June 8, 2016 – Federal Register Recent Federal Regulation Documents

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Meredyth M. Forbes, Albert Einstein College of Medicine: Based on an assessment conducted by the Albert Einstein College of Medicine (AECM), an admission from the Respondent, and additional analysis conducted by ORI in its oversight review, ORI found that Ms. Meredyth M. Forbes, former Graduate Student, AECM, engaged in research misconduct in research supported by National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), grants R01 GM089979, T32 GM007491, R01 GM55101, and R01 GM88202 and National Institute of Child Health and Human Development (NICHD), NIH, grant T32 HD007502. ORI found that Respondent engaged in research misconduct by intentionally falsifying and/or fabricating data reported in the following three (3) published papers and four (4) meeting presentations:

The Department of the Treasury, 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 a continuing information collection, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently the Bureau of the Fiscal Service within the Department of the Treasury is soliciting comments concerning the Electronic Funds Transfer (EFT) Market Research Study.

The Agricultural Marketing Service (AMS) published a proposed rule in the Federal Register on April 13, 2016 (71 FR 21956) on Organic Livestock and Poultry Practices. This document extends the comment period for the proposed rule for 30 days from June 13, 2016 to July 13, 2016. Multiple stakeholders requested that AMS extend the comment period due to the complexity and importance of the proposal. AMS is granting an extension.

The Department of Commerce (the ``Department'') preliminarily determines that certain iron mechanical transfer drive components (``iron transfer drive components'') from Canada are being, or are likely to be, sold in the United States at less than fair value (``LTFV''), as provided in section 733(b) of the Tariff Act of 1930, as amended (the ``Act''). The period of investigation is October 1, 2014 through September 30, 2015. The estimated dumping margins of sales at LTFV are listed in the ``Preliminary Determination'' section of this notice. Interested parties are invited to comment on this preliminary determination.

This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in: Intellectual Property: U.S. Provisional Patent Application 61/477,020 entitled ``Human Monoclonal Antibody Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011/0-US-01], PCT Patent Application PCT/US2012/034186 entitled ``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011/0-PCT-02], Chinese Patent Application 201280029201.3 entitled ``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011/0-CN-03], European Patent 2699603 entitled ``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011/0-EP-04], and validated in France, Germany and the United Kingdom, United States Patent 9,206,257 entitled ``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011/0-US-05], United States Patent Application 14/837,903 entitled ``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011/0-US-06], European Patent Application 15188264.4 entitled ``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011/0-EP-07], United States Patent Application 15/090,873 entitled ``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130- 2011/0-US-12], Chinese Patent Application 201610290837.3 entitled ``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011/0-CN-13], European Patent Application 16166924.7 entitled ``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011/0-EP-14], and all continuing U.S. and foreign patents/patent applications for the technology family, to Lentigen Technology, Inc. The patent rights to these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America. The prospective exclusive licensed territory may be the United States, Australia, Canada, the European Union, Russia, China, Hong Kong, Japan, Taiwan, South Korea and Singapore, and the field of use may be limited to: ``The development of a glypican-3 (GPC3) chimeric antigen receptor (CAR)-based immunotherapy using autologous (meaning one individual is both the donor and the recipient) primary human lymphocytes (T cells or NK cells) transfected with a lentiviral or retroviral vector, wherein the vector expresses a CAR having (1) a single antigen specificity and (2) comprising at least: (a) The complementary determining region (CDR) sequences of the anti-GPC3 antibody known as HN3; and (b) a T cell signaling domain; for the prophylaxis and treatment of GPC3-expressing cancers.''

The Department of Commerce (Department) preliminarily determines that circular welded carbon-quality steel pipe (CWP) from the United Arab Emirates (UAE) is being, or is likely to be, sold in the United States at less than fair value (LTFV), as provided in section 733(b) of the Tariff Act of 1930, as amended (the Act). The period of investigation (POI) is October 1, 2014, through September 30, 2015. The estimated weighted-average dumping margins of sales at LTFV are shown in the ``Preliminary Determination'' section of this notice. Interested parties are invited to comment on this preliminary determination.

The Food and Drug Administration (FDA) has determined the regulatory review period for ALPROLIX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claim that human biological product.

The Department of Defense is publishing this notice to announce the following Federal advisory committee meeting of the Defense Advisory Committee on Military Personnel Testing.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the estimated reporting, recordkeeping, and third-party disclosure burden associated with the Mammography Quality Standards Act requirements.

