June 17, 2016 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) has determined the regulatory review period for ORBACTIV and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.

This temporary rule implements possession limits and permit requirements for the commercial and recreational blueline tilefish fisheries in waters north of the Virginia/North Carolina border. These interim management measures are necessary to prevent a return to an unregulated fishery which could result in overfishing and to temporarily constrain fishing effort on the blueline tilefish stock while a long-term management plan is implemented. These measures are expected to constrain fishing mortality and help ensure the long-term sustainability of the stock, while potentially preventing overfishing.

This notice is issued in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i). NASA hereby gives notice of its intent to grant an exclusive, research only license in the United States to evaluate the invention described and claimed in U.S. Patent Application No. 15/ 055,247; NASA Case No. KSC-13907 entitled ``Controlled Release Materials for Anti-Corrosion Agents,'' to SynMatter, LLC, having its principal place of business at 16914 Deer Oak Lane, Orlando, Florida 32828. The patent rights in these inventions have been assigned to the United States of America as represented by the Administrator of the National Aeronautics and Space Administration. The prospective exclusive, research only license will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7.

A Request for Panel Review was filed on behalf of Selenis Canada, Inc. with the United States Section of the North American Free Trade Agreement (NAFTA) Secretariat on June 6, 2016 pursuant to NAFTA Article 1904. Panel Review was requested of the International Trade Commission's final determination regarding Polyethylene Terephthalate Resin from Canada. The final injury determination was published in the Federal Register on May 4, 2016 (81 FRN 26832) and the effective antidumping order was published in the Federal Register on May 6, 2016 (81 FRN 27929). The NAFTA Secretariat has assigned case number USA-CDA- 2016-1904-01 to this request.

Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on April 11, 2016, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of Daimler AG of Stuttgart, Germany. Supplements to the Complaint were filed on April 28, 2016 and April 29, 2016. On May 2, 2016, the Commission voted on Complainant's request to postpone the determination on whether to institute an investigation based on the Complaint, which was approved by the Commission. See EDIS Doc. ID 580171 (May 3, 2016). Complainant further supplemented the Complaint on May 18, 2016. The complaint as supplemented alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain passenger vehicle automotive wheels by reason of infringement of U.S. Design Patent No. D542,211 (``the '211 patent''); U.S. Design Patent No. D582,330 (``the '330 patent''); U.S. Design Patent No. D656,078 (``the '078 patent''); U.S. Design Patent No. D569,776 (``the '776 patent''); U.S. Design Patent No. D602,834 (``the '834 patent''); U.S. Design Patent No. D582,328 (``the '328 patent''); U.S. Design Patent No. D542,726 (``the '726 patent''); U.S. Design Patent No. D604,221 (``the '221 patent''); U.S. Design Patent No. D570,760 (``the '760 patent''); U.S. Design Patent No. D544,823 (``the '823 patent''); U.S. Design Patent No. D486,437 (``the '437 patent''); U.S. Design Patent No. D562,207 (``the '207 patent''); U.S. Design Patent No. D635,904 (``the '904 patent''); U.S. Design Patent No. D618,150 (``the '150 patent''); U.S. Design Patent No. D585,802 (``the '802 patent''); U.S. Design Patent No. D532,733 (``the '733 patent''); U.S. Design Patent No. D572,646 (``the '646 patent''); U.S. Design Patent No. D578,949 (``the '949 patent''); U.S. Design Patent No. D638,772 (``the '772 patent''); U.S. Design Patent No. D522,946 (``the '946 patent''); U.S. Design Patent No. D638,766 (``the '766 patent''); and U.S. Design Patent No. D610,516 (``the '516 patent''); and U.S. Trademark Registration No. 3,614,891 (``the '891 mark''); U.S. Trademark Registration No. 4,423,458 (``the '458 mark''); U.S. Trademark Registration No. 3,305,055 (``the '055 mark''); U.S. Trademark Registration No. 1,807,353 (``the '353 mark''); U.S. Trademark Registration No. 1,660,727 (``the '727 mark''); U.S. Trademark Registration No. 657,386 (``the '386 mark''); U.S. Trademark Registration No. 285,557 (``the '557 mark''); U.S. Trademark Registration No. 4,076,271 (``the '271 mark''); U.S. Trademark Registration No. 3,224,584 (``the '584 mark''); U.S. Trademark Registration No. 3,309,265 (``the '265 mark''); U.S. Trademark Registration No. 2,876,643 (``the '643 mark''); U.S. Trademark Registration No. 2,909,827 (``the '827 mark''); U.S. Trademark Registration No. 2,654,240 (``the '240 mark''); U.S. Trademark Registration No. 2,712,292 (``the '292 mark''); U.S. Trademark Registration No. 2,028,111 (``the '111 mark''); U.S. Trademark Registration No. 2,699,216 (``the '216 mark''); U.S. Trademark Registration No. 2,716,842 (``the '842 mark''); U.S. Trademark Registration No. 2,599,862 (``the '862 mark''); U.S. Trademark Registration No. 2,028,107 (``the '107 mark''); U.S. Trademark Registration No. 4,669,601 (``the '601 mark''); U.S. Trademark Registration No. 3,103,610 (``the '610 mark''); U.S. Trademark Registration No. 2,028,112 (``the '112 mark''); U.S. Trademark Registration No. 3,100,860 (``the '860 mark''); U.S. Trademark Registration No. 2,026,254 (``the '254 mark''); U.S. Trademark Registration No. 2,815,926 (``the '926 mark''); U.S. Trademark Registration No. 3,221,423 (``the '423 mark''); U.S. Trademark Registration No. 2,227,526 (``the '526 mark''); U.S. Trademark Registration No. 3,019,109 (``the '109 mark''); U.S. Trademark Registration No. 2,837,833 (``the '833 mark''); and U.S. Trademark Registration No. 2,529,332 (``the '332 mark''). The complaint further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337. The complainant requests that the Commission institute an investigation and, after the investigation, issue a general exclusion order, or in the alternative a limited exclusion order, and cease and desist orders.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) The quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Annalisa Gnoleba, Public Health Analyst, Cancer Prevention Fellowship Program, 9609 Medical Center Drive, Room 2E-108 Bethesda, Maryland 20892-9776 or call non-toll-free number (240)-276-7146 or Email your request, including your address to: gnolebaad@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing.

