September 2018 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing a public meeting entitled ``Tobacco Product Application Review.'' This meeting is intended to improve public understanding and provide FDA feedback on the policies and processes for submitting and reviewing tobacco product marketing applications, including the general scientific principles relevant to various application pathways, to assist those considering submitting marketing applications for tobacco products under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a guidance for industry entitled ``Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other Entities.'' This guidance sets forth FDA's policy regarding compounding and repackaging of radiopharmaceuticals for human use by State-licensed nuclear pharmacies, Federal facilities, and other entities that hold a radioactive materials (RAM) license for medical use issued by the Nuclear Regulatory Commission (NRC) or by an Agreement State. Because such radiopharmaceuticals are not eligible for exemptions from provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to the production of drugs, FDA is issuing this guidance to describe the conditions under which it generally does not intend to take action for violations of certain provisions of the FD&C Act when these entities compound or repackage radiopharmaceuticals.

The Environmental Protection Agency (EPA) is planning to submit an information collection request (ICR), ``National Emission Standard for Hazardous Air Pollutants (NESHAP) for Asbestos (40 CFR part 61, subpart M) (Renewal)'' (EPA ICR No. 0111.15, OMB Control No. 2060-0101) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA). Before doing so, the EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a second notice requesting comment on the proposed extension of the ICR, which is currently approved through March 31, 2019. The burden in this notice includes changes in reporting and recordkeeping resulting from a recent action on an alternative work practice and a planned change to allow electronic reporting for notifications. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

In accordance with the Privacy Act of 1974, the Department of Homeland Security (DHS) proposes to modify a current DHS system of records titled, ``DHS/All-016 Correspondence Records System of Records.'' This system of records allows the Department to collect and maintain correspondence records. The Department is updating this system of records to reflect changes to the categories of individuals, categories of records, and routine uses. Specifically, these changes include expanding the categories of individuals to include third party subjects of correspondence who may not be the sender or recipient. The Department is also expanding the categories of records to permit the collection of an individual's phone number, call and customer service center records, receipt number, case numbers relevant to the correspondence, and account IDs associated with correspondence between the Department and the responding party. DHS is updating routine use (E) and adding routine use (F) to comply with new policies pertaining to data breach procedures. The Department is making non-substantive edits to the routine uses to align with previously published Department systems of records notices (SORNs). Lastly, this notice includes non- substantive changes to simplify the formatting and text of the previously published notice. This modified system will be included in the DHS inventory of record systems.

This notice announces the existence of and requests comments on the proposed airworthiness design standards for acceptance of the Vertical Aviation Technologies (VAT) Model S-52L rotorcraft under the regulations for primary category aircraft.

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 a previously approved information collection. Applicable federal regulations prescribe certification standards for aircraft, aircraft engines, propellers appliances and parts. The information collected is used to determine compliance and applicant eligibility. The respondents are aircraft parts designers, manufacturers, and aircraft owners.

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 the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

This is a notice of an Administrative declaration of a disaster for the State of Kansas dated 09/14/2018. Incident: Flash Flooding, Flooding and Severe Storms. Incident Period: 09/01/2018 through 09/03/2018.

The U.S. Nuclear Regulatory Commission (NRC) is issuing Revision 4 to Regulatory Guide (RG) 1.160, ``Monitoring the Effectiveness of Maintenance at Nuclear Power Plants.'' Regulatory Guide 1.160, Revision 4, has been revised to address new issues identified since Revision 3 of RG 1.160 was issued. This RG endorses, with clarifications, NUMARC 93-01, ``Industry Guidelines for Monitoring the Effectiveness of Maintenance at Nuclear Power Plants,'' Revision 4F. The proposed revision describes methods that are acceptable to the NRC staff for compliance with the requirements for monitoring the effectiveness of maintenance at nuclear power plants.

The Environmental Protection Agency (EPA) is taking final action to approve a portion of a revision to the Chattanooga-Hamilton County portion of the Tennessee State Implementation Plan (SIP) submitted by the State of Tennessee through the Tennessee Department of Environment and Conservation (TDEC) on behalf of the Chattanooga- Hamilton County Air Pollution Control Bureau (Chattanooga-Hamilton County) on June 25, 2008. The revision amends the definition of ``volatile organic compounds'' (VOC) to be consistent with state and Federal regulations. The portion of the SIP revision that EPA is approving is consistent with the requirements of the Clean Air Act (CAA or Act). EPA will act on the other portions of the June 25, 2008, submittal in a separate action.

The Environmental Protection Agency (EPA) is issuing a proposed rule to address scientific integrity requirements in the creation of a contract clause for inclusion in solicitations and contracts when the contractor may be required to perform, communicate, or supervise scientific activities or use scientific information to perform advisory and assistance services. This clause will complement the EPA scientific integrity policy to ensure all scientific work developed and used by the Government is accomplished with scientific integrity.

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 Office of Head Start will further delay the compliance date for programs to meet background checks requirements and participate in their state or local Quality Rating and Improvement Systems (QRIS). The Department delayed the compliance dates for these standards through a previous document in the Federal Register. Since then, we have learned programs could benefit from more time as they work to align with state systems to meet these federal standards.

The Department of Commerce (Commerce) determines that imports of polytetrafluoroethylene (PTFE) resin from the People's Republic of China (China) are being, or are likely to be, sold in the United States at less than fair value (LTFV). The final dumping margins of sales at LTFV are listed in the ``Final Determination'' section of this notice.

As a result of this first sunset review, the Department of Commerce (Commerce) finds that revocation of the antidumping duty order on xanthan gum from the People's Republic of China (China) would be likely to lead to continuation or recurrence of dumping, at the level indicated in the ``Final Results of Sunset Review'' section of this notice.