January 2018 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of November 29, 2017. In the notice of availability, FDA requested comments on draft guidance for industry and FDA staff entitled ``Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application Studies.'' The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

In accordance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which provides opportunity for public comment on new or revised data collections, the Railroad Retirement Board (RRB) will publish periodic summaries of proposed data collections. Comments are invited on: (a) Whether the proposed information collection is necessary for the proper performance of the functions of the agency, including whether the information has practical utility; (b) the accuracy of the RRB's estimate of the burden of the collection of the information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden related to the collection of information on respondents, including the use of automated collection techniques or other forms of information technology. 1. Title and purpose of information collection: Railroad Service and Compensation Reports/System Access Application; OMB 3220-0008. Under Section 9 of the Railroad Retirement Act (RRA) and Section 6 of the Railroad Unemployment Insurance Act (RUIA), the Railroad Retirement Board (RRB) maintains for each railroad employee, a record of compensation paid to that employee by all railroad employers for whom the employee worked after 1936. This record, which is used by the RRB to determine eligibility for, and amount of, benefits due under the laws it administers, is conclusive as to the amount of compensation paid to an employee during such period(s) covered by the report(s) of the compensation by the employee's railroad employer(s), except in cases when an employee files a protest pertaining to his or her reported compensation within the statute of limitations cited in Section 9 of the RRA and Section 6 of the RUIA. To enable the RRB to establish and maintain the record of compensation, employers are required to file with the RRB, reports of their employees' compensation, in such manner and form and at such times as the RRB prescribes. Railroad employers' reports and responsibilities are prescribed in 20 CFR 209. The RRB currently utilizes Form BA-3, Annual Report of Creditable Compensation, and Form BA-4, Report of Creditable Compensation Adjustments, to secure the required information from railroad employers. Form BA-3 provides the RRB with information regarding annual creditable service and compensation for each individual who worked for a railroad employer covered by the RRA and RUIA in a given year. Form BA-4 provides for the adjustment of any previously submitted reports and also the opportunity to provide any service and compensation that had been previously omitted. Requirements specific to Forms BA-3 and BA-4 are prescribed in 20 CFR 209.8 and 209.9. Employers currently have the option of submitting BA-3 and BA-4 reports electronically by CD-ROM, secure Email, File Transfer Protocol (FTP), or online via the RRB's Employer Reporting System (ERS). The information collection also includes RRB Form BA-12, Application for Employer Reporting internet Access, and Form G-440, Report Specifications Sheet. Form BA-12 is completed by railroad employers to obtain system access to ERS. Once access is obtained, authorized employees may submit reporting forms online to the RRB. The form determines what degree of access (view/only, data entry/ modification or approval/submission) is appropriate for that employee. It is also used to terminate an employee's access to ERS. Form G-440, Report Specifications Sheet, serves as a certification document for Forms BA-3 and BA-4 as well as other RRB employer reporting forms (Form BA-6a, BA-6 Address Report (OMB 3220-0005), Form BA-9, Report of Separation Allowance or Severance Pay (OMB 3220-0173) and Form BA-11, Report of Gross Earnings (OMB 3220-0132)). It records the type of medium the report was submitted on, and serves as a summary recapitulation sheet for reports filed on paper. The RRB proposes minor non-burden impacting changes to Form BA-12 and G-440.

The Renewable Energy and Energy Efficiency Advisory Committee (REEEAC) will hold a meeting on Thursday, February 22, 2018 at the U.S. Department of Commerce Herbert C. Hoover Building in Washington, DC. The meeting is open to the public with registration instructions provided below.

