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

Results 201 - 250 of 52,753
Office of Minority Health and Health Equity Strategic Priorities; Establishment of a Public Docket; Request for Comments
Document Number: 2019-28417
Type: Notice
Date: 2020-01-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is opening a public docket to solicit input and comments from interested stakeholders, including racial and ethnic minority, underrepresented, and underserved populations in establishing strategic priorities for the Office of Minority Health and Health Equity (OMHHE). This will help the Agency ensure that important health concerns are carefully considered in establishing priorities.
Agency Information Collection Activities; Proposed Collection; Comment Request; Special Protocol Assessment; Guidance for Industry
Document Number: 2019-28408
Type: Notice
Date: 2020-01-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) 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 in the April 2018 guidance for industry entitled ``Special Protocol Assessment'' (Revision 1).
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Data System for Organ Procurement and Transplantation Network, OMB No. 0915-0157-Extension
Document Number: 2019-28370
Type: Notice
Date: 2020-01-03
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for an opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: The National Health Service Corps and Nurse Corps Interest Capture Form OMB No. 0915-0337-Extension
Document Number: 2019-28368
Type: Notice
Date: 2020-01-03
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Countermeasures Injury Compensation Program OMB No. 0915-0334-Extension
Document Number: 2019-28367
Type: Notice
Date: 2020-01-03
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with of 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. OMB may act on HRSA's ICR only after the 30 day comment period for this Notice has closed.
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; Correction
Document Number: 2019-28364
Type: Rule
Date: 2020-01-03
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical errors that appeared in the final rule with comment period that appeared in the November 12, 2019, issue of the Federal Register titled ``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.''
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meetings
Document Number: 2019-28359
Type: Notice
Date: 2020-01-03
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2019-28358
Type: Notice
Date: 2020-01-03
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.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-28357
Type: Notice
Date: 2020-01-03
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of an Exclusive Patent License: Development and Commercialization of CD19/CD22 Chimeric Antigen Receptor (CAR) Therapies for the Treatment of B-Cell Malignancies
Document Number: 2019-28356
Type: Notice
Date: 2020-01-03
Agency: Department of Health and Human Services, National Institutes of Health
The National Cancer 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 CJ Healthcare, (``CJ''), located in Seoul, Republic of Korea.
Prospective Grant of an Exclusive Patent License: Use of the CD47 Phosphorodiamidate Morpholino Oligomers for the Treatment, Prevention, and Diagnosis of Solid Tumors
Document Number: 2019-28355
Type: Notice
Date: 2020-01-03
Agency: Department of Health and Human Services, National Institutes of Health
The National Cancer 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 Morphiex Biotherapeutics (``Morphiex'') located in Boston, MA.
Transparency in Coverage
Document Number: 2019-28290
Type: Proposed Rule
Date: 2020-01-03
Agency: Department of Health and Human Services
This document extends the comment period for the proposed rule entitled, ``Transparency in Coverage,'' that published in the November 27, 2019, issue of the Federal Register. The comment period for the proposed rule, which would close on January 14, 2020, is extended 15 days to January 29, 2020.
Medicare and Medicaid Programs; Adjustment of Civil Monetary Penalties for Inflation; Continuation of Effectiveness and Extension of Timeline for Publication of the Final Rule
Document Number: 2019-28363
Type: Rule
Date: 2020-01-02
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document announces the continuation of, effectiveness of, and the extension of the timeline for publication of a final rule. We are issuing this document in accordance with the Social Security Act (the Act), which allows an interim final rule to remain in effect after the expiration of the timeline specified in the Act if the Secretary publishes a notice of continuation explaining why the regular timeline was not complied with.
Meeting of the Advisory Commission on Childhood Vaccines
Document Number: 2019-28294
Type: Notice
Date: 2020-01-02
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Commission on Childhood Vaccines (ACCV) will hold public meetings for the 2020 calendar year (CY). Information about ACCV, agendas, and materials for these meetings can be found on the ACCV website at https://www.hrsa.gov/advisory- committees/vaccines/index.html.
