Department of Health and Human Services August 19, 2020 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or we) is announcing the availability of a statement added to the docket for the public meeting entitled ``Testing Methods for Asbestos in Talc and Cosmetic Products Containing Talc'' to address information provided in connection with the public meeting. FDA held the public meeting on February 4, 2020, to discuss and obtain scientific data and information on topics related to cosmetic products with talc as an ingredient, specifically, testing methodologies, terminology, and criteria that could be applied to characterize and measure asbestos and other potentially harmful elongate mineral particles (EMPs) that may be present as contaminants in such products. The meeting included presentations by members of an interagency working group (the Interagency Working Group on Asbestos in Consumer Products or IWGACP).

In accordance with the Federal Advisory Committee Act, the CDC, announces the following meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This meeting is open to the public, limited only by the ports available. The audio conference line has 150 ports for callers. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcome to listen to the meeting by joining the teleconference (information below).

The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a 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 the Proposed Revision and solicits comments on the information collection requirements related to Certification of Maintenance of Effort for Title III and Certification of Long Term Care Ombudsman Program Expenditures.

The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry entitled ``Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c).'' This guidance describes FDA's policy concerning the conditions under which the Agency generally does not intend to take regulatory action against an applicant or a contract research organization (CRO) that retains less than the quantity of reserve samples (that is, samples of the test article and reference standard that were used in bioavailability (BA) or bioequivalence (BE) testing) required in our regulations. FDA developed this guidance in light of technological advances in FDA's ability to test retention samples and in response to communications from applicants and CROs requesting to retain a lower quantity of these reserve samples.