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

This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Clinical Laboratory Improvement Advisory Committee (CLIAC), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through February 19, 2022.

In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency.'' On February 4, 2020, the Secretary of Health and Human Services (HHS) determined that there is a public health emergency and that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the novel coronavirus (2019-nCoV). Rapid detection of Coronavirus Disease-2019 (COVID-19) cases in the United States requires wide availability of diagnostic testing to control the emergence of this rapidly spreading, severe illness. This guidance describes a policy regarding laboratories using tests they develop and validate before FDA has issued an Emergency Use Authorization (EUA) for their test in order to achieve more rapid testing capacity in the United States. The guidance document is immediately in effect, but it remains subject to comment in accordance with the Agency's good guidance practices.

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 or Agency) is announcing the availability of a draft guidance for industry entitled ``Inclusion of Older Adults in Cancer Clinical Trials.'' This draft guidance provides recommendations regarding the inclusion of older adult patients in clinical trials of drugs for the treatment of cancer. For the purpose of this draft guidance, older adults are those age 65 years and older. The draft guidance emphasizes the particular importance of including adults over age 75 years in cancer clinical trials. Specifically, this draft guidance includes recommendations for including an adequate representation of older adults in cancer clinical trials to better enable evaluation of the benefit-risk profile of cancer drugs in this population.

The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice entitled ``Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff; Draft Document; Availability; Establishment of Public Docket; Request for Comments'' that appeared in the Federal Register of November 7, 2019. The Agency is taking this action to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA, the Agency, or we) is finalizing a ban on electrical stimulation devices (ESDs) for self- injurious or aggressive behavior. FDA has determined that these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling. This ban includes both new devices and devices already in distribution and use; however, this ban provides transition time for those individuals currently subject to ESDs for the identified intended use to transition off ESDs under the supervision of a physician.

Through this Request for Information (RFI), the Administration for Children and Families (ACF), in the U.S. Department of Health and Human Services (HHS), seeks to further the development of employment programs for nonresident parents by soliciting information and recommendations from a broad array of stakeholders in the public and private sectors, including state, regional, tribal, and local areas. The Foundations for Evidence-Based Policymaking Act of 2018 (Evidence Act) requires federal agencies to develop evidence-building plans to identify and address policy questions relevant to programs, policies, and regulations of the agency. In this vein, ACF will analyze information collected from this RFI to continue developing a learning and action agenda to better understand the effectiveness of employment programs for nonresident parents.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``The `Deemed To Be a License' Provision of the BPCI Act: Questions and Answers.'' This guidance is intended to provide answers to common questions about FDA's implementation of the statutory provision under which an application for a biological product approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as of March 23, 2020, will be deemed to be a license for the biological product under the Public Health Service Act (PHS Act) on March 23, 2020. This guidance also describes FDA's compliance policy for the labeling of biological products that will be the subject of deemed biologics license applications (BLAs). This guidance is intended to facilitate planning for the March 23, 2020, transition date and provide further clarity regarding the Agency's implementation of this statutory provision. This guidance finalizes the draft guidance of the same title issued on December 12, 2018.

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 Food and Drug Administration (FDA or Agency) is announcing the withdrawal of a guidance for industry entitled ``Exocrine Pancreatic Insufficiency Drug ProductsSubmitting NDAs,'' which was issued in 2006. The guidance set forth the Agency's thinking on data and information that may support a new drug application (NDA) for a proposed pancreatic enzyme product (PEP) that contains pancreatin or pancrelipase and is intended for the treatment of exocrine pancreatic insufficiency (EPI). FDA is withdrawing the guidance because an NDA for such a product may not be submitted after March 23, 2020. Sponsors interested in submitting a biologics license application (BLA) for a proposed PEP should contact the Agency with any questions.

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 recordkeeping requirements for manufacturers of medicated animal feeds.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Soft (Hydrophilic) Daily Wear Contact LensesPerformance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff.'' The device-specific guidance identified in this notice was developed in accordance with the final guidance entitled ``Safety and Performance Based Pathway.'' This draft guidance is not final nor is it in effect at this time.