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

HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``AHRQ Managing Unhealthy Alcohol Use in Primary Care Initiative.''

The Administration for Children and Families (ACF) is requesting a 3-year extension of the Children's Justice Act Program Instruction (OMB #0970-0425, expiration 4/30/2020). There are no changes requested to the form.

The meeting of the Allergenic Products Advisory Committee scheduled for May 15, 2020, is canceled. The Allergenic Products Advisory Committee meeting scheduled for May 15, 2020, to discuss and make recommendations on the safety and efficacy of Peanut (Arachis hypogaea) Allergen Extract manufactured by DBV Technologies, S.A, has been canceled to allow time for the FDA to review outstanding issues. The Agency intends to continue evaluating the product and will schedule an Advisory Committee meeting in the future, as needed. The meeting was announced in the Federal Register on February 24, 2020.

The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act. On February 4, 2020, the Secretary determined pursuant to his authority under section 564 of the FD&C Act that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves a novel (new) coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China in 2019 (2019-nCoV). The virus is now named SARS-CoV-2, which causes the illness COVID-19. On the basis of this determination, he also declared that circumstances exist justifying the authorization of emergency use of medical devices, including alternative products used as medical devices, pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.

The National Institute for Occupational Safety and Health (NIOSH), of the Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is adding coronavirus disease 2019 (COVID-19), the disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), to the List of Potentially Life-Threatening Infectious Diseases to Which Emergency Response Employees May be Exposed. The list and companion guidelines are published by NIOSH pursuant to the Ryan White HIV/AIDS Treatment Extension Act of 2009. NIOSH encourages medical facilities to review the agency's guidelines describing the manner in which medical facilities should make determinations on whether an emergency response employee was exposed to COVID-19, the disease caused by SARS-CoV-2.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Lead Exposure and Prevention Advisory Committee (LEPAC). This meeting is open to the public by web conference; however, advance registration is needed by April 15, 2020, to receive the information to join the meeting. The registration link is https://rossstrategic.zoom.us/webinar/register/ WN_I76JZ04RT5SVinnqu_tSYw. The public comment period is scheduled on April 29, 2020, from 1:45 p.m. until 2:00 p.m., EDT. Individuals wishing to make a comment during the public comment period, please email your name, organization, and phone number by April 15, 2020, to LEPAC@cdc.gov.

The Health Information Technology Advisory Committee (HITAC) was established in accordance with section 4003(e) of the 21st Century Cures Act and the Federal Advisory Committee Act. The HITAC, among other things, identifies priorities for standards adoption and makes recommendations to the National Coordinator for Health Information Technology (National Coordinator). The HITAC will hold public meetings throughout 2020. See list of public meetings below.

The Food and Drug Administration (FDA or we) is announcing the cancellation of following public meeting entitled ``International Cooperation on Cosmetics Regulation (ICCR)Preparation for ICCR-14 Meeting.'' The purpose of the public meeting was to invite public input on various topics pertaining to the regulation of cosmetics.

This Request for Information (RFI) is intended to gather broad public input to assist the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in developing the NIDDK Strategic Plan. NIDDK invites input from: The scientific research community; patients and caregivers; health care providers and health advocacy organizations; scientific and professional organizations; federal agencies; and other stakeholders, including interested members of the public. Organizations are strongly encouraged to submit a single response that reflects the views of their organization and their membership as a whole.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, National Center for Injury Prevention and Control, (BSC, NCIPC). This meeting is open to the public limited only by the ports available. There will be 2,000 telephone ports available. The public comment period will be at the end of the meeting from 3:00 p.m.-3:45 p.m., EDT. The public is encouraged to register to participate by telephone and/or provide public comment using the registration form available at the link provided: https://www.surveymonkey.com/r/P6ZN7QX. Written comments may also be submitted for the meeting record in advance using the registration form. Individuals registered to provide public comment will be called upon to speak based on the order of registration. After persons who have registered have spoken, any remaining time in the public comment period will be used for members of the public who have not registered, but wish to offer comment. Each individual making public comment during the meeting will have a 2-minute speaking limit to allow for as many comments as possible. Registered individuals may also request that their written comments be read during the meeting, but such comments will be subject to the same duration limit.

In accordance with the Federal Advisory Committee Act, the CDC announces the following virtual meeting of the Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH). This meeting is open to the public via webcast and by teleconference. If you wish to attend, please see the NIOSH website to register (https://www.cdc.gov/niosh/bsc/) or call (404-498-2539) at least five business days in advance of the meeting. Teleconference is available toll-free; please dial (855) 644-0229, and the participant passcode 9777483. Adobe Connect webcast will be available at https:// odniosh.adobeconnect.com/nioshbsc/ for up to 100 participants. The public is welcome to participate during the public comment period, from 12:45 p.m., EDT to 1:00 p.m., EDT on April 28, 2020. Please note that the public comment period ends at the time indicated above. Each commenter will be provided up to five minutes for comment. A limited number of time slots are available and will be assigned on a first come-first served basis. Written comments will also be accepted from those unable to attend the public session via an on-line form at the following website: https://www.cdc.gov/niosh/bsc/contact.html.

The Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB) is accepting mandatory formula grant applications and State Plans from states and territories for the development of and implementation for Title V State Sexual Risk Avoidance Education (SRAE) Program. The Title V State SRAE Funding Opportunity Announcement sets forth the application requirements for the receipt of the following documents from applicants and awardees: Application, State Plan, and Performance Progress Report.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Patient-Centered Outcomes Research Clinical Decision Support: Current State and Future Directions.''

The Office of Human Services, Emergency Preparedness and Response (OHSEPR) is the emergency management office of the U.S. Department of Health and Human Services' (HHS) Administration for Children and Families (ACF). OHSEPR is requesting a 3-year extension of the Immediate Disaster Case Management Intake Assessment tool (OMB #0970-0461). The content of the form has not changed. There is one modification to the proposed use of resulting aggregate data, to include a use to advance research with a goal of developing a Quality Assurance/Performance Improvement process.

This document is to inform the public that the Director of the Centers for Disease Control and Prevention, an agency of the Department of Health and Human Services, has issued an Order suspending the introduction of persons into the United States.

The Centers for Disease Control and Prevention (CDC), a component of the Department of Health and Human Services (HHS), announces the issuance of a No Sail Order and Suspension of Further Embarkation on March 14, 2020 for all cruise ships that are not voluntarily suspending operation.