July 19, 2013 – Federal Register Recent Federal Regulation Documents
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Publication of Iran General License D
The Department of the Treasury's Office of Foreign Assets Control (``OFAC'') is publishing General License D issued under the Iranian transactions sanctions program on May 30, 2013. General License D authorizes the exportation and reexportation to persons in Iran of certain services, software, and hardware incident to the exchange of personal communications, subject to certain limitations.
Utah Resource Advisory Council Meeting/Conference Call
In accordance with the Federal Land Policy and Management Act and the Federal Advisory Committee Act, the Bureau of Land Management's (BLM) Utah Resource Advisory Council (RAC) will host a meeting/conference call.
Proposed Substances To Be Evaluated for Set 27 Toxicological Profiles
The Agency for Toxic Substances and Disease Registry (ATSDR) within the Department of Health and Human Services (HHS) is initiating the development of its 27th set of toxicological profiles (CERCLA Set 27). This notice announces the list of proposed substances that will be evaluated for Comprehensive Environmental Response Compensation and Liability Act(CERCLA) Set 27 toxicological profile development. ATSDR's Division of Toxicology and Human Health Sciences is soliciting public nominations from the list of proposed substances to be evaluated for toxicological profile development. ATSDR also will consider the nomination of any additional, non-CERCLA substances that may have public health implications, on the basis of ATSDR's authority to prepare toxicological profiles for substances not found at sites on the National Priorities List. The agency will do so in order to ``...establish and maintain inventory of literature, research, and studies on the health effects of toxic substances'' under CERCLA Section 104(i)(1)(B), to respond to requests for consultation under section 104(i)(4), and to support the site-specific response actions conducted by ATSDR, as otherwise necessary.
Agency Information Collection Activities: Submission to OMB for Reinstatement, Without Change, of a Previously Approved Collection; Comment Request
The NCUA intends to submit the following information collection to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. chapter 35). This information collection is published to obtain comments from the public and is required under Section 205 of the Federal Credit Union Act (FCU Act) to allow federally-insured credit unions (FICUs) to purchase assets or assume liabilities of privately- insured credit unions, other financial institutions, or their successor in interest.
Agency Information Collection Activities: Submission to OMB for Reinstatement, Without Change, of a Previously Approved Collection; Comment Request
The NCUA intends to submit the following information collection to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chapter 35). This information collection is published to obtain comments from the public. NCUA is renewing the requirements for Federally Insured Credit Unions to maintain an information security program and an incident response plan that complies with Title V of the Gramm-Leach-Bliley Act, 15 U.S.C. 6801 et seq. The program and response plan are required by Part 748 of the NCUA Rules and Regulations. Appendix B contains guidance on creating an effective incident response plan in the event of unauthorized access to member information and the requirements of the notices distributed to the affected members.
Agency Information Collection Activities; Submission to OMB for Reinstatement, With Change, of a Previously Approved Collection
The NCUA, as part of their continuing effort to reduce paperwork and respondent burden, invite the general public and other Federal agencies to take this opportunity to comment on information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). NCUA is soliciting comments concerning the Suspicious Activity Report (SAR). As Bank Secrecy Act (BSA) administrator, the Financial Crimes Enforcement Network (FinCEN) transitioned from a system originally designed for collecting industry specific paper forms to a modernized information technology environment centered on electronic reporting. Based on financial institution type, depository institutions, broker-dealers in securities, futures commission merchants and introducing brokers in commodities, insurance companies, mutual funds, money services businesses, and casinos currently filed reports on four separate forms. FinCEN's objective is to have one electronically-filed dynamic and interactive BSA-SAR that will be used by all filing institutions to report suspicious activity as of April 1, 2013. There are no proposed changes to the regulatory reporting criteria for information collection. Federally insured credit unions will continue to follow the regulation, interagency guidance, and filing instructions to determine when a report should be filed and what information should be included on the report. The interactive BSA-SAR includes several new data fields and introduces data fields from the SARs of other industries. On March 29, 2012, FinCEN released guidance \1\ titled, ``Filing FinCEN's new Currency Transaction Report and Suspicious Activity Report''. This guidance clarified expectations and notes that FinCEN is making available additional and more specific data elements (i.e., characterizations of suspicious activity and types of financial services) as a more efficient way to bring information about suspicious activity to the attention of FinCEN and law enforcement. The guidance clarified the addition of new and expanded data elements; however, the guidance does not create an expectation that financial institutions will revise internal programs, or develop new programs, to capture information that reflects the expanded lists.
Proposed Collection, Comment Request
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) [44 U.S.C. 3506(c)(2)(A)]. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. The Bureau of Labor Statistics (BLS) is soliciting comments concerning the proposed extension of the ``American Time Use Survey.'' A copy of the proposed information collection request (ICR) can be obtained by contacting the individual listed below in the ADDRESSES section of this notice.
