Department of Health and Human Services December 30, 2019 – Federal Register Recent Federal Regulation Documents

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.