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

Medicare, Medicaid, and Children's Health Insurance Programs; Program Integrity Enhancements to the Provider Enrollment Process; Extension of Timeline for Publication of the Final Rule
Document Number: 2019-03697
Type: Proposed Rule
Date: 2019-02-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document announces the extension of the timeline for publication of the ``Medicare, Medicaid, and Children's Health Insurance Programs; Program Integrity Enhancements to the Provider Enrollment Process'' final rule. We are issuing this document in accordance with the Social Security Act (the Act), which requires notice to be provided in the Federal Register if there are exceptional circumstances that cause us to publish a final rule more than 3 years after the publication date of the proposed rule. In this case, the complexity of the rule and the scope of the comments received warrant the extension of the timeline for publication.
Science Advisory Board to the National Center for Toxicological Research Advisory Committee; Notice of Meeting
Document Number: 2019-03562
Type: Notice
Date: 2019-02-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Science Advisory Board (SAB) to the National Center for Toxicological Research (NCTR). The general function of the committee is to provide advice and recommendations to the Agency on research being conducted at the NCTR. At least one portion of the meeting will be closed to the public.
Agency Information Collection Request; 60-Day Public Comment Request
Document Number: 2019-03546
Type: Notice
Date: 2019-02-28
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.
Change of Address; Technical Amendment
Document Number: 2019-03542
Type: Rule
Date: 2019-02-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is amending its regulations to reflect a change of address for the Center for Drug Evaluation and Research's (CDER's) Office of Generic Drugs (OGD) Document Room from Rockville, MD, to Beltsville, MD. This action is being taken to ensure accuracy and clarity in the Agency's regulations.
Food Additives Permitted in Feed and Drinking Water of Animals; Gamma-Linolenic Acid Safflower Oil
Document Number: 2019-03514
Type: Rule
Date: 2019-02-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we, or Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of gamma- linolenic acid safflower oil (GLA safflower oil) as a source of omega-6 fatty acids in dry food for adult cats in the maintenance life stage. This action is in response to a food additive petition filed by Arcadia Biosciences, Inc.
Agency Information Collection Activities; Proposed Collection; Comment Request; Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
Document Number: 2019-03507
Type: Notice
Date: 2019-02-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with the standards for the growing, harvesting, packing, and holding of produce for human consumption.
Submission for OMB Review; Descriptive Study of the Unaccompanied Refugee Minors Program (New Collection)
Document Number: 2019-03489
Type: Notice
Date: 2019-02-28
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Planning, Research, and Evaluation (OPRE) at the Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS) is proposing data collection activities as part of a project to better understand the range of child welfare services and benefits provided through the Unaccompanied Refugee Minors (URM) Program.
Indian Health Service Strategic Plan Fiscal Year 2019-2023
Document Number: 2019-03486
Type: Notice
Date: 2019-02-28
Agency: Department of Health and Human Services, Indian Health Service
In follow-up to the Indian Health Service (IHS) request for comments on the Draft IHS Strategic Plan Fiscal Year (FY) 2018-2022 issued in the Federal Register (FR) on July 24, 2018, (see 83 FR 35012; July 24, 2018; hereafter ``July 2018 FR document''), the IHS is announcing the final plan entitled: IHS Strategic Plan FY 2019-2023. The IHS is also making available on the IHS Strategic Plan website, a response to comments document that addresses comments received on the Draft IHS Strategic Plan from the July 2018 FR document.
Agency Information Collection Activities: Proposed Collection; Comment Request; Correction
Document Number: 2019-03462
Type: Notice
Date: 2019-02-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects the information provided for [Document Identifier: CMS-10065/10066] titled ``Hospital Notices: IM/DND.''
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2019-03459
Type: Notice
Date: 2019-02-28
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.
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2019-03449
Type: Notice
Date: 2019-02-28
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meetings
Document Number: 2019-03448
Type: Notice
Date: 2019-02-28
Agency: Department of Health and Human Services, National Institutes of Health
Quality Considerations for Continuous Manufacturing; Draft Guidance for Industry; Availability
Document Number: 2019-03413
Type: Notice
Date: 2019-02-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Quality Considerations for Continuous Manufacturing.'' This draft guidance provides information regarding FDA's current thinking on the quality considerations for continuous manufacturing of small molecule, solid oral drug products that are regulated by the Center for Drug Evaluation and Research (CDER). The draft guidance describes several key quality considerations and provides recommendations for how applicants should address these considerations in new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplemental NDAs and ANDAs, for small molecule, solid oral drug products that are produced via a continuous manufacturing process. FDA supports the development and implementation of continuous manufacturing for drug substances and all finished dosage forms where appropriate, including those submitted in NDAs, ANDAs, drug master files, biologics license applications (BLAs), and nonapplication over the counter products. Scientific principles described in this draft guidance may also be applicable to continuous manufacturing technologies used for these drugs. However, this draft guidance is not intended to provide recommendations specific to continuous manufacturing technologies used for biological products under a BLA.
