February 26, 2019 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Assessing the Effects of Food on Drugs in INDs and NDAsClinical Pharmacology Considerations.'' This draft guidance provides recommendations to sponsors planning to conduct food-effect trials for orally administered products as part of investigational new drug applications (INDs), new drug applications (NDAs), and supplements to these applications. This draft guidance, when final, revises and replaces part of the 2002 FDA guidance for industry entitled ``Food-Effect Bioavailability and Fed Bioequivalence Studies'' (2002 Food Effect Guidance).

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.

On December 20, 2018, the United States Court of International Trade (Court) issued a final judgment in Prosperity Tieh Enterprise Co., Ltd. et al. v. United States, Consol. Court No. 16-00138; Slip Op. 18-175 (CIT Dec. 20, 2018), sustaining the Department of Commerce's (Commerce) remand results for the final determination of the antidumping investigation of certain corrosion-resistant steel products (CORE) from Taiwan, covering the period of investigation (POI) April 1, 2014, through March 31, 2015. Commerce is notifying the public that the Court has made a final judgment that is not in harmony with Commerce's amended final determination of the antidumping investigation, and that Commerce is amending the final determination.

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.

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.

The Small Business Administration (SBA) intends to request approval, from the Office of Management and Budget (OMB) for the collection of information described below. The Paperwork Reduction Act (PRA) requires federal agencies to publish a notice in the Federal Register concerning each proposed collection of information before submission to OMB, and to allow 60 days for public comment in response to the notice. This notice complies with that requirement.

In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. The Federal Register Notice with a 60-day comment period soliciting comments on the following collection of information was published on December 20, 2018. The information to be collected is necessary because the FAA needs accurate and up to date data indicating who is performing maintenance on behalf of air carriers, what type of maintenance is being performed, and where the maintenance is being performed. This collected information will be used by the FAA to adequately target its inspection resources for surveillance and make accurate risk assessments.

In accordance with the Paperwork Reduction Act of 1995, we, the National Park Service (NPS) are proposing to renew an information collection.

The Internal Revenue Service, 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. Currently, the IRS is soliciting comments concerning Form 5306, Application for Approval of Prototype or Employer Sponsored Individual Retirement Account.

The Internal Revenue Service, 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. Currently, the IRS is soliciting comments concerning Form 4669, Statement of Payments Received.

The Internal Revenue Service, 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. Currently, the IRS is soliciting comments concerning Revenue Ruling 2000-35, Automatic Enrollment in Section 403(b) Plans.

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 Generation-Skipping Transfer Tax Return For Terminations.

The Department of Homeland Security, U.S. Customs and Border Protection 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 (PRA). The information collection is published in the Federal Register to obtain comments from the public and affected agencies.

This NOA documents DLA's decision to proceed with the proposed action to upgrade the Main Gate Access Control Point at Defense Distribution Depot, San Joaquin California, and Surrounding Area following the completion of an Environmental Assessment (EA). The EA was prepared as required under the National Environmental Policy Act (NEPA) of 1969.

We, the U.S. Fish and Wildlife Service (Service), determine the northern subspecies of scarlet macaw (Ara macao cyanoptera) is an endangered species under the Endangered Species Act of 1973 (Act), as amended; the northern distinct population segment (DPS) of the southern subspecies of scarlet macaw (A. m. macao) is a threatened species under the Act, and the southern DPS of the southern subspecies of scarlet macaw (A. m. macao) and subspecies crosses (A. m. cyanoptera and A. m. macao) to be threatened species based on similarity of appearance. We are also establishing a rule pursuant to section 4(d) of the Act for the A. m. macao subspecies and subspecies crosses to provide for its further conservation.

We are adopting a new airworthiness directive (AD) for all Airbus SAS Model A350-941 airplanes. This AD was prompted by reports of an overheat failure mode of the hydraulic engine-driven pump (EDP), and a determination that the affected EDP needs to be replaced with an improved EDP. This AD requires replacement of a certain EDP with an improved EDP. We are issuing this AD to address the unsafe condition on these products.

We are adopting a new airworthiness directive (AD) for all Saab AB, Saab Aeronautics Model SAAB 2000 airplanes. This AD was prompted by reports that certain fuel probes indicated misleading fuel quantities on the engine indicating and crew alerting system (EICAS). This AD requires a functional check of certain fuel probes, and replacement with a serviceable part if necessary. We are issuing this AD to address the unsafe condition on these products.

We, the U.S. Fish and Wildlife Service (Service or USFWS), propose to remove the Borax Lake chub (currently listed as Gila boraxobius), a fish native to Oregon, from the Federal List of Endangered and Threatened Wildlife on the basis of recovery. This proposal is based on a review of the best available scientific and commercial information, which indicates that the threats to the Borax Lake chub have been eliminated or reduced to the point where the species no longer meets the definition of an endangered or threatened species under the Endangered Species Act of 1973, as amended (Act). We are seeking information and comments from the public regarding this proposed rule.

The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its spent fuel storage regulations by revising the Holtec International HI-STORM 100 Cask System listing within the ``List of approved spent fuel storage casks'' to include Amendment No. 13 to Certificate of Compliance No. 1014. Amendment No. 13 would revise Appendix B of the technical specifications to update the initial uranium weight for the 16x16B and 16x16C assembly classes to match the value for 16x16A.