Department of Health and Human Services April 19, 2019 – Federal Register Recent Federal Regulation Documents
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Technical Performance Assessment of Quantitative Imaging in Premarket Device Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Technical Performance Assessment of Quantitative Imaging in Premarket Device Submissions.'' This draft guidance document provides recommendations on the information that should be included in premarket submissions for devices that include quantitative imaging functions. This draft guidance is not final nor is it in effect at this time.
Removal of Compliance Deadline for Closed-Circuit Escape Respirators and Clarification of Post-Approval Testing Standards for Closed-Circuit Escape Respirators
With this deregulatory action, the Department of Health and Human Services (HHS) revises regulatory language to remove a deadline by which respirator manufacturers must discontinue the manufacturing, labeling, and sale of certain self-contained self-rescuer models. The National Institute for Occupational Safety and Health (NIOSH) within the Centers for Disease Control and Prevention, HHS, has determined that discontinuing the manufacturing, labeling, and sale of certain self-contained self-rescuer models is likely to result in a shortage of person-wearable large capacity escape respirators for underground coal miners who rely on these devices. In addition to removing the compliance deadline, HHS is also modifying regulatory language to clarify that post-approval testing of closed-circuit escape respirators may exclude human subject testing and environmental conditioning, at the discretion of NIOSH.
Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Technical Considerations for Non-Clinical Assessment of Medical Devices containing Nitinol.'' Due to the unique properties of nitinol, the Agency has developed this draft guidance to provide FDA's current thinking on technical considerations specific to devices using nitinol. This draft guidance document is intended to provide clarity and consistency in recommended non-clinical assessments across a variety of medical devices that contain nitinol. This draft guidance is not final nor is it in effect at this time.
Bispecific Antibody Development Programs; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Bispecific Antibody Development Programs.'' This draft guidance provides recommendations to assist industry and other parties involved in the bispecific antibody drug development process. The draft guidance focuses on general regulatory and scientific considerations for bispecific antibodies, but not on development of a particular bispecific antibody. Industry and other stakeholders are encouraged to engage FDA to discuss their individual bispecific antibody under development.
Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling: Nutrition Facts Label and Supplement Facts Label
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 nutrition facts label and supplement facts label, which the Agency believes will serve to promote and protect public health.
Proposed Substances To Be Evaluated for Toxicological Profile Development
The Agency for Toxic Substances and Disease Registry (ATSDR) within the Department of Health and Human Services is initiating the development of another set of Toxicological Profiles. This notice solicits public nominations of substances for ATSDR to evaluate for Toxicological Profile development. ATSDR will consider nominations from the Substance Priority List (available at https://www.atsdr.cdc.gov/ SPL/). ATSDR also accepts nominations for non-Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERLA) substances that may have public health implications, on the basis of ATSDR's authority to prepare Toxicological Profiles for substances not found at sites on the CERCLA National Priorities List. For more information on the CERCLA National Priorities List, visit https:// www.epa.gov/superfund/superfund-national-priorities-list-npl. The agency will do so in order to establish and maintain an inventory of literature, research, and studies on the health effects of toxic substances, to respond to requests for consultation, and to support the site-specific response actions conducted by ATSDR, as otherwise necessary.
Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Food Facilities
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 Agency's regulations that require registration for domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States.
Adoption and Foster Care Analysis and Reporting System
ACF proposes to amend the Adoption and Foster Care Analysis and Reporting System (AFCARS) regulations. This notice of proposed rulemaking (NPRM) amends the AFCARS regulations that require title IV-E agencies to collect and report data to ACF on children in out-of-home care, who exit out-of-home care to adoption or legal guardianship, and children who are covered by a title IV-E adoption or guardianship assistance agreement.
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