initio and be deemed a breach of this Agreement. If any involuntary Transfer of any of the Covered Shares shall occur, the transferee (which term, as used herein, shall include any and all transferees and subsequent transferees of the initial transferee) shall take and hold such Covered Shares subject to all of the restrictions, liabilities and rights under this Agreement, which shall continue in full force and effect until valid termination of this Agreement.

  • Restrictions on Activities of the Trust Notwithstanding any other provision of this Agreement and any provision of law that otherwise so empowers the Trust, so long as any Certificates are outstanding, the Trust shall not, and none of the Trustee, the Delaware Trustee, the Company or the Servicer shall knowingly cause the Trust to, do any of the following:

  • Limitation on the Authority of the Manager to Purchase and Sell Securities for the Account of Certain Underwriters Notwithstanding any provision of this AAU authorizing the Manager to purchase or sell any Securities or Other Securities (including arranging for the sale of Contract Securities) or over-allot in arranging sales of Securities for the accounts of the several Underwriters, the Manager may not, in connection with the Offering of any Securities, make any such purchases, sales, and/or over-allotments for the account of any Underwriter that, not later than its acceptance of the Invitation Wire relating to such Offering, has advised the Manager that, due to its status as, or relationship to, a bank or bank holding company such purchases, sales, and/or over-allotments are prohibited by applicable law. If any Underwriter so advises the Manager, the Manager may allocate any such purchases, sales, and over-allotments (and the related expenses) which otherwise would have been allocated to your account based on your respective Underwriting Percentage to your account based on the ratio of your Original Underwriting Obligation to the Original Underwriting Obligations of all Underwriters other than the advising Underwriter or Underwriters, or in such other manner as the Manager will determine.

  • Application of Takeover Protections; Rights Agreements The Company and the Board of Directors have taken all necessary action, if any, in order to render inapplicable any control share acquisition, business combination, poison pill (including any distribution under a rights agreement) or other similar anti-takeover provision under the Company’s charter documents or the laws of its state of incorporation that is or could reasonably be expected to become applicable to any of the Purchasers as a result of the Purchasers and the Company fulfilling their obligations or exercising their rights under the Transaction Documents, including, without limitation, the Company’s issuance of the Securities and the Purchasers’ ownership of the Securities.

  • Other Activities of the Adviser The services of the Adviser to the Corporation are not exclusive, and the Adviser may engage in any other business or render similar or different services to others including, without limitation, the direct or indirect sponsorship or management of other investment based accounts or commingled pools of capital, however structured, having investment objectives similar to those of the Corporation, so long as its services to the Corporation hereunder are not impaired thereby, and nothing in this Agreement shall limit or restrict the right of any manager, partner, member (including its members and the owners of its members), officer or employee of the Adviser to engage in any other business or to devote his or her time and attention in part to any other business, whether of a similar or dissimilar nature, or to receive any fees or compensation in connection therewith (including fees for serving as a director of, or providing consulting services to, one or more of the Corporation’s portfolio companies, subject to applicable law). The Adviser assumes no responsibility under this Agreement other than to render the services called for hereunder. It is understood that directors, officers, employees and stockholders of the Corporation are or may become interested in the Adviser and its affiliates, as directors, officers, employees, partners, stockholders, members, managers or otherwise, and that the Adviser and directors, officers, employees, partners, stockholders, members and managers of the Adviser and its affiliates are or may become similarly interested in the Corporation as stockholders or otherwise.

  • Assistance with Business Combination For a period of ninety days following the Effective Date, in the event any person or entity (regardless of any FINRA affiliation or association) is engaged to assist the Company in its search for a Business Combination candidate or to provide any similar Business Combination-related services, the Company will provide the following information (the “Business Combination Information”) to the Representative: (i) complete details of all services and copies of agreements governing such services (which details or agreements may be appropriately redacted to account for privilege or confidentiality concerns); and (ii) justification as to why the person or entity providing the Business Combination-related services should not be considered an “underwriter and related person” with respect to the Company’s initial public offering, as such term is defined in Rule 5110 of FINRA’s Conduct Rules. The Company also agrees that proper disclosure of such arrangement or potential arrangement will be made in the proxy statement which the Company will file for purposes of soliciting shareholder approval for the Business Combination. Upon the Company’s delivery of the Business Combination Information to the Representative, the Company hereby expressly authorizes the Representative to provide such information directly to FINRA as a result of representations the Representative have made to FINRA in connection with the Offering.

  • Actions Prior to the Distribution Prior to the Effective Time and subject to the terms and conditions set forth herein, the Parties shall take, or cause to be taken, the following actions in connection with the Distribution:

  • Terms of the Merger Upon the execution and delivery of this Agreement and the effectiveness of the Merger, each share of stock then issued and outstanding by Target by virtue of the Merger and without any action on the part of the holder(s) thereof, no longer be outstanding and shall be canceled and retired and cease to exist, other than one share of Target's subsidiary, which shall be owned by Public Corporation, and all other Target shares shall be converted into the right to receive, upon surrender of the certificate representing such shares, the consideration set forth under paragraph 1.03 hereof

Time is Money Join Law Insider Premium to draft better contracts faster.