Department of Health and Human Services January 12, 2022 – Federal Register Recent Federal Regulation Documents

On December 30, 2021, HRSA approved updates to the HRSA- supported Women's Preventive Services Guidelines (Guidelines) that address health needs specific to women. The Guidelines are based on clinical recommendations from the Women's Preventive Services Initiative (WPSI), a coalition of experts and health professional organizations convened by the American College of Obstetricians and Gynecologist (ACOG) under a cooperative agreement awarded by HRSA. Under the Public Health Service Act and pertinent regulations, preventive care and screenings for women provided for in comprehensive guidelines supported by HRSA are required to be covered without cost sharing by group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage. This 2021 update adds one additional service, Preventing Obesity in Midlife Women, and revises five services: Breastfeeding Services and Supplies, Contraception, Screening for Human Immunodeficiency Virus Infection, Counseling for Sexually Transmitted Infections, and Well-Woman Preventive Visits. This notice serves as an announcement of the decision to update the Guidelines as further described below. Please see https://www.hrsa.gov/womens-guidelines/ for additional information.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to pilot the collection of race and ethnicity data on Part C and D enrollment forms. 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 Office of Planning, Research, and Evaluation (OPRE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), proposes interview data collection activities for the Success Sequence Interviews study.

The Food and Drug Administration (FDA or the Agency) published a notice in the Federal Register of November 1, 2021, for the determination of a regulatory review period for purposes of patent extension for the human biological product, ENHERTU. This document corrects that notice by adjusting the applicable regulatory review period for the testing phase and approval phase of the product, ENHERTU.