Medicare Program; CY 2020 Revisions to Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid Promoting Interoperability Program Requirements for Eligible Professionals; Establishment of an Ambulance Data Collection System; Updates to the Quality Payment Program; Medicare Enrollment of Opioid Treatment Programs and Enhancements to Provider Enrollment Regulations Concerning Improper Prescribing and Patient Harm; and Amendments to Physician Self-Referral Law Advisory Opinion Regulations Final Rule; and Coding and Payment for Evaluation and Management, Observation and Provision of Self-Administered Esketamine Interim Final Rule; Correction
Document Number: 2019-28005
Type: Rule
Date: 2020-01-02
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical errors in the final rule that appeared in the November 15, 2019 Federal Register entitled, ``Medicare Program; CY 2020 Revisions to Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid Promoting Interoperability Program Requirements for Eligible Professionals; Establishment of an Ambulance Data Collection System; Updates to the Quality Payment Program; Medicare Enrollment of Opioid Treatment Programs and Enhancements to Provider Enrollment Regulations Concerning Improper Prescribing and Patient Harm; and Amendments to Physician Self-Referral Law Advisory Opinion Regulations Final Rule; and Coding and Payment for Evaluation and Management, Observation and Provision of Self- Administered Esketamine Interim Final Rule'' (referred to hereafter as the ``CY 2020 PFS final rule'').
Determination That GLUCOPHAGE (Metformin Hydrochloride) Oral Tablets, 500 Milligrams, 850 Milligrams, and 1 Gram, and GLUCOPHAGE XR (Metformin Hydrochloride) Oral Extended-Release Tablets, 500 Milligrams and 750 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2019-28270
Type: Notice
Date: 2019-12-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) has determined that, GLUCOPHAGE (metformin hydrochloride) oral tablets, 500 milligrams (mg), 850 mg, and 1 gram (g), and GLUCOPHAGE XR (metformin hydrochloride) oral extended-release tablets, 500 mg and 750 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to these products as long as they meet relevant legal and regulatory requirements.
International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; World Health Organization; Scheduling Recommendations; AB-FUBINACA; 5F-AMB-PINACA; 5F-MDMB-PICA; 4-F-MDMB-BINACA; 4-CMC; N-ethylhexedrone; alpha-PHP; DOC; Crotonyl Fentanyl; Valeryl Fentanyl; Flualprazolam and Etizolam; Request for Comments
Document Number: 2019-28269
Type: Notice
Date: 2019-12-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is providing interested persons with the opportunity to submit written comments concerning recommendations by the World Health Organization (WHO) to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances. The comments received in response to this notice will be considered in preparing the United States' position on these proposals for a meeting of the United Nations Commission on Narcotic Drugs (CND) in Vienna, Austria, in March 2020. This notice is issued under the Controlled Substances Act (CSA).
Advisory Council on Alzheimer's Research, Care, and Services; Meeting
Document Number: 2019-28268
Type: Notice
Date: 2019-12-31
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 January 27, 2020 meeting, an invited panel will present lessons from epidemiology on understanding current rates of dementia, future trends, and potential preventive strategies. The Advisory Council will hear about the Department of Defense's Peer Reviewed Alzheimer's Research Program as well as an update on the recommendations from the Alzheimer's Disease-Related Dementias Research Summit. Federal workgroups will also provide updates on work completed in the last quarter.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2019-28249
Type: Notice
Date: 2019-12-31
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Focus Groups About Drug Products as Used by the Food and Drug Administration
Document Number: 2019-28247
Type: Notice
Date: 2019-12-31
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 (PRA).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Unique Device Identification System
Document Number: 2019-28246
Type: Notice
Date: 2019-12-31
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.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-28245
Type: Notice
Date: 2019-12-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Meeting
Document Number: 2019-28244
Type: Notice
Date: 2019-12-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting
Document Number: 2019-28243
Type: Notice
Date: 2019-12-31
Agency: Department of Health and Human Services, National Institutes of Health
Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics; Guidance for Industry; Availability
Document Number: 2019-27868
Type: Rule
Date: 2019-12-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled ``Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics.'' The final guidance provides questions and answers on topics related primarily to implementing two final rules, one entitled ``Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments,'' and the other entitled ``Food Labeling: Revision of the Nutrition and Supplement Facts Labels.'' The final guidance also discusses formatting issues for dual-column labeling, products that have limited space for nutrition labeling, and additional issues dealing with compliance.
Solicitation of New Safe Harbors and Special Fraud Alerts
Document Number: 2019-27202
Type: Proposed Rule
Date: 2019-12-31
Agency: Department of Health and Human Services, Office of Inspector General
In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this annual notification solicits proposals and recommendations for developing new, or modifying existing, safe harbor provisions under section 1128B(b) of the Social Security Act (the Act), (the anti-kickback statute), as well as developing new OIG Special Fraud Alerts.
