December 14, 2017 – Federal Register Recent Federal Regulation Documents
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Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs
This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 to implement changes arising from our continuing experience with these systems. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program.
Compliance Date for Form 10-D Hyperlink Requirements
The Securities and Exchange Commission (``Commission'') is publishing this document to inform the public that it has set a compliance date for its previously-adopted exhibit hyperlinking requirements for Form 10-Ds that require hyperlinks to any exhibits filed with Form ABS-EE. The Commission on March 1, 2017 required registrants that file registration statements and reports subject to the exhibit requirements under Item 601 of Regulation S-K, or that file Forms F-10 or 20-F, to include a hyperlink to each exhibit listed in the exhibit index of these filings, but deferred setting a compliance date with respect to any Form 10-D that will require hyperlinks to any exhibits filed with Form ABS-EE until the Commission announced that technical programming changes to allow issuers to include Form 10-D and Form ABS-EE in a single submission had been completed, and published a notification of the compliance date for Form 10-D in the Federal Register.
Agency Information Collection Activities: Proposed Collection; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery
The U.S. Small Business Administration (SBA) is submitting a Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' to the Office of Management and Budget (OMB) for approval under the Paperwork Reduction Act (PRA). This information collection is part of a Federal Government-wide effort to streamline the process to seek feedback from the public on the agency's service delivery. SBA previously published a 60-day notice soliciting public comment on the proposed information collection. This 30-day notice, as required by the PRA, provides an additional opportunity for public comment on the Generic ICR.
Food Crediting in Child Nutrition Programs: Request for Information
The National School Lunch Program, School Breakfast Program, Child and Adult Care Food Program, and Summer Food Service Program (Child Nutrition Programs), which are administered by the United States Department of Agriculture (USDA), Food and Nutrition Service (FNS), play a critical role in ensuring that America's children have access to the nutritious food they need to learn and succeed in the classroom, afterschool, and during the summer. It is FNS' responsibility to establish and support the meal patterns and nutrition standards (collectively referred to as meal patterns) in the Child Nutrition Programs that advance the goals of providing nutritious and satisfying meals to a broad population of children. At the same time, FNS works to simplify the menu planning process for Program operators to promote the efficient use of Program funds and provide a wide variety of food choices to menu planners and children. In order to claim Federal reimbursement, Child Nutrition Program operators must serve meals and snacks that meet the minimum meal pattern requirements of the respective Program. Crediting is the process designed by FNS to specify how individual food items contribute to the Child Nutrition Programs' meal patterns. Several factors impact how food products can credit toward reimbursable meals, such as volume, weight, and overall nutrient profile. The purpose of this Request for Information is to help FNS gather feedback from a wide variety of stakeholders on how FNS' crediting system can best address today's evolving food and nutrition environment, as well as to offer first-rate customer service to those operating and benefitting from the Child Nutrition Programs. FNS welcomes comments from all interested stakeholders. While FNS is interested in your general comments about the crediting process, FNS also invites comments on the crediting of several specific food products. FNS is especially interested in understanding both the possible benefits and any negative impacts associated with potential changes to how certain foods may or may not credit.
Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data; Public Workshop; Request for Comments
The Food and Drug Administration (FDA or Agency) is announcing the following public workshop entitled ``Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data.'' The purpose of the public workshop is to convene a discussion on how a person seeking to develop and submit proposed draft guidance relating to patient experience data for consideration by FDA may submit such proposed draft guidance to the Agency. This workshop will inform development of patient-focused drug development guidance as required by the 21st Century Cures Act (Cures Act). FDA plans to publish a background document approximately 2 weeks before the workshop date.
Pacific Fishery Management Council; Public Meeting (Webinar)
The Pacific Fishery Management Council's (Pacific Council) will host the Area 2A Pacific Halibut Managers Coordination Meeting via webinar. The meeting is open to the public.
