Department of Health and Human Services – Federal Register Recent Federal Regulation Documents

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Office of the Director, National Institutes of Health; Notice of Closed Meeting
Document Number: 2020-11444
Type: Notice
Date: 2020-05-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-11443
Type: Notice
Date: 2020-05-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-11442
Type: Notice
Date: 2020-05-28
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Substances To Be Evaluated for Toxicological Profile Development
Document Number: 2020-11423
Type: Notice
Date: 2020-05-28
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
The Agency for Toxic Substances and Disease Registry (ATSDR) within the Department of Health and Human Services is initiating the development of another set of Toxicological Profiles. This notice solicits public nominations of substances for ATSDR to evaluate for Toxicological Profile development. ATSDR will consider nominations from the Substance Priority List (available at https://www.atsdr.cdc.gov/ SPL/). ATSDR also accepts nominations for non-Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA) substances that may have public health implications, on the basis of ATSDR's authority to prepare Toxicological Profiles for substances not found at sites on the CERCLA National Priorities List. For more information on the CERCLA National Priorities List, visit https://www.epa.gov/superfund/superfundnational-priorities-li st-npl. The agency will do so in order to establish and maintain an inventory of literature, research, and studies on the health effects of toxic substances, to respond to requests for consultation, and to support the site-specific response actions conducted by ATSDR, as otherwise necessary.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-11381
Type: Notice
Date: 2020-05-28
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Adoption Call to Action Data Collection (New Data Collection)
Document Number: 2020-11362
Type: Notice
Date: 2020-05-27
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration on Children, Youth and Families (ACYF), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data for a new descriptive study, Adoption Call to Action (ACTA) Data Collection.
Submission for OMB Review; Immediate Disaster Case Management Intake Assessment
Document Number: 2020-11312
Type: Notice
Date: 2020-05-27
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Human Services, Emergency Preparedness and Response (OHSEPR) is the emergency management office of the U.S. Department of Health and Human Services' (HHS) Administration for Children and Families (ACF). OHSEPR is requesting a 3-year extension of the Immediate Disaster Case Management Intake Assessment tool (OMB #0970-0461). The content of the form has not changed. There is one modification to the proposed use of resulting aggregate data, to include a use to advance research with a goal of developing a Quality Assurance/Performance Improvement process.
Submission for OMB Review; Office of Refugee Resettlement Unaccompanied Refugee Minors Program Application and Withdrawal of Application or Declination of Placement Form (Previous OMB #0970-0498)
Document Number: 2020-11307
Type: Notice
Date: 2020-05-27
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Refugee Resettlement (ORR) is requesting a 3- year extension of the application and Withdrawal of Application or Declination of Placement Form for the Unaccompanied Refugee Minors (URM) Program. Proposed revisions to each instrument are minimal. These forms were previously approved under OMB #0970-0498, expiration 7/31/ 2020. ORR is currently seeking a new OMB number specific to these forms, as they were previously approved as part of another information collection package for ORR's Unaccompanied Alien Children's program.
Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments; Public Meeting; Request for Comments
Document Number: 2020-11306
Type: Notice
Date: 2020-05-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is hosting a virtual public meeting entitled ``Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments,'' and an opportunity for public comment. This public meeting will take place virtually due to extenuating circumstances and will be held by webcast only.
Agency Father Generic Information Collection Request; 60-Day Public Comment Request
Document Number: 2020-11289
Type: Notice
Date: 2020-05-27
Agency: Department of Health and Human Services
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.
Q3C(R8) Recommendations for the Permitted Daily Exposures for Three Solvents-2-Methyltetrahydrofuran, Cyclopentyl Methyl Ether, and Tert-Butyl Alcohol-According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents; International Council for Harmonisation; Draft Guidance for Industry; Availability
Document Number: 2020-11280
Type: Notice
Date: 2020-05-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of draft recommendations for new permitted daily exposures (PDEs) for the residual solvents 2-methyltetrahydrofuran, cyclopentyl methyl ether, and tert-butyl alcohol. The PDEs were developed according to the methods for establishing exposure limits included in the guidance for industry entitled ``Q3C Impurities: Residual Solvents.'' The recommendations were prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance is intended to recommend acceptable amounts for the listed residual solvents in pharmaceuticals for the safety of patients.
