Department of Health and Human Services March 4, 2019 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities; Proposed Collection; Comment Request; Data Collection Materials for the Annual Performance Reporting of the Administration for Community Living's American Indian, Alaskan Natives and Native Hawaiian Programs
The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to the Revision of a Currently Approved Collection (ICR Rev) and solicits comments on the information collection requirements related to the annual Program Performance Report (PPR) for the American Indian, Alaskan Natives and Native Hawaiian Programs under Title VI of the Older Americans Act.
Renewal of Cooperative Agreement With the Institut Pasteur International Network
The Office of the Assistant Secretary for Preparedness and Response (ASPR), in the Department of Health and Human Services intends to provide a Single Source Five Year Cooperative Agreement to Institut Pasteur International Network (IPIN) through the Pasteur Foundation. The Cooperative Agreement will support continue to guide and support public health capacities to prepare for, detect, and respond to potential public health emergencies caused by human influenza viruses, zoonotic diseases, and other emerging infectious diseases with pandemic potential in West and Central Africa, and Southeast Asia to support the health security of the United States. The total proposed cost of the Single Source Cooperative Agreement is not to exceed $5 million over the five-year life of the Cooperative Agreement.
Renewal of Cooperative Agreement With the Pan American Health Organization
The Office of the Assistant Secretary for Preparedness and Response (ASPR), in the Department of Health and Human Services (HHS) intends to provide a Single Source Three Year Cooperative Agreement to the Pan American Health Organization (PAHO). The Cooperative Agreement will continue to improve operational capabilities to provide timely, coordinated, and quality medical response to disasters in the Americas region by supporting the WHO Emergency Medical Teams (EMT) Initiative. The collaboration between ASPR and PAHO will focus on supporting PAHO's strategy to develop and train national emergency medical teams with a set of global standards in each country in the region to ensure they can respond to emergencies within their own borders. PAHOs regional strategy for the EMT Initiative concentrates on building emergency medical teams domestically, for each country in the region, to ensure they can respond to emergencies within their own borders first, thereby reducing dependence on U.S. medical assets/capabilities. The total proposed cost of the Single Source Cooperative Agreement is not to exceed $1 million over the three-year life of the Cooperative Agreement.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA or Agency) 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; Submission for Office of Management and Budget Review; Comment Request; Exempt Infant Formula Production: Current Good Manufacturing Practices, Quality Control Procedures, Conduct of Audits, and Records
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.
List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act
The Food and Drug Administration (FDA or Agency) is evaluating substances that have been nominated for inclusion on a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need (the 503B Bulks List). Drug products that outsourcing facilities compound using bulk drug substances on the 503B Bulks List can qualify for certain exemptions from the Federal Food, Drug, and Cosmetic Act (FD&C Act) provided certain conditions are met. This notice identifies two bulk drug substances that FDA has considered and is not including on the list at this time: Nicardipine hydrochloride and vasopressin. Additional bulk drug substances nominated by the public for inclusion on this list are currently under consideration and will be the subject of future notices.
Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for industry entitled ``Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' This guidance describes policies that FDA intends to use in evaluating bulk drug substances nominated for use in compounding under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for inclusion on the list of bulk drug substances that can be used in compounding under section 503B.
Health Information Technology Advisory Committee 2019 Schedule
The Health Information Technology Advisory Committee (HITAC) was established in accordance with section 4003(e) of the 21st Century Cures Act and the Federal Advisory Committee Act. The HITAC, among other things, identifies priorities for standards adoption and makes recommendations to the National Coordinator for Health Information Technology (National Coordinator). The HITAC will hold public meetings throughout 2019. See list of public meetings below.
Solicitation of Written Comments To Inform Development of a National Youth Sports Strategy
The Department of Health and Human Services (HHS) solicits written comments from the public on specific topics and questions that will inform the development of the National Youth Sports Strategy.
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 US Zika Pregnancy registry, is to seek Paperwork Reduction Act (PRA) clearance to monitor the frequency and types of adverse birth outcomes for women with laboratory evidence of Zika virus infection during pregnancy and their infants and to strengthen the public health response to the Zika virus disease outbreak.
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 the Birth Defects Study To Evaluate Pregnancy exposureS (BD-STEPS). The purpose of BD- STEPS is to identify modifiable maternal exposures in pregnancy that may increase the risk for having a pregnancy affected by certain major, structural birth defects. This revision proposes to add stillbirths without defects to the study population for two Centers and implement a supplemental telephone interview for these two Centers' stillbirths (with and without birth defects) and their controls.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Online Application Order Form for Products from the Healthcare Cost and Utilization Project (HCUP).'' This proposed information collection was previously published in the Federal Register on December 18, 2018 and allowed 60 days for public comment. AHRQ received no substantive comments from members of the public. The purpose of this notice is to allow an additional 30 days for public comment.
Compliance With Statutory Program Integrity Requirements
The Office of Population Affairs (OPA), in the Office of the Assistant Secretary for Health, issues this final rule to revise the regulations that govern the Title X family planning program (authorized by Title X of the Public Health Service Act) to ensure compliance with, and enhance implementation of, the statutory requirement that none of the funds appropriated for Title X may be used in programs where abortion is a method of family planning and related statutory requirements. Accordingly, OPA amends the Title X regulations to clarify grantee responsibilities under Title X, to remove the requirement for nondirective abortion counseling and referral, to prohibit referral for abortion, and to clarify compliance obligations with state and local laws. In addition, Title X regulations are amended to clarify access to family planning services where an employer exercises a religious or moral objection. Finally, Title X regulations are amended to require physical and financial separation to ensure clarity regarding the purpose of Title X and compliance with statutory program integrity provisions, and to encourage family participation in family planning decisions, as required by Federal law.
21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program
This proposed rule would implement certain provisions of the 21st Century Cures Act, including conditions and maintenance of certification requirements for health information technology (health IT) developers under the ONC Health IT Certification Program (Program), the voluntary certification of health IT for use by pediatric health care providers, and reasonable and necessary activities that do not constitute information blocking. The implementation of these provisions would advance interoperability and support the access, exchange, and use of electronic health information. The proposed rule would also modify the 2015 Edition health IT certification criteria and Program in additional ways to advance interoperability, enhance health IT certification, and reduce burden and costs.
Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability and Patient Access for Medicare Advantage Organization and Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans in the Federally-Facilitated Exchanges and Health Care Providers
This proposed rule is intended to move the health care ecosystem in the direction of interoperability, and to signal our commitment to the vision set out in the 21st Century Cures Act and Executive Order 13813 to improve access to, and the quality of, information that Americans need to make informed health care decisions, including data about health care prices and outcomes, while minimizing reporting burdens on affected plans, health care providers, or payers.
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