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

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that a meeting is scheduled to be held for the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB). The meeting will be open to the public; a public comment session will be held during the meeting. Pre-registration is required for members of the public who wish to attend the meeting and who wish to participate in the public comment session. Individuals who wish to attend the meeting and/or send in their public comment via email should send an email to CARB@hhs.gov. Registration information is available on the website https://www.hhs.gov/paccarb and must be completed by February 19, 2020; all in-person attendees must pre-register by this date. Additional information about registering for the meeting and providing public comment can be obtained at https://www.hhs.gov/paccarb on the Meetings page.

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), Office of the Director, Office of Acquisitions and Logistics Management (OALM), Small Business Program Office (SBPO), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt Jakob Disease by Blood and Blood Components.'' The draft guidance provides blood establishments that collect blood and blood components with revised recommendations intended to reduce the possible risk of transmission of Creutzfeldt-Jakob disease (CJD) and variant Creutzfeldt-Jakob disease (vCJD) by blood and blood components. The recommendations in the draft guidance apply to the collection of Whole Blood and blood components intended for transfusion or for use in further manufacturing, including Source Plasma. The draft guidance replaces the document entitled ``Amendment to `Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt- Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products,' '' Draft Guidance for Industry, dated December 2017, and when finalized, will supersede the document entitled ``Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products, Guidance for Industry,'' dated May 2010 and updated January 2016.

In accordance with the Federal Advisory Committee Act, this notice announces that the Centers for Disease Control and Prevention (CDC)/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHAC) has scheduled a public meeting. Information about CHAC can be found at https://www.cdc.gov/maso/facm/ facmCHACHSPT.html.

This notice announces the next meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC). The BSC, a federally chartered, external advisory group composed of scientists from the public and private sectors, will review and provide advice on programmatic activities. This meeting is by webcast only and is open to the public. Written comments will be accepted and registration is required for oral comment and to access the webcast. Information about the meeting and registration are available at https:// ntp.niehs.nih.gov/go/165.

The Food and Drug Administration (FDA or we) is responding to the submission styled as an objection submitted by Earthjustice on behalf of Breast Cancer Prevention Partners, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Environmental Defense Fund, Environmental Working Group, and the Natural Resources Defense Council, on the final rule that amended the food additive regulations to no longer authorize the use of benzophenone, ethyl acrylate, eugenyl methyl ether, myrcene, pulegone, and pyridine as synthetic flavoring substances for use in food. The final rule also amended the food additive regulations to no longer provide for the use of benzophenone as a plasticizer in rubber articles intended for repeated use in contact with food. After reviewing the submission, we have concluded that the submission we received is not an objection and consequently does not provide a basis for modifying the regulations.

The CDC within the HHS announces the next meeting of the CPSTF on February 12, 2020.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Long Term Follow-Up After Administration of Human Gene Therapy Products.'' The guidance document provides sponsors, who are developing a human gene therapy (GT) product, recommendations regarding the design of long term follow- up (LTFU) observational studies for the collection of data on delayed adverse events following administration of a GT product. This guidance finalizes the draft guidance of the same title dated July 2018 and supersedes the document entitled ``Guidance for Industry: Gene Therapy Clinical TrialsObserving Subjects for Delayed Adverse Events'' dated November 2006. This guidance also supplements the guidance entitled ``Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus during Product Manufacture and Patient Follow-up; Guidance for Industry.''

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Human Gene Therapy for Rare Diseases; Guidance for Industry.'' The final guidance document provides recommendations to stakeholders developing a human gene therapy (GT) product intended to treat a rare disease in adult and/or pediatric patients regarding the manufacturing, preclinical, and clinical trial design issues for all phases of the clinical development program. Such information is intended to assist sponsors in designing clinical development programs for such products, where there may be limited study population size and potential feasibility and safety issues as well as issues relating to the interpretability of bioactivity/efficacy outcomes that may be unique to rare diseases or to the nature of the GT product itself. The guidance announced in this notice finalizes the draft guidance of the same title dated July 2018.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Human Gene Therapy for Hemophilia; Guidance for Industry.'' The guidance document provides recommendations to stakeholders developing human gene therapy (GT) products for the treatment of hemophilia. The guidance provides recommendations on the clinical trial design and related development of coagulation factor VIII (hemophilia A) and IX (hemophilia B) activity assays, including how to address discrepancies in factor VIII and factor IX activity assays. The guidance also includes recommendations regarding preclinical considerations to support development of GT products for the treatment of hemophilia. The guidance announced in this notice finalizes the draft guidance of the same title dated July 2018.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry.'' The guidance provides sponsors of retroviral vector-based human gene therapy products recommendations regarding the testing for replication competent retrovirus (RCR) during the manufacture of retroviral vector-based gene therapy products, and during follow-up monitoring of patients who have received retroviral vector-based gene therapy products. Recommendations include the identification and amount of material to be tested, and general testing methods. In addition, recommendations are provided on monitoring patients for evidence of retroviral infection after administration of retroviral vector-based gene therapy products. The guidance supersedes the document entitled ``Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors,'' dated November 2006. The guidance announced in this notice finalizes the draft guidance of the same title dated July 2018.

The Food and Drug Administration (FDA) is requesting nominations for voting members, excluding consumer representative, to serve on the Patient Engagement Advisory Committee (the Committee) in the Center for Devices and Radiological Health. Nominations will be accepted for current and upcoming vacancies effective with this notice. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.