National Institute of Nursing Research; Notice of Closed Meetings
Document Number: 2020-11277
Type: Notice
Date: 2020-05-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meetings
Document Number: 2020-11276
Type: Notice
Date: 2020-05-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2020-11275
Type: Notice
Date: 2020-05-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-11274
Type: Notice
Date: 2020-05-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-11273
Type: Notice
Date: 2020-05-27
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2020-11272
Type: Notice
Date: 2020-05-27
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Request; 30-Day Public Comment Request
Document Number: 2020-11250
Type: Notice
Date: 2020-05-26
Agency: Department of Health and Human Services
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.
Guidance Documents Related to Coronavirus Disease 2019 (COVID-19); Availability
Document Number: 2020-11238
Type: Notice
Date: 2020-05-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of FDA guidance documents related to the Coronavirus Disease 2019 (COVID-19) public health emergency (PHE). This notice of availability (NOA) is pursuant to the process that FDA announced, in the Federal Register of March 25, 2020, for making available to the public COVID-19-related guidances. The guidances identified in this notice address issues related to the COVID-19 PHE and have been issued in accordance with the process announced in the March 25, 2020, notice. The guidances have been implemented without prior comment, but they remain subject to comment in accordance with the Agency's good guidance practices.
Announcement of the Re-Approval of AABB (Formerly Known as the American Association of Blood Banks) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988
Document Number: 2020-11235
Type: Notice
Date: 2020-05-26
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the application of AABB for approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. We have determined that AABB meets or exceeds the applicable CLIA requirements. In this notice, we announce the approval and grant AABB deeming authority for a period of 4 years. This deeming authority is granted to AABB for the Blood Bank and Transfusion Service (BB/TS) program, the Immunohematology Reference Laboratory (IRL) program, the Molecular Testing (MT) program, and the Cellular Therapy (CT) program.
Medicare and Medicaid Programs; Application From The Joint Commission (TJC) for Continued CMS-Approval of Its Ambulatory Surgical Center (ASC) Accreditation Program
Document Number: 2020-11234
Type: Notice
Date: 2020-05-26
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed notice acknowledges the receipt of an application from The Joint Commission for continued recognition as a national accrediting organization for Ambulatory Surgical Centers that wish to participate in the Medicare or Medicaid programs.
National Indian Health Outreach and Education
Document Number: 2020-11210
Type: Notice
Date: 2020-05-26
Agency: Department of Health and Human Services, Indian Health Service
Amendment and Extension of Order Under Sections 362 and 365 of the Public Health Service Act; Order Suspending Introduction of Certain Persons From Countries Where a Communicable Disease Exists
Document Number: 2020-11179
Type: Notice
Date: 2020-05-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), a component of the Department of Health and Human Services (HHS), announces the amendment of an Order issued on March 20, 2020 and extended on April 20, 2020 under Sections 362 and 365 of the Public Health Service Act, and associated implementing regulations, that temporarily suspends the introduction of certain aliens based on the Director's determination that introduction of aliens, regardless of their country of origin, migrating through Canada and Mexico into the United States creates a serious danger of the introduction of COVID-19 into the United States, and the danger is so increased by the introduction of such aliens that a temporary suspension is necessary to protect the public health. This amendment and extension was issued on May 20, 2020 and shall remain in effect until the CDC Director determines that the danger of further introduction of COVID-19 into the United States from covered aliens has ceased to be a serious danger to the public health, and the Order is no longer necessary to protect the public health. CDC shall review the latest information regarding the status of the COVID-19 pandemic and associated public health risks every thirty days to ensure that the Order remains necessary to protect the public health.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2020-11161
Type: Notice
Date: 2020-05-26
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Findings of Research Misconduct
Document Number: 2020-11158
Type: Notice
Date: 2020-05-26
Agency: Department of Health and Human Services, Office of the Secretary
Findings of research misconduct have been made against Mr. Logan Fulford (Respondent), who was a graduate research assistant, Cincinnati Children's Hospital Medical Center (CCHMC), and former graduate student, University of Cincinnati (UC). Mr. Fulford engaged in research misconduct in research supported by National Cancer Institute (NCI), National Institutes of Health (NIH), grant R01 CA142724 and National Heart, Lung, and Blood Institute (NHLBI), NIH, grant R01 HL084151. The administrative actions, including supervision for a period of two (2) years, were implemented beginning on May 8, 2020, and are detailed below.
