Executive Office of the President – Federal Register Recent Federal Regulation Documents

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.

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: https://www.tricare.mil/ocfo/mcfs/ubo/mhs_rates.cfm.