March 5, 2014 – Federal Register Recent Federal Regulation Documents

This notice announces an open meeting of the Hydrogen and Fuel Cell Technical Advisory Committee (HTAC). The Federal Advisory Committee Act, Pub. L. No. 92-463, 86 Stat. 770, requires notice of the meeting be announced in the Federal Register.

This regulation establishes tolerances for indirect or inadvertent residues of fluopicolide in or on corn, field, forage; corn, field, grain; corn, field, stover. Valent U.S.A. Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

We, the U.S. Fish and Wildlife Service (Service), advise the public that we intend to prepare a draft Environmental Assessment (EA) to evaluate the impacts of, and alternatives to, the proposed issuance of an incidental take permit to the Barton Springs/Edwards Aquifer Conservation District (District). The permit, issued under the Endangered Species Act, as amended (Act), would allow for potential take of two federally listed species associated with the ongoing management and withdrawal of groundwater from the Barton Springs segment of the Edwards Aquifer (Aquifer) in Central Texas.

FMCSA announces its decision to exempt 65 individuals from its rule prohibiting persons with insulin-treated diabetes mellitus (ITDM) from operating commercial motor vehicles (CMVs) in interstate commerce. The exemptions will enable these individuals to operate CMVs in interstate commerce.

The U.S. Department of the Treasury 's Office of Foreign Assets Control (``OFAC'') is publishing the names of seven individuals and ten entities whose property and interests in property have been blocked pursuant to the Foreign Narcotics Kingpin Designation Act (``Kingpin Act'') (21 U.S.C. 1901-1908, 8 U.S.C. 1182).

The United States Patent and Trademark Office (USPTO), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on the continuing information collection, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)).

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients With Disorders Affecting the Hematopoietic System'' dated March 2014. The guidance document provides advice to potential sponsors, such as cord blood banks, registries, transplant centers, or individual physicians serving as sponsor-investigators, to assist in the submission of an investigational new drug application (IND) for certain hematopoietic progenitor cells from placental/umbilical cord blood (HPC, Cord Blood), when such HPC, Cord Blood units are not licensed, and when a suitable human leukocyte antigen (HLA) matched cord blood transplant is needed for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment and there is no satisfactory alternative treatment available. If unlicensed HPC, Cord Blood units are made available for clinical use, they must be distributed under an IND. The guidance announced in this document finalizes the draft guidance of the same title dated June 2013 and supersedes the final guidance entitled ``Guidance for Industry and FDA Staff: Investigational New Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications'' dated June 2011.

The Food and Drug Administration (FDA) is announcing that the Center for Biologics Evaluation and Research (CBER) will be moving its offices and laboratories from various Rockville and Bethesda, MD, locations to the FDA White Oak campus in Silver Spring, MD. The move will commence on or about May 1, 2014, and will end approximately 8 weeks later, on or about July 1, 2014. During this time persons may continue to send applications and other submissions electronically via the FDA Electronic Submissions Gateway to CBER for review, evaluation, or other handling. However, persons should send submissions on paper or on electronic media (CD, DVD), as well as lot release samples to CBER's new mailing addresses once they take effect. CBER's new mailing addresses, including the dates they take effect, as well as other information concerning CBER's move to the FDA White Oak campus in Silver Spring, MD, will be provided on the FDA Web site at https:// www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsan dTobacco/ CBER/ucm385240.htm, as they become available. During the period required for relocation of files, equipment, and Agency personnel, CBER will make every effort to meet its review time frames and minimize any potential delay. Should delays affecting receipt and review of applications and other submissions occur, we intend to update the FDA Web site as needed.

The Leahy-Smith America Invents Act includes provisions for prioritized examination of patent applications (also referred to as ``Track I''), which have been implemented by the United States Patent and Trademark Office (Office) in previous rulemakings. This interim rule simplifies the Track I prioritized examination practice to reduce the number of requests for prioritized examination that must be dismissed. In order to enable rapid processing and examination of those applications, the previous rulemakings provided that an application having a request for Track I prioritized examination requires, upon filing of the application, an inventor's oath or declaration and all required fees, and contains no more than four independent claims, thirty total claims, and no multiple dependent claims. Accordingly, any request for Track I prioritized examination not meeting all of the requirements on filing must be dismissed. The Office has found that many such dismissals are due to the application as filed not including a properly executed inventor's oath or declaration, not including the excess claims fees or application size fee due, or improperly including a multiple dependent claim or claims in excess of the permitted number. The Office has determined that the time periods for meeting those requirements when filing a request for Track I prioritized examination could be expanded while maintaining the Office's ability to timely examine the patent application.

This notice contains a summary of a petition seeking relief from specified requirements of 14 CFR. The purpose of this notice is to improve the public's awareness of, and participation in, this aspect of 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.

The Food and Drug Administration (FDA or we) is reopening the comment period for the draft guidance for industry entitled ``Ingredients Declared as Evaporated Cane Juice.'' A notice announcing the availability of the draft guidance was published in the Federal Register of October 7, 2009, to advise industry of FDA's view that the common or usual name for the solid or dried form of sugar cane syrup is ``dried cane syrup,'' and that sweeteners derived from sugar cane syrup should not be declared on food labels as ``evaporated cane juice'' because that term falsely suggests the sweeteners are juice. We have not reached a final decision on the common or usual name for this ingredient and are reopening the comment period to request further comments, data, and information about the basic nature and characterizing properties of the ingredient sometimes declared as ``evaporated cane juice,'' how this ingredient is produced, and how it compares with other sweeteners.

This Notice announces the Department's annual adjustments to the Income Eligibility Guidelines to be used in determining eligibility for free and reduced price meals and free milk for the period from July 1, 2014 through June 30, 2015. These guidelines are used by schools, institutions, and facilities participating in the National School Lunch Program (and Commodity School Program), School Breakfast Program, Special Milk Program for Children, Child and Adult Care Food Program and Summer Food Service Program. The annual adjustments are required by section 9 of the Richard B. Russell National School Lunch Act. The guidelines are intended to direct benefits to those children most in need and are revised annually to account for changes in the Consumer Price Index.

In accordance with the Paperwork Reduction Act of 1995, this notice invites the general public and other public agencies to comment on the proposed collection. This is a revision of a currently approved collection in the Supplemental Nutrition Assistance Program and concerns Retail Store Applications (Forms FNS-252; FNS-252-E; FNS-252- R; FNS-252-2; and FNS-252-C).

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.

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.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR Part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.