October 23, 2013 – Federal Register Recent Federal Regulation Documents

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.

This rule temporarily exempts yellow fleshed and white skin (white types) potatoes from minimum quality, maturity, pack, marking, and inspection requirements under the Washington potato marketing order through June 30, 2014. The marketing order regulates the handling of Irish potatoes grown in Washington and is administered locally by the State of Washington Potato Committee (Committee). During the temporary exemption period, reports will be required from handlers of yellow fleshed and white types of potatoes to obtain information necessary to administer the marketing order. This rule is expected to reduce overall industry expenses and increase net returns to producers and handlers while giving the industry the opportunity to explore alternative marketing strategies.

This Notice implements Title II of the Notification and Federal Employee Antidiscrimination and Retaliation Act of 2002 (No FEAR Act of 2002). It is the annual obligation for Federal agencies to notify all employees, former employees, and applicants for Federal employment of the rights and protections available to them under the Federal Anti-discrimination and Whistleblower Protection Laws.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry 188 entitled ``Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine.'' The purpose of this guidance is to assist sponsors or non-applicants with filling out Form FDA 1932, ``Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report,'' in both paper and electronic format, as required by FDA regulations.

The Board of the First Responder Network Authority (FirstNet) will hold a Special Meeting via telephone conference (teleconference) on October 25, 2013.

In accordance with the Federal Land Policy and Management Act of 1976 and the Federal Advisory Committee Act of 1972, the U.S. Department of the Interior, Bureau of Land Management (BLM) Wyoming Resource Advisory Council (RAC) will meet as indicated below.

We propose to adopt a new airworthiness directive (AD) for certain The Boeing Company Model 777F series airplanes. This proposed AD was prompted by a report of a fire that originated near the first officer's seat and caused extensive damage to the flight deck. This proposed AD would require replacing the low-pressure oxygen hoses with non-conductive low-pressure oxygen hoses in the stowage box and supernumerary ceiling area. We are proposing this AD to prevent electrical current from passing through an internal, anti-collapse spring of the low-pressure oxygen hose, which can cause the low- pressure oxygen hose to melt or burn and lead to an oxygen-fed fire on the flight deck.

The Environmental Protection Agency has submitted an information collection request (ICR), National Volatile Organic Compound Emission Standards for Automobile Refinish Coatings (EPA ICR No. 1765.07, OMB Control No. 2060-0353), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This is a proposed extension of the ICR, which is currently approved through October 31, 2013. Public comments were previously requested via the Federal Register (78 FR 31921) on May 28, 2013 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

The Environmental Protection Agency has submitted an information collection request (ICR), Mobile Air Conditioner Retrofitting Program (EPA ICR No. 1774.06, OMB Control No. 2060-0450), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This is a proposed extension of the ICR, which is currently approved through October 31, 2013. Public comments were previously requested via the Federal Register (78 FR 37220) on June 20, 2013 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

On Thursday, September 12, 2013 (78 FR 56219-56220), the Department of Defense published a notice announcing an October 1, 2013 meeting of the National Commission on the Structure of the Air Force in Bossier City, Louisiana. On Thursday, September 26, 2013 (78 FR 59343- 59344), the Department of Defense published a notice announcing an October 4, 2013 meeting of the National Commission on the Structure of the Air Force in Colorado Springs, Colorado. On October 3, 2013 (78 FR 61342-61343), the Department of Defense published a notice announcing an October 9, 2013 meeting of the National Commission on the Structure of the Air Force in Chicopee, Massachusetts. Under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), and the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), this notice announces that the National Commission on the Structure of the Air Force meetings scheduled for Tuesday, October 1, Friday, October 4, 2013 and Wednesday, October 9, 2013 were cancelled due to the government shutdown.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Elemental Impurities.'' Prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), this guidance is intended to develop a harmonized approach for the control of elemental impurities that helps industry avoid the uncertainty and duplication of work resulting from differing requirements across ICH regions. It includes the specific elements to be limited and the appropriate limits for impurities, and emphasizes control of supply chains and risk assessments. It is expected to provide appropriate safety-based limits for the control of elemental impurities, consistent expectations for test requirements and regulatory filings, and a global policy for limiting elemental impurities, both qualitatively and quantitatively, in drug products and ingredients.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 14: Bacterial Endotoxins Test General Chapter.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Bacterial Endotoxins Test General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. The guidance is in the form of an annex to the core guidance on the Q4B process entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions (core ICH Q4B guidance).

The Food and Drug Administration (FDA) is correcting a document that appeared in the Federal Register of September 23, 2013 (78 FR 58313). The document announced a public meeting entitled ``Fibromyalgia Public Meeting on Patient-Focused Drug Development'' and opportunity for public comment. The document published with an incorrect date for submission of electronic and written comments. This document corrects that error.

The Food and Drug Administration (FDA) has determined that Potassium Citrate, 10 milliequivalents/packet (mEq/packet) and 20 mEq/ packet, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for Potassium Citrate, 10 mEq/packet and 20 mEq/packet, if all other legal and regulatory requirements are met.