2017 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of two draft guidances for industry entitled ``In Vitro Metabolism- and Transporter-Mediated Drug-Drug Interaction Studies'' (in vitro DDI guidance) and ``Clinical Drug Interaction StudiesStudy Design, Data Analysis, and Clinical Implications'' (clinical DDI guidance). These two draft guidances will update and replace the revised draft guidance for industry entitled ``Drug Interaction StudiesStudy Design, Data Analysis, Implications for Dosing, and Labeling Recommendations'' issued February 21, 2012 (2012 draft guidance). These draft guidances are intended to assist drug developers in the planning and evaluation of drug-drug interaction (DDI) potential during drug development. In particular, the in vitro DDI guidance focuses on in vitro experimental approaches for evaluating metabolizing enzyme- and transporter-based drug interaction potential and how to extrapolate in vitro data to decide on the need for clinical DDI studies. The clinical DDI guidance focuses on clinical studies that evaluate the potential for DDIs, which alter a drug's pharmacokinetics by modulating the effects of drug metabolizing enzymes and transporters, and advises sponsors on the timing and design of the clinical studies, interpretation of the results, and options for managing DDIs in patients. Together, these two draft guidances describe a systematic, risk-based approach to the assessment of DDIs.

The Department of the Treasury will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on these requests.

The United States International Trade Commission (ITC) has determined that certain crystalline silicon photovoltaic (CSPV) cells (whether or not partially or fully assembled into other products) are being imported into the United States in such increased quantities as to be a substantial cause of serious injury, or the threat thereof, to the domestic industry producing an article that is like or directly competitive with the imported articles. The Commissioners who voted in the affirmative are now conducting a process to recommend a safeguard measure for the President to apply. The Office of the United States Trade Representative (USTR), on behalf of the Trade Policy Staff Committee (TPSC), is announcing a process so that, once the ITC makes its recommendation, domestic producers, importers, exporters, and other interested parties may submit their views and evidence on the appropriateness of the recommended safeguard measure and whether it would be in the public interest. USTR also invites interested parties to participate in a public hearing regarding this matter.

The Board is finalizing its interim final rule amending its regulations for processing requests under the Freedom of Information Act (``FOIA'') pursuant to the FOIA Improvement Act of 2016 (the ``Act''). The amendments clarify and update procedures for requesting information from the Board, extend the deadline for administrative appeals, and add information on dispute resolution services. The interim final rule became effective on December 27, 2016. This rulemaking finalizes the interim rule with minor edits.

As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. 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 Commission 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 Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will submit 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.

EPA is taking direct final action on a revision to the formaldehyde standards for composite wood products final rule, published in the Federal Register on December 12, 2016. The revision will update multiple voluntary consensus standards that have been updated, superseded, or withdrawn since publication of the notices of proposed rulemaking on June 10, 2013 and will amend an existing regulatory provision regarding the correlation of quality control test methods.

DOT is extending the deadline and comment period for materials related to the Interim National Multimodal Freight Network (Interim NMFN), as established in a notice published on June 6, 2016 at 81 FR 36381. The original notice asked for comments by September 6, 2016. The reopening and extension of the comment period is based on input received from DOT stakeholders that the September 6, 2016 closing date did not provide sufficient time for submission of comments to the Department, as well as an analysis that some comments submitted by States did not include the required statutory certification. DOT agrees that the comment period should be reopened and extended. Therefore, the comment period on the establishment of the Interim NMFN is reopened.

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 continuing information collections, as required by the Paperwork Reduction Act of 1995. The IRS is soliciting comments concerning the health insurance marketplace statement.

This notice amends the notice of an emergency declaration for the State of Mississippi (FEMA-3393-EM), dated October 7, 2017, and related determinations.

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 continuing information collections, as required by the Paperwork Reduction Act of 1995. The IRS is soliciting comments concerning the declaration for federal employment.

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 continuing information collections, as required by the Paperwork Reduction Act of 1995. The IRS is soliciting comments concerning the treaty-based return position disclosure.

In the Federal Register notice that was originally published on October 5, 2017, (Volume 82, Number 192, Page 46611), the meeting date is now changed. The new date for the meeting is, Tuesday, November 14, 2017.

This notice amends the notice of a major disaster declaration for the Seminole Tribe of Florida (FEMA-4341-DR), dated September 27, 2017, and related determinations.

This notice amends the notice of a major disaster declaration for the State of California (FEMA-4344-DR), dated October 10, 2017, and related determinations.

This notice amends the notice of a major disaster declaration for the State of Georgia (FEMA-4338-DR), dated September 15, 2017, and related determinations.

This notice amends the notice of a major disaster declaration for the State of California (FEMA-4344-DR), dated October 10, 2017, and related determinations.

The Federal Emergency Management Agency, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public to take this opportunity to comment on a reinstatement, without change, of a previously approved information collection for which approval has expired. In accordance with the Paperwork Reduction Act of 1995, this notice seeks comments concerning the National Flood Insurance Program, Mortgage Portfolio Protection Program (MPPP), which is an option that companies participating in the National Flood Insurance Program can use to bring their mortgage loan portfolios into compliance with the flood insurance purchase requirements.

This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, this aspect of the FAA's regulatory activities. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.