January 2020 – Federal Register Recent Federal Regulation Documents

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.

Pursuant to the Federal Advisory Committee Act notice is hereby given that the Mobile Sources Technical Review Subcommittee (MSTRS) will meet on March 31, 2020. The MSTRS is a subcommittee under the Clean Air Act Advisory Committee. This is an open meeting. The meeting will include discussion of current topics and presentations about activities being conducted by EPA's Office of Transportation and Air Quality. The preliminary agenda for the meeting and any notices about change in venue will be posted on the Subcommittee's website: https://www2.epa.gov/caaac/mobile-sources-technical-review-sub committee- mstrs-caaac. MSTRS listserv subscribers will receive notification when the agenda is available on the Subcommittee website. To subscribe to the MSTRS listserv, send an email to mccubbin.courtney@epa.gov.

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 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 Department of Commerce (Commerce) determines that certain fabricated structural steel (fabricated structural steel) from Mexico is being, or is likely to be, sold in the United States at less than fair value (LTFV). The period of investigation (POI) is January 1, 2018 through December 31, 2018. The final dumping margins of sales at LTFV are shown in the ``Final Determination'' section of this notice.

The Department of Commerce (Commerce) determines that certain fabricated structural steel (fabricated structural steel) from the People's Republic of China (China) is being, or is likely to be, sold in the United States at less than fair value (LTFV). The period of investigation is July 1, 2018 through December 31, 2018. The final dumping margins of sales at LTFV are listed below in the ``Final Determination'' section of this notice.

The Department of Commerce (Commerce) determines that certain fabricated structural steel (fabricated structural steel) from Canada is being, or is likely to be, sold in the United States at less than fair value (LTFV). The period of investigation (POI) is January 1, 2018 through December 31, 2018. The final dumping margins of sales at LTFV are listed below in the ``Final Determination'' section of this notice.

In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.

NASA hereby gives notice of its intent to grant a partially exclusive patent license in the United States to practice the inventions described and claimed in U.S. Patent No. 8,167,204 B2 for an invention entitled ``Wireless Damage Location Sensing System,'' NASA Case Number LAR-17593-1; U.S. Patent No. 7,086,593 B2 for an invention entitled ``Magnetic Field Response Measurement Acquisition System,'' NASA Case Number LAR-16908-1; U.S. Patent No. 7,159,774 B2 for an invention entitled ``Magnetic Field Response Measurement Acquisition System,'' NASA Case Number LAR-17280-1; U.S. Patent No. 8,430,327 B2 for an invention entitled ``Wireless Sensing System Using Open-Circuit, Electrically-Conductive Spiral-Trace Sensor,'' NASA Case Number LAR- 17294-1; U.S. Patent No. 8,042,739 B2 for an invention entitled ``Wireless Tamper Detection Sensor and Sensing System,'' NASA Case Number LAR-17444-1; U.S. Patent No. 7,814,786 B2 for an invention entitled ``Wireless Sensing System for Non-Invasive Monitoring of Attributes of Contents in a Container,'' NASA Case Number LAR-17488-1; U.S. Patent No. 8,673,649 B2 for an invention entitled ``Wireless Chemical Sensor and Sensing Method for Use Therewith,'' NASA Case Number LAR-17579-1; U.S. Patent No. 9,329,149 B2 for an invention entitled ``Wireless Chemical Sensor and Sensing Method for Use Therewith,'' NASA Case Number LAR-17579-2; U.S. Patent No. 9,733,203 B2 for an invention entitled ``Wireless Chemical Sensing Method,'' NASA Case Number LAR-17579-3; U.S. Patent No. 8,179,203 B2 for an invention entitled ``Wireless Electrical Device Using Open-Circuit Elements Having No Electrical Connections,'' NASA Case Number LAR-17711-1; and U.S. Patent No. 10,193,228 B2 for an invention entitled ``Antenna for Near Field Sensing and Far Field Transceiving,'' NASA Case Number LAR- 18400-1, to Gyra Systems, Inc., having its principal place of business in La Mesa, CA. The fields of use may be limited to package monitoring quality sensors to detect changes in product quality and authenticity, such as pharmaceutical, food, beverage, tobacco, and cosmetics products and/or similar field(s) of use thereto. NASA has not yet made a determination to grant the requested license and may deny the requested license even if no objections are submitted within the comment period.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Long Term Follow-Up After Administration of Human Gene Therapy Products.'' The guidance document provides sponsors, who are developing a human gene therapy (GT) product, recommendations regarding the design of long term follow- up (LTFU) observational studies for the collection of data on delayed adverse events following administration of a GT product. This guidance finalizes the draft guidance of the same title dated July 2018 and supersedes the document entitled ``Guidance for Industry: Gene Therapy Clinical TrialsObserving Subjects for Delayed Adverse Events'' dated November 2006. This guidance also supplements the guidance entitled ``Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus during Product Manufacture and Patient Follow-up; Guidance for Industry.''

This notice publishes the current list of 574 Tribal entities recognized by and eligible for funding and services from the Bureau of Indian Affairs (BIA) by virtue of their status as Indian Tribes. The list is updated from the notice published on February 1, 2019 (84 FR 1200).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Human Gene Therapy for Rare Diseases; Guidance for Industry.'' The final guidance document provides recommendations to stakeholders developing a human gene therapy (GT) product intended to treat a rare disease in adult and/or pediatric patients regarding the manufacturing, preclinical, and clinical trial design issues for all phases of the clinical development program. Such information is intended to assist sponsors in designing clinical development programs for such products, where there may be limited study population size and potential feasibility and safety issues as well as issues relating to the interpretability of bioactivity/efficacy outcomes that may be unique to rare diseases or to the nature of the GT product itself. The guidance announced in this notice finalizes the draft guidance of the same title dated July 2018.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Human Gene Therapy for Hemophilia; Guidance for Industry.'' The guidance document provides recommendations to stakeholders developing human gene therapy (GT) products for the treatment of hemophilia. The guidance provides recommendations on the clinical trial design and related development of coagulation factor VIII (hemophilia A) and IX (hemophilia B) activity assays, including how to address discrepancies in factor VIII and factor IX activity assays. The guidance also includes recommendations regarding preclinical considerations to support development of GT products for the treatment of hemophilia. The guidance announced in this notice finalizes the draft guidance of the same title dated July 2018.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry.'' The guidance provides sponsors of retroviral vector-based human gene therapy products recommendations regarding the testing for replication competent retrovirus (RCR) during the manufacture of retroviral vector-based gene therapy products, and during follow-up monitoring of patients who have received retroviral vector-based gene therapy products. Recommendations include the identification and amount of material to be tested, and general testing methods. In addition, recommendations are provided on monitoring patients for evidence of retroviral infection after administration of retroviral vector-based gene therapy products. The guidance supersedes the document entitled ``Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors,'' dated November 2006. The guidance announced in this notice finalizes the draft guidance of the same title dated July 2018.

The National Science Foundation (NSF) is announcing plans to establish this collection. In accordance with the requirements of the Paperwork Reduction Act of 1995, we are providing opportunity for public comment on this action. After obtaining and considering public comment, NSF will prepare the submission requesting Office of Management and Budget (OMB) clearance of this collection for no longer than 3 years.

The Department of Commerce (Commerce) preliminarily determines that Pidilite Industries Limited (Pidilite), a producer/exporter of carbazole violet pigment 23 (CVP 23) from India, did not sell subject merchandise at prices below normal value (NV) during the period of review (POR) December 1, 2017 through November 30, 2018.