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

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Ensuring Access to Equitable, Affordable, Client-Centered, Quality Family Planning Services
Document Number: 2021-07762
Type: Proposed Rule
Date: 2021-04-15
Agency: Department of Health and Human Services
The Office of Population Affairs (OPA), in the Office of the Assistant Secretary for Health, proposes to revise the rules issued on March 4, 2019, establishing standards for compliance by family planning services projects authorized by Title X of the Public Health Service Act. Those rules have undermined the public health of the population the program is meant to serve. The Department proposes to revise the 2019 rules by readopting the 2000 regulations, with several modifications needed to strengthen the program and ensure access to equitable, affordable, client-centered, quality family planning services for all clients, especially for low-income clients.
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2021-07746
Type: Notice
Date: 2021-04-15
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2021-07745
Type: Notice
Date: 2021-04-15
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2021-07735
Type: Notice
Date: 2021-04-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Meeting
Document Number: 2021-07712
Type: Notice
Date: 2021-04-15
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2021-07711
Type: Notice
Date: 2021-04-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Minority Health and Health Disparities; Notice of Meeting
Document Number: 2021-07710
Type: Notice
Date: 2021-04-15
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2021-07709
Type: Notice
Date: 2021-04-15
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2021-07708
Type: Notice
Date: 2021-04-15
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Evaluation of LifeSet (New Collection)
Document Number: 2021-07688
Type: Notice
Date: 2021-04-15
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) is proposing a new information collection activity to assess the impact and implementation of LifeSet, a program that provides services and supports to young adults ages 17 to 21 with previous child welfare involvement. Data collection efforts will include accessing administrative data from the child welfare agency, program, and other private and governmental databases; surveys of young adults (participants and those receiving services as usual); interviews and focus groups with program and child welfare agency administrators and staff; interviews and focus groups with young adult program participants; and interviews with other program stakeholders.
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program and Value-Based Purchasing Program for Federal Fiscal Year 2022
Document Number: 2021-07556
Type: Proposed Rule
Date: 2021-04-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2022. In addition, the proposed rule includes a proposed forecast error adjustment for FY 2022, proposes updates to the diagnosis code mappings used under the Patient Driven Payment Model (PDPM), proposes to rebase and revise the SNF market basket, proposes to implement a recently-enacted SNF consolidated billing exclusion along with the required proportional reduction in the SNF PPS base rates, and includes a discussion of a methodology to recalibrate the PDPM parity adjustment. In addition, the proposed rule includes proposals for the SNF Quality Reporting Program (QRP) and the SNF Value-Based Purchasing (VBP) Program, including a proposal to suppress the use of the SNF readmission measure for scoring and payment adjustment purposes in the FY 2022 SNF VBP program because we have determined that circumstances caused by the public health emergency for COVID-19 have significantly affected the validity and reliability of the measure and resulting performance scores.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification for a New Dietary Ingredient
Document Number: 2021-07641
Type: Notice
Date: 2021-04-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) 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; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring
Document Number: 2021-07639
Type: Notice
Date: 2021-04-14
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Mark Reinhard: Final Debarment Order
Document Number: 2021-07638
Type: Notice
Date: 2021-04-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Mark Reinhard from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Reinhard was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Mr. Reinhard was given notice of the proposed permanent debarment and an opportunity to request a hearing to show why he should not be debarred within the timeframe prescribed by regulation. Mr. Reinhard has not responded to the notice. Mr. Reinhard's failure to respond and request a hearing within the prescribed timeframe constitutes a waiver of his right to a hearing concerning this action.
Agency Information Collection Request. 60-Day Public Comment Request
Document Number: 2021-07622
Type: Notice
Date: 2021-04-14
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.
Agency Information Collection Request. 30-Day Public Comment Request
Document Number: 2021-07620
Type: Notice
Date: 2021-04-14
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.
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2021-07612
Type: Notice
Date: 2021-04-14
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-07611
Type: Notice
Date: 2021-04-14
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2021-07610
Type: Notice
Date: 2021-04-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Meeting
Document Number: 2021-07609
Type: Notice
Date: 2021-04-14
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; FY 2022 Hospice Wage Index and Payment Rate Update, Hospice Conditions of Participation Updates, Hospice and Home Health Quality Reporting Program Requirements
Document Number: 2021-07344
Type: Proposed Rule
Date: 2021-04-14
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This rule proposes updates to the hospice wage index, payment rates, and aggregate cap amount for Fiscal Year 2022. This rule proposes changes to the labor shares of the hospice payment rates, proposes clarifying regulations text changes to the election statement addendum that was implemented on October 1, 2020, includes information on hospice utilization trends and solicits comments regarding hospice utilization and spending patterns. In addition, this rule proposes to make permanent selected regulatory blanket waivers that were issued to Medicare-participating hospice agencies during the COVID-19 public health emergency and updates the hospice conditions of participation. The proposed rule would update the Hospice Quality Reporting Program. The proposed rule requests information on advancing to digital quality measurement, the use of Fast Healthcare Interoperability Resources, addresses the White House Executive Order related to health equity in the Hospice Quality Reporting Program and provides updates to advancing Health Information Exchange. Finally, this rule proposes changes beginning with the January 2022 public reporting for the Home Health Quality Reporting Program to address exceptions related to the COVID-19 public health emergency.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-07559
Type: Notice
Date: 2021-04-13
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice
Document Number: 2021-07549
Type: Notice
Date: 2021-04-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) 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.
Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea; Public Workshop; Request for Comments
Document Number: 2021-07548
Type: Notice
Date: 2021-04-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we), the National Institute of Allergy and Infectious Diseases (NIAID), and the Centers for Disease Control and Prevention (CDC) are announcing the following public workshop entitled ``Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea.'' The purpose of the public workshop is to discuss the nonclinical and clinical pharmacology data and clinical trial design considerations regarding developing antimicrobial drugs for the treatment of gonorrhea.
Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2021-07546
Type: Notice
Date: 2021-04-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. The general function of the subcommittee 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.
Advisory Council on Alzheimer's Research, Care, and Services; Meeting
Document Number: 2021-07535
Type: Notice
Date: 2021-04-13
Agency: Department of Health and Human Services
This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. During the May 3, 2021 meeting the Advisory Council will hear invited presentations from a panel of experts on dementia detection and diagnosis, care models, and access to care for those with younger onset dementia. Federal workgroups will also provide updates on work completed in the last quarter.
Solicitation of Nominations for Membership To Serve on the Advisory Committee on Training in Primary Care Medicine and Dentistry
Document Number: 2021-07533
Type: Notice
Date: 2021-04-13
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is seeking nominations of qualified candidates for consideration for appointment as members of the Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD or Committee).
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-07515
Type: Notice
Date: 2021-04-13
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2021-07514
Type: Notice
Date: 2021-04-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2021-07512
Type: Notice
Date: 2021-04-13
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Closed Meeting
Document Number: 2021-07487
Type: Notice
Date: 2021-04-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2021-07478
Type: Notice
Date: 2021-04-13
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 (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.
Medicare Program; FY 2022 Inpatient Psychiatric Facilities Prospective Payment System and Quality Reporting Updates for Fiscal Year Beginning October 1, 2021 (FY 2022)
Document Number: 2021-07433
Type: Proposed Rule
Date: 2021-04-13
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would update the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPF), which include psychiatric hospitals and excluded psychiatric units of an Inpatient Prospective Payment System (IPPS) hospital or critical access hospital. This rule also proposes to update and clarify the IPF teaching policy with respect to IPF hospital closures and displaced residents and proposes a technical change to the 2016-based IPF market basket price proxies. In addition, this proposed rule would update quality measures and reporting requirements under the Inpatient Psychiatric Facilities Quality Reporting (IPFQR) Program. These changes would be effective for IPF discharges occurring during the Fiscal Year (FY) beginning October 1, 2021 through September 30, 2022 (FY 2022).
Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs; Reopening of the Comment Period
Document Number: 2021-07452
Type: Notice
Date: 2021-04-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice announcing a public meeting and requesting comments that appeared in the Federal Register of October 13, 2020. In that notice, FDA announced a public meeting, which was held on November 16, 2020, and requested public input on a potential revised approach for considering the human medical importance of antimicrobial new animal drugs when assessing and managing the antimicrobial resistance risks associated with the use of antimicrobial drugs in animals. Specifically, the Agency requested comments on the potential revised process for ranking antimicrobials according to their relative importance in human medicine, on the potential criteria for their ranking, and on the resulting ranked list of antimicrobial drugs. We are taking this action in response to technical difficulties submitting comments to the Federal eRulemaking portal.
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meetings
Document Number: 2021-07435
Type: Notice
Date: 2021-04-12
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Child Care Improper Payments Data Collection Instructions
Document Number: 2021-07425
Type: Notice
Date: 2021-04-12
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families is proposing revisions to an approved information collection, Child Care Improper Payments Data Collection Instructions (OMB #0970-0323, expiration 10/ 31/2021). There are minor changes requested to the form.
Proposed Information Collection Activity; Survey of the National Survey of Child and Adolescent Well-Being (NSCAW) Adopted Youth, Young Adults, and Adoptive Parents (0970-0555)
Document Number: 2021-07420
Type: Notice
Date: 2021-04-12
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) seeks approval for an extension with no changes to a one-time study to examine familial outcomes 8 years or more after a child's adoption from the child welfare system. The primary objective of this study is to estimate the prevalence of instability events that occur in families who have adopted children who have exited the foster care system. The second objective is to understand risk and protective factors associated with post adoption instability. Office of Management and Budget (OMB) approval expires September 30, 2021, and this request is to extend approval to allow for the completion of data collection.
Proposed Collection; 60-Day Comment Request; Post-Award Reporting Requirements Including Research Performance Progress Report Collection (OD)
Document Number: 2021-07397
Type: Notice
Date: 2021-04-12
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Proposed Collection; 60-Day Comment Request; PHS Applications and Pre-Award Reporting Requirements (OD)
Document Number: 2021-07396
Type: Notice
Date: 2021-04-12
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-07379
Type: Notice
Date: 2021-04-12
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 TEMPORARY HALT IN RESIDENTIAL EVICTIONS TO PREVENT THE FURTHER SPREAD OF COVID-19. The information collection originally pertained to the September 4, 2020 CDC Order of the same name that temporarily halts residential evictions of covered persons for nonpayment of rent from September 4, 2020, through December 31, 2020. The Consolidated Appropriations Act, 2021, statutorily extended CDC's Order until January 31, 2021. On January 29, 2021, the CDC Director renewed the Order until March 31, 2021. As of March 31, the Order is further extended until June 30, 2021. The Declaration in this information collection request will serve as an attestation by a tenant, lessee, or resident that they meet the criteria therein, to prevent an eviction proceeding per the Order issued by the CDC.
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2021-07378
Type: Notice
Date: 2021-04-12
Agency: Department of Health and Human Services, National Institutes of Health
Animal Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate
Document Number: 2021-07377
Type: Notice
Date: 2021-04-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is issuing this notice to request that public stakeholders notify FDA of their intent to participate in periodic consultation meetings on reauthorization of the Animal Drug User Fee Act (ADUFA). The statutory authority for ADUFA expires September 30, 2023. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA consult with a range of stakeholdersincluding patient and consumer advocacy groups, veterinary professionals, and scientific and academic expertsin developing recommendations for the next ADUFA program and hold discussions with these stakeholders at least once every 4 months during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure consistent stakeholder representation at the consultation meetings.
Animal Generic Drug User Fee Act; Public Meeting; Request for Comments
Document Number: 2021-07375
Type: Notice
Date: 2021-04-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following virtual public meeting entitled ``Animal Generic Drug User Fee Act.'' The purpose of the public meeting is to invite public comment on the Animal Generic Drug User Fee Act (AGDUFA) program and suggestions regarding the features FDA should consider for the next reauthorization of the AGDUFA program. The meeting will be open to the public.
Animal Generic Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Generic Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate
Document Number: 2021-07374
Type: Notice
Date: 2021-04-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is issuing this notice to request that public stakeholders notify FDA of their intent to participate in periodic consultation meetings on reauthorization of the Animal Generic Drug User Fee Act (AGDUFA). The statutory authority for AGDUFA expires September 30, 2023. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA consult with a range of stakeholdersincluding patient and consumer advocacy groups, veterinary professionals, and scientific and academic expertsin developing recommendations for the next AGDUFA program and hold discussions with these stakeholders at least once every 4 months during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure consistent stakeholder representation at the consultation meetings.
Animal Drug User Fee Act; Public Meeting; Request for Comments
Document Number: 2021-07373
Type: Notice
Date: 2021-04-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following virtual public meeting entitled ``Animal Drug User Fee Act.'' The purpose of the public meeting is to invite public comment on the Animal Drug User Fee Act (ADUFA) program and suggestions regarding the features FDA should consider for the next reauthorization of the ADUFA program. The meeting will be open to the public.
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2022 and Updates to the IRF Quality Reporting Program
Document Number: 2021-07343
Type: Proposed Rule
Date: 2021-04-12
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2022. As required by statute, this proposed rule includes the classification and weighting factors for the IRF prospective payment system's case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2022. In addition, this proposed rule includes proposals for the IRF Quality Reporting Program (QRP).
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-07342
Type: Notice
Date: 2021-04-09
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.
National Institute of Biomedical Imaging and Bioengineering; Notice of Meeting
Document Number: 2021-07341
Type: Notice
Date: 2021-04-09
Agency: Department of Health and Human Services, National Institutes of Health
Draft Recommendations for Prevention and Control of Infections in Neonatal Intensive Care Unit Patients: Central Line-Associated Blood Stream Infections (CLABSI)
Document Number: 2021-07337
Type: Notice
Date: 2021-04-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (DHHS), announces the opening of a docket to obtain comment on the Draft Recommendations for Prevention and Control of Infections in Neonatal Intensive Care Unit Patients: Central Line-associated Blood Stream Infections (CLABSI). (``Draft Guideline''). The Draft Guideline provides new, evidence-based recommendations specific to the prevention and control of central line- associated blood stream infections (CLABSI) in neonatal intensive care unit (NICU) patients.
Lavipharm Laboratories, Inc., et al.; Withdrawal of Approval of Five Abbreviated New Drug Applications
Document Number: 2021-07335
Type: Notice
Date: 2021-04-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing approval of five abbreviated new drug applications (ANDAs) from multiple holders of those ANDAs. The basis for the withdrawal is that these ANDA holders have repeatedly failed to file required annual reports for those ANDAs and have failed to satisfy the requirement to have an approved risk evaluation and mitigation strategy (REMS).