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

HRSA is seeking nominations of qualified candidates for consideration for appointment as members of the Advisory Committee on Infant Mortality (ACIM). The ACIM provides advice to the Secretary of HHS on Department activities and programs directed at reducing infant mortality and improving the health status of pregnant women and infants. With a focus on life course, ACIM addresses disparities in maternal health to improve maternal health outcomes, including preventing and reducing maternal mortality and severe maternal morbidity. HRSA is seeking nominations of qualified candidates to fill positions on the ACIM.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA) and two abbreviated new animal drug applications (ANADAs) at the sponsors' request because the products are no longer manufactured or marketed.

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.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a revised draft guidance for industry, entitled ``Draft Guidance for Levonorgestrel.'' The revised draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for a levonorgestrel intrauterine device.

The Food and Drug Administration (FDA or Agency) has determined that CARDENE (nicardipine hydrochloride) injection, 25 milligrams (mg)/10 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for nicardipine hydrochloride injection, 25 mg/10 mL, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA or Agency) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Blood Products Advisory Committee (BPAC) for the Center for Biologics Evaluation and Research notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative(s) to serve on the BPAC. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for future vacancies effective October 1, 2020, with this notice.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Identifying Information Needs and Communication Channels for Reaching At-Risk Populations During Emergencies''. This information collections aims to understand the preferences, needs, and challenges of persons with limited English proficiency (LEP) in accessing and understanding health protection information during an infectious disease emergency as well as persons who will likely help them navigate and understand health information during an outbreak: Family, physicians, staff at community-based organizations, and staff at local public health agencies.

The Administration for Children and Families (ACF), Office of Planning, Research, and Evaluation is requesting public comment on new data collection activities to gather information about how Maternal, Infant, and Early Childhood Home Visiting (MIECHV) local implementing agencies (LIAs) recruit families for program participation and work with their community referral partners to recruit families. The project is designed to examine challenges programs experience reaching caseload capacity and how challenges might be overcome.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for MAVYRET and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claims that human drug product.

Notice is hereby given that the Indian Health Service (IHS) is establishing the geographic boundaries of the Purchased/Referred Care Delivery Area (PRCDA) (formerly Contract Health Service Delivery Area or CHSDA) for six newly recognized Tribes: The Chickahominy Indian Tribe, the Chickahominy Indian TribeEastern Division, the Upper Mattaponi Tribe, the Rappahannock Tribe, Inc., the Monacan Indian Nation, and the Nansemond Indian Tribe.

The Food and Drug Administration (FDA or we) is classifying the radiological computer-assisted diagnostic (CADx) software for lesions suspicious for cancer into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the radiological CADx software for lesions suspicious for cancer's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify medical image analyzers applied to mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection, postamendments class III devices (regulated under product code MYN), into class II (special controls), subject to premarket notification. These devices are intended to direct the clinician's attention to portions of an image that may reveal abnormalities during interpretation of patient radiology images by the clinician. FDA is also identifying the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device type.

Findings of research misconduct have been made against Ozgur Tataroglu, Ph.D. (Respondent), former postdoctoral fellow, Department of Neurobiology, University of Massachusetts Medical School (UMMS). Dr. Tataroglu engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), grants R01 GM066777 and R01 GM079182. The administrative actions, including supervision for a period of three (3) years, were implemented beginning on December 30, 2019, and are detailed below.

The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.

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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed study entitled ``Empirical Study of Promotional Implications of Proprietary Prescription Drug Names.''