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.

The Food and Drug Administration (FDA) is withdrawing approval of five new animal drug applications (NADAs) and an abbreviated new animal drug application (ANADA). This action is being taken at the sponsors' request because these products are no longer manufactured or marketed.

The Coast Guard published a notice in the Federal Register on June 2, 2016, announcing a Towing Safety Advisory Committee meeting, via teleconference. That notice listed the wrong day of the week for the date of the meeting. The notice should have stated, Wednesday, June 22, 2016. This notice removes the incorrect day-of-the-week reference.

Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a briefing meeting of the New Mexico Advisory Committee to the Commission will convene at 10:00 a.m. (MDT) on Friday, June 24, 2016, at the Main Library, 501 Copper Avenue NW., Albuquerque, NM 87102. The purpose of the briefing meeting is to explore the topic of Elder Abuse. The Briefing topics will include elder care services, non or limited access to care that may be impacted by finances, legal services, and structure of services. The New Mexico Advisory Committee will hear from individuals, advocacy groups, community organizations, and representatives of local, state, and Federal agencies. A planning meeting will convene at 6:00 p.m. (MDT) on Thursday, June 23, 2016, at a location that is TBD. The purpose of the planning meeting is for the committee to review the agenda and procedures of the next day briefing meeting. . If other persons who plan to attend the meeting require other accommodations, please contact Evelyn Bohor at ebohor@usccr.gov at the Rocky Mountain Regional Office at least ten (10) working days before the scheduled date of the meeting. Time will be set aside at the end of the briefing so that members of the public may address the Committee after the formal presentations have been completed. Persons interested in the issue are also invited to submit written comments; the comments must be received in the regional office by Monday, July 24. Written comments may be mailed to the Rocky Mountain Regional Office, U.S. Commission on Civil Rights, 1961 Stout Street, Suite 13-201, Denver, CO 80294, faxed to (303) 866- 1050, or emailed to Evelyn Bohor at ebohor@usccr.gov. Persons who desire additional information may contact the Rocky Mountain Regional Office at (303) 866-1040. Records and documents discussed during the meeting will be available for public viewing as they become available at https:// database.faca.gov/committee/meetings.aspx?cid=264 and clicking on the ``Meeting Details'' and ``Documents'' links. Records generated from this meeting may also be inspected and reproduced at the Rocky Mountain Regional Office, as they become available, both before and after the meeting. Persons interested in the work of this advisory committee are advised to go to the Commission's Web site, www.usccr.gov, or to contact the Rocky Mountain Regional Office at the above phone number, email or street address.

Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Missouri Advisory Committee (Committee) will hold a meeting on Tuesday, June 28, 2016, at 1:00 p.m. CDT for the purpose of discussing approval of a report to the Commission regarding civil rights and police/community interactions in Missouri. Members of the public can listen to the discussion. This meeting is available to the public through the following toll-free call-in number: 888-539-3612, conference ID: 2570459. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur regular charges for calls they initiate over wireless lines according to their wireless plan, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977- 8339 and providing the Service with the conference call number and conference ID number. Members of the public may comment in advance of the meeting, or at the designated public comment period during the meeting. Written comments may be mailed to the Midwestern Regional Office, U.S. Commission on Civil Rights, 55 W. Monroe St., Suite 410, Chicago, IL 60615. They may also be faxed to the Commission at (312) 353-8324, or emailed to Corrine Sanders at csanders@usccr.gov. Persons who desire additional information may contact the Midwestern Regional Office at (312) 353-8311. Records generated from this meeting may be inspected and reproduced at the Midwestern Regional Office, as they become available, both before and after the meeting. Records of the meeting will be available at https://database.faca.gov/committee/meetings.aspx?cid=258. Click on ``meeting details'' and ``documents'' to download. Persons interested in the work of this Committee are directed to the Commission's Web site, https://www.usccr.gov, or may contact the Midwestern Regional Office at the above email or street address.

Petitions for Reconsideration (Petitions) have been filed in the Commission's Rulemaking proceeding by James Arden Barnett, Jr., Esq., on behalf of Global Automakers, Inc., Ari Q. Fitzgerald, on behalf of Alliance of Automobile Manufacturers, and Stephen E. Coran, on behalf of The Wireless Internet Service Providers Association.