Notice of Meeting
Document Number: 2019-03383
Type: Notice
Date: 2019-02-27
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) is announcing a Special Emphasis Panel (SEP) meeting on Conference Grants (R13).
Notice of Meeting
Document Number: 2019-03382
Type: Notice
Date: 2019-02-27
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) is announcing a Special Emphasis Panel (SEP) meeting on AHRQ-HS-18-002, ``Screening and Management of Unhealthy Alcohol Use in Primary Care: Dissemination and Implementation of PCOR Evidence (R18).''
Submission for OMB Review; 30-Day Comment Request Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (NIAID)
Document Number: 2019-03357
Type: Notice
Date: 2019-02-27
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.
National Institute on Aging: Notice of Closed Meeting
Document Number: 2019-03351
Type: Notice
Date: 2019-02-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging: Notice of Closed Meeting
Document Number: 2019-03350
Type: Notice
Date: 2019-02-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2019-03349
Type: Notice
Date: 2019-02-27
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-03348
Type: Notice
Date: 2019-02-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2019-03346
Type: Notice
Date: 2019-02-27
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Opportunity To Co-Sponsor OMH National Minority Health Month Steps Challenge
Document Number: 2019-03296
Type: Notice
Date: 2019-02-26
Agency: Department of Health and Human Services
OMH announces the opportunity for public and non-profit entities to co-sponsor the National Minority Health Month National Steps Challenge for April 2019. Potential co-sponsors must have a demonstrated interest in reducing health disparities among minority communities, advancing the HHS Physical Activity Guidelines and improving the health of Americans through promoting regular physical activity.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Foreign Supplier Verification Programs for Food Importers
Document Number: 2019-03282
Type: Notice
Date: 2019-02-26
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.
Assessing the Effects of Food on Drugs in Investigational New Drug Applications and New Drug Applications-Clinical Pharmacology Considerations; Draft Guidance for Industry; Availability
Document Number: 2019-03247
Type: Notice
Date: 2019-02-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Assessing the Effects of Food on Drugs in INDs and NDAsClinical Pharmacology Considerations.'' This draft guidance provides recommendations to sponsors planning to conduct food-effect trials for orally administered products as part of investigational new drug applications (INDs), new drug applications (NDAs), and supplements to these applications. This draft guidance, when final, revises and replaces part of the 2002 FDA guidance for industry entitled ``Food-Effect Bioavailability and Fed Bioequivalence Studies'' (2002 Food Effect Guidance).
Bioavailability Studies Submitted in New Drug Applications or Investigational New Drug Applications-General Considerations; Draft Guidance for Industry; Availability
Document Number: 2019-03246
Type: Notice
Date: 2019-02-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Bioavailability Studies Submitted in NDAs or INDsGeneral Considerations.'' This draft guidance provides recommendations to sponsors planning to include bioavailability (BA) information for drug products in investigational new drug applications (INDs), new drug applications (NDAs), and NDA supplements. This draft guidance revises and replaces FDA's March 2014 draft guidance for industry entitled ``Bioavailability and Bioequivalence Studies Submitted in NDAs or INDsGeneral Considerations,'' which addresses BA or bioequivalence (BE) studies for INDs, NDAs, and NDA supplements.
Prescription Drug-Use-Related Software; Establishment of a Public Docket; Request for Comments; Reopening of Comment Period
Document Number: 2019-03241
Type: Notice
Date: 2019-02-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is reopening the comment period for the notice entitled ``Prescription Drug-Use- Related Software; Establishment of a Public Docket; Request for Comments'' that appeared in the Federal Register of November 20, 2018. The Agency is taking this action to allow interested persons additional time to submit comments.
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2019-03207
Type: Notice
Date: 2019-02-26
Agency: Department of Health and Human Services, National Institutes of Health
Sunscreen Drug Products for Over-the-Counter Human Use
Document Number: 2019-03019
Type: Proposed Rule
Date: 2019-02-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is issuing this proposed rule to put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products. This proposed rule describes the conditions under which FDA proposes that OTC sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded. It is being published as part of the ongoing review of OTC drug products conducted by FDA. It is also being published to comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Sunscreen Innovation Act (SIA).
Agency Information Collection Activities; Proposed Collection; Comment Request; Focused Mitigation Strategies To Protect Food Against Intentional Adulteration
Document Number: 2019-03197
Type: Notice
Date: 2019-02-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on collections of information describing mitigation strategies to protect food against intentional adulteration.
Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations; Reopening of Comment Period
Document Number: 2019-03195
Type: Proposed Rule
Date: 2019-02-25
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 November 15, 2018. In the Federal Register of December 20, 2018, the Agency extended the comment period until February 13, 2019. The Agency is taking this action to reopen the comment period to allow interested persons additional time to submit comments due to technical issues with the Federal eRulemaking Portal (https://www.regulations.gov) on February 13, 2019.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level
Document Number: 2019-03193
Type: Notice
Date: 2019-02-25
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.
