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

The Food and Drug Administration (FDA, the Agency, or we) is hosting a public meeting entitled ``Independent Third-Party Assessment of IND FDA-Sponsor Communication Practices in PDUFA VI,'' and an opportunity for public comment. The meeting will include a presentation from an independent third-party contractor about its assessment of FDA- sponsor communications during the investigational new drug (IND) stage of drug/biologic development in the Prescription Drug User Fee Act (PDUFA) VI; a series of presentations by and a panel discussion with invited regulatory and industry representatives, and an open public comment period. This meeting is intended to satisfy FDA's commitment to host a public meeting about the assessment no later than March 2021.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic 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.

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 Medicare and Medicaid Services (CMS) is requesting that a new information collection request (ICR) related to the Medicare Current Beneficiary Survey (MCBS) (OMB clearance 0938- 0568) be processed under the emergency clearance process. Due to CMS' determination that this collection of information is needed prior to the expiration of time periods established under its regulations, an emergency clearance is requested. Once the emergency information collection request is approved, CMS plans to seek public comments during the required 60-day and 30-day notice and comment periods associated with obtaining a standard (non-emergency) OMB approval for extending the information collection request as part of the MCBS (collected under 0938-0568). The approval of this information collection package is necessary because of the urgent need to obtain timely data to assess the impact of the coronavirus pandemic on the Medicare population. Adding a COVID-19 Supplement to the MCBS data collection in October 2020 will provide critical information to CMS and the public.

The Administration for Community Living (ACL) announces the intent to award a single-source supplement to the current cooperative agreement held by The National Council on Aging for the project Piloting the Remote Delivery of Falls Prevention Programs. The purpose of this supplement is to scale-up research activities for falls prevention interventions delivered remotely/virtually.

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 ``Awardee Lead Profile Assessment (ALPA).'' The ICR includes a survey to collect information to identify jurisdictional legal frameworks governing funded childhood lead poisoning prevention programs in the United States, and strategies for implementing childhood lead poisoning prevention activities in the United States.

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 Respiratory Protective Devices 42 CFR part 84Regulation. The purpose of the data collection is to enable 42 CFR part 84 respirator approval certification activities.

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 ``Reducing Fatigue Among Taxi Drivers'' with the goal of evaluating two interventions, a training and a wrist-device that provides personalized daily fatigue scores, designed to enable taxi drivers to reduce their fatigue levels. This research study involves two parts: Development of a fatigue management eLearning training tool designed for drivers-for-hire (e.g., taxi drivers; ride sourcing drivers); and an evaluation of the effectiveness of this training alone and paired with the wrist-device that provides personalized daily fatigue scores.

This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Advisory Committee on Breast Cancer in Young Women (ACBCYW), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through June 17, 2022.

In accordance with the Federal Advisory Committee Act, the CDC, announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public. Time will be available for public comment. The meeting will be webcast live via the World Wide Web.

In accordance with the requirements of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is establishing a new department-wide system of records, 09-90-2001, Records Used for Surveillance and Study of Epidemics, Preventable Diseases and Problems. The new system of records replaces, and is broader than, a similar system of records maintained by HHS' Centers for Disease Control and Prevention (CDC), which HHS is rescinding in this notice, 09-20-0113 Epidemic Investigation Case Records.

The Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), is proposing an order to revoke the approved method for detecting residues of carbadox, a carcinogenic new animal drug used in swine feed. An approved method is required by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as implemented by regulation, to show that no residue of carcinogenic concern from a new animal drug persists in any edible tissue or in any food derived from treated animals. The currently approved method measures quinoxaline-2-carboxylic acid (QCA) as a marker residue to detect the presence of any residue of carcinogenic concern. CVM is proposing to revoke the approved method for carbadox based on our determination that it is inadequate to monitor residue of carcinogenic concern in compliance with FDA's operational definition of no residue because there is no established relationship between QCA measured by the approved method and the residue of carcinogenic concern.

This final notice announces our decision to approve The Joint Commission (TJC) for continued recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs.

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) has realigned functions under the Office of the Deputy Assistant Secretary for Administration (ODASA). This realignment establishes the Office of Transformation, Business, and Management; establishes the Office of Government Contracting Services; realigns functions currently organized under the Immediate Office, Office of Workforce Planning and Development, and Office of Financial Services; and renames the Office of Financial Services to the Office of Grants Policy.

In accordance with the Federal Advisory Committee Act, HHS is hereby giving notice that the Advisory Commission on Childhood Vaccines (ACCV) charter has been renewed. The effective date of the renewed charter is July 20, 2020.

In accordance with the requirements of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is establishing a new system of records, 09-90-2002, ``COVID-19 Insights Collaboration Records.'' HHS will use the records in this system of records to create and maintain a new database to be used by HHS to understand, track, and respond to the novel coronavirus known as SARS- CoV-2 and the outbreak of COVID-19 (the disease caused by SARS-CoV-2) which the Secretary of Health and Human Services declared a public health emergency effective January 27, 2020, and the World Health Organization (WHO) declared a pandemic on March 11, 2020. Creating and maintaining the new database may include retrieving identifiable records about patients by the patients' personal identifiers in order to connect, combine, or de-duplicate records that are about the same individual; however, at this time, HHS does not plan to retrieve records by personal identifier when using the resulting database for research, analysis, or other public health activities.