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

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters Premarket Notification (510(k)) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff.'' The FDA is issuing this draft guidance document to provide recommendations for 510(k) submissions for peripheral percutaneous transluminal angioplasty (PTA) balloons and specialty catheters (e.g., infusion catheters, PTA balloon catheters for in-stent restenosis (ISR), scoring/cutting balloons). This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA or we) is announcing a public meeting entitled ``Testing Methods for Asbestos in Talc and Cosmetic Products Containing Talc.'' The purpose of the public meeting is to discuss and obtain scientific information on topics related to testing methodologies, terminology, and criteria that can be applied to characterize and measure asbestos and other potentially harmful elongate mineral particles (EMPs) that may be present as contaminants in talc and cosmetic products manufactured using talc as an ingredient.

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public, limited only by room seating. The meeting room accommodates 216 for public seating. Room 245, adjacent to the meeting room, will be available once the meeting room reaches capacity, providing up to 18 additional seats. Time will be available for public comment. The meeting will be webcast live via the World Wide Web; for meeting registration and more information on ACIP please visit the ACIP website: https://www.cdc.gov/vaccines/acip/ index.html.

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 information collection associated with our General Administrative Practice and Procedures regulations.

The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of 249 abbreviated new drug applications (ANDAs) from multiple holders of those ANDAs and is announcing an opportunity for the ANDA holders to request a hearing on this proposal. The basis for the proposal is that these ANDA holders have repeatedly failed to file required annual reports for those ANDAs.

The Office of Planning, Research, and Evaluation (OPRE) within the Administration for Children and Families (ACF) is proposing data collection activities conducted for the Next Generation of Enhanced Employment Strategies (NextGen) Project. The objective of this project is to identify and rigorously evaluate innovative interventions designed to promote employment and economic security among low-income individuals with complex challenges to employment. The project will include an experimental impact study, descriptive study, and cost study.

The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice entitled ``Drug Products Labeled as Homeopathic; Draft Guidance for Food and Drug Administration Staff and Industry'' that appeared in the Federal Register of October 25, 2019. The Agency is taking this action to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 19 new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

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 Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``Modernizing FDA's Data Strategy.'' The purpose of the public meeting and the request for comments is to discuss possible Agency level approaches to modernizing FDA's data strategy, including approaches to data quality, data stewardship, data exchange, and data analytics.

The Food and Drug Administration (FDA) is announcing the revocation of three Emergency Use Authorizations (EUAs) (the Authorizations) issued to OraSure Technologies, Inc. (OraSure) for the OraQuick Ebola Rapid Antigen Test used with whole blood specimens; OraSure for the OraQuick Ebola Rapid Antigen Test used with cadaveric oral fluid swab specimens; and DiaSorin Inc. (DiaSorin) for the LIAISON XL Zika Capture IgM II assay. FDA revoked both of OraSure's Authorizations on October 10, 2019, under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), in consideration of a De Novo classification request granted to OraSure for the OraQuick Ebola Rapid Antigen Test on October 10, 2019. FDA revoked DiaSorin's Authorization on October 28, 2019, under the FD&C Act, in consideration of the premarket clearance of DiaSorin's LIAISON XL Zika Capture IgM II assay, which FDA determined to be substantially equivalent to a legally marketed class II predicate device on October 28, 2019. The revocations, which include an explanation of the reasons for each revocation, are reprinted in this document.

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).