Department of Health and Human Services June 2018 – Federal Register Recent Federal Regulation Documents

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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 Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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 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 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 the recommended labeling of certain beers subject to our labeling jurisdiction.

The Food and Drug Administration (FDA or Agency) is announcing a public hearing to solicit comments on FDA's Predictive Toxicology Roadmap, which was issued by FDA on December 6, 2017. FDA is seeking comments on how to foster the development and evaluation of emerging toxicological methods and new technologies and incorporate these methods and technologies into regulatory review, as applicable.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on March 14, 2018. The notice announced the voluntary withdrawal of approval of four abbreviated new drug applications (ANDAs) from two applicants, effective April 13, 2018. In particular, the notice indicated that FDA was withdrawing approval of the following ANDA after receiving a withdrawal request from Sun Pharmaceutical Industries, Ltd., c/o Sun Pharmaceutical Industries, Inc. (Sun Pharmaceutical), 2 Independence Way, Princeton, NJ 08540: ANDA 076045, Lorazepam Tablets USP, 0.5 milligram (mg), 1 mg, and 2 mg. Before withdrawal of this ANDA became effective, however, Sun Pharmaceutical informed FDA that it did not want approval of the ANDA withdrawn. Because Sun Pharmaceutical timely requested that approval of this ANDA not be withdrawn, the approval of ANDA 076045 is still in effect.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Development of Non- Traditional Therapies for Bacterial Infections.'' The purpose of the public workshop is to discuss the general development considerations of non-traditional therapies, including pre-clinical development, early clinical studies, and phase 3 clinical trial designs to evaluate safety and efficacy.

This Request for Information (RFI) is intended to gather broad public input on the conduct of a multi-site national research effort to develop and test approaches for the systematic implementation and sustainability of an integrated set of evidence-based interventions across healthcare, behavioral health, justice systems, state and local governments, and community organizations to prevent and treat opioid misuse and Opioid Use Disorders (OUD). The goals are to decrease fatal and non-fatal overdoses, decrease the incidence of OUD and related infectious diseases (e.g., Hepatitis C and HIV), increase the number of individuals receiving medication-assisted treatment (MAT), increase the proportion retained in treatment beyond 6 months, and increase the number of individuals receiving needed recovery support services.

The Food and Drug Administration (FDA, Agency, or we) Center for Drug Evaluation and Research (CDER) is announcing two new efforts to gather feedback on the use of quality metrics to modernize pharmaceutical quality systems and advance innovation based on stakeholder feedback. These efforts include Type C formal meeting requests and pre-abbreviated new drug application (pre-ANDA) meeting requests, and a pilot study to gain feedback from those establishments for which Type C formal meetings or pre-ANDA meetings do not apply (e.g., active pharmaceutical ingredients (API) establishments, contract manufacturing organizations, over-the-counter (OTC) monograph products establishments, or marketed unapproved finished drug products establishments). Participation in either of these efforts is voluntary and the programs are intended to foster the joint efforts of FDA and stakeholders to further develop an FDA Quality Metrics Program. The FDA Quality Metrics Program aims to evaluate a new approach for regulatory oversight of pharmaceutical products through the collection of certain quality information developed and maintained in the course of manufacturing drugs under current good manufacturing practices. FDA intends to use quality metrics data to further develop the Agency's risk-based inspection scheduling (e.g., decreased surveillance inspection frequency for certain establishments) to improve the efficiency and effectiveness of establishment inspections, improve FDA's evaluation of drug manufacturing and control operations, and identify situations in which there may be a risk for drug supply disruption.

The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the HICPAC. The HICPAC consists of 14 experts in fields including but not limited to, infectious diseases, infection prevention, healthcare epidemiology, nursing, clinical microbiology, surgery, hospitalist medicine, internal medicine, epidemiology, health policy, health services research, public health, and related medical fields. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the committee's objectives. Nominees will be selected based on expertise in the fields of infectious diseases, infection prevention, healthcare epidemiology, nursing, environmental and clinical microbiology, surgery, internal medicine, and public health. Federal employees will not be considered for membership. Members may be invited to serve for four-year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of HICPAC objectives https:// www.cdc.gov/hicpac/.

This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Safety and Occupational Health Study Section, Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through June 30, 2020.

The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the U.S. Patents and Patent Applications listed in the Supplementary Information section of this notice to Atara Biotherapeutics Inc. (``Atara'') located in South San Francisco, CA.

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.

This action removes the outmoded regulations for the Ricky Ray Hemophilia Relief Fund Program. The program and its implementing regulation have been rendered obsolete by the statutory language in the authorizing legislation stating that the Fund should terminate on the expiration of the 5-year period beginning on the date of the enactment of the Act. The statute was enacted on November 12, 1998; thus, the fund expired on November 12, 2003.

The Food and Drug Administration (FDA or we) is announcing the following public meeting entitled ``FDA's Comprehensive, Multi-Year Nutrition Innovation Strategy.'' The purpose of the public meeting is to give interested persons an opportunity to discuss FDA's nutrition innovation strategy, including: A standard icon or symbol for the claim ``healthy''; a more efficient review strategy for evaluating qualified health claims; statements or claims that could facilitate innovation to promote healthful eating patterns; approaches for modernizing standards of identity; possible changes that could make ingredient information more consumer friendly; and FDA's educational campaign for consumers about the updated Nutrition Facts Label that consumers will be seeing in the marketplace.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Antimicrobial Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.