Department of Health and Human Services October 1, 2021 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) 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.

The ACF, OHSEPR announces the intent to award four single- source grants in the amount of up to $300,000 to the following recipients: United Way Worldwide, Alexandria, VA; National Association of Social Workers, Washington, DC; American Public Human Services Association, Arlington, VA; and National Association of County Human Services Administrators, Washington, DC. The purpose of these awards is to facilitate the coordination of human services to U.S. Citizens and their dependents evacuating to the United States from Afghanistan. These organizations are key players in the leadership, coordination, or direct provision of human services after an emergency and have direct access to their constituencies and networks. U.S. citizens and their dependents (repatriates) eligible for temporary assistance under the U.S. Repatriation Program can receive up to 90 days of temporary assistance which includes transportation, food, medical care, cash assistance, temporary lodging, and case management. These awards will ensure appropriate training and technical assistance, coordination, and subject matter expertise as repatriates connect to human services entities.

The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines).

The Food and Drug Administration (FDA, Agency, or we) 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 requests comments on the information collection associated with FDA research in obtaining information from pharmacists and other management at outsourcing facilities and related human prescription drug compounding businesses. The research supports a comprehensive analysis of the outsourcing facility sector that informs ongoing FDA work in this area.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of June 25, 2021. The document announced the withdrawal of approval of 36 abbreviated new drug applications (ANDAs) from multiple applicants as of July 26, 2021. The document indicated that FDA was withdrawing approval of the following ANDA, after receiving a withdrawal request from Yung Shin Pharmaceutical Ind. Co. Ltd., authorized U.S. agent, Carlsbad Technology, Inc./Simon Law, 5922 Farnsworth Ct., Suite 101, Carlsbad, CA 92008: ANDA 065152, Cephalexin Capsules, Equivalent to (EQ) 250 milligrams (mg) base and EQ 500 mg base. Before FDA withdrew the approval of this ANDA, Yung Shin Pharmaceutical Ind. Co. Ltd. informed FDA that it did not want the approval of the ANDA withdrawn. Because Yung Shin Pharmaceutical Ind. Co. Ltd. timely requested that approval of this ANDA not be withdrawn, the approval of ANDA 065152 is still in effect.

The Food and Drug Administration (FDA or we) 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.

The U.S. Department of Health and Human Services (HHS) Office of Minority Health (OMH) hereby gives notice that OMH is establishing a Center for Indigenous Innovation and Health Equity Tribal Advisory Committee (CIIHE TAC) and accepting nominations of qualified candidates to serve as primary and alternate delegates for the CIIHE TAC, in alignment with the 12 geographic areas served by the Indian Health Service (IHS).