Department of Health and Human Services May 14, 2019 – Federal Register Recent Federal Regulation Documents
Results 1 - 10 of 10
Considerations in Demonstrating Interchangeability With a Reference Product; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Considerations in Demonstrating Interchangeability With a Reference Product.'' This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement under the Public Health Service Act (PHS Act). This guidance is one in a series of guidances that FDA has developed to implement the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).
Tribal Consultation Meetings
Pursuant to the Improving Head Start for School Readiness Act of 2007, notice is hereby given of six 1-day Tribal Consultation (TC) Sessions to be held between the HHS)/ACF, OHS leadership and the leadership of tribal governments operating Head Start (including Early Head Start) programs. The purpose of these consultation sessions is to discuss ways to better meet the needs of American Indian and Alaska Native children and their families, taking into consideration funding allocations, distribution formulas, and other issues affecting the delivery of Head Start services in their geographic locations. Six TCs will be held as part of HHS/ACF and/or ACF TC Sessions.
Privacy Act of 1974; System of Records Notice
In accordance with the requirements of the Privacy Act of 1974, as amended, HHS is revising a department-wide system of records, System No. 09-90-1601 titled Outside Experts Recruited for Non-FACA Activities, to add records about outside consultants used by HHS' Administration for Children and Families, Office of Trafficking in Persons (ACF/OTIP).
Announcement of Meeting of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030
The U.S. Department of Health and Human Services (HHS) announces the next meeting of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030 (Committee) regarding the development of national health promotion and disease prevention objectives for 2030. The meeting will be held online via webinar and is open to the public. The Committee will discuss the nation's proposed health promotion and disease prevention objectives and will provide recommendations to improve health status and reduce health risks for the nation by the year 2030. The Committee will deliberate and prioritize its recommendations for implementing the Healthy People 2030 objectives and develop recommendations regarding graphics for communicating key Healthy People 2030 elements. Pursuant to the Committee's charter, the Committee's advice must assist the Secretary in reducing the number of objectives while ensuring that the selection criteria identifies the most critical public health issues that are high-impact priorities supported by current national data.
Announcement of Meeting of the National Clinical Care Commission
The National Clinical Care Commission (the Commission) will conduct its third meeting on June 27, 2019. The Commission will evaluate and make recommendations to the U.S. Department of Health and Human Services (HHS) Secretary and Congress regarding improvements to the coordination and leveraging of federal programs related to awareness and clinical care for complex metabolic or autoimmune diseases that result from issues related to insulin that represent a significant disease burden in the United States, which may include complications due to such diseases.
Agency Information Collection Activities: Proposed Collection; Comment Request
AHRQ invites public comment on its Request for Information (RFI) to inform potential revisions to the Consumer Assessment of Healthcare Providers and Systems Health Plan Survey 5.0. The Consumer Assessment of Healthcare Providers and Systems (CAHPS[supreg]) Health Plan Survey 5.0 is one of the CAHPS family of surveys that assess patients' experiences with health care providers, in different settings, and with health plans. The CAHPS surveys cover topics that are important to patients and that they are best able to assess, such as the communication with providers and access to health care services. This RFI requests public comment regarding the relevance and validity of the questions on CAHPS Health Plan Survey 5.0 (the Survey), and any user concerns about revisions to the Survey.
Board of Scientific Counselors, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (BSC, NCEH/ATSDR)
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (BSC, NCEH/ATSDR). This meeting is open to the public, limited only by available seating. The meeting room accommodates approximately 60 people. The public is also welcome to listen to the meeting by calling 800-810-6806, passcode 8137872, limited by 75 lines. The deadline for notification of attendance is May 24, 2019. The public comment period is scheduled on June 25, 2019 from 2:30 p.m. until 2:45 p.m., EDT and June 26, 2019 from 10:10 a.m. until 10:25 a.m., EDT. Individuals wishing to make a comment during Public Comment period, please email your name, organization, and phone number by May 24, 2019 to Shirley Little at snl7@cdc.gov.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
