2017 – Federal Register Recent Federal Regulation Documents

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.

The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.

The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.

The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.samhsa.gov/workplace.

The Food and Drug Administration (FDA) is publishing notice that an applicant for a proposed biosimilar product notified FDA that a patent infringement action was filed in connection with the applicant's biologics license application (BLA). Under the Public Health Service Act (PHS Act), an applicant for a proposed biosimilar product or interchangeable product must notify FDA within 30 days after the applicant was served with a complaint in a patent infringement action described under the PHS Act. FDA is required to publish notice of the complaint in the Federal Register.

The Food and Drug Administration (FDA) is proposing to reclassify single-use female condoms, renaming the device to ``single- use internal condom,'' a postamendments class III device (product code MBU), into class II (special controls) subject to premarket notification (510(k)). FDA is also identifying the proposed special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is proposing this reclassification on its own initiative based on new information. FDA is also proposing to amend the existing device identification for ``female condom,'' a preamendments class III device (product code OBY), by renaming the device ``multiple- use female condom,'' to distinguish it from the ``single-use internal condom.'' If finalized, this order will reclassify single-use female condoms from class III to class II and reduce regulatory burdens on industry as these types of devices will no longer be required to submit a premarket approval application (PMA) but can instead submit a less burdensome 510(k) before marketing their device.

Section 106 of the Consumer Product Safety Improvement Act (CPSIA) made ASTM F963-07[epsi]1, Standard Consumer Safety Specification for Toy Safety, a mandatory consumer product safety standard. That section also provides procedures for revisions to the standard. In accordance with these procedures, the Commission (CPSC or Commission) recently allowed the update to ASTM F963, ASTM F963-17, Standard Consumer Safety Specification for Toy Safety (ASTM F963-17), to become the mandatory toy standard, with one exception. This direct final rule incorporates by reference ASTM F963-17, with one exception, and updates the existing notice of requirements (NOR) that provides the criteria and process for Commission acceptance of accreditation of third party conformity assessment bodies for testing for ASTM F963 pursuant to the Consumer Product Safety Act (CPSA).

The Committee on Rules of Practice and Procedure will hold a meeting on January 4, 2018. The meeting will be open to public observation but not participation. An agenda and supporting materials will be posted at least 7 days in advance of the meeting at: https:// www.uscourts.gov/rules-policies/records-and-archives-rules-co mmittees/ agenda-books.

The Internal Revenue Service (IRS), 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 information collections, as required by the Paperwork Reduction Act of 1995. The IRS is soliciting comments concerning Form 5498-QA, ABLE Account Contribution Information, and Form 1099-QA, Distributions from ABLE Accounts.

The Charter for the Internal Revenue Service Advisory Council (IRSAC) has been renewed for one year beginning November 24, 2017.

Pursuant to the Privacy Act of 1974, and Office of Management and Budget (OMB) Circular No. A-108, notice is hereby given that the Federal Bureau of Investigation (FBI), a component within the United States Department of Justice (Department or DOJ), proposes to establish a new system of records titled, ``FBI Online Collaboration Systems,'' JUSTICE/FBI-004. This system of records will cover all FBI online collaboration systems that facilitate online collaboration between the FBI and its criminal justice, intelligence, national security, emergency management, public safety, and private sector partners, as well as to support internal collaboration for and external collaboration among such partners in the United States and approved countries worldwide. Expanding available collaboration tools of the FBI and its partners enables the FBI to carry out its national security and criminal justice missions. Elsewhere in this Federal Register, DOJ is concurrently issuing a Notice of Proposed Rulemaking to exempt JUSITCE/ DOJ-004 from certain provisions of the Privacy Act.

The Department of Defense is publishing the unclassified text of an arms sales notification.

The U.S. Nuclear Regulatory Commission (NRC) reviewed an application by Sacramento Municipal Utility District (SMUD or the licensee) for amendment of Materials License No. SNM-2510, which authorizes the storage of spent nuclear fuel and greater than Class C waste at the Rancho Seco Independent Spent Fuel Storage Installation, located in Herald, California. The licensee requested authorization to allow the continued storage of byproduct nuclear material to check the functionality of radiation detection instruments.

HUD submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public comment.

This notice announces a Town Hall meeting in accordance with section 1886(d)(5)(K)(viii) of the Social Security Act (the Act) to discuss fiscal year (FY) 2019 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS). Interested parties are invited to this meeting to present their comments, recommendations, and data regarding whether the FY 2019 new medical services and technologies applications meet the substantial clinical improvement criterion.