Department of Health and Human Services 2019 – Federal Register Recent Federal Regulation Documents

Results 401 - 450 of 3,514
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-24614
Type: Notice
Date: 2019-11-13
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Subcommittee Meetings for the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC)
Document Number: 2019-24598
Type: Notice
Date: 2019-11-13
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Secretary of Health and Human Services (Secretary) announces subcommittee meetings of the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC). The meetings are open to the public and can be accessed via telephone only. Agenda with call-in information will be posted on the SAMHSA website prior to the meetings at: https://www.samhsa.gov/about-us/advisory-councils/meetings. The meetings will include information on the following focus areas: Data, Access, Treatment and Recovery, Justice, and Finance. Committee Name: Interdepartmental Serious Mental Illness Coordinating Committee (subcommittee meetings). Date/Time/Type:
Medicare Program; CY 2020 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts
Document Number: 2019-24441
Type: Notice
Date: 2019-11-13
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the inpatient hospital deductible and the hospital and extended care services coinsurance amounts for services furnished in calendar year (CY) 2020 under Medicare's Hospital Insurance Program (Medicare Part A). The Medicare statute specifies the formulae used to determine these amounts. For CY 2020, the inpatient hospital deductible will be $1,408. The daily coinsurance amounts for CY 2020 will be: $352 for the 61st through 90th day of hospitalization in a benefit period; $704 for lifetime reserve days; and $176 for the 21st through 100th day of extended care services in a skilled nursing facility in a benefit period.
Medicare Program; Medicare Part B Monthly Actuarial Rates, Premium Rates, and Annual Deductible Beginning January 1, 2020
Document Number: 2019-24440
Type: Notice
Date: 2019-11-13
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the monthly actuarial rates for aged (age 65 and over) and disabled (under age 65) beneficiaries enrolled in Part B of the Medicare Supplementary Medical Insurance (SMI) program beginning January 1, 2020. In addition, this notice announces the monthly premium for aged and disabled beneficiaries, the deductible for 2020, and the income-related monthly adjustment amounts to be paid by beneficiaries with modified adjusted gross income above certain threshold amounts. The monthly actuarial rates for 2020 are $283.20 for aged enrollees and $343.60 for disabled enrollees. The standard monthly Part B premium rate for all enrollees for 2020 is $144.60, which is equal to 50 percent of the monthly actuarial rate for aged enrollees (or approximately 25 percent of the expected average total cost of Part B coverage for aged enrollees) plus $3.00 repayment amount required under current law. (The 2019 standard premium rate was $135.50, which included the $3.00 repayment amount.) The Part B deductible for 2020 is $198.00 for all Part B beneficiaries. If a beneficiary has to pay an income-related monthly adjustment, he or she will have to pay a total monthly premium of about 35, 50, 65, 80 or 85 percent of the total cost of Part B coverage plus a repayment amount of $4.20, $6.00, $7.80, $9.60 or $10.20 respectively.
Medicare Program; CY 2020 Part A Premiums for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement
Document Number: 2019-24439
Type: Notice
Date: 2019-11-13
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This annual notice announces Medicare's Hospital Insurance (Part A) premium for uninsured enrollees in calendar year (CY) 2020. This premium is paid by enrollees age 65 and over who are not otherwise eligible for benefits under Medicare Part A (hereafter known as the ``uninsured aged'') and by certain disabled individuals who have exhausted other entitlement. The monthly Part A premium for the 12 months beginning January 1, 2020 for these individuals will be $458. The premium for certain other individuals as described in this notice will be $252.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Controlled Correspondence Related to Generic Drug Development
Document Number: 2019-24562
Type: Notice
Date: 2019-11-12
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 (PRA).
Haemonetics Manufacturing, Inc.; Withdrawal of Approval of Abbreviated New Drug Application of Anticoagulant Citrate Dextrose Solution A, USP
Document Number: 2019-24527
Type: Notice
Date: 2019-11-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of abbreviated new drug application (ANDA) BA 710497/0 for Anticoagulant Citrate Dextrose Solution A, USP (ACD-A), In Plastic Bags, held by Haemonetics Manufacturing, Inc. Haemonetics Manufacturing, Inc., requested in writing that the Agency's approval of the application be withdrawn because the drug is no longer being marketed and has waived its opportunity for a hearing.
