Department of Health and Human Services March 2019 – Federal Register Recent Federal Regulation Documents

The Department of Health and Human Services (HHS) provides notice of a public listening session; invites the public to attend; and solicits request to provide oral remarks to inform the development of the National Youth Sports Strategy.

The Food and Drug Administration (FDA or we) is classifying the device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

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 FDA's regulations on current good manufacturing practice (CGMP) for positron emission tomography (PET) drugs.

The Food and Drug Administration (FDA or we) is classifying the transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Cancer Clinical Trial Eligibility Criteria: Brain Metastases.'' This draft guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of drugs or biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for the treatment of cancer. Specifically, this draft guidance includes recommendations on the inclusion of patients with brain metastases. Patients with brain metastases have historically been excluded from clinical trials due to concerns of poor functional status, shortened life expectancy, or increased risk of toxicity. Given the prevalence of brain metastases in patients with cancer, their systematic exclusion from clinical trials may result in the assessment of an investigational drug's efficacy or safety in a trial population that is not fully representative of the patient population that will be prescribed the drug in clinical practice. Broadening cancer trial eligibility criteria can maximize the generalizability of trial results and the ability to understand the therapy's benefit-risk profile across the patient population likely to use the drug in clinical practice without jeopardizing patient safety.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies.'' This draft guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of drugs or biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for the treatment of cancer. Specifically, this guidance includes recommendations on the inclusion of patients with organ dysfunction or with prior or concurrent malignancies. Broadening cancer trial eligibility criteria can maximize the generalizability of trial results and the ability to understand the therapy's benefit-risk profile across the patient population likely to use the drug in clinical practice without jeopardizing patient safety.

The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July, August, and September 2018. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to make technical amendments to improve the readability of the regulations.

The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention announces the availability of a draft NORA Agenda entitled National Occupational Research Agenda for Healthy Work Design and Well-being for public comment. To view the notice and related materials, visit https:// www.regulations.gov and enter CDC-2019-0018 in the search field and click ``Search.''

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institute on Drug Abuse (NIDA) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

NIOSH announces the availability of the final National Occupational Research Agenda for Public Safety.

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 information collection, provisions of the notification procedure for substances generally recognized as safe (GRAS).

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 information collection involving interviews of pharmaceutical manufacturers who submit 351(k) biologics license applications (BLAs) to FDA under the Program for Enhanced Review Transparency and Communication (the Program) during FYs 2018 through 2021.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) will hold a meeting. The meeting will be open to the public.

Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP website at: http:/ /www.dhhs.gov/ohrp/sachrp-committee/meetings/.

Notice is hereby given, pursuant to the provisions of the Federal Advisory Committee Act (FACA) and the Preventing Sex Trafficking and Strengthening Families Act, that the charter for the of the National Advisory Committee on the Sex Trafficking of Children and Youth in the United States (Committee) was renewed on January 18, 2019. The renewal is available at https:// www.acf.hhs.gov/otip/resource/2019naccharter. Notice is also given that a meeting of the National Advisory Committee on the Sex Trafficking of Children and Youth in the United States (Committee) will be held on May 28, 2019. The purpose of the meeting is for the Committee to discuss its work on its interim report on recommended best practices for States to follow in combating the sex trafficking of children and youth based on multidisciplinary research and promising, evidence-based models and programs. The members will remain in Phoenix on May 29 to conduct subcommittee meetings and a fact finding site visit.