December 2011 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is extending the comment period for the notice that appeared in the Federal Register of Thursday, November, 10, 2011 (76 FR 70151). In the notice, FDA requested comments on the draft guidance that has been developed to promote the initiation of clinical investigations to evaluate the medical devices under FDA's Investigational Device Exemptions (IDE) regulations. The Agency is taking this action to allow interested persons additional time to submit comments.

In accordance with relevant provisions of the Harmonized Tariff Schedule of the United States (HTS), the Office of the United States Trade Representative (USTR) is providing notice of its determination of the trade surplus in certain sugar and syrup goods and sugar-containing products of Chile, Morocco, Costa Rica, the Dominican Republic, El Salvador, Guatemala, Honduras, Nicaragua, and Peru. As described below, the level of a country's trade surplus in these goods relates to the quantity of sugar and syrup goods and sugar-containing products for which the United States grants preferential tariff treatment under (i) the United StatesChile Free Trade Agreement (Chile FTA), in the case of Chile; (ii) the United StatesMorocco Free Trade Agreement (Morocco FTA), in the case of Morocco; (iii) the Dominican RepublicCentral AmericaUnited States Free Trade Agreement (CAFTA-DR), in the case of Costa Rica, the Dominican Republic, El Salvador, Guatemala, Honduras, and Nicaragua, and (iv) the United StatesPeru Trade Promotion Agreement (Peru TPA), in the case of Peru.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of a worldwide exclusive evaluation option license, to practice the inventions embodied in U.S. Provisional Patent Application No. 60/ 176,373, filed January 14, 2000 and currently abandoned [HHS Ref. No. E-176-1999/0-US-01]; PCT Application PCT/US01/00981, filed January 12, 2001 and currently expired [HHS Ref. No. E-176-1999/0-PCT-02]; U.S. Patent Application No. 10/169,975, filed July 12, 2002 and issued as U.S. Patent No. 7,087,589 on August 8, 2006 [HHS Ref. No. E-176-1999/0- US-06]; U.S. Patent Application No. 11/500,860, filed August 8, 2006 and issued as U.S. Patent No. 7,790,735 on September 14, 2006 [HHS Ref. No. E-176-1999/0-US-07]; Australian Patent Application No. 2001230913, filed January 12, 2001 and issued as Australian Patent No. 2001230913 on October 13, 2005 [HHS Ref. No. E-176-1999/0-AU-03]; Canadian Patent Application No. 2,397,366, filed January 12, 2001 and issued as Canadian Patent No. 2,397,366 on March 15, 2011 [HHS Ref. No. E-176- 1999/0-CA-04]; European Patent Application No. 01903043.6, filed January 12, 2001 and issued as European Patent No. 1252160 on August 6, 2006 and currently abandoned [HHS Ref. No. E-176-1999/0-EP-05]; and UK Patent Application No. 01903043.6, filed January 12, 2001 and issued as UK Patent No. 1252160 on August 16, 2006 [HHS Ref. No. E-176-1999/0-GB- 08], entitled ``Methanocarba Cycloalkyl Nucleoside Analogues'' to Cornovus Pharmaceuticals, Inc., a company incorporated under the laws of the State of Delaware having its headquarters in Farmington, Connecticut. The United States of America is the assignee of the rights of the above inventions. The prospective exclusive evaluation option license territory may be ``worldwide'', and the field of use may be limited to ``The use of (1'S,2R,3S,4'R,5'S)-4- (6-amino-2-chloro-9H-purin-9-yl)-1-[phosphoryloxymethyl] bicycle[3.1.0]hexane-2,3-diol) (MRS2339) to treat and/or prevent cardiac diseases in humans.'' Upon the expiration or termination of the exclusive evaluation option license, Cornovus Pharmaceuticals, Inc. will have the right to execute an exclusive patent commercialization license which will supersede and replace the exclusive evaluation option license with no greater field of use and territory than granted in the evaluation license.

In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.), this document announces that an Information Collection Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval. This is a request to renew an existing approved collection. The ICR which is abstracted below describes the nature of the collection and the estimated burden and cost.

In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.), this document announces that an Information Collection Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval. This is a request to renew an existing approved collection. The ICR, which is abstracted, below describes the nature of the collection and the estimated burden and cost.