National Institute on Aging; Notice of Closed Meeting
Document Number: 2019-03191
Type: Notice
Date: 2019-02-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2019-03189
Type: Notice
Date: 2019-02-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2019-03188
Type: Notice
Date: 2019-02-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2019-03187
Type: Notice
Date: 2019-02-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2019-03186
Type: Notice
Date: 2019-02-25
Agency: Department of Health and Human Services, National Institutes of Health
Meeting of the Advisory Committee on Organ Transplantation
Document Number: 2019-03185
Type: Notice
Date: 2019-02-25
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the Federal Advisory Committee Act (FACA), this notice announces that the Secretary's Advisory Committee on Organ Transplantation (ACOT) has scheduled a public meeting. Information about ACOT and the agenda for this meeting can be found on the ACOT website at https://www.organdonor.gov/about-dot/acot.html.
Meeting of the Advisory Council on Blood Stem Cell Transplantation
Document Number: 2019-03184
Type: Notice
Date: 2019-02-25
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the Federal Advisory Committee Act (FACA), this notice announces that the Secretary's Advisory Council on Blood Stem Cell Transplantation (ACBSCT) has scheduled a public meeting. Information about ACBSCT and the agenda for this meeting can be found on the ACBSCT website at https://bloodcell.transplant.hrsa.gov/about/ advisory_council/meetings/index.html.
National Advisory Council on the National Health Service Corps
Document Number: 2019-03180
Type: Notice
Date: 2019-02-25
Agency: Department of Health and Human Services, Health Resources and Service Administration
In accordance with the Federal Advisory Committee Act, the National Advisory Council on the National Health Service Corps (NACNHSC) has scheduled public meetings for the 2019 calendar year (CY). Information about the NACNHSC, agendas, and materials for these meetings can be found on the NACNHSC website at https://nhsc.hrsa.gov/ about/national-advisory-council-nhsc/index.html.
Request for Information Regarding Grandfathered Group Health Plans and Grandfathered Group Health Insurance Coverage
Document Number: 2019-03170
Type: Proposed Rule
Date: 2019-02-25
Agency: Employee Benefits Security Administration, Department of Labor, Department of Health and Human Services, Internal Revenue Service, Department of Treasury, Department of the Treasury
This document is a request for information regarding grandfathered group health plans and grandfathered group health insurance coverage. Given the limited information available regarding such coverage, the Department of the Treasury, the Department of Labor, and the Department of Health and Human Services (the Departments) are issuing this request for information to gather input from the public in order to better understand the challenges that group health plans and group health insurance issuers face in avoiding a loss of grandfathered status, and to determine whether there are opportunities for the Departments to assist such plans and issuers, consistent with the law, in preserving the grandfathered status of group health plans and group health insurance coverage in ways that would benefit employers, employee organizations, plan participants and beneficiaries, and other stakeholders.
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2019-03152
Type: Notice
Date: 2019-02-25
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2019-03151
Type: Notice
Date: 2019-02-25
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute: Notice of Closed Meeting
Document Number: 2019-03150
Type: Notice
Date: 2019-02-25
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2019-03149
Type: Notice
Date: 2019-02-25
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute: Notice of Closed Meeting
Document Number: 2019-03148
Type: Notice
Date: 2019-02-25
Agency: Department of Health and Human Services, National Institutes of Health
Implanted Brain-Computer Interface Devices for Patients With Paralysis or Amputation-Nonclinical Testing and Clinical Considerations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2019-03144
Type: Notice
Date: 2019-02-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Implanted Brain- Computer Interface Devices for Patients with Paralysis or Amputation Nonclinical Testing and Clinical Considerations.'' Implanted brain-computer interface (BCI) devices are neuroprostheses that interface with the central or peripheral nervous system to restore lost motor and/or sensory capabilities in patients with paralysis or amputation. This draft guidance provides recommendations for nonclinical testing and study design considerations for investigational device exemptions feasibility and pivotal clinical studies. This draft guidance is not final nor is it in effect at this time.
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Document Number: 2019-03129
Type: Notice
Date: 2019-02-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance.
World Trade Center Health Program; Petition 020-Stroke; Finding of Insufficient Evidence
Document Number: 2019-02941
Type: Proposed Rule
Date: 2019-02-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
On August 26, 2018, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 020) to add ``two forms of stroke, both ischemic and non-aneurysmal hemorrhagic,'' to the List of WTC-Related Health Conditions (List). Upon reviewing the scientific and medical literature, including information provided by the petitioner, the Administrator has determined that the available evidence does not have the potential to provide a basis for a decision on whether to add stroke to the List. The Administrator also finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.
Medicare Program; Announcement of the Re-Approval of COLA Under the Clinical Laboratory Improvement Amendments of 1988
Document Number: 2019-03169
Type: Notice
Date: 2019-02-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the application of COLA for re-approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for the specialty and subspecialty areas listed in this notice under CLIA. We have determined that COLA meets or exceeds the applicable CLIA requirements. We are announcing the re-approval and grant COLA deeming authority for a period of 6 years.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2019-03102
Type: Notice
Date: 2019-02-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services