Agency Information Collection Activities; Proposed Collection; Comment Request; Development Disabilities State Plan Information Collection; OMB #0985-0029
Document Number: 2019-24523
Type: Notice
Date: 2019-11-12
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a 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 Proposed Extension without Change and solicits comments on the information collection requirements related to Development Disabilities State Plan.
Agency Information Collection Activities; Proposed Collection; Comment Request; State Program Report; OMB #0985-0008
Document Number: 2019-24522
Type: Notice
Date: 2019-11-12
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) 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 section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to Proposed Revision for the information collection requirements related to the State Program Report.
Agency Information Collection Activities; Proposed Collection; Comment Request; The National Adult Maltreatment Reporting System; OMB #0985-0054
Document Number: 2019-24521
Type: Notice
Date: 2019-11-12
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a 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 Proposed Extension without Change and solicits comments on the information collection requirements related to the National Maltreatment Reporting System (NAMRS).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications
Document Number: 2019-24513
Type: Notice
Date: 2019-11-12
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Additional Materials; Reopening of the Comment Period
Document Number: 2019-24511
Type: Proposed Rule
Date: 2019-11-12
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 proposed rule that appeared in the Federal Register of August 16, 2019. The Agency is providing additional information in the docket and reopening the public comment period for 15 days to afford the public an opportunity to comment on this additional information.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Format and Content Requirements for Over-the-Counter Drug Product Labeling
Document Number: 2019-24509
Type: Notice
Date: 2019-11-12
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 (PRA).
National Institutes of Health Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-24466
Type: Notice
Date: 2019-11-12
Agency: Department of Health and Human Services
Request for Information for Six Chemicals To Develop Immediately Dangerous to Life or Health (IDLH) Values.
Document Number: 2019-24465
Type: Notice
Date: 2019-11-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) intends to evaluate the scientific data for 6 chemicalsallyl alcohol, bromine chloride, hydrogen bromide, hydrogen iodide, lewisite (a chemical warfare agent), and propylene imineto develop new or updated Immediately Dangerous to Life or Health (IDLH) values.
Medicare, Medicaid, and Children's Health Insurance Programs; Provider Enrollment Application Fee Amount for Calendar Year 2020
Document Number: 2019-24443
Type: Notice
Date: 2019-11-12
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a $595.00 calendar year (CY) 2020 application fee for institutional providers that are initially enrolling in the Medicare or Medicaid program or the Children's Health Insurance Program (CHIP); revalidating their Medicare, Medicaid, or CHIP enrollment; or adding a new Medicare practice location. This fee is required with any enrollment application submitted on or after January 1, 2020 and on or before December 31, 2020.
Medicare Program: Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Revisions of Organ Procurement Organizations Conditions of Coverage; Prior Authorization Process and Requirements for Certain Covered Outpatient Department Services; Potential Changes to the Laboratory Date of Service Policy; Changes to Grandfathered Children's Hospitals-Within-Hospitals; Notice of Closure of Two Teaching Hospitals and Opportunity To Apply for Available Slots
Document Number: 2019-24138
Type: Rule
Date: 2019-11-12
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for Calendar Year 2020 based on our continuing experience with these systems. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. Also, this final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. In addition, this final rule with comment period establishes a process and requirements for prior authorization for certain covered outpatient department services; revise the conditions for coverage of organ procurement organizations; and revise the regulations to allow grandfathered children's hospitals- within-hospitals to increase the number of beds without resulting in the loss of grandfathered status; and provides notice of the closure of two teaching hospitals and the opportunity to apply for available slots for purposes of indirect medical education (IME) and direct graduate medical education (DGME) payments.
Request for Public Comments on a DRAFT NIH Policy for Data Management and Sharing and Supplemental DRAFT Guidance
Document Number: 2019-24529
Type: Notice
Date: 2019-11-08
Agency: Department of Health and Human Services, National Institutes of Health
The National Institutes of Health (NIH) is seeking public comments on a DRAFT NIH Policy for Data Management and Sharing and supplemental DRAFT guidance. The purpose of this DRAFT Policy and supplemental DRAFT guidance is to promote effective and efficient data management and sharing to further NIH's commitment to making the results and accomplishments of the research it funds and conducts available to the public.
Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2019-24446
Type: Notice
Date: 2019-11-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
HHS gives notice of a decision to designate a class of employees from the Y-12 Plant in Oak Ridge, Tennessee, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2019-24445
Type: Notice
Date: 2019-11-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
HHS gives notice of a decision to designate a class of employees from the West Valley Demonstration Project in West Valley, New York, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Delegation of Authority
Document Number: 2019-24402
Type: Notice
Date: 2019-11-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-24382
Type: Notice
Date: 2019-11-08
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Request; 60-Day Public Comment Request
Document Number: 2019-24360
Type: Notice
Date: 2019-11-08
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.
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2019-24356
Type: Notice
Date: 2019-11-08
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule Amounts, DMEPOS Competitive Bidding Program (CBP) Amendments, Standard Elements for a DMEPOS Order, and Master List of DMEPOS Items Potentially Subject to a Face-to-Face Encounter and Written Order Prior to Delivery and/or Prior Authorization Requirements
Document Number: 2019-24063
Type: Rule
Date: 2019-11-08
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule updates and makes revisions to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2020. This rule also updates the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury (AKI). This rule also updates requirements for the ESRD Quality Incentive Program (QIP). In addition, this rule establishes a methodology for calculating fee schedule payment amounts for new Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) items and services, and a methodology for making adjustments to the fee schedule amounts established using supplier or commercial prices if such prices decrease within 5 years of establishing the initial fee schedule amounts. This rule also revises existing regulations related to the DMEPOS competitive bidding program. This rule also streamlines the requirements for ordering DMEPOS items, and develops a new list of DMEPOS items potentially subject to a face-to-face encounter, written orders prior to delivery and/or prior authorization requirements. Finally, this rule summarizes responses to requests for information on data collection resulting from the ESRD PPS technical expert panel, changing the basis for the ESRD PPS wage index, and new requirements for the competitive bidding of diabetic testing strips.
Medicare and Medicaid Programs; CY 2020 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; Home Health Quality Reporting Requirements; and Home Infusion Therapy Requirements
Document Number: 2019-24026
Type: Rule
Date: 2019-11-08
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule with comment period updates the home health prospective payment system (HH PPS) payment rates and wage index for CY 2020; implements the Patient-Driven Groupings Model (PDGM), a revised case-mix adjustment methodology, for home health services beginning on or after January 1, 2020. This final rule with comment period also implements a change in the unit of payment from 60-day episodes of care to 30-day periods of care, as required by section 51001 of the Bipartisan Budget Act of 2018, hereinafter referred to the ``BBA of 2018'', and finalizes a 30-day payment amount for CY 2020. Additionally, this final rule with comment period: Modifies the payment regulations pertaining to the content of the home health plan of care; allows therapist assistants to furnish maintenance therapy; and changes the split percentage payment approach under the HH PPS. For the Home Health Value-Based Purchasing (HHVBP) model, we are finalizing provisions requiring the public reporting of the Total Performance Score (TPS) and the TPS Percentile Ranking from the Performance Year 5 (CY 2020) Annual TPS and Payment Adjustment Report for each home health agency in the nine Model states that qualified for a payment adjustment for CY 2020. This final rule with comment period also finalizes the following updates to the Home Health Quality Reporting Program (HH QRP): Removal of a measure; adoption of two new measures; modification of an existing measure; and a requirement for HHA's to report standardized patient assessment data beginning with the CY 2022 HH QRP. Additionally, we are finalizing our proposal to re-designate our current HH QRP regulations in a different section of our regulations and to codify other current policies in that new regulatory section with one substantive change as well as a few technical edits. We are not finalizing our proposal to remove question 10 from all of the HH Consumer Assessment of Healthcare Providers and Systems (CAHPS) surveys. Lastly, it sets forth routine updates to the home infusion therapy payment rates for CY 2020, payment provisions for home infusion therapy services for CY 2021 and subsequent years, and solicits comments on options to enhance future efforts to improve policies related to coverage of eligible drugs for home infusion therapy.
