Department of Health and Human Services August 13, 2019 – Federal Register Recent Federal Regulation Documents
Results 1 - 21 of 21
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Accessories
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Q-Submission Program for Medical Devices
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 requests for feedback submitted under the Q-Submission Program for medical devices.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Comprehensive HIV Prevention and Care for Men Who Have Sex with Men of Color. This study is designed to support state and local health departments to develop and implement demonstration projects for provision of comprehensive human immunodeficiency virus (HIV) prevention and care services for men who have sex with men (MSM) of color by creating a collaborative with community based organizations (CBOs), clinics and other health care providers, and behavioral health and social services providers in their jurisdiction.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Performance Measurement for STD Prevention. This information collection is for the 59 state, local, and territorial health departments that are recipients of CDC's cooperative agreement PS19-1901 STD PCHD. The information collection covers key performance measures that will be used to assess recipients' individual and collective progress towards the larger aims of the cooperative agreement, direct technical assistance to recipients, and obtain information needed to help assess the cooperative agreement's public health impact.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a Generic Information Collection Request for Cognitive Testing and Pilot Testing for the National Center for Chronic Disease Prevention and Health Promotion. A generic clearance is needed to support methodological studies that improve information quality and the efficiency of information collection.
Advisory Committee; National Mammography Quality Assurance Advisory Committee; Renewal
The Food and Drug Administration (FDA) is announcing the renewal of the National Mammography Quality Assurance Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the National Mammography Quality Assurance Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until July 7, 2021.
Scientific Advisory Committee on Alternative Toxicological Methods; Announcement of Meeting; Request for Comments
This notice announces the next meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM). SACATM, a federally chartered external advisory group of scientists from the public and private sectors, including representatives of regulated industry and national animal protection organizations, advises the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), and the Director of the National Institute of Environmental Sciences (NIEHS) and NTP regarding statutorily mandated duties of ICCVAM and activities of NICEATM. The meeting is open to the public and registration is requested for both attendance and oral comments and required to access the webcast. Information about the meeting and registration are available at https://ntp.niehs.nih.gov/go/ 32822.
Incorporating Alternative Approaches in Clinical Investigations for New Animal Drugs; Public Meeting; Extension of Comment Period
The Food and Drug Administration (FDA, the Agency, or we) is extending the comment period for the notice of public meeting entitled ``Incorporating Alternative Approaches in Clinical Investigations for New Animal Drugs; Public Meeting; Request for Comments'' that appeared in the Federal Register of July 9, 2019. In the notice of public meeting, FDA requested comments on the use of complex adaptive and other novel investigation designs, data from foreign countries, real world evidence, and biomarkers and surrogate endpoints in animal drug development and regulatory decision making. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Head Start Designation Renewal System
In this NPRM, we propose changes to two of the seven conditions of the Designation Renewal System for Head Start Grantees (DRS): The condition related to the Classroom Assessment Scoring System: Pre-K (CLASS) and the fiscal condition related to audit findings. For the CLASS condition, we propose to remove the lowest 10 percent criterion and set more rigorous minimum thresholds across all three domains that grantees must meet in order to avoid competition. For the fiscal condition, we propose to add a second criterion that would consider additional findings from annual audits. A grantee would be required to compete for continued funding if they met either criterion. We also propose technical changes within part 1304 subpart B (Designation Renewal) to remove any outdated provisions to the regulation. These technical fixes were not included in the publication of the Head Start Program Performance Standards (performance standards) final rule in 2016 because the Designation Renewal section of the regulation was not open for amendment in the revision of the performance standards.
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