Executive Office of the President – Federal Register Recent Federal Regulation Documents
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Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the Regulation of the Products of Biotechnology
On July 2, 2015, the Executive Office of the President (EOP) issued a memorandum (Ref. 1) directing the primary agencies that regulate the products of biotechnologythe U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA)to update the Coordinated Framework for the Regulation of Biotechnology (51 FR 23302; June 26, 1986) (Ref. 2), develop a long-term strategy to ensure that the Federal biotechnology regulatory system is prepared for the future products of biotechnology, and commission an expert analysis of the future landscape of biotechnology products to support this effort. The memorandum's objectives are to ensure public confidence in the regulatory system and to prevent unnecessary barriers to future innovation and competitiveness by improving the transparency, coordination, predictability, and efficiency of the regulation of biotechnology products while continuing to protect health and the environment. The purpose of this Request for Information (RFI) is to solicit relevant data and information, including case studies, that can assist in the development of the proposed update to the Coordinated Framework for the Regulation of Biotechnology (CF) to clarify the current roles and responsibilities of the EPA, FDA, and USDA and the development of a long-term strategy consistent with the objectives described in the July 2, 2015 EOP memorandum. In addition to this RFI, the update to the CF will undergo public comment before it is finalized.
The Office of National Drug Control Policy (ONDCP), Executive Office of the President, finalizes its portion of the uniform Federal assistance rule published by the Office of Management and Budget, in the Federal Register on December 19, 2014.
Continuation of the National Emergency With Respect to Persons Who Commit, Threaten To Commit, or Support Terrorism
Presidential Determination on Major Drug Transit or Major Illicit Drug Producing Countries for Fiscal Year 2016
Delegation of Authority To Transfer Certain Funds in Accordance With Section 610 of the Foreign Assistance Act of 1961
Fiscal Year 2015 Cost of Hospital and Medical Care Treatment Furnished by the Department of Defense Medical Treatment Facilities; Certain Rates Regarding Recovery From Tortiously Liable Third Persons
By virtue of the authority vested in the President by Section 2(a) of Pub. B. 87-603 (76 Stat. 593; 42 U.S.C. 2652), and delegated to the Director of the Office of Management and Budget (OMB) by the President through Executive Order No. 11541 of July 1, 1970, the rates referenced below are hereby established. These rates are for use in connection with the recovery from tortiously liable third persons for the cost of inpatient medical services furnished by military treatment facilities through the Department of Defense. They are the same rates as the Adjusted Standardized Amounts inpatient third party reimbursement rates that became effective October 1, 2014, for billing medical insurers, but require a different approval authority for the purpose of billing for tort liability. The rates have been established in accordance with the requirements of OMB Circular A-25, requiring reimbursement of the full cost of all services provided. The Fiscal Year 2015 Inpatient Medical Rates referenced are effective upon publication of this notice in the Federal Register and will remain in effect until further notice. Previously published outpatient medical and dental, and cosmetic surgery rates remain in effect until further notice. Pharmacy rates are updated periodically. A full disclosure of the rates is posted on Defense Health Agency's Uniform Business Office Web site: http://www.tricare.mil/ocfo/mcfs/ubo/mhs_rates.cfm.
The Office of Management and Budget (OMB) is correcting the final guidance that appeared in the Federal Register on September 14, 2010 (75 FR 55673) and December 26, 2013 (78 FR 78589). OMB is amending the guidance to make technical corrections where needed. The final guidance is revised to remove references to the ``System of Award Management'' and replace them with the correct term ``System for Award Management''. With respect to the technical corrections to the final guidance, these corrections are included only where it has come to the attention of the Council on Financial Assistance Reform (COFAR) that particular language in the final guidance did not match with the COFAR's intent and would result in an erroneous implementation of the guidance. These technical corrections will go into effect at the time of issuance. Guidance on effective/applicability date is revised to allow a grace period of two fiscal years for non-Federal entities to implement changes to their procurement policies and procedures in accordance with guidance on procurement standards. Other requirements in the section remain as originally published. Technical corrections are made to eliminate conflicting or unclear language and grammatical inconsistencies or citation errors throughout.
Designating the International Renewable Energy Agency as a Public International Organization Entitled To Enjoy Certain Privileges, Exemptions, and Immunities