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

Health Information Technology Advisory Committee 2019 Schedule
Document Number: 2019-00565
Type: Notice
Date: 2019-01-31
Agency: Department of Health and Human Services
The Health Information Technology Advisory Committee (HITAC) was established in accordance with section 4003(e) of the 21st Century Cures Act and the Federal Advisory Committee Act. The HITAC, among other things, identifies priorities for standards adoption and makes recommendations to the National Coordinator for Health Information Technology (National Coordinator). The HITAC will hold public meetings throughout 2019. See list of public meetings below.
Medicare Program; Administrative Law Judge Hearing Program for Medicare Claim and Entitlement Appeals; Quarterly Listing of Program Issuances-October Through December 2018
Document Number: 2019-00564
Type: Notice
Date: 2019-01-31
Agency: Department of Health and Human Services
This quarterly notice lists the OMHA Case Processing Manual (OCPM) instructions that were published from October through December 2018. This manual standardizes the day-to-day procedures for carrying out adjudicative functions, in accordance with applicable statutes, regulations, and OMHA directives, and gives OMHA staff direction for processing appeals at the OMHA level of adjudication.
Administrative Simplification: Modification of the Requirements for the Use of Health Insurance Portability and Accountability Act of 1996 (HIPAA) National Council for Prescription Drug Programs (NCPDP) D.0 Standard
Document Number: 2019-00554
Type: Proposed Rule
Date: 2019-01-31
Agency: Department of Health and Human Services, Office of the Secretary
This proposed rule would adopt a modification to the requirements for the use of the Telecommunication Standard Implementation Guide, Version D, Release 0 (Version D.0), August 2007, National Council for Prescription Drug Programs by requiring covered entities to use the Quantity Prescribed (460-ET) field for retail pharmacy transactions for Schedule II drugs. The modification would enable covered entities to clearly distinguish whether a prescription is a ``partial fill,'' where less than the full amount prescribed is dispensed, or a refill, in the HIPAA retail pharmacy transactions. We believe this modification is important to ensure information is available to help prevent impermissible refills of Schedule II drugs, which would help to address the public health concerns associated with prescription drug abuse in the United States.
Proposed Information Collection Activity; Comment Request; Correction
Document Number: 2019-00509
Type: Notice
Date: 2019-01-31
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families erroneously published a document in the Federal Register of December 19, 2018 (83 FR 65167). This current publication supersedes the referenced previous publication. This Notice provides the opportunity for public comment on the described U.S. Repatriation Program Forms. Description: The United States (U.S.) Repatriation Program was established by Title XI, Section 1113 of the Social Security Act (Assistance for U.S. Citizens Returned from Foreign Countries) to provide temporary assistance to U.S. citizens and their dependents who have been identified by the Department of State (DOS) as having returned, or been brought from a foreign country to the U.S. because of destitution, illness, war, threat of war, or a similar crisis, and are without available resources immediately accessible to meet their needs. The Secretary of the Department of Health and Human Services (HHS) was provided with the authority to administer this Program. On or about 1994, this authority was delegated by the HHS Secretary to the Administration for Children and Families (ACF) and later re-delegated by ACF to the Office of Human Services Emergency Preparedness and Response (OHSEPR). The Repatriation Program works with States, Federal agencies, and non-governmental organizations to provide eligible individuals with temporary assistance for up to 90 days. This assistance is in the form of a loan and must be repaid to the Federal Government. The Program was later expanded in response to legislation enacted by Congress to address the particular needs of persons with mental illness (24 U.S.C. Sections 321 through 329). Further refinements occurred in response to Executive Order (E.O.) 11490 (as amended), which gave HHS the responsibility to ``develop plans and procedures for assistance at ports of entry to U.S. personnel evacuated from overseas areas, their onward movement to final destination, and follow-up assistance after arrival at final destination.'' In addition, under E.O. 12656 (53 CFR 47491), ``Assignment of emergency preparedness responsibilities,'' HHS was given the lead responsibility to develop plans and procedures to provide assistance to U.S. citizens and others evacuated from overseas. Overall, the Program manages two major activities, Emergency and Non-emergency Repatriation. The ongoing routine arrivals of individual repatriates and the repatriation of individuals with mental illness constitute the Program Non-emergency activities. Emergency activities are comprised of group repatriations (evacuations of 50-500 individuals) and emergency repatriations (evacuations of 500 or more individuals). Operationally, these activities involve different kinds of preparation, resources, and implementation. However, the core Program policies and administrative procedures are essentially the same. The Program provides services through agreements with local repatriation service providers (e.g. States, federal agencies, non- governmental agencies, etc.). For the purpose of this Program, local repatriation service provider (local provider) has the same definition of ``agency'' as defined under 45 CFR 212.1 (i). The list of Repatriation Forms is as follows: 1. Emergency and Group Processing Form (RR-01): During an emergency repatriation, individuals complete portions of this form to apply for repatriation assistance. Then State personnel use the form to perform a preliminary eligibility assessment. Authorized ACF staff make final eligibility decisions. 