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

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Geriatric Information in Human Prescription Drug and Biological Product Labeling.'' This draft guidance is intended to assist applicants of human prescription drug and biological products in determining the appropriate placement and content of geriatric information in labeling. The goal of this draft guidance is to provide recommendations to help ensure that appropriate information on the use of prescription drugs and biological products in geriatric patients is consistently placed in the proper sections and subsections within labeling so that the information is clear and accessible to health care practitioners and includes content that guides the safe and effective use in geriatric patients. This draft guidance provides additional examples of geriatric use statements in labeling and examples of when the labeling regulations authorize FDA to permit applicants to omit or revise specific information otherwise required in the Geriatric Use subsection. We are withdrawing the guidance for industry entitled ``Content and Format for Geriatric Labeling'' (October 2001) and replacing it with this draft guidance.

The Department of Health and Human Services, National Institutes of Health published a Final rule; technical amendments document in the Federal Register on September 1, 2020. That document requires a correction in the SUPPLEMENTARY INFORMATION section.

HRSA is providing notice of a technical issue in the collection of public comments responding to a previous Federal Register notice, dated August 20, 2020, submitted to the American Academy of Pediatrics through its publicly available web-based portal during the period from August 20-27, 2020. After receiving no comments during this timeframe, a routine test found that the database that records public comments was not connected to the comment form on the web page. This technical issue has been resolved and the system is functional and collecting comments. HRSA encourages members of the public who may have previous submitted comments to resubmit and is extending the time period for public comments in response to proposed updates to the Periodicity Schedule of the Bright Futures Recommendations for Pediatric Preventive Health Care (``Bright Futures Periodicity Schedule''). The Bright Futures Periodicity Schedule is part of the HRSA-supported preventive service guidelines for infants, children, and adolescents under, and is maintained, in part, through a national cooperative agreement, the Bright Futures Pediatric Implementation Program.

The Food and Drug Administration (FDA or Agency) is issuing this notice to request that public stakeholders, including patient and consumer advocacy groups, healthcare professionals, and scientific and academic experts notify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Generic Drug User Fee Amendments of 2017 (GDUFA). At the end of September 2022, new legislation will be required for FDA to continue collecting generic drug user fees for subsequent fiscal years for the generic drug program. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next GDUFA program. The FD&C Act also requires that FDA hold continued discussions with patient and consumer advocacy groups at least monthly during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these monthly discussions by establishing consistent stakeholder representation.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of September 2, 2020. The document announced the availability of post-marketing pediatric-focused safety reviews of products posted between September 23, 2019, and September 1, 2020, on FDA's website but not presented at the September 15, 2020, Pediatric Advisory Committee meeting. The document was published with the incorrect product name for one of the post-marketing pediatric-focused safety reviews listed under Center for Biologics Evaluation and Research. This document corrects that error.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Recognition and Withdrawal of Voluntary Consensus Standards; Guidance for Industry and Food and Drug Administration Staff.'' This guidance identifies the principles FDA uses for recognizing a standard, and it explains the extent of recognition and other supplementary information. It provides information on how you may request recognition as well as circumstances under which FDA may withdraw recognition. This guidance also responds to a provision of the 21st Century Cures Act (Cures Act) by updating published guidance on these topics.

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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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.

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 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 HIV Outpatient Study (HOPS). The Centers for Disease Control and Prevention is requesting a three-year extension to the previously approved project to continue collecting standardized HIV clinical and behavioral data at private HIV care practices and university based U.S. clinics participating in the HOPS.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, Center for Preparedness and Response, (BSC, CPR). This is a virtual meeting that is open to the public, limited only by the number of net conference access available, which is 500. Pre-registration is required by accessing the link at https://cdc.zoomgov.com/webinar/register/ WN_bV_Jrvp4QZGHZFao0moqPg.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Healthcare Infection Control Practices Advisory Committee (HICPAC). This meeting is open to the public, limited only by audio phone lines available. The public is also welcome to listen to the meeting by dialing 1-877-924-1748, passcode: 6118574. A total of 200 lines will be available. Registration is required. To register for this call, please go to www.cdc.gov/hicpac.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

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

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 the issuance of four Emergency Use Authorizations (EUAs) (the Authorizations) for drugs for use during the COVID-19 pandemic. FDA issued four Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as requested by the Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA), Fresenius Medical Care, Gilead Sciences, Inc., and Fresenius Kabi USA, LLC. The Authorizations contain, among other things, conditions on the emergency use of the authorized drugs. The Authorizations follow the February 4, 2020, determination by the Secretary of HHS that there is a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves a novel (new) coronavirus. The virus is now named SARS-CoV-2, which causes the illness COVID-19. On the basis of such determination, the Secretary of HHS declared on March 27, 2020, that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to the FD&C Act, subject to the terms of any authorization issued under that section. FDA is also announcing the subsequent revocation of the Authorization issued to BARDA for oral formulations of chloroquine phosphate and hydroxychloroquine sulfate. FDA revoked this authorization on June 15, 2020. The Authorizations, and the revocation, which include an explanation of the reasons for issuance or revocation, are reprinted in this document.

The Department of Health and Human Services (HHS) issues this final rule to amend the Foreign Quarantine Regulations administered by the Centers for Disease Control and Prevention (CDC). This final rule provides a procedure for the CDC Director to suspend the right to introduce and prohibit introduction, in whole or in part, of persons from such foreign countries or places as the Director shall designate in order to avert the danger of the introduction of a quarantinable communicable disease into the United States, and for such period of time as the Director may deem necessary for such purpose.

As required by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) will hold a meeting. The meeting will be open to the public. At the August ACBTSA meeting, the committee voted to form work groups to further develop and prioritize actionable recommendations to the Assistant Secretary for Health. For this meeting, the committee will discuss and vote on recommendations from the work groups to improve the blood community's response to future public health emergencies.