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

HRSA is providing supplemental funding for one year to the current recipients of HRSA-15-021, Quality Improvement Capacity for Impact Project.

This document corrects a technical error that appeared in the final notice published in the Federal Register on September 28, 2020 entitled ``Medicare Program; Approval of Application by The Compliance Team for Initial CMS-Approval of Its Home Infusion Therapy Accreditation Program.''

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 ``Online training for law enforcement to reduce risks associated with shift work and long work hours.'' This study will develop and pilot test a new, online, interactive training program tailored for the law enforcement community that relays the health and safety risks associated with shift work, long work hours, and related workplace sleep issues, and presents strategies for managers and officers to reduce these risks.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. to achieve expeditious commercialization of results of federally-funded research and development.

The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Secretary of HHS has determined that establishment of the Medicaid Reentry Stakeholder Group, as required by the Medicaid Reenty Act, is desirable to provide advice and consultation to the Secretary on innovative strategies to help individuals who are inmates of public institutions, and otherwise eligible for Medicaid, ensure continuity of coverage and seamless transitions back to the community. HHS is soliciting nominations for non-Federal members of the Stakeholder Group.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, and Combination Products under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act.'' This guidance describes recommended procedures to obtain a National Drug Code (NDC) for certain FDA-approved prescription drugs that are imported into the United States in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act), which would provide an additional avenue through which these drugs could be sold at a lower cost in the U.S. market. This guidance is intended to address certain challenges in the private market faced by manufacturers seeking to sell their drugs at lower costs. This guidance finalizes the draft guidance issued on December 23, 2019.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic PotentialQuestions and Answers.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. The draft guidance contains revised questions and answers (Q&As) for the ICH guidance for industry ``E14 Clinical Evaluation of the QT/ QTc Interval Prolongation and Proarrhythmic Potential for Non- Antiarrhythmic Drugs'' and new Q&As for the ICH guidance for industry ``S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals'' that provide recommendations on considerations for an integrated risk assessment combining nonclinical and clinical datain particular, at later stages of drug development when clinical data are available. The draft guidance is intended to provide a harmonized approach to integrate nonclinical and clinical information for proarrhythmia risk assessment to streamline drug development and provide clarity on regulatory decision making.

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 Strengthening U.S. Response to Resistant Gonorrhea, which is to intended to enhance U.S. state and local public health surveillance and program infrastructure, build capacity to support rapid detection and public health response to antibiotic-resistant gonorrhea (an urgent public health threat), and advance the understanding of epidemiological factors contributing to antibiotic-resistant gonorrhea. CDC is requesting a three-year approval.

The Office on Trafficking in Persons (OTIP), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data for a new survey, the National Advisory Committee on the Sex Trafficking of Children and Youth in the United States (NAC) Recommendations and State Self- Assessment Survey.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the rescission of an Agency Order that was published in the Federal Register on February 24, 2020.

The Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing a two-wave data collection as part of the National Survey of Early Care and Education (NSECE) (OMB #0970-0391), which will be conducted October 2020 through June 2021. The objective of the NSECE COVID-19 Follow-up is to document the nation's current supply of early care and education (ECE) services that is home-based providers, center-based providers, and the center-based provider workforce. In the context of the COVID-19 pandemic, the NSECE COVID-19 Follow-up will deepen our understanding of the state of ECE supply and the ECE workforce following the initial period of crisis, including changes in supply or departures from and re-entries to the workforce.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe.'' This guidance is intended to assist applicants in responding to complete response letters (CRLs) to abbreviated new drug applications (ANDAs) submitted to FDA under the Federal Food, Drug, and Cosmetic Act. This guidance provides information and recommendations regarding potential courses of action for an ANDA applicant after issuance of a CRL as well as the actions that FDA may take if the applicant fails to respond to a CRL. In addition, this guidance recommends information an applicant may submit in its request for an extension to respond to a CRL as well as a non-exhaustive list of factors that FDA will consider in determining whether such a request is reasonable.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.'' This guidance describes studies and information that FDA recommends be used when submitting premarket notifications (510(k)s) for blood glucose monitoring systems (BGMSs) that are for prescription point-of-care use.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic RiskQuestions and Answers.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. The draft guidance provides a practical approach that is applicable to the identification, categorization, qualification, and control of mutagenic impurities to limit potential carcinogenic risk. Since the ICH M7 Guideline was finalized, the worldwide experience with implementation of the recommendations for DNA reactive (mutagenic) impurities has given rise to requests for clarification relating to the assessment and control of DNA reactive (mutagenic) impurities. To facilitate the implementation of the ICH M7 Guideline, the ICH M7 Implementation Working Group has developed a series of questions and answers (Q&As). The scope of this draft Q&A guidance follows that of the ICH M7 Guideline. The draft Q&A guidance is intended to clarify, promote the convergence of, and improve the harmonization of the considerations for assessment and control of DNA reactive (mutagenic) impurities and of the information that should be provided when developing drugs, completing marketing authorization applications, and using drug master files.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment.'' Sponsors may encounter challenges in identifying methods to assess the numerous and heterogeneous Coronavirus Disease 2019 (COVID-19)-related symptoms across subjects when designing clinical trials of drugs to treat or prevent COVID-19 in adult and adolescent outpatient subjects. To assist sponsors, this guidance describes an example with a set of common COVID-19-related symptoms as well as an approach to their measurement for use in clinical trials. Given the public health emergency presented by COVID- 19, this guidance document is being implemented without prior public comment because FDA has determined that prior public participation is not feasible or appropriate, but it remains subject to comment in accordance with the Agency's good guidance practices.