2. Emergency and Group Repatriation Financial Form (RR-02): States and supporting agencies complete this form if they have entered into an agreement with OHSEPR allowing for reimbursement of reasonable and allowable costs during emergency repatriation activities. 3. Repatriation Loan Waiver and Deferral Request Form (RR-03): Eligible repatriates, authorized legal custodians, or authorized state staff complete this form to request a waiver or deferral of a repatriation loan. 4. Non-Emergency Monthly Financial Statement Form (RR-04): States and other authorized OHSEPR agencies use this form to request reimbursement of reasonable and allowable costs for the provision of temporary assistance during non-emergency activities. 5. Privacy and Repayment Agreement Form (RR-05): This form authorizes HHS to release personally identifiable information to appropriate agencies for the purpose of providing services. In addition, through this form, eligible repatriates or authorized legal custodians agree to accept services under the Program's terms and conditions, which include repaying the federal government for services received. 6. Refusal of Temporary Assistance Form (RR-06): Eligible repatriates or authorized legal custodians use this form to confirm and record their decision to relinquish repatriation services. 7. Temporary Assistance and Extension Request Form (RR-07): To request an extension of assistance beyond the 90-day eligibility period, eligible repatriates, authorized legal custodians, or authorized state staff submit this form to OHSEPR or its designated grantee generally 14 days prior to the expiration of the repatriate's eligibility period. 8. Emergency and Group Repatriation State Request for Federal Support Form (RR-08): During emergency repatriation activities, OHSEPR- activated states must use this form to request support and/or assistance from the federal government, including but not limited to augmentation of personnel, funding, and reimbursement. Respondents: Repatriation Program local repatriation service providers and individuals repatriated or evacuated by DOS from overseas. These respondents are authorized under Title XI, Section 1113 of the Social Security Act (42 U.S.C. 1313), Executive Order 12656 (amended by E.O. 13074, February 9, 1998; E.O. 13228, October 8, 2001; E.O. 13286, February 28, 2003), and 45 CFR 211 & 212.
Guidance Regarding Agency Interpretation of “Rabies-Free” as It Relates to the Importation of Dogs Into the United States
Document Number: 2019-00506
Type: Notice
Date: 2019-01-31
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) is publishing this guidance for dog owners and importers who seek to admit a dog without a valid rabies vaccination certificate into the United States. Under current regulations, all dogs admitted into the United States must be accompanied by a valid rabies vaccination certificate unless the dog's owner or importer submits satisfactory evidence that the dog has only been in a rabies-free country if it is less than 6 months old or has only been in a rabies-free country for the 6 months before arrival if it is older than 6 months. Through this guidance, CDC is clarifying that it interprets ``rabies-free'' for the purposes of dog importation to mean ``canine rabies virus variant (CRVV)-free.'' For all other public health purposes, CDC will continue to apply the general definition of ``rabies free,'' which includes and reflects the rabies status of all terrestrial animals and not just dogs. This guidance further describes the considerations taken into account by experts in determining whether a country qualifies as CRVV-free. This notice also informs dog owners and importers on where to locate up-to-date information on a country's CRVV status to facilitate a dog's entry or re-entry into the United States.
Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2019-00492
Type: Notice
Date: 2019-01-31
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 Pulmonary-Allergy Drugs Advisory Committee. The general function of the committee 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.
Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2019-00483
Type: Notice
Date: 2019-01-31
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 Neurological Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
Microbiology Devices Panel Advisory Committee; Notice of Meeting
Document Number: 2019-00464
Type: Notice
Date: 2019-01-31
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 Microbiology Devices Panel. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format; Draft Guidance for Industry; Availability
Document Number: 2019-00458
Type: Notice
Date: 2019-01-31
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 ``Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format.'' This draft guidance is intended to assist holders of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) with their submission of required marketing status notifications.
Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act
Document Number: 2019-00448
Type: Notice
Date: 2019-01-31
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 reporting harmful and potentially harmful constituents (HPHCs).
National Institutes of Health
Document Number: 2019-00447
Type: Notice
Date: 2019-01-31
Agency: Department of Health and Human Services
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.
Meeting of the Advisory Commission on Childhood Vaccines
Document Number: 2019-00439
Type: Notice
Date: 2019-01-31
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Advisory Commission on Childhood Vaccines (ACCV) has scheduled public meetings for the 2019 calendar year (CY). Information about ACCV, agendas, and materials for these meetings can be found on the ACCV website at: http://www.hrsa.gov/advisorycommittees/ childhoodvaccines/index.html.