Agency Information Collection Activities: Submission to OMB for Reinstatement, With Change, of a Previously Approved Collection; Comment Request
The NCUA intends to submit the following information collection to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chapter 35). This information collection is published to obtain comments from the public. NCUA has authorized federal credit unions to advance money to members to cover account deficits without having a credit application on file if the credit union has a written overdraft policy. 12 CFR 701.21(c)(3). NCUA has also authorized federally insured credit unions to offer lending-related incentive pay to employees, provided they establish written policies regarding such plans. 12 CFR 701.21(c)(8).
Agency Information Collection Activities: Submission to OMB for Reinstatement, Without Change, of a Previously Approved Collection; Comment Request
The NCUA intends to submit the following information collection to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chapter 35). This information collection is published to obtain comments from the public. Section 741.2 of the NCUA Rules and Regulations (12 CFR part 741) places a maximum borrowing limit on federally insured credit unions. State chartered federally insured credit unions must seek a waiver of the borrowing limit from the NCUA Regional Director prior to exceeding this limitation.
Agency Information Collection Activities: Submission to OMB for Reinstatement, Without Change, of a Previously Approved Collection; Comment Request
The NCUA intends to submit the following information collection to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chapter 35). This information collection relates to 12 CFR part 713 which requires a federal credit union (FCU) to monitor its eligibility to qualify for a higher fidelity coverage deductible and to notify the NCUA if its financial condition changes resulting in the loss of that eligibility for the higher deductible. This information collection notice is published to obtain comments from the public. This requirement enables NCUA to monitor the FCU's financial condition for safety and soundness purposes and helps to assure that FCUs are properly and adequately protected against potential losses due to insider abuse such as fraud and embezzlement.
Agency Information Collection Activities: Submission to OMB for Reinstatement, With Change, of a Previously Approved Collection; Comment Request
The NCUA is submitting the following information collection to the Office of Management and Budget (OMB) for reinstatement under the Paperwork Reduction Act of 1995 (Pub. L. 104-13; 44 U.S.C. Chapter 35). Notice of this information collection is published to obtain comments from the public. Under the Home Mortgage Disclosure Act (HMDA), financial institutions that meet the reporting criteria must compile and make available data about their housing-related lending activity. The data is made available to the public for the purposes of: (i) Helping to determine whether financial institutions are serving the housing needs of their communities; (ii) assisting public officials in distributing public-sector investment so as to attract private investment to areas where it is needed; and (iii) assisting in identifying possible discriminatory lending patterns and enforcing anti-discrimination statutes. The information collection will assist NCUA to ensure credit unions are in compliance with fair lending laws and regulations.
Agency Information Collection Activities: Submission to OMB for Reinstatement, With Change, of a Previously Approved Collection; Comment Request
The NCUA intends to submit the following information collection to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chapter 35). This information collection is published to obtain comments from the public. The collection requires each Federal Credit Union (FCU) to establish reasonable policies and procedures for implementing the guidelines to identify possible risks to account holders or customers or to the safety and soundness of the institution or creditor (Red Flag Regulations). Each FCU is also required to develop an Identity Theft Prevention Program, provide staff training, and report to the board of directors, a committee thereof, or senior management at least annually. In addition, credit and debit card issuers are generally required to assess the validity of change of address requests.
Agency Information Collection Activities: Submission to OMB for Reinstatement, With Change, of a Previously Approved Collection; Comment Request
The NCUA intends to submit the following information collection to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chapter 35). This information collection notice is published to obtain comments from the public. This is related to NCUA's regulation on mergers of federally-insured credit unions and voluntary termination or conversion of insured status.
Agency Information Collection Activities: Submission to OMB for Reinstatement, Without Change, of a Previously Approved Collection; Comment Request
The NCUA intends to submit the following information collection to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chapter 35). This information collection is published to obtain comments from the public. The information collection applies to credit unions that engage in member business lending and requires written loan policies that address the various aspects of the member business loan program. Credit unions desiring a waiver from appraisal requirements, aggregate construction and development loan, loan-to-value ratios, personal liability and guarantee requirements, unsecured lending limits to one borrower, aggregate unsecured lending limits, or outstanding loans to one borrower limits of Part 723 must submit certain information to NCUA for consideration. Finally, a credit union seeking regulatory approval to purchase certain business loans in addition to those, which are statutorily limited, must submit certain information to NCUA for consideration.
Agency Information Collection Activities: Submission to OMB for Reinstatement, With Change, of a Previously Approved Collection; Comment Request
The NCUA intends to submit the following information collection to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chapter 35). The information collection relates to requests for non-public records and for testimony by NCUA employees in legal proceedings. This information collection notice is published to obtain comments from the public.