Military Lending Act Limitations on Terms of Consumer Credit Extended to Service Members and Dependents
The Department of Defense (Department) is amending its interpretive rule for the Military Lending Act (the MLA). The MLA, as implemented by the Department, limits the military annual percentage rate (MAPR) that a creditor may charge to a maximum of 36 percent, requires certain disclosures, and provides other substantive consumer protections on ``consumer credit'' extended to Service members and their families. On July 22, 2015, the Department amended its regulation primarily for the purpose of extending the protections of the MLA to a broader range of closed-end and open-end credit products (the July 2015 Final Rule). On August 26, 2016, the Department issued the first set of interpretations of that regulation in the form of questions and answers; the present interpretive rule amends and adds to those questions and answers to provide guidance on certain questions the Department has received regarding compliance with the July 2015 Final Rule.
New Postal Product
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submission for OMB Review; 30-Day Comment Request; Special Volunteer and Guest Researcher Assignment (Office of Intramural Research, Office of the Director)
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.
Meetings of Humanities Panel
The National Endowment for the Humanities will hold three meetings of the Humanities Panel, a federal advisory committee, during January, 2018. The purpose of the meetings is for panel review, discussion, evaluation, and recommendation of applications for financial assistance under the National Foundation on the Arts and Humanities Act of 1965.
Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMB
The Board of Governors of the Federal Reserve System (Board) is adopting a proposal to extend for three years, without revision, the Reporting Requirements Associated with Regulation XX Concentration Limit (FR XX) and Financial Company (as defined) Report of Consolidated Liabilities (FR XX-1) (OMB No. 7100-0363).
Intent To Grant Exclusive Patent License to Montana Emergent Technologies
The U.S. Geological Survey (USGS), Department of the Interior, is contemplating the grant of an exclusive license in the United States of America, its territories, possessions and commonwealths, to USGS's interest in the invention embodied in U.S. Provisional Application No. 62/333,616, titled ``Subsurface Environment Sampler,'' to Montana Emergent Technologies (MET). USGS requests public comments on or objections to the proposed grant.
Submission for OMB Review; Comment Request
The Department of Defense has submitted to OMB for clearance, the following proposal for collection of information under the provisions of the Paperwork Reduction Act.
Agency Information Collection Activities; Comment Request; Teacher Cancellation Low Income Directory
In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension of an existing information collection.
Agency Information Collection Activities; Comment Request; Work Colleges Application and Agreement
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a new information collection.
Agency Information Collection Activities; Comment Request; Work Colleges Expenditure Report
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a new information collection.
Revision to Children's Gasoline Burn Prevention Act Regulation
The Children's Gasoline Burn Prevention Act (CGBPA or the Act) adopted as a consumer product safety rule, the child-resistance requirements for closures on portable gasoline containers published in the ASTM voluntary standard, Standard Specification for Determination of Child Resistance of Portable Fuel Containers for Consumer Use, ASTM F2517-05. ASTM F2517 was revised in 2015. These revisions became law under the Act, which the Commission codified through a direct final rule in 2015. On November 13, 2017, the Commission received notice from ASTM that a revision to ASTM F2517 was published in November 2017. In this direct final rule the Commission reviews and evaluates the revised ASTM F2517, finding that the revisions carry out the purposes of the CGBPA's requirements. Accordingly, the 2017 revisions to the child- resistance requirements will be automatically incorporated and apply as the statutorily mandated standard for closures on portable gasoline containers. This direct final rule updates the Commission's regulation to reflect that the requirements for closures on portable gasoline containers must meet the requirements in ASTM F2517-17.
Agency Information Collection Activities; Proposed eCollection eComments Requested; Reinstatement, With Change, of a Previously Approved Collection for Which Approval Has Expired: FBI eFOIA Form
The Department of Justice (DOJ), Office of Justice Programs, Federal Bureau of Investigation, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. This proposed information collection was previously published in the Federal Register, on October 10, 2017 allowing for a 60 day comment period.
Reasonable Charges for Medical Care or Services; v3.23, 2018 Calendar Year Update and National Average Administrative Prescription Drug Charge Update
This Department of Veterans Affairs (VA) notice updates the data for calculating the ``Reasonable Charges'' collected or recovered by VA for medical care or services. This notice also updates the ``National Average Administrative Prescription Costs'' for purposes of calculating VA's charges for prescription drugs that were not administered during treatment, but provided or furnished by VA to a veteran.
Surface Transportation Project Delivery Program; TxDOT Audit #4 Report
The Surface Transportation Project Delivery Program allows a State to assume FHWA's environmental responsibilities for review, consultation, and compliance for Federal highway projects. When a State assumes these Federal responsibilities, the State becomes solely responsible and liable for carrying out the responsibilities it has assumed, in lieu of FHWA. Prior to the Fixing America's Surface Transportation (FAST) Act of 2015, the Program required semiannual audits during each of the first 2 years of State participation to ensure compliance by each State participating in the Program. This notice announces and solicits comments on the fourth audit report for the Texas Department of Transportation's (TxDOT) participation in accordance with these pre-FAST Act requirements.
Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Information Collections Being Reviewed by the Federal Communications Commission Under Delegated Authority
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Terrestrial Use of the 2473-2495 MHz Bands for Low-Power Mobile Broadband Networks; Amendments to Rules for the Ancillary Terrestrial Component of Mobile Satellite Service Systems
In this document, the Commission announces that the Office of Management and Budget (OMB) has approved, for a period of three years, the information collection associated with the Commission's Terrestrial Use of the 2473-2495 MHz bands for Low-Power Mobile Broadband Networks; Amendments to Rules for the Ancillary Terrestrial Component of Mobile Satellite Service Systems Report and Order's (Order) modified rules for the operation of an Ancillary Terrestrial Component. This document is consistent with the Order, which stated that the Commission would publish a document in the Federal Register announcing the effective date of those rules.
Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Accelerating Wireless Broadband Deployment by Removing Barriers to Infrastructure Investment
The Federal Communications Commission (Commission) eliminates historic preservation review of replacement utility poles that support communications equipment, subject to conditions that ensure no effects on historic properties. The Commission also consolidates historic preservation requirements in a single new rule.
Information Collection Request to Office of Management and Budget; OMB Control Number: 1625-0011
In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting an extension of its approval for the following collection of information: 1625-0011, Applications for Private Aids to Navigation and for Class I Private Aids to Navigation on Artificial Islands and Fixed Structures; without change. Our ICR describes the information we seek to collect from the public. Before submitting this ICR to OIRA, the Coast Guard is inviting comments as described below.
Public Workshop on Safety Assessment for Investigational New Drug Safety Reporting; Correction
The Food and Drug Administration is correcting a notice entitled ``Safety Assessment for Investigational New Drug Safety Reporting; Public Workshop'' that appeared in the Federal Register of November 27, 2017. The document announced a public workshop to engage external stakeholders in discussions related to finalizing the draft guidance entitled ``Safety Assessment for IND Safety Reporting.'' The date of the meeting has changed.
Government-Owned Inventions; Availability for Licensing
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.
Safety Zone; Delaware River, Pipeline Removal, Marcus Hook, PA
This interim rule modifies and extends the effective period of the existing temporary safety zone encompassing all navigable waters within a 250-yard radius of Commerce Construction vessels and machinery conducting diving and pipeline removal operations in the Delaware River, in the vicinity of Anchorage 7, near Marcus Hook, PA. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created by diving and pipeline removal operations. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Delaware Bay. We invite your comments on this rulemaking.
Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Marketing Act of 1987; Administrative Procedures, Policies, and Requirements
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 the information collection in the regulations on the Prescription Drug Marketing Act of 1987; Administrative Procedures, Policies, and Requirements.
Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals
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 the information collection for the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals.
Agency Information Collection Activities: Submission to the Office of Management and Budget for Review and Approval; Abandoned Mine Reclamation Funds
In accordance with the Paperwork Reduction Act of 1995, we, the Office of Surface Mining Reclamation and Enforcement (OSMRE) are proposing to renew an information collection with revisions relating to abandoned mine reclamation funds.
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