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

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Government-Owned Inventions; Availability for Licensing
Document Number: 2018-20664
Type: Notice
Date: 2018-09-24
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2018-20663
Type: Notice
Date: 2018-09-24
Agency: Department of Health and Human Services, National Institutes of Health
Patient Engagement Advisory Committee; Notice of Meeting
Document Number: 2018-20640
Type: Notice
Date: 2018-09-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a forthcoming public advisory committee meeting of the Patient Engagement Advisory Committee (the Committee). The general function of the Committee is to provide advice to the Commissioner, or designee, on complex issues relating to medical devices, the regulation of devices, and their use by patients. The meeting will be open to the public.
Proposed Information Collection Activity; Comment Request
Document Number: 2018-20594
Type: Notice
Date: 2018-09-21
Agency: Department of Health and Human Services, Administration for Children and Families
Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2018-20571
Type: Notice
Date: 2018-09-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Modified Risk Tobacco Product Application: Application for Copenhagen® Snuff Fine Cut, a Loose Moist Snuff Tobacco Product Submitted by U.S. Smokeless Tobacco Company LLC
Document Number: 2018-20562
Type: Notice
Date: 2018-09-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability for public comment of a modified risk tobacco product application (MRTPA) for Copenhagen[supreg] Snuff Fine Cut, a loose moist snuff tobacco product submitted by U.S. Smokeless Tobacco Co. LLC.
Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank; Draft Guidance for Food and Drug Administration Staff, Responsible Parties, and Submitters of Certain Applications and Submissions to the Food and Drug Administration; Availability
Document Number: 2018-20560
Type: Notice
Date: 2018-09-21
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 ``Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank; Draft Guidance for FDA Staff, Responsible Parties, and Submitters of Certain Applications and Submissions to FDA.'' The draft guidance provides the current thinking of FDA's Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and Center for Devices and Radiological Health (CDRH) regarding civil money penalties that may be assessed against responsible parties and/or submitters of certain applications and submissions to FDA regarding drug products, biological products, and device products who violate applicable Federal Food, Drug, and Cosmetic Act (FD&C Act) prohibitions relating to requirements, including implementing regulations, submitting registration and/or results information to the ClinicalTrials.gov data bank, and/or certain certifications to FDA.
National Eye Institute; Notice of Closed Meeting
Document Number: 2018-20525
Type: Notice
Date: 2018-09-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2018-20524
Type: Notice
Date: 2018-09-21
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-20522
Type: Notice
Date: 2018-09-21
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-20520
Type: Notice
Date: 2018-09-21
Agency: Department of Health and Human Services, National Institutes of Health
Privacy Act of 1974; Matching Program
Document Number: 2018-20510
Type: Notice
Date: 2018-09-20
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with subsection (e)(12) of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is providing notice of a new computer matching program between CMS and the Department of Homeland Security (DHS)/United States Citizenship and Immigration Services (USCIS), ``Verification of United States Citizenship and Immigration Status Data for Eligibility Determinations.'' In this matching program, DHS/USCIS provides CMS with immigrant, nonimmigrant, and naturalized or derived citizenship status information needed to make enrollment and exemption eligibility determinations as required by the Patient Protection and Affordable Care Act (ACA).
Medicare Program; Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2019
Document Number: 2018-20506
Type: Notice
Date: 2018-09-20
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2019. The calendar year 2019 AIC threshold amounts are $160 for ALJ hearings and $1,630 for judicial review.
Notice of New NIH Policy Manual 1311-Preventing and Addressing Harassment and Inappropriate Conduct and New Policy Statement on Inappropriate Relationships in the Workplace
Document Number: 2018-20505
Type: Notice
Date: 2018-09-20
Agency: Department of Health and Human Services, National Institutes of Health
The National Institutes of Health (NIH) announces Policy Manual Chapter: 1311Preventing and Addressing Harassment and Inappropriate Conduct and a new Policy Statement addressing Personal Relationships in the Workplace. These policies apply to federal employees, contractors, trainees, and fellows who perform work for the NIH. The NIH expects that organizations receiving NIH funds have in place similarly rigorous policies and related procedures for their employees, contractors, trainees, and fellows who engage in agency- funded activities.
Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier; Guidance for Industry; Availability
Document Number: 2018-20503
Type: Notice
Date: 2018-09-20
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 final guidance for industry entitled ``Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier.'' This guidance specifies whether and under what circumstances packages and homogenous cases of product not labeled with a product identifier shall be grandfathered from certain requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance finalizes the draft guidance issued on November 27, 2017.
Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers; Draft Guidance for Industry; Availability
Document Number: 2018-20502
Type: Notice
Date: 2018-09-20
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 ``Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers.'' This draft guidance intends to clarify questions relating to product identifiers that are required by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA) for packages and homogenous cases of certain drug products. Sections of the FD&C Act require manufacturers and repackagers to affix or imprint a product identifier to each package and homogenous case of a product intended to be introduced in a transaction into commerce beginning November 27, 2017, and November 28, 2018, respectively. This draft guidance intends to clarify these requirements.
Government-Owned Inventions; Availability for Licensing
Document Number: 2018-20484
Type: Notice
Date: 2018-09-20
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
National Center for Complementary & Integrative Health; Amended Notice of Meeting
Document Number: 2018-20483
Type: Notice
Date: 2018-09-20
Agency: Department of Health and Human Services, National Institutes of Health
Supplemental Evidence and Data Request on Depression in Children: Systematic Review
Document Number: 2018-20481
Type: Notice
Date: 2018-09-20
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review of Depression in Children: Systematic Review, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2018-20472
Type: Notice
Date: 2018-09-20
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 final guidance entitled ``Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing.'' The United States Pharmacopeia (USP) drug substance monograph for Heparin Sodium, and drug product monographs for Heparin Lock Flush Solution and Heparin Sodium Injection, recently have undergone several revisions following serious and fatal events related to the use of heparin sodium products. Investigation of heparin product overdose errors identified the expression of drug strength in the labels as a major contributing factor in these errors. This guidance document addresses these safety concerns by clarifying new expectations for labeling with regard to the revised heparin USP monographs, as well as outlining safety testing recommendations.
Performance Review Board Members
Document Number: 2018-20445
Type: Notice
Date: 2018-09-20
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) is publishing the names of the Performance Review Board Members who are reviewing performance for Fiscal Year 2018.
Product Identifier Requirements Under the Drug Supply Chain Security Act-Compliance Policy; Guidance for Industry; Availability
Document Number: 2018-20444
Type: Notice
Date: 2018-09-20
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 final guidance for industry entitled ``Product Identifier Requirements Under the Drug Supply Chain Security Act Compliance Policy.'' This guidance describes FDA's intention with regard to enforcement of the Drug Supply Chain Security Act (DSCSA) provision requiring manufacturers to begin affixing or imprinting product identifiers on their products beginning November 27, 2017. This guidance finalizes the draft guidance issued on July 3, 2017.
Health Resources and Services Administration Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children
Document Number: 2018-20428
Type: Notice
Date: 2018-09-20
Agency: Department of Health and Human Services
The Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) has scheduled a public meeting. Information about the ACHDNC, a roster of members, the meeting agenda, as well as past meeting summaries is located on the ACHDNC website at https:// www.hrsa.gov/advisory-committees/heritable-disorders/index.ht ml.
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2018-20425
Type: Notice
Date: 2018-09-20
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meetings
Document Number: 2018-20424
Type: Notice
Date: 2018-09-20
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2018-20423
Type: Notice
Date: 2018-09-20
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases Notice of Closed Meeting
Document Number: 2018-20422
Type: Notice
Date: 2018-09-20
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2018-20421
Type: Notice
Date: 2018-09-20
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-20420
Type: Notice
Date: 2018-09-20
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute Notice of Closed Meetings
Document Number: 2018-20419
Type: Notice
Date: 2018-09-20
Agency: Department of Health and Human Services
National Cancer Institute; Notice of Meeting
Document Number: 2018-20418
Type: Notice
Date: 2018-09-20
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2018-20417
Type: Notice
Date: 2018-09-20
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-20416
Type: Notice
Date: 2018-09-20
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2018-20415
Type: Notice
Date: 2018-09-20
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-20414
Type: Notice
Date: 2018-09-20
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-20413
Type: Notice
Date: 2018-09-20
Agency: Department of Health and Human Services, National Institutes of Health
Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3
Document Number: 2018-20375
Type: Rule
Date: 2018-09-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is amending the food additive regulation for vitamin D3 to replace the current Reference Daily Intake (RDI) percentage values of calcium in 100 percent fruit juices and fruit juice drinks with absolute values and to update the reference for vitamin D3 specifications. We are taking this action in response to a food additive petition filed by the Juice Products Association.
