Department of Health and Human Services November 9, 2018 – Federal Register Recent Federal Regulation Documents
Results 1 - 6 of 6
Tedor Pharma, Inc., et al.; Withdrawal of Approval of 10 Abbreviated New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 10 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Determination That AXIRON (Testosterone) Transdermal Metered Solution, 30 Milligrams/1.5 Milliliter Actuation, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that AXIRON (testosterone) transdermal metered solution, 30 milligrams (mg)/1.5 milliliter (mL) actuation, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product if they meet relevant legal and regulatory requirements.
Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Notice of Intent To Prepare an Environmental Impact Statement and Notice of Scoping Meeting
In accordance with the National Environmental Policy Act, the National Institutes of Health (NIH) is issuing this notice to advise the public that an environmental impact statement will be prepared for the Surgery, Radiology and Lab Medicine Building with associated Utility Vault and Patient Parking Garage project located on the National Institutes of Health, Bethesda Campus, Bethesda, Maryland.
Decision to Designate a Class of Employees From the Sandia National Laboratories in Albuquerque, New Mexico, To Be Included in the Special Exposure Cohort
HHS gives notice of a decision to designate a class of employees from the Sandia National Laboratories in Albuquerque, New Mexico, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Patient Protection and Affordable Care Act; Exchange Program Integrity
This proposed rule would revise standards relating to oversight of Exchanges established by states, periodic data matching frequency and authority, and the length of a consumer's authorization for the Exchange to obtain updated tax information. This proposed rule would also propose new requirements for certain issuers related to the collection of a separate payment for the premium portion attributable to coverage for certain abortion services. Many of these proposed changes would help strengthen Exchange program integrity.
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