Department of Health and Human Services September 2021 – 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 National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Commercialization Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Summary Information section of this notice to Blue Water Vaccines, Inc. (BWV), having a place of business in Cincinnati, Ohio, U.S.A.

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy (REMS) in an Evolving Opioid Crisis.'' Convened by the Duke-Margolis Center for Health Policy and supported by a cooperative agreement between FDA and Duke-Margolis, the purpose of the public workshop is to give stakeholders an opportunity to provide input on aspects of the current opioid crisis that could be mitigated in a measurable way by requiring mandatory prescriber education as part of a REMS. We expect interested stakeholders to include healthcare providers, healthcare professional associations, pharmacists, pharmacy benefit managers, public and private insurers, patient organizations, Federal and State Agencies, providers of continuing education for healthcare professionals, and the public. A second public workshop is being planned to solicit input on additional issues associated with a move to mandatory prescriber education under a REMS, such as operational and technical issues related to such a system and what should be included in potential mandatory prescriber education.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``S12 Nonclinical Biodistribution Considerations for Gene Therapy Products.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance provides harmonized recommendations for the conduct and overall design of nonclinical biodistribution (BD) studies for gene therapy (GT) products. Considerations for interpretation and application of the BD data to support a nonclinical development program and inform the design of clinical trials are also provided. The recommendations in the guidance endeavour to facilitate the development of investigational GT products, while avoiding unnecessary use of animals, in accordance with the 3Rs (reduce/refine/replace) principles. The draft guidance is intended to promote harmonization of recommendations for BD studies for investigational GT products and facilitate a more efficient and timely nonclinical development program.

The Food and Drug Administration (FDA, Agency, or we) is reopening the comment period for the draft guidance for industry entitled ``ICH Q12: Implementation Considerations for FDA-Regulated Products'' published in the Federal Register of May 20, 2021. FDA is reopening the comment period to allow interested persons additional time to submit comments.

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 Administration for Children and Families' (ACF) Office of Family Assistance plans to submit a generic information collection (GenIC) request under the umbrella generic: Generic Clearance for Financial Reports used for ACF Mandatory Grant Programs (0970-0510). This request includes a reporting form and associated instructions for financial information to be completed by grant recipients of Temporary Assistance for Needy Families (TANF) Pandemic Emergency Assistance Funding authorized by the American Rescue Plan Act of 2021.

The Food and Drug Administration (FDA) is requesting nominations for members to serve on the Tobacco Products Scientific Advisory Committee, in the Center for Tobacco Products. 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's (FDA) Center for Drug Evaluation and Research (CDER) is announcing a Novel Excipient Review Pilot Program (Pilot Program). The Pilot Program is voluntary and intended to allow excipient manufacturers to obtain FDA review of certain novel excipients prior to their use in drug formulations. The Pilot Program seeks to foster development of excipients that may be useful in scenarios in which excipient manufacturers and drug developers have cited difficulty in using existing excipients.

The Department of Health and Human Services, National Institutes of Health published a Notice in the Federal Register on August 31, 2021. That Notice requires a correction in the SUPPLEMENTARY INFORMATION section.

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH), Office of the Director (OD) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

In compliance with the requirement for the 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.

In accordance with the Federal Advisory Committee Act, the CDC announces the following virtual meeting for the World Trade Center Health Program Scientific/Technical Advisory Committee (WTCHP STAC). A notice of this WTCHP STAC meeting has also been posted on the committee website at: https://www.cdc.gov/wtc/stac_meeting.html.

The Food and Drug Administration (FDA, Agency, or we) 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 information collection associated with reclassification of medical devices.

The Food and Drug Administration (FDA or we) is announcing a virtual public meeting entitled ``FDA New Era of Smarter Food Safety Summit on E-Commerce: Ensuring the Safety of Foods Ordered Online and Delivered Directly to Consumers.'' The purpose of the public meeting is to engage with stakeholders and invite input on various topics pertaining to the implementation of Core Element 3.1 of the New Era of Smarter Food Safety Blueprint. We intend to use information resulting from the public meeting to determine what action(s), if any, should be taken to help ensure the safe production and delivery of human and animal foods sold through new e-commerce business models.

The Food and Drug Administration (FDA) is correcting a notice entitled ``Pediatric Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.'' The document announced a meeting of the Pediatric Advisory Committee. The document was published with the incorrect docket number and end time of the meeting. This document corrects those errors.

HHS gives notice of a determination concerning a petition to add a class of employees from Superior Steel Company, in Carnegie, Pennsylvania, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA).

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 Data Collection Through Web Based Surveys for Evaluating Act Against AIDS Social Marketing Campaign Phases Targeting Consumers. This proposed information collection activity includes the use of web surveys to test campaign messaging.