This rule amends the Export Administration Regulations (EAR) by adding twenty-one persons under twenty-three entries to the Entity List. The twenty-one persons who are added to the Entity List have been determined by the U.S. Government to be acting contrary to the national security or foreign policy interests of the United States. These twenty-one persons will be listed on the Entity List under the destinations of Bulgaria, China, Kazakhstan, Russia, Syria, and the United Arab Emirates (U.A.E.). In addition, this rule amends the EAR by removing three entities from the Entity List. This rule removes one entity listed under the destination of Taiwan and two entities listed under the destination of the U.A.E. from the Entity List. All three of the removals are the results of requests for removal received by BIS pursuant to the section of the EAR used for requesting removal or modification of an Entity List entry and a review of information provided in the removal requests. Finally, this final rule modifies two existing entries on the Entity List. This rule modifies one entry under China and one entry under Pakistan to provide additional or modified addresses and/or names for these persons.

Pursuant to section 994(a), (o), and (p) of title 28, United States Code, the United States Sentencing Commission is considering promulgating amendments to the sentencing guidelines, policy statements, and commentary. This notice sets forth the proposed amendments and, for each proposed amendment, a synopsis of the issues addressed by that amendment. This notice also sets forth several issues for comment, some of which are set forth together with the proposed amendments, and one of which (regarding retroactive application of proposed amendments) is set forth in the SUPPLEMENTARY INFORMATION section of this notice.

The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.

This report is being published as required by the Statutory Pay-As-You-Go (PAYGO) Act of 2010. The Act requires that OMB issue an annual report and a sequestration order, if necessary.

Consistent with Executive Order 13771 entitled ``Reducing Regulation and Controlling Regulatory Costs,'' and Executive Order 13777 entitled, ``Enforcing the Regulatory Reform Agenda,'' and as part of the efforts of HUD's Regulatory Reform Task Force, this document informs the public that HUD is reviewing its existing and planned manufactured housing regulatory actions to assess their actual and potential compliance costs and reduce regulatory burden. HUD invites public comment to assist in identifying regulations that may be outmoded, ineffective or excessively burdensome and should be modified, streamlined, replaced or repealed.

In the regulation of health care, the United States has a long history of providing conscience-based protections for individuals and entities with objections to certain activities based on religious belief and moral convictions. Multiple such statutory protections apply to the Department of Health and Human Services (HHS, or the Department) and the programs or activities it funds or administers. The Department proposes to revise regulations previously promulgated to ensure that persons or entities are not subjected to certain practices or policies that violate conscience, coerce, or discriminate, in violation of such Federal laws. Through this rulemaking, the Department proposes to grant overall responsibility to its Office for Civil Rights (OCR) for ensuring that the Department, its components, HHS programs and activities, and those who participate in HHS programs or activities comply with Federal laws protecting the rights of conscience and prohibiting associated discriminatory policies and practices in such programs and activities. In addition to conducting outreach and providing technical assistance, OCR will have the authority to initiate compliance reviews, conduct investigations, supervise and coordinate compliance by the Department and its components, and use enforcement tools otherwise available in civil rights law to address violations and resolve complaints. In order to ensure that recipients of Federal financial assistance and other Department funds comply with their legal obligations, the Department will require certain recipients to maintain records; cooperate with OCR's investigations, reviews, or other enforcement actions; submit written assurances and certifications of compliance to the Department; and provide notice to individuals and entities about their conscience and associated anti-discrimination rights, as applicable.

We are adopting a new airworthiness directive (AD) for Airbus Helicopters Model AS350B, AS350BA, AS350B1, AS350B2, AS350B3, AS350D, AS355E, AS355F, AS355F1, AS355F2, AS355N, AS355NP, EC130B4, and EC130T2 helicopters. This AD requires inspecting the main rotor (M/R) mast jet oil lubrication hose (oil hose). This AD is prompted by a report of a blocked oil hose. The actions of this AD are intended to prevent an unsafe condition on these helicopters.

We propose to adopt a new airworthiness directive (AD) for certain serial numbered Bell Helicopter Textron Canada Limited (BHTC) Model 429 helicopters. This proposed AD would require marking a serial number on life-limited forward spars and actuator fitting assemblies. The actions of this proposed AD are intended to prevent an unsafe condition on these products.

This rule establishes, amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures (ODPs) for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.

This rule establishes, amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures (ODPs) for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.