December 18, 2017 – Federal Register Recent Federal Regulation Documents

The Environmental Protection Agency (EPA) is proposing to approve several different revisions to the State Implementation Plan (SIP) submitted to EPA by the Vermont Department of Environmental Conservation (VT DEC). On May 23, 2017, Vermont submitted revisions to EPA satisfying the VT DEC's earlier commitment to adopt and submit revisions that meet certain requirements of the federal Prevention of Significant Deterioration (PSD) air permit program. Vermont's submission also included revisions relating to the federal nonattainment new source review (NNSR) permit program. This action proposes to approve those revisions and also proposes to fully approve certain of Vermont's infrastructure SIPs (ISIPs), which were conditionally approved by EPA on June 27, 2017. Additionally, EPA is proposing to approve several other minor regulatory changes to the SIP submitted by VT DEC on May 23, 2017. This action is being taken in accordance with the Clean Air Act.

The Agency is issuing this notice to announce the opportunity to provide additional nominations for experts to serve as ad hoc members for the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) reviewing physiologically-based pharmacokinetic (PBPK) modeling to address pharmacokinetic differences between and within species on six selected pesticidal active ingredients. This meeting of the FIFRA SAP, originally scheduled for October 24-27, 2017, has been postponed until 2018. New dates for this meeting will be announced in a separate notice.

Further to the NASA Federal Register notice of December 12, 2017 (see citation above), NASA announces an invitation for public nominations of U.S. citizens to serve as potential members of the National Space Council Users' Advisory Group (UAG). The UAG is a new Federal advisory committee under the Federal Advisory Committee Act (FACA) being established pursuant to the National Aeronautics and Space Administration Authorization Act, Fiscal Year 1991 (Pub. L. 101-611, Section 121) and Executive Order 13803, Section 6 (``Reviving the National Space Council'') signed by the President on June 30, 2017. The UAG is purely advisory and will ensure that the interests of industry and other non-Federal entities are adequately represented in the deliberations of the National Space Council. NASA is sponsoring the UAG on behalf of the National Space Council, an Executive Branch interagency coordinating committee chaired by the Vice President, which is tasked with advising and assisting the President on national space policy and strategy. Members of the UAG will serve either as ``Representatives'' (representing industry, other non-Federal entities, and other recognizable groups of persons involved in aeronautical and space activities), or as ``Special Government Employees'' (individual subject matter experts or consultants). Deadline: The deadline for NASA to receive all public nominations is January 10, 2018. Instructions for Public Nominations: U.S. citizens or organizations may nominate individuals for consideration as potential members of the UAG. Interested candidates may also self-nominate. The candidate must be a U.S. citizen, may not be a regular government employee, and must not be registered by the Department of Justice under the Foreign Agents Registration Act (FARA), 22 U.S.C. 611 et seq. Additionally, a candidate for a Special Government Employee appointment must not be federally registered as a lobbyist under the Lobbying Disclosure Act of 1995, 2 U.S.C. 1602, as amended. Nominations must be contained in an email to NASA attaching the required documents. All nominations should include a cover letter, a resume (including contact information for the individual) and a professional biography demonstrating professional stature, knowledge and experience commensurate with achieving the UAG's purpose as set forth in Public Law 101-611, Section 121. Each document must not exceed one page. The cover letter must be a signed letter saved as a PDF file, indicate the category of membership for which the individual is being nominated (``Representative'' or ``Special Government Employee''), and contain an affirmative statement that the individual meets all aforesaid requirements. Cover letters for Representative nominations must also indicate why the individual should be considered for membership relative to the UAG's representational objectives, and be on the supporting organization's letterhead. Cover letters for Special Government Employee nominations must also identify the subject area(s) where the individual's expertise and/or consultative stature is nationally recognized relative to the UAG's advisory objectives. Nominations must be submitted in a single email attaching the cover letter, resume, and professional biography to HQ-UAGnoms@nasa.gov. Hard copies such as paper documents sent through postal mail will not be accepted. Privacy Act Notification: The information provided in response to this announcement will support membership selection of the National Space Council Users' Advisory Group (UAG). Its collection is authorized by the Federal Advisory Committee Act (FACA), Public Law 92-463, 5 U.S.C. App., as amended; 5 U.S.C. 3109; Title V of Public Law 100-685; Public Law 101-611, Section 121; Executive Order 13803 of June 30, 2017, Section 6; and 44 U.S.C. 3101. Providing this information is voluntary, but not providing it or not providing it as requested may result in information or an individual not being considered in the UAG membership selection process. NASA may share this information for authorized purposes consistent with the purpose for which it is collected. Elaboration and conditions of information disclosure may be found under ``Routine Uses'' of the full System of Records Notice for System 10SPER, ``Special Personnel Records'' (15-118, 81 FR 10, pp. 2244-2247) at https://www.gpo.gov/fdsys/pkg/FR-2016-01-15/pdf/2016- 00689.pdf and in Appendix B (11-091, 76 FR 200, pp. 64112-64114) at https://www.gpo.gov/fdsys/pkg/FR-2011-10-17/pdf/2011-26731.pd f.

