March 2019 – Federal Register Recent Federal Regulation Documents

In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.

The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning negotiated service agreements. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that SYMDEKO (tezacaftor/ivacaftor), manufactured by Vertex Pharmaceutical, Inc., meets the criteria for a priority review voucher.

This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council on Alzheimer's Research, Care, and Services provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. The April 29, 2019 meeting of the Advisory Council will focus on person-centered planning for older adults including information about implementation of care plans for people living with cognitive symptoms. There will also be discussion about the use of antipsychotic medication for people with dementia and other conditions living in community settings.

Notice is hereby given that the Environmental Protection Agency (EPA) has designated one new equivalent method for measuring concentrations of ozone (O3) in ambient air.

The Local Government Advisory Committee (LGAC) will meet in Washington, DC, on Thursday, May 2, 2019, 9:30 a.m.-5:35 p.m. (EDT), and Friday, May 3, 2019, 10:00 a.m.-12:30 p.m. (EDT). The focus of the Committee meeting will be on issues pertaining to water and water infrastructure issues; Waters of the U.S., emerging contaminants; superfund and brownfields; risk communication and other issues in EPA's Strategic Plan. The Small Communities Advisory Subcommittee (SCAS) will meet in Washington, DC, on Friday, May 3, 2019, 8:00 a.m.-9:00 a.m. (EDT). The Subcommittee will discuss water infrastructure, community revitalization, agricultural issues, and other issues and recommendations to the Administrator regarding environmental issues affecting small communities. These are open meetings, and all interested persons are invited to participate. The SCAS will hear comments from the public between 8:40 a.m. and 8:45 a.m. on Friday, May 3, 2019. The LGAC will hear comments from the public between and 10:20 a.m. and 10:30 a.m. on Friday, May 3, 2019. Individuals or organizations wishing to address the Subcommittee or the Committee will be allowed a maximum of five minutes to present their point of view. Also, written comments should be submitted electronically to eargle.frances@epa.gov for the LGAC and to mercurio.cristina@epa.gov for the SCAS. Please contact the Designated Federal Officers (DFO) at the numbers listed below to schedule a time on the agenda. Time will be allotted on a first-come first-serve basis, and the total period for comments may be extended if the number of requests for appearances requires it.

The Environmental Protection Agency (EPA) is proposing to approve a revision to the Chattanooga portion of the Tennessee State Implementation Plan (SIP), provided by the State of Tennessee, through the Tennessee Department of Environment and Conservation (TDEC) from Chattanooga/Hamilton County Air Pollution Control Bureau by a letter dated September 12, 2018. The revision updates the National Ambient Air Quality Standards (NAAQS) in the Chattanooga portion of the Tennessee SIP to reflect recent revisions made to the NAAQS. EPA is proposing to approve the changes because they are consistent with the Clean Air Act (CAA or Act).

The Environmental Protection Agency (EPA) is proposing to approve two revisions to the Jefferson County portion of the Kentucky State Implementation Plan (SIP), submitted by the Commonwealth of Kentucky, through the Kentucky Division of Air Quality (KDAQ), through a letter dated March 15, 2018. The changes were submitted by KDAQ on behalf of the Louisville Metro Air Pollution Control District (LMAPCD) (also referred to herein as Jefferson County) and make minor ministerial amendments to applicability dates and clarify standards applicable to both existing and new volatile organic compounds (VOC) water separators. EPA is proposing to approve these changes because they are consistent with the Clean Air Act (CAA or Act).

The Environmental Protection Agency (EPA) is proposing to approve revisions to the Alabama State Implementation Plan (SIP), submitted by the State of Alabama, through the Alabama Department of Environmental Management (ADEM), via two letters dated May 7, 2012, and August 27, 2018. The proposed SIP revisions relate to the State's Prevention of Significant Deterioration (PSD) permitting regulations. In particular, the revisions add a definition of ``replacement unit'' and provide that a replacement unit is a type of existing emissions unit under the definition of ``emissions unit.'' This action is being taken pursuant to the Clean Air Act (CAA or Act).

