Department of Health and Human Services August 2023 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is correcting a notice entitled ``Statement of Organization, Functions, and Delegations of Authority'' that appeared in the Federal Register of August 14, 2023. The document announced amendments to the organization structure for FDA, Center for Devices and Radiological Health (CDRH), Office of Strategic Partnerships and Technology Innovation (OST). Although HHS approved these amendments on June 27, 2023, the Notice inadvertently omitted to include the following language: ``FDA will not implement the new organizational structure until after the necessary requirements are completed.'' This document corrects that error.

The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is seeking nominations for membership on the Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS). The BSC, NCHS consists of up to 15 experts including the Chair in fields associated with the scientific and technical program objectives of the Center.

This notice announces our decision to approve the Joint Commission for continued recognition as a national accrediting organization for critical access hospitals that wish to participate in the Medicare or Medicaid programs.

The Food and Drug Administration (FDA or Agency) is denying a request for a hearing submitted by David Roy Winne (Winne) and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Winne 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 Winne was convicted of multiple felonies under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. Winne was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Winne submitted a request for hearing but failed to file with the Agency information and analysis sufficient to create a basis for a hearing.

The Administration for Community Living (ACL) is providing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (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 a proposed extension without change information collection and solicits comments on the information collection requirements related to the project titled Assessing ACL's American Indian, Alaskan Natives and Native Hawaiian Programs (OMB Control Number 0985-0059).

HRSA will provide supplemental award funds to all 25 Sickle Cell Disease (SCD) Newborn Screening (NBS) Follow-up Program (FP) grantees for $56,000 each for fiscal year 2023. The funds will support in-scope grant activities related to health care services, increasing access to medical and social support services, and conducting outreach to help connect individuals living with SCD to follow-up care.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Cancer Prevention Program of the National Cancer Institute (NCI) is seeking a partner in the private sector to develop a vaccine directed against nicotine or a related molecule called arecoline, with the goal of reducing or eliminating the craving of such substance(s) in smokers or betel nut users.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (cNADAs) during April, May, and June 2023. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve their accuracy and readability.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors.'' The guidance announced in this notice is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of FDA- regulated products in carrying out their responsibilities related to informed consent. The guidance provides the Agency's recommendations regarding informed consent and describes FDA regulatory requirements to help assure the protection of the rights and welfare of human subjects in clinical investigations. This guidance finalizes the draft guidance entitled, ``Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors,'' issued on July 15, 2014, and supersedes FDA's guidance entitled ``A Guide to Informed Consent,'' issued in September 1998.

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 the information collection pertaining to the registration of human drug compounding outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and associated fees.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Ildiko M. Knoll for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Ms. Knoll engaged in a pattern of importing or offering for import misbranded drugs (i.e., in an amount, frequency, or dosage that is inconsistent with personal or household use) that are not designated in an authorized electronic data interchange system as products regulated by FDA. Ms. Knoll was given notice of the proposed debarment and was given an opportunity to request a hearing to show why she should not be debarred. As of May 29, 2023 (30 days after receipt of the notice), Ms. Knoll had not responded. Ms. Knoll's failure to respond and request a hearing constitutes a waiver of her right to a hearing concerning this matter.