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

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.

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.

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.

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.

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).

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: https://www.hrsa.gov/advisorycommittees/ childhoodvaccines/.

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.

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.

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.

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.

The Secretary is amending the February 27, 2015, Declaration issued pursuant to the Public Health Service Act, amended December 9, 2015 and December 2, 2016, to update the term ``Ebola Virus Disease'' to ``Ebola disease'' (EBOD) throughout the declaration and to clarify the definition of EBOD. The amendment also expands the Covered Countermeasures beyond the single therapeutic listed in prior declarations but limit coverage to Covered Countermeasures that are directly supported by the United States (U.S.) Federal Government, consistent with the terms of the Declaration, and is republishing the Declaration in its entirety as amended.

On October 18, 2018 the National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), published a notice in the Federal Register [83 FR 52834] announcing the availability of a Partnership Opportunity to Identify Products for Fentanyl Exposure in Personal Protective Equipment Information Database. Written comments were to be received by November 19, 2018. In response to requests from interested parties, NIOSH is announcing the reopening of the comment period.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, National Center for Injury Prevention and Control, (BSC, NCIPC).

The subcommittees listed in the DATES section of this notice are part of AHRQ's Health Services Research Initial Review Group Committee. Grant applications are to be reviewed and discussed at these meetings. Each subcommittee meeting will commence in open session before closing to the public for the duration of the meeting.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the data collection project titled ``Canine leptospirosis surveillance in Puerto Rico.'' This surveillance project aims to characterize the epidemiology of canine leptospirosis, assess the applicability of canine Leptospira vaccines used in Puerto Rico, and determine potential rodent, livestock, and wildlife reservoirs for leptospirosis. Findings from the study will be used to develop recommendations for the prevention of leptospirosis in dogs, focus human surveillance efforts, and guide further investigations on leptospirosis in Puerto Rico.

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public, limited only by room seating. The meeting room accommodates 216 for public seating. Rooms 245, 246, and 247, adjacent to the meeting room, will be available once the meeting room reaches capacity, providing up to 120 additional seats. Time will be available for public comment. The meeting will be webcast live via the World Wide Web; for instructions and more information on ACIP please visit the ACIP website: https://www.cdc.gov/ vaccines/acip/.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Subcommittee for Procedure Reviews (SPR) of the Advisory Board on Radiation and Worker Health (ABRWH). This meeting is open to the public, but without a public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcome to listen to the meeting by joining the audio conference (information below). The audio conference line has 150 ports for callers.

This notice amends Federal Register notice 83 FR 63662, published December 11, 2018, announcing the availability of the Draft National Toxicology Program (NTP) Monograph on the Systematic Review of Evidence of Long-Term Neurological Effects Following Acute Exposure to the Organophosphorus Nerve Agent Sarin for public comment prior to peer review. In partnership with the National Institutes of Health (NIH) Countermeasures Against Chemical Threats (CounterACT) Program, the Office of Health Assessment and Translation (OHAT), Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS), conducted a systematic review to evaluate the evidence of long-term neurological damage in humans after acute, sub- lethal exposure to sarin. The peer-review meeting will be held by webcast only and open to the public; registration will be required for attendance by webcast and to present oral comments. Information about the meeting and registration is available at https://ntp.niehs.nih.gov/ go/36051.

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.