Department of Health and Human Services November 14, 2022 – Federal Register Recent Federal Regulation Documents
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Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin; International Council for Harmonisation; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation. The draft guidance updates the ICH guidance for industry ``Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin'' issued in September 1998 to reflect advances in scientific knowledge and regulatory expectations. The draft guidance is intended to describe risk-based principles and mitigation strategies to assure the viral safety of biotechnology products, including the data necessary to submit in a marketing application.
Charter Renewal for the Advisory Committee on Heritable Disorders in Newborns and Children
In accordance with the Federal Advisory Committee Act (FACA) and the Public Health Service (PHS) Act, HHS is hereby giving notice that the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) has been renewed. The effective date of the charter renewal is November 10, 2022.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-July Through September 2022
This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from April through June 2022, relating to the Medicare and Medicaid programs and other programs administered by CMS.
Determination of Regulatory Review Period for Purposes of Patent Extension; PREVYMIS IV Solution, New Drug Application 209940
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for PREVYMIS IV Solution, new drug application (NDA) 209940, and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; PREVYMIS, New Drug Application 209939
The Food and Drug Administration (FDA, Agency, or we) has determined the regulatory review period for PREVYMIS, new drug application (NDA) 209939, and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Medicare and Medicaid Programs; Announcement of Application From a Hospital Requesting Waiver for Organ Procurement Service Area
This notice acknowledges the receipt of an application from a hospital that has requested a waiver of statutory requirements that would otherwise require the hospital to enter into an agreement with its designated organ procurement organization (OPO). This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.
Medicare and Medicaid Programs; Announcement of Application From a Hospital Requesting Waiver for Organ Procurement Service Area
This notice acknowledges the receipt of an application from a hospital that has requested a waiver of statutory requirements to enter into an agreement with an organ procurement organization (OPO) other than its designated organ procurement organization. This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.
Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance entitled ``Referencing the Definition of `Device' in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents.'' FDA is issuing this guidance to promote clarity regarding references to the terms ``device'' and ``counterfeit device'' in guidance, regulatory documents, communications, and other public documents.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Data To Support Social and Behavioral Research as Used by the Food and Drug Administration
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.
Protection of Human Subjects and Institutional Review Boards, and Institutional Review Boards; Cooperative Research; Extension of Comment Period
The Food and Drug Administration (FDA or the Agency) is extending the comment period for two proposed rules that appeared in the Federal Register of September 28, 2022. In the proposed rule entitled ``Protection of Human Subjects and Institutional Review Boards,'' FDA requested comments on proposed changes to its regulations regarding obtaining and documenting informed consent from research participants, and institutional review board membership and functions, including continuing review (Docket No. FDA-2021-N-0286). In the proposed rule entitled ``Institutional Review Boards; Cooperative Research,'' FDA requested comment on a change to its regulations that would require any institution located in the United States participating in FDA-regulated cooperative research to rely on approval by a single institutional review board (IRB) for that portion of the research that is conducted in the United States, with some exceptions (Docket No. FDA-2019-N-2175). The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
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