Department of Health and Human Services March 26, 2019 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research; Guidance for Industry.'' The guidance document provides the recommendations of the Center for Biologics Evaluation and Research (CBER) on the use of standards in product development and control as well as the use of such standards in CBER's managed review process. CBER recognizes the value of standards and encourages the use of appropriate standards in the development and control of CBER-regulated medical products. Sponsors' use of standards can facilitate product development and provide a more efficient evaluation of regulatory submissions. The guidance announced in this notice finalizes the draft guidance of the same title dated December 2017.

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 FDA's recordkeeping and registration requirements for shell egg producers.

On November 28, 2018, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 021) to add ``multiple deep vein thrombosis and pulmonary embolism'' to the List of WTC-Related Health Conditions (List). Upon reviewing the scientific and medical literature, including information provided by the petitioner, the Administrator has determined that the available evidence does not have the potential to provide a basis for a decision on whether to add deep vein thrombosis or pulmonary embolism to the List. The Administrator also finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.

The Office of Head Start currently requires Head Start programs to operate 100-percent of their preschool center-based slots for 1,020 annual hours by August 1, 2021, which would substantially increase the minimum amount of time preschool children must receive Head Start services. We believe the approach to require all center- based programs to increase their hours of operation was too prescriptive and will reduce grant recipients' flexibility to meet the needs of the communities they serve. It would be costly for grantees to meet the increased service-duration requirement and would likely result in a reduction in the number of children served by Head Start. For these reasons, we propose to remove the 100-percent service duration requirement from the HSPPS. We also propose technical changes to our Program Structure regulations.