National Institute on Minority Health and Health Disparities; Notice of Closed Meetings
Document Number: 2020-11153
Type: Notice
Date: 2020-05-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2020-11152
Type: Notice
Date: 2020-05-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meetings
Document Number: 2020-11151
Type: Notice
Date: 2020-05-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meetings
Document Number: 2020-11150
Type: Notice
Date: 2020-05-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Amended Notice of Meeting
Document Number: 2020-11149
Type: Notice
Date: 2020-05-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2020-11148
Type: Notice
Date: 2020-05-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2020-11147
Type: Notice
Date: 2020-05-26
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-11146
Type: Notice
Date: 2020-05-26
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Amended Notice of Meeting
Document Number: 2020-11125
Type: Notice
Date: 2020-05-22
Agency: Department of Health and Human Services, National Institutes of Health
Request for Nominations on the Tobacco Products Scientific Advisory Committee
Document Number: 2020-11065
Type: Notice
Date: 2020-05-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting nominations for a nonvoting representative of the interests of the tobacco growers to serve on the Tobacco Products Scientific Advisory Committee (TPSAC), in the Center for Tobacco Products. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore encourages nominations of appropriately qualified candidates from these groups. A nominee may either be self- nominated or nominated by an organization. In addition, FDA is requesting that any industry organizations interested in participating in the selection of a nonvoting representative of the interests of the tobacco growers industry to serve on the TPSAC, notify FDA in writing. Nominations will be accepted for either the representative to serve on TPSAC or for the selection group effective with this notice.
Center for Scientific Review Amended; Notice of Meeting
Document Number: 2020-11063
Type: Notice
Date: 2020-05-22
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2020-11061
Type: Notice
Date: 2020-05-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2020-11060
Type: Notice
Date: 2020-05-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-11059
Type: Notice
Date: 2020-05-22
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2020-11058
Type: Notice
Date: 2020-05-22
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-11057
Type: Notice
Date: 2020-05-22
Agency: Department of Health and Human Services, National Institutes of Health
Availability of Program Application Instructions for Medicare Improvements for Patients and Providers Act (MIPPA) Program Funds
Document Number: 2020-11050
Type: Notice
Date: 2020-05-22
Agency: Department of Health and Human Services
The purpose of MIPPA funding is to enhance statewide and local coalition building focused on outreach, education, and one-to-one assistance activities to Medicare beneficiaries likely to be eligible for the Low Income Subsidy program (LIS) or the Medicare Savings Programs (MSP), above and beyond those regular activities planned in response to other funding. ACL will provide funding to State Health Insurance Assistance Programs (SHIP), Area Agencies on Aging (AAA), and Aging and Disability Resource Center (ADRC). ACL seeks plans from applicants that will describe how the MIPPA funds will be used for outreach, education, and one-on-one application assistance over the next year. ACL requests that applicants submit a one (1) year state plan with specific project strategies to: 1. Enhance their one-on-one assistance, education, and outreach efforts to eligible Medicare beneficiaries regarding their preventive, wellness, and limited income benefits; 2. Describe how the SHIP, AAA, and ADRC efforts will be coordinated to provide outreach to beneficiaries with limited incomes statewide including rural areas and tribal entities; 3. Review and update previous MIPPA plans to reflect successes achieved to date and direct their efforts to enhance and expand their MIPPA outreach activities; and 4. Set performance goals, taking into account the MIPPA Performance Measures (PMs) implemented in Grant Year 2019 [Performance Measures include: Overall MIPPA Contacts; Overall Persons Reached through Outreach; MIPPA Target Populations (Under 65, Rural, Native American, English as a Secondary Language); and Contacts with Applications Submitted]. Additionally, programs should ensure MIPPA counselors