The Coast Guard announces that it will impose conditions of entry on vessels arriving from ports in the Republic of Seychelles. Conditions of entry are intended to protect the United States from vessels arriving from countries that have been found to have deficient anti-terrorism port measures in place.

The U.S. Department of Energy (``DOE'') gives notice of a Decision and Order (Case Number 2018-009) that grants to TCL air conditioner (zhongshan) Co., Ltd. (``TCL AC''), a waiver from specified portions of the DOE test procedure for determining the energy efficiency of specified central air conditioners and heat pumps. TCL AC is required to test and rate specified basic models of its central air conditioners and heat pumps in accordance with the alternate test procedure specified in the Decision and Order.

FMCSA announces that it has received an application from PJ Helicopters, Inc. (PJH) requesting an exemption from two provisions of the hours-of-service (HOS) regulations for its ground support equipment operators. PJH requested relief from the 14-hour rule and the requirement that drivers have 10 consecutive hours off-duty at the end of the work shift. The exemption would allow PJH's ground support equipment operators a 16-hour window within which to complete all driving, and enable these operators to use an 8-consecutive hour off duty break, combined with at least two other off duty hours during the 16-hour window within which driving would be completed, in lieu of taking 10 consecutive hours off duty. If granted, the exemption would cover PJH's CMV operators only when they are responding to or returning from an active incident as requested by an officer of a public agency or public utility. PJH believes that granting these exemptions will have no adverse safety impacts while its ground support equipment operators are responding to said incidents. FMCSA requests public comment on PJH's application for exemptions.

The Committee is proposing to add products and service to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities, and deletes services previously furnished by such agencies.

The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the ACBCYW. The ACBCYW consists of 15 experts in fields associated with breast cancer, disease prevention, early detection, diagnosis, public health, social marketing, genetic screening and counseling, treatment, rehabilitation, palliative care, and survivorship in young women, or in related disciplines with a specific focus on young women. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the committee's objectives. Nominees will be selected based on expertise in the fields of breast health, breast cancer, disease prevention and risk reduction, survivorship (including metastatic breast cancer), hereditary breast and ovarian cancer (HBOC), or in related disciplines with a specific focus on young women. Persons with personal experience with early onset breast cancer are also eligible to apply. This includes, but may not be limited to breast cancer survivors

The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the HICPAC. The HICPAC consists of 14 experts in fields including but not limited to, infectious diseases, infection prevention, healthcare epidemiology, nursing, clinical microbiology, surgery, hospitalist medicine, internal medicine, epidemiology, health policy, health services research, public health, and related medical fields. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the committee's objectives. Nominees will be selected based on expertise in the fields of infectious diseases, infection prevention, healthcare epidemiology, nursing, environmental and clinical microbiology, surgery, internal medicine, and public health. Federal employees will not be considered for membership. Members may be invited to serve for four-year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of HICPAC objectives https:// www.cdc.gov/hicpac/.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Healthcare Infection Control Practices Advisory Committee (HICPAC). This meeting is open to the public, is limited only by room seating available, (120). The public is also welcome to listen to the meeting via teleconference at 888-455- 9748, passcode: 4373458; 100 teleconference lines are available. Time will be available for public comment. The public is welcome to submit written comments in advance of the meeting. Comments should be submitted in writing by email to the contact person listed below. The deadline for receipt of written public comment is May 2, 2019. All requests must contain the name, address, and organizational affiliation of the speaker, as well as the topic being addressed. Written comments should not exceed one single-spaced typed page in length and delivered in 3 minutes or less. Members of the public who wish to provide public comments should plan to attend the public comment session at the start time listed. Please note that the public comment period may end before the time indicated, following the last call for comments. Written comments received in advance of the meeting will be included in the official record of the meeting. Registration is required to attend in person or on the phone. Interested parties must be processed in accordance with established federal policies and procedures and may register at https://www.cdc.gov/hicpac/.