Best Practices in Drug and Biological Product Postmarket Safety Surveillance for Food and Drug Administration Staff; Draft Document; Availability; Establishment of Public Docket; Request for Comments
Document Number: 2019-24332
Type: Notice
Date: 2019-11-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is establishing a public docket to collect comments on a draft document that details best practices for drug safety surveillance entitled ``Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff.'' The 21st Century Cures Act (Cures Act) was enacted on December 13, 2016, and requires that FDA make publicly available on its internet website best practices for drug safety surveillance activities. The draft document sets forth risk-based principles by which FDA conducts ongoing postmarketing safety surveillance for drug and biological products to address the Cures Act requirements. FDA is seeking public comment on the draft best practices in drug and biological product postmarket safety surveillance.
Agency Information Collection Request: 60-Day Public Comment Request
Document Number: 2019-24296
Type: Notice
Date: 2019-11-07
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.
Findings of Research Misconduct
Document Number: 2019-24291
Type: Notice
Date: 2019-11-07
Agency: Department of Health and Human Services, Office of the Secretary
Findings of research misconduct have been made against Erin N. Potts Kant (Respondent), former Clinical Research Coordinator, Division of Pulmonary, Allergy, and Critical Care Medicine (PMCCM), Duke University School of Medicine (Duke). Ms. Potts Kant engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), grants HL105702, HL005009, HL058795, HL036982, HL044984, HL062472, HL067021, HL067281, HL067669, HL068072, HL073896, HL077291, HL077763, HL079915, HL081285, HL081763, HL082504, HL084123, HL084917, HL085655, HL086887, HL087094, HL090146, HL090265, HL098099, HL091140, HL091335, HL091642-02, HL092994, HL073907, and HL111151; National Institute of Allergy and Infectious Diseases (NIAID), NIH, grants AI081672, AI089756, AI068822, AI056101, AI067798, AI074751, AI050021, AI058161, AI064789, and AI052201; National Institute on Environmental Health Sciences (NIEHS), NIH, grants ES020426, ES007943, ES011961, ES012496, ES016836, ES012717, ES015675, ES016126, ES016347, ES016659, and ES020350; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NIH, grants DK050814, DK077159, and DK077307; National Cancer Institute (NCI), NIH, grants CA142842 and CA092656; National Center for Research Resources (NCRR), NIH, grants RR005959 and RR024127; and National Institute of Child Health and Human Development (NICHD), NIH, grant HD043728. The administrative actions, including permanent debarment, were implemented beginning on October 1, 2019, and are detailed below.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Healthy Start Evaluation and Quality Improvement, OMB No. 0915-0338-Revision
Document Number: 2019-24278
Type: Notice
Date: 2019-11-07
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2019-24263
Type: Notice
Date: 2019-11-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting
Document Number: 2019-24261
Type: Notice
Date: 2019-11-07
Agency: Department of Health and Human Services, National Institutes of Health
Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2019-24244
Type: Notice
Date: 2019-11-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC, announces the following meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This meeting is open to the public, limited only by the space available. The meeting space accommodates approximately 150 people and the audio conference line has 150 ports for callers. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcome to listen to the meeting by joining the teleconference (information below).
Notice of Interest Rate on Overdue Debts
Document Number: 2019-24237
Type: Notice
Date: 2019-11-07
Agency: Department of Health and Human Services, Office of the Secretary
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-July Through September 2019
Document Number: 2019-24235
Type: Notice
Date: 2019-11-06
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from July through September 2019, relating to the Medicare and Medicaid programs and other programs administered by CMS.
Request for Nominations From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on the Allergenic Products Advisory Committee
Document Number: 2019-24233
Type: Notice
Date: 2019-11-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Allergenic Products Advisory Committee (APAC) for the Center for Biologics Evaluation and Research notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative(s) to serve on the APAC. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-24232
Type: Notice
Date: 2019-11-06
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Threshold of Regulation for Substances Used in Food-Contact Articles
Document Number: 2019-24230
Type: Notice
Date: 2019-11-06
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Assessment of Terms and Phrases Commonly Used in Prescription Drug Promotion
Document Number: 2019-24229
Type: Notice
Date: 2019-11-06
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled ``Assessment of Terms and Phrases Commonly Used in Prescription Drug Promotion.''
