Department of Health and Human Services February 25, 2019 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities; Proposed Collection; Comment Request; Focused Mitigation Strategies To Protect Food Against Intentional Adulteration
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on collections of information describing mitigation strategies to protect food against intentional adulteration.
Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations; Reopening of Comment Period
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the proposed rule that appeared in the Federal Register of November 15, 2018. In the Federal Register of December 20, 2018, the Agency extended the comment period until February 13, 2019. The Agency is taking this action to reopen the comment period to allow interested persons additional time to submit comments due to technical issues with the Federal eRulemaking Portal (https://www.regulations.gov) on February 13, 2019.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level
The Food and Drug Administration (FDA or Agency) 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.
Meeting of the Advisory Committee on Organ Transplantation
In accordance with the Federal Advisory Committee Act (FACA), this notice announces that the Secretary's Advisory Committee on Organ Transplantation (ACOT) has scheduled a public meeting. Information about ACOT and the agenda for this meeting can be found on the ACOT website at https://www.organdonor.gov/about-dot/acot.html.
Meeting of the Advisory Council on Blood Stem Cell Transplantation
In accordance with the Federal Advisory Committee Act (FACA), this notice announces that the Secretary's Advisory Council on Blood Stem Cell Transplantation (ACBSCT) has scheduled a public meeting. Information about ACBSCT and the agenda for this meeting can be found on the ACBSCT website at https://bloodcell.transplant.hrsa.gov/about/ advisory_council/meetings/.
National Advisory Council on the National Health Service Corps
In accordance with the Federal Advisory Committee Act, the National Advisory Council on the National Health Service Corps (NACNHSC) has scheduled public meetings for the 2019 calendar year (CY). Information about the NACNHSC, agendas, and materials for these meetings can be found on the NACNHSC website at https://nhsc.hrsa.gov/ about/national-advisory-council-nhsc/.
Request for Information Regarding Grandfathered Group Health Plans and Grandfathered Group Health Insurance Coverage
This document is a request for information regarding grandfathered group health plans and grandfathered group health insurance coverage. Given the limited information available regarding such coverage, the Department of the Treasury, the Department of Labor, and the Department of Health and Human Services (the Departments) are issuing this request for information to gather input from the public in order to better understand the challenges that group health plans and group health insurance issuers face in avoiding a loss of grandfathered status, and to determine whether there are opportunities for the Departments to assist such plans and issuers, consistent with the law, in preserving the grandfathered status of group health plans and group health insurance coverage in ways that would benefit employers, employee organizations, plan participants and beneficiaries, and other stakeholders.
Implanted Brain-Computer Interface Devices for Patients With Paralysis or Amputation-Nonclinical Testing and Clinical Considerations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Implanted Brain- Computer Interface Devices for Patients with Paralysis or Amputation Nonclinical Testing and Clinical Considerations.'' Implanted brain-computer interface (BCI) devices are neuroprostheses that interface with the central or peripheral nervous system to restore lost motor and/or sensory capabilities in patients with paralysis or amputation. This draft guidance provides recommendations for nonclinical testing and study design considerations for investigational device exemptions feasibility and pivotal clinical studies. This draft guidance is not final nor is it in effect at this time.
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance.
World Trade Center Health Program; Petition 020-Stroke; Finding of Insufficient Evidence
On August 26, 2018, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 020) to add ``two forms of stroke, both ischemic and non-aneurysmal hemorrhagic,'' to the List of WTC-Related Health Conditions (List). Upon reviewing the scientific and medical literature, including information provided by the petitioner, the Administrator has determined that the available evidence does not have the potential to provide a basis for a decision on whether to add stroke to the List. The Administrator also finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.
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