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

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Jin Su Park for a period of 10 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Park was convicted of one felony count under Federal law for Importing Merchandise Contrary to Law, Causing an Act to be Done and of one felony count of introducing Misbranded Drugs into Interstate Commerce, causing an Act to be Done. The factual basis supporting both of Mr. Park's convictions, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Park was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of January 19, 2019 (30 days after receipt of the notice), Mr. Park had not responded. Mr. Park's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring John Seil Lee for a period of 10 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Lee was convicted of one felony count under Federal law for conspiracy to import merchandise contrary to law and to defraud the United States and of one felony count under Federal law for importing merchandise contrary to law. The factual basis supporting both of Mr. Lee's convictions, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Lee was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of March 15, 2020 (30 days after receipt of the notice), Mr. Lee had not responded. Mr. Lee's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.

The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting expedited review of an information collection request from the Office of Management and Budget (OMB) and inviting public comments on the proposed collection. The request consists of several forms that allow the Unaccompanied Alien Children (UAC) Program to provide services to UAC as required by statute and ORR policy.

The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting expedited review of an information collection request from the Office of Management and Budget (OMB) and inviting public comments on the proposed collection. The request consists of several forms that allow the Unaccompanied Alien Children (UAC) Program to place UAC referred to federal agencies into care provider facilities and to transfer UAC within the ORR care provider network.

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 Agency for Healthcare Research and Quality (AHRQ) announces a Special Emphasis Panel (SEP) meeting on ``COVID-19 REVISION SUPPLEMENT APPLICATION ZHS1 HSR-0 (03) HEALTHCARE SYSTEMS & VALUE RESEARCH (HSVR).'' This SEP meeting will be closed to the public.

To facilitate implementation of the reporting requirements of the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (Right to Try Act), the Food and Drug Administration (FDA, the Agency, or we) is proposing to establish requirements for the deadline and contents of submission of an annual summary. This proposed rule, if finalized, would implement the statutory requirement under provisions of the Right to Try Act for submission of an annual summary by sponsors and manufacturers who provide an eligible investigational drug for use by an eligible patient.

The CDC, National Center for Health Statistics (NCHS), Classifications and Public Health Data Standards Staff, announces the following meeting of the ICD-10 Coordination and Maintenance (C&M) Committee meeting. This meeting is open to the public, limited only by audio and web conferences lines available. Online Registration is not required.

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

The Agency for Healthcare Research and Quality (AHRQ) announces a Special Emphasis Panel (SEP) meeting on ``HCRT SEP 2020/10 ZHS1 HSR A (01).'' This SEP meeting will be closed to the public.

The Agency for Healthcare Research and Quality (AHRQ) announces a Special Emphasis Panel (SEP) meeting on ``HSQR ZHS1 HSR X- (02).'' This SEP meeting will be closed to the public.

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.

HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by 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.

The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health, is announcing the availability of a guidance document titled, ``Guidance on Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements.'' The guidance document provides OHRP's first formal guidance on this topic. The document, which is available on OHRP's website at https://www.hhs.gov/ohrp/regulations-and-policy/guidance/ index.html, is intended primarily for institutions, IRBs, investigators, HHS funding agencies, and others that may be responsible for the review, conduct, or oversight of nonexempt research involving human subjects conducted or supported by HHS. The guidance document announced in this notice finalizes the draft guidance that was made available for public comment through a notice in the Federal Register on July 25, 2018 (83 FR 35278). OHRP received 2 comments from individuals or organizations on the draft document and those comments were considered as the guidance was finalized.

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 the Agency) is publishing an order setting forth the Agency's final determination to exempt a list of class II devices from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for the list of class II devices. The exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. FDA is also amending the codified language for the list of class II devices to reflect this final determination. FDA is publishing this order in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The Centers for Disease Control and Prevention (CDC), a component of the U.S. Department of Health and Human Services (HHS), announces a second modification and extension of the No Sail Order and Other Measures Related to Operations that was issued on April 15, 2020. This Order applies to cruise ships defined as commercial, non-cargo, passenger-carrying vessels with the capacity to carry 250 or more individuals (passengers and crew) and with an itinerary anticipating an overnight stay onboard or a 24-hour stay onboard for either passengers or crew, that are operating in international, interstate, or intrastate waterways, subject to the jurisdiction of the United States. This Order shall additionally apply to cruise ships operating outside of U.S. waters if the cruise ship operator intends for the ship to return to operating in international, interstate, or intrastate waterways, subject to the jurisdiction of the United States during the period that this Order is in effect.