Agency Information Collection Activities: Submission to OMB for Reinstatement, Without Change, of a Previously Approved Collection; Comment Request
The NCUA intends to submit the following information collection to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. chapter 35). This information collection is published to obtain comments from the public. Section 701.32 of the NCUA Rules and Regulations (12 CFR 701) limits nonmember and public unit deposits in federally insured credit unions to 20 percent of their shares or $3.0 million, whichever is greater.
Agency Information Collection Activities: Submission to OMB for Reinstatement, Without Change, of a Previously Approved Collection; Comment Request
The NCUA intends to submit the following information collection to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. chapter 35). This information collection is published to obtain comments from the public. Part 741, Section 741.11 of the NCUA Rules and Regulations contains a provision that any insured credit union must apply for and receive approval from the regional director before establishing a credit union branch outside the United States unless the foreign branch is located on a United States military institution or embassy outside the United States.
Agency Information Collection Activities: Submission to OMB for Reinstatement of a Previously Approved Information Collection; Comment Request
The NCUA intends to submit the following information collection to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chapter 35). This information collection is published to obtain comments from the public.
Agency Information Collection Activities: Submission to OMB for Reinstatement, With Change, of a Previously Approved Collection; Comment Request
The NCUA intends to submit the following information collection to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. chapter 35). This information collection is published to obtain comments from the public. Part 749 of the NCUA Regulations directs each credit union to have a vital records preservation program that includes procedures for maintaining duplicate vital records at a location far enough from the credit union's offices to avoid the simultaneous loss of both sets of records in the event of a disaster. Part 749 requires a written vital records preservation program that includes a schedule for the storage and destruction of records and emergency contact information for employees, officials, regulatory offices, and vendors used to support vital records.
Gulf of Mexico Fishery Management Council; Public Meeting
The Gulf of Mexico Fishery Management Council (Council) will hold a meeting of the Standing, Special Mackerel and Special Reef Fish Scientific and Statistical Committees (SSC).
Richard C. Theuer; Filing of Food Additive Petition and Citizen Petition
The Food and Drug Administration (FDA or we) is announcing that Richard C. Theuer, Ph.D., has filed a petition proposing that the food additive regulations be amended to prohibit the use of carrageenan and salts of carrageenan in infant formula. In addition, the petitioner has submitted a citizen petition, under FDA regulations, requesting that we amend the generally recognized as safe (GRAS) regulations to prohibit the use of Chondrus extract (carrageenin) in infant formula.
Meeting of the Public Safety Officer Medal of Valor Review Board
This is an announcement of a meeting of the Public Safety Officer Medal of Valor Review Board to review and vote on recommendations for the 2012-2013 Medal of Valor nominations, consider issues relevant to the nomination review process, discuss pending ceremonies and upcoming activities and other relevant Board issues related thereto. The meeting date and time is listed below.
Narcolepsy Public Meeting on Patient-Focused Drug Development
The Food and Drug Administration (FDA) is announcing a public meeting and an opportunity for public comment on Patient-Focused Drug Development for narcolepsy. Patient-Focused Drug Development is part of FDA's performance commitments in the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patients' perspectives on the impact of narcolepsy on daily life as well as the available therapies for narcolepsy.
Privacy Act of 1974; System of Records
The United States Postal Service[supreg] is proposing to modify four General Privacy Act Systems of Records. These updates are being made to account for additional methods that the Postal Service uses to contact applicants, employees, and former employees. Additionally, changes are being made to one record system to include assessments of postal employees and to expand the locations where information from such assessments may be stored. Lastly, changes are being made to another record system pertaining to personnel research to include former Postal Service employees as a category of individuals covered by that system and to modify one of the purposes of the system.
Bracco Diagnostics et al.; Withdrawal of Approval of 52 New Drug Applications and 77 Abbreviated New Drug Applications
The Food and Drug Administration (FDA) is withdrawing approval of 52 new drug applications (NDAs) and 77 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Product Change-Priority Mail Negotiated Service Agreement
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.
Product Change-Priority Mail Negotiated Service Agreement
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.
Drawbridge Operation Regulations; Arthur Kill, NY
The Commander, First Coast Guard District, has issued a temporary deviation from the regulations governing the operation of the Arthur Kill AK Railroad Bridge across Arthur Kill, mile 11.6, between Staten Island, New York and Elizabeth, New Jersey. Under this temporary deviation the bridge may remain in the closed position for four days to facilitate scheduled maintenance. This deviation is necessary to facilitate tie and miter rail replacement on the lift span.
Government-Owned Inventions; Availability for Licensing
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.
