Department of Health and Human Services July 27, 2023 – Federal Register Recent Federal Regulation Documents

The Regulatory Flexibility Act of 1980 and Executive Order (E.O.) 12866 require the semiannual issuance of an inventory of rulemaking actions under development throughout the Department, offering for public review summarized information about forthcoming regulatory actions.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations Premarket Notification (510(k)) Submissions.'' FDA is issuing this guidance to provide labeling recommendations for Hydrogen Peroxide- Based Contact Lens Care Products (HPCPs) submitted in premarket notification (510(k)) submissions. The labeling recommendations in this guidance are intended to promote the safe and effective use of HPCPs and help consumers receive and understand information regarding the benefits and risks associated with the use of the device.

On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance related to the ``generic'' clearance process. Generally, this is an expedited clearance process by which agencies may obtain OMB's approval of collection of information requests that are ``usually voluntary, low- burden, and uncontroversial,'' do not raise any substantive or policy issues, and do not require policy or methodological review. The process requires the submission of an overarching plan that defines the scope of the individual collections that may be submitted under that umbrella. This notice is intended to advise the public of our intent to extend OMB's approval of our MACPro (Medicaid and CHIP Program) umbrella and all of the individual generic collection of information requests that fall under that umbrella. This notice also provides the public with general instructions for obtaining documents that are associated with such collections and for submitting comments.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``CDER's Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality.'' This guidance describes a program at FDA's Center for Drug Evaluation and Research (CDER) to make public a comprehensive listing of recognized voluntary consensus standards related to pharmaceutical quality. This program facilitates submissions by external stakeholders and FDA staff proposing voluntary consensus standards related to pharmaceutical quality for recognition. CDER believes that this program will help promote innovation in pharmaceutical development and manufacturing and streamline the preparation and assessment of marketing applications for products regulated by CDER. This guidance finalizes the draft guidance of the same title issued on February 14, 2019.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Kemin Industries, Inc., proposing that the food additive regulations be amended to provide for the safe use of chromium propionate to be used as a source of chromium in turkey feed.

The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Diana Daffin 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 Ms. Daffin was convicted of a felony under Federal law for conduct that relates to the regulation of any drug product under the FD&C Act. Ms. Daffin was given notice of the proposed permanent debarment and was given an opportunity to request a hearing to show why she should not be debarred. As of April 2, 2023 (30 days after receipt of the notice), Ms. Daffin has not responded to the notice. Ms. Daffin's failure to respond and request a hearing within the prescribed timeframe constitutes a waiver of her right to a hearing concerning this action.