Medicare and Medicaid Programs; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction
Document Number: 2018-19599
Type: Proposed Rule
Date: 2018-09-20
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would reform Medicare regulations that are identified as unnecessary, obsolete, or excessively burdensome on health care providers and suppliers. This proposed rule would increase the ability of health care professionals to devote resources to improving patient care by eliminating or reducing requirements that impede quality patient care or that divert resources away from furnishing high quality patient care.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-20372
Type: Notice
Date: 2018-09-19
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.
Postapproval Changes to Drug Substances; Draft Guidance for Industry; Availability; Correction
Document Number: 2018-20317
Type: Notice
Date: 2018-09-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration is correcting a notice entitled ``Postapproval Changes to Drug Substances; Draft Guidance for Industry; Availability'' that appeared in the Federal Register of September 11, 2018. The document announced a draft guidance that provides recommendations to holders of approved new drug applications, abbreviated new drug applications, new animal drug applications, abbreviated new animal drug applications, and holders of drug master files and veterinary master files who may want to make a change to the drug substance manufacturing process during the drug product application postapproval period. The document was published with the incorrect docket number. This document corrects that error.
Announcement of Intent To Issue an OPDIV-Initiated Supplement Under the Standing Announcement for Residential (Shelter) Services for Unaccompanied Children, HHS-2017-ACF-ORR-ZU-1132
Document Number: 2018-20295
Type: Notice
Date: 2018-09-18
Agency: Department of Health and Human Services, Administration for Children and Families
Administration for Children and Families, Office of Refugee Resettlement, announces the intent to issue an OPDIV-Initiated Supplement in multiple installments to BCFS Health and Human Services, San Antonio, TX. The aggregate total of the multiple installments will not exceed $367,860,381. The first two installments will be issued prior to September 30, 2018. The remaining installments will be issued after September 30, 2018 on to be determined dates. ORR has been identifying additional capacity to provide shelter for potential increases in apprehensions of Unaccompanied Children at the U.S. Southern Border. Planning for increased shelter capacity is a prudent step to ensure that ORR is able to meet its responsibility, by law, to provide shelter for Unaccompanied Alien Children referred to its care by the Department of Homeland Security (DHS). To ensure sufficient capacity to provide shelter to unaccompanied children referred to HHS, BCFS proposed to provide ORR with 3,800 beds in an expedited manner.
Notice of Closed Meeting
Document Number: 2018-20289
Type: Notice
Date: 2018-09-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Listing of Color Additives Subject to Certification; D&C Black No. 4; Confirmation of Effective Date
Document Number: 2018-20288
Type: Rule
Date: 2018-09-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is confirming the effective date of July 10, 2018, for the final rule that appeared in the Federal Register of June 7, 2018, and that amended the color additive regulations to provide for the safe use of D&C Black No. 4 for coloring ultra-high molecular weight polyethylene (UHMWPE) non- absorbable sutures for use in general surgery.
Meeting of the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment
Document Number: 2018-20269
Type: Notice
Date: 2018-09-18
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Centers for Disease Control and Prevention (CDC)/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHACHSPT) has scheduled a public meeting. Information about the CHACHSPT can be found here: https://www.cdc.gov/maso/facm/ facmchachspt.html. An agenda may be requested by emailing CHACAdvisoryComm@hrsa.gov.
National Advisory Council on Migrant Health
Document Number: 2018-20268
Type: Notice
Date: 2018-09-18
Agency: Department of Health and Human Services
The Secretary's National Advisory Council on Migrant Health (NACMH) has scheduled a public meeting. Information about NACMH and the agenda for this meeting can be found on the NACMH website at: https:// bphc.hrsa.gov/qualityimprovement/strategicpartnerships/nacmh/ index.html.
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2018-20267
Type: Notice
Date: 2018-09-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Meeting
Document Number: 2018-20266
Type: Notice
Date: 2018-09-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2018-20265
Type: Notice
Date: 2018-09-18
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2018-20264
Type: Notice
Date: 2018-09-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2018-20263
Type: Notice
Date: 2018-09-18
Agency: Department of Health and Human Services, National Institutes of Health