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

The Office of Refugee Resettlement (ORR) is requesting a 3- year extension of the application and Withdrawal of Application or Declination of Placement Form for the Unaccompanied Refugee Minors (URM) Program. Proposed revisions to each instrument are minimal. These forms were previously approved under OMB #0970-0498, expiration 7/31/ 2020. ORR is currently seeking a new OMB number specific to these forms, as they were previously approved as part of another information collection package for ORR's Unaccompanied Alien Children's program.

In accordance with the Federal Advisory Committee Act (FACA), HHS is hereby giving notice that the National Advisory Council on the National Health Service Corps (NACNHSC) Charter is amended. The effective date is February 20, 2020.

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 2021 and 2023 National Youth Risk Behavior Surveys (YRBS). CDC is requesting a three-year approval to reinstate, with changes, the data collection for the national YRBS, a biennially school-based survey of high school students 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 ``Delta Impact Cooperative Agreement Evaluation Data Collection Instruments'', to collect information from recipients related to program evaluation activities for cooperative agreement CDC-RFA-CE18-1801: Domestic Violence Prevention Enhancement and Leadership Through Alliances (DELTA) Impact.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Clinical Laboratory Improvement Advisory Committee (CLIAC). This meeting is open to the public, limited only by the space available. The meeting room accommodates approximately 100 people. The public is also welcome to view the meeting by webcast. Check the CLIAC website on the day of the meeting for the webcast link www.cdc.gov/cliac.

The Food and Drug Administration's (FDA or Agency) Center for Devices and Radiological Health (CDRH or Center) is announcing its voluntary Electronic Submission Template and Resource (eSTAR) Pilot Program. The eSTAR Pilot Program is voluntary and intends to improve consistency and efficiency in both industry's preparation and FDA's review of premarket notification (510(k)) submissions. During the voluntary eSTAR Pilot Program, pilot participants will have the opportunity to provide input to FDA on eSTAR.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.'' FDA has updated this guidance to implement the waiver improvements section of the 21st Century Cures Act (the Cures Act), which requires FDA to revise ``Section V. Demonstrating Insignificant Risk of an Erroneous ResultAccuracy'' of the guidance ``Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices'' (``2008 CLIA Waiver Guidance'') that was issued on January 30, 2008. The remainder of the 2008 CLIA Waiver Guidance, with exception of technical edits for consistency with the newly amended section V, has not been substantively changed. This final guidance provides additional and updated approaches for demonstrating that a test meets the statutory criteria for waiver and includes FDA's revised thinking regarding ``the appropriate use of comparable performance between a waived user and a moderately complex laboratory user to demonstrate accuracy.''

The Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (DHHS), announces the opening of a docket to obtain comment on the DRAFT Infection Control in Healthcare Personnel: Epidemiology and Control of Selected Infections Transmitted Among Healthcare Personnel and Patients: Diphtheria, Group A Streptococcus, Meningococcal Disease, and Pertussis Sections (``Draft Guideline''). The Draft Guideline updates four sections of the Guideline for infection control in health care personnel, 1998 (``1998 Guideline''), Part E: Epidemiology and Control of Selected Infections Transmitted Among Health Care Personnel and Patients, and their corresponding recommendations in Part II of the 1998 Guideline: ``4. Diphtheria;'' ``9. Meningococcal Disease;'' ``12. Pertussis;'' and ``18. Streptococcus, group A infection.'' The updated recommendations in the Draft Guideline are intended for use by the leaders and staff of Occupational Health Services (OHS) to facilitate the provision of occupational infection prevention and control (IPC) services to healthcare personnel (HCP) for the management of exposed or infected HCP who may be contagious to others in the workplace.

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 Agency) is announcing the availability of the draft guidance entitled ``Product Labeling for Laparoscopic Power Morcellators.'' This draft guidance proposes updated ``Contraindications'' and ``Warnings'' in product labeling information to reflect the state of the science and available technology regarding use of laparoscopic power morcellators (LPMs). This draft guidance is not final nor is it in effect at this time.

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 or we) is announcing that we have filed a petition, submitted by Unilever, proposing that the food additive regulations be amended to provide for the safe use of potassium iodate in salt added to select food categories as a source of dietary iodine.

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.

Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP website at: http:/ /www.dhhs.gov/ohrp/sachrp-committee/meetings/.

In compliance with the Paperwork Reduction Act of 1995 (PRA), the Indian Health Service (IHS) invites the general public to comment on the information collection titled, ``Indian Health Service Medical Staff Credentials,'' OMB Control Number 0917-0009, that expires February 29, 2020. This proposed information collection project was previously published in the Federal Register (84 FR 70197) on December 20, 2019, and allowed 60 days for public comment, as required by the PRA. The IHS received one comment regarding this collection. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB.

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 Youth Outreach Generic Clearance for the National Center for Health Statistics. This generic clearance is designed to facilitate outreach efforts in the fields of math and science to young people (K through college) and those who support them.

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 ``Occupational Driver Safety at Intersections.'' The purpose of this data collection is to gather experimental information in the CDC Motor Vehicle Safety Research Laboratory on the effects of occupation, vehicle type, vehicle approach speed, signal light logic, and emergency response status on emergency vehicle driver decision-making at intersections. The information will also be used to formulate science-based safety recognition training materials and an advanced driver assistant tool to enhance occupational driver (e.g., law enforcement officers and firefighters) safety at intersections.