In compliance with the Paperwork Reduction Act (PRA)(44 U.S.C. 3501 et seq.), this document announces that an Information Collection Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval. This is a request to renew an existing approved collection. The ICR, which is abstracted below, describes the nature of the information collection and its estimated burden and cost.

In compliance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), this document announces that an Information Collection Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval. This is a request to renew an existing approved collection. The ICR, which is abstracted below, describes the nature of the information collection and its estimated burden and cost.

The National Archives and Records Administration (NARA) publishes notice at least once monthly of certain Federal agency requests for records disposition authority (records schedules). Once approved by NARA, records schedules provide mandatory instructions on what happens to records when no longer needed for current Government business. They authorize the preservation of records of continuing value in the National Archives of the United States and the destruction, after a specified period, of records lacking administrative, legal, research, or other value. Notice is published for records schedules in which agencies propose to destroy records not previously authorized for disposal or reduce the retention period of records already authorized for disposal. NARA invites public comments on such records schedules, as required by 44 U.S.C. 3303a(a).

The proposed information collection requirement described below will be submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal.

This Notice applies to investors interested in investment opportunities in rural infrastructure; these potential investors are encouraged to contact the Department of Agriculture (USDA). The Rural Development Act of 1972 established USDA's authority to make loans and grants to rural communities. Currently, USDA manages a loan portfolio of approximately $150 billion, of which $5.3 billion is for community facilities. USDA seeks to partner with investors willing to create and implement investment structures that would improve rural communities' access to capital by expanding the leveraging of USDA's community facilities loan funds. Given current turbulent market conditions, these investments may be particularly attractive to the private sector as they have historically provided low-risk, steady cash flows. USDA is open to considering a variety of different investment structures.

This rule is submitted as an interim final rule (IFR) in order to meet the Congressional requirement set forth in the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2011, Section 724, which required the Department of Defense to prescribe regulations by June 20, 2011, to establish the criteria, as had previously been studied in accordance with Section 717 of the NDAA 2008, that would allow licensed or certified mental health counselors to be able to independently provide care to TRICARE beneficiaries and receive payment for those services. Under current TRICARE requirements, mental health counselors (MHCs) are authorized to practice only with physician referral and supervision. This interim final rule establishes a transition period to phase out the requirement for physician referral and supervision for MHCs and to create a new category of allied health professionals, to be known as certified mental health counselors (CMHCs), who will be authorized to practice independently under TRICARE. During this transition period the MHCs who do not meet the requirements for independent practice as established in this rule, may continue to provide services to TRICARE beneficiaries under the requirements of physician referral and ongoing supervision. This transition period, ending December 31, 2014, will allow time for those MHCs who seek to continue providing services under the TRICARE program to meet the independent practice requirements as outlined in this notice. After December 31, 2014, the Department of Defense will no longer recognize those mental health counselors who do not meet the criteria for a CMHC and will no longer allow them to provide services even upon the referral and supervision of a physician.

This part implements policy established in DoD Instruction 5200.01. It assigns responsibilities and provides procedures for members of the public to request a declassification review of information classified under the provisions of Executive Order 13526, or predecessor orders.

This notice contains a summary of a petition seeking relief from specified requirements of title 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 FAA assigned the Aviation Rulemaking Advisory Committee (ARAC) a new task to develop a comprehensive program of voluntary accreditation for commercial air tour operators that are not required under parts 91 and 135 of Title 14 of the Code of Federal Regulations (14 CFR) to maintain their aircraft under a continuous airworthiness maintenance program (CAMP). This task addresses, in part, the ARAC recommendation developed by the Commercial Air Tours Maintenance (CATM) Working Group, which the FAA accepted on February 1, 2011. This notice informs the public of a new ARAC activity and solicits membership for the new Commercial Air Tour Voluntary Accreditation Program Working Group.

The Bureau of Land Management (BLM) announces the availability of the Record of Decision (ROD) for the project, located in San Diego County. The Secretary of the Interior approved the ROD on December 19, 2011, which constitutes the Department's final decision.

This document announces the availability of an FAA Notice that would require FAA inspectors to review 14 CFR part 135 approved training programs to identify and correct those programs which erroneously issued credit for previous training or checking. The document also provides guidance on constructing reduced hour training programs based on previous experience. Upon review of the comments and any necessary revision, this document would cancel and replace FAA Order 8900.1, Volume 3, Chapter 19, Paragraph 3-1111.