Submission for OMB Review; 30-Day Comment Request; National Children's Study (NCS) Vanguard Data and Sample Archive and Access System (Eunice Kennedy Shriver National Institute of Child Health and Human Development)
Document Number: 2019-00437
Type: Notice
Date: 2019-01-31
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-00433
Type: Notice
Date: 2019-01-31
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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2019-00422
Type: Notice
Date: 2019-01-31
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2019-00421
Type: Notice
Date: 2019-01-31
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2019-00420
Type: Notice
Date: 2019-01-31
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2019-00419
Type: Notice
Date: 2019-01-31
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
National Institute of Nursing Research; Notice of Closed Meeting
Document Number: 2019-00417
Type: Notice
Date: 2019-01-31
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-00416
Type: Notice
Date: 2019-01-31
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Building Evidence on Employment Strategies for Low-Income Families (BEES) (New Collection)
Document Number: 2019-00414
Type: Notice
Date: 2019-01-31
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) is proposing a data collection activity as part of the Building Evidence on Employment Strategies for Low-Income Families (BEES). The purpose of BEES is to evaluate the effectiveness of a broad range of innovative programs designed to boost employment and earnings among low-income Americans. Within this general focus area, ACF has a particular interest in programs that serve adults whose employment prospects have been affected by substance use disorder (SUD), opioid use disorder (OUD), mental health conditions, and justice involvement. ACF expects that a subset of programs to be evaluated will serve these specific target populations. To meet these objectives, this study will include impact and implementation evaluations for up to 21 sites, as well as descriptive work focused on other sites that have a focus on clients with opioid use and other substance abuse disorders. When possible, a randomized control trial research design will be used for the impact evaluations. The purpose of the current submission is to request approval for data collection needed for the BEES study.
Proposed Information Collection Activity; Sexual Risk Avoidance Education Program (SRAE) Performance Analysis Study (PAS) (New Collection)
Document Number: 2019-00413
Type: Notice
Date: 2019-01-31
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Planning, Research, and Evaluation and the Family and Youth Services Bureau in the Administration for Children and Families (ACF) propose data collection activity as part of the Sexual Risk Avoidance Education (SRAE) Program Performance Analysis Study (PAS). The goal of the study is to collect, analyze and report on performance measures data for the Sexual Risk Avoidance Education Program.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2019-00411
Type: Notice
Date: 2019-01-31
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.
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-00410
Type: Notice
Date: 2019-01-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2019-00409
Type: Notice
Date: 2019-01-31
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-00408
Type: Notice
Date: 2019-01-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meeting
Document Number: 2019-00407
Type: Notice
Date: 2019-01-31
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Comment Request
Document Number: 2019-00405
Type: Notice
Date: 2019-01-31
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Document Number: 2019-00403
Type: Notice
Date: 2019-01-31
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Bureau of Health Workforce Performance Data Collection, OMB No. 0915-0061-Revision
Document Number: 2019-00402
Type: Notice
Date: 2019-01-31
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.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; National Health Service Corps Scholar/Students to Service Travel Worksheet, OMB No. 0915-0278-Extension
Document Number: 2019-00394
Type: Notice
Date: 2019-01-31
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.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Healthy Start Evaluation and Quality Improvement, OMB No. 0915-0338-Revision
Document Number: 2019-00393
Type: Notice
Date: 2019-01-31
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, 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; Title: Health Resources and Service Administration Uniform Data System, OMB No. 0915-0193-Revision
Document Number: 2019-00392
Type: Notice
Date: 2019-01-31
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.
Proposed Information Collection Activity; Comment Request
Document Number: 2019-00388
Type: Notice
Date: 2019-01-31
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Document Number: 2019-00386
Type: Notice
Date: 2019-01-31
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Document Number: 2019-00381
Type: Notice
Date: 2019-01-31
Agency: Department of Health and Human Services, Administration for Children and Families
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-00363
Type: Notice
Date: 2019-01-31
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review Notice of Closed Meeting
Document Number: 2019-00359
Type: Notice
Date: 2019-01-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2019-00357
Type: Notice
Date: 2019-01-31
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-00356
Type: Notice
Date: 2019-01-31
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-00355
Type: Notice
Date: 2019-01-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2019-00354
Type: Notice
Date: 2019-01-31
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: 2019-00353
Type: Notice
Date: 2019-01-31
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: 2019-00352
Type: Notice
Date: 2019-01-31
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: 2019-00351
Type: Notice
Date: 2019-01-31
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: 2019-00350
Type: Notice
Date: 2019-01-31
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: 2019-00349
Type: Notice
Date: 2019-01-31
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: 2019-00348
Type: Notice
Date: 2019-01-31
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: 2019-00347
Type: Notice
Date: 2019-01-31
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: 2019-00346
Type: Notice
Date: 2019-01-31
Agency: Department of Health and Human Services, National Institutes of Health