Prospective Grant of Exclusive License: Live Attenuated Dengue Tetravalent Vaccine Containing a Common 30 Nucleotide Deletion in the 3'-UTR of Dengue Types 1, 2, 3, and 4
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR Part 404, that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of a an exclusive license to practice the following invention as embodied in the following patent applications: (1) E-120-2001/0, Whitehead et al., ``Development of Mutations Useful for Attenuating Dengue Viruses and Chimeric Dengue Viruses'', European Patent Application Number 02739358.6 (now European Patent Number 1402075, validated in Austria, Belgium, Switzerland/Liechtenstein, Germany, Denmark, Spain, Finland, France, the United Kingdom, Ireland, Italy, the Netherlands, Sweden and Turkey), filed May 22, 2002, United States Patent Application Number 10/719,547 (now U.S. Patent Number 7,226,602), filed November 21, 2003, Canadian Patent Application Number 2448329 (now Canadian Patent Number 2448329), filed May 22, 2002, Australian Patent Application Number 20022312011 (now Australian Patent Number 20022312011), filed May 22, 2002, Australian Patent Application Number 2008203275 (now Australian Patent Number 2008203275), filed May 22, 2002, Australian Patent Application Number 2012200637, filed May 22, 2002, United States Patent Application Number 11/446,050, filed June 2, 2006, now U.S. Patent Number 7,560,118, issued July 14, 2009, United States Patent Application Number 12/396,376 (now United States Patent Number 8,039,003), filed March 2, 2009, United States Patent Application Number 13/240,849, filed September 22, 2011, European Patent Application Number 10181776.5, filed May 22, 2002, European Patent Application Number 10181786.4, filed May 22, 2002, and European Patent Application Number 10181804.5, filed May 22, 2002 (2) E-089-2002/0,1, Whitehead et al., ``Dengue Tetravalent Vaccine Containing a Common 30 Nucleotide Deletion in The 3'-UTR of Dengue Types 1,2,3, And 4, or Antigenic Chimeric Dengue Viruses 1,2,3, And 4'', United States Patent Application Number 10/970,640 (now United States Patent Number 7,517,531), filed October 21, 2004, Canadian Patent Application Number 2483653, filed April 25, 2003, European Patent Application Number 03724319.3 (now European Patent Number 1554301, validated in Austria, Belgium, Bulgaria, Switzerland/Liechtenstein, Estonia, Finland, France, the United Kingdom, Ireland, Iceland, Italy, Lithuania, Malta, the Netherlands, Poland, Portugal, Romania, Sweden, Slovenia, Slovakia, Turkey, Cyprus, Croatia, Czech Republic, Denmark, Germany, Greece, Hungary, Latvia, Luxembourg, and Monaco), filed April 25, 2003, Japanese Patent Application Number 2004-50077, filed April 25, 2003, Australian Patent Application 2003231185 (now Australian Patent Number 2003231185), filed April 25, 2003, United States Patent Application Number 12/398,043 (now United States Patent Number 8,075,903), filed March 4, 2009, United States Patent Application Number 13/305,639, filed November 28, 2011, European Patent Application Number 10177735.7, filed April 25, 2003, and European Patent Application Number 10177740.7, filed April 25, 2003, and (3) E-139-2006/0, Whitehead et al., ``Development of Dengue Vaccine Components'', Australian Patent Application 2007285929, filed August 15, 2007, Canadian Patent Application Number 2661296, filed August 15, 2007, Chinese Patent Application Number 200780031489.4, filed August 15, 2007, European Patent Application Number 07840969.5, filed August 15, 2007, United States Patent Application Number 12/376,756 (now U.S. Patent Number 8,337,860), filed February 6, 2009, and United States Patent Application Number 13/692,557, filed December 3, 2012 to Merck Sharp & Dohme Corp., having a place of business in Whitehouse Station, New Jersey, U.S.A. The patent rights in this invention have been assigned to the United States of America.
Grosvenor Alternative Funds Master Trust, et al.; Notice of Application
Summary of Application: Applicants request an order that would permit them to enter into and materially amend subadvisory agreements without shareholder approval and would grant relief from certain disclosure requirements. Applicants: Grosvenor Alternative Funds Master Trust (``Master Trust''), Grosvenor Alternative Funds (``GAF Trust''), and Grosvenor Capital Management, L.P. (the ``Initial Adviser'') (collectively, ``Applicants'').
Safety Zone; Maritime Heritage Festival Fireworks, St. Helens, OR
The Coast Guard is establishing a safety zone in St. Helens, OR. This safety zone is necessary to help ensure the safety of the maritime public during a planned fireworks display and will do so by prohibiting unauthorized persons and vessels from entering the safety zone unless authorized by the Sector Columbia River Captain of the Port or his designated representatives.
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