Department of Health and Human Services January 7, 2020 – Federal Register Recent Federal Regulation Documents

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 provisions of our regulations related to public index listing of legally marketed unapproved new animal drugs for minor species of animals.

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.

On December 17, 2019, HRSA approved an update to the HRSA- supported Women's Preventive Services Guidelines (Guidelines) that addresses health needs specific to women. The Guidelines are based on clinical recommendations from the Women's Preventive Services Initiative. Preventive care and screenings for women provided for in comprehensive guidelines supported by HRSA are required to be covered without cost-sharing by non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage. This 2019 update adds one additional serviceScreening for Anxietyto the HRSA-supported Women's Preventive Services Guidelines to the 11 preventive services that were last updated in 2017. The 11 services included in the 2017 update are: Breast Cancer Screening for Average Risk Women, Breastfeeding Services and Supplies, Screening for Cervical Cancer, Contraception, Screening for Gestational Diabetes Mellitus, Screening for Human Immunodeficiency Virus Infection, Screening for Interpersonal and Domestic Violence, Counseling for Sexually Transmitted Infections, Well-Woman Preventive Visits, Screening for Diabetes Mellitus after Pregnancy, and Screening for Urinary Incontinence. This notice serves as an announcement of the decision to update the guidelines as listed below. Please see https:// www.hrsa.gov/womens-guidelines/ for additional information.

The Agency for Healthcare Research and Quality (AHRQ) invites nominations of individuals qualified to serve as members of the U.S. Preventive Services Task Force (USPSTF).

The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry entitled ``Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization.'' The guidance describes, among other things, how FDA intends to prioritize its enforcement resources with regard to the marketing of ENDS products that do not have premarket authorization.