Department of Health and Human Services March 11, 2014 – Federal Register Recent Federal Regulation Documents
Results 1 - 25 of 25
HHS Approval of Entities That Certify Medical Review Officers (MRO)
The current version of the Department of Health and Human Services (HHS) Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines), effective on October 1, 2010, addresses the role and qualifications of Medical Review Officers (MROs) and HHS approval of entities that certify MROs. Subpart M-Medical Review Officer (MRO), Section 13.1(b), ``Who may serve as an MRO?'' states as follows: ``Nationally recognized entities that certify MROs or subspecialty boards for physicians performing a review of Federal employee drug testing results that seek approval by the Secretary must submit their qualifications and a sample examination. Based on an annual objective review of the qualifications and content of the examination, the Secretary shall publish a list in the Federal Register of those entities and boards that have been approved.'' HHS has completed its review of entities that train and certify MROs, in accordance with requests submitted by such entities to HHS. (1) The HHS Secretary approves the following MRO certifying entities that offer both MRO training and certification through examination:
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Citizen Petitions and Petitions for Stay of Action Subject to the Federal Food, Drug, and Cosmetic Act
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Draft Guidance for Industry on Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment.'' The purpose of this draft guidance is to assist sponsors in the development of drug products for the treatment of chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME).
Environmental Impact Statement for the Proposed Rule, Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Public Meeting on Scoping of Environmental Impact Statement and Extension of Comment Period for Environmental Impact Statement
The Food and Drug Administration (FDA or we) is announcing the extension of the public scoping period for Environmental Impact Statement (EIS), as well as a public scoping meeting to discuss the scope of the EIS for the proposed rule to establish standards for growing, harvesting, packing, and holding of produce for human consumption. FDA is holding a public scoping meeting as part of our ongoing efforts to seek public input on the issues and alternatives that we should consider when preparing the EIS and to provide information about the EIS process (including how to submit comments, data, and other information to the rulemaking docket), to solicit oral stakeholder and public comments on the scope of the EIS, and to respond to questions about the EIS.
Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D2
The Food and Drug Administration (FDA or we) is responding to objections that we have received on the final rule that amended the food additive regulations authorizing the use of vitamin D2 bakers yeast as a source of vitamin D2 and as a leavening agent in yeast-leavened baked products at levels not to exceed 400 International Units (IU) of vitamin D2 per 100 grams (g) in the finished food. After reviewing the objections to the final rule, FDA has concluded that they do not provide a basis for amending or revoking the regulation.
Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2015
This final rule sets forth payment parameters and oversight provisions related to the risk adjustment, reinsurance, and risk corridors programs; cost sharing parameters and cost-sharing reductions; and user fees for Federally-facilitated Exchanges. It also provides additional standards with respect to composite premiums, privacy and security of personally identifiable information, the annual open enrollment period for 2015, the actuarial value calculator, the annual limitation in cost sharing for stand-alone dental plans, the meaningful difference standard for qualified health plans offered through a Federally-facilitated Exchange, patient safety standards for issuers of qualified health plans, and the Small Business Health Options Program.
New Animal Drugs; Change of Sponsor
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 110 approved new animal drug applications (NADAs) and 14 approved abbreviated new animal drug applications (ANADAs) for new animal drug for use in animal feed from Pfizer, Inc., including its several subsidiaries and divisions, to Zoetis, Inc.
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