Medicaid Program; Medicaid Fiscal Accountability Regulation; Supplement and Extension of Comment Period
Document Number: 2019-28179
Type: Proposed Rule
Date: 2019-12-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document extends the comment period for the proposed rule entitled ``Medicaid Program; Medicaid Fiscal Accountability Regulation'' that appeared in the November 18, 2019 Federal Register. The comment period for the proposed rule, which would end on January 17, 2020, is extended 15 days to February 1, 2020. We additionally note that based on public comments received on this proposed rule, we will adjust the effective dates of our policies to allow for adequate implementation timelines, as appropriate.
Office of the Secretary Notice of Meeting
Document Number: 2019-28156
Type: Notice
Date: 2019-12-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: 2019-28155
Type: Notice
Date: 2019-12-30
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2019-28154
Type: Notice
Date: 2019-12-30
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2019-28153
Type: Notice
Date: 2019-12-30
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: 2019-28152
Type: Notice
Date: 2019-12-30
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2019-28151
Type: Notice
Date: 2019-12-30
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of an Exclusive Patent License: The Development of Autologous Kita-Kyushu Lung Cancer Antigen 1 (KK-LC-1) T Cell Receptor (TCR) for the Treatment of KK-LC-1 Expressing Human Cancer
Document Number: 2019-28150
Type: Notice
Date: 2019-12-30
Agency: Department of Health and Human Services, National Institutes of Health
The National Cancer 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 T-Cure Biosciences, Inc. (T-Cure), located in Sherman Oaks, California.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine and Oral Fluid Drug Testing for Federal Agencies
Document Number: 2019-28149
Type: Notice
Date: 2019-12-30
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the internet at https:// www.samhsa.gov/workplace/resources/drug-testing/certified-lab -list.
Cheeses and Related Cheese Products; Proposal To Permit the Use of Ultrafiltered Milk; Reopening the Comment Period
Document Number: 2019-28145
Type: Proposed Rule
Date: 2019-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is reopening the comment period for the proposed rule published in the Federal Register of October 19, 2005, entitled ``Cheeses and Related Cheese Products; Proposal to Permit the Use of Ultrafiltered Milk.'' The proposed rule would amend our regulations to provide for the use of fluid ultrafiltered (UF) milk in the manufacture of standardized cheeses and related cheese products. We are reopening the comment period to receive new information and further comment on current industry practices regarding the use of fluid UF milk and fluid UF nonfat milk in the manufacture of standardized cheeses and related cheese products, and the declaration of fluid UF milk and fluid UF nonfat milk when used as ingredients in standardized cheeses and related cheese products.
Importation of Certain Food and Drug Administration-Approved Human Prescription Drugs, Including Biological Products, Under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability; Correction
Document Number: 2019-28141
Type: Notice
Date: 2019-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
This document corrects the Notice of Availability from the Food and Drug Administration (FDA, Agency, or we) announcing the availability of a draft guidance for industry entitled ``Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act,'' which published in the Federal Register on Monday, December 23, 2019. This draft guidance describes procedures to obtain a National Drug Code (NDC) for an FDA-approved prescription drug that is imported into the United States in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act), which would provide an additional avenue through which drugs could be sold at a lower cost in the U.S. market. This draft guidance is intended to address certain challenges in the private market faced by manufacturers seeking to sell their drugs at lower costs. The Notice was published with two omissions. This document corrects those omissions by republishing the Notice in its entirety to include the omitted language.
Submission for OMB Review; 30-Day Comment Request Post-Award Reporting Requirements Including Research Performance Progress Report Collection (OD/OPERA)
Document Number: 2019-28130
Type: Notice
Date: 2019-12-30
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Submission for OMB Review; 30-Day Comment Request PHS Applications and Pre-Award Reporting Requirements (OD/OPERA)
Document Number: 2019-28129
Type: Notice
Date: 2019-12-30
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Submission for OMB Review; Provision of Child Support Services in IV-D Cases Under the Hague Child Support Convention; Federally-Approved Forms (OMB #0970-0488)
Document Number: 2019-28109
Type: Notice
Date: 2019-12-30
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF) is requesting a three-year extension of the Hague Child Support Forms (OMB #0970-0488, expiration 4/30/2020). There are no changes requested to the form.