The information collection requirements described below will be submitted to the Office of Management and Budget (``OMB'') for review, as required by the Paperwork Reduction Act (``PRA''). The FTC is seeking public comments on its proposal to extend for an additional three years its OMB clearance for the information collection requirements contained in the Commission's Business Opportunity Rule (``Rule''). That clearance expires on January 31, 2018.

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

In this document, the Commission announces that the Office of Management and Budget (OMB) has approved the non-substantive change request for the information collection requirements contained in FCC 17-137. This document is consistent with the Report and Order, which stated that the Commission would publish a document in the Federal Register announcing OMB approval and the effective date of these rules.

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 30 days of public comment.

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 30 days of public comment.

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 30 days of public comment.

The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) announces an opportunity for commercial manufacturers to work with CDC's National Center for Immunization and Respiratory Diseases (NCIRD) on the validation of pertussis serological kits prior to submission to the Food and Drug Administration (FDA) for marketing authorization. CDC is interested in the development of an assay that is an Immunoglobulin G (IgG) anti-pertussis toxin (PT) enzyme-linked immunosorbent assay (ELISA), calibrated to an international reference standard (such as FDA Reference Standard Lot #3, World Health Organization (WHO) International Standard 06/140, or equivalents). The ELISA will be used for in vitro serological diagnosis of pertussis in clinical cases of selected age groups. CDC will be able to provide guidance, materials, and evaluation support for the manufacturer; however, the manufacturer will be responsible for submitting a premarket submission to FDA with adequate information, including any analytical or clinical data needed to support the submission, to demonstrate to FDA that FDA can grant marketing authorization to the product.

Notice is hereby given that a meeting of the Labor Advisory Committee for Trade Negotiation and Trade Policy has been postponed until further notice. This meeting, which was closed to the public, was scheduled for December 15, 2017, from 2 p.m. to 4 p.m., at the U.S. Department of Labor, Secretary's Conference Room, 200 Constitution Ave. NW, Washington, DC.

The FHWA invites public comments about our intention to request the Office of Management and Budget's (OMB) approval for a new information collection, which is summarized below under Supplementary Information. We are required to publish this notice in the Federal Register by the Paperwork Reduction Act of 1995.

U.S. Agency for International Development (USAID) is making efforts to reduce the paperwork burden. USAID invites the general public and other Federal agencies to take this opportunity to comment on the following proposed and/or continuing information collections, as required by the Paperwork Reduction Act for 1995. Comments are requested concerning: (a) The accuracy of the burden estimates; (b) ways to enhance the quality, utility, and clarity of the information collected; and (c) 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.

The Board is providing notice of the aggregate global indicator amounts for purposes of a calculation for 2017, which is required under the Board's rule regarding risk-based capital surcharges for global systemically important bank holding companies (GSIB surcharge rule).

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Investigational IVDs Used in Clinical Investigations of Therapeutic Products.'' This draft guidance is intended to assist sponsors of clinical investigations of therapeutic products that also include investigational in vitro diagnostics (IVDs) and institutional review boards (IRBs) that review such investigations in complying with the Investigational Device Exemption (IDE) regulation. This draft guidance is also intended to assist FDA staff participating in the review of these investigations. This draft guidance is not final nor is it in effect at this time.