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

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 the collection of information for the ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery.''

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 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), 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 Possession, Use, and Transfer of Select Agents and Toxins (42 CFR part 73). This information collection intends to support the Public Health Safety and Bioterrorism Preparedness and Response Act of 2002 and ensure select agents or toxins are managed appropriately to prevent any threats to human health or safety. Data will be used to fulfill the requirements promulgated by HHS under this part and also subject to corresponding regulations promulgated by USDA.

The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this Notice to Lyell Immunopharma, Inc. (``Lyell''), located in South San Francisco, CA.

The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to NeoImmune Tech, Inc. (NeoImmune), located in Rockville, Maryland.

The Office of Planning, Research and Evaluation (OPRE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), proposes survey data collection activities as part of the Youth Empowerment IDEAS study.

The Food and Drug Administration (FDA or Agency) is proposing to reclassify nucleic acid-based hepatitis C virus (HCV) ribonucleic acid (RNA) devices intended for the qualitative or quantitative detection or genotyping of HCV RNA, postamendments class III devices (product codes MZP and OBF), into class II (general controls and special controls), subject to premarket notification. FDA is also proposing a new device classification regulation with the name ``nucleic acid-based Hepatitis C virus (HCV) ribonucleic acid tests'' along with the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness for these devices. FDA is proposing this reclassification on its own initiative. If finalized, this order will reclassify these types of devices from class III (general controls and premarket approval) to class II (general controls and special controls) and reduce the regulatory burdens associated with these devices, as these types of devices will no longer be required to submit a premarket approval application (PMA), but can instead submit a premarket notification (510(k)) and obtain clearance before marketing their device.

The Food and Drug Administration (FDA or Agency) is amending certain medical device regulations to accurately reflect the devices exempted from premarket notification (510(k)) as indicated in the lists published on April 13, 2017, and July 11, 2017. FDA published a final amendment, final order in the Federal Register of December 30, 2019 (``Final Order'') codifying the two Federal Register notices. The present revisions are necessary to correct editorial errors to ensure that the codified is consistent with the exemptions in the Federal Register notices. The rule does not impose any new regulatory requirements on affected parties. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act.'' Due to the Coronavirus Disease 2019 (COVID-19) pandemic, FDA has been closely monitoring the medical product supply chain with the expectation that it may be impacted by the COVID-19 outbreak, potentially leading to supply disruptions or shortages of drug and biological products in the United States. The guidance is intended to assist applicants and manufacturers in providing FDA timely, informative notifications about changes in the production of certain drugs and biological products that will, in turn, help the Agency in its efforts to prevent or mitigate shortages of such products. 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. In addition, this guidance is intended to remain in effect for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS). However, the recommendations and processes described in the guidance are expected to assist the Agency more broadly in its efforts to prevent and mitigate shortages, including under circumstances outside of the COVID-19 public health emergency and reflect the Agency's current thinking on this issue. Therefore, within 60 days following the termination of the public health emergency, FDA intends to revise and replace this guidance with any appropriate changes following the public health emergency and in consideration of comments received on this guidance and the Agency's experience with implementation.

This final notice announces our decision to approve The Joint Commission (TJC) for continued recognition as a national accrediting organization for home health agencies (HHAs) that wish to participate in the Medicare or Medicaid programs. A HHA that participates in Medicaid must also meet the Medicare conditions of participation (CoPs).

The Food and Drug Administration (FDA) is withdrawing approval of eight new animal drug applications (NADAs) at the sponsor's request because the products are no longer manufactured or marketed.