Department of Health and Human Services December 21, 2022 – Federal Register Recent Federal Regulation Documents

This rule would implement requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, enacted on March 30, 2010collectively, the Affordable Care Act. Specifically, this proposed rule would adopt standards for ``health care attachments'' transactions, which would support both health care claims and prior authorization transactions, and a standard for electronic signatures to be used in conjunction with health care attachments transactions. To better support the use of the proposed standards for attachments transactions with prior authorization transactions, this rule also proposes to adopt a modification to the standard for the referral certification and authorization transaction (X12 278) to move from Version 5010 to Version 6020.

The Food and Drug Administration (FDA or Agency) has determined that ZYBAN (Bupropion Hydrochloride) Tablets, Extended Release, 150 Milligrams, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled ``Best Practices for Convening a GRAS Panel.'' This guidance document is intended for any person who is responsible for a conclusion that a substance may be used in food on the basis of the generally recognized as safe (GRAS) provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) when that person convenes a panel of experts (``GRAS panel'') to independently evaluate whether the available scientific data, information, and methods establish that the substance is safe under the conditions of its intended use in human food or animal food. This guidance provides our current thinking on best practices to identify GRAS panel members who have appropriate and balanced expertise; to take steps to reduce the risk that bias (or the appearance of bias) will affect the credibility of the GRAS panel's output (often called a ``GRAS panel report''), including the assessment of potential GRAS panel members for conflict of interest and the appearance of conflict of interest; and to limit the data and information provided to a GRAS panel to public information (e.g., by not providing the GRAS panel with information such as trade secret information).

The Office of Child Care (OCC), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting a 3-year extension of the CCDF Consumer Education website and Reports of Serious Incidents and Death (Office of Management and Budget (OMB) #: 0970-0473, expiration date: April 30, 2023). There are no changes requested to the reporting requirements.

The Food and Drug Administration (FDA or Agency) is announcing the withdrawal of the guidance document entitled ``Enforcement Policy Regarding Federal VCPR Requirements to Facilitate Veterinary Telemedicine During the COVID-19 Outbreak,'' which was issued in March 2020. FDA is withdrawing this guidance document in recognition that the conditions that created the need for the enforcement policy have evolved, such that the policy is no longer needed.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.