familiarity with integrated care programs that support beneficiaries' independence at home and in the community, including Programs of All-Inclusive Care for the Elderly, Medicare Advantage Special Needs Plans and Supplemental benefits, and other integrated care programs for Medicare and Medicaid dual eligible beneficiaries. Applicant plans should go above and beyond those regular activities planned in response to other funding. State agencies may prepare either one statewide plan or separate plans for each eligible agency. Announcement Type: Initial. Funding Opportunity Number: CIP-MI-20-001. Statutory Authority: The statutory authority for grants under this program announcement is contained in the 2006 Reauthorization of the Older Americans ActSection 202 and the Medicare Improvements for Patients and Providers Act of 2008Section 119, Public Law (Pub. L.) 110-275 as amended by the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act), reauthorized by the American Taxpayer Relief Act of 2012 (ATRA), the Protecting Access to Medicare Act of 2014, and the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), the Bipartisan Budget Act of 2018, and the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020. Catalog of Federal Domestic Assistance (CFDA) Number: 93.071.
Prospective Grant of an Exclusive Patent License: Antibody-Based Therapy for the Treatment of CD20 Expressing Lymphomas
Document Number: 2020-11036
Type: Notice
Date: 2020-05-22
Agency: Department of Health and Human Services, National Institutes of Health
The National Heart, Lung, and Blood Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to Retargeted Therapeutics, a corporation incorporated under the laws of the state of Delaware.
Agency Information Collection Activities; Proposed Collection; Comment Request; State Petitions for Exemption From Preemption
Document Number: 2020-11033
Type: Notice
Date: 2020-05-22
Agency: Food and Drug Administration, Department of Health and Human Services
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 the information collection provisions of our reporting requirements contained in existing FDA regulations governing state petitions for exemption from preemption.
Notice of Purchased/Referred Care Delivery Area Designation for the Little Shell Tribe of Chippewa Indians of Montana
Document Number: 2020-11010
Type: Notice
Date: 2020-05-21
Agency: Department of Health and Human Services, Indian Health Service
Notice is hereby given that the Indian Health Service (IHS) is establishing the geographic boundaries of the Purchased/Referred Care Delivery Area (PRCDA) (formerly Contract Health Service Delivery Area or CHSDA) for the newly federally recognized Little Shell Tribe of Chippewa Indians of Montana.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2020-11001
Type: Notice
Date: 2020-05-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 Information Collections to Advance State, Tribal, Local, and Territorial (STLT) Governmental Agency and System Performance, Capacity, and Program Delivery. This collection allows CDC to collaborate with partners throughout the nation and the world to monitor health, detect and investigate health problems, conduct research to enhance prevention, develop and advocate sound public health policies, implement prevention strategies, promote healthy behaviors, foster safe and healthful environments, and provide leadership and training.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2020-11000
Type: Notice
Date: 2020-05-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 Preventive Health and Health Services Block Grant. The PHHS Block Grant allows awardees to prioritize the use of funds to fill funding gaps in programs that deal with leading causes of death and disability, as well as the ability to respond rapidly to emerging health issues, including outbreaks of food- borne infections and water-borne diseases.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2020-10999
Type: Notice
Date: 2020-05-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 Using Real-time Prescription and Insurance Claims Data to Support the HIV Care Continuum which will collect data to evaluate the efficacy of using administrative insurance and prescription claims (billing) data to identify and intervene upon persons with HIV who fail to fill antiretroviral (ARV) prescriptions.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2020-10998
Type: Notice
Date: 2020-05-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2020-10997
Type: Notice
Date: 2020-05-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services