Department of Health and Human Services July 26, 2021 – Federal Register Recent Federal Regulation Documents
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Medical Devices; Class I Surgeon's and Patient Examination Gloves
The Department of Health and Human Services (HHS or ``the Department'') issued a Notice in the Federal Register of January 15, 2021, (``the January 15 notice'') which identified seven types of reserved class I devices that the Department had determined no longer require premarket notification. The Department and the Food and Drug Administration (FDA or ``the Agency'') issued a Notice in the Federal Register of April 16, 2021 (``the April 16 notice'') explaining the basis for our current view that the seven types of reserved class I devices identified in the January 15 notice require a premarket notification, and explaining why the reasoning supporting the prior determination was unsound. HHS and FDA sought comment on the matters discussed in the April 16 notice, and have considered the comments that were submitted to the docket. HHS and FDA are issuing this final order and determination that the seven types of class I surgeon's gloves and patient examination gloves listed in the January 15 notice are reserved class I devices for which a premarket notification is required.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: COVID-19 Provider Relief Fund Reporting Activities, OMB No. 0906-XXXX New
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.
Meeting of the Tick-Borne Disease Working Group
As required by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the Tick-Borne Disease Working Group (TBDWG) will hold a virtual meeting. The meeting will be open to the public. For this meeting, TBDWG members will focus on plans to develop the next report due December 2022 on federal tick-borne activities and research, taking into consideration the 2018 and 2020 reports. The 2022 report will address a wide range of topics related to tick-borne diseases, such as, surveillance, prevention, diagnosis, diagnostics, and treatment; identify advances made in research, as well as overlap and gaps in tick-borne disease research; and provide recommendations regarding any appropriate changes or improvements to such activities and research.
National Center for Health Statistics (NCHS), ICD-10 Coordination and Maintenance (C&M) Committee Meeting
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. Online Registration is not required.
Advisory Committee on Immunization Practices (ACIP)
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (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. For more information on ACIP please visit the ACIP website: http:/ /www.cdc.gov/vaccines/acip/.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 National Breast and Cervical Cancer Early Detection Program (NBCCEDP) Monitoring Activities. Proposed study is designed to collect information about implementation, including delivery of screening and follow-up clinical services, and outcomes of the NBCCEDP.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 Focus Group Testing to Effectively Plan and Tailor Cancer Prevention and Control Communication Campaigns. CDC is requesting a Revision to this Generic Clearance to include an additional cancer-related communications campaign, expand the modes of data collection to include online focus groups and in- depth interviews (in-person, phone, and online), and to focus on respondents from the general public.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 Application for Training, which supports the management and evaluation of online training and professional development opportunities for public health and health care professionals.
Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC). The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. Matters considered at the meeting will include discussion of the toxicity risks of adeno-associated virus (AAV) vector-based gene therapy products. The discussion topics include oncogenicity risks due to vector genome integration and safety issues identified during preclinical and/or clinical evaluation. The meeting will be open to the public on both days. FDA is establishing a docket for public comment on this document.
Jonathan Doyle: Final Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Jonathan Doyle for a period of 5 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Mr. Doyle was convicted of a felony count under Federal law for conduct relating to the importation into the United States of an article of food. Mr. Doyle was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of April 8, 2021 (30 days after receipt of the notice), Mr. Doyle has not responded. Mr. Doyle's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
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