Department of Health and Human Services February 24, 2017 – Federal Register Recent Federal Regulation Documents
Results 1 - 18 of 18
New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application
The Food and Drug Administration (FDA) is withdrawing approval of an abbreviated new animal drug application (ANADA) at the sponsor's request because the product is no longer manufactured or marketed.
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor's Address
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September and October 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of several applications and a change of a sponsor's address.
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Pantex Plant in Amarillo, Texas, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from Area IV of the Santa Susana Field Laboratory in Ventura County, California, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Decision To Evaluate a Petition To Designate a Class of Employees From Santa Susana Field Laboratory in Eastern Ventura County, California, To Be Included in the Special Exposure Cohort
NIOSH gives notice of a decision to evaluate a petition to designate a class of employees from Area IV of the Santa Susana Field Laboratory in eastern Ventura County, California, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Health Insurance MarketplaceSM
This notice announces the next meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace\SM\,\1\ Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.
New Animal Drugs for Use in Animal Feed; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of eight supplemental new animal drug applications (NADAs). The effect of these supplemental applications will be to change the marketing status from over-the- counter (OTC) use to use by veterinary feed directive (VFD) for these antimicrobial drugs of importance to human medicine, administered to food-producing animals in medicated feed. Where applicable, FDA is also withdrawing approval of those parts of the NADAs that pertain to use of these antimicrobial drugs for production indications. These actions are being taken at the sponsors' requests because these particular medicated feeds will no longer be manufactured or marketed. These applications were submitted in voluntary compliance with the goals of FDA Center for Veterinary Medicine's (CVM's) Judicious Use Initiative. In addition, the animal drug regulations are being amended to reflect the voluntary withdrawal of approval of certain entire NADAs and abbreviated new animal drug applications (ANADAs) that were affected by this initiative.
New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications
The Food and Drug Administration (FDA) is withdrawing approval of 18 new animal drug applications (NADAs) and 2 abbreviated new animal drug applications (ANADAs). These withdrawals of approval of NADAs and ANADAs for antimicrobial drugs of importance to human medicine that are administered to food-producing animals in medicated feed are being made because the products are no longer manufactured or marketed. These actions are consistent with the FDA Center for Veterinary Medicine's initiative for the Judicious Use of Antimicrobials.
Medicare Program; Public Meetings in Calendar Year 2017 for All New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding and Payment Determinations
This notice announces the dates, time, and location of the Healthcare Common Procedure Coding System (HCPCS) public meetings to be held in calendar year 2017 to discuss our preliminary coding and payment determinations for all new public requests for revisions to the HCPCS. These meetings provide a forum for interested parties to make oral presentations or to submit written comments in response to preliminary coding and payment determinations. The discussion will be focused on responses to our specific preliminary recommendations and will include all items on the public meeting agenda. As indicated in this notice, we are reorganizing public meeting content under two main headings: Drugs/Biologicals/Radiopharmaceuticals/Radiologic Imaging Agents, and Durable Medical Equipment (DME) and Accessories; Orthotics and Prosthetics (O & P); Supplies and ``Other''.
Medicare and Medicaid Programs: Application From the Center for Improvement in Healthcare Quality for Continued Approval of Its Hospital Accreditation Program
This proposed notice acknowledges the receipt of an application from the Center for Improvement in Healthcare Quality (CIHQ) for continued recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs.
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