Department of Health and Human Services December 11, 2018 – Federal Register Recent Federal Regulation Documents
Results 1 - 13 of 13
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.
Su-Chiao Kuo: Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Dr. Su-Chiao Kuo for a period of 3 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Kuo was convicted of a misdemeanor under the FD&C Act for causing the introduction or delivery for introduction into interstate commerce of prescription drugs that were misbranded. In addition, FDA has determined that the type of conduct that served as the basis for the conviction undermines the process for the regulation of drugs. Dr. Kuo was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Kuo failed to request a hearing. Dr. Kuo's failure to request a hearing constitutes a waiver of her right to a hearing concerning this action.
Submission for OMB Review; 30-Day Comment Request National Cancer Institute (NCI) Future Fellows Resume Databank
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
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 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 is charged by statute with responsibility for considering and acting upon the petitions.
Nominations to the Advisory Committee on Blood and Tissue Safety and Availability
The Office of Assistant Secretary for Health (OASH) is seeking nominations of qualified individuals to be considered for appointment as members of the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA). ACBTSA is a Federal advisory committee within the Department of Health and Human Services. Management support for the activities of this Committee is the responsibility of the OASH. The qualified individuals will be nominated to the Secretary of Health and Human Services for consideration of appointment as members of the ACBTSA. Members of the Committee, including the Chair, are appointed by the Secretary. Members are invited to serve on the Committee for up to four-year terms.
Draft NTP Monograph on the Systematic Review of Evidence of Long-Term Neurological Effects Following Acute Exposure to the Organophosphorus Nerve Agent Sarin; Availability of Document; Request for Comments; Notice of Peer-Review Meeting
The National Toxicology Program (NTP) announces availability of the Draft NTP Monograph on the Systematic Review of Evidence of Long-Term Neurological Effects Following Acute Exposure to the Organophosphorus Nerve Agent Sarin for public comment prior to peer review. In partnership with the National Institutes of Health (NIH) Countermeasures Against Chemical Threats (CounterACT) Program, the Office of Health Assessment and Translation (OHAT), Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS), conducted a systematic review to evaluate the evidence of long-term neurological damage in humans after acute, sub-lethal exposure to sarin. The date for the peer review is not yet set; however, it is anticipated to occur in early 2019. The peer-review meeting will be held by webcast only and open to the public; registration will be required for attendance by webcast and to present oral comments. Information about the meeting and registration is available at https://ntp.niehs.nih.gov/go/36051.
The Food and Drug Administration's Proposed Current Good Manufacturing Practice Policies for Outsourcing Facilities: Considerations Regarding Access to Office Stock; Public Meeting; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting entitled ``FDA's Proposed Current Good Manufacturing Practice Policies for Outsourcing Facilities: Considerations Regarding Access to Office Stock.'' Stakeholders, including healthcare providers (HCPs) and medical specialty groups, have expressed concerns regarding the availability of certain compounded drug products from outsourcing facilities that they would like to have on-hand as in-office supplies of non-patient-specific compounded drugs (``office stock''). The purpose of the public meeting is to provide HCPs, outsourcing facilities, entities considering becoming outsourcing facilities, and other interested parties with an opportunity to present to FDA their perspectives concerning access to office stock from outsourcing facilities in light of FDA's enforcement policies as proposed in the revised draft guidance on current good manufacturing practice (CGMP) for human drug compounding outsourcing facilities.
Current Good Manufacturing Practice-Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a revised draft guidance entitled ``Current Good Manufacturing PracticeGuidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.'' This revised draft guidance describes FDA's policies regarding compounders registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as outsourcing facilities and the current good manufacturing practice (CGMP) requirements in FDA regulations. Based on feedback from stakeholders and comments received on the initial draft guidance, the guidance is being revised, in part, to reflect further consideration of how CGMP requirements should be applied in light of the size and scope of an outsourcing facility's operations.
David J. Fishman: Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Dr. David J. Fishman for a period of 3 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Fishman was convicted of a misdemeanor under the FD&C Act for causing the introduction or delivery for introduction into interstate commerce of prescription drugs that were misbranded. In addition, FDA has determined that the type of conduct that served as the basis for the conviction undermines the process for the regulation of drugs. Dr. Fishman was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Fishman failed to request a hearing. Dr. Fishman's failure to request a hearing constitutes a waiver of his right to a hearing concerning this action.
The Tobacco Products Scientific Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Tobacco Products Scientific Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA, the Agency, or we) is amending its regulations to revise the list of drug products that have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective. Drug products appearing on this list may not be compounded under the exemptions provided by sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the final rule adds two entries to this list of drug products.
Advancing Tobacco Control Practices To Prevent Initiation of Tobacco Use Among Youth and Young Adults, Eliminate Exposure to Secondhand Smoke, and Identify and Eliminate Tobacco-Related Disparities; Request for Information
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) leads comprehensive efforts to prevent the initiation of tobacco use among youth and young adults; eliminate exposure to secondhand smoke; help current smokers quit; and identify and eliminate tobacco-related disparities. In late 2017, CDC solicited input from the public in the Federal Register Notice 82 FR 50428 regarding nationwide priorities for cessation. CDC is currently reviewing and compiling public comments to inform future activities that could efficiently and cost effectively help people quit using tobacco by employing evidence-based treatment options. CDC will share the outcome of this request for information with the public on a date to be determined. Now, CDC is seeking information to inform future activities to advance tobacco control practices that prevent initiation of tobacco use among youth and young adults; eliminate exposure to secondhand smoke; and identify and eliminate tobacco-related disparities.
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