Department of Health and Human Services September 29, 2021 – Federal Register Recent Federal Regulation Documents

This is a primary data collection request for the Study of Disability Services Coordinators and Inclusion in Head Start (New Collection). The study aims to provide a nationally representative picture of the Early Head Start (EHS) and Head Start (HS) Disability Services Coordinator (DSC) workforce, as well as services provided to children with disabilities and their families within these programs and how EHS/HS collaborates with services in the community, including health providers, Local Education Agencies, and Part C. This is the first study of the HS/EHS DSC workforce and will contain three Phases of data collection using surveys and qualitative interviews.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Electronic Submission Template for Medical Device 510(k) Submissions.'' FDA is issuing this draft guidance to introduce submitters of premarket notification (510(k)) submissions to the Center for Devices and Radiological Health and Center for Biologics Evaluation and Research to the current resources and associated content developed to support 510(k) electronic submissions to FDA. This draft guidance, when finalized, is intended to represent one of several steps in meeting FDA's commitment to the development of electronic submission templates to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Nontuberculous Mycobacterial Pulmonary Disease Caused by Mycobacterium avium Complex: Developing Drugs for Treatment.'' The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of nontuberculous mycobacterial pulmonary disease (NTM-PD) caused by Mycobacterium avium complex (MAC).