Department of Health and Human Services January 2020 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 293
Submission for OMB Review; National Human Trafficking Training and Technical Assistance Center (NHTTAC) Evaluation Package (OMB #0970-0519)
The Office on Trafficking in Persons (OTIP), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting to continue data collection with an increased number of respondents to the previously approved information collection, National Human Trafficking Training and Technical Assistance Center (NHTTAC) Evaluation Package (OMB #0970-0519, expiration 10/31/2021). This request was originally approved under expedited review and increased the estimated burden hours from 689 hours to 9,497 hours. In addition, the previously approved Stop, Observe, Ask, and Respond to human trafficking (SOAR) Online Participant Feedback Form was restructured into a long and short form to reduce burden for information collected on SOAR Online training participants outside of the NHTTAC learning management system. There are no changes requested to the items on any forms.
Guidelines for Determining the Probability of Causation Under the Energy Employees Occupational Illness Compensation Program Act of 2000; Technical Amendments
In August 2019, the Department of Health and Human Services (HHS) published an interim final rule to revise its regulations to update references to the International Classification of Disease (ICD) codes from ICD-9-CM to ICD-10-CM, and remove outdated references to chronic lymphocytic leukemia from Energy Employees Occupational Illness Compensation Program regulations. These technical amendments have no effect on the cancer eligibility requirement under the Program because all cancer types are eligible to receive a dose reconstruction from NIOSH. Thus, no eligible claimant will be adversely impacted by the rulemaking finalized in this document.
Secretarial Determination To Lower Head Start Center-Based Service Duration Requirements
The Secretary of Health and Human Services has the authority, on or before February 1, 2020, to lower the percentage of center-based funded enrollment slots for which Head Start programs must provide 1,020 annual hours of planned class operations, based on an assessment of the availability of sufficient funding to mitigate a substantial reduction in funded enrollment. The Secretary hereby gives notice of his exercise of that authority to reduce the percentage from 100 percent (all) of a Head Start program's center-based slots, to 45 percent of a Head Start program's center-based slots.
Agency Information Collection Request; 30-Day Public Comment Request
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Study of Oncology Indications in Direct-to-Consumer Television Advertising
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.
Notice To Announce Request for Information To Assist in the Development of a New Strategic Plan for the National Institute on Deafness and Other Communication Disorders, for 2022-2026
The National Institute on Deafness and Other Communication Disorders (NIDCD) is in the process of developing a new Strategic Plan for 2022-2026 to help guide the research it supports over the next five years. Through this Request for Information, NIDCD invites researchers in academia and industry, health care professionals, patient advocates and health advocacy organizations, scientific or professional organizations, Federal agencies, and other interested members of the public to provide ideas to inform development of NIDCD's next strategic plan.
Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities; Proposed Collection; Comment Request; Endorser Status and Explicitness of Payment in Direct-to-Consumer Promotion
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed study entitled ``Endorser Status and Explicitness of Payment in Direct-to-Consumer Promotion.''
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 Capacity Building Assistance Program: Data Management, Monitoring, and Evaluation. The purpose of this data collection is to evaluate the CDC cooperative agreement program entitled CDC-RFA-PS19-1904: Capacity Building Assistance (CBA) for High Impact HIV Prevention Program Integration.
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: ``Consumer Assessment of Healthcare Providers and Systems (CAHPS) Health Plan Survey Database.'' In accordance with the Paperwork Reduction Act of 1995, AHRQ invites the public to comment on this proposed information collection.
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 the National Hospital Ambulatory Medical Care Survey (NHAMCS). NHAMCS collects facility and visit information on ambulatory care services utilization in non-Federal, short stay hospitals in the United States.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use-Premarket Notification (510(k)) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Arthroscopy Pump Tubing Sets Intended for Multiple Patient UsePremarket Notification (510(k)) Submissions.'' FDA has developed this draft guidance document to assist in the preparation of premarket notification submissions (510(k)) for arthroscopy pump tubing sets intended for multiple patient use. This draft guidance outlines the device design considerations, risk mitigation strategies, and testing recommendations for arthroscopy pump tubing sets intended for multiple patient use. This draft guidance document also clarifies the terminology used to describe arthroscopy pump tubing sets intended for multiple patient use. This draft guidance is not final nor is it in effect at this time.
Meeting of the Presidential Advisory Council on HIV/AIDS
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA or the Council) will be holding the 66th full Council meeting in Washington, DC. Agenda items will include: Discussion of Ending the HIV Epidemic: A Plan for America (EHE) Jurisdictional Plans, Focusing on the Four Pilot Sites: DeKalb County, Georgia; Baltimore, Maryland; East Baton Rouge, Louisiana; and the Cherokee Nation of Oklahoma; the Ready, Set, PrEP National Program; Stigma as a BarrierShared Experiences and Challenges from International and Domestic Perspectives; and Women and HIV. The meeting will be open to the public; a public comment session will be held during the meeting. Pre-registration is encouraged for members of the public who wish to attend the meeting and who wish to participate in the public comment session. Individuals who wish to attend the meeting and/or send in their public comment via email should send an email to PACHA@hhs.gov. Pre-Registration must be complete by Monday, February 3, 2020.
Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Draft Guidance for Industry; Availability; Extension of Comment Period
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice entitled ``Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Draft Guidance for Industry; Availability'' that appeared in the Federal Register of December 20, 2019. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
National Institute of Neurological Disorders and Stroke, Muscular Dystrophy Coordinating Committee Call for Committee Membership Nominations
The Office of the Secretary of the Department of Health and Human Services (HHS) is seeking nominations for an individual to serve as a nonfederal public member on the Muscular Dystrophy Coordinating Committee.
Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment.'' This guidance is intended to help sponsors planning to use minimal residual disease (MRD) as a biomarker in clinical trials conducted under an investigational new drug application (IND) or to support marketing approval of drugs and biological products for treating specific hematologic malignancies. An analysis of marketing applications showed inconsistent quality of MRD data. Based on this analysis and discussion at various public workshops on MRD, FDA identified a need to provide guidance on the use of MRD as a biomarker in regulatory submissions. This guidance finalizes the draft guidance of the same title issued on October 16, 2018.
Submission for OMB Review; Domestic Victims of Human Trafficking Program Data (New Collection)
The Office on Trafficking in Persons (OTIP), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS) is proposing to collect data for the Domestic Victims of Human Trafficking Program (DVHT). The DVHT Program is inclusive of three distinct programs: The Domestic Victims of Human Trafficking and Services Outreach Program, Demonstration Grants to Strengthen the Response to Victims of Human Trafficking in Native Communities Program, and the Strengthen the Health Care Response for Victims of Human Trafficking Program grants. The data collection instruments are intended to collect information for all three DVHT programs.
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 ``Evaluation of Patient-Centered Outcomes Research Trust Fund Training Program.'' This proposed information collection was previously published in the Federal Register on December 13th, 2019 and allowed 60 days for public comment. AHRQ did not receive comments from members of the public. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Submission for OMB Review; 30-Day Comment Request; Information Program on Clinical Trials: Maintaining a Registry and Results Databank (National Library of Medicine)
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Prospective Grant of Exclusive Patent License: Antibody-Based Therapeutics and Chimeric Antigen Receptors Targeting Glypican-2
The National Cancer Institute (NCI), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive, sublicensable patent license to Stanford University, (``Stanford''), a non-profit university located in California, in its rights to the inventions and patents listed in the SUPPLEMENTARY INFORMATION section of this notice.
Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
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