Submission for OMB Review; Coparenting and Healthy Relationship and Marriage Education for Dads (New Collection)
Document Number: 2019-28108
Type: Notice
Date: 2019-12-30
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), Office of Planning, Research, and Evaluation (OPRE) proposes to collect information as part of the Coparenting and Healthy Relationship and Marriage Education for Dads (CHaRMED) study. The purpose of the CHaRMED study is to better understand the services that fatherhood programs provide in the areas of Healthy Marriage and Relationship Education (HMRE) and coparenting to learn what strategies hold promise for promoting active engagement in these services.
Agency Information Collection Activities; Proposed Collection; Public Comment Request; State Health Insurance Assistance Program (SHIP) Data Performance Reports and Information Collection Tools
Document Number: 2019-28105
Type: Notice
Date: 2019-12-30
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 revision of an existing collection of information, and to allow 60 days for public comment in response to the notice. This is a revision request for the Office of Management and Budget (OMB) approval for the modification and use of the Data Performance Reports and Information Collection tools for the State Health Insurance Assistance Program (SHIP) under OMB 0985-0040 that expires March 31, 2020.
Agency Information Collection Activities; Proposed Collection; Comment Request; SHIP-SMP Survey of Group Outreach and Education Events, Formerly the “Senior Medicare Program National Beneficiary Survey”, OMB #0985-0056
Document Number: 2019-28104
Type: Notice
Date: 2019-12-30
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 Revision and solicits comments on the information collection requirements related to the ``National SHIP-SMP Beneficiary Survey of Group Outreach and Education Events''.
Agency Information Collection Activities; Proposed Collection; Comment Request; SHIP-SMP Survey of One-on-One Assistance, Formerly the “National Beneficiary Survey of State Health Insurance Assistance Program (SHIP)”, OMB #0985-0057
Document Number: 2019-28101
Type: Notice
Date: 2019-12-30
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 Revision and solicits comments on the information collection requirements related to the ``SHIP-SMP Survey of One-on-One Assistance''.
Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification
Document Number: 2019-28098
Type: Notice
Date: 2019-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) 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 information collection associated with medical device premarket notification (510(k)).
Proposed Information Collection Activity; Form ACF-196T, Tribal TANF Financial Report (OMB #0970-0345)
Document Number: 2019-28090
Type: Notice
Date: 2019-12-30
Agency: Department of Health and Human Services, Administration for Children and Families
Form ACF-196T is used by tribes to report expenditures for the Tribal Temporary Assistance for Needy Families (TANF) grant. The Administration for Children and Families (ACF) will use the financial data provided by tribes to estimate quarterly funding needs, calculate award amounts, and assess compliance with statutory and regulatory requirements. ACF is requesting an extension with no changes to the form and minor updates to the instructions.
Medicare Program; Advanced Alternative Payment Model (APM) Incentive Payment Advisory for Clinicians-Request for Current Banking Information for Qualifying APM Participants
Document Number: 2019-28010
Type: Rule
Date: 2019-12-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This advisory is to alert certain clinicians who are Qualifying APM participants (QPs) and eligible to receive an Advanced Alternative Payment Model (APM) Incentive Payment that CMS does not have the current banking information needed to disburse the payment. This advisory provides information to these clinicians on how to update their banking information to receive this payment.
Announcement of the Advisory Panel on Outreach and Education (APOE); January 15, 2020 Meeting
Document Number: 2019-28004
Type: Notice
Date: 2019-12-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the next meeting of the APOE (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace, Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.
Submission of Plans for Cigarette Packages and Cigarette Advertisements; Draft Guidance for Industry; Availability
Document Number: 2019-27991
Type: Notice
Date: 2019-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Submission of Plans for Cigarette Packages and Cigarette Advertisements.'' This guidance, when finalized, would assist those required to submit cigarette plans for cigarette packages and cigarette advertisements by providing recommendations related to those submissions, including information on what should be in a cigarette plan, who should submit a cigarette plan, and when to submit a cigarette plan.
Medical Devices; Exemptions From Premarket Notification for Class I and Class II Devices
Document Number: 2019-27394
Type: Rule
Date: 2019-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) identified a list of class I devices and class II devices that are now exempt from premarket notification requirements, subject to certain limitations. FDA published the lists of final determinations in accordance with procedures established by the 21st Century Cures Act (Cures Act). Although each classification regulation for each such type of device shall be deemed amended to incorporate such exemption, we are publishing this final order to amend the codified language for each listed class I and class II device's classification regulation to reflect the final determinations. FDA's action decreases regulatory burden on the medical device industry and eliminates private costs and expenditures required to comply with certain Federal regulations.