The Agricultural Marketing Service (AMS) of the Department of Agriculture (USDA) proposes to revise 18 U.S. grade standards for canned vegetables issued on or before August 3, 1998. AMS is proposing to replace the two-term grading system (dual nomenclature) with a single term to describe each quality level for the grade standards identified in this notice. Terms using the letter grade would be retained and the descriptive term would be eliminated. For example, grade standards using the term ``U.S. Grade A'' or ``U.S. Fancy'' would be revised to use the term ``U.S. Grade A.'' Likewise, grade standards using the term ``U.S. Grade B'' or ``U.S. Extra Standard'' would be revised to use the single term ``U.S. Grade B.'' These changes would bring the grade standards in line with the present quality levels being marketed today and provide guidance in the effective use of these products. Editorial changes would also be made to the grade standards that conform to recent changes made in other grade standards.

HHS gives notice of a decision to designate a class of employees from the Argonne National Laboratory-West site in Scoville, Idaho, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.

HHS gives notice of a decision to designate a class of employees from the Lawrence Livermore National Laboratory site in Livermore, California, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.

We are revising an earlier proposed airworthiness directive (AD) for certain Dassault Aviation Model MYSTERE-FALCON 50, MYSTERE- FALCON 900, FALCON 900EX, FALCON 2000, and FALCON 2000EX airplanes. The NPRM proposed to require modification of the anti-collision light bonding. The NPRM was prompted by a report of an in-flight lightning strike to the WHELEN anti-collision light located on the top of the vertical fin tip that caused severe damage and resulted in the loss of some airplane functions. This action revises the NPRM by clarifying the applicability. We are proposing this supplemental NPRM (SNPRM) to prevent loss of electrical power and essential airplane functions, and possible reduced control of the airplane. Since these actions impose an additional burden over those proposed in the NPRM, we are reopening the comment period to allow the public the chance to comment on these proposed changes.

The Employment and Training Administration (ETA), U.S. Department of Labor (DOL), announces the availability of approximately $100 million in grant funds authorized under the American Competitiveness and Workforce Improvement Act of 1998 (ACWIA), as amended (codified at 29 U.S.C. 3224a) for America's Promise Job-driven Grant Program. Under this Funding Opportunity Announcement (FOA), DOL will award grants through a competitive process to organizations to create or expand regional partnerships between employers, economic development, workforce development, community colleges, training programs, K-12 education systems, and community-based organizations that make a commitment to provide a pipeline of workers to fill existing job openings. DOL expects to fund approximately 20-40 grants, with individual grant amounts ranging from $1 million to $6 million. The grant period for performance for this FOA is 48 months, including all necessary implementation and start-up activities. The complete FOA and any subsequent FOA amendments in connection with this funding opportunity are described in further detail on ETA's Web site at https://www.doleta.gov/grants/find_grants.cfm or on https:// www.grants.gov/. The Web sites provide application information, eligibility requirements, review and selection procedures, and other program requirements governing this funding opportunity.

The Environmental Protection Agency (EPA) is approving two SIP revisions submitted by the State of Iowa. First, EPA is approving the definition of greenhouse gas, which will make the state's definition consistent with the Federal definition, and add greenhouse gases to emission inventory requirements. Second, EPA is approving Iowa's revision to its Prevention of Significant Deterioration (PSD) program, specifically to the definition of ``subject to regulation,'' and to adopt by reference the most recent Federal plantwide applicability limitations (PALs) provisions.