Department of Health and Human Services July 3, 2019 – Federal Register Recent Federal Regulation Documents
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Meeting of the the Substance Abuse and Mental Health Services Administration's National Advisory Council
Notice is hereby given of the meeting on July 23, 2019, of the Substance Abuse and Mental Health Services Administration's (SAMHSA) National Advisory Council (SAMHSA NAC). The meeting is open to the public and can be accessed via telephone only. Agenda with call-in information will be posted on the SAMHSA website prior to the meeting at: https://www.samhsa.gov/about-us/advisory-councils/meetings. The meeting will include remarks and dialogue from the Assistant Secretary for Mental Health and Substance Use; updates from the SAMHSA Centers Directors, and a council discussion with SAMHSA NAC members.
Liebel-Flarsheim Company LLC, et al.; Withdrawal of Approval of 11 New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 11 new drug applications (NDAs) 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Patient Safety Organizations: Voluntary Relinquishment for QA to QI LLC
The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) authorizes AHRQ, on behalf of the Secretary of HHS, to list as a patient safety organization (PSO) an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ has accepted a notification of voluntary relinquishment from QA to QI LLC, PSO number P0091, of its status as a PSO, and has delisted the PSO accordingly.
Determination That CLAFORAN (Cefotaxime Sodium) for Injection, 500 Milligrams/Vial, 1 Gram/Vial, 2 Grams/Vial and 10 Grams/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that CLAFORAN (cefotaxime sodium) for injection, 500 milligrams (mg)/vial, 1 gram (g)/vial, 2 g/vial and 10 g/vial, was not withdrawn from sale for reasons of safety or effectiveness.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 as long as they meet relevant legal and regulatory requirements.
Pharmaceutical Distribution Supply Chain Pilot Projects; Reopening of Comment Period; Request for Information
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notices (requests for information) that published in the Federal Register of April 15, 2016, and April 28, 2017. FDA is requesting comments regarding issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, and identifying system attributes that are necessary to implement the requirements established under the Drug Supply Chain Security Act (DSCSA). The information gathered from reopening of the comment period will allow supply chain stakeholders to share information about relevant piloting activities that are conducted outside of FDA's DSCSA Pilot Project Program to inform DSCSA implementation by FDA and supply chain stakeholders.
Determination That THAM Solution (Tromethamine) Injectable, 3.6 Grams/100 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that THAM Solution (tromethamine) injectable, 3.6 grams (g)/ 100 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for tromethamine injectable, 3.6g/100 mL, if all other legal and regulatory requirements are met.
Patient Engagement Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA) is announcing a forthcoming public advisory committee meeting of the Patient Engagement Advisory Committee (the Committee). The general function of the Committee is to provide advice to the Commissioner, or designee, on complex issues relating to medical devices, the regulation of devices, and their use by patients. The meeting will be open to the public.
DHL Laboratories Inc.; Withdrawal of Approval of a New Drug Application for Dextrose 5% Injection in Plastic Container, 5 Grams/100 Milliliters
The Food and Drug Administration (FDA) is withdrawing approval of new drug application (NDA) 019971 for Dextrose 5% Injection in Plastic Container, 5 grams (g)/100 milliliters (mL), held by DHL Laboratories Inc., 155 Medical Science Dr., Union, SC 23979. The basis for the withdrawal is that the holder of the NDA has repeatedly failed to file required annual reports for the NDA.
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.
National Vaccine Injury Compensation Program; List of Petitions Received
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims (the Court) is charged by statute with responsibility for considering and acting upon the petitions.
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