Expedited OMB Review: Proposed Information Collection Activity; National Human Trafficking Training and Technical Assistance Center (NHTTAC) Evaluation Package (OMB #0970-0519)
Document Number: 2019-24200
Type: Notice
Date: 2019-11-06
Agency: Department of Health and Human Services, Administration for Children and Families
The Office on Trafficking of Persons (OTIP), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting expedited review of an information collection request from OMB for an increase in the 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 will increase the estimated burden hours from 689 hours to 9,495 hours. In addition, the previously approved SOAR Online participant feedback form has been restructured into a long and a 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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-24194
Type: Notice
Date: 2019-11-06
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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 ``Outcome Measure Harmonization and Data Infrastructure for Patient Centered Outcomes Research in Depression.'' This proposed information collection was previously published in the Federal Register on August 22, 2019 and allowed 60 days for public comment. No substantive comments were received by AHRQ during these 60 days. The purpose of this notice is to allow an additional 30 days for public comment.
Reporting of Pregnancy Success Rates from Assisted Reproductive Technology (ART) Programs; Proposed Additional Data Collection Fields; Request for Comment
Document Number: 2019-24174
Type: Notice
Date: 2019-11-06
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the opening of a public docket to obtain comment and review of proposed additional data collection fields and reporting requirement modification for reporting of pregnancy success rates from assisted reproductive technology (ART) programs. This reporting is required by the Fertility Clinic Success Rate and Certification Act of 1992 (FCSRCA).
Meeting of the Advisory Commission on Childhood Vaccines
Document Number: 2019-24166
Type: Notice
Date: 2019-11-06
Agency: Department of Health and Human Services, Health Resources and Services Administration
The original Federal Register Notice announcing the December 2019 Advisory Commission on Childhood Vaccines (ACCV) meeting indicated that this meeting would be held December 5-6, 2019. This meeting is not being conducted over two days, and instead will only take place only on December 5, 2019. The ACCV will hold a public meeting on December 5, 2019, at 10:00 a.m. Eastern Time via Adobe Connect and telephone conference. This will not be an in-person meeting. The public can join the meeting by: 1. (Audio Portion) Calling the conference phone number: 800-988- 0218 and providing the following information:
Agency Information Collection Request; 60-Day Public Comment Request
Document Number: 2019-24157
Type: Notice
Date: 2019-11-05
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.
Patient Safety Organizations: Voluntary Relinquishment for Symbria SAFE
Document Number: 2019-24152
Type: Notice
Date: 2019-11-05
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) authorizes AHRQ, on behalf of the Secretary of HHS, to list as a patient safety organization (PSO) an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ accepted a notification of proposed voluntary relinquishment from Symbria SAFE, PSO number P0146, of its status as a PSO, and has delisted the PSO accordingly.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Scholarships for Disadvantaged Students, OMB No. 0915-0149-Revision
Document Number: 2019-24111
Type: Notice
Date: 2019-11-05
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR have been provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30 day comment period for this Notice has closed.
Meeting of the National Advisory Council for Healthcare Research and Quality
Document Number: 2019-24081
Type: Notice
Date: 2019-11-05
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-24080
Type: Notice
Date: 2019-11-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meeting
Document Number: 2019-24079
Type: Notice
Date: 2019-11-05
Agency: Department of Health and Human Services, National Institutes of Health
Basic Health Program; Federal Funding Methodology for Program Years 2019 and 2020
Document Number: 2019-24064
Type: Rule
Date: 2019-11-05
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document provides the methodology and data sources necessary to determine federal payment amounts for program years 2019 and 2020 to states that elect to establish a Basic Health Program under the Affordable Care Act to offer health benefits coverage to low-income individuals otherwise eligible to purchase coverage through Affordable Insurance Exchanges.
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