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

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 welcome to listen to the meeting by teleconference; 200 teleconference lines are available, and registration is required.

HRSA is soliciting comments and recommendations regarding HRSA's intent to establish the HRSA Tribal Advisory Council (TAC) and is seeking nominations of qualified tribal officials as candidates for consideration for appointment as voluntary delegate members of the HRSA TAC. Due to delays caused by the global impact of the Coronavirus Disease 2019 (COVID-19), HRSA is extending the deadline for the submissions of nominations of qualified tribal officials for consideration for appointment as voluntary delegate members of the HRSA TAC. Nominations for membership must now be received on or before July 6, 2020. This 60-day extension will allow tribes and tribal serving organizations the additional time needed to identify qualified tribal officials as candidates and submit comprehensive nomination packages.

A goal of the Performance Measures and Adulthood Preparation Subjects (PMAPS) studies project is to collect, analyze, and report on performance measures data for the Personal Responsibility Education Program (PREP) programs. The Office of Planning, Research, and Evaluation (OPRE) and the Family and Youth Services Bureau (FYSB) in the Administration for Children and Families (ACF) request a revision to a currently approved information collection (OMB No. 0970-0497; expiration date: 04/30/2020). The purpose of the request is to make adaptions to the participant entry and exit surveys, and continue the ongoing data collection of the performance measures from PREP grantees.

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 Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled ``Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements During the COVID-19 Public Health Emergency.'' 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. The guidance communicates the Agency's intention not to enforce certain requirements for the onsite monitoring activities and certificates for the currently recognized accreditation bodies (ABs) and accredited third-party certification bodies (CBs) in the Accredited Third-Party Certification Program for human and animal food in certain circumstances. Because travel restrictions and advisories related to COVID-19 may impact the ability of recognized ABs and accredited CBs to conduct onsite activities, this guidance provides temporary flexibility so that recognized ABs can maintain the accreditations of their CBs, and so that already-issued certifications need not lapse, in certain circumstances.

The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry entitled ``Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization (Revised).'' This is a revision to the guidance which describes, among other things, how FDA intends to prioritize its enforcement resources with regard to the marketing of ENDS products that do not have premarket authorization. FDA is revising this guidance to change the date required to submit premarket authorization applications to the Agency from May 12, 2020, to September 9, 2020.

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

The National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) hereby announces updates to the Best Pharmaceuticals for Children Act (BPCA) Program priorities for 2020-2021. The Best Pharmaceuticals for Children Act (BPCA) seeks to improve the level of information on the safe and effective use of pharmaceuticals used to treat children. The BPCA requires that the NIH identify the drugs of highest priority for study in pediatric populations, publish a list of drugs/needs in pediatric therapeutics, and fund studies in the prioritized areas. This notice will provide a brief update on the current progress of the BPCA Program and provide the current Priority List of Needs in Pediatric Therapeutics.

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 welcome to listen to the meeting by teleconference at 1-800-369-1817, and the passcode is 5200122; 200 teleconference lines are available. Registration is required. Interested parties may register at https:// www.cdc.gov/hicpac.

The Department of Health and Human Services (HHS), Office of Research Integrity (ORI) is seeking information and comments from entities and individuals regarding best practices for sequestering evidence during research misconduct proceedings under 42 CFR part 93. In particular, ORI is interested in learning about challenges and solutions in sequestering digital evidence, such as data stored in cloud environments and on personal electronic equipment or storage devices. ORI will use this information to prepare guidelines to support institutions carrying out research misconduct proceedings. Responses to the RFI must be received electronically at the email address provided below no later than 5:00 p.m. ET 45 days after the publication of this RFI. Interested parties are to submit comments electronically to OASH- ORI-Public-Comments@hhs.gov. Include ``Sequestration RFI'' in the subject line of the email. Mailed paper submissions and submissions received after the deadline will not be reviewed.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Centers for Disease Control and Prevention (CDC) announces the availability of the final CDC Recommendations for Hepatitis C Screening Among AdultsUnited States, 2020.

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 information collection provisions in FDA's infant formula recall regulations.

In accordance with the Federal Advisory Committee Act, this notice announces that the Secretary's Advisory Commission on Childhood Vaccines (ACCV) has scheduled a public meeting. Information about ACCV and the agenda for this meeting can be found on the ACCV website at https://www.hrsa.gov/advisory-committees/vaccines.

The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice, published in the Federal Register of January 3, 2020. In the notice, FDA opened a public docket to solicit input and comments from interested stakeholders, including racial and ethnic minority, underrepresented, and underserved populations on the Office of Minority Health and Health Equity Strategic Priorities (OMHHE). FDA is reopening the comment period to update comments and to receive any new information.

The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) is soliciting nominations for appointment of individuals qualified to serve as new members of the Community Preventive Services Task Force (CPSTF). New CPSTF members will serve a five-year term starting in 2021 or 2022. For efficiency and to reduce the burden on the public, the CPSTF nomination process seeks to fill vacancies anticipated for both calendar years 2021 and 2022.