2015 – Federal Register Recent Federal Regulation Documents

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 any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of a voting consumer representative to serve on the Patient Engagement Advisory Committee (the Committee) notify FDA in writing. FDA is also requesting nominations for a voting consumer representative to serve on the Committee. Nominees recommended to serve as a voting consumer representative may either be self-nominated or may be nominated by a consumer organization. Nominations will be accepted for the current vacancy effective with this notice. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore encourages nominations of appropriately qualified candidates from these groups.

The Food and Drug Administration (FDA or Agency) is announcing the establishment of the Patient Engagement Advisory Committee (the Committee). The Committee will provide advice to the Commissioner of Food and Drugs (the Commissioner) or designee, on complex issues relating to medical devices, regulation of devices, and their use by patients. The Committee may consider topics such as Agency guidance and policies, clinical trial or registry design, patient preference study design, benefit-risk determinations, device labeling, unmet clinical needs, available alternatives, patient reported outcomes and device- related quality of life or health status issues, and other patient- related topics. The Agency is also announcing the establishment of a public docket for comments on the potential topics.

The Under Secretary of Defense (Acquisition, Technology, and Logistics) is waiving the statutory limitation of 10 U.S.C. 2534 for certain defense items produced in the United Kingdom (UK). United States Code, Title 10, section 2534, limits DoD procurement of certain items to sources in the national technology and industrial base. The waiver will permit procurement of enumerated items from sources in the UK, unless otherwise restricted by statute.

DoD is making technical amendments to the Defense Federal Acquisition Regulation Supplement (DFARS) to provide needed editorial changes.

The Advisory Committee on Rules of Appellate Procedure will hold a two-day meeting. The meeting will be open to public observation but not participation.

The Federal Trade Commission has issued a Statement of Enforcement Principles Regarding ``Unfair Methods of Competition'' Under Section 5 of the FTC Act. The Statement describes the underlying antitrust principles that guide the Commission's application of its statutory authority to take action against ``unfair methods of competition'' prohibited by Section 5 of the FTC Act but not necessarily by the Sherman Act or the Clayton Act.

The Department of Justice (DOJ), Criminal Division, Asset Forfeiture and Money Laundering Section, 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. The proposed information collection is published to obtain comments from the public and affected agencies. This proposed information collection was previously published in the Federal Register Volume 80 FR 42546, on July 17, 2015, allowing for a 60 day comment period.

HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.

The Institute of Museum and Library Services (``IMLS'') finalizes its portion of the uniform federal assistance rule published by the Office of Management and Budget.

NHTSA is proposing a rule prescribing procedures for the assessment of civil penalties and for interpreting the factors for determining the amount of a civil penalty or the amount of a compromise under the National Traffic and Motor Vehicle Safety Act (Safety Act), to implement the Moving Ahead for Progress in the 21st Century Act (MAP-21). MAP-21 states that the Secretary of Transportation shall determine the amount of civil penalty or compromise under the Safety Act. MAP-21 identifies mandatory factors that the Secretary must consider and discretionary factors for the Secretary to consider as appropriate in making such determinations. MAP-21 further directs NHTSA to issue a rule providing an interpretation of these penalty factors. NHTSA is also proposing to update our regulations to conform it to the statutory civil penalty maximums enacted in MAP-21, the increased penalties and damages for odometer fraud, and the statutory penalty for knowingly and willfully submitting materially false or misleading information to the Secretary after certifying the same information as accurate.

This notice announces actions taken by Texas Department of Transportation (TxDOT) and Federal agencies that are final within the meaning of 23 U.S.C. 139(l)(1). The actions relate to a proposed highway project making improvements to Interstate Highway (IH) 30 from Cooper Street to State Highway (SH) 161, in Tarrant County and Dallas County in the State of Texas. Those actions grant licenses, permits, and approvals for the project.

On July 15, 2015, notice was published on page 41545 of the Federal Register (volume 80, number 135) of determinations made by the Department of State pertaining to certain objects to be imported for temporary display in the exhibition ``Gauguin to Picasso: Masterworks from Switzerland, The Staechelin & Im Obersteg Collections.'' The referenced notice is corrected here to provide express notice of an extension in the period of temporary display within the United States of certain of the objects, and express notice of an additional exhibition and venue for a certain object. Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, et seq.; 22 U.S.C. 6501 note, et seq.), Delegation of Authority No. 234 of October 1, 1999, Delegation of Authority No. 236-3 of August 28, 2000 (and, as appropriate, Delegation of Authority No. 257 of April 15, 2003), I hereby determine that certain objects to be imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at The Phillips Collection, Washington, District of Columbia, between on or about October 10, 2015, and on or about January 11, 2017, in the exhibition ``Gauguin to Picasso: Masterworks from Switzerland, The Staechelin & Im Obersteg Collections,'' and at possible additional exhibitions or venues yet to be determined, and the exhibition or display of one of the above- referenced exhibit objects at the Taft Museum of Art, Cincinnati, Ohio, from on or about February 20, 2016, until on or about May 29, 2016, in the exhibition ``Daubigny, Monet, Van Gogh: Impressions of Landscape,'' and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these Determinations be published in the Federal Register.

The Defense Nuclear Facilities Safety Board (Board) published a notice in the Federal Register of July 27, 2015, (80 FR 44335), concerning a two-session public hearing and open meeting on August 26, 2015, at the Three Rivers Convention Center, 7016 West Grandridge Boulevard, Kennewick, Washington 99352. The Board corrected that notice in the Federal Register of August 28, 2015, (80 FR 52265), by postponing the Session II open meeting and supplementing the Session I hearing. The Board has now voted to cancel, in lieu of postponing, the Session II open meeting portion of the proceeding. The vote record for the cancellation of the open meeting will be posted on the Board's public Web site.

The Coast Guard is modifying the operating schedule that governs the Snake Creek Bridge across Snake Creek, Islamorada, FL. This temporary interim rule will change the drawbridge operation schedule to determine whether a permanent change to the schedule is needed. This temporary interim rule will allow Snake Creek Bridge to open on signal, except that from 8 a.m. to 6 p.m., the draw need open only on the hour. The Bridge owner, Florida Department of Transportation, and local officials requested this action to assist in reducing vehicle traffic caused by frequent bridge openings.

The Coast Guard is establishing a temporary safety zone for all waters of the Kaskaskia River, surface to bottom, between mile 28 and 29. This temporary safety zone is necessary to protect persons and property from potential damage and safety hazards during the New Athens Drag Boat Race. During the period of enforcement, entry into this safety zone is prohibited unless specifically authorized by the Captain of the Port (COTP) Upper Mississippi River or other designated representative.

As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.

Pursuant to Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C. App. 2), notice is hereby given of a meeting of the Commercial Space Transportation Advisory Committee (COMSTAC). The meeting will take place on Tuesday, October 20, 2015, from 8:00 a.m. to 5:00 p.m., and Wednesday, October 21, 2015, from 8:30 a.m. to 4:30 p.m. at the National Transportation Safety Board Conference Center, 429 L'Enfant Plaza SW., Washington, DC 20594. This will be the 61st meeting of the COMSTAC. The proposed schedule for